Publications

Foley Hoag lawyers are frequent contributors to legal and industry publications, and offer insightful analysis in our own publications ― many of which are available in downloadable eBook format here at foleyhoag.com.

Featured Publications

Foley Hoag's eBook Library offers you valuable information on today's most important issues, with titles including Follow-on Biologics and Patent Reform, Patenting, and Five Common Employment Law Hazards for Start-Ups.

Final Pharmaceutical and Medical Device Manufacturer Conduct Regulations
by Colin Zick, Pat Cerundolo and Tad Heuer

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.

Download the Final Pharmaceutical and Medical Device Manufacturer Conduct Regulations eBook (.pdf) 

 

Follow-on Biologics and Patent Reform: Will They Discourage Venture Capital Investment in the Biotechnology Industry?
by Don Ware and Nick Littlefield 

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.

Download the Foley Hoag Follow-on Biologics eBook (.pdf) 

Patenting: A Guidebook for Those Involved in Legally Protecting Products and Technologies
by Beth E. Arnold

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.

Download the Foley Hoag Patenting Guidebook eBook (.pdf) 

 

Five Common Employment Law Hazards for Start-Ups
by Michael L. Rosen

Emerging, venture capital-backed companies typically face a host of legal considerations but have limited personnel and monetary resources to address all of them comprehensively. Often lacking in-house human resources and legal expertise, many emerging companies employ a “band-aid” approach to HR-related issues, addressing problems only as they arise. There are, however, a few common employment law issues to be aware of, and a bit of advance understanding and planning can do a great deal to minimize the downstream risks of expensive legal headaches.

Download the Foley Hoag Common Employment Law Hazards eBook (.pdf) 


Title Date Authors Type Download
New H-1B Filings for FY 2011 Begin April 1st Mar 17, 2010 Kevin J. Fitzgerald, Punam Singh Rogers Alert

Employment Bulletin - March 17, 2010

SUMMARY

On April 1, 2010, the U.S. Citizenship and Immigration Services (“USCIS”) will begin accepting new H-1B petitions for employment commencing on October 1, 2010. New H-1B petitions are subject to an annual limit of 65,000 new H-1B visas, plus an additional 20,000 visas for foreign workers with an advanced degree from a U.S. academic institution.

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Biotech Patent Held Invalid For Failing to Disclose Preferred Host Cells Mar 11, 2010 Claire Laporte, DeAnn F. Smith, Jeremy A. Younkin Alert

Intellectual Property Alert - March 11, 2010

SUMMARY

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.

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Employment Bulletin - March 3, 2010 Mar 3, 2010 Robert A. Fisher Alert

President Obama Extends COBRA Subsidy for Unemployed Workers Again

SUMMARY

Last night, President Obama signed into law the Temporary Extension Act of 2010, which among other provisions, includes a further extension of the federal COBRA subsidy created by the American Recovery and Reinvestment Act of 2009 (“ARRA”). Under ARRA, employees who were involuntarily terminated between September 1, 2008 and December 31, 2009 are entitled to a government subsidy of 65% of the premium cost for health care continuation coverage under COBRA for a period of nine months.

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SEC Adopts Enhanced Proxy Statement Disclosures Focusing on Compensation and Governance Mar 3, 2010 Dean F. Hanley Alert

Business Alert - March 3, 2010

SUMMARY

The Securities and Exchange Commission has adopted a number of new rules that will affect public company disclosures in the areas of compensation, director qualifications and suitability, corporate governance and reporting of the results of shareholder meetings.

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Massachusetts May Pick Up the PACE Mar 1, 2010 Mary Beth Gentleman, Adam Wade, Rebecca L. Puskas Alert

Energy Technology & Renewables Alert - March 1, 2010

SUMMARY

A financing concept for energy efficiency and renewable energy projects that seems to be sweeping the nation has made its way to Massachusetts. A provision of a major bill now pending in the House Ways and Means Committee would enable Massachusetts municipalities to issue Property Assessed Clean Energy ("PACE") bonds to finance energy efficiency or renewable energy generation projects in commercial and residential properties. PACE bonds are typically issued by municipalities. The proceeds are lent to property owners to finance energy efficiency retrofits or the up-front costs of installing renewable energy systems. The projects are treated as "betterments", much like a sewer or septic system fees; the borrower repays the loan over time through annual assessments on their property tax bill.

