Aaron F. Barkoff
Aaron Barkoff, Ph.D., is a patent litigator who specializes in pharmaceutical and biotechnology patent law. He has impressive trial experience in Hatch-Waxman litigation, representing clients that range from the world’s largest pharmaceutical companies to smaller, generic drug companies.
As the demand for legal expertise in the biotechnology and pharmaceutical areas continues to grow, Aaron’s strong technical background, combined with his deep understanding of FDA regulatory issues, allows him to counsel clients on patent litigation strategy for their new products, as well as related regulatory strategies. His advice in relation to FDA regulations includes Orange Book patent listings, patent term extensions under Section 156 and patent certification strategies.
In 2006, Aaron founded Orange Book Blog, a respected blog reporting on new developments at the intersection of patent and FDA law. He is a frequent speaker on pharmaceutical and biotechnology patent law, and he has authored many articles on such topics.
- Invalidity Due to Public Use in ANDA Cases, Orange Book Blog (September 17, 2013) View File
- Supreme Court Decides That “Reverse Payment” Settlements Shall be Subjected to “Rule of Reason” Antitrust Analysis, Orange Book Blog (June 17, 2013) View File
- Momenta Pharmaceuticals Files Supreme Court Petition in 271(e)(1) Safe Harbor Case, Orange Book Blog (February 25, 2013) View File
- District of Delaware Invalidates Entecavir Patent as Obvious, Orange Book Blog (February 11, 2013) View File
- Novo Nordisk Requests FDA Advisory Opinion Concerning Orange Book Listing of Patents on Pre-Filled Drug Delivery Devices, Orange Book Blog (February 5, 2013) View File
- “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, American Intellectual Property Law Association
- 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