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.

RECENT CASES

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.)
Lead trial counsel for Piramal Healthcare in ANDA litigation concerning Latuda® (lurasidone hydrochloride). Case settled on terms favorable to Piramal.

Amgen Inc. et al. v. Accord BioPharma, No. 18-61828 (S.D. Fla.)
Lead trial counsel for Accord BioPharma in biosimilar litigation concerning Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Case pending.

Bial – Portela & CA, SA et al. v. Alkem Laboratories Ltd., No. 18-304 (D. Del.)
Lead trial counsel for Alkem Laboratories in ANDA litigation concerning Aptiom® (eslicarbazepine acetate). Trial scheduled for June 2022.

Amgen Inc. v. Amneal Pharms. LLC, et al., No. 16-853 (D. Del.)
Lead trial counsel for Piramal Healthcare in ANDA litigation concerning Sensipar® (cinacalcet hydrochloride). Won trial verdict of non-infringement. Advised Piramal through at-risk launch. Won Federal Circuit affirmance of non-infringement. Currently pursuing damages for Piramal from injunction bond posted by Amgen.

EnviroLogix Inc. v. Ionian Technologies, LLC et al., Nos. IPR2018-00405 and -00406 (PTAB)
Lead IPR counsel for Ionian Technologies (part of Abbott) concerning isothermal DNA amplification. Won decisions denying institution of IPR on all grounds.