Foley Hoag - Healthcare

Wed, 12 Sep 2007 21:02:22 EDT

Have been involved in drafting many important pieces of health legislation over the past decade, including 1997 Food and Drug Administration Modernization Act, Orphan Drug Act, Health Insurance Portability and Accountability Act of 1996 and other comprehensive healthcare reform legislation, and legislation involving specific changes to Medicare and Medicaid law

Healthcare Compliance and Investigations

Wed, 12 Sep 2007 21:02:22 EDT

On behalf of our client, we made the first voluntary disclosure of Medicare over-billing in New England under the Office of Inspector General’s voluntary disclosure protocol. We negotiated the related settlement agreement, as well as an innovative corporate integrity agreement. As a result, we avoided lengthy litigation that could have led to our client being barred from participation in the Medicare program.

Healthcare Compliance and Investigations

Wed, 12 Sep 2007 21:02:22 EDT

Represented an individual who was the target of a federal grand jury investigation. The matter involved allegations that he and his company paid illegal kickbacks to physicians to encourage the purchase of kidney dialysis supplies. We successfully prevented charges from being brought against him.

Healthcare Compliance and Investigations

Wed, 12 Sep 2007 21:02:22 EDT

Represented physician groups under investigation as part of the Office of Inspector General’s national Physicians at Teaching Hospitals (“PATH”) audit initiative

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

Involved in the reauthorization of pediatric drug exclusivity provisions. These provisions require drug companies to perform pediatric testing and labeling on new products, but they also grant manufacturers a six-month patent extension for pediatric labeling.

Wed, 12 Sep 2007 11:27:19 EDT

Legislative Representation: Represented leading pharmaceutical and biotech companies in connection with the Medicare Prescription Drug, Improvement and Modernization Act of 2003. We now advise companies on implementation of the act.

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

Represented clients on issues related to drug pricing and reform of the Average Wholesale Price (AWP) for drugs

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

In connection with the reauthorization of the Prescription Drug User Fee Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act, we represented several leading pharmaceutical and biotechnology companies and industry trade associations

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

Involved in legislation relating to competitive bidding for certain durable medical equipment

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

Represented companies under the Orphan Drug Act. This act is credited with giving rise to the biotech industry through its provision of seven years of marketing exclusivity to the companies that develop drugs or biologics for patients with rare diseases

Legislative Representation

Wed, 12 Sep 2007 21:02:22 EDT

Involved in issues related to “Hatch-Waxman” patent term issues

Healthcare Compliance and Investigations

Wed, 12 Sep 2007 21:02:22 EDT

Drafted the compliance policies of a physician practice at a major teaching hospital and advised that practice on the establishment of its compliance program

On the Agenda: Law and the Environment, Financing Growth, and Non-Competes—Foley Hoag Launches Three New Blogs

Tue, 03 Nov 2009 14:48:13 EDT

Today Foley Hoag LLP is pleased to announce the launch of three new blogs, designed and created as a forum to discuss pressing issues in today’s marketplace. The firm is pleased to present the Law and the Environment Blog, the Massachusetts Noncompete Law Blog, and the Emerging Enterprise Center Blog.

The blogs are primarily managed by three Foley Hoag partners, Seth Jaffe, Mike Rosen, and Dave Broadwin, respectively, and grown out of conversations addressing some of the most pressing issues of the day.

The blogs are available at:

Emerging Enterprise Center Blog - http://www.emergingenterprisecenterblog.com
Law and the Environment - http://www.lawandenvironment.com
Massachusetts Noncompete Law - http://www.massachusettsnoncompetelaw.com

Foley Hoag Welcomes Susie Ahn, Health Policy Specialist

Tue, 03 Nov 2009 14:48:17 EDT

Bolstering a team of experienced life sciences specialists in the Government Strategies practice, law firm Foley Hoag LLP announced the arrival of Susie Ahn, former Director of Federal Government Relations for the Washington, DC-based Biotechnology Industry Organization (BIO).

Foley Hoag Congratulates Rising Stars

Wed, 26 Sep 2007 16:48:53 EDT

Foley Hoag congratulates 29 lawyers in the firm who were recently named to the 2007 list of Massachusetts Super Lawyers: Rising Stars. Rising Stars are lawyers in practice up to ten years and/or under 40 years of age. The group is nominated by the current roster of Massachusetts Super Lawyers and then voted on by the publishers of Law & Politics.

Working Mother and Flex-Time Lawyers Recognize Foley Hoag

Tue, 03 Nov 2009 14:48:17 EDT

Working Mother magazine, a leading source of information for career-oriented mothers, and Flex-Time Lawyers LLC, a national consulting firm advising attorneys and legal employers on work/life balance, have included Foley Hoag LLP in the prestigious list of the 50 “Best Law Firms for Women.”

Foley Hoag Lawyers in Chambers USA 2010

Wed, 16 Jun 2010 10:49:44 EDT

Foley Hoag lawyers and practice areas retain a number of top rankings in Chambers and Partners, a leading U.K.-based research and publishing company, has ranked Foley Hoag lawyers and practice areas in its 2010 guide. A total of 26 lawyers are ranked in the following practice areas for Massachusetts: Antitrust, Banking & Finance, Bankrupcty/Restructuring, Corporate/M&A, Environment, Health Care, Hedge & Mutual Funds, Intellectual Property, Labor & Employment, Litigation: General Commercial, Litigation: White Collar Crime & Government Investigations, Private Equity: Venture Capital Investment. The International Arbitration practice is ranked nationally.

Foley Hoag Files Amicus Brief for Biotechnology Industry Organization

Tue, 03 Nov 2009 14:48:11 EDT

Lawyers in Foley Hoag’s Intellectual Property Group prepared an amicus brief on behalf of its client, the Biotechnology Industry Organization (BIO), submitted today to the U.S. Court of Appeals for the Federal Circuit in the Amgen v. Hoffmann-LaRoche appeal.

Cramer Completes Launch of FoleyHoag.com

Fri, 16 Nov 2007 11:11:30 EDT

The original version of this release is available here: http://www.crameronline.com/news/10302007.html

Cramer, a digital marketing and event solutions agency, announced today that the company has completed the reintroduction of Foley Hoag’s web site, www.foleyhoag.com. The new site supplements Foley Hoag’s recently launched identity and advertising campaign, featuring the tagline “Driving Business Advantage.” The cross-media campaign expands the firm’s brand by highlighting Foley Hoag’s expertise in a number of key legal practice areas including dispute resolution and intellectual property, as well as depth in the life sciences and technology industries.

Foley Hoag Represents Ecuador in Suit against Colombia, Seeking to Stop Aerial Coca Spraying That Has Dispersed into Ecuador, Sickening Villagers and Livestock, Damaging Croplands and Poisoning Ecosystems

Tue, 01 Sep 2009 10:26:16 EDT

The Republic of Ecuador has filed suit at the International Court of Justice in The Hague, the Netherlands, against the government of Colombia, in an effort to stop or restrict aerial anti-coca spraying that has allegedly sickened people on the Ecuadorean side of the border and harmed livestock, farmland, and sensitive, ecologically diverse jungle areas.

Kelly Childress Joins Foley Hoag's Government Strategies Group

Tue, 03 Nov 2009 14:48:16 EDT

Adding to the team of life sciences specialists in the Government Strategies practice, law firm Foley Hoag LLP welcomes Kelly Childress, most recently the Health Policy Advisor to Congressman Mike Rogers of Michigan.

Kelly joins as a Health Policy Specialist, adding to a nationally recognized team of legislative and regulatory professionals working with biotechnology, pharmaceutical and medical device companies.

Bruce Quinn, MD, PhD Joins the Foley Hoag Government Strategies Practice as Health Policy Specialist

Tue, 03 Nov 2009 14:48:15 EDT

Foley Hoag LLP is pleased to announce that Bruce Quinn, M.D., Ph.D., MBA, formerly the Contractor Medical Director for the California Medicare Part B program, has joined the firm’s Government Strategies practice. Dr. Quinn joins the practice as Senior Health Policy Specialist, where he will focus on Medicare coverage and payment matters for new technologies.

The New "Gift Ban" Statute in Massachusetts: a Primer on Compliance and Enforcement

Thu, 29 Oct 2009 13:30:51 EDT

Speaking to in-house counsel, compliance and marketing executives from pharmaceutical and medical device companies, lawyers from Foley Hoag LLP recently offered a primer on Massachusetts’ recently-enacted Pharmaceutical and Medical Device Manufacturer Conduct Rules, commonly known as the “Gift Ban Statute.”

Foley Hoag LLP Represents Inverness in Acquisition of Cholestech Corp.

Wed, 26 Sep 2007 16:48:54 EDT

Foley Hoag LLP recently represented Inverness Medical Innovations Inc. in its widely-reported acquisition of healthcare diagnostic tools provider Cholestech Corp. Inverness Medical Innovations, Inc. is a major global developer, manufacturer and marketer of advanced, pioneering consumer and professional medical diagnostic products.

Terms and Trends in University Patent License Agreements Released by Foley Hoag

Wed, 26 Sep 2007 16:48:54 EDT

Foley Hoag LLP today announced at BIO 2007 preliminary results of its survey, Terms and Trends in Patent License Agreements with Universities and Other Research Institutions. As a service to the life sciences industry, Foley Hoag surveyed biotechnology companies, universities and other research institutions to identify trends and gauge the "market" for specific terms in license agreements.

Foley Hoag Names New Chairs of Intellectual Property Group

Wed, 26 Sep 2007 16:48:53 EDT

Foley Hoag LLP announced that well-known patent litigator Donald R. Ware became chair of the firm's expanded Intellectual Property Group and Dana Gordon, a registered patent attorney and scientist, became deputy chair.

Foley Hoag Launches Second Annual "Terms and Trends in Patent License Agreements" Survey

Thu, 22 Jan 2009 12:57:14 EDT

Foley Hoag LLP’s Life Sciences practice recently launched its second Terms and Trends in Patent Licensing Agreements survey for 2008. As a service to the life sciences industry, the survey will again explore the forces, dynamics, and trends driving licensing deals between academic and private research institutions and the companies seeking to commercialize their discoveries.

Pending response rates, the survey results will be initially announced at BIO 2008 in San Diego, with a formal close of the survey to be announced at a later date. To complete the survey click here, contact Natalie Shaw at 617-832-7102 or visit Foley Hoag at BIO 2008, booth 3213.

Foley Hoag’s Life Sciences Practice provides a full range of services including patent litigation, prosecution and strategy; corporate finance and securities; mergers, acquisitions and strategic alliances; FDA and reimbursement; government strategies; venture capital and emerging companies, and product liability and complex tort.

Foley Hoag Names Three New Partners

Tue, 03 Nov 2009 14:48:11 EDT

Foley Hoag LLP is pleased to announce three lawyers were recently promoted to Partner.

Human Rights Campaign Releases Corporate Equality Index, Names Foley Hoag Among Top Firms for Second Consecutive Year

Fri, 13 Mar 2009 12:36:22 EDT

The Human Rights Campaign Foundation, the educational arm of the Human Rights Campaign, released its 2008 Corporate Equality Index ranking Foley Hoag LLP among the nation’s top employers for the gay, lesbian, bisexual and transgender employees, consumers and investors.

Foley Hoag Lawyers Included in Massachusetts Super Lawyers 2006

Mon, 06 Apr 2009 10:43:42 EDT

Forty-three lawyers at Foley Hoag LLP were recently named to the Massachusetts Super Lawyers 2006 list. In addition, three partners - Seth Jaffe, Michael Keating, and Nicholas Theodorou - were included in the "Top 100" list. Lisa Wood, also a Foley Hoag partner, appears on the "Top 50 Women" list.

Medicare Regulatory Attorney Jayson Slotnik Joins Foley Hoag's Life Sciences Practice

Wed, 02 Dec 2009 14:56:40 EDT

Adding to its leading team of life sciences regulatory attorneys and policy specialists, Foley Hoag LLP announced that Jayson Slotnik, a former director of Medicare and Medicaid reimbursements at the Biotechnology Industry Organization, has joined the firm’s Government Strategies practice in Washington, DC.

Now’s the Time:
Foley Hoag Forms Economic Crisis Team

Fri, 13 Mar 2009 17:33:55 EDT

Stepping up on behalf of clients buffeted by the ongoing financial crisis, law firm Foley Hoag has formed an Economic Crisis Team, comprised of lawyers from multiple practices focused on helping companies cope with the fast-changing landscape – from internal investigations and enforcement proceedings, to increased regulatory compliance, securities and other types of litigation, bankruptcies and restructurings, as well as emergency financing and deal-making.

Hot Topics, Legal Insight and Industry Trends: Foley Hoag Newsroom Enhanced with Video Launches at BIO 2009

Thu, 03 Dec 2009 12:09:09 EDT

The law firm Foley Hoag LLP unveils the Foley Hoag Newsroom today at BIO 2009. The enhanced newsroom, found at foleyhoagnewsroom.com, offers timely industry insights in digital and print format from lawyers at the firm focused on the life sciences industry.

Foley Hoag LLP to present at CBI’s Forum on Effective Patent, IP and Trademark Strategies for the Bio/Pharmaceutical and Medical Device Industries

Mon, 22 Oct 2007 14:08:21 EDT

The Center for Business Intelligence is pleased to announce that Foley Hoag LLP will be presenting a session at the Forum on Effective Patent, IP and Trademark Strategies for the Bio/Pharmaceutical and Medical Device Industries

Foley Hoag Launches Healthcare Law and Policy Blog

Thu, 17 Jun 2010 09:11:44 EDT

Eight lawyers from Foley Hoag’s Government Strategies practice have launched the Healthcare Law and Policy Blog, a timely resource focusing on regulatory issues, Medicare coverage and reimbursement, healthcare compliance and investigations, legislative representation, physician practice issues and health information, privacy and security in the healthcare and life sciences industries.

Global Bio-Chem Technology Group Company Limited, Foley Hoag LLP, and Adduci, Mastriani & Schaumberg LLP Prevail in International Trade Commission Patent Infringement Investigation

Thu, 07 Aug 2008 10:30:37 EDT

Global Bio-Chem Technology Group Company Limited and its affiliates (GBT), the largest lysine producer in China and the largest vertically integrated corn-based biochemical manufacturer in Asia, has prevailed after an evidentiary hearing before the United States International Trade Commission (USITC) in a patent infringement investigation brought by Ajinomoto Heartland LLC and Ajinomoto Co., Inc. (Ajinomoto). In today’s ruling, the Administrative Law Judge (ALJ) held that the claims of Ajinomoto’s two patents were invalid for failure to disclose the best mode of practicing the invention, thus finding no violation of Section 337 of the Tariff Act of 1930. The ALJ also ruled that both patents were unenforceable because Ajinomoto had committed inequitable conduct. The law firms Foley Hoag LLP, Adduci, Mastriani & Schaumberg LLP and East Associates represent GBT in the investigation.

Li Weigang, Assistant General Manager of Global Bio-Chem Technology Group Company Limited, said, “We are pleased that the ALJ has determined that there was no violation of Section 337. Today’s ruling maintains continued competition in the marketplace, which will benefit American consumers during this time of rising food prices.”

Foley Hoag Continues Expansion of Government Strategies Group with Addition of Lindsey Toohey

Wed, 06 May 2009 16:44:38 EDT

Bolstering a team of experienced life sciences specialists in the Government Strategies practice, law firm Foley Hoag LLP announced the arrival of Lindsey Toohey as Health Policy Specialist. Ms. Toohey was formerly Senior Health Policy Advisor to Senator Kent Conrad, Chairman of the Senate Committee on the Budget.

Foley Hoag Partner Dean Richlin Admitted to American College of Trial Lawyers

Wed, 15 Oct 2008 12:59:09 EDT

Foley Hoag LLP congratulates Dean Richlin, Partner and Co-Chair of the Litigation Department, for becoming a Fellow of the American College of Trial Lawyers, one of the premier legal associations in America.

Foley Hoag Selected as one of 2008 Top 100 Law Firms for Diversity

Tue, 03 Nov 2009 14:48:15 EDT

Multicultural Law addresses diversity in the legal profession by encompassing power, leadership, and integrity. Multicultural Law is a breath of fresh air for the legal community. Our readers are accomplished lawyers in need of advice, information, and motivation that Multicultural Law provides.

Multicultural Law is in its third year and has a circulation of over 40,000 professionals in the legal community. Distribution includes a variety of legal organizations, such as the National Bar Association, National Asian Pacific American Bar Association, and the National Hispanic Bar Association. Multicultural Law is mailed to every fortune 500 and 1000 General Counsel Office and ABA Accredited Law School Career Office.

An alphabetical listing of The Top 100 Law Firms for Diversity is available at www.multiculturallaw.com.

Foley Hoag Launches New Identity and Integrated Marketing Campaign

Sat, 22 Sep 2007 15:17:14 EDT

Law firm Foley Hoag LLP has introduced an ambitious new identity and advertising campaign, highlighting its leading dispute resolution and intellectual property practices and its depth in life sciences and technology. Featuring the tagline “Driving Business Advantage,” Foley Hoag’s new platform is designed to bypass conventional law firm messaging to address client demands from their legal advisors for fresh thinking and a keen understanding of client business needs.

The creative centerpiece of the campaign is a series of ads featuring images by noted fashion photographer Rodney Smith, whose work has appeared in New York Magazine and The New York Times Magazine. Instead of touting case wins or deals completed, the ads – comprised of arresting black-and-white images of formally dressed men and women in unlikely settings – are meant to provoke business people to stop and consider how they view big-picture challenges and plot their paths to success.

Foley Hoag's Young Lawyers 'Rising' To The Top

Fri, 28 Sep 2007 14:59:17 EDT

Known for its adherence to excellence in lawyering, Foley Hoag LLP's longstanding tradition of recruiting the best legal minds is evidenced in the 2005 edition of SUPER LAWYERS' MASSACHUSETTS RISING STARS: A COMPREHENSIVE LISTING OF THE BEST YOUNG LAWYERS IN MASSACHUSETTS.

Foley Hoag Names New Partners

Thu, 29 Oct 2009 13:30:48 EDT

Foley Hoag LLP is pleased to announce four promotions to Partner, effective January 1.

Cynthia Lewiton Jackson, Former Global Director of Career Development at Bain & Company, Joins Foley Hoag

Tue, 27 Jan 2009 09:34:23 EDT

Cynthia Lewiton Jackson, former Global Director of Career Development at Bain & Company, has joined the law firm Foley Hoag LLP as its first Director of Professional Development. In this role, Ms. Jackson will be responsible for developing and implementing a firmwide career development program for its lawyers and staff.

Barrett Thornhill Joins Foley Hoag's Government Strategies Group

Tue, 06 Nov 2007 17:23:40 EDT

Adding to the team of life sciences specialists in the Government Strategies practice, law firm Foley Hoag LLP announces that Barrett Thornhill, former Director of Federal Government Relations at the Biotechnology Industry Organization (BIO) has joined the firm’s Washington office as a Health Policy Specialist.

Two Foley Hoag Lawyers Recognized by Washingtonian Magazine as Area's Best Lawyers

Thu, 29 Nov 2007 16:18:11 EDT

Two Foley Hoag lawyers, Paul Reichler and Paul Kim, were recently lauded by Washingtonian magazine in their annual “Best Of” issue. The article cites the top 1% of lawyers in the Washington, D.C. areas in 28 specialties. Paul Reichler was noted for international work and Paul Kim for his FDA experience.

Foley Hoag Partner Colin Zick Nominated to North American Regional Vice Chair of the Health Care Industries Practice Group of Lex Mundi

Thu, 29 Oct 2009 13:30:49 EDT

Foley Hoag congratulates Colin Zick, a partner in the Boston office, on his recent nomination to North American Regional Vice Chair of the Health Care Industries Practice Group of Lex Mundi, a global network of independent law firms. He will serve in the role for a four-year term, 2009-2013.

Thomas Barker, Former General Counsel of the U.S. Dept. of Health & Human Services, Joins Foley Hoag’s Washington Office

Fri, 02 Apr 2010 10:47:40 EDT

Foley Hoag LLP announced that Thomas Barker, the former acting General Counsel at the Department of Health and Human Services (HHS) and a legislative veteran who has worked on health care policy issues on both sides of the aisle, has joined the firm as a partner in its Healthcare and Life Sciences practices.

Live @ BIO 2008: Innovation, Commercialization, and Protecting Assets

Tue, 03 Nov 2009 14:48:14 EDT

Foley Hoag LLP released a snapshot of key legal, business, and regulatory issues facing the life sciences industry at the BIO 2008 conference in San Diego. Partners serving a variety of areas, from patent prosecution and strategy to corporate/finance, FDA/regulatory and litigation offer emerging and established companies in the life sciences industry with a roadmap of how to navigate some of the pressing issues facing this highly competitive sector.

Foley Hoag Selected as one of 2007 Top 100 Law Firms for Diversity

Wed, 26 Sep 2007 16:48:52 EDT

Foley Hoag LLP has been selected as one of Multicultural Law’s 2007 Top 100 Law Firms for Diversity.

Foley Hoag Government Strategies Practice Gears up for 2009 Activity

Thu, 29 Oct 2009 13:30:49 EDT

Anticipating the rollout of the nearly $800 billion Stimulus Package making its way through Congress, several practices at Foley Hoag LLP have formed an interdisciplinary team to assist clients seeking advice on securing funding for capital projects and growth initiatives. Those practices include Energy Technology & Renewables, Environment, Government Strategies, Infrastructure & Privatization and Life Sciences practices.

Massachusetts Governor Deval Patrick has traveled to Washington recently, lobbying for federal funding for areas such as transportation and infrastructure, life sciences initiatives and clean technology/environmental initiatives. All areas are expected to be active in 2009 and will provide much of the region’s growth and activity.

Foley Hoag Joins American Lawyer's Select Group of Top 50 A-List Firms

Tue, 03 Nov 2009 14:48:13 EDT

The American Lawyer named Foley Hoag LLP to its annual “A-List” of the country’s 50 elite law firms that are "best at balancing a thriving business with their obligations to the profession." Inclusion in the A-List is based not only on economic success but also on success in furthering diversity, pro bono work, and associate satisfaction.

EEC Perspectives - January 2009

Mon, 02 Nov 2009 12:07:54 EDT

Included in this Issue:

A Market Perspective by Carl Stjernfeldt
Selected New England “Series A” Round Transactions - Third Quarter 2008
Commentary from John Hancock
Terms of Selected New England "Series A" Rounds 2008
Commentary from Alex Aber
The Activity Level Summary: New England "Series A" and First Round Transactions by Industry
National "Series A" and First Round Transactions by Industry
Size of New England 2008 Year to Date "Series A" and First Round Transactions by Industry
Commentary from Dave Broadwin

Qui Tam? Now More Plaintiffs Will Qualify

Wed, 07 Apr 2010 15:33:16 EDT

An important mechanism for bringing suit against healthcare providers and pharmaceutical and medical device companies – the Qui Tam Action – has been expanded as part of the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) (the "PPACA").

Supreme Judicial Court Extends Anti-Discrimination Laws to Small Businesses

Wed, 29 Oct 2008 12:47:50 EDT

Chapter 151B, the Massachusetts anti-discrimination statute, does not apply to small employers, meaning those with fewer than six employees. However, last Friday, the Massachusetts Supreme Judicial Court (“SJC”) held that an employee may nonetheless sue a small employer for discrimination under the Massachusetts Equal Rights Act. The decision has potential ramifications for all employers -- large or small -- because it suggests that a plaintiff has a claim for discrimination under the Massachusetts Equal Rights Act whenever Chapter 151B does not apply, such as discrimination claims brought by non-employees.

Labor & Employment Datasheet

Fri, 21 Dec 2007 11:29:21 EDT

Succeeding in today’s highly-complex marketplace requires paying particular attention to labor and employment issues. Our long-standing strength in representing employers in labor relations and employment litigation defense issues is complemented by our experience in dealing with the emerging issues confronting employers in the 21st century.

Our goal is to provide pragmatic business advice and a cost-effective approach aimed at helping you achieve results.

