Geoffrey Biegler

Geoff is a seasoned life sciences litigator with a particular focus on pharmaceuticals, biotechnology and medical devices, including Hatch-Waxman cases, Biologics Price Competition and Innovation Act (BPCIA) cases, competitor pharmaceutical and biotechnology cases, and life sciences-related post-grant proceedings at the Patent Trial and Appeal Board (PTAB).

Geoff has served as lead or co-lead counsel in multiple cases, conducted numerous trial witness examinations, and successfully argued many key hearings, including Markman hearings, PTAB oral arguments and preliminary injunctions. He also has extensive experience directing litigation strategy, including harmonizing patent disputes that include multiple international jurisdictions, as well as advising clients on intellectual property portfolio development and life cycle management.

Geoff has handled disputes related to many of the world’s top-selling drugs and devices, including Moderna’s Spikevax; Gilead’s HIV therapies Odefsey, Descovy and Vemlidy; Gilead’s HCV therapies Sovaldi, Harvoni and Epclusa; Kite’s Yescarta; Alovtech’s adalimumab biosimilar; Genentech/Roche’s Xeloda; Cephalon’s Amrix; Myriad Genetics’ BRCA1/BRCA2 genetic testing; and CRISPR-Cas9 gene-editing technology, among others.

Geoff also frequently teaches and speaks on life sciences litigation topics, including the regulatory framework of the Hatch-Waxman Act and the BPCIA.

Geoff’s recent representative experience includes:

