Fiacco

Barbara A. Fiacco

Partner
Co-Chair, Patent Litigation Practice
Boston

I craft strategies to achieve successful outcomes for companies and research institutions involved in complex, high-stakes IP disputes.

Barbara Fiacco is Co-Chair of the Patent Litigation Practice and represents life sciences companies and research institutions in complex intellectual property and patent litigation matters. Her practice focuses on the biomedical field, including gene therapy, epigenetics, sequencing technology, recombinant DNA technology, therapeutic antibodies, small molecule compounds, drug delivery, molecular diagnostics, and medical devices. 

She has represented leading pharmaceutical and life sciences clients in significant patent infringement lawsuits that have resulted in summary judgment or other favorable outcomes for her clients. Barbara also represents these clients in trade secret, inventorship, and technology transfer disputes as well as other commercial litigation.

Barbara is a Past President of the American Intellectual Property Law Association (AIPLA) and a Past President of the United States section of the International Association for the Protection of Intellectual Property (AIPPI-US), serving from 2019 to 2020. She has held a number of leadership roles in AIPLA and has represented this premier intellectual property law association in testimony on behalf of AIPLA before the Senate Judiciary Committee’s Subcommittee on Intellectual Property as well as in amicus briefs to the Supreme Court.

Education

  • Harvard Law School, J.D., cum laude, 1996
  • Dartmouth College, A.B., magna cum laude, with high honors in government, 1991

Bar and Court Admissions

BAR ADMISSIONS
  • Massachusetts
COURT ADMISSIONS
  • U.S. District Court for the District of Massachusetts
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. Court of Appeals for the First Circuit
  • U.S. Supreme Court

Experience

  • Represented Krystal Biotech in litigation brought by PeriphaGen alleging misappropriation of trade secrets and acts of “unfair competition” in connection with Krystal’s vector development. PeriphaGen also sought to add two of its employees as inventors to several of Krystal’s U.S. patents directed to methods of treating skin disorders by delivering certain genes using replication-defective HSV-1 vectors. Obtained favorable settlement for client.
  • Represented Celsee in District of Delaware patent infringement and false advertising dispute with 10x Genomics concerning instruments for single-cell analysis and associated consumables. Obtained favorable settlement just before trial.  
  • Represented Dana-Farber Cancer Institute as trial counsel in patent litigation against Bristol-Myers Squibb and Ono Pharmaceutical concerning inventorship and ownership of groundbreaking patents directed to PD-1/PD-L1 cancer immunotherapy. Obtained judgment for Dana-Farber correcting inventorship, making Dana-Farber a co-owner of all the patents. The Court of Appeals for the Federal Circuit affirmed the judgment in all respects, 964 F.3d 1365 (Fed. Cir. 2020), and the United States Supreme Court denied Defendants’ petition for writ of certiorari (May 2021).
  • Represented Becton, Dickinson and the Regents of the University of California in patent infringement litigation asserting multiple patents covering polymer dye reagents and their use in flow cytometry, resulting in the negotiation of a favorable settlement just before trial.
  • As lead counsel for Bioverativ, obtained successful claim construction rulings to support infringement claims and request for injunctive relief against CSL’s extended half-life Factor IX therapeutic product Idelvion®.
  • Represented Bioverativ in Patent Trial and Appeal Board, defeating IPR petitions asserting obviousness challenges against two patents directed to hemophilia B treatment regimens using Factor IX fusion proteins. 
  • Represented 3M in connection with PTAB appeals involving reexamination of three patents directed to antiseptic caps for cleaning medical instruments.  The PTAB reversed on all grounds for all three patents.
  • Filed an amicus brief in the Supreme Court on behalf of 3M and fourteen other large U.S. companies in Cuozzo Speed Technologies, LLC v. Lee, challenging the PTAB’s use of the “broadest reasonable interpretation” rule in post-grant proceedings.
  • Obtained judgment on the pleadings for FitNow in connection with its mobile application LoseIt! in a patent infringement action filed in the District of Utah, invalidating the asserted patent prior to any discovery.
  • Argued on behalf of the Biotechnology Industry Organization (BIO) as amicus before the en banc Court of Appeals for the Federal Circuit in Lexmark International, Inc. v. Impression Products, Inc., concerning international and domestic patent exhaustion.
  • Represented Becton Dickinson in a patent infringement suit brought by Gen-Probe involving methods of automating nucleic acid diagnostic assays and related consumable products. Obtained favorable settlement just before trial.
  • Defended University of Massachusetts (UMass) in federal court action brought by Max Planck Institute and Alnylam Pharmaceuticals against three co-owners of patent applications directed to therapeutic uses of RNA interference. Obtained judgment in favor of UMass on all damages claims asserted against it and global settlement agreement by which UMass became co-owner of Max Planck’s competing patent applications on RNA interference.
  • Represented Johns Hopkins University and Xanthus Pharmaceuticals in a dispute over ownership of intellectual property relating to a novel method of treating autoimmune disorders, resulting in negotiation of patent license.
  • Represented the respondent in a Section 337 investigation of patents involving genetically engineered bacteria for the production of lysine.  We obtained a ruling that the two patents were invalid and unenforceable due to inequitable conduct.
  • Defended Becton, Dickinson and Company in a patent infringement suit brought by Enzo Biochem involving nucleotide sequences used in genetic probes. Summary judgment of invalidity was affirmed in Enzo Biochem, Inc. v. Gen-Probe, Inc. et al., 424 F.3d 1276 (Fed. Cir. 2005.).
  • Defended Becton, Dickinson and Company in a contract dispute over the licensing of certain monoclonal antibodies.
  • Represented QLT Inc. in a patent infringement suit brought by Massachusetts Eye and Ear Infirmary involving inventorship of patented methods for treating age-related macular degeneration using QLT’s proprietary drug Visudyne®. We obtained a district court order correcting inventorship to add QLT’s scientist to the patent, leading to stipulated dismissal.
  • Author of numerous amicus briefs on behalf of professional and trade associations, including Supreme Court briefs in Supap Kirtsaeng DBA Bluechristine99 v. John Wiley & Sons, Inc., Octane Fitness v. Icon, Highmark v. Allcare, Mayo Cinic v. Prometheus Laboratories, and Microsoft v. i4i.