We handle a wide variety of issues facing our clients each day. Some of these matters include:

Attempts to seek class-wide relief in wage-and-hour and other actions
Efforts by unions to obtain neutrality and card-check agreements
Increased efforts to control employment litigation costs through alternative dispute resolution, particularly arbitration
Enforcement of non-competition agreements and protection of trade secrets
Sarbanes-Oxley investigations
Claims for stock options and other employment benefits
Providing advice on numerous issues arising from the National Labor Relations Act and various state labor law
Assisting clients in collective bargaining matters
Representing employers before the National Labor Relations Board
Handling grievance and interest arbitrations arising under collective bargaining agreements
Helping employers preserve their non-union status in the face of organizing campaigns
Assisting employers in obtaining the appropriate bargaining units during a union election

A Reversal of Medtronic v. Riegel? A Legislative Update on Liability Against Medical Device Companies

Fri, 10 Apr 2009 11:00:34 EDT

On March 5, 2009, both the House and the Senate proposed legislation amending the Federal Food, Drug, and Cosmetic Act to reverse the 2008 Supreme Court decision in Medtronic v. Riegel H.R. 1346; S. 540. The law, if passed, would permit plaintiffs to bring state law liability suits against medical device companies with respect to devices approved by the federal Food and Drug Administration ("the FDA") under the premarket approval ("PMA") process, a longer, more complicated evaluation process undertaken by the FDA in approving a device.

Health Care Compliance Update - March 2, 2006

Mon, 20 Jul 2009 11:15:14 EDT

In This Issue:

Federal Regulations Proposed to Govern Donations of Electronic Health Record Technology to Physicians
Deficit Reduction Act of 2005 Adds to Compliance Obligations of Providers
OIG Creates Opportunity for Patient Assistance Programs in Part D
Brigham & Women’s Hospital Faxes Patient Records to Bank; Don’t Let This Happen to You!
Peer Review Privilege Limited By Massachusetts Courts
Failed Gene Therapy Study Gives Rise to Action Under Massachusetts Law
Misrepresenting Fees Result in Consumer Protection Law Violation
Mental Health Counselor Sentenced in Medicare Fraud Case

Medicare Authorities To Reduce Payment for Covered Items or Services

Fri, 09 Jul 2010 16:53:23 EDT

This chart shows a side-by-side comparison of Least Costly Alternatives, Inherent Reasonableness, and Functional Equivalence.

Obama Administration Issues Final 2010 Call Letter for Medicare Advantage Organizations

Thu, 09 Apr 2009 15:11:28 EDT

On March 30, 2009, the Centers for Medicare & Medicaid Services (CMS) issued its 2010 Call Letter for Medicare Advantage (MA) organizations (MAOs) and Part D plans. The purpose of the annual Call Letter is to provide information that will help Medicare Advantage organizations, contractors, and prescription drug plan (PDP) sponsors prepare their bids for the upcoming contract year. Bids are due in to CMS on June 1, 2009.

[continues...]

Doing Business in Massachusetts

Wed, 17 Mar 2010 16:34:47 EDT

This guide is intended to provide foreign businesspeople with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States, and particularly in the Commonwealth of Massachusetts. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as by direct regulation.

FDA Acknowledges Deviations in Menaflex Knee Device Clearance

Mon, 02 Nov 2009 12:08:27 EDT

In an unusual “preliminary report” released yesterday, the Food and Drug Administration (FDA) admitted to “multiple departures from processes, procedures, and practices” in the 510(k) clearance of ReGen Biologics’ Menaflex knee repair implant, which “leave[s] the basis for a review decision in question.” The report, authored by FDA Acting Chief Counsel Michael Landa, Acting Chief Scientist Jesse Goodman, and Associate Commissioner for Policy and Planning Jeffrey Shuren, recommends an independent science-based reevaluation of the Menaflex 510(k) clearance decision.

Uniform Prudent Management of Institutional Funds Act Liberalizes Endowment Spending and Clarifies Investment Standards for Charitable Institutions

Thu, 16 Jul 2009 17:37:34 EDT

Massachusetts recently joined 39 other states and the District of Columbia by enacting a version of the Uniform Prudent Management of Institutional Funds Act (UPMIFA). Most notably, and in contrast to prior law, UPMIFA permits Massachusetts institutions that hold funds exclusively for charitable purposes to tap into endowment funds whose values have depreciated below their “historic dollar values” (i.e., “underwater” endowment funds). The new law, which is effective as of June 30, 2009, also applies to funds held by a trustee for a charitable community trust.

The H1N1 Influenza (Swine Flu) Outbreak: HHS Emergency Authorities to Respond

Fri, 01 May 2009 09:58:14 EDT

The recent outbreak of H1N1 influenza virus, or swine flu, in the United States and across the world has prompted the United States government to respond in several ways, including through the use of some of the post-9/11 statutory enactments. It is possible that the HHS Secretary will invoke additional waivers available to her as a result of this outbreak. This memorandum analyzes the statutory authorities available to the Secretary, the means by which they can be triggered, and historical precedent.

Intellectual Property Brochure

Mon, 02 Nov 2009 12:08:24 EDT

To succeed in today’s technology-driven world, every companymust maximize the strategic value of its intellectual property.At Foley Hoag, we use our technical expertise and deepexperience to enhance the power of your technology globally.Claims to exclusive ownership of a process, design or productraise complex issues. In today’s global marketplace, conflictshave increased—making intellectual property managementa top priority for successful companies. We will help you:

Implement a strategy to protect and expand your intellectual property assets
Proactively protect your assets to keep your success on track
Evaluate the validity of conflicting claims, and if necessary, take action to defeat those claims
Resolve conflicts through commercial agreements

We can help you manage your current intellectual property assetsand build value for your new technologies or other inventions.Our intellectual property lawyers have earned a reputation forcreatively handling the full range of intellectual property, includingpatent, trademark, copyright, trade secrets, due diligence, andlitigation throughout the United States and internationally for largeand small businesses, universities, individuals, venture capitalfirms and institutional investors.

Health Care Compliance Update - Spring 2005

Mon, 20 Jul 2009 11:15:13 EDT

In this issue:

Federal Subpoenas Issued to Medical Device Manufacturers
Massachusetts Court Finds a Cause of Action for Unauthorized Disclosure of Health Records
Court Applies Massachusetts Healthcare Whistleblower Statute
Medical Group Information Made More Accessible by CMS
Massachusetts High Court Upholds Damages for Physician Who Claimed Defamation by Boston Globe
CMS Plans to Pay Auditors’ Share of Overpayments
HIPAA News:
- CMS Issues HIPAA Privacy Enforcement Procedures
- HHS Issues Proposed Rule On HIPAA Enforcement
- HHS Issues Letter Regarding Disclosure of Health Information by Professional Liability Insurer

Medical Device Tax Provisions in Health Care Reform Legislation

Thu, 25 Mar 2010 13:23:35 EDT

The Patient Protection and Affordable Care Act of 2009 (Pub. L. No. 111-148),¹ which President Obama signed into law on March 23, 2010 imposes an annual fee on medical device manufacturers and importers. The “Health Care and Education Affordability Reconciliation Act of 2010” (H.R. 4872, or the “Reconciliation Package”) ², as revised by the amendment reported to the Reconciliation Package on March 20, 2010, and passed by the House of Representatives on March 21, 2010,³would impose an excise tax on medical device manufacturers. Below we provide an overview of these provisions, which are found in Section 9009 of Pub. L. No. 111-148 and Section 1405 of the Reconciliation Package, and how the two provisions differ. [continues...]

Jump-Starting Biomedical Research and Development: The New Therapeutic Tax Credit and Cash Grant Program

Fri, 30 Apr 2010 12:18:45 EDT

The Qualifying Therapeutic Discovery Project Tax Credit program was created by the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148. This new, and temporary, program will be a valuable tool to incentivize industry to develop cutting edge drugs, diagnostics, biologics, and medical devices. [continues... ]

Five Common Employment Law Hazards for Start-Ups

Thu, 29 Apr 2010 13:09:25 EDT

Contents

1. Exposure to Liability in the Hiring Process

2. Failure to Adequately Document Terms and Conditions of Employment

3. Misclassification Issues
- Employee or Independent Contractor
- Exempt or Non-exempt

4. Failure to Comply with Wage Payment Laws

5. Inadequate Protection of Intellectual Property

Life Sciences Opportunities for NIH Recovery Act Funding

Mon, 02 Nov 2009 12:08:26 EDT

The passage of the American Recovery and Reinvestment Act of 2009 provides enormous opportunities for biomedical research and the life sciences industry. The National Institutes of Health (NIH) received $10.4 billion in the Recovery Act, the majority of which will be used to either fund R01 applications that were reviewed last year and which scored well, but weren't funded, or to award supplements for existing NIH grants. However, the NIH has published notices announcing two excellent opportunities to obtain Recovery Act funding for new scientific projects.

FDA Recommends Actions to Improve Oversight of Medical Devices

Thu, 05 Aug 2010 14:35:33 EDT

On Wednesday, August 4, 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released for public comment two preliminary reports recommending steps to: (1) foster medical device innovation; (2) enhance regulatory predictability; and (3) improve patient safety. According to CDRH Director Jeffrey Shuren, MD, JD, the actions proposed in the reports represent “a blueprint for smarter medical device oversight” and are intended to advance CDRH’s responsibility to both protect and promote public health. The reports were prepared by two separate internal groups within CDRH, both convened in September 2009. [continues... ]

Product Liability Update - May 22, 2009

Thu, 11 Mar 2010 08:31:43 EDT

Foley Hoag LLP publishes this quarterly Update concerning developments in Product Liability and related law of interest to product manufacturers and sellers.

Included In This Update:

United States Supreme Court Holds State Law Failure-to-Warn Claims Involving Prescription Drugs Not Preempted by FDA Approval of Warnings Absent Clear Evidence FDA Would Have Rejected Plaintiff’s Proposed Warning
First Circuit Holds Class Action Fairness Act Requires Removing Defendant To Demonstrate “Reasonable Probability” That Amount In Controversy Exceeds $5 Million
First Circuit Holds “Home State” Exception to Federal Jurisdiction Under Class Action Fairness Act Does Not Require Consideration of Citizenship of Class Members in Other Class Actions Arising Out of Same Factual Nucleus
Massachusetts Supreme Judicial Court Holds “Light” Cigarettes Class Action Not Preempted by Cigarette Labeling and Advertising Act Based on United States Supreme Court Ruling, Not Subject to Chapter 93A Because FTC Consent Decree Did Not Affirmatively Permit Defendant’s Statement
Massachusetts Federal District Court Dismisses Putative Class Action Against Manufacturer of Recalled Heartworm Medication Based on Economic Loss Rule and Plaintiff’s Inability to Show Compensable Loss Where She Received Product’s Expected Benefit

For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.

Awaiting Further Guidance from CMS, Hospitals Seeking to Craft On-Call Physician Compensation Policies May Look to OIG Advisory Opinion for Guidance

Fri, 24 Jul 2009 11:42:38 EDT

In a recent opinion issued by the Health and Human Services (HHS) Office of Inspector General (OIG) on May 14, 2009, Advisory Opinion No. 09-05 [.pdf], the OIG concluded that there are circumstances under which a hospital may compensate physicians for taking on-call coverage in the emergency department without running afoul of the federal Anti-Kickback statute. The OIG’s advisory opinion enters a space that has not yet been filled with guidance from the Centers for Medicare & Medicaid Services (CMS). Although OIG Advisory Opinions are written to apply only to the party that requested the opinion, hospitals should be aware of this recent development as it relates to requirements under Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C. §1395dd, and its regulations, at 42 C.F.R. 489.24. [continues...]

Cutting-Edge Research and Development Receives Boost from Health Care Reform: An Overview of the Cures Acceleration Network

Fri, 30 Apr 2010 16:02:30 EDT

As provisions of the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148 are implemented to expand coverage and improve the quality of health care, it is important for the health care industry to be aware of another provision in PPACA – the Cures Acceleration Network, which will be a valuable tool to fund the development of cutting edge drugs, diagnostics, biologics, and medical devices. [continues... ]

May 15 Deadline for Filing IRS Form 990-N

Wed, 13 May 2009 17:24:26 EDT

As a result of a new requirement first implemented in 2008, tax-exempt organizations with gross receipts of $25,000 or less may be required to file IRS Form 990-N, the “e-Postcard.” The e-Postcard must be filed no later than the 15th day of the fifth month following the end of the organization's tax year. For example, an organization whose tax year ends December 31 must submit the e-Postcard by the following May 15.

Massachusetts Issues Comprehensive Data Security Regulations

Fri, 17 Oct 2008 14:38:34 EDT

Last year, in the wake of the TJ Maxx data security breach, Massachusetts enacted a data security law intended to protect residents from identity theft. The law provides that businesses must provide prompt notice of security breaches relating to personal information. “Personal information” means a person’s name together with either his or her Social Security Number, driver’s license number, state identification number, financial account number, credit card number or debit card number. Because all employers hold their employees’ Social Security numbers, the law applies to all employers in Massachusetts, not just those businesses that collect customer information, such as retailers.

Hatch-Waxman Safe Harbor Inapplicable to Research Tools

Wed, 06 Aug 2008 16:02:27 EDT

In a decision that will have far reaching implications for drug and medical device development, the Court of Appeals for the Federal Circuit held yesterday that the Hatch-Waxman safe harbor of 35 U.S.C. § 271(e)(1) is inapplicable to patented research tools that are not themselves subject to the FDA review process. While the decision is good news for the providers of research tools such as drug screening assays, it will make drug and medical device development in the United States costlier and more risky.

International Litigation and Arbitration Practice Summary

Tue, 01 Sep 2009 10:32:38 EDT

Engagements Include:

Litigation and Arbitration between Sovereign States
Arbitration between Sovereign States and Investors
International Commercial Arbitration
Litigation before the United States Courts

Foley Hoag Secures ITC Victory

Thu, 21 Aug 2008 10:57:45 EDT

Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company, has prevailed in a patent litigation brought by Ajinomoto Co., Inc in the International Trade Commission.

A Foley Hoag patent litigation team, including Claire Laporte, DeAnn Smith, and Jeremy Younkin, invalidated the asserted claims of two US patents. The Administrative Law Judge of the International Trade Commission also found both patents unenforceable because Ajinomoto committed inequitable conduct.

The decision represents an important victory for the Chinese biotechnology industry. Li Weigang, Assistant General Manager of GBT, said, "We are pleased that the Administrative Law Judge has determined there was no violation of Section 337. This ruling maintains continued competition in the marketplace, which will benefit American consumers during this time of rising food prices."

The Washington, DC firm Adduci, Mastriani & Schaumberg LLP are co-counsel with Foley Hoag LLP.

The full Press Release is available here.

Biosimilars Pathway Enacted

Wed, 24 Mar 2010 19:10:41 EDT

On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this legislation. Included therein is a provision (Section7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated biological license application (ABLA) submitted to the Food and Drug Administration (FDA).

Massachusetts House and Senate Pass Compromise Restrictions on Pharmaceutical & Medical Device Marketing

Fri, 01 Aug 2008 14:03:21 EDT

In recent months, the Massachusetts Legislature has been considering legislation to limit or ban certain marketing activities of pharmaceutical and medical device companies. On the last day of the legislative session, July 31, the House and Senate voted to accept the conference committee report concerning health care cost containment legislation, (Senate 2863.) This legislation includes the provision regulating gifts by pharmaceutical and medical device manufacturers to physicians.

Obligations of Insurer and Policyholder

Tue, 06 Apr 2010 12:21:43 EDT

Introduction

The insurance relationship is primarily one of contract, with the insurance policy as the principal source of the parties’ obligations. As with other types of insurance, the duties of the parties—and the consequences of breaching those duties—are affected by government regulation, primarily in the form of state statutes addressing insurer conduct. Another source of law affecting insurance obligations is the judiciary. As liability insurance disputes became a staple of the courts’ civil dockets during the second half of the twentieth century, recurring issues generated a significant body of common law. Nevertheless, in any study of the obligations of insurer and insured under liability coverages, there is no avoiding the oft-used insurer admonition, “Read Your Policy.”

The Employee Free Choice Act: Understanding the Act and Protecting your Business

Fri, 17 Jul 2009 16:04:48 EDT

The Employee Free Choice Act is proposed federal legislation that would greatly improve union chances of winning certification elections and would increase union membership throughout the country. Businesses have identified the EFCA as a serious threat and one that has a good chance of becoming law.

At this point, no one can predict whether the EFCA will pass as proposed, whether it will pass in an amended form, or whether it will pass at all. But, regardless, union organizing activity will likely increase in coming years due to the changed political environment, and employers need to be prepared.

I hope that you find the information in this booklet helpful, and please feel free to contact me if you have any questions.

Sincerely,

Jonathan A. Keselenko
Partner, Labor and Employment Department
Partner, Labor and Employment Department

EEC Perspectives - September 2008

Mon, 20 Jul 2009 11:15:03 EDT

Included in this Issue:

A Market Perspective
Ham Lord, Managing Director, Launchpad Ventures

Angel financing is more than just seed round financing for future venture capital deals. In fact, angels fund 10 to 20 times more companies than venture firms do on an annual basis. This is because many angel deals will never need the type of large financing ($10M+) that is typical of most venture deals.
Structuring a Seed Stage Investment
David A. Broadwin, Partner, Foley Hoag LLP

Many of the entrepreneurs who walk through our doors at the EEC are at the seed/angel stage and are looking for those kinds of investments as well as advice around how to structure the investments so as to (a) fund the early needs of the business and (b) not create barriers to a larger investment later in the life of the business.

Massachusetts Form PC: Notice of Increase in Minimum Threshold for Reviewed Financial Statements

Wed, 31 Dec 2008 09:05:10 EDT

Most public charities organized, operating or soliciting funds in Massachusetts are required to file Form PC with the Massachusetts Attorney General’s Non-Profit Organizations/Public Charities Division within four and one-half months of the end of each fiscal year. The Form PC requires several attachments, including financial statements for public charities having minimum amounts of gross support and revenue. The Massachusetts legislature increased the minimum threshold for filing such statements from $100,000 to $200,000.

Massachusetts House Revises Legislation Concerning Proposed Pharmaceutical Gift Ban

Tue, 22 Jul 2008 16:08:29 EDT

In recent months, the Massachusetts Legislature has been considering legislation to limit or ban certain marketing activities of pharmaceutical and medical device companies. In April 2008, the Massachusetts Senate approved a proposal that would significantly restrict pharmaceutical marketing to physicians and health care facilities. This proposal was subsequently revised by the Massachusetts House on July 16, 2008. The progress and outcome of this marketing legislation is of significant importance to anyone involved in the Massachusetts biotechnology, health care, and drug and device sectors.

The Foley Hoag Foundation 2007 Annual Report

Fri, 17 Jul 2009 15:59:36 EDT

Established in December 1980 by the partners of law firm Foley Hoag, The Foley Hoag Foundation is a private foundation that seeks to combat racism, especially among youth, in the City of Boston. The Foundation awards grants to organizations working to improve the racial climate in Boston by addressing issues of diversity and racism. Grantee organizations achieve their goals through a variety of means, including arts and cultural activities, youth leadership and recreational programs. Other grantees provide advocacy assistance, enabling individuals to confront racism through legal or political action. Some grantee organizations work to prepare young children to live in the reality of a multicultural society, others engage teens, and a few target a primarily adult constituency.

The Foley Hoag Foundation was the first—and remains the only— foundation to focus exclusively on the improvement of race relations in Boston. The trustees are fortunate to have the unqualified endorsement of Foley Hoag, which has provided an enormous amount of financial, administrative and moral support.

Q&A Series: When Your Public Company Must Restate Its Financial Statements

Mon, 02 Nov 2009 12:07:47 EDT

Excerpt:

Q: In the course of doing this year's audit, our independent auditor found a problem with our previously issued financial statements. What do we do now?

A: You need to know more. You do not have to restate your financial statements unless they are materially wrong, although bear in mind that the Securities and Exchange Commission (SEC) has said that materiality can be “qualitative” as well as “quantitative.” See Staff Accounting Bulletin No. 99.

Work through the potential issues and determine what, if anything, needs to be restated. Be sure that your independent auditor considers possible accounting alternatives to a restatement, like a cumulative catch-up. Also, you need to understand why the problems occurred; evidence of fraud, for example, will surely call for additional action. Once you have reason to believe that there is a material error, you should shut down trading in the company's securities by insiders. You may also have to suspend outstanding shelf registration statements, if there are any.

New Administration Further Postpones Mandatory E-Verify for Government Contractors until May 2009

Wed, 02 Dec 2009 17:25:05 EDT

Today the federal government agreed to further postpone implementation of the E-Verify requirement for federal contractors until May 21, 2009 at the earliest.

Personalized Diagnostics: The Struggle for Position

Thu, 29 Apr 2010 15:30:24 EDT

For several major cancers, drug selection already pivots on biomarker results (e.g., trastuzumab for breast cancer, and gefitinib and erlotinib for lung cancer). Fast-paced advances in genomic and proteomic laboratory technologies could enable the widespread use of molecular testing before therapy selection in any field of medicine. This article describes two potentially large obstructions to such innovation. First, laboratory tests have traditionally been commodities with low prices, prices that matched the resources required to operate the laboratory technology itself.

Funding opportunities in the American Recovery and Reinvestment Act of 2009 and the Serve America Act

Mon, 21 Dec 2009 17:01:13 EDT

Two recent laws, the American Recovery and Reinvestment Act of 2009 (“ARRA,” commonly known as the stimulus package) and the Edward M. Kennedy Serve America Act, provide funding opportunities for nonprofits and social entrepreneurs to expand their services and accommodate additional volunteers. Organizations can apply for ARRA funds immediately. While funding for the Serve America Act will depend upon the 2010 federal budget, organizations may wish to assess their needs now in anticipation of the Act going into effect on October 1, 2009.

Supreme Court Decision in Citizens United v. Federal Election Commission Changes the Landscape for Corporate Funding of Election Communications

Fri, 19 Feb 2010 13:56:03 EDT

The Supreme Court’s recent decision in the Citizens United case has focused widespread public attention on the issue of corporate and union spending in federal election campaigns. On January 21, 2010, the Court ruled that corporations and labor unions will now be allowed to use general treasury funds to promote or oppose electoral candidates — a decision that has elicited strong reactions from the President, legislators, and the general public.

National Biodefense Science Board Presents Recommendations

Mon, 05 Apr 2010 18:14:39 EDT

The Assistant Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie, requested that the NBSB take a leadership role in the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) review currently underway at ASPR. The NBSB's Medical Countermeasures Research and Development Working Group, as well as the Medical Countermeasures Markets and Sustainability Working Group have been developing background on these issues since early 2008.

Phase II of the FDA’s Transparency Initiative: The Transparency Task Force Releases Draft Recommendations on FDA’s Public Disclosure Policies

Fri, 21 May 2010 16:44:06 EDT

Transparency Initiative

In June 2009, Dr. Margaret Hamburg, the newly appointed Commissioner of Food and Drugs, announced the Food and Drug Administration (“FDA” or “Agency”) Transparency Initiative and created the FDA Transparency Task Force to carry out the Initiative. The goals of the initiative were in keeping with President Obama’s January 2009 memorandum calling for “creating an unprecedented level of openness in Government” to “promote accountability and provide information for citizens about what their Government is doing.” [continues...]

North vs. South: Affymetrix files more patent cases against Southern Calif. rival Illumina, expanding reach into Europe

Mon, 02 Nov 2009 12:07:47 EDT

Originally published in Drug Discovery News, November 2007.

Affymetrix Inc. filed a second wave of patent infringement lawsuits against San Diego-based Illumina Inc. in late October. The three cases—in the United States, the United Kingdom and Germany—claim that all of Illumina’s BeadArray products, as well as the genome-analysis and array technologies Illumina acquired when it bought Solexa, infringe various Affymetrix patents.

Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements

Wed, 09 Sep 2009 14:26:22 EDT

In March, President Obama signed an executive order lifting the Bush Administration restrictions on federal funding for human embryonic stem cell (HE S) research. The possibility of new federal funding opportunities, in combination with more than a decade of scientific advances in both embryonic and adult stem cell research, signal that stem cell-based therapies (“SCBT”) could soon be available for patients in a clinical setting. For those wishing to commercialize such therapies, it will be important to ascertain how the U.S. Food and Drug Administration (“FDA ”), which has regulatory authority over U.S. marketing of SCBT, will exercise this oversight.

This article is not intended to be an exhaustive dissertation on all laws and regulations pertaining to stem cell research, embryonic or otherwise.1 Rather, it discusses the controversial history of federal funding for stem cell research, and then focuses on regulations and guidelines likely to govern FDA approval of clinical applications of SCBT. It also discusses some of the recent recommendations included in the International Society for Stem Cell Research Guidelines in the context of U.S. application of those recommendations. (continues...)