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SEC Adopts New Short Selling Rule Feb 26, 2010 Meredith A. Haviland, Jeffrey D. Collins, Peter M. Rosenblum Alert

The Foley Adviser - February 26, 2010

SUMMARY

On February 23, 2009, the Securities and Exchange Commission (the “SEC”) adopted a new short selling rule which places restrictions on the short selling of securities which experience a price decline of 10% or more in one day. In a press release regarding the adoption of the new “alternative uptick rule” (Rule 201) (http://www.sec.gov/news/press/2010/2010-26.htm) the measure was described as one “intended to promote market stability and preserve investor confidence.”

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Supreme Court Decision in Citizens United v. Federal Election Commission Changes the Landscape for Corporate Funding of Election Communications Feb 19, 2010 Dean Richlin, Paul T. Kim, Tad Heuer, Zachary Gerson Alert

Business Alert - February 19, 2010

SUMMARY

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.

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Appeals Court Limits The Scope of Lilly Ledbetter Fair Pay Act Feb 18, 2010 Lisa Burnett Alert

Employment Bulletin - February 18, 2010

SUMMARY

In the first appellate-level opinion interpreting the Lilly Ledbetter Fair Pay Act of 2009, the Court of Appeals for the District of Columbia Circuit held in Schuler v. PriceWaterhouseCoopers, LLC, that an employer’s denial of a promotion was not a “discriminatory compensation decision or other practice,” within the meaning of the statute. In that case, the plaintiff acknowledged that his claim was untimely prior to the enactment of the Ledbetter Act but argued that the new law extended the statute of limitations and thus revived his claim.

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Reminder: March 1, 2010 Deadline to Comply With Massachusetts Information Security Regulations Is Right Around the Corner Feb 17, 2010 Gabriel M. Helmer Alert

Security & Privacy Alert - February 17, 2010

SUMMARY

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.

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EEC Perspectives - February 2010 Feb 12, 2010 David A. Broadwin, David R. Pierson Update Download

2009 Annual Review of Venture Capital Financings

SUMMARY

Included in this Issue:

  • The Top of the List  – Dave Broadwin

  • The Numbers – David Pierson

  • Selected New England "Series A" Round Transactions: Fourth Quarter 2009

  • Selected New England "Series B" and Later Round Transactions: Fourth Quarter 2009

  • Terms of Selected New England "Series A" Rounds 2009

  • Terms of Selected New England "Series B" and Later Rounds 2009

  • The Activity Level Summary

        – New England "Series A" Transactions by Industry

        – New England "Series B" and Later Round Transactions by Industry

        – National "Series A" Transactions by Industry

        – National "Series B" and Later Round Transactions by Industry

  • Size of New England 2009 "Series A" Transactions by Industry

  • Size of New England 2009 "Series B" and Later Round Transactions by Industry

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Justice Department Seeks Increased Funding for Fraud Prevention and Enforcement; Financial, Mortgage and Healthcare Fraud Remain Key Priorities in FY 2011 Budget Feb 5, 2010 Nicholas C. Theodorou, Daniel Marx Alert

Business Crimes Alert - February 5, 2010

SUMMARY

Earlier this week, Attorney General Eric Holder announced that the President’s FY 2011 budget request includes a staggering $29.2B for the Justice Department, an increase over the actual FY 2010 budget appropriation of $1.5B and 2,880 positions. 

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Massachusetts Makes Energy Efficiency “First Fuel”; 3-Year Utility Plans Approved by DPU Feb 5, 2010 Mary Beth Gentleman, Rebecca L. Puskas Alert

Energy Technology & Renewables Alert - February 5, 2010

SUMMARY

On January 28, 2010, the Massachusetts Department of Public Utilities (DPU) approved three-year energy efficiency plans submitted by the state’s investor-owned electric, natural gas utilities, and the Cape Light Compact, which serves portions of Cape Cod. The goal of the plans is to achieve a 2.4 percent reduction in electricity use across the state, and a 1.15 percent reduction in natural gas use.

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Employment Bulletin - February 5, 2010 Feb 5, 2010 Lyndsey M. Kruzer Alert

Obama Administration Proposes Initiative to Combat Misclassification of Employees as Independent Contractors

SUMMARY

President Obama’s proposed federal budget for the 2011 fiscal year highlights one of its key enforcement priorities - to fight the misclassification of employees as independent contractors. The proposed budget for the Department of Labor includes a $25 million “Misclassification Initiative”, which is intended to assist the Department in identifying and reducing employee misclassification. If passed, the initiative would allow the DOL to hire additional investigators and enforcement personnel and would create competitive grants to encourage the states to address the issue.

