Aaron F. Barkoff Ph.D., Shareholder
Aaron Barkoff leads the Hatch-Waxman and Biosimilar litigation practice at McAndrews. He has extensive first-chair trial experience in ANDA litigation. Over his 20-year career, he has represented clients ranging from the world’s largest pharmaceutical companies to start-ups, now focusing on generic and biosimilar companies. He has also represented both petitioners and patent owners in more than a dozen IPRs at the Patent Trial and Appeal Board.
Aaron’s strong technical background in biochemistry and biotechnology, combined with his deep understanding of FDA regulatory issues, enables him to provide life science companies with keen insights on patent litigation strategy. He also advises clients on Orange Book patent listings, patent term extensions, and FDA exclusivity.
Aaron is the founder and editor of Orange Book Blog, a widely-read blog reporting on developments at the intersection of patent and FDA law.
Astellas US LLC et al. v. Apotex Inc. et al., No. 18-1675 (D. Del.) Lead trial counsel for Accord Healthcare in ANDA litigation regarding Lexiscan® (regadenoson). Trial scheduled for January 2022
Sumitomo Dainippon Pharma Co., Ltd. et al. v. Piramal Healthcare UK Ltd., No. 18-13478 (D.N.J.)
Amgen Inc. et al. v. Accord BioPharma, No. 18-61828 (S.D. Fla.)
Bial – Portela & CA, SA et al. v. Alkem Laboratories Ltd., No. 18-304 (D. Del.)
Amgen Inc. v. Amneal Pharms. LLC, et al., No. 16-853 (D. Del.)
EnviroLogix Inc. v. Ionian Technologies, LLC et al., Nos. IPR2018-00405 and -00406 (PTAB)