Economic Crisis Team Datasheet

Mon, 02 Nov 2009 12:07:52 EDT

Foley Hoag LLP’s interdisciplinary team counsels and protects the interests of its clients facing new realities, challenges and risks framed by today’s tumultuous economic and market conditions. By maintaining an active and engaged dialogue with our clients during this period of economic distress, our lawyers are better able to adapt to the changing legal needs of clients affected in the short term. More importantly, our immersion in their businesses and industries enables our lawyers to provide sound, strategic counsel to protect our clients’ interests in the longer term. The Economic Crisis Team delivers forward-thinking advice, focusing on long-standing core, integrated strengths of the firm.

Topics include:

Financial investigations, enforcement proceedings and litigation
Federal and state securities regulation
Deal-making, corporate finance and investment restructuring
Bankruptcy, corporate reorganization and financial disputes

Foley Hoag Co-Hosts Congressional Briefing on Biodefense

Mon, 05 Apr 2010 18:10:07 EDT

Since 2001, the previous Administration and Congress drafted comprehensive policy documents, enacted major legislation and approved significant appropriations addressing the risks associated with the bioterrorism threat and the need for biodefense preparedness. Foley Hoag is playing a key role in educating and informing the new Administration and Congress on these issues through a series of educational briefings.

Emerging Enterprise Center Brochure

Wed, 19 Dec 2007 12:20:24 EDT

For years, Foley Hoag has served the entrepreneurial and venture communities in Greater Boston and beyond. Our depth of experience allows us to handle the broad range of issues these organizations face with efficiency and skill. The Emerging Enterprise Center at Foley Hoag is the next logical step in our partnership with emerging markets, reinforcing our committment to providing strategic legal advice and business insight.

Failure to Obtain Opinion of Counsel May Be Evidence of Intent to Induce Infringement

Thu, 25 Sep 2008 16:14:00 EDT

Yesterday, in Broadcom Corp. v. Qualcomm Inc. (Nos. 2008-1199, -1271, -1272), the Federal Circuit held that an accused infringer’s failure to obtain an opinion of counsel may be considered as evidence to support a determination that it actively induced infringement by a third party. Specifically, the Court ruled that the presence or absence of an opinion is relevant to whether an accused infringer “‘knew or should have known’ that its actions would cause another to directly infringe.”

Many Federal Contractors Will Have To Comply With E-Verify

Mon, 02 Nov 2009 12:08:04 EDT

Yesterday, a new federal rule took effect, which requires many federal contractors to use the E-Verify system to determine their employees’ eligibility to work in the United States. E-Verify is a free web-based system operated by the Department of Homeland Security, in partnership with the Social Security Administration. The system compares employee information from the Employment Eligibility Verification Forms (I-9) against federal government databases in order to verify workers’ employment eligibility. Under the new rule, many companies which are awarded a federal contract after September 8, 2009 will be required to enroll in E-Verify within 30 days of the contract award date. The contractor will need to use the system to verify employment eligibility for all new hires, regardless of whether the employee will work on the federal contract, and also for all existing employees who perform work on the contracts.

ONC Establishes Temporary Certification Program for EHR Technology

Tue, 22 Jun 2010 15:29:37 EDT

On June 18, 2010, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule establishing a temporary certification program to test and certify health information technology (HIT), including electronic health records (EHRs). This temporary certification program will be used to ensure that “Certified EHR Technology” is available for adoption by eligible professionals, eligible hospitals and critical access hospitals (CAHs) for purposes of qualifying for incentives under the Health Information Technology for Economic and Clinical Health (HITECH) Medicare and Medicaid EHR Incentive Programs, as established under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111–5).

Corporate Social Responsibility Brochure

Wed, 19 Dec 2007 12:20:18 EDT

Excerpt:

Corporate globalization presents companies with unanticipated risks and challenges. Businesses are held to higher standards of accountability with respect to social, environmental and ethical practices. Companies unresponsive to these demands risk damage to their reputations, brand image and competitiveness. We help savvy business leaders limit their companies’ risk by incorporating internationally recognized standards into their strategic planning, crisis response strategies and relationships with stakeholders.

Benefits of our counsel include:

Reduction of threat to corporate reputation
Reduction of legal risks associated with the uncertainties of globalization
Enhanced brand image
Increased customer and employee loyalty and retention Improved relationships with external stakeholders and public opinion leaders

Download the Foley Hoag Corporate Social Responsibility Brochure (.pdf)

EEC Perspectives - December 2008

Mon, 20 Jul 2009 11:15:05 EDT

Included in this Issue:

A Market Perspective by Vinit Nijhawan
Selected New England “Series B” and Later Round Transactions
Commentary from David Pierson
Terms of Selected New England Series B and Later Rounds
Commentary from Amanda Vendig
The Activity Level Summary: New England Series B and Later Round Transactions by Industry
National Series B and Later Round Transactions by Industry
Size of New England 2008 Year to Date Series B and Later Round Transactions by Industry
Commentary from Jerry O’Connor

USCIS Initiates Expanded Employer Site Visit Program

Wed, 02 Dec 2009 17:42:54 EDT

The US Citizenship and Immigration Services (“USCIS”) has initiated a significantly expanded version of its Site Visit Program in an effort to uncover fraud in the H-1B temporary worker program. Because of a funding increase, USCIS is increasing the number of employer site visits, and, in the coming months, many employers who have sponsored foreign nationals for employment-based nonimmigrant petitions will be the subject of an investigation.

Prescription Drug Pedigree: Proliferation of State Laws Calls for Federal Action

Tue, 15 Apr 2008 15:22:33 EDT

The Prescription Drug Marketing Act was enacted in 1988 to establish, among other things, a system for tracking drugs through the manufacturing and marketing processes. implementing regulations regarding these pedigree provisions for prescription drugs have been delayed for years. The Food and Drug Administration has issued it’s own stay on implementation, and a recent lawsuit by prescription drug distributors over the scope of the pedigree requirements has contributed to the delay as well.

The resulting lack of clear of federal criteria for prescription drug pedigrees has created an opportunity for states to pass their own pedigree laws, leading to a patchwork of diverse, often conflicting, state standards. Prescription drug distributors find it increasingly difficult to comply with the multitude of state laws, thus the time is ripe for federal action to create uniform pedigree requirements.

Food and Drug Datasheet

Thu, 16 Jul 2009 16:47:08 EDT

Foley Hoag’s Food and Drug Practice provides regulatory and legislative advice to leading biotechnology, pharmaceutical, medical device, and health care companies regulated by the Food and Drug Administration (FDA). Lawyers at Foley Hoag understand the critical regulations and policies affecting product development schedules, regulatory compliance, and timely product approvals. In representing clients, our lawyers work with senior agency managers, congressional staff, and Members of Congress to shape agency interpretations, clarify regulatory guidance, challenge adverse decisions, develop effective compliance plans, and enact legislation into law.

Patenting Guidebook

Fri, 17 Jul 2009 16:03:59 EDT

Preface:

Patenting generally offers a superior means for legally protecting most inventions, particularly since:

copyright, when available, does not provide a broad scope of protection; and
the ability to effectively protect an invention as a trade secret is in constant jeopardy, due to publication or oral disclosure.

Unfortunately, the patenting process can be complicated, time-intensive and costly. However, costs can often be minimized and opportunities for establishing value in products and technology maximized if scientists and business professionals with an understanding of the patenting process are actively involved throughout.

This publication was prepared to provide an overview of patenting, particularly as it pertains to innovative technologies such as biotechnology and information technology.

Opportunities for the Life Sciences Industry: American Recovery and Reinvestment Act to Deliver $150 Billion for Healthcare

Thu, 11 Mar 2010 08:47:12 EDT

President Obama signed H.R. 1, the American Recovery and Reinvestment Act of 2009 (Recovery Act) into law on February 17, 2009. The bill represents the largest investment in public works since the Great Depression.

The Recovery Act allocates more than $150 billion to health related programs, and makes significant down payments on medical research, comparative effectiveness initiatives, and health information technology. The chart below describes the major health provisions in the Recovery Act.

Massachusetts Life Sciences Initiative Signed into Law

Thu, 07 Jan 2010 10:40:46 EDT

On June 16, 2008, Massachusetts Governor Deval Patrick signed into law legislation (.pdf) that provides a total of $1 billion over the next ten years to support the development of the life sciences industry in Massachusetts. The legislation, commonly known as the Life Sciences Initiative (LSI), is designed to stimulate research, development, manufacturing, and commercialization in the life sciences sector and, ultimately, to increase employment and associated tax revenues. To achieve these goals, the LSI significantly expands the activities of the recently created Massachusetts Life Sciences Center (LSC) by dramatically increasing the funding available for capital expenditures, grant programs and other incentives. The LSI also establishes an aggressive set of tax incentives that include a broad array of refundable and other types of tax credits.

President Obama Extends COBRA Subsidy for Unemployed Workers

Wed, 23 Dec 2009 12:26:42 EDT

On December 21, 2009, President Barack Obama signed into law an extension of the federal COBRA subsidy created by the American Recovery and Reinvestment Act of 2009 (“ARRA”).

Product Liability Update - February 24, 2009

Thu, 11 Mar 2010 08:32:10 EDT

Foley Hoag LLP publishes this quarterly Update concerning developments in Product Liability and related law of interest to product manufacturers and sellers.

Included In This Update:

United States Supreme Court Holds Federal Cigarette Labeling and Advertising Act Does Not Preempt State Law Claim Alleging Unfair and Deceptive Advertising of "Light" Cigarettes
Massachusetts Supreme Judicial Court Affirms Denial of Certification of Nationwide Class Based on Lack of Opt-Out Rights Under Massachusetts Law, Affirms Denial of Statewide Class Based on Dissimilarities Among Class Members as to Statute of Limitations Defense
Massachusetts Federal District Court Holds Class Counsel Fees in Claims-Made Settlements Will Be Awarded By Reference to Value of Benefits Actually Claimed By Class Members, Rather than Maximum Possible Benefits
Massachusetts Federal District Court Dismisses Claims Against Missile System Manufacturer Because United States Army's Successful Assertion of State Secrets Privilege Over System's Technical Specifications and Other Information Prevented Manufacturer from Presenting Fair Defense
Massachusetts Superior Court Grants Summary Judgment For Crane Manufacturer Because Crane Owner's Discarding of Allegedly Defective Components Prevented Plaintiff From Proving Claims

For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.

New IRS Annual Information Return Required for Small Tax-Exempt Organizations – Form 990-N (e-Postcard)

Thu, 01 May 2008 17:08:36 EDT

Until now, most small tax-exempt organizations, defined as those with gross receipts of $25,000 or less per year, have not been required to file an annual information return with the Internal Revenue Service (the “IRS”).

However, small tax-exempt organizations must now file an annual electronic information return – the Form 990-N, also known as the e-Postcard. This requirement covers all tax periods beginning after December 31, 2006. The e-Postcard must be filed no later than the 15th day of the 5th month following the end of the organization’s tax year. For example, an organization whose tax year ends December 31 must submit the e-Postcard by the following May 15.

Reminder: March 1, 2010 Deadline to Comply With Massachusetts Information Security Regulations Is Right Around the Corner

Wed, 01 Sep 2010 16:29:56 EDT

Businesses that have not adopted written information security programs to comply with the Massachusetts information security regulations have little more than a week to wrap up their compliance efforts. Monday, March 1, 2010 is the deadline set by the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) for businesses around the world that handle the personal information of Massachusetts residents to comply with the strict Massachusetts regulations.

EEC Perspectives - March 2009

Mon, 02 Nov 2009 12:07:56 EDT

Included in this Issue:

The End of Doom and Gloom by Dave Broadwin
The Numbers by David Pierson
Selected New England Series “A” Round Transactions: Fourth Quarter 2008
Selected New England Series “B” and Later Round Transactions: Fourth Quarter 2008
Terms of Selected New England Series A Rounds 2008
Terms of Selected New England Series B and Later Rounds
The Activity Level Summary
New England Series A and First Round Transactions by Industry
New England Series B and Later Round Transactions by Industry
National Series A and First Round Transactions by Industry
National Series B and Later Round Transactions by Industry
Size of New England 2008 Series A and First Round Transactions by Industry
Size of New England 2008 Series B and Later Round Transactions by Industry

Generic drug laws ready for reform by government

Fri, 21 Sep 2007 10:59:24 EDT

After years of debate over allegations of anticompetitive conduct by the pharmaceutical industry, both Congress and the Food and Drug Administration (FDA) are poised to take final action to change key features of the generic drug approval process and substantially reform the 1984 Hatch-Waxman amendments.

The Benefits of Patent Marking – And of Getting It Right

Fri, 04 Apr 2008 10:07:04 EDT

While marking products to indicate that they are patented is necessary to maximize your patent rights, a recent case highlights the importance of marking the products accurately.

Technology Datasheet

Mon, 02 Nov 2009 12:08:33 EDT

Maintaining a leadership position in competitive, dynamic industries like software and technology is always challenging. At Foley Hoag, our lawyers are dedicated to helping you meet this challenge. Our goal is to become an essential partner to our clients in the software and technology industries. We understand your business, and we’ve been involved in many important industry milestones. For example, we assisted our clients in the:

Initial public offering of Cullinet Software, which became the first software company listed on the New York Stock Exchange
Merger of Powersoft with Sybase, which was the largest merger in the software industry
Merger of PRI Automation and Brooks Automation, creating the largest automation company in the semiconductor industry
Acquisition of the defense and intelligence group of American Management Systems by CACI International, creating the largest publicly traded company devoted to providing information technology services to the United States Government

Final Pharmaceutical and Medical Device Manufacturer Conduct Regulations

Tue, 05 Jan 2010 09:32:00 EDT

On March 11, 2009, the Massachusetts Public Health Council promulgated final regulations (105 CMR 970.000) for the administration of Chapter 111N of the Massachusetts General Laws, which governs the marketing activities of pharmaceutical and medical device manufacturing companies. When the Legislature passed Chapter 111N in August 2008 (as Section 14 of Chapter 305 of the Acts of 2008) (the “Law”), Massachusetts joined the District of Columbia and six other states in regulating the relationships between the pharmaceutical and medical device industries and physicians.

Understanding these final regulations is of significant importance to anyone involved in the Massachusetts biotechnology, health care, and drug and device sectors. The regulations apply broadly to pharmaceutical or medical device manufacturing companies (“PMDMCs”), including companies that are “directly” engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. In accordance with the requirements of the Law, the regulations establish a fine of $5,000 for each knowing and willful violation.

2009 Updates to Delaware General Corporation Law - Part 3: Improved Shareholder Access to Proxy Materials – Now, What Will the SEC Do?

Mon, 02 Nov 2009 12:07:49 EDT

Delaware has added two new sections to the General Corporation Law, effective August 1, 2009. While the legislature appears to be concerned about improving shareholder access to proxy materials, the effect of these changes may not be clear for a while.

Attorney General of Massachusetts Announces Initiative on Executive and Director Compensation

Thu, 03 Sep 2009 17:31:25 EDT

The compensation practices of nonprofit organizations in Massachusetts just became subject to increased scrutiny. The Non-Profit Organizations/Public Charities Division of the Office of the Attorney General of Massachusetts announced yesterday that it is turning its attention to compensation paid by health care systems and health care insurers to their executives and directors. Depending on the outcome of its investigation and new reporting requirements, the Division may expand its review to other sectors.

HHS Proposed Major Changes to HIPAA Privacy, Security and Enforcement Rules

Mon, 12 Jul 2010 14:45:54 EDT

On July 8, 2010, the Department of Health and Human Services (“HHS”) issued a notice of proposed rulemaking (“NPRM” or “proposed rule”) modifying the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy, Security, and Enforcement Rules pursuant to the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which was enacted February 17, 2009 as part of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5. [more...]

USCIS Delays Imposition of E-Verify Obligations On Federal Contractors

Tue, 13 Jan 2009 13:11:40 EDT

In response to a lawsuit brought by the U.S. Chamber of Commerce and other industry groups, the U.S. Citizenship and Immigration Service (USCIS) has agreed to delay the imposition of the E-Verify system on federal contractors until February 20, 2009. E-Verify is an automated, web-based system for verifying employees’ identity and their authorization to work in the United States. As we explained in our December 1, 2008 bulletin, a new federal rule would have required federal contractors to use this system beginning on January 15, 2009. However, USCIS has agreed to a one-month postponement so that the federal court can decide whether the recent lawsuit has any merit. The Chamber of Commerce and others allege that the executive order making the system mandatory is invalid and seek an injunction against enforcement of the rule. We will update you as the lawsuit progresses.

For more information, see our December 1, 2008 bulletin.

State Extends Deadline for Compliance With Data Security Regulations Until May 1, 2009

Thu, 11 Mar 2010 08:49:52 EDT

We recently informed you that Massachusetts enacted comprehensive data security regulations relating to a 2007 data security law intended to protect Massachusetts residents from identity theft. A copy of the bulleting explaining the regulations can be found here. These regulations, which had been slated to take effect on January 1, 2009, will impose a significant compliance obligation on virtually all businesses with employees or customers in Massachusetts. In light of current economic conditions, the general deadline for compliance with Massachusetts’ data security regulations has been extended to May 1, 2009, while the deadline for obtaining written certification of security compliance from third party providers, and for encrypting portable devices other than laptops, has been extended to January 1, 2010.

Foley Hoag is holding a seminar at its Boston office regarding the law and its regulations on December 10, 2008, beginning at 7:30 a.m. Click here for more information.

Product Liability Update - October 13, 2009

Thu, 11 Mar 2010 08:31:02 EDT

Foley Hoag LLP publishes this quarterly Update concerning developments in Product Liability and related law of interest to product manufacturers and sellers.

Included In This Update:

First Circuit Affirms Summary Judgment for Vinyl Chloride Suppliers, Holding Sophisticated User Doctrine Only Required Analysis of Decedent’s Employer’s Knowledge of Product’s Risks, Not Whether Suppliers Reasonably Relied on Employer to Transmit Warnings to Employees
First Circuit Reverses Summary Judgment for Beryllium Suppliers, Holding Jury Could Find Plaintiff Reasonably Did Not Know Likely Cause of Her Harm Until Limitations Period and Sophisticated User Doctrine Does Not Apply Because Jury Could Find Plaintiff’s Employer Did Not Know Particulars of Beryllium Risk
Massachusetts Federal District Court Finds Jurisdiction Over Complaint Against Fetal Gender Detector Manufacturer and Distributor, Holding Counsel’s Affidavit Showed Amount in Controversy Exceeded Jurisdictional Minimum Under Class Action Fairness Act and Plaintiffs Alleged Defendant Had Opportunity to Cure Warranty Breach as Required for Magnuson-Moss Act Jurisdiction
Massachusetts Federal District Court Remands Asbestos Failure-to-Warn Claims to State Court, Holding Defendants Demonstrated No Colorable Federal Contractor Defense Where They Did Not Show Government Prescribed Content of Warning Rather Than Simply Remaining Silent
Massachusetts Superior Court Holds Order Requiring Nursing Home to Disclose Non-Party Patient’s Medical Records Relevant to Litigation Does Not Violate Health Insurance Portability and Accountability Act (HIPAA) or Massachusetts Unfair or Deceptive Practices Statute

For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.

Final 409A Deadline Looming: All Deferred Compensation Arrangements Must be in Full Compliance by December 31, 2008

Mon, 20 Jul 2009 11:15:46 EDT

Section 409A is an extremely broad law that covers many arrangements not generally considered deferred compensation, such as stock options, bonus plans, and severance and change in control agreements. In general, 409A governs any arrangement where an employee or consultant has a vested right to compensation in one year that will be paid in a later year, unless the arrangement fits into one of the exemptions to 409A. Arrangements subject to 409A must comply with strict rules as to the time and form of payment, and it is very difficult to make changes to an arrangement once it is in place. Any deferred compensation arrangement that does not comply with 409A will subject the employee or consultant to income tax liability at the time that the right to payment vests (even if there is no right to receive payment at that time), together with a 20% penalty tax on the deferred amount. (continues)

Labor & Employment Brochure

Mon, 02 Nov 2009 12:08:25 EDT

Providing strategic advice and litigation services to our business clients nationwide

Our long-standing strength in representing employers in labor relations and employment litigation defense issues is complemented by our experience in dealing with the emerging issues confronting employers in the 21st century.

Our goal is to provide pragmatic business advice and a cost-effective approach aimed at helping our clients achieve results – prompting those clients to place our Labor and Employment lawyers at the top of the Chambers USA rankings for four consecutive years.

Topics include:

Labor Law Strategies
Wage and Hour Litigation
Non-Competition Agreements and Related Issues
Employment Discrimination and Harassment Litigation
Wrongful Discharge and Other Disputes
ERISA and Benefi ts-Related Litigation
Business Immigration Services
Preventative Counseling

Life Sciences Alert - FDA Releases New IVD Device Studies Draft Guidance

Thu, 21 Feb 2008 17:00:18 EDT

On October 25, 2007 the Food and Drug Administration (FDA) released the “Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions,” open for public comment for 90 days.This is the third draft guidance related to in vitro diagnostic (IVD) tests that FDA has released in the last 14 months, marking notably increased agency attention to these products.

Healthcare Alert - CMS Guidance on Implementation of Reduction in Coverage Gap

Mon, 03 May 2010 16:34:32 EDT

As initially enacted, standard prescription drug coverage under Medicare Part D contains a “gap” in coverage during which a Part D enrollee is fully liable for their prescription drug costs. Social Security Act § 1860D-2(b)(3)(A), 42 U.S.C. § 1395w-102(b)(3)(A). In plan year 2010, once a beneficiary incurs $2,830 in Part D spending (split between the enrollee and the plan), Part D coverage will cease until the beneficiary incurs true out-of-pocket spending of $4,550.

Biotech Patent Held Invalid For Failing to Disclose Preferred Host Cells

Thu, 11 Mar 2010 14:35:49 EDT

On March 8, 2010, the Federal Circuit affirmed a ruling of the International Trade Commission invalidating the asserted claims of two U.S. patents for failure to meet the best mode requirement. Ajinomoto Co., Inc. v. ITC, available here. Foley Hoag represented the prevailing party, Global Bio-Chem Technology Group Company Limited (GBT), a Chinese biotechnology company. The patents covered the production of lysine using genetically modified bacteria.

Travel to the United States in 2009 May Become More Complicated for Some Foreign Citizens

Mon, 29 Dec 2008 11:29:17 EDT

Because many foreign citizens travel to the United States to visit family around the holiday season, we wanted to alert you to a change which will take effect on January 12, 2009. In the past, eligible citizens of designated visa waiver countries could apply at a port of entry for admission to the United States as a nonimmigrant for up to 90 days for business or pleasure without first obtaining a nonimmigrant visa. However, on January 12, 2009, the Department of Homeland Security will implement an electronic travel authorization system (“ESTA”). Under ESTA, all citizens of visa waiver countries who plan to travel to the U.S. without a visa will need to apply for an ESTA travel authorization prior to boarding a U.S.-bound airplane or cruise ship. As of January 12, 2008, visa waiver travel will not be permitted without such an advance travel authorization.

Follow-on Biologics and Patent Reform

Mon, 02 Nov 2009 12:08:24 EDT

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which includes biotechnology and medical devices, accounted for 28% of VC money invested, the largest investment sector in 2006.

As Life Sciences venture capital investing has risen, the biotechnology industry has become increasingly dependent on such funding. This is particularly true for start-up companies that cannot rely on revenue from marketed biologics to fund their research and development pipeline. To cover the nearly $1 billion capital investment required to bring a biologic drug to market (from discovery through clinical trials and FDA approval), early-stage companies rely on VC investing. Investing in emerging companies, however, is risky for a venture capitalist: only 1 in 10 drugs discovered actually makes it to market, and despite the more than $50 billion spent on biotech drugs in 2006, the great majority of early-stage companies never reach the point of net profitability.

Vermont Pharmaceutical Gift Ban & Disclosure Act: Statutory Summary

Mon, 02 Nov 2009 12:08:28 EDT

Included In This Issue:

An Act Relating to the Marketing of Prescribed Products: Current Status
Background and Overview
Summary of Chapter 59 of the Vermont Acts of 2009 (Senate Bill 48)
Next Steps

Download the June 2009 Foley Hoag Life Sciences Update (.pdf)

Health Care Compliance Update - February 2005

Mon, 20 Jul 2009 11:15:14 EDT

In this issue:

Status of Health Care Compliance Efforts in Doubt As Supreme Court Strikes Down Sentencing Guidelines
TAP Defendants Acquitted; Implications for Future Prosecutions Still Unclear
Hospital Employees Suspended After Trying to Access President Clinton’s Medical Records
California Law Raises Bar for Ethics Compliance for Drug and Device Manufacturers
First HIPAA Criminal Prosecution Results in Jail Time
GAO Concludes HIPAA Implementation “Went More Smoothly Than Expected”
Massachusetts Nursing Home Hit with $162,500 Civil Penalty for Clean Water Act Violations

H-1B Filing Deadline for FY 2010 is Fast Approaching and Stimulus Package Imposes New Restrictions on Hiring Foreign Workers

Wed, 02 Dec 2009 17:27:35 EDT

On April 1, 2009, the U.S. Citizenship and Immigration Services (“USCIS”) will begin accepting new H-1B petitions for employment commencing on October 1, 2009. For most employers, new H-1B petitions are subject to an annual limit of 65,000 new H-1B visas. An additional 20,000 visas are available each year to foreign workers with an advanced degree from a U.S. academic institution. The annual quota only applies to new H-1B visas, not to individuals who already hold H-1B status. Foreign nationals who work at universities and non-profit research organization are also excluded from the numerical cap.

