Overview

Geoff Biegler is a seasoned life sciences litigator with a particular focus on pharmaceuticals and biotechnology, including Hatch-Waxman cases, BPCIA cases, competitor pharmaceutical and biotechnology cases, and life sciences-related post-grant proceedings at the PTAB. 

Geoff has extensive experience litigating both Hatch-Waxman cases and competitor pharmaceutical and biotechnology cases for products including Odefsey®, Descovy®, Vemlidy®, Sovaldi®, Harvoni®, and Epclusa® (Gilead), Yescarta® (Kite), adalimumab (Alvotech), Xeloda® (Genentech/Roche), Amrix® (Cephalon), BRCA1/BRCA2 genetic testing (Myriad Genetics), and CRISPR-Cas9 technology, among others.

In the context of those disputes, Geoff has successfully managed and tried matters through all phases of litigation, mediation, and arbitration in a variety of forums, spanning from the U.S. District Court for the District of Delaware to the Central District of California, including the U.S. International Trade Commission and the PTAB. Geoff has also handled due diligence efforts, pre-suit investigations, and assisted his clients in managing post-grant proceedings before the Patent Trial and Appeal Board.  In addition to his experience in U.S. jurisdictions, Geoff also has significant experience managing and harmonizing patent disputes that include fronts on multiple, international jurisdictions.

In the courtroom, Geoff has conducted numerous witness examinations at trials and hearings, argued a variety of dispositive and non-dispositive motions, including Markman hearings and preliminary injunctions, and has extensive experience managing complex discovery and directing case strategy. 

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

Experience

Gilead Sciences v. Apotex, et al. (D. Del.): Represented Gilead in Hatch-Waxman litigation over Vemlidy®, Descovy®, Odefsey®, Gilead’s breakthrough treatments for HIV and HBV against 9 different generics who filed 15 ANDAs. Gilead won on all terms at Markman and the case settled favorably the morning of trial.

Alvotech USA Inc. et al. v. AbbVie Inc. et al., 1:21-cv-00589 (E.D. Va.); AbbVie Inc. et al v. Alvotech hf., 1-21-cv-02258 (N.D. Ill.): Represented Alvotech in its multi-jurisdiction biosimilar dispute with AbbVie over arthritis drug adalimumab, sold as Humira, the world’s top-selling drug by revenue with more than $75 billion in sales in the past four years. Alvotech sought to invalidate AbbVie’s patents and assert claims of patent misuse by AbbVie for its assertion of more than 60 patents in the “minefield of IP” (as described by AbbVie’s CEO) that AbbVie uses to deter competition in the market. In March 2022, the matter was resolved through a settlement under which Abbvie will grant Alvotech a license to its Humira patents and the nonexclusive right to market a Humira biosimilar starting on July 1, 2023.

Juno v. Kite (C.D. Cal.): Represented Kite in litigation over Kite’s CAR-T cancer product Yescarta®, including putting on Kite’s written description expert at jury trial. After trial, the Federal Circuit found Juno’s patent invalid for lack of written description, clearing Kite of any liability in the matter.

Multiple confidential matters involving CRISPR Cas-9 technology. 

Gilead Sciences, et al v. Teva USA, Inc., v. Natco Pharam, et al. (D.N.J.): Managed Hatch-Waxman litigation against multiple generic companies related to abbreviated new drug applications for Gilead’s hepatitis C treatment SOVALDI® (sofosbuvir).  Case settled prior to trial. 

ResMed v. Fisher & Paykel: Counsel for ResMed in patent dispute over CPAP flow generator and mask products spanning district court litigation, the International Trade Commission, multiple worldwide litigations, and over ten IPR proceedings. Case settled prior to trial. 

Gilead Sciences, Inc. v. AbbVie, Inc. (D. Del.): Managed litigation for Gilead in competitor pharmaceutical litigation involving Gilead’s Hepatitis C treatment, Harvoni®. The litigation was resolved shortly before trial.

Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof (ITC) – Trial counsel for complainant ResMed through Commission decision in case involving patent infringement by CPAP flow generator and mask products. Following the hearing, the Commission found a violation of Section 337. 

In re: BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation (D. Utah): Trial counsel for plaintiff Myriad Genetics in multi-district litigation involving patents related to the BRCA1 and BRCA2 genes. 

Hoffman-La Roche and Genentech v. Teva (D.N.J.): counsel for Roche and Genetech in Hatch-Waxman litigation involving XELODA® oral chemotherapy treatment.  The litigation settled shortly before trial. 

NUTech Ventures v. Syngenta Seeds (D. Neb.): Counsel for NUTech Ventures (associated with the University of Nebraska-Lincoln) in patent case related to genetically modified corn. Argued and obtained successful Markman ruing on behalf of NUTech. Case settled in 2014. 

3M Innovative Properties Co. v. Avery Dennison (D. Minn.): Counsel for 3M in patent and antitrust cases related to retroreflective sheeting used on highway road signs.  Obtained successful Markman and summary judgment rulings on behalf of 3M. Cases settled in 2013. 

3M Innovative Properties  Co. v. DuPont (D. Minn.): Counsel for 3M in patent infringement case related to ion-exchange based emulsifier technology for removing APFO during manufacturing process for Teflon®. Case settled after claim construction. 

In re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (D. Del.): Represented plaintiff Cephalon in multi-district Hatch-Waxman litigation involving Cephalon’s skeletal muscle relaxant drug product, Amrix®. The case resulted in a finding of infringement and validity for Cephalon.

Maquet v. Terumo (N.D. Cal.) and In the Matter of Certain Vein Harvesting Surgical Systems and Components Thereof (ITC): Counsel for defendant Terumo in district court and ITC cases involving Terumo’s VirtuoSaph Endoscopic Vein Harvesting System.  Both cases settled favorably. 

Sciele Pharma, Inc., et al v. Mylan Labs., et al (D. Del.): Counsel for plaintiffs in Hatch-Waxman action over blood-pressure drug, Sular®. Case successfully resolved upon patent expiration. 

MIT & Repligen v. ImClone Corp. (D.Mass.): Counsel for plaintiffs in patent litigation over cell lines used to manufacture the late-stage colon cancer drug Erbitux®.  Case settled on morning of opening statements for $65 million. 

Professional associations

  • American Intellectual Property Law Association
  • Federal Circuit Bar Association
  • Federal Bar Association