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Securities and Exchange Commission Publishes Its Interpretive Release on Climate Change Related Disclosures Feb 5, 2010 Dean F. Hanley, Seth D. Jaffe, Amy E. Boyd Alert

Business Alert - February 5, 2010

SUMMARY

In early February, the Securities and Exchange Commission published an interpretive release (Release Nos. 33-9106 and 34-61469) about public company disclosures related to climate change. The Commission has previously stated that it is not making new law, nor is it taking a position on any aspect of the debate concerning climate change. Instead, the release summarizes the current state of that debate, reminds companies of the existing regulatory scheme requiring disclosures concerning environmental and climate matters, and then — in what is clearly the most helpful part of this fairly short release — enumerates and describes the kinds of disclosures that the Commission believes would be, and should be, captured by the current regulatory system.

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New Massachusetts Data Security Law and Regulations - Comprehensive Information Security Plan required before March 1, 2010 Feb 3, 2010 Catherine M. Anderson, Jeffrey D. Collins Alert

The Foley Adviser - February 3, 2010

SUMMARY

As many of you are aware, The Commonwealth of Massachusetts has adopted a new data security law, and regulations thereunder (the "Regulations"), intended to protect its residents from identity theft.  While the new law primarily addresses the required response by a company which is subject to an identity theft (prompted by the TJX data breach), the Regulations also set forth measures that businesses, including investment advisers and private fund managers, located in Massachusetts or elsewhere must take to safeguard the personal information of Massachusetts residents.  Such measures include the adoption of a comprehensive information security program.

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Investment Adviser Important Dates and Reminders Feb 3, 2010 Meredith A. Haviland, Jeffrey D. Collins Alert

The Foley Adviser - February 3, 2010

SUMMARY

Annual Compliance Reviews

All investment advisers registered with the Securities and Exchange Commission (“SEC”) are required to review their compliance policies and procedures at least annually.  Many advisers traditionally conduct this review in March of each year.  Registered advisers should commence their annual reviews promptly and document the review process.

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New Federal Earmark Rules Will Impact For-Profit Companies Feb 1, 2010 Paul T. Kim, Kalah Auchincloss, Tad Heuer Alert

Business Alert - February 1, 2010

SUMMARY

The system by which Congress awards earmarks during the annual appropriations process has recently come under increased scrutiny. As a result, both the President and congressional leaders have introduced initiatives aimed at increasing the transparency of the earmark process. The most recent reforms are two new policies—enacted in FY10 appropriations bills and thus now law—that require executive branch review of all congressionally-requested earmarks and a “competitive bidding process” for all earmarks designated for for-profit entities. Understanding these significant new restrictions on earmarks is therefore essential for any company or organization that is considering applying for federal earmark funds. Of the new reforms, Congressman David Obey (D-WI), Chairman of the House Appropriations Committee, recently stated that "in practical terms, it ends the practice of earmarks being the functional equivalent of sole source contracts."

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SEC to Require Companies to Disclose Global Warming Risks Jan 29, 2010 Dean F. Hanley, Seth D. Jaffe, Amy E. Boyd Alert

Business Alert - January 29, 2010

SUMMARY

The U.S. Securities and Exchange Commission (SEC) issued interpretive guidance yesterday which requires publicly traded companies to consider the impacts of climate change – both the physical damage it could cause, as well as the economic impacts of domestic and international greenhouse gas emissions-reduction rules – and disclose those risks to investors.

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SEC Adopts Revised Custody Rule Enhancing Controls That Apply To Registered Investment Advisers Jan 11, 2010 Meredith A. Haviland, Jeffrey D. Collins Alert

The Foley Adviser - January 11, 2010

SUMMARY

On December 16, 2009, the Securities and Exchange Commission (the “SEC” or “Commission”) approved the adoption of amendments to Rule 206(4)-2 of the Investment Advisers Act of 1940 (the “Advisers Act”), which relates to custody of client assets. The final rule was published on December 30, 2009 and will become effective 60 days after publication.

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President Obama Extends COBRA Subsidy for Unemployed Workers Dec 23, 2009 Robert A. Fisher

President Obama Extends COBRA Subsidy for Unemployed Workers

SUMMARY

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”).

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