The New Stimulus Package Creates Premium Subsidy for COBRA Continuation Coverage

Thu, 03 Dec 2009 12:16:39 EDT

On February 17, 2009, President Barack Obama signed into law the American Recovery and Reinvestment Act of 2009 (the “Act”). Among other changes, the Act helps individuals who are out of work to pay for health care continuation coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”). Below is a summary of the major changes to COBRA. We expect the federal government to soon issue further guidance regarding the implementation of certain aspects of the law, and we will inform you of these developments.

2009 Updates to Delaware General Corporation Law - Part 2: Elimination of "Empty Voting"

Mon, 02 Nov 2009 12:07:49 EDT

By an amendment effective August 1, 2009 to section 213(a) of its General Corporation Law, Delaware has provided a way for corporate boards to avoid a problem sometimes referred to as “empty voting.” The purpose of the change is to better align shareholders’ voting rights with their actual economic interests.

Ten Commandments: Prudent Activities for the Board of Directors of a Not-For-Profit Corporation

Wed, 16 Jul 2008 10:05:23 EDT

The directors of a not-for-profit corporation are bound by two general types of legal duties:

A duty of care

The duty to perform their responsibilities in good faith, in a manner reasonably believed to be in the best interest of the corporation, and with such care as an ordinarily prudent person would be in similar circumstances; and

A duty of loyalty

The duty to keep the interests of the corporation paramount above personal interests when acting for or on behalf of the corporation.

The following Ten Commandments provide examples of some of the actions a board of directors should take to act in accordance with its legal duties... (continues)

CMS Issues Hospital Payment Proposed Rule for 2010 – Affecting 3,500 Acute Care Hospitals

Mon, 11 May 2009 15:15:35 EDT

On May 1, 2009 the Centers for Medicare & Medicaid Services (CMS, or the Agency) issued a proposed rule (.pdf) for the FY2010 Medicare hospital inpatient prospective payment systems (IPPS). The regulation proposes revisions to policies and payment rates for general acute care hospitals paid under the Medicare hospital IPPS and also inpatient stays in long-term care hospitals (LTCHs) under the LTCH Prospective Payment System (LTCH PPS). The proposed rule would also implement certain provisions made by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, Pub. L. 110-275) and the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-5).

[continues...]

Massachusetts Determination of Need Process Expanded to Include New Green Building Standards

Thu, 11 Mar 2010 08:51:19 EDT

As soon as January 1, 2009, new construction or gut renovation of a healthcare facility in Massachusetts may need to meet green building standards.

On September 24, 2008, the Massachusetts Department of Public Health ("DPH") approved new guidelines (the "Guidelines") that incorporate the Leadership in Energy and Environmental Design-Health Care ("LEED-HC") and Green Guide for Health Care ("GGHC") green building standards into the Determination of Need ("DoN") process. The Guidelines will apply to all DoN applications filed on or after January 1, 2009 (for hospitals and clinics) or July 1, 2009 (for nursing homes). [continues...]

USCIS Is Still Accepting H-1B Petitions

Wed, 02 Dec 2009 17:34:25 EDT

Yesterday, the U.S. Citizenship and Immigration Services (“USCIS”) announced that the annual cap of 65,000 new H-1B visas has not yet been met and that it is continuing to accept new H-1B petitions. To date, USCIS has only received approximately 42,000 petitions to be processed under the new H-1B cap, plus approximately 20,000 additional petitions filed under the special cap for foreign workers with an advanced degree from a U.S. academic institution.

Legal Analysis: A Low Dose Prescription

Thu, 13 Dec 2007 14:30:28 EDT

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration (“FDA”) has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this “off-label” use. The drug company wants to get the word out quickly about the new use.

Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?
Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?
If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?
Under what circumstances can a company provide “off-label” information to doctors?

Download A Low Dose Prescription: Criminal Prosecution of Off-Label Drug Promotion (.pdf)

Tips for Planning Reductions in Force

Mon, 02 Nov 2009 12:08:33 EDT

We know that the recent financial crisis and related economic downturn unfortunately are causing many employers to consider ways to reduce operational expenses, including through workforce restructuring and layoffs. We offer a few preliminary considerations: any such reduction-in-force (RIF) must be carefully planned and executed both to minimize exposure to liability under various employment laws and to mitigate negative effects on employee morale and operations. The following are some issues for employers to consider as they grapple with whether and how to implement a layoff.

Questions Include:

Is a Layoff Necessary?
Voluntary or Involuntary Program?
Develop Uniform Selection Criteria
Conduct a Layoff Analysis
Is Advance Notice Required
Severance and ERISA
Asking for a Release
Don't Forget Immigration Implications
Don't Lose Sight of Termination Basics

Tax and Benefits Alert - November 20, 2007

Tue, 27 Nov 2007 21:36:40 EDT

The I.R.S. recently issued its annual cost-of-living adjustments applicable in 2008 to qualified retirement (pension, profit-sharing, § 401(k), money purchase and stock bonus) plans.

Massachusetts Issues New Regulations Regarding the Fair Share Contribution under the Health Care Reform Law

Tue, 07 Oct 2008 10:34:58 EDT

Last week, the Massachusetts Division of Health Care Finance & Policy issued new regulations defining what is “a fair and reasonable” contribution by an employer towards health insurance under the Massachusetts Health Care Reform Law. Under that law, the state is permitted to assess an annual per-employee fee called the Fair Share Contribution (FSC) against non-contributing employers with 11 or more full-time equivalent employees. The fee can be as much as $295 per employee. To avoid the fee, the law requires an employer to offer a group health insurance plan and to make a “fair and reasonable” premium contribution towards that insurance. The new regulations make this test more stringent in order to increase the number of employers who are subject to the FSC.

New Immigration Enforcement Efforts Aimed at Employers

Wed, 02 Dec 2009 17:36:47 EDT

The Obama Administration announced earlier this year that U.S. Immigration and Customs Enforcement (ICE) would implement a new, comprehensive strategy to reduce the demand for illegal employment and protect employment opportunities for the nation's lawful workforce. Moreover, the Administration made it clear that this new enforcement effort would be targeted at employers and ICE is now focusing resources on investigating employers suspected of employing undocumented workers.

EEC Perspectives - May 2009

Mon, 02 Nov 2009 12:07:57 EDT

Included in this Issue:

Get Your Pole Vaults Out - Mark Haddad
The Numbers - Amanda Vendig
Selected New England Series A Round Transactions: First Quarter 2009
Selected New England Series B and Later Round Transactions: First Quarter 2009
Terms of Selected New England Series A Rounds 2009
Terms of Selected New England Series B and Later Rounds
The Activity Level Summary

New England Series A and First Round Transactions by Industry
New England Series B and Later Round Transactions by Industry
National Series A and First Round Transactions by Industry
National Series B and Later Round Transactions by Industry

Size of New England 2009 Series A and First Round Transactions by Industry
Size of New England 2009 Series B and Later Round Transactions by Industry

Trade Secrets: A Guidebook for Technical and Business Professionals Involved in Legally Protecting Products, Technologies and Services

Mon, 02 Nov 2009 12:08:34 EDT

Trade secrets can be a valuable component of an intellectual property (IP) portfolio, whether as a complement to patents or as an alternative. Companies benefit from an IP portfolio that matches the unique benefits of trade secrets and patents to the types of information they seek to protect. Trade secret protection can be available immediately, without going through a government agent, whereas a patent is available only after an application to and approval by the government. And unlike patents, trade secrets provide IP protection of potentially infinite duration. Trade secret protection is also available for a broad array of information for which patents are not available.

Government Strategies Data Sheet

Fri, 23 Jan 2009 14:37:01 EDT

Republished January 23, 2009

We believe that public policy should enhance the lives of citizens—and that can best be accomplished through partnership with business. Foley Hoag’s Government Strategies practice is focused on achieving results for our clients that are mutually beneficial to everyone involved.

We work with Fortune 100, start–up businesses and other clients to help develop effective new public policy, assess the impact of recent regulations and refine the implementation of enacted legislation.

We will help you overcome your legal, policy, and political challenges by:

Providing strategic management of complex legislative and regulatory issues
Building lasting relationships with key decision makers
Anticipating future policy challenges and advising you accordingly
Building coalitions to advocate on behalf of shared interests
Providing counsel through crisis management and congressional investigations
Enhancing understanding of agency decisions, authority and statutory changes
Monitoring all types of legislative activities and advising you of their status
Negotiating with regulatory agencies

The core strength of Foley Hoag’s Government Strategies practice is the unsurpassed experience of our lawyers. Most of our government strategies lawyers have worked in senior-level positions in the White House, on Capitol Hill, in regulatory agencies, and in industry trade associations.

Our trademark is a unique combination of broad-based legislative and regulatory experience and significant substantive knowledge, particularly in the following areas:

Life sciences, including pharmaceuticals, biotechnology and medical devices
Energy and regulated industries
Energy technology and renewables
Education
Foreign policy and interactions with sovereign governments
Corporate social responsibility
International trade

Product Liability Update - August 31, 2009

Thu, 11 Mar 2010 08:31:25 EDT

Foley Hoag LLP publishes this quarterly Update concerning developments in Product Liability and related law of interest to product manufacturers and sellers.

Included In This Update:

Massachusetts Supreme Judicial Court Holds Sale Terms Mandating Individualized Arbitration of Claims Violate Public Policy of Unfair and Deceptive Practices Statute Favoring Classwide Resolution of Small-Value Consumer Claims
Massachusetts Federal District Court Holds Requirement that Electronic Documents be Produced as Kept in Usual Course of Business Requires Production of Files in “Native” Format But Does Not Require Producing Party to Scan Electronic Documents for Optical Character Recognition, Refuses to Require Blanket Production of Electronic Documents’ Metadata
Massachusetts Federal District Court Holds Plaintiffs’ Pharmaceutical Causation Experts’ Opinions Admissible Because Based on Extrapolation of Collective Epidemiological Study to Drug at Issue, Evidence of Biological Plausibility and Adverse Event Reports
Massachusetts Federal District Court Denies Certification of Putative Class of Consumers and Third-Party Payors Alleging Fraudulent Marketing of Drug Because Causation Could Not Be Demonstrated by Classwide Statistical Evidence and Hence Common Issues Regarding Marketing Would Not Predominate Over Individual Issues of Causation
Massachusetts Federal District Court in Actions Alleging Off-Label Promotion of Drug Dismisses Fraud Claims For Failure to Allege Physicians’ Reliance on a Particular Misrepresentation, Refuses to Dismiss Fraudulent Concealment Claims as Duplicative of Failure-to-Warn Claims Because of Scienter Requirement of Fraudulent Concealment

For more information about the Product Liability and Complex Tort Practice Group, please contact Dave Geiger.

EEC Perspectives - February 2009

Mon, 02 Nov 2009 12:07:55 EDT

Included in this Issue:

A Market Perspective – Justin J. Perreault, General Partner, Commonwealth Capital Ventures
Selected New England “Series B” and Later Round Transactions
Commentary from David Pierson
Terms of New England Series B and Later Rounds
Commentary from Bruce Kinn
The Activity Level Summary - New England Series B and Later Round Transactions by Industry
Size of New England 2008 Year to Date Series B and Later Round Transactions by Industry
Commentary from Amanda Vendig

New Health Information Privacy and Security Provisions in the American Recovery and Reinvestment Act of 2009

Mon, 02 Nov 2009 12:08:30 EDT

Somewhat lost in the American Recovery and Reinvestment Act of 2009 (“ARRA”), among the hundreds of pages describing billions in stimulus spending and tax relief, are significant new health information privacy and security provisions. These provisions have the potential to impact every “covered entity” under HIPAA, including hospitals, physicians and health plans, as well as “business associates” who were not previously covered by HIPAA.

New Fee Assessed on Brand Pharmaceutical Manufacturers

Thu, 25 Mar 2010 09:44:03 EDT

Section 9008 of the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) imposes an annual fee on branded prescription pharmaceutical manufacturers and importers. This memorandum analyzes the structure and operation of the fee.

FDA Releases Initial Draft Guidance on Risk Evaluation and Mitigation Strategies (REMS): Seeking Input from Stakeholders

Mon, 02 Nov 2009 12:08:27 EDT

The Food and Drug Administration (FDA) announced on September 30 that it has released a draft guidance [.pdf] for industry, titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.” Comments to the draft guidance are due by December 30, 2009, and should be submitted according to the instructions in the Federal Register [.pdf] notice announcing the draft guidance.

Wyeth v. Levine: No Federal Preemption for Drug Labeling

Thu, 11 Mar 2010 08:48:21 EDT

Excerpt:

The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined that the foundation of federal regulation for pharmaceuticals is that the drug manufacturer has the responsibility for the adequacy of its warnings. The decision by Justice Stevens, joined by Kennedy, Souter, Ginsburg and Breyer, rejected Wyeth’s argument that it was impossible to comply both with FDA regulations on warnings and with a state law duty, imposed by jury verdict, that a stronger warning against a particular method of administration of the drug was required. The Supreme Court also rejected, over a rigorous dissent, the proposition that state court product liability claims obstructed the purposes and objectives of the federal drug labeling regulations... (continues)

Health Information Technology Provisions in the Recovery Act

Fri, 17 Jul 2009 16:01:41 EDT

The following is an overview of the health information technology (HIT) provisions in H.R. 1, the American Recovery and Reinvestment Act of 2009 (ARRA, or Recovery Act), which President Obama signed into law on February 17, 2009. This document reviews potential funding sources and key decision makers for HIT at the Department of Health and Human Services (HHS) and its agencies. This overview highlights the HIT incentive payments, which are the largest piece of HIT funding in the Recovery Act, how various provisions of the HIT provisions are to be implemented, when they are required or expected to happen, and who the key players will be in the process.

2009 Updates to Delaware General Corporation Law - Part 1: Enhanced Protection for Directors

Mon, 02 Nov 2009 12:07:49 EDT

Effective August 1, 2009, Delaware has amended section 145(f) of the Delaware General Corporation Law to address the problem created by the Delaware Chancery Court’s recent decision in Schoon v. Troy Corp., 948 A.2d 1157 (Del. Ch. 2008).

Regulatory Summary of 105 CMR 970.000 - Final Pharmaceutical & Medical Device Manufacturer Conduct Regulations

Mon, 02 Nov 2009 12:08:26 EDT

EEC Perspectives - July 2008

Mon, 20 Jul 2009 11:15:00 EDT

Included in this Issue:

A Market Perspective: Foster Hinshaw on 'B' Rounds - Opportunity in 'Gloom and Doom'
In 2002, during the valley of the tech bubble burst, one of the most respected VC’s in the tech community said to me, "It’s all about survival, survival, survival – I don’t know if we will ever recover". Notwithstanding, the resiliency of our tech community proved its intrinsic value to the economy and there were some nice IPO’s and exits from companies that were incubating during the bubble years (including FAST, EqualLogic and Netezza). Today the news is similar: (a) zero IPOs in Q2 2008; (b) the financial sector is in a major, albeit predictably cyclical, reset; and worse (c) another 1970’s style energy crisis is on us. (continues...)
Selected New England "Series B" and Later Round Transactions
Terms of New England Series B and Later Rounds
The Activity Level Summary

Coverage and Reimbursement for Molecular Diagnostics: Current Issues and Options

Fri, 17 Jul 2009 15:57:32 EDT

Personalized medicine – getting the right treatment to the right patient at the right time – will be a major pillar of efforts to bring increased effectiveness and efficiency to healthcare. Today, we know far more about the molecular heterogeneity of major diseases, including cancer. It is clear that targeted and more effective medical treatments will often be unattainable unless physicians have precise molecular information about the patient’s disease. In short, is a priority that our healthcare system (both private payors and Medicare) facilitates the adoption of new molecular technologies when they are shown to be efficient and effective.

In re Bilski: Trouble Ahead for Biotech?

Thu, 06 Nov 2008 09:30:53 EDT

Last week, in In re Bilski, No. 2007-1130, the United States Court of Appeals for the Federal Circuit, sitting en banc, articulated the test for whether a process is eligible for patent protection under section 101 of the Patent Act, 35 U.S.C. § 101. The majority opinion, joined by nine of the court’s twelve judges, relies heavily on decades-old Supreme Court precedent and rejects other tests, including State Street Bank’s “useful, concrete, and tangible result” inquiry. Although this case has been closely watched as a “business methods” patent case, the decision has profound implications for protecting inventions in life sciences. At the same time, it leaves open many questions that ultimately will determine the scope of section 101. The debate over what is patent-eligible subject matter has just begun.

Health Canada Releases Draft Biosimilar Approval Guidance

Thu, 27 Mar 2008 14:38:07 EDT

Health Canada released a draft guidance this week which would allow approval of “subsequent entry biologics” (SEB) based on an abbreviated complement of clinical data, provided the SEB is shown to be “similar” to a reference, approved biologic product.[1] While the U.S. continues to heatedly debate legislation which would create a pathway for abbreviated approval of biosimilars, or follow-on biologics, by the U.S. Food and Drug Administration (FDA), Canada is advancing its implementation of such a pathway with the release of the SEB draft guidance. The European Union has permitted approval of biosimilar products since 2005.

Like FDA guidance documents in the U.S., Health Canada guidance documents do not have the force of law in Canada. However, the draft guidance indicates that the Canadian Food and Drug Regulations will be amended to provide “a comprehensive legal basis” for the regulation of SEBs and that in the interim, the draft guidance will provide a flexible SEB regulatory framework. The Canadian Minister of Health also plans to publish additional guidance documents that will further elaborate information and data requirements for specific classes of SEBs. Public comments on the SEB draft guidance are due April 16.

DOL Issues New FMLA Regulations

Tue, 09 Dec 2008 13:45:07 EDT

Recently, the U.S. Department of Labor (“DOL”) published its Final Regulations relating to the Family and Medical Leave Act (“FMLA”). These long-awaited regulations―the first regulatory revisions in over a decade―will go into effect on January 16, 2009. Below is a summary of some of the more important aspects of these regulations. Because the final regulations are almost two hundred pages in length and contain hundreds of changes, the summary below should not, of course, be considered comprehensive.

Massachusetts Gives Businesses Until January 1, 2010 to Adopt Information Security Programs To Comply With Recent Identity Theft Regulations

Wed, 01 Sep 2010 16:28:58 EDT

On Thursday, February 12, 2009, the Massachusetts Office of Consumer Affairs and Business Regulation (OCABR) issued a public statement indicating that it is extending the May 1, 2009 deadline to comply with recent Massachusetts identity theft regulations until January 1, 2010.

Government Asked to Provide Certainty and Incentives for Countermeasure Development

Mon, 05 Apr 2010 18:02:59 EDT

This week, the Institute of Medicine convened a workshop to examine federal policies and activities related to discovery through approval of medical countermeasures for responding to public health emergencies. Another meeting also took place this week which was organized by the National Biodefense Science Board to review the management and structure of the countermeasures development program.

HIPAA

Fri, 21 Sep 2007 10:59:25 EDT

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) will fundamentally change the way personal health information is used and disclosed. These changes will impact every health care provider and health insurer in the United States, as well as a substantial number of employers.

The Era of Medicare Defining, Measuring and Paying for Quality

Fri, 21 Sep 2007 10:59:35 EDT

Since implementation in 1994 of a substantially improved small business investment company program, the number of privately-managed small business investment companies receiving reasonably-prices, government-backed financing has increased rapidly. In the federal fiscal year ended Sept. 30, 2000 alone, SBICs invested nearly $5.5 billion in over 3,000 businesses. This represents an increase of 30% over the prior year, due primarily to the growing popularity of the Small Business Administration's equity leverage program. Not only have the levels of government-backed funding for program participants increased dramatically, but at the same time those funding levels have become more reliable by becoming less dependent on Congressional budget appropriations.

EEC Perspectives - May 2008

Mon, 20 Jul 2009 11:15:00 EDT

Included in this Issue:

A Market Perspective: Axel Bichara on the State of the Technology Industry
Technology innovation has been accelerating during the last centuries and will continue to do so. Innovation helps drive entrepreneurship and new business opportunities. That’s good news for entrepreneurs and early-stage investors in the US where the state of innovation andentrepreneurship continue to be exceptional. There are plenty of excellent startup opportunities. The funding environment for start-ups will remain strong, with an abundance of capital from both VC and private investors. (continues...)
New England First Round Transactions

Last Minute Reprieve: FTC Gives Businesses Until August 1, 2009 to Adopt Identity Theft Prevention Programs To Comply With Federal Red Flags Rules

Wed, 01 Sep 2010 16:30:21 EDT

On Thursday, April 30, 2009, just 24 hours before the Federal Trade Commission (FTC) was set to begin enforcement of federal Red Flags Rules, the FTC announced that it was giving businesses three additional months, until August 1, 2009, to comply with the new identity theft regulations. The FTC also promises to provide a “template” for compliance directed to “entities that have a low risk of identity theft.” This announcement is welcome news for businesses that have been struggling to develop a compliant program by the end of the day today.

Are Genes No Longer Patentable?

Fri, 02 Apr 2010 12:09:18 EDT

In a much anticipated decision that has attracted the attention of pharmaceutical and biotech companies, medical researchers, physicians, attorneys and patients concerned about their risk for breast or ovarian cancer, Judge Robert W. Sweet of the U.S. District Court for the Southern District of New York ruled in favor of the plaintiffs on March 29, 2010 in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. [continues... ]

EEC Perspectives - October 2008

Mon, 20 Jul 2009 11:15:04 EDT

Included in this Issue:

A Market Perspective
Selected New England "Series A" Round Transactions
Commentary from Bruce Kinn
Terms of Selected New England Series A Rounds 2008
Commentary from Mark Haddad
The Activity Level Summary: New England Series A and First Round Transactions by Industry
Size of New England 2008 Year to Date Series A and First Round Transactions by Industry
Commentary from Paul Sweeney

Bipartisan Follow-on-Biologics Legislation Introduced in the House

Fri, 14 Mar 2008 16:21:11 EDT

Key Members of the House Committee on Energy & Commerce have introduced bipartisan legislation which would create an abbreviated approval pathway for biosimilars or follow-on-biologics (FOBs). The Pathway for Biosimilars Act, H.R. 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), enhances the prospects for congressional action in 2008, following Senate HELP Committee action last year on S. 1695, a comparable bipartisan bill introduced by Senators Kennedy, Enzi, Clinton and Hatch.

A Stronger MedPAC May Be Part of Health Reform

Mon, 20 Jul 2009 11:22:21 EDT

As part of the health care reform debate unfolding in Washington, the Senate Finance Committee, in particular, has made cutting costs in Medicare a priority issue as a means of financing broader health care reform. [continues...]

Healthcare Alert - Interim Grandfather Rule Summary

Wed, 23 Jun 2010 14:56:31 EDT

On June 14, 2010, the Departments of Treasury, Labor, and Health and Human Services published the Interim Final Rules for group health plans and health insurance coverage relating to status as a grandfathered health plan under the Patient Protection and Affordable Care Act (PPACA) with request for comments. Comments are due on or before 60 days after publication in the Federal Register.

New Form I-9 Goes Into Effect Today

Wed, 02 Dec 2009 17:33:55 EDT

The revised Form I-9, Employment Eligibility Verification (Rev. 02/02/09), goes into effect today for all U.S. employers. This form must be used for all new hires and for existing employees who require re-verification. Employers are not otherwise required to replace completed I-9 forms with the revised form.

Medicare Coverage & Payment For New Technologies

Thu, 18 Jun 2009 10:48:38 EDT

Understanding Medicare coverage and payment policy is critical to the successful launch of any new life sciences technology. Foley Hoag’s Medicare Coverage & Payment Practice provides regulatory and legislative advice to a broad array of leading life sciences companies, including:

global pharmaceutical and biotechnology firms,
trade associations,
venture capital and investment funds,
patient associations and advocacy groups, and
early-stage companies.

