Aaron Barkoff is a Shareholder at McAndrews. His practice focuses on pharmaceutical and biotechnology patent litigation. He has extensive trial experience in ANDA litigation, and has represented clients ranging from the world’s largest pharmaceutical companies to innovative specialty and generic drug companies. He also represents both patent owners and petitioners in Inter Partes Review proceedings at the Patent Trial and Appeal Board.

Aaron’s strong technical background, combined with his deep understanding of FDA regulatory issues, enables him to provide life science companies with keen insights on patent litigation strategy, including biosimilar litigation strategy under the BPCIA. 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

Genentech, Inc. et al. v. Laurus Labs, Ltd. et al., No. 19-78 (D. Del.)
Lead trial counsel for Accord Healthcare in ANDA litigation concerning Esbriet® (pirfenidone). Case pending.

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 settled on terms favorable to Accord.

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). Case pending.

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. Federal Circuit appeal pending.

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