Publications

  • The Federal Circuit: no special treatment for this specialized court, MASSACHUSETTS LAWYERS WEEKLY (July 2007)
  • Research collaborations: Avoiding possible traps, MASS HIGH TECH (April 2007) also published in INTELLECTUAL PROPERTY COUNSELOR (2008)
  • Co-author, The Federal Circuit Ends the Adverse Inference: Do you still need an opinion of the counsel?, INTELLECTUAL PROPERTY & TECHNOLOGY LAW JOURNAL (November 2004)

Honors & Involvement

HONORS
  • Recognized in the IAM Patent 1000 for individual patent litigators in Massachusetts (2013, 2015, 2017); cited as a “biomedical expert,” “another winning patent litigator,” "supremely capable,” “terrific communicator,” “super-smart attorney who can have rational conversations about how to solve complicated problems” and “excellent and extremely professional”
  • Ranked by Chambers USA as one of Massachusetts' leading intellectual property lawyers (2011, 2018-2022) 
  • Listed in The Best Lawyers in America for Biotechnology Law and Intellectual Property (2011) and Biotechnology and Life Sciences Practice, Litigation – Intellectual Property and Litigation – Patent (2012-2023)
  • Named Best Lawyers’ Boston Biotechnology and Life Sciences Practice Lawyer of the Year (2020) and Boston Biotechnology Law Lawyer of the Year (2018)
  • 2015 President’s Outstanding Service Award from the American Intellectual Property Law Association (AIPLA) 
  • Recognized in Managing Intellectual Property’s Top 250 Women in IP, a guide to the leading female intellectual property attorneys in the United States (2013-2022)
  • Recognized as a Patent Star for Massachusetts in Managing Intellectual Property's IP Stars List (2017-2022)
  • Recognized in the 2011 IAM Patent Litigation 250 as a top-ranked individual patent litigator and life sciences patent litigator

INVOLVEMENT
  • Foundation for Advancement of Diversity in IP Law, Trustee, Chair of Scholar Clerkship Committee (2021-present) 
  • American Intellectual Property Law Association (AIPLA), President (2019-2020), Fellow (2015-present), Board Member (2011-2014), Chair of Legislation Committee (2014-2016), Chair of Patent Law Committee (2009-2011) and Chair of Membership Committee (2005-2007)
  • Law360 Intellectual Property Law Section, Advisory Board (2020)
  • Biotechnology Industry Organization International Convention Program Committee (2015-2017)
  • Boston Intellectual Property American Inn of Court, Program Committee Chair (2015-present)
  • Belmont Planning Board, Vice Chair (2015-2017)
  • American Bar Foundation, Fellow
  • American Bar Association, Intellectual Property Law Section Member
  • Boston Bar Association, Member
  • Women’s Bar Association, Member
  • Boston Patent Law Association, Member
  • Federal Circuit Bar Association, Member
  • Bloomberg BNA, Patent, Trademark & Copyright Journal (PTCJ) Advisory Board (2013-2015)