New Federal Health Reform Law Includes “Sunshine” Reporting Requirements for Drug and Device Manufacturers

Thu, 25 Mar 2010 15:15:10 EDT

On March 23, President Obama signed into law the Patient Protection and Affordable Care Act (Pub. L. No. 111-148). Section 6002 of the Act (the “new federal law”) creates significant new obligations for drug and device manufacturers, by requiring annual disclosure filings detailing their financial relationships with physicians and teaching hospitals. These new federal requirements are also known as the “Sunshine” provisions, since they were originally proposed in 2007 as the “Physician Payments Sunshine Act” by Senators Charles Grassley and Herb Kohl. [continues...]

Healthcare Alert - Interim Final Rules on Preexisting Condition, Lifetime & Annual Limits, Rescissions, and other Patient Protections

Wed, 23 Jun 2010 14:47:20 EDT

On June 22, 2010, the Departments of the Treasury, Labor, and Health and Human Services issued interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preexisting condition exclusion, lifetime and annual dollar limits on benefits, rescissions, and patient protections. These interim final regulations are effective 60 days after publication in the Federal Register. Comments are due on or before 60 days after publication.

Supreme Court Favors Express Preemption of Medical Device State Tort Claims

Thu, 21 Feb 2008 17:13:31 EDT

On February 20, in an 8-1 decision, the United States Supreme Court held that state common law tort claims against medical device manufacturers are preempted by FDA’s approval under the Premarket Approval (PMA) process. The decision dramatically enhances the regulatory compliance defense for Class III medical devices that receive Premarket Approval (PMA) from the Food and Drug Administration (FDA).

USCIS Requires Federal Contractors to Use New E-Verify System

Mon, 01 Dec 2008 11:36:30 EDT

Effective January 15, 2009, the United States Citizenship and Immigration Service (USCIS) will require federal contractors to use its E-Verify system. E-Verify is an automated system of verifying employees’ identity and authorization to work through the databases of both the Social Security Administration and the Department of Homeland Security. Enrollment will be required for most prime federal contracts with a period of performance longer than 120 days, a value above the simplified acquisition threshold ($100,000), and for work to be performed in the United States. This requirement also will apply to indefinite delivery or indefinite quantity contracts. The federal contractor and any covered subcontractors will need to enroll in E-Verify within 30 days of the contract award date.

Comprehensive Health Care Reform Enacted into Law

Tue, 20 Apr 2010 11:40:09 EDT

President Obama has signed the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) and an associated reconciliation bill that "fixes" certain fiscal elements in the Act. The Act is intended over ten years to expand health coverage to 32 million uninsured Americans and reduce the Federal budget deficit by $143 billion, while banning discrimination on the basis of pre-existing conditions, gender or health status, and ending lifetime and annual limits on health benefits. [continues... ]

Summary of Proposed DPH Regulations 105 CMR 970.000 - Pharmaceutical and Medical Device Manufacturer Conduct

Wed, 17 Dec 2008 10:46:51 EDT

Excerpt:

On August 10, 2008, Governor Patrick signed into law omnibus healthcare cost containment legislation, entitled an Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, Chapter 305 of the Acts of 2008. Section 14 of this Act created Chapter 111N of the Massachusetts General Laws, entitled Pharmaceutical and Medical Device Manufacturer Conduct. Chapter 111N governs the marketing activities of pharmaceutical and medical device manufacturing companies, and establishes certain related disclosure requirements. With the enactment of this legislation, Massachusetts joined the District of Columbia and six other states in regulating the relationships between the pharmaceutical and medical device industries and physicians... (continues)

Tumor’s Molecular Missile Blunts Body’s Defense

Wed, 28 Nov 2007 13:20:02 EDT

Foley Hoag client Dr. Margaret Shipp and her colleagues at Dana-Farber Cancer Institute have discovered that Galectin-1, a carbohydrate-binding protein, is useful for the prognosis, diagnosis, and treatment of Hodgkin's Lymphoma. Philip Choi, Hathaway Russell and DeAnn Smith, of Foley Hoag's Intellectual Property Group handled the IP matters for the work described in the attached article in Focus Online, the newsletter of Harvard Medical, Dental and Public Health Schools.

The full article is available here: http://focus.hms.harvard.edu/2007/091407/oncology.shtml.

Litigios y Arbitrajes Internacionales

Tue, 01 Sep 2009 10:33:02 EDT

Litigios y Arbitrajes entre Estados Soberanos
Arbitrajes entre Estados
Soberanos e Inversionistas
Arbitrajes Internacionales Comerciales
Litigios ante las Cortes de los Estados Unidos

Client Alert: FDA Issues Order Requiring Safety and Effectiveness Information from Older Medical Devices

Mon, 02 Nov 2009 12:08:27 EDT

On April 9, 2009, the Food and Drug Administration (FDA, or the Agency) issued an order that requires manufacturers of 25 high risk Class III medical devices, which were marketed before 1976 but have not yet undergone the premarket approval (PMA) review process, to submit safety and effectiveness information to the Agency. 74 Fed. Reg. 16214-17 (Apr. 9, 2009).

FTC Gives Businesses Until May 1, 2009 to Adopt Identity Theft Prevention Plans that Comply With Recent FTC “Red Flags” Regulations

Wed, 01 Sep 2010 16:32:04 EDT

On Wednesday, October 22, 2008, the Federal Trade Commission issued an Enforcement Policy Statement that it will delay some elements of enforcement of recent “Red Flags” regulations until May 1, 2009, instead of the original November 1, 2008 date.

NIH Releases Guidelines for Federal Funding of Human Embryonic Stem Cell Research

Tue, 12 May 2009 11:55:21 EDT

On March 9, 2009, President Obama lifted former President Bush’s restrictions on federal funding for human embryonic stem cell research by signing Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. In the Executive Order, the President permits the Secretary of Health and Human Services (“HHS”), through the Director of the NIH, to support and conduct “responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”

[continues...]

Massachusetts Special Commission Proposes Abolition of Traditional Fee-For-Service Health Care Payment Model and Adoption of Global Payments

Thu, 10 Sep 2009 10:40:46 EDT

Overview

On July 16, 2009, the Massachusetts Special Commission on the Health Care Payment System (“the Commission”) released its final report [.pdf], in which it recommends abolishing the traditional “fee-for-service” (“FFS”) payment model for all public and private payers in Massachusetts, and replacing FFS with a “global payments” model. Under a global payments model, health care providers would be compensated prospectively for most (or all) of the care their patients will receive over a set contractual period. As Massachusetts would be the first state in the nation to eliminate FFS for both public and private payers, this proposal would, if implemented, constitute a significant change in how health care is delivered and reimbursed. Additionally, the Massachusetts payment reforms could provide a model for national payment reform initiatives. Understanding the Commission’s recommendations is therefore crucial for anyone involved in the health care, insurance, biotechnology, or drug and device sectors. [continues...]

New Medicare Tax Targets Investment Income

Fri, 26 Mar 2010 17:21:23 EDT

Last night, March 25, 2010, Congress passed a “reconciliation bill” that amends the Health Care Act signed by President Obama on March 23. The President is expected to sign the amended legislation next week. The amended legislation introduces a new 3.8 percent Medicare “contribution” payable by individuals, and some estates and trusts, on “net investment income.” The new tax will first apply in 2013.

Medical Devices Play a Large Role in Massachusetts Health Care Fraud Unit Cases: September 2008 – September 2009

Wed, 19 Aug 2009 15:56:11 EDT

A retrospective review of the cases brought by the Massachusetts U.S. Attorney’s Office Health Care Fraud Unit between September 2008 and September 2009 reveals a high number of cases involving medical devices as compared to drugs or other medical products. Medical devices include a wide range of products, such as implants, stents, heart pacemakers, fetal monitors, x-ray equipment, and thermometers. They are used in patients for the purposes of diagnosis, therapy or surgery. By definition, medical devices do not achieve their primary intended purposes through “chemical action” and are not “dependent upon being mobilized” to achieve their primary intended purposes. Medical devices often require approval by the Food & Drug Administration (“FDA”) before they may be legally distributed and marketed.

The gamut of products that may be considered medical devices are reflected in the cases brought by the Health Care Fraud Unit over this past year.

IRS Issues Final Instructions for Redesigned Form 990

Tue, 23 Dec 2008 13:34:30 EDT

The Internal Revenue Service (IRS) has released final instructions for completing the Form 990, the annual information return filed by most non-profit entities, which has undergone its first major redesign in almost 30 years. The new Form 990 will be phased in over three years, starting with fiscal years beginning on or after January 1, 2008. The old Form 990 will not be accepted beginning with the 2008 tax year. Full instructions on the new Form 990 are available on the IRS Web site.

ACI's Advanced Forum on Biotech Patents

Tue, 26 May 2009 11:08:39 EDT

Come to the one forum that will help you revise your strategies to adapt to new industry standards.

Emerging from a turbulent year of new case law, a resurgence of the proposed PTO rules, uncertainty associated with a new administration, and tough economic conditions, biotech patent practitioners must prepare for a new phase in this ever-evolving field. And with groundbreaking legislation regarding patent reform and follow-on biologics on the horizon, patent counsel must rise to the challenge to overcome increasing rejections, promote innovation and maximize profitability.

With this in mind, ACI’s 11th Advanced Forum on Biotech Patents once again brings together a high-caliber team of experienced biotech patent counsel who will share their collective knowledge and provide you with the most up to date strategies you can immediately incorporate into your practice.

Foley Hoag's Barbara Fiacco to speak at this conference.

For more details, please access ACI's website.

Information and Communications Technology at Greenbuild: The Springboard for Innovation and Execution

Fri, 30 Oct 2009 10:39:13 EDT

Buildings play a critical role in protecting and improving our environment and the health of the people who occupy them. The most dramatic effects come from the use of information and communication technologies (ICT), which can reduce far more emissions than they generate, through both revolutionary breakthroughs and simple adjustments. The role of ICT is a consistent thread throughout Greenbuild, from new teaching tools and performance measurements, through interactive technologies, real-time response, and the vast array of ICT tools that support the design and deployment of energy and environmental solutions.

Foley Hoag Partner Mark Barnet will deliver the welcome address.

Personalized Medicine: Is There a Role For Devices in the Coming Revolution?

Fri, 30 Oct 2009 10:39:18 EDT

David Hendren of Catalyst Health Ventures with moderate a panel on personalized medicine in the device space, exploring cost benefit trade-offs between the blockbuster model and individualized treatment.

C5’s Biotech Patenting Conference

Mon, 04 May 2009 14:08:35 EDT

C5’s Biotech Patenting Conference is the ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today. You cannot afford to miss this essential briefing on the state of biotech patenting as it reels from not only new scientific advances, but also legislative and practical changes in the rules of patent practice. It seems at every turn, patent practice is being assailed, whether through internal rule changes from the EPO, profound court cases such as Olanzapine, the treatment of biosimilars and gene patents or overhauling legislation designed to pull the rug out from under traditional patent practice.

Foley Hoag's Barbara Fiacco will be speaking at this conference.

NECINA WEB SIG Kickoff Meeting and Seminar: Collaborative Innovation Networks

Fri, 30 Oct 2009 10:39:22 EDT

Collaborative Innovation Networks, or COINs, are cyberteams of self-motivated people with a collective vision, enabled by technology to collaborate in creating a cool trend - an innovation - by sharing ideas, information, and work. COINs have been around for hundreds of years. Many of us have already been a part of one without knowing it. What makes COINs so relevant today is that the concept has reached its tipping point - thanks to the Internet and the World Wide Web. COINs are powered by swarm creativity. People work together in a structure that enables a fluid creation and exchange of ideas. It may look chaotic from the outside, but the structure of a COIN is like a beehive or ant colony, immensely productive because each team member knows intuitively what she or he needs to do.

National Summit on Personalized Health Care

Thu, 11 Sep 2008 15:36:40 EDT

This invitation-only Summit will enable a highly interactive exchange between key decision makers from every sector of health care to create strategies and action plans to accelerate the integration of personalized health care into clinical practice and health care delivery.

The Future for Home Use Devices

Thu, 06 May 2010 10:33:51 EDT

Join us in a conversation with industry thought leaders for a panel discussion on the rapidly growing category of home health care products and the technologies that are driving opportunities. Experts from the business sector, technology, and human-centered design will share key data, information, and point of views on trends affecting this space.

Medical Device Pricing & Reimbursement

Tue, 13 Apr 2010 17:14:26 EDT

Bruce Quinn, M.D. of Foley Hoag LLP is speaking on the American Conference Institute panel, "Coverage, Coding and Payment: A Re-Examination of the Basics in View of New Devices and Technologies."

Medical Development Group

Wed, 12 Sep 2007 21:02:01 EDT

Relatively few medical device company start-ups succeed. Why? Many factors could contribute: Leadership and investors may lack sufficient experience. The organization and internal infrastructure may not be developed in time. The market changes or turns out not to be as expected. Longer than anticipated product development or FDA approval, or an inability to obtain suitable reimbursement levels, can drain cash and put a financial strain on a fledgling organization.

Mass High Tech's 8th Annual BioForum

Mon, 11 Jan 2010 13:18:18 EDT

“Partnerships have become the No. 1 topic of discussion for big pharma and small biotechs alike. Never have the stakes been bigger. MHT’s BioForum panel of platform technology entrepreneurs and experts will explore the dangers of jumping into a partnership too early, strategies for due diligence in potential partners and strategy distinctions between longer-term operational partnerships vs. onetime product alliances.”

Foley Hoag Partner Jeff Quillen will be participation in this dicussion.

CFO Roundtable Forum: Mergers & Acquisitions - Execution for Strategic Advantage

Wed, 04 Nov 2009 13:47:52 EDT

NOTE: Attendance is limited to financial executives.

This panel will discuss the legal, strategic and operational issues faced by executives in the world of mergers and acquisitions. The audience will hear the perspectives of a CFO who led the sale process for their company, a CFO who led the acquisition strategy of his company, an executive from the leading provider of on-line data rooms to discuss how due diligence has been accelerated by technology, and a partner of a law firm which is very active in advising corporate M&A transactions. This program will offer two CPE credits.

Foley Hoag's John Hancock will participate in the panel discussion.

December 2008 Forum: Expert Panels, Advisory Boards and User Groups - Using Key Opinion Leaders to Help Achieve Business Goals

Fri, 30 Oct 2009 10:39:07 EDT

Market input is a crucial element of success in any business enterprise. From a start-up to a mature operating business, failure to get comprehensive information on market needs, perceptions and trends may quickly bring a promising venture from excitement to frustration. Early stage entrepreneurs are particularly vulnerable for several reasons: convincing data on market segments, target users, decision makers and sales processes are generally a pre-requisite for successful fund raising; obtaining good market intelligence usually requires a financial investment; and finally, because quite often one or more of the company founders, officers or directors are part of the target user population, there is a temptation to skip market research and rely on the personal knowledge or anecdotal information.

Mobile Advertising - Industry Revenue Enhancer or Distraction?

Fri, 30 Oct 2009 10:39:21 EDT

We have been hearing a lot of buzz over the last few years about mobile advertising adding significant revenue to the wireless industry across the value chain. However, mobile advertising is still an insignificant percentage of the mobile revenues and the advertising spend. What does that mean for the future of mobile advertising? Will it indeed significantly add to both the top and bottom lines or will it just be another revenue sliver? What must the industry and the players do to have this market sector grow?

TCN - Founder Equity Issues

Fri, 30 Oct 2009 10:39:28 EDT

This limited seat members-only luncheon provides attendees invaluable information on addressing Founder equity issues to avoid the pitfalls that can reduce the value of the enterprise to the Founders and harm a company's ability to attract investment capital. Working lunch programs are hosted by TCN's professional service sponsors to provide tactical level information designed to accelerate the fundraising process.

PLI Corporate Compliance and Ethics Institute 2007

Fri, 21 Sep 2007 10:59:32 EDT

Designing an effective risk assessment is a key element of any comprehensive compliance program. Knowing how to gather the relevant information and dealing with the latest legal issues is crucial. At PLI's premier Corporate Compliance and Ethics Institute 2007, top in-house counsel, outside counsel and corporate compliance officers will equip you with the latest techniques in this and other major compliance areas.

Medical Development Group Forum Panel

Thu, 10 Jan 2008 16:36:11 EDT

Health care policy decisions made at the Federal and State levels have profound effects upon the regulatory requirements for bringing new medical technologies to market and operating a business, the availability of financing for new enterprises, the development of a labor force with the skills necessary to meet industry’s needs, patterns of coverage and reimbursement for both diagnostics and therapeutics, and the ability of providers to meet the health care needs of an aging population. Join a panel of leading health policy analysts and advocates for a discussion of some of the critical policy initiatives that will help shape the future of medical device and other life science companies in Massachusetts and the nation.

TCN: Funding Expedition™ Mixer

Tue, 30 Sep 2008 09:26:00 EDT

Are you an entrepreneur wanting to learn more about navigating New England’s business and funding landscape? Are you an investor seeking to mentor and become even more integrated in New England’s entrepreneurial community? Save this date to bring your ideas to a (free) networking event with entrepreneurial experts!

MIT Enterprise Forum Innovation Series: The Future of Biotech

Wed, 04 Nov 2009 13:48:12 EDT

Keynote Speaker: G. Steven Burrill, Chief Executive Officer, Burrill & Company

Moderator: Janice T. Bourque, Senior Vice President and Group Head, Life Sciences, Comerica Bank

Stem Cell Panel:

Chad Cowan, Ph.D., Harvard University Department of Stem Cell and Regenerative Biology and Massachusetts General Hospital
Richard A. Insel, M.D., Executive Vice President, Research, Juvenile Diabetes Research Foundation
Celia M. Witten, M.D., Ph.D., Director, Office of Cellular, Tissue, and Gene Therapy, Center for Biologics Evaluation and Research Food and Drug Administration

Understanding the New Data Security Law

Thu, 13 Nov 2008 12:20:36 EDT

Last year, Massachusetts enacted a comprehensive data security law intended to protect residents from identity theft. While many assumed that the law would be focused on protecting consumers, it broadly covers all businesses with employees in Massachusetts, not just those that collect customer information. Recent regulations impose significant compliance obligations on all employers and require action by the beginning of the year.

From Science to Compliance: Navigating the Regulatory Maze

Wed, 04 Nov 2009 13:48:15 EDT

Moving your bio-pharma product from Discovery to IND through to Production requires critical compliance choices at each step in the process. In this panel-based workshop you will learn from industry experts how compliance choices for life science companies guide the workflow management process. Good choices lead to intelligent tradeoffs in the capture and cataloging of intellectual property, product development research, product quality characterization for clinical trials and final product QC/QA record keeping for scaled production release. Where you are in your company’s life-cycle, whether you are an emerging new business or an innovative established business often constrains the cost/benefit and associated risk/reward tradeoffs in how you implement quality programs at each step in the product commercialization process. Learn the ins and outs of the regulatory maze so you can make the right compliance choice at the right time.

Prescription Drug Pricing

Fri, 29 Feb 2008 09:58:34 EDT

With changes to AMP, increased transparency and the uncertainty of AWP’s future, it is now more important than ever to have a comprehensive pricing strategy in place. To ensure your rebate reimbursement exposure is limited, that you are being adequately reimbursed for drugs provided to beneficiaries or that pricing for government programs is not negatively affecting commercial prices, you need to understand the changes that are taking place and devise a strategy to deal with them.

Nearly every major component of the pharmaceutical industry, as well as public and private healthcare, is in a tailspin. R&D, IP, product and formulary placement, and patient access all have been touched by these reforms in some way.

These newest reforms are at the root of new and continuing anxieties over pricing transparency and fraud and abuse. They also exacerbate the scope of existing dilemmas, such as public and private pricing litigation and criminal enforcement actions. Will Medicare Part D pricing and AMP reform under the DRA bring something akin to the long-waged civil and criminal AWP suits?

Hear from those in the trenches of pricing and reimbursement, and hear first-hand how the new landscape is evolving. Network with your peers and benefit from the written materials prepared by the speakers especially for this program.

Foley Hoag Partner, Nick Theodorou, will be moderating the Federal Pricing Enforcement Update.

2009 M&A Outlook

Wed, 04 Nov 2009 13:47:36 EDT

A panel of distinguished investment bankers will discuss the current market for M&A, share some recent statistics and offer their outlook for 2009.

Foley Hoag Partner Bill Kolb will moderate the discussion.

Wireless Interference in the Clinical Environment and Wireless Regulatory and Interoperability Update

Wed, 04 Nov 2009 13:48:23 EDT

Technology changes rapidly, but nowhere does it change as rapidly as in healthcare. The convergence of multiple wireless technologies with the need for “better, cheaper, faster” healthcare is driving the evolution of medical devices (along with healthcare in general) in directions and speeds never seen before. The presentation will discuss the increasing use of wireless communications technologies in healthcare, the benefits, the problems, the obstacles, and the opportunities.

September 2009 Supernetworking: Start-up Funding in Hard Times

Wed, 04 Nov 2009 13:48:18 EDT

Last year’s SuperNetworking event addressed how difficult medical device and diagnostics entrepreneurs had “…securing equity investments despite the fact that investors (VCs, private equity firms, etc.) have large amounts of uncommitted capital.” What a difference a year makes! This year’s kickoff event addresses the challenges these same entrepreneurs now face, given today’s extremely difficult economic and financing environment. We are pleased to be able to offer attendees perspectives from both the private and public sectors, in what is sure to be an informative evening for medical device entrepreneurs of all stripes.

Mass Technology Leadership Council's Health Care Lunch & Learn

Wed, 10 Oct 2007 16:52:35 EDT

The senior market continues to explode demanding attention of the healthcare market. With fewer clinicians to care for the seniors, businesses are stepping forward with technology solutions to help seniors monitor and manage their health from their home whether it is in the community or on a senior living campus.

According to Forrester, the Healthcare Unbound market (i.e. "technologies away from formal institutions") for ADL/Elder technologies will surpass $1 billion in 2010. This represents opportunities for many different healthcare applications including Personal Emergency Response, Vitals Monitoring, Medication Management and Remote Home (sensor- based) Monitoring.

Healthcare technology companies are taking different paths to reach out to the senior market both from a segmentation and partnership perspective. Who will ultimately bring these products and services to the seniors (and their families), pay for them and support them on an ongoing basis?

4th Advance Forum on Import Compliance

Mon, 08 Sep 2008 09:09:24 EDT

Now in its 4th successful year, the American Conference Institute’s Advanced Forum on Import Compliance, is the event that import compliance professionals rely on for comprehensive, insightful and practical guidance on how to set up a successful import compliance program. Benefit from the practical perspective of senior corporate customs compliance executives including Del Monte, Hasbro, IBM, Raytheon, Hitachi, General Electric, Nestle, Target, Tyco International, and Williams-Sonoma. Get an update on 10+2, ACE, ISA, C-TPAT validations and import safety standards, and hear from top CBP representatives on enforcement priorities.

Foley Hoag Partner Jayne Bultena will lead a presentation titled "Fundamentals of FDA Compliance: What You Need to Know When Importing Food, Drugs and Devices."

Designing Cardiovascular Devices

Fri, 21 Sep 2007 10:59:21 EDT

This seminar provides attendees with an overview of cardiovascular anatomy, physiology and pathophysiology from a medical device perspective. The unique Begin with the Body in Mind™ approach first tries to understand how the body is "designed" to work – then how to design a medical device to work with the body – not against it! Multiple examples of cardiovascular devices and procedural videos are presented in an interactive format with a discussion of what they do well and where improvements can be made.

BIO 2009 International Convention

Wed, 06 May 2009 16:15:52 EDT

Foley Hoag is a proud sponsor of the 2009 BIO International Convention, which will be held May 18-21, 2009 at the Georgia World Congress Center in Atlanta, GA. For more information related to this convention, please visit BIO's website at bio.org.

TiE: Emerging Opportunities in Green IT

Wed, 04 Nov 2009 13:48:20 EDT

What are the business drivers and needs of clean technology industry? What works well, and what are the white spaces? Join us for this exciting discussion with a panel of experts who are leveraging the power Information and Communication Technology to fight against Climate Change while improving quality of life. Learn how the current economic downturn and President Obama’s focus on renewable energy create exciting opportunities in Green IT.

Foley Hoag Partner, Mark Haddad, will moderate the panel discussion.

