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 is recognized in the IAM Patent 1000. IAM said he litigates “high-stakes patent infringement cases with poise.” It also noted that “Innovative and thorough, Aaron has excellent writing and presentation skills, which go a long way towards the favorable outcomes he achieves; his style is systematic, convincing, and calm. He responds with incredible speed and communicates with you as if he’s across the table, not across the country.”
His 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.