Barbara Fiacco represents clients in complex intellectual property and patent litigation matters. Her technology-related practice focuses on the biomedical field, including counsel to companies with activities focusing on recombinant DNA, monoclonal antibodies, small molecule compounds, drug delivery, molecular diagnostics, and medical devices. She has defended 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 contract disputes and other commercial litigation. Before joining Foley Hoag, Barbara served as a law clerk to the Honorable Richard J. Cardamone of the United States Court of Appeals for the Second Circuit. Representative Experience The following is a brief summary of Barbara's experience and accomplishments: · Filed an amicus brief in the United States Supreme Court on behalf of the Association of University Technology Managers in Mayo Collaborative and Mayo Clinic Rochester v. Prometheus Laboratories, Inc., arguing the importance of patents in the transfer of early-stage research for further development and commercialization. · Filed an amicus brief in the United States Supreme Court on behalf of the American Intellectual Property Law Association in Microsoft Corp. v. i4i, concerning the standard of proof required to invalidate a patent. · Currently representing Becton Dickinson in a patent infringement suit brought by Gen-Probe involving methods of automating nucleic acid diagnostic assays and related consumable products. · Currently representing Biogen Idec in the Classen Immunotherapies case on remand from Supreme Court to the Federal Circuit involving the scope of patentable subject matter under 35 U.S.C. § 101. · Filed an amicus brief in the Court of Appeals for the Federal Circuit on behalf of the Biotechnology Industry Organization in Amgen Inc. v. Hoffmann-LaRoche, Amgen's patent infringement suit over Roche's Mircera® drug product. · Currently representing Johns Hopkins University and Xanthus Pharmaceuticals in a dispute over ownership of intellectual property relating to a novel method of treating autoimmune disorders pending in Delaware Court of Chancery. · 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. · Filed an amicus brief in the Court of Appeals for the Federal Circuit on behalf of the American Intellectual Property Law Association in In re Bilski, concerning the scope of statutory subject matter under 35 U.S.C. § 101. · 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. · Defended Atrix Laboratories in a patent infringement suit brought by TAP Pharmaceuticals involving biodegradable polymers used for drug delivery. Under terms of a settlement, Atrix obtained a royalty-free license under TAP's past and future patents to make Atrix's prostate cancer drug Eligard®. · Represented Baxter Healthcare in the patent infringement and breach of contract litigation with Genetics Institute involving technology for the manufacture and purification of recombinant Factor VIII. Professional / Civic Involvement · American Intellectual Property Law Association (AIPLA) Chair, Patent Law Committee; Member, Amicus Committee; Co-Chair, Patents/Litigation Working Group of Special Committee on Legislation · 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 · Boston Intellectual Property American Inn of Court, Member Speeches and Conferences · Speaker, "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) · Speaker, "How to Stay Out of the Fire: Hot Topics in Ethics for In-House IP Attorneys," BIO Intellectual Property Counsel Conference," (April 2011) · Speaker, "Patent Resolution Processes for Follow-On Biologics," American Conference Institute, Follow-On Biologics Conference (June 2010) · Speaker, "Biosimilars Legislation: A Done Deal or a Deal Undone? Patent Enforcement," BIO Intellectual Property Counsel Conference (April 2010) · Speaker, "The Implications of In re Bilski on Biotech Inventions," C5 Biotech Patenting Conference (October 2009) · Speaker, "Recent Case Law Developments and the Biotechnology Industry," Boston Patent Law Association Conference (October 2009) · Speaker, "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) · Speaker, "Biosimilars Regulatory & Exclusivity Issues: U.S. Perspective," C5 Biotech Patenting Conference (June 2009) · Speaker, "In re Bilski: Implications of Biotech Inventions," BIO Intellectual Property Counsel Conference (March 2009) · Speaker, "The Bounds of Patent Eligibility in the Aftermath of the Bilski Decision," Boston Patent Law Association (January 2009) · Speaker, "Proposed Biosimilars Legislation: The New Patent Regime," American Conference Institute(September 2008) · Speaker, "Intellectual Property Update," Association of Corporate Counsel (ACC) Northeast Chapter Annual Program (September 2008) · Speaker, "Key Issues: Patent Reform Act of 2007," SBIR ASSETs (March 2008) · Speaker, "Major Changes for Patent Lawyers and Litigators," MCLE (June 2007) · Speaker, "Life Sciences IP Due Diligence for Buyers: Overcoming Attorney-Client Privilege and Ethical Concerns When Conducting Due Diligence," American Conference Institute (April 2007) · Speaker, "The Implications of Knorr-Bremse," American Intellectual Property Law Association Mid-Winter Institute (2005) 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) Industries Life Sciences Honors/Awards Recognized in the 2011 IAM PATENT LITIGATION 250 as a top-ranked individual patent litigator and life sciences patent litigator Ranked in CHAMBERS USA as an up-and-coming lawyer for Intellectual Property: Massachusetts (2010) and as one of Massachusetts' leading intellectual property lawyers (2011) Listed in THE BEST LAWYERS IN AMERICA (2011-2012) Named as a "Rising Star" in Intellectual Property Litigation, Super Lawyers' Massachusetts Rising Stars (2005, 2006, and 2007) |