Panelists:

Rajesh Nair, Founder, CTO, Degree Controls
Terry Swack, Co-Founder and CEO, Sustainable Minds
Alexander Wissner-Gross, Co-Founder, CO2 Stats

CFO RoundTable Forum presents Treasurer Tim Cahill and State and Local Tax Experts

Fri, 30 Oct 2009 10:39:03 EDT

Our featured speaker will be Tim Cahill, Treasurer of the Commonwealth of Massachusetts. Treasurer Cahill will discuss several topics including:

The 2008 capital markets crisis, and its impact on the Commonwealth.
What the 2008 election will mean for the Commonwealth.
The state's plan to keep Massachusetts a "business-friendly" environment.

Business for Social Responsibility (BSR) 2006 Annual Conference

Wed, 12 Sep 2007 21:02:01 EDT

The Business for Social Responsibility (BSR) Annual Conference serves as both a construction site and an exhibition hall for the work of building a more just and sustainable global economy. As a Supporting Sponsor of BSR's 2006 Conference, Foley Hoag's Corporate Social Responsibility Group will interact with other business leaders in the field and provide insight about successfully incorporating CSR into top-level legal strategies to gain a competitive advantage. NGO and public policy leaders from more than 40 countries will be on hand to share what they have accomplished in the last year, as well as the issues and efforts that are affecting leading companies now and in the future.

BIO 2010 International Convention

Fri, 16 Apr 2010 13:34:49 EDT

Going to BIO 2010 in Chicago? Foley Hoag is a proud sponsor of BIO 2010, and the exclusive sponsor of the Legal/Intellectual Property Track.

ACC Annual Meeting '08

Fri, 05 Sep 2008 17:05:49 EDT

Foley Hoag is a proud Gold Sponsor of the ACC's 2008 Annual Meeting. Visit our booth on the exhibition floor, and attend sessions featuring Foley Hoag lawyers.

Session 113: In-house Counsel as Circus Ringmaster, on Monday, October 20 from 11:00 a.m.-12:30 p.m. Michael Keating from Foley Hoag will join this panel in the Global/International Legal Affairs program track.
Session 202: The Tricks & Traps of Corporate Intrapreneurship & Entrepreneurial Investment: Getting the Most Out of a New Business, on Monday, October 20 from 2:30-4:00 p.m. This program will be moderated by Foley Hoag Partner Peter Rosenblum and will be presented as part of the Small Law Department track.

Stay tuned to this page for more information on what Foley Hoag has planned for ACC's 2008 Annual Meeting.

MassTLC Healthcare/IT Summit: Is the Consumer the Next Big HealthCare IT Buyer? Opportunities & Obstacles

Mon, 09 Jun 2008 16:39:33 EDT

During the past 18 months, we've seen significant investment in patient-centric healthcare technology solutions from major IT vendors such as Microsoft (HealthVault), Google (Google Health), IBM (Center for HealthCare Management), Intel (Digital Health Group), and Apple (iPhone as healthcare platform -- Kleiner Perkins is investing $100M into companies developing new applications for the iPhone).

T3 - Profitable International Expansion

Fri, 30 Oct 2009 10:39:26 EDT

The “If You Build It, They Will Come” theory does not apply to setting up a profitable international distribution model. Technology companies seeking to reach new markets face extraordinary operational complexity when deploying distribution channels in multiple countries. The goal is to establish an integrated, global operations footprint that balances highly efficient supply networks and uses effective communication and evaluation techniques to drive both growth and profitability.

Understanding the American Recovery & Reinvestment Act: NIH Life Sciences Grants and Funding for Health Information Technology

Tue, 05 May 2009 13:10:23 EDT

President Obama signed H.R. 1, the American Recovery and Reinvestment Act of 2009 (“Recovery Act”) into law on February 17, 2009. The bill represents the largest investment in public works since the Great Depression and is an effort to revitalize an economy in crisis by infusing $787 billion into state coffers, small businesses, and struggling families.

The Recovery Act includes more than $150 billion for the healthcare industry, including $10.4 billion for the National Institute of Health (NIH) and $19.2 billion for Health Information Technology (HIT). For life sciences researchers and healthcare technologists, this means incredible opportunities for new funding.

7th Annual BioForum

Thu, 15 Jan 2009 10:15:38 EDT

Join Mass High Tech for our 7th annual BioForum, Outlook on Biotech: Survival Strategies. Each year, our Bio Forum highlights key industry trends through lively and insightful discussion by the region's top life sciences thought leaders. Now more than ever, you won't want to miss this opportunity to learn best practices, share insights and network with your peers.

Foley Hoag Partner Jeff Quillen will moderate the discussion.

BSR Annual Conference -- San Francisco

Tue, 16 Oct 2007 13:49:42 EDT

Business for Social Responsibility understands that to shape a truly sustainable future for business and society, it is essential to consciously design innovative strategies to get there. A reactive approach, or one focused on isolated best practices, won't deliver the results we want and need. A sustainable future depends on integrated, comprehensive solutions at the ever-changing intersection of business and society.

CFO Roundtable Forum

Fri, 30 Oct 2009 10:39:03 EDT

Program begins at 8:00 a.m.

Panelists:
Kenneth Bement, Project Manager, Financial Accounting Standards Board
Jeff Mead, Managing Partner, CCR Group
Ed Tiffany, Chief Financial Officer, CambridgeSoft

Receive an update on FASB Revenue Recognition Project, auditors and CFOs perspectives on revenue recognition challenges and opportunities plus a roundtable discussion on three real-life revenue recognition challenges – strategic and financial reporting challenges faced by these CFOs. This program will offer 3 CPE credits.

Medical Development Group: What VCs want and how they get it: Assessing, Reducing and Managing Investment Risk

Wed, 04 Nov 2009 13:48:11 EDT

This is a program for optimists! Despite the gloomy headlines and uncertain economic outlook, this may actually be a good time for entrepreneurs to start new companies and raise venture capital. Recent VC transaction statistics show that the financing market for early-stage start-ups remains surprisingly robust. VCs continue to seek out promising new technologies which target large markets and address unmet clinical needs. The trick is knowing what matters most to your potential investors and addressing these issues early in the company formation process. Our experienced panel will offer their views on the current environment for venture capital financing and how best to address the needs of these investors.

Social Networking Series: Building a Social Media Strategy

Wed, 11 Nov 2009 15:27:39 EDT

Many companies have found that traditional marketing campaigns are no longer effective in reaching target audiences. The rules of marketing have changed. Consumers no longer trust information provided through traditional marketing vehicles and have learned to ignore most marketing messages.

{T3} Managing Your Burn Rate

Wed, 04 Nov 2009 13:48:18 EDT

With credit markets distressed and equity hard to come by cash is not just king -- it’s more like gold, and entrepreneurs need to manage it like a precious and scarce commodity.

In this T-Cubed session a panel of CFO’s and consultants will share their experience in extending the cash in their respective organizations while balancing other critical factors.

2009 National Summit on Personalized Health Care

Fri, 04 Dec 2009 13:36:52 EDT

The annual Summit on Personalized Health Care, held in Deer Valley, Utah, assembles the world's most influential thought leaders in personalized health care (PHC) to collaborate on progress and plans related to each key community’s agenda. In addition to an annual "reality check", the Summit offers a rich source of peer-level networking and high-level, cross-silo interaction that enriches policy and decision making, targeted development and investment, and overall innovation.

Foley Hoag is a Community Sponsor of the Summit on Personalized Health Care, as well as a participant in the Health Insurance track.

Healthcare Technology: Selling Successfully to the Corporate, Consumer and Payor Segments

Wed, 04 Nov 2009 13:48:03 EDT

There are distinct customers in the healthcare technology market, each with their own purchasing needs, attitudes, policies and budgets and all of which are undergoing constant change. Healthcare technology companies face the challenge of creating offerings that “speak to” these markets, while continually refining products, services, and sales strategies in response to shifts in the healthcare landscape.

FDA Bootcamp: Basic Training for Products Liability and Patent Lawyers

Thu, 19 Mar 2009 15:37:41 EDT

ACI’s FDA Boot Camp, the industry standard in providing non-regulatory professionals with a regulatory background, has been designed to give products and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of the FDAAA.

Foley Hoag's Don Ware will be speaking on Follow-On (Comparable or Biosimilar) Biologics.

Tuck Business & Society Conference 2009: Is Capitalism Sustainable?

Fri, 09 Jan 2009 09:55:13 EDT

The Tuck Business & Society Conference, the leading graduate student-run conference on sustainability and socially responsible business since 2002, provides a dynamic forum for current and future business leaders, industry experts, and community stakeholders to discuss the responsibilities and opportunities businesses face in today’s society. There has never been a more critical time to integrate business success, social responsibility, and environmental sustainability.

Foley Hoag's Mark Barnett will present on “Clean Tech: Overcoming Barriers to Economically Sustainable Renewable Energy,” scheduled for Thursday from 5:00-6:30 pm.

Ethical Challenges and the CFO

Fri, 30 Oct 2009 10:39:32 EDT

A CFO must establish and maintain the ethical framework for her or his organization. As the "conscience of the company," the CFO is often the final decision-maker on ethical issues, not only inside of the finance and accounting organization, but also in other areas such as customer relations, human resources, marketing communications, and in dealing with society at large. Indeed, as doing business has become more global, ethical issues have increased in complexity. Behavior that might be thought as ethical in the U.S., might be considered unethical to other cultures. CFOs who are often accused of seeing things in black and white, have discovered that business ethics have many shades of gray.

Career Management Workshop

Thu, 07 Jan 2010 10:37:25 EDT

Kick off the New Year with a boost to your career at these dynamic workshops, co-sponsored for the very first time by MDG and the ISPE Boston Area Chapter.

Photonics/Optics - Understanding the Latest Applications of Light-based Technologies in Medical, Consumer, Industrial, and Defense Sectors presented by the EntreTech Forum

Wed, 04 Nov 2009 13:48:13 EDT

Whether for treating disease, advancing solar energy cells or enhancing semiconductor performance, recent advances in photonics and optics have created myriad opportunities for entrepreneurs to break new ground across a tremendously wide spectrum of commercial activity. As ever, the Greater Boston area’s potent mix of university resources and entrepreneurial culture have made our region a leader in a new and constantly evolving technological field.

A Case Study of a Biotechnology-Related Action Before the International Trade Commission

Fri, 30 Oct 2009 10:38:59 EDT

A case study of an International Trade Commission Section 337 investigation will be presented. The session will provide a comprehensive overview of fast-paced 337 proceedings before the ITC, as well as the unique rules applicable to these investigations. Session participants will hear directly from experienced 337 litigation counsel from the United States and China. A hypothetical case study will walk session participants through a biotechnology-related proceeding, from the filing of the complaint to final adjudication.

SBIR/STTR Workshop: Strategies for Succe$$

Fri, 17 Oct 2008 16:38:08 EDT

Wondering how to address the funding gap? Have you considered applying for a SBIR, STTR or RO1? Federal funding may play a crucial role in starting and growing your small business without diluting your ownership. Did you know that it is now possible to receive ~4Million $$s from some SBIR agencies? Wondering if your technology is a fit for a solicitation? or Have you have applied & been unsuccessful? Then this workshop is for you!

MBC Law and Policy Committee Breakfast Educational Program/Networking Meeting

Tue, 20 Nov 2007 10:42:37 EDT

The Food and Drug Administration Amendments Act of 2007 (FDAAA) is arguably the most significant reform of drug safety in five decades. Its implementation will affect all sectors of FDA-regulated industry. For instance, in the area of drug safety and surveillance, FDAAA provides FDA with expanded authority to require a system of Risk Evaluation and Mitigation Strategies (REMS) for select drugs, order labeling changes, require post-market clinical studies, and fine those who fail to comply. In the area of clinical trials, FDAAA expands the current clinical trial registry into a comprehensive and publicly available Internet-based clinical trials database. Parties conducting clinical trials are required to register with the database and link to any existing published results, with civil monetary penalties imposed upon those who fail to comply.

To MBA or Not To MBA: Pros and Cons of Obtaining a Business Degree

Tue, 29 Apr 2008 09:40:44 EDT

Many in science and technology wonder whether or not they need an MBA to start a business, or how a business degree might advance their careers. This panel discussion features four successful scientists and engineers in business who either got MBAs, or succeeded without them, discussing the pros and cons of their choices.

Inspired Leadership: Women Leading Business into a Brighter Economy

Wed, 25 Feb 2009 13:59:42 EDT

Take a break from the recession to be inspired by the women leading top companies in Massachusetts through the best of times, and the worst of times. Hear the insight of CEOs from The Commonwealth Institute's Annual Top 100 Woman-Led Businesses List who are helping to shape the region's next generation of female executives.

Barbara Hamelburg, Partner at Foley Hoag, will join Trish Karter, CEO of Dancing Deer Baking Company and Kathy Sherbrooke, CEO of Circles, to discuss:

How to be part of a team and continue to be a strong leader
Strategies for delegating responsibilities to balance the workload
The overwhelming value of mentorship
Realistic expectations that keep your team inspired
Lessons learned from past economic slumps

Don't miss this opportunity to take these valuable "lessons learned" and apply them to your own leadership style during these challenging times.

This event is sponsored by Foley Hoag LLP

IEEE Consultants Network Meeting

Fri, 30 Oct 2009 10:39:13 EDT

Do you need more clients?
Are your old methods not working like they used to?
Are you ready to try new ideas?

Then this presentation is for you!

The Interoperability Challenge: Getting Devices to Talk to Each Other

Fri, 08 Jan 2010 14:20:57 EDT

Your bank can text you if your account balance is too low, but a medication pump doesn’t have the feedback technology to prevent an overdose. Our program examines the challenges of making medical devices speak a common "language" so that say, results from a diagnostic device can be immediately transmitted to another vendor's treatment device. You’ll hear the latest in medical device open systems and an update from the Founding Director of the Program on Medical Device Interoperability at CIMIT regarding what’s currently in use clinically. Join us for an evening of “straight talk” about instrument collaboration.

NEHI - Health Reform and the First 100 Days

Wed, 28 Jan 2009 16:12:35 EDT

Foley Hoag's Nick Littlefield to serve as a speaker at NEHI's interactive forum, Health Reform and the First 100 Days.

Women Entrepreneurs in Science and Technology (WEST)

Thu, 10 Jan 2008 16:36:11 EDT

You are invited to the annual WEST holiday party to be held at the British Consulate in Cambridge on January 17th.

The WEST celebration will provide excellent opportunities for:

Getting to know the WEST community
Enjoying delicious food
Being entertained and informed

This event is designed for men and women who want to learn more about WEST, network with colleagues, have fun, and celebrate women, entrepreneurship, science and technology.

Entertainment includes stand-up comedy by Sumedha Bahri who is a patent attorney at Hamilton, Brook, Smith & Reynolds by day, and an aspiring and talented humorist at night. There will also be formal and informal networking opportunities.

Process Analytical Technology (PAT)/Quality by Design (QbD): Integrated Systems in the Future Pharma Business Landscape

Wed, 04 Nov 2009 13:48:14 EDT

This presentation describes several applications of PAT and QbD approaches in bioprocess development and manufacturing for (1) monitoring, (2) controlling, (3) real-time release and (4) optimization. Examples from various cases will be presented, including new process analytic concepts for bioprocess monitoring, design of experiments, and multivariate data analysis.

Participants will gain valuable insight and a useful roadmap for leading their organizations to make the necessary changes for PAT and QbD.

Turning it Around: Restructuring, Refinancing, Recapitalizing and Other Responses to the Economic Crisis

Wed, 04 Nov 2009 13:48:21 EDT

Corporate defaults have trended sharply upward, creating crises for some and opportunities for others. As a business owner or investor you will likely need to know how to avoid, exploit or manage insolvency or bankruptcy situations in your own business, or in that of your customers, suppliers or competitors

The Intergenerational Game: Playing to Win in the New Work Place

Fri, 28 Aug 2009 16:32:39 EDT

In-ter-gen-er-a-tion-al, when used as an adjective, is defined as “being or occurring between generations”. Welcome to the Intergenerational Game, one that’s changing all the rules in today’s workplace. To win it, professionals and companies have to translate and harness the particular qualities of Boomers, the Gen-Xers, and the Gen-Nexters, in order to build and manage today’s blended and thoroughly unique work force.

Impact of the 2008 Election on the Labor and Employment Laws

Thu, 13 Nov 2008 11:45:17 EDT

With President-elect Barack Obama’s victory and Democratic gains in Congress, major changes in workplace laws are on the horizon. These could include:

A reshaping of the laws governing employee unionization, including changes in the manner by which employers become unionized, expansion of those employees who are eligible to be in a union, and binding arbitration for first contracts;
Expanded coverage of the Family and Medical Leave Act;
Limiting enforcement of binding arbitration provisions in employment agreements;
Easing time limits for filing pay-related discrimination lawsuits;
Increasing the minimum wage; and
Appointments and nominations at administrative agencies charged with enforcing labor and employment laws.

In addition, changes are likely during the Bush Administration’s final months in office, including new regulations to the FMLA.

Join Foley Hoag's Labor and Employment lawyers and John Regan for a discussion of the impact of the election on U.S. and Massachusetts employers and for strategies to deal with the anticipated changes.

SPEAKER:
John Regan, Executive Vice President for Government Affairs for Associated Industries of Massachusetts (A.I.M.)

WEST

Fri, 21 Sep 2007 10:59:37 EDT

Nancy Briefs, a successful scientist and CEO who will be sharing her “lessons learned” about growing and sustaining a medical device company. Nancy’s perspective on outsourcing, building great teams and capturing innovation will only be some of the touchstones on this evening which will allow the audience to not only learn, but converse with Nancy and the other members of the WEST community.

Cost Effective Solutions for Any Market Environment

Tue, 08 Sep 2009 14:06:30 EDT

Business owners are right to be focused on the growth of their company but putting the right foundation in place is critical to assure success.

In this informative workshop you will learn...

Effective Benefit Cost Management
5 common mistakes that business owners make that waste money and leave them exposed
Why companies find themselves over insured but under protected?
Critical concepts to sustain profits and impact the bottom line
Maximizing returns for the Business Owner
Performing a Zero Based Analysis

The Life Sciences Revolution: Translating Hot Science to Business Value in Epigenetics

Mon, 29 Mar 2010 13:32:32 EDT

As Annual Gold Sponsor of the MIT Enterprise Forum of Cambridge, Foley Hoag would like to invite you as our guest

Join us for a keynote address by world-renowned life sciences leader G. Steven Burrill, CEO of Burrill & Company, a San Francisco-based venture capital and private equity firm, merchant bank, and media conglomerate.

T3 - Overcoming The Odds: Successful Transactions During Turbulent Times

Fri, 30 Oct 2009 10:39:29 EDT

So you are ready to sell your privately held business. As if the issues raised by the current credit crisis were not enough, you will also have to grapple with the ever present complex web of governance issues that arise in these types of transactions:

differences among major stockholders and/or members of the Board of Directors regarding proper direction and strategy for the business
divergent views among different constituencies about value
differing stockholder needs for liquidity and views about exit timing
different perceptions generally between active and passive stockholders

Join us on October 28 when Cronus Partners will host a panel discussion regarding these topics, including a case study of a recently completed transaction that presented these issues.

Speakers:
Alan Canzano, Managing Director, Cronus Partners LLC
Michael Blanco, Chief Executive Officer, Resolute Partners, LLC
Reggie Babcock, Managing Director, Endeavour Advisors, LLC
Craig Hoffman, President, Bill Blass

Networking and Career Growth - TiEWIN SIG Event

Wed, 04 Nov 2009 13:48:21 EDT

The recent economic cataclysm changed the professional world forever. Today, job seekers should steer away from traditional techniques, and the employed should create a career development and networking plan both within and outside their organizations.

What is important today is networking over the years: building relationships that are two-way, developing collaborative partnerships, appreciating interactions, expressing sincere congratulations when others are promoted, and engaging in conversations spanning a variety of issues.

When many individuals are all well-qualified for a job, something "more" must stand out in the final candidate. This "more" may be related to job accomplishments, but likely, the "more" is related to relationships, perhaps the one who is best known, or the one who is most liked, or the one who has consistently good interactions with others.

ABA Midyear Meeting - Hot Topics in Patent Litigation in the Aftermath of Major Decisions

Tue, 20 Jan 2009 09:41:35 EDT

The American Bar Association 2009 Midyear Meeting of the Intellectual Property Law Section is offereing a program that addresses the current state of copyright, patent, and license protection of computer software.

Foley Hoag's Phil Swain will moderate the presententation on "Hot Topics in Patent Litigation in the Aftermath of Major Decisions, " scheduled for Saturday, February 14, 2009 from 3:00-5:00 pm.

MassMEDIC's New Pharmaceutical and Medical Code of Conduct Law Seminar

Wed, 04 Nov 2009 13:48:09 EDT

MassMEDIC's seminar, "Are You Ready To Comply with Massachusetts' New Pharmeutical and Medical Device Code of Conduct Law?," will focus on how the new law will impact the way your medtech company interacts with healthcare practitioners in this state.

Foley Hoag's Pat Cerundolo will be providing a review of how the proposed regulations will specifically affect medtech companies.

MassNetComms: CTIA Wireless 2009 Show Review

Wed, 04 Nov 2009 13:48:11 EDT

The CTIA Wireless 2009 Show, April 1-3 in Las Vegas is the most important global technology event of the year.

Join us on Tuesday April 7 after you return, or if you didn't for a roundtable breakfast and share what you saw there that was inspiring? What did you see that you enjoyed the most? What did you learn by attending? What were the overarching trends? Everyone has their own perspective on the show, but it's too easy to miss one of the big trends. The more diverse perspectives add to our overall understanding, and less slips through the cracks. A moderator will lead the group discussion that teases out the key trends and take-aways from the show. Those who were not able to attend the show are also encourage to come and learn from the show attendees.

ENET: Building Superior Teams: Key to Growth and Funding for your Startup Company

Wed, 04 Nov 2009 13:48:00 EDT

Building superior teams is the key element to growth and to funding of a startup company, and never more so than in the current difficult economic environment.

When investors consider your business, it is often said the three things they focus on are “management, management and management.” Investors invest in people, and it is the people; the management team that must have the skills and dexterity to succeed where others have failed. Seldom is a business plan carried out precisely on plan – there are pitfalls, changes, choices to be made.

Sunny Days Ahead for the Cloud Environment: What's Real for You Now in Cloud Computing

Wed, 04 Nov 2009 13:47:56 EDT

While “cloud” has become a new tech buzzword, knowing if, when and how to use cloud-based services effectively has been, well, cloudy. Thought-leaders from cloud providers, platform-as-a-service and cloud management vendors and some of their customers will discuss what is real and what is buzz. This program will feature demos from emerging startups in the cloud ecosystem that allow you to take advantage of cloud computing today.

AIPPI's 41st World Intellectual Property Congress

Mon, 08 Sep 2008 09:09:23 EDT

AIPPI is a French acronym for the International Association for the Protection of Intellectual Property. The organization is over 100 years old, dating back to the Treaty of Paris, and holds an international congress every other year. The congress is the largest meeting of general intellectual property attorneys in the world. The Boston meeting will be AIPPI's 41st Congress and the first one in the United States since 1975. We expect over 2,000 participants from around the world, plus another 1,000 or more accompanying persons. The attendees will include both outside intellectual property counsel and corporate intellectual property counsel from companies such as Microsoft, Rohm & Haas, Yahoo!, General Electric, SAP, and Sun Microsystems.

Building a High Growth Business Model

Tue, 08 Sep 2009 14:01:11 EDT

Only a select few early-stage companies will have what it takes to get growth capital from outside investors. This session will outline some of the characteristics of fundable companies - from business plan fundamentals to rule-of-thumb metrics used by angel and venture capital investors.

MassTLC Life Sciences: Networking Lunch and Roundtable Discussion

Thu, 24 Apr 2008 12:58:17 EDT

Networking Lunch and Roundtable Discussion with members of the MassTLC Life Sciences Advisory Board and thought leaders from industry and academia. Guests include executives from Merck, the Broad Institute, and other companies. Topics will include collaboration among technologists, academics, and life science businesses, and future directions in life science technologies. Space is strictly limited, so please take the time to RSVP.

ACC Annual Meeting 2009

Thu, 01 Oct 2009 14:30:27 EDT

Foley Hoag is a proud Blue Sponsor of the ACC's 2009 Annual Meeting. Visit Booth #509 on the exhibition floor and attend sessions featuring Foley Hoag lawyers.

Session 809 - SEC Update on Wednesday, October 21st from 9:00 a.m. - 10:30 a.m. Foley Hoag Partner Peter Rosenblum will be participating in this session, which is part of the Updates Track.
Session 310 - How to Thrive When You Cross State Lines or Go Worldwide: Multi-jurisdictional Nonprofit Operations 101 on Wednesday, October 21st from 11:00 a.m. - 12:30 p.m. Foley Hoag Partner Dean Richlin will be participating in this session, which is part of the Ethics Track.