• Co-lead counsel for Moderna in litigation brought by Alnylam over Moderna’s COVID-19 vaccine, Spikevax. Two separate cases were dismissed after favorable Markman rulings in Moderna v. Alnylam (D. Del.)
• Co-lead counsel for Gilead in a post-grant review proceeding filed by Atea Pharmaceuticals, alleging that a Gilead patent covering novel nucleoside phosphoramidate prodrugs was unpatentable. After a preliminary response, the board denied institution of Atea’s request for post-grant review in Atea Pharmaceuticals v. Gilead Sciences (PTAB)
• Lead counsel for NeuroDerm and Mitsubishi Tanabe Pharma in a post-grant review challenging an AbbVie patent related to treatments for Parkinson’s disease. The board found all claims of AbbVie’s patent unpatentable in a final written decision in NeuroDerm Ltd. v AbbVie (PTAB)
• Co-lead counsel for Gilead in Hatch-Waxman litigation over Vemlidy, Descovy and Odefsey (its breakthrough treatments for HIV and hepatitis B virus) against nine different generics that filed 15 abbreviated new drug applications (ANDAs), winning on all terms at Markman and settling favorably the morning of trial in Gilead Sciences v. Apotex, et al. (D. Del.)*
• Represented Alvotech in its multijurisdiction biosimilar dispute with AbbVie over arthritis drug adalimumab, sold as Humira – the world’s top-selling drug by revenue – in Alvotech USA Inc. et al. v. AbbVie Inc. et al., 1:21-cv-00589 (E.D. Va.) and AbbVie Inc. et al. v. Alvotech hf., 1:21-cv-02258 (N.D. Ill.)*
• Trial counsel for Kite in litigation over its chimeric antigen receptor T-cell (CAR-T) cancer product Yescarta, including putting on Kite’s written description expert at a jury trial. After trial, the US Court of Appeals for the Federal Circuit found Juno’s patent invalid for lack of written description, clearing Kite of any liability in Juno Therapeutics, Inc. v. Kite Pharma, Inc. (C.D. Cal.)*
• Trial counsel for a confidential arbitration matter involving CRISPR Cas-9 technology*
• Represented Gilead in Hatch-Waxman litigation against multiple generic companies related to ANDAs for Gilead’s hepatitis C treatment Sovaldi (sofosbuvir), resulting in the case being settled prior to trial in Gilead Sciences, Inc., et al. v. Teva USA, Inc., Gilead Sciences Inc. et al v. Natco Pharma, et al. (D.N.J.)*
• Represented ResMed in a patent dispute over continuous positive airway pressure (CPAP) flow generator and mask products spanning district court litigation, the US International Trade Commission (ITC), multiple worldwide litigations and 10+ inter partes review proceedings, with the case being settled prior to trial in ResMed v. Fisher & Paykel (ITC)*
• Represented Gilead in competitor pharmaceutical litigation involving Gilead’s hepatitis C treatment, Harvoni, with the litigation being resolved shortly before trial in Gilead Sciences, Inc. v. AbbVie, Inc. (D. Del.)*
• Trial counsel for ResMed in an ITC investigation involving patent infringement by CPAP flow generator and mask products. After the hearing, the ITC found a violation of Section 337 in Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof (ITC)*
• Trial counsel for Myriad Genetics in multidistrict litigation involving patents related to the BRCA1 and BRCA2 genes in In re: BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation (D. Utah)*
• Represented Roche and Genentech in Hatch-Waxman litigation involving Xeloda oral chemotherapy treatment, with the litigation settled shortly before trial in Hoffman-La Roche and Genentech v. Teva (D.N.J.)*
• Represented NUtech Ventures (associated with the University of Nebraska-Lincoln) in a patent case related to genetically modified corn, and argued and obtained a successful Markman ruling on behalf of NUtech, resulting in the case being settled in NUtech Ventures v. Syngenta Seeds (D. Neb.)*
• Represented 3M in a patent infringement case related to ion-exchange based emulsifier technology used in the manufacturing process for Teflon, with the case settled after claim construction in 3M Innovative Properties Co. v. DuPont (D. Minn.)*
• Represented Cephalon in multidistrict Hatch-Waxman litigation involving its skeletal muscle relaxant drug product, Amrix, resulting in a finding of infringement and validity for Cephalon in In re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (D. Del.)*
• Defended Terumo in district court and ITC cases involving its VirtuoSaph Endoscopic Vein Harvesting System, with both cases settled favorably in Maquet v. Terumo (N.D. Cal.) and In the Matter of Certain Vein Harvesting Surgical Systems and Components Thereof (ITC)*
• Represented the plaintiffs in Hatch-Waxman action over blood pressure drug Sular, with the case being successfully resolved upon patent expiration in Sciele Pharma, Inc., et al. v. Mylan Labs., et al. (D. Del.)*
• Represented the plaintiffs in patent litigation over cell lines used to manufacture the late-stage colon cancer drug Erbitux, with the case being settled on the morning of opening statements for $65 million in MIT & Repligen v. ImClone Corp. (D.Mass.)*

*Representation handled before joining Cooley

Speaking engagements

• Co-presenter, “Life Sciences Litigation: Biosimilars, 2024 Year in Review,” Cooley Rx series, January 2025
• Co-presenter, “Life Sciences Litigation: Hatch-Waxman, 2024 Year in Review,” Cooley Rx series, December 2024
• Co-presenter, “North America Life Science Patent Litigation Review 2024,” Pharma & Biotech Patent Litigation Summit, North America 2024, October 2024
• Co-presenter, “Regulatory Exclusivity Update in Europe and the USA and the Interplay With IP Strategy,” Life Sciences Strategy Summit on IP & Exclusivity, October 2024
• Co-presenter, “Life Sciences Litigation: Preparing for Successful Hatch-Waxman Litigation,” Cooley Rx series, May 2024
• Co-presenter, “Life Sciences Litigation: Hatch-Waxman, 2023 Year in Review,” Cooley Rx series, January 2024
• Co-presenter, “Life Sciences Litigation: Biosimilars, 2023 Year in Review,”Cooley Rx series, December 2023
• Co-presenter, “Life Sciences Litigation: Learnings from 40 Years of Litigation Under the Hatch-Waxman Act,”Cooley Rx series, September 2023