Speaking Engagements

  • “The Implications of Cuozzo Speed Tech v. Lee on Patent Prosecution and Post-Issuance Review Proceedings,” AIPLA Webinar (July 2016)
  • “US Patents & Global Business -- Clear Borders or Blurred Lines?” BIO Intellectual Property Counsels Conference (June 2016)
  • “Demystifying IPRs for Effective Use in the Biosimilars Landscape” ACI Biosimilars (June 2016)
  • “The New Biosimilars Pathway: Litigation Implications and Strategies for Biopharma and Biosimilar Companies” AIPLA 2016 Spring Meeting (May 2016)
  • “Through the Looking Glass: Life in a Post-Lexmark World” BIO Intellectual Property Counsels Conference (March 2016)
  • “Patent Litigation in the New Era” Bloomberg BNA (January 2016)
  • “Patent Litigation in the New Era” Bloomberg BNA (November 2015)
  • “Patent Reform in the US Congress: An Overview of Current Legislation,” AIPLA Webinar (September 2015)
  • “The Old Girls’ Network: Exploring Which Women’s Initiatives are Working to Create and Sustain a Robust Life Sciences Network,” Women Leaders in Life Sciences (July 2015)
  • “Who Has the Keys to Your IP? Protecting Against Intellectual Property Theft”, BIO Intellectual Property Counsels International Convention (June 2015)
  • “The Next Battle Ground Strategies for Obtaining or Challenging Preliminary Injunctions” ACI Biosimilars (June 2015)
  • “At the Hop DJs, (Inter) Parties, and (Patent) Dances” BIO Intellectual Property Counsels Conference (April 2015)
  • “Claim Issues: Nautilus/Indefiniteness and Teva/Deference to Trial Court” Bloomberg BNA - Impact of the Supreme Court on Patent Enforcement (March 2015) 
  • “Top Issues to Master for a Thriving Career,” ABA 2014 Annual Meeting: Young Lawyers Division (August 2014)
  • “Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies,” American Conference Institute’s 5th Annual Summit on Biosimilars (June 2014)
  • “Octane Fitness & Highmark: A Look at the Supreme Court’s New Standards for Attorney Fee Awards” AIPLA Webinar (June 2014)
  • “Section 112 - It’s Baaack! Nautilus Inc. v. Biosig Instruments: The Supreme Court Considers the Federal Circuit’s Indefiniteness Standard,” BIO Intellectual Property Counsels Conference (April 2014)
  • “Shedding Light: Lighting Ballast and Managing Claim Construction,” BIO Intellectual Property Counsels Conference (April 2014)
  • “U.S. Biosimilars Litigation: Procedures and Implications - Biosimilar Checklists,” Boston Patent Law Association – Hot Topics in European and US Patent Law (April 2014)
  • “Innovative Practice Resources for Meeting with Success during Inter Partes Review,” American Conference Institute’s 3rd Comprehensive Guide to Patent Reform (January 2014)
  • “The Great Race - Congress and the Courts on Fee-Shifting,” Association of Corporate Patent Counsel (ACPC) 2014 Winter Meeting (January 2014)
  • “Preparing for the Impending Reality of Biosimilars Patent Litigation: Immediate Action Plans for the First Wave,” American Conference Institute’s 4th Advanced Forum on Biosimilars (June 2013)
  • “AIA Litigation Perspectives,” “Intersection of AIA IPR and District Court Litigation,” “The Impact of eBay v. MercExchange,” and “§101’s Impact on Litigation,”  Duke Patent Law Institute (May 2013)
  • “Therasense Revisited: Where Are We Now with Inequitable Conduct?” Boston Intellectual Property American Inn of Court (April 2013)
  • “Patent Opinions Revisited: New Risks, New Rewards,” BIO Intellectual Property Counsels Conference (March 2013)
  • “The Post-AIA World: Factoring the Impact of Patent Reform into Biosimilars Prosecution and Litigation Strategies,” American Conference Institute’s 3rd Advanced Forum on Biosimilars (May 2012)
  • “Strategies for Litigation Under the Biologics Price Competition and Innovation Act,” New Jersey Intellectual Property Law Association (March 2012)
  • “Biosimilars Through the Hatch-Waxman Lens: Anticipating Litigation Challenges and Understanding the Evolving Landscape,” American Conference Institute’s 2nd West Coast Edition - Hatch-Waxman Series Pre-Conference Workshop (December 2011)
  • “Developing Proactive Procedures and Biosimilar Litigation Strategies: From Early Planning through the Exchange of Patent Lists,” American Conference Institute’s 2nd Annual Conference on Biosimilars (June 2011)
  • "The Advent of Biosimilars in the U.S.:  Where Are We Now?  Where Are We Likely Headed?," 26th Annual ABA Intellectual Property Law Conference (April 2011)
  • "How to Stay Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys," BIO Intellectual Property Counsels Conference," (April 2011)
  • "Patent Resolution Processes for Follow-On Biologics," American Conference Institute, Follow-On Biologics Conference (June 2010)
  • "Biosimilars Legislation: A Done Deal or a Deal Undone? Patent Enforcement," BIO Intellectual Property Counsels Conference (April 2010)
  • "The Implications of In re Bilski on Biotech Inventions," C5 Biotech Patenting Conference (October 2009)
  • "Recent Case Law Developments and the Biotechnology Industry," Boston Patent Law Association Conference (October 2009)
  • "Preparing for the Inevitable Enactment of Follow-on Biologics Legislation and Adopting a Practical Approach to Integrating FOB's into your Patent Strategies," American Conference Institute, 11th Advanced Forum on Biotech Patents (September 2009)
  • "Biosimilars Regulatory & Exclusivity Issues: U.S. Perspective," C5 Biotech Patenting Conference (June 2009)
  • "In re Bilski: Implications of Biotech Inventions," BIO Intellectual Property Counsels Conference (March 2009)