The 2009 Personalized Medicine Conference

Thu, 18 Jun 2009 14:00:49 EDT

This conference will bring together the wide variety of stakeholders in both the public and private sector to examine both the opportunities and challenges facing those involved in the development and realization of personalized medicine.

Foley Hoag's Senior Health Policy Specialist, Bruce Quinn, will be speaking at this conference.

ACI: FDA Boot Camp

Thu, 11 Jun 2009 09:19:19 EDT

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of FDAAA.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:

The organization, jurisdiction, functions, and operations of the FDA
The essentials of the approval process for drugs, biologics, and devices, including:
NDAs
INDs
BLAs
OTC approval
510 K submissions
PMA process
Clinical trials for drugs and biologics and the clearance process for devices
The classification of devices and the concept of “risk-based” classification
The role of the Hatch-Waxman Act in the patenting of drugs and biologics
Labeling in the drug and biological products approval process
cGMPs and other manufacturing concerns relative to products liability
Proactive adverse events monitoring
Recalls, product withdrawals, and FDA oversight authority

When is Your Business Right for Venture Capital Funding?

Tue, 09 Sep 2008 11:12:29 EDT

Entrepreneurs with great ideas assume that investors will want a piece of the action and will fund their company. Our speaker, Margaret Lawrence, will address the issues that help an investor determine if a company is appropriate for institutional investment, and discuss when in a company's lifecycle it should try to obtain Venture Capital or Angel funding.

Picking Winners and Losers in Health Care

Wed, 11 Nov 2009 15:27:38 EDT

Institutional and strategic investors have triaged their existing portfolios to identify winners and losers. How will the winners be supported going forward? Will the losers be sold, partnered, put in hibernation or taken over by co-investors? After focusing on their existing portfolios, some investors are now looking externally for potential winners. The financial crisis did not alter the pace of medical innovation and healthcare reform might introduce a host of new opportunities. Who are the buyers, what are they looking for and how are they structuring their deals to assure success? Our panel will address these questions, and yours, with reference to early-stage and late-stage companies.

SBIR & STTR Workshop for Small Businesses and Entrepreneurs in the Medical Device Industry

Fri, 30 Oct 2009 10:39:25 EDT

As capital markets scale up and investors seek out bigger returns, medtech entrepreneurs are struggling to find the critical seed funding needed to move their technologies from concept to initial design and testing. Many are turning to federal and state funding sources as a way to bridge the gap between friends and family money and their first round of institutional investment.

What's New in Selected Fields - Neuroscience and Neurotechnology

Fri, 30 Oct 2009 10:39:18 EDT

Advances in neuroscience are revolutionizing our understanding of the human brain. The national economic burden from neurological disorders in the US alone is estimated at $500 billion. However, new research and new products are yielding a vastly improved understanding of brain disease and injuries, human cognition and behavior, creating an unprecedented ability to treat and heal those in need.

Tech Talk Tuesday {T3} - Selecting an Equity Investor

Wed, 04 Nov 2009 13:48:16 EDT

With credit markets distressed and equity hard to come by, it seems counterintuitive that entrepreneurs have a choice of equity investors to target for funds. However, capital is still being invested and successful companies are able to raise new rounds, albeit at lower valuations and with longer due diligence processes.

A prudent entrepreneur will consider all equity options seeking to maximize the long term growth and value of the company. Each equity investor will describe best practices on how to do so.

Medical Development Group -- Getting Your Money Out

Fri, 30 Oct 2009 10:39:19 EDT

Program details coming soon...

Patient, Heal Thyself: How to Succeed with Online Consumer Health Sites

Fri, 30 Oct 2009 10:39:18 EDT

With consumer-directed care, patients are being asked to play a greater role in their health care. Moreover, those with chronic diseases often get better counsel from other sufferers than they do from physicians. This talk will cover the most effective ways to design and evaluate online health communities.

Changes in the health care system and the pervasiveness of the Internet have led to an increased use of the Internet by health care consumers. 80% of people in the US who use the Internet are using it for health searches.

Full Circle of Innovation: From Surgical Suite Invention to a Surgical Product

Fri, 30 Oct 2009 10:39:20 EDT

Traditional way of bringing new medical devices to market begins with market research (if we’re lucky) or with a new idea within the R&D team. After a rigorous market validation, product development, and regulatory clearance, the product is finally launched into the medical world. Today, physicians are getting much more active in challenging and changing this process. We are seeing a variety of new technologies, conceived in the surgical suite or at the patient side, brought out via hospital-based technology transfer organizations. Transfer of a physician’s concept into a commercial product involves traditional risks and efforts as well as new challenges for all the participants.

Photonics and Optics - Bright Ideas? At the Speed of Light?

Fri, 30 Oct 2009 10:39:10 EDT

The Photonics and Optics field links a wide range of disciplines impacting the generation, use, control, delivery, and manipulation of light and its related properties. Among many of its mainstream uses, photonics/optics underpins much of our modern telecommunications and media infrastructure, security sensor/detector technology, lasers and light displays. However, the Boston-area’s researchers are pushing the limits of what photonics/optics makes possible just as regional entrepreneurs are aggressively seeking ways to commercialize that research. Photonics/Optics are increasingly critical in biomedical, nanofabrication, control and measurement applications to name a few. The April 15th EntreTech Forum focuses on understanding the present and future state of Photonics/Optics science and applications, and how entrepreneurs view related opportunities.

Growth Opportunities from Healthcare Reform: Personalized Medicine and Healthcare IT

Thu, 11 Feb 2010 14:26:57 EDT

The current political turmoil and confusion surrounding the direction of President Obama's healthcare "reform" legislation are a sideshow in terms of the game-changing trends that will alter the practice of U.S. healthcare in the future. Previous legislative actions and seismic policy shifts are changing the basis of power and will fundamentally affect healthcare delivery as we know it.

The World Health Care Congress Leadership Summit on Personalized Health Care

Mon, 07 Dec 2009 10:23:40 EDT

The World Health Care Congress Leadership Summit on Personalized Health Care convenes senior level executives from hospitals, health systems, health plans and pharmaceutical companies to explore the evolution of personalized medicine from concept to main stream health care delivery. As personalized medicine has the potential to revolutionize medical care, this conference is created to bring together a wide variety of stakeholders in both the public and private sector to examine both the opportunities and challenges facing those involved in the development and realization of personalized medicine.

Foley Hoag's Kalah Auchincloss will be participating in the "Bridging the Gap to Personalized Medicine: An FDA-Reform Look at Regulations and Implications" session.

Skidmore Business Network presents Richard Laxer, '83 ~ President and CEO, GE Capital Solutions

Fri, 30 Oct 2009 10:39:25 EDT

Our evening event will include a dynamic presentation from Rich Laxer, class of 1983, and the opportunity to network with fellow Skidmore alumni and friends & family of alumni. Rich is a 22-year GE veteran who was recently named President and CEO of GE Capital Solutions, one of the company's largest financial services businesses, with leasing, financing and asset management operations in 30 countries and assets of more than $92 billion. Prior to his current role, Laxer led GE Corporate Financial Services London-based European businesses, responsible for factoring and transaction activities, including leveraged finance, corporate restructurings and distressed/secondary debt investments. Laxer was in Tokyo from 2001 to 2003 running GE's Asia Pacific Real Estate activities. Prior to that, he established and headed-up GE Real Estates Fund Capital Group in New York. Rich, who joined General Electric via its Financial Management Program, holds a B.S. in Business from Skidmore College.

Life Sciences Presentation: A Call to Arms - Data Standards in Collaborative Research

Fri, 30 Oct 2009 10:39:16 EDT

Dr. Martin Leach, Executive Director, Basic Research and Biomarker IT, Merck Research Laboratories

Arguing that the rate of development and adoption of research data standards has been unsatisfactory, Martin challenges the life sciences community in general - and the biopharma community in particular - to leverage lessons learnt in the clinical realm. He aims to extend recent successes in the adoption of data standards in areas like gene expression analysis into other critical areas, such as pharmacology and translational medicine.

Back to School: ACC's Annual Update of Critical Developments

Fri, 30 Oct 2009 10:38:55 EDT

The kids' lunchboxes are packed, and their knapsacks full of new supplies. It's time to turn your attention to making sure you're on top of all of the latest developments. 2008 has been a busy year: Ongoing developments in the corporate and securities areas, continuing statutory and other changes on the labor and employment front, and case law in the intellectual property realm that should affect how you do business. In-house counsel must continue to be vigilant in making sure that their companies' business practices stay ahead of the curve. So sharpen your pencils and join Foley Hoag who will review these developments and arm you with the knowledge you need to succeed in 2009 and beyond.

Medical Development Group

Fri, 21 Sep 2007 10:59:30 EDT

Relatively few medical device companies are able to drive rapid adoption of their products. One of the reasons is that a truly successful launch requires a significant amount of planning and coordination among many different groups from development to regulatory to reimbursement to sales, marketing and supply chain, etc.

Medical Development Group: Future of Clinical Diagnostics

Thu, 27 Sep 2007 17:34:53 EDT

What does the future hold for clinical diagnostics, more precisely in vitro diagnostics (IVD)? What role has this important modality played, and what role is it expected to play, in the practice of medicine and the delivery of care? And, what does that mean for would-be entrepreneurs contemplating an entry into this space?

AIPLA Women in IP Annual Networking Dinner

Tue, 03 Feb 2009 12:17:58 EDT

Foley Hoag is proud to host a night of Networking, Mentoring and Outreach at this year's AIPLA's Women in IP Annual Networking Dinner on February 12, 2009. The purpose of the dinners is to provide female intellectual property law attorneys with an opportunity to meet with other women for an evening of mentoring, networking, and education.

European In Vitro Diagnostic Regulatory & Reimbursement Conference

Thu, 18 Jun 2009 16:28:14 EDT

This meeting, which is being held in Frankfurt, Germany, will discuss health economics and its role in the value of diagnostics as well as market access issues, reimbursement, opportunities and risks for innovative products.

Foley Hoag's Senior Health Policy Specialist, Bruce Quinn, will be speaking.

TCN - Growth and Exits

Fri, 30 Oct 2009 10:39:27 EDT

Always start with an exit in mind. Hear a founder's perspective and an investor's perspective on critical factors in creating a successful company and planning for a valuable exit event.

This interactive discussion will also address the legal logistics, timetables, regulatory challenges and pitfalls to avoid as you approach your exit. You'll learn a spectrum of options to help you navigate through your path to success.

Software as a Service: Another Software Architecture Paradigm

Fri, 30 Oct 2009 10:39:25 EDT

Many applications are now being built to be centrally hosted and accessed via web services. Since this model eliminates the need to support installations with different configurations and platforms, this model is especially attractive to small and medium sized business. It allows their applications to reach a much larger audience than they would otherwise be able to support. This talk will discuss the architectural and technological challenges in building applications of this type.

Software as a service (SaaS) is an increasingly popular approach to delivering software via the web. A third party develops and hosts the software. Customers pay for using, not owning, the software. Currently, technologies such as Web services or REST are used to provide an interface over the web. Doing this relieves customers of having an IT staff responsible for maintaining applications software. This model also works well for small to mid-size software application companies that want to minimize their onsite support costs. SaaS can leverage the long tail distribution model to allow customers who normally could not afford certain business applications to be able to use them.

2009 Financing Outlook

Wed, 04 Nov 2009 13:47:44 EDT

Jeffrey Quillen , Partner at Foley Hoag and Kevin Bitterman of Polaris Venture Partners, will discuss the recent financing environment. A Venture Capital firm will offer their insight as to the how to be attractive to investors in the current economic climate.

The night will include discussions related to the following:

1. Where to find investors, what types of industries are VC’s investing in?
2. How the current economy is affecting investing terms in regards to preferences.
3. What additional hurdles need to be met to obtain Series B or C financing.
4. Issues surrounding financing for Bio techs / Pharma Companies.

FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers

Thu, 28 Feb 2008 15:39:58 EDT

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports…patent concerns…exclusivity… All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And recent court cases and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The same can be said of securities experts and business executives in the life sciences arena.

Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.

However, many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.

ACI’s FDA Boot Camp has been designed to give products and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies, including the nuances of FDAAA.

Let's Get Real About Diversity

Wed, 09 Apr 2008 17:32:08 EDT

In our effort to improve Boston’s reputation for diversity in the legal market, the affinity bar associations are joining forces for a group event to have a candid discussion of where Boston’s legal community has been, where it is now, and where it is going. Panelists will discuss their experiences relating to questions and topics that matter most to diverse attorneys in Boston. We look forward to inspiring the diversity discussion that never seems to take place.

Managing Legal Risks in Structuring & Conducting Clinical Trials

Mon, 08 Sep 2008 09:09:24 EDT

American Conference Institute’s 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is the one place that industry professionals can come to resolve these and other pressing concerns. At a time when the pressure on and outcry against the industry have never been greater and negative reports continue to flood the media, this is the only event that will allow you to respond to the increased demand for more transparency in the clinical research process from every angle: legislation, regulation, compliance, and litigation. Its front-line faculty includes experts from sponsors, CROs, hospitals and academic research institutions, as well as expert attorneys and current and former government enforcers.

The Counter-Revolution in Patent Law

Fri, 30 Oct 2009 10:39:32 EDT

For the past 25 years, Congress and the courts have strengthened the rights of patent holders. But now there are widespread concerns that the law has gone too far in protecting those rights to the detriment of economic growth and innovation in the United States. As a result, the pendulum is starting to swing back. In its last three terms, the U.S. Supreme Court has issued rulings that cut back on the rights of patent holders and even the Court of Appeals for the Federal Circuit—once the champion of patent rights—has begun changing direction. Congress is working on legislation that would bring profound changes to patent law. This program will look at how patent law got to where it is today, how that pendulum is swinging back and what the ramifications will be for lawyers who concentrate on patent law as well as lawyers who advise businesses generally.

Foley Hoag's Don Ware will be a member of the faculty for this program.

ABA Midyear Meeting - IP Protection of Computer Software: The State of Copyright, Patent, and License Protection for Computer Programs

Tue, 27 Jan 2009 10:04:10 EDT

Foley Hoag's Marc Temin will moderate the presententation on “IP Protection of Computer Software: The State of Copyright, Patent, and License Protection for Computer Programs,” scheduled for Saturday, February 14, 2009 from 1:45-3:00 pm.

Breast Cancer: Closing the Research Gap

Thu, 03 Apr 2008 15:04:18 EDT

We’re on a mission to end breast cancer forever. Join us.

Every three minutes a woman in the U.S. is diagnosed with breast cancer. Every 13 minutes one woman dies of breast cancer. It is tragic that America’s racial and ethnic minorities, the poor and those with little or no health insurance are the most likely to be in the second group.

Come hear from breast cancer experts about the latest in research and what’s on the horizon. And as we discuss the promise of these advancements we will highlight the importance of greater government investment in helping discover and deliver the cures.

WEST: Cross-Functional Teams

Wed, 04 Nov 2009 13:48:22 EDT

Teams play an increasingly important role in business. Cross-functional teams in particular can help improve the creativity and capacity of the company by involving members from diverse parts of the organization. However building, managing, and becoming effective members of teams presents an array of challenges. This panel discussion will address the characteristics of effective team leaders and members, factors that can derail a team, the rationale for forming cross-functional teams, and the value of participating in cross-functional teams for individuals and the organization.

This event is sponsored by Foley Hoag LLP

Product Development and Management Association (PDMA)

Fri, 30 Oct 2009 10:39:24 EDT

Come and meet fellow PDMA members in a relaxed setting. We will taste and explore New World wines and enjoy hors d'oeuvres.

During this meeting, we will also ratify the new PDMA New England Chapter Board for 2008. Learn more about how you can get involved with the local PDMA chapter and foster the New England tradition of being leaders in innovation.

Early-Stage Life Sciences Technology Conference III

Mon, 17 Sep 2007 18:18:39 EDT

The Early-Stage Life Sciences Technology Conference is a showcase for life sciences technologies developed at the research institutions, hospitals and universities of Massachusetts and for recently formed Massachusetts companies. The Forum is an opportunity for these companies and researchers to present technologies with commercial potential to an audience of angel investors, venture capitalists and corporate investors.

2009 Venture Capital Funding Outlook

Wed, 04 Nov 2009 13:47:39 EDT

Foley Hoag Partner Dave Broadwin moderates a panel of distinguished venture capitalists will discuss the current market for venture capital funding and the outlook for 2009.
Discussion will include:

1. Keys to obtaining funding; from first round to follow on rounds
2. Top 10 ways not to get funded; what you don’t want to do
3. Where the money is going, areas of focus for venture investments
4. Update on current trends in Terms, Conditions and Valuations
5. Strategy and the market for company exits

After E-Discovery: Data Security & Privacy

Tue, 24 Feb 2009 15:48:48 EDT

After E-Discovery: Data Security and Privacy , an overview of data securty and privacy law at the federal, state and international level, then will move on to practical suggestions for auditing your company's existing procedures, developing new procedures and securing vendor compliance.

ENET: Raising Money from Angels in Difficult times

Fri, 30 Oct 2009 10:39:25 EDT

Angel investing fills that gap between friends and family funding and venture capital. According to the UNH Center for venture research, total angel investment in 2007 was $26 billion, with more than 57,000 entrepreneurs receiving funding. Recent banking industry turmoil has led to rethinking of investment strategies. Our panel will comment on what has changed for those seeking capital from angels.

Funding Sources and Funding Processes of Various Stage Entrepreneurial

Fri, 30 Oct 2009 10:39:04 EDT

Early Stage Companies can often be financed through various strategic alliances with vendors, customers, distributors, OEMs, VARs, universities, technology partners, or third parties with complementary products and services. This can be a great way to help build early technology and help an early stage company get through certain development milestones that can increase the likelihood of equity financing. However, these relationships do not always have the anticipated outcome that each party expects, with the priorities, rights, and responsibilities of the parties sometimes becoming confused or altered.

Health, Sports & Technology at Fenway Park

Sat, 22 Sep 2007 17:10:51 EDT

A Harvard-MIT Division of Health Sciences and Technology Fundraising Event for Student Support. Please join us for a reception on the famed Green Monster followed by dinner overlooking the park and Boston skyline.

Nanotechnology and Nanohealthcare: Big Medicine in Nanometer-Scale Dimensions

Wed, 26 May 2010 13:17:16 EDT

Join us in a conversation with industry and academic thought leaders for a panel discussion of the benefits and opportunities for nanotechnology in healthcare and developing applications of nanomedicine.

ACC Annual Update of Critical Developments

Thu, 04 Oct 2007 17:02:37 EDT

The kids' lunchboxes are packed, and their knapsacks full of new supplies. It's time to turn your attention to making sure you're on top of all of the latest developments that affect how you do business. 2007 has been a busy year: Groundbreaking decisions in the litigation arena, continuing regulatory and disclosure guidelines, evolving immigration concerns, and revolutionary developments in the area of patent reform. In-house counsel must continue to be vigilant in making sure that their companies' business practices stay ahead of the curve. So sharpen your pencils and join Foley Hoag and a panel of in-house experts who will review these developments and arm you with the knowledge you need to succeed in 2008 and beyond.

2008 Venture Capital Funding Outlook

Tue, 13 Nov 2007 10:06:31 EDT

A panel of distinguished venture capitalists will discuss the current market for venture capital funding and the outlook for 2008. Discussion will include:

Keys to obtaining funding; from first round to follow on rounds
Top 10 ways not to get funded; what you don’t want to do
Update on current trends in Terms, Conditions and Valuations
Strategy and the market for company exits

Panelists will include:

Ahmet Ozlap, Partner at Atlas Venture
Paul Ciriello, Managing Partner at Fairhaven Capital Ventures

Get an insider’s view into the current Boston Venture Capital Marketplace. Arm yourself with the latest information you need to raise money, including an understanding of what makes your company an attractive investment. This event will surely provide financial executives with the information they need to better understand how to raise money and what it takes to attract growth capital.

There will be extensive question and answer periods during the presentation with adjournment by 7:30PM.

Members of the Massachusetts Society of CPA’s are eligible to earn one hour of CPE for attending.

Ahmet Ozalp is a Partner in the technology group at Atlas Venture. He joined the firm in 2003, and focuses on investment opportunities in cable, broadband, digital media, convergence, consumer electronics, and wireless markets.

Paul Ciriello is a Managing Partner at Fairhaven Capital Partners, LLC. He was a Managing Director and Founding Group Head at TD Capital Ventures. Mr. Ciriello joined the firm in 2000 and has over 18 years of technology, business management, and venture capital experience.

Arranged by:
MA CPA Society High Technology Group; hightechcpa@yahoo.com
Geoffrey Kent and Rachel Hodis Co-Chairpersons

Personalized Medicine Coalition

Wed, 08 Oct 2008 08:54:22 EDT

Personalized health care is emerging as the single most-significant development in health care in the 21st century. It springs forth from the recent sequencing of the human genome, major technical advances that facilitate our ability to understand the uniqueness of each individual at the molecular level, and advances in the field of bioinformatics. Michael Leavitt, Secretary of the U.S. Department of Health and Human Services (DHHS), defines personalized health care as: “the basic scientific breakthroughs of the human genome with computer-age ability to exchange and manage data. Increasingly it will give us the ability to deliver the right treatment to the right patient at the right time - every time.”

AIPLA: 2009 Mid-Winter Institute

Mon, 26 Jan 2009 16:48:40 EDT

The American Intellectual Property Law Association (AIPLA) 2009 Mid-Winter Institute is offereing a program dedicated to The Legislative Agenda for the 111th Congress–Patents, Copyrights and Trademarks.

Foley Hoag's Susan Barbieri Montgomery will participate on the panel discussing "New Trademark Initiatives, " scheduled for Thursday, January 29, 2009 from 9:00 a.m.- 12:00 p.m.

Expansion to China

Wed, 04 Nov 2009 13:48:02 EDT

Join us for a morning of networking and lively panel discussion. We will explore the pros and cons for outsourcing and doing business in China. You'll learn from multinational and start-up firms about technology and outsourcing, business entry and growth in China. This event is exclusively sponsored by Ningbo National High-Tech Industrial Development Zone.

Moderator: Douglas Banks, Editor, Mass High Tech

Panelist:

Charlie Jing, China President, Ceva Group
Mark Hodges, Chief Customer Officer, PTC
Christa R. Bleyleben

Drug Information Association (DIA) 44th Annual Meeting

Wed, 04 Jun 2008 14:02:16 EDT

This session consists of three presentations on advanced device regulatory topics from the Masters of Science degree program in regulatory affairs and health policy at Massachusetts College of Pharmacy and Health Sciences: • Comparison of approval processes for drugs and implantable devices for the same indication. Are the risks and agency standards the same? •. The current standards used by FDA in 510(k) clearances and the impact of court decisions on the agency's thinking, and what can be expected from the GAO 510(k) study mandated by the Sept. 2007 amendments to the Food, Drug and Cosmetic Act. • The barriers to spontaneous reporting of device events and the impact on manufacturer reporting and patient safety issues.

Medical Development Group: Leveraging High-Brightness LEDs in the Design of Endoscopy Systems - Technology, Challenges and System-level Issues

Wed, 04 Nov 2009 13:48:11 EDT

The rapid evolution of High Brightness LEDs (HBLEDs) and their attendant benefits have enabled new classes of diagnostic, therapeutic and surgical instrumentation. A systems-level view of HBLED application development is generally required, however, to overcome some of the inherent design challenges. On March 11th, Mr. Eskow will discuss various aspects of HBLED systems, with a special focus on endoscopy.

Recruiting and Career Management

Fri, 30 Oct 2009 10:39:25 EDT

How do I attract and retain talent in this rapidly changing and globalized economy? How do I navigate for career advancement? Whether you are an entrepreneur, seasoned executive, mid-career professional or in early phase of your career, questions like these are likely top of mind. Getting answers to these questions are critical to the success of your company or to your own professional success. There is no time more pressing than today’s turbulent economic environment to get clarity on these issues.TiE Institute is bringing together experts from the industry to help you navigate these questions. These experts will provide their perspectives and answer your questions in an interactive workshop that will cover three main topics:

Recruiting and Retention
Career Management
Organizational design and team building

Moderator:
Aaron Lapat, Managing Director, J. Robert Scott

Panelists:
Mitch Tyson, CEO & Director, Advanced Electron Beams (AEB)
Clark Curtis, Human Resources Consultant

The Massachusetts Pharmaceutical and Medical Device Marketing and Disclosure Regulations

Wed, 04 Nov 2009 13:48:08 EDT

The Department of Public Health has recently promulgated final regulations on Pharmaceutical and Medical Device Manufacturer Conduct, 105 CMR 970.000. Biotechnology and medical device companies will need to comply by July 1, 2009 and beyond, or face enforcement actions by the Massachusetts Attorney General, the DA or the DPH. At this breakfast program, experienced Foley Hoag attorneys and industry executives will provide valuable insight into key issues facing the industry as it turns to compliance and avoiding, or surviving, possible investigations and enforcement actions. Interested attendees should include general and compliance counsel and executives.

