Betsy Flanagan

Betsy is an experienced trial lawyer who specializes in life sciences patent litigation, and she has substantial experience representing innovators against generic (abbreviated new drug application) challenges in Hatch-Waxman litigation. She has achieved significant wins in district court and defended them on appeal. Betsy also counsels pharmaceutical and biotech companies to strategically strengthen their patent portfolios for litigation.

Betsy’s life sciences litigation practice spans federal district courts, the US Court of Appeals for the Federal Circuit, the Patent Trial and Appeal Board (PTAB), and arbitration forums. Her litigation experience extends to new chemical entities, biologics, formulations and medical devices. She has substantial expertise in litigating method of treatment patents, including section viii “carve out” strategies.

In addition to serving as lead counsel and her stand-up experience in bench and jury trials and hearings, Betsy leads all phases of litigation, including pre-filing due diligence, claim construction, fact and expert discovery, and settlement negotiations. Betsy also has played significant roles in complex, multi-jurisdictional cases, as well as appeals through the Federal Circuit and US Supreme Court. She has been repeatedly recognized for her high-impact life sciences litigation work.

Before joining Cooley, Betsy served as the managing partner of the Minneapolis office of Fish & Richardson. She takes pride in mentoring the next generation of lawyers, and she is a regular presenter on life sciences litigation topics. During law school, Betsy was lead managing editor of the Minnesota Law Review.

Betsy’s recent representative experience

• Lead counsel representing the plaintiffs in Hatch-Waxman litigation over Parkinson’s disease agent Xadago (safinamide)
• Trial counsel for Exela Pharma Sciences in Hatch-Waxman litigation for its ELCYS product, resulting in a district court decision of infringement and no invalidity, and denials of institution on three of four post-grant review petitions at the PTAB, in Exela Pharma Sciences LLC v. Eton Pharmaceuticals Inc., No. 1:20cv365 (D. Del.)*
• Trial and appellate counsel for a branded pharmaceutical company concerning induced infringement by a generic challenger involving a section viii “carve out” label*
• Represented a pharmaceutical startup in arbitration asserting breach of contract claims*
• Defended a major diagnostic clinic against infringement allegations by securing a §101 dismissal*

*Representation handled prior to joining Cooley

Speaking engagements

• Co-presenter, “Global PTE/PTA Considerations: Essential Information to Commercialise International Life Science Products,” Life Sciences Strategy Summit on IP & Exclusivity, October 2024
• Co-presenter, "Life Sciences Litigation: Patent Litigation Damages Strategies, Trends and Legal Developments," Cooley Rx series, June 2024
• Co-presenter, "Life Sciences Litigation: Hatch-Waxman, 2023 Year in Review," Cooley Rx series, January 2024
• Co-presenter, “Life Sciences Litigation: Learnings from 40 Years of Litigation Under the Hatch-Waxman Act,” Cooley Rx series, September 2023