Aaron F. Barkoff, Ph.D.
Aaron Barkoff focuses on pharmaceutical and biotechnology patent litigation. He has impressive trial experience in ANDA litigation, representing clients ranging from the world's largest pharmaceutical companies to 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. Further, he 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.
- “Biosimilars Boot Camp for the Paragraph IV Litigator,” ACI’s 4th Annual Paragraph IV Disputes Master Symposium, September 2016
- “Patent Barriers to Biosimilars in the United States,” CPhI’s 5th Annual Pharma IPR India Conference, March 2016
- “Inter Partes Reviews of Pharmaceutical Patents: Understanding How IPRs are Changing the Landscape of Innovator/Generic Litigation,” IPO IP Chat Channel webinar, July 2014
- “Biosimilar Patent Litigation,” Barclay’s Generic Pharmaceuticals Symposium, April 2014
- “Forfeiture of 180-Day Exclusivity,” Momentum Events’ International Congress on Paragraph IV Litigation, September 2013
- “Regulatory Challenges and Current Trends,” International Bar Association World Life Sciences Conference, May 2013
- “Practical Implications of Recent Decisions on Inducement of Infringement,” ACI’s Paragraph IV Disputes Conference, December 2012
- “Potential Controversies in BPCIA Patent Litigation,” IIR USA’s Business of Biosimilars & Generic Drugs Conference, September 2012
- “Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges,” ACI’s Paragraph IV Disputes Conference, April 2012
Professional & Community Involvement
- Member, American Bar Association – Sections of Intellectual Property Law and Litigation
- Member, Intellectual Property Owners Association – Pharmaceutical and Biotechnology Issues Committee
- Member, The Food and Drug Law Institute
Areas of Practice
Bar Admissions / Registrations
- U.S. District Court for the Northern District of Illinois
- U.S. District Court for the District of Columbia
- U.S. District Court for the Western District of Wisconsin
- U.S. Court of Appeals for the Federal Circuit
- U.S. Patent and Trademark Office
- University of Chicago Law School, J.D.
- University of Wisconsin-Madison, Ph.D., Biochemistry
- Lawrence University, B.A., Biology