Women’s Health: New Markets, Expanding Opportunities

Thu, 14 Jan 2010 09:39:06 EDT

Women and those who love them: learn about the latest advances is detecting and treating conditions that threaten their lives and the quality of those lives. From the latest methods of detecting and treating breast cancer to improving the lives of the sixteen percent of women experiencing incontinence, our clinical specialists and industry leaders will share their knowledge with you. Prepare to be challenged to create new devices serving unmet clinical needs in mammography, MRI and ultrasound.

ACI: Expert Witness & Scientific Evidence Summit

Tue, 15 Jul 2008 16:42:01 EDT

The Drug and Device Summit on Expert Witnesses and Scientific Evidence will feature top-notch, experienced pharmaceutical and device defense litigators, who will discuss with you strategies that have worked in convincing judges to render an expert's opinion inadmissible right when it counts. An advanced, one-day course specifically designed to present a forum for senior-level litigators to cross-fertilize and share best practices, this summit will share with you proven strategies to ensure your client's case does not progress beyond the Daubert hearing.

Women in Energy Networking Event

Tue, 14 Apr 2009 09:26:04 EDT

Dust off the business cards, put on your perfect smile and get ready to just have some fun with your energy colleagues. There will be no panel discussions or presentations – just an opportunity to enjoy the tradition of Women in Energy over cocktails and networking!

Special guest FERC Commissioner, Suedeen Kelly will provide her unique insight on the amazing evolution and revolution of the energy industry.

Opportunities in Low Cost IT Domestic Sourcing

Wed, 04 Nov 2009 13:48:13 EDT

In today's economic climate companies have to be smarter and more efficient. Sometimes some of the best resources available to companies are often overlooked and right next door. Join us for lunch and a thoughtful discussion with local New England technology and government leaders who are finding support in their back yard.

Speakers include:

What is domestic sourcing and what are the implications for my company's bottom line?

Jeff Lande, EVP, TechAmerica

Best Practices - real world examples of local companies and states that are implementing domestic sourcing

John Richardson, Commissioner, Maine Department of Economic and Community Development (DECD)
Others TBA

ACI: Biotech Patents

Fri, 05 Sep 2008 17:05:49 EDT

The ACI Biotech Patent Conference is the ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today. You cannot afford to miss this essential briefing on the state of biotech patenting as it reels from not only new scientific advances, but also legislative and practical changes in the rules of patent practice. It seems at every turn, patent practice is being assailed, whether through internal rule changes from the USPTO, profound federal court cases, public opinion demanding access to biosimilars, or overhauling legislation designed to pull the rug out from under traditional patent practice. The Biotech Patent community almost uniformly decries these changes as a potential for disaster.

Acquisitions - The Acquirer's Perspective

Thu, 19 Nov 2009 16:03:46 EDT

With the IPO market moribund, and the venture capital sector searching for a new investment model in an environment characterized by risk aversion and a shrunken pool of limited partner funding sources, exit by acquisition is emerging as the most important route to financial return for entrepreneurs and investors. A robust understanding of the wants and needs of potential acquirers is therefore essential to the development of a successful medical device startup business strategy and plan.

Medical Development Group: Emerging Technologies for Pulmonary/Sleep Medicine

Wed, 04 Nov 2009 13:48:11 EDT

The fields of pulmonary and sleep medicine offer substantial opportunities for the development of innovative technologies: large and growing patient populations, significant unmet need, unresolved technical issues in the delivery of care, clinical assessment and/or patient monitoring. There is enormous business potential awaiting enterprises that commercialize effective emphysema therapies, new bronchodilators and advanced drug delivery systems, and/or more effective approaches to the diagnosis and treatment of sleep apnea.

Our expert panel will combine specific operational and business development experience with a comprehensive perspective on the clinical, product development needs and business issues in these exciting clinical areas.

Mass Technology Transfer Center

Fri, 21 Sep 2007 10:59:31 EDT

This platform will highlight a new medical device techology, a non-invasive, rapid monitor for shock.

Medical Development Group: Unmet Clinical Needs and Potential Device Soultions

Fri, 30 Oct 2009 10:39:19 EDT

Despite enormous advances in medical technology in recent years and decades, and a corresponding increase in therapeutic options available to treat patients in many disease areas, there are still numerous intractable clinical problems as well as inadequacies in diagnostic and surgical tools and techniques. These unmet clinical needs define the past failures and the future opportunities for emerging medtech companies.

Symposium on Healthcare Fraud Investigations

Fri, 29 Feb 2008 09:58:34 EDT

The challenge of obtaining full comprehension of the complex and constantly changing, laws and regulations governing Medicare and Medicaid is well documented. Nonetheless, in the current environment of ever increasing government scrutiny of the healthcare industry, there is no room for error. With staggering settlements extracted to date and the increased potential for criminal penalties, it is imperative that you fully understand the implications of every statement and action you, your client, and employees of your institution make when you are the target of an investigation into Medicare and Medicaid practices.

American Conference Institute has created this program specifically to address the challenges being faces by the healthcare industry today. Led by an exceptional faculty packed with current and former Medicare and Medicaid regulatory and enforcement officials, senior compliance and audit professionals, and white collar experts, this event will prepare you for any queries, formal inquiries, and investigations. By the end of the Symposium on Healthcare Fraud Investigations you will be thoroughly grounded in liability-limiting approaches for:

Providing voluntary disclosures that will help to mitigate penalties
Navigating the ins and outs of provider financial agreements in violation of the evolving Stark laws and anti-kickback regulations
Determining the consequences for refusing to waive attorney-client privilege for specific types of information requested by investigators
Mobilizing your internal audit function to detect misconduct in Medicare and Medicaid practices

In addition, to complete your overall conference experience, be sure to attend the post-conference workshop, Ensuring the Effectiveness of Your Compliance Program in Light of Changing Regulations. Our expert panel of healthcare compliance professionals will provide you with the best practices for conducting an annual audit of the healthcare compliance program and the best ways to incorporate new regulatory developments into the existing program.

Foley Hoag Partner, Dean Richlin, will be speaking on Preventing and Defending False Claims Act Violations in Healthcare and Qui Tam Lawsuits.

Association of Corporate Counsel (ACC) 2007 Annual Meeting

Wed, 10 Oct 2007 14:39:31 EDT

Foley Hoag is a proud Gold Sponsor of the ACC's 2007 Annual Meeting. Visit our booth #415 on the exhibition floor, and attend sessions featuring Foley Hoag lawyers:

Session 005: Using Plaintiff's Lawyers for High-Stakes Litigation, on Monday, October 29 from 9:00-10:30 a.m. Michael Keating from Foley Hoag will join a panel including Michael Avenatti, Plantiff Lawyer, Eagan, O'Malley & Avenatti; Clint B. Davis, General Counsel, Endocare, Inc.; Jodie Kelley, Vice President and Deputy General Counsel, Fannie Mae; and Michael V. Ward, General Counsel of Kensington Computer Products, ACCO Brands Corporation.
Session 709: Expanding Your Influence: Not Your Father's (or Mother's) GC Role, on Tuesday, October 30 from 4:30-6:00 p.m. This program will be moderated by Foley Hoag Co-Managing Partner Michele Whitham, with panelists including Ellen Chiniara, General Counsel at Inverness Medical Innovations, Inc.; Catherine McEvilly, Assistant General Counsel, Honda North America Inc.; and David McEvoy, Vice President and General Counsel at ATG.

Foley Hoag will also host the ACC's Northeast Chapter at a dinner on Monday, October 29 at NoMI Restaurant, overlooking Chicago's "Miracle Mile" and its famed Water Tower.

Medical Development Group

Mon, 17 Sep 2007 18:48:14 EDT

Physician Relationships: What can be learned in developing a collaborative approach enhancing their experience with products, services and company, that in turn results in customer loyalty.

Stem Cells and Advances in Cellular Reprogramming - A Presentation by Richard A. Young, PhD

Wed, 11 Nov 2009 15:27:41 EDT

Dr. Richard A. Young is a Member of the Whitehead Institute for Biomedical Research and an internationally recognized authority on cell circuitry, combining novel high-throughput biological methods with new computational techniques to investigate the mechanisms that control genes in living cells.

Dr. Young and his colleagues’ recent discovery of the core regulatory circuitry of human embryonic stem cells could provide the foundation for future therapeutic strategies against major human diseases.

Dr. Young’s awards include Yale’s Wilbur Cross Medal and the Chiron Corporation Biotechnology Research Award. He has served as an adviser to the National Institutes of Health and the World Health Organization.

About Whitehead Institute for Biomedical Research

Whitehead Institute for Biomedical Research is a nonprofit research institution that has defined the cutting edge of biomedical science since its inception in 1982. Wholly independent in its governance, finances, and research programs, Whitehead shares a teaching affiliation with Massachusetts Institute.

The Promise of Tissue Engineering: Making Regenerative Medicine a Reality

Wed, 15 Apr 2009 11:00:56 EDT

Dramatic advances in the fields of biochemistry, cell and molecular biology, genetics, biomedical engineering and materials science have given rise to the remarkable cross-disciplinary field of tissue engineering, or regenerative medicine. Tissue engineering uses synthetic or naturally derived, engineered biomaterials to replace damaged or defective tissues, such as bone, skin, and even organs.

Large Scale Funding Opportunities and Health Care Reform as a Growth Engine for Life Sciences Companies Webinar

Mon, 07 Dec 2009 10:24:20 EDT

The FreeMind Group and Foley Hoag LLP webinar will provide an introduction to the services of FreeMind Group, a consulting firm that specializes in raising funds from government agencies through grants and contracts, and Foley Hoag LLP, a full service law firm with particular expertise in the life sciences industry. FreeMind Group will provide an overview of large scale funding opportunities for life sciences companies. Foley Hoag will discuss critical issues at various agencies, including the NIH, FDA, and CMS, and in Congressional health care reform legislation that could impact the life sciences industry.

Speakers:

Mr. Joel Knopf, MSc, MBA, Senior Consultant, FreeMind Group LLC
Kalah Auchincloss, Foley Hoag LLP

Mass Technology Leadership Council -- The New Influencers

Fri, 30 Oct 2009 10:39:18 EDT

The Mass Technology Leadership Council presents Paul Gillin, author of the book The New Influencers.

Blogging, podcasting and other social media are profoundly disrupting the mainstream media and marketing industries. Paul Gillin's The New Influencers explores these forces by identifying the influencers, their goals and their motivations. The book also offers advice for marketers at both large and small organizations on how to influence the influencers.

The New Influencers explores:

Why social media are now so important in consumer decisions
How to leverage the blogosphere to enhance your company's message
Strategies for taking advantage of this new medium
The need for transparency and how to make it work for your benefit
Action items for both small and large businesses
Whether and how your organization should use blogs, podcasts and other social media tools in your marketing strategy

TCN - Strategic Alliances

Fri, 30 Oct 2009 10:39:31 EDT

The Art of Medical Device Project Management

Mon, 17 Sep 2007 18:23:40 EDT

Medical device development is normally a complex process, involving participation from all disciplines within an organization, and at the same time must be accomplished within the regulatory requirements set forth by the FDA. Project management is a formal discipline that many organizations have adopted to address these development challenges.

Effective project management will "keep things from falling through the cracks", by utilizing proven tools and techniques. Project management can play an important and valuable role in medical device development. Effective project management combined with a predictable and measurable product development process can transform medical technology into a successful medical device product.

Medical device development is normally a complex process, involving participation from all disciplines within an organization, and at the same time must be accomplished within the regulatory requirements set forth by the FDA. Project management is a formal discipline that many organizations have adopted to address these development challenges. A project manager leading a medical device development project faces many unique challenges including compliance with complex regulatory requirements such as the FDA QSR and ISO 13485 Design Controls.

Medical Development Group Networking: Using the Internet to Network Efficiently - LinkedIn, Facebook, Etc.

Fri, 30 Oct 2009 10:39:19 EDT

SPEAKER: Louise Rijk, VP Sales & Marketing, Advanced Media Productions

Marketing to and networking through social networks such as Facebook, MySpace, LinkedIn, Plaxo and social messaging utilities like Twitter enable people to communicate and exchange business information with everyone and anyone they trust.

This presentation is for business owners, companies, online marketers and everyone else who wants to learn more about the future of information sharing and networking, and marketing through social media.

ACI: International Clinical Trials

Fri, 30 Oct 2009 10:39:15 EDT

With clinical trials undertaken by U.S. pharmaceutical and biotech companies increasingly being designed as international in scope, it is critical for sponsors to overcome the key legal and regulatory obstacles inherent in conducting such trials. The international variability in legal frameworks for recruiting, reimbursements, data privacy, and human subject protection has made drafting international CTAs and negotiating informed consent documents a constant struggle. And with indemnity requirements, IP protections, and publication rights varying by country and region, boilerplate contractual provisions must be carefully adapted to reflect specific concerns relating to the sites being utilized.

In addition, as acceptable payment practices differ in some countries, it is essential that companies be aware of how the Foreign Corrupt Practices Act relates to the practical issues that commonly arise during the course of clinical trials overseas. And there are important ways that companies can anticipate and manage their litigation risks, but first they must understand the applicable liability theories and who may have standing to sue. The globalization of clinical research, combined with Congress’ growing interest in clinical trial results and the FDA’s new rules for foreign clinical studies used in drug approval applications, have raised the bar for companies that operate overseas. It is far more than a question of overcoming language barriers.

In response, once again American Conference Institute, the creator of the ten-time Clinical Trials conference, presents its global companion: 3rd National Legal and Regulatory Forum on Conducting International Clinical Trials. This one-of-a-kind event will provide those charged with managing legal and regulatory risks in conducting international trials with practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

Alternatives for Commercializing a Medical Device

Fri, 30 Oct 2009 10:38:56 EDT

This MDG Forum event will address a dilemma that is faced by many medical device entrepreneurs – how to move from an interesting (patented) idea to a commercially viable product. The meeting will feature a panel of experienced practitioners, each of whom will advocate for a particular approach to furthering product development. The discussion will focus on a case, distributed by Harvard Business School, in order to make a consistent presentation of alternative approaches. The case is “Endius, Inc.: Alternatives for Developing a New Medical Device”. For those interested in ordering the case from HBS Publishing, the case number is DMI011.

TiE

Tue, 04 Dec 2007 15:26:42 EDT

The TIE Institute, in Collaboration with the Special Interest Groups, will be launching a series of seminars of broad interest to TIE members, titled "Opportunities for Entrepreneurs". Our goal is to give TIE members exposure to technology developments in Massachusetts that create opportunities for entrepreneurs, with the expectation that interactions between leading-edge scientists and engineers on the one hand and entrepreneurs on the other will create new businesses, which is TIE's over-arching goal.

Windhover's The RPM Report presents FDA/CMS Summit for BioPharma Executives

Fri, 05 Oct 2007 10:34:35 EDT

If you make FDA/CMS Summit an annual must-attend like hundreds of other pharmaceutical and biotech leaders, keep ahead of the curve and mark your calendars NOW.

Key Benefits for Attending FDA/CMS Summit:

Hear the critical trends and changes that affect your regulatory strategy successful strategies for dealing with FDA and CMS
Walk away with practical, real life lessons from some of the most experienced pharmaceutical and biotechnology executives on how they handle regulatory obstacles
Get face-to-face access to the top regulatory thought leaders and policy makers
Benchmark your regulatory strategy against all the major pharmaceutical and biotech companies

Hear the Regulators’ First-Hand Perspectives on:

User fees
Health care fraud prosecutions, especially in the new prescription drug benefit
Drug development and NDA approval strategies
Drug safety, risk management and post-market surveillance
Biogenerics/follow-on biologics
Personalized medicine
Pharma marketing and promotions regulation and enforcement
Marketing and promotion regulation and enforcement
Medicaid and Medicare reimbursement
Medicare Part D
Critical Path Initiative
Pricing Strategies

Last year’s FDA/CMS Summit highlighted all of the biggest names in government: Andrew von Eschenbach, Acting Commissioner, FDA, Mark McClellan, MD, CMS Administrator, Steven Galson, MD, Director, Center for Drug Evaluation and Research, FDA, and Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, FDA.

For more on this program, visit http://www.windhover.com/dotcom/conferences/index.asp?page=fda-cms.

Shining the Light on You: Catching the Interest and Capturing Investment Dollars in Today's Turbulent Markets for Small and Microcap Companies

Fri, 30 Oct 2009 10:39:06 EDT

You're invited to attend a session designed by investment bankers, communications professionals, investors and legal professionals who work day in and day out with small and microcap companies that will teach you effective strategies to better navigate the investment markets and secure both the interest and financial support you need to achieve your business goals.

Defending Allegations of Illegal Kickbacks

Fri, 21 Sep 2007 10:59:21 EDT

Our lawyers successfully defended an individual who was the target of a federal grand jury investigation on allegations that he and his company paid illegal kickbacks to physicians to encourage the purchase of kidney dialysis supplies. We successfully prevented charges from being brought against him.

Disclosing Medicare Over-billing

Wed, 12 Sep 2007 21:02:22 EDT

On behalf of our client, we made the first voluntary disclosure of Medicare over-billing in New England under the Office of Inspector General’s voluntary disclosure protocol. Our lawyers negotiated the related settlement agreement, as well as an innovative corporate integrity agreement. As a result, we avoided lengthy litigation that might have led to our client being barred from participation in the Medicare program.

Leading Counsel to Issuers in Public Offerings

Fri, 21 Sep 2007 10:59:19 EDT

Our lawyers are leaders in representing issuers in public offerings, including a recent notable transaction involving a $100 million-plus initial public offering for a healthcare software company following its leveraged recapitalization.

Major Legislative Milestones

Fri, 28 Sep 2007 14:59:17 EDT

Our lawyers worked on key pieces of health legislation while working as congressional staff members. These include the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), the 1997 Food and Drug Administration reform law, the Orphan Drug Act, and the Health Insurance Portability and Accountability Act of 1996, and the Public, Health, Security and Bioterrorism Preparedness and Response Act. We have also worked on legislation involving specific changes to Medicare and Medicaid law. Today, our lawyers represent several leading pharmaceutical and biotechnology companies and industry trade associations in their implementation of and ongoing preparedness for these laws.

Foley Hoag - Healthcare

Healthcare Compliance and Investigations

Healthcare Compliance and Investigations

Healthcare Compliance and Investigations

Legislative Representation

Legislative Representation

Legislative Representation

Legislative Representation

Legislative Representation

Legislative Representation

Healthcare Compliance and Investigations

On the Agenda: Law and the Environment, Financing Growth, and Non-Competes—Foley Hoag Launches Three New Blogs

Foley Hoag Welcomes Susie Ahn, Health Policy Specialist

Foley Hoag Congratulates Rising Stars

Working Mother and Flex-Time Lawyers Recognize Foley Hoag

Foley Hoag Lawyers in Chambers USA 2010

Foley Hoag Files Amicus Brief for Biotechnology Industry Organization

Cramer Completes Launch of FoleyHoag.com

Foley Hoag Represents Ecuador in Suit against Colombia, Seeking to Stop Aerial Coca Spraying That Has Dispersed into Ecuador, Sickening Villagers and Livestock, Damaging Croplands and Poisoning Ecosystems

Kelly Childress Joins Foley Hoag's Government Strategies Group

Bruce Quinn, MD, PhD Joins the Foley Hoag Government Strategies Practice as Health Policy Specialist

The New "Gift Ban" Statute in Massachusetts: a Primer on Compliance and Enforcement

Foley Hoag LLP Represents Inverness in Acquisition of Cholestech Corp.

Terms and Trends in University Patent License Agreements Released by Foley Hoag

Foley Hoag Names New Chairs of Intellectual Property Group

Foley Hoag Launches Second Annual "Terms and Trends in Patent License Agreements" Survey

Foley Hoag Names Three New Partners

Human Rights Campaign Releases Corporate Equality Index, Names Foley Hoag Among Top Firms for Second Consecutive Year

Foley Hoag Lawyers Included in Massachusetts Super Lawyers 2006

Medicare Regulatory Attorney Jayson Slotnik Joins Foley Hoag's Life Sciences Practice

Now’s the Time:Foley Hoag Forms Economic Crisis Team

Hot Topics, Legal Insight and Industry Trends: Foley Hoag Newsroom Enhanced with Video Launches at BIO 2009

Foley Hoag LLP to present at CBI’s Forum on Effective Patent, IP and Trademark Strategies for the Bio/Pharmaceutical and Medical Device Industries

Foley Hoag Launches Healthcare Law and Policy Blog

Global Bio-Chem Technology Group Company Limited, Foley Hoag LLP, and Adduci, Mastriani & Schaumberg LLP Prevail in International Trade Commission Patent Infringement Investigation

Foley Hoag Continues Expansion of Government Strategies Group with Addition of Lindsey Toohey

Foley Hoag Partner Dean Richlin Admitted to American College of Trial Lawyers

Foley Hoag Selected as one of 2008 Top 100 Law Firms for Diversity

Foley Hoag Launches New Identity and Integrated Marketing Campaign

Foley Hoag's Young Lawyers 'Rising' To The Top

Foley Hoag Names New Partners

Cynthia Lewiton Jackson, Former Global Director of Career Development at Bain & Company, Joins Foley Hoag

Barrett Thornhill Joins Foley Hoag's Government Strategies Group

Two Foley Hoag Lawyers Recognized by Washingtonian Magazine as Area's Best Lawyers

Foley Hoag Partner Colin Zick Nominated to North American Regional Vice Chair of the Health Care Industries Practice Group of Lex Mundi

Thomas Barker, Former General Counsel of the U.S. Dept. of Health & Human Services, Joins Foley Hoag’s Washington Office

Live @ BIO 2008: Innovation, Commercialization, and Protecting Assets

Foley Hoag Selected as one of 2007 Top 100 Law Firms for Diversity

Foley Hoag Government Strategies Practice Gears up for 2009 Activity

Foley Hoag Joins American Lawyer's Select Group of Top 50 A-List Firms

EEC Perspectives - January 2009

Qui Tam? Now More Plaintiffs Will Qualify

Supreme Judicial Court Extends Anti-Discrimination Laws to Small Businesses

Labor & Employment Datasheet

A Reversal of Medtronic v. Riegel? A Legislative Update on Liability Against Medical Device Companies

Health Care Compliance Update - March 2, 2006

Medicare Authorities To Reduce Payment for Covered Items or Services

Obama Administration Issues Final 2010 Call Letter for Medicare Advantage Organizations

Doing Business in Massachusetts

FDA Acknowledges Deviations in Menaflex Knee Device Clearance

Uniform Prudent Management of Institutional Funds Act Liberalizes Endowment Spending and Clarifies Investment Standards for Charitable Institutions

The H1N1 Influenza (Swine Flu) Outbreak: HHS Emergency Authorities to Respond

Intellectual Property Brochure

Health Care Compliance Update - Spring 2005

Medical Device Tax Provisions in Health Care Reform Legislation

Jump-Starting Biomedical Research and Development: The New Therapeutic Tax Credit and Cash Grant Program

Five Common Employment Law Hazards for Start-Ups

Life Sciences Opportunities for NIH Recovery Act Funding

FDA Recommends Actions to Improve Oversight of Medical Devices

Product Liability Update - May 22, 2009

Awaiting Further Guidance from CMS, Hospitals Seeking to Craft On-Call Physician Compensation Policies May Look to OIG Advisory Opinion for Guidance

Cutting-Edge Research and Development Receives Boost from Health Care Reform: An Overview of the Cures Acceleration Network

May 15 Deadline for Filing IRS Form 990-N

Massachusetts Issues Comprehensive Data Security Regulations

Hatch-Waxman Safe Harbor Inapplicable to Research Tools

International Litigation and Arbitration Practice Summary

Foley Hoag Secures ITC Victory

Biosimilars Pathway Enacted

Massachusetts House and Senate Pass Compromise Restrictions on Pharmaceutical & Medical Device Marketing

Obligations of Insurer and Policyholder

Now’s the Time:
Foley Hoag Forms Economic Crisis Team