Inter Partes Review in ANDA Litigation

The Leahy-Smith America Invents Act (AIA) aimed to provide cost-effective alternatives to district court litigation through expedited review of issued patents in the United States Patent and Trademark Office (USPTO) through post-grant review. One procedure in particular, inter partes review (IPR), permits a petitioner to challenge an issued patent's validity under 35 U.S.C. §§ 102 and 103 based on patents and printed publications. The unique statutory framework of Hatch-Waxman litigation, however, requires patent owners and challengers alike to carefully consider the potential implications IPR has on current or anticipated Abbreviated New Drug Application (ANDA) litigation. Mark J. Feldstein, Ph.D. discusses the statute and regulations governing IPR, explain the unique interplay between the Hatch-Waxman Act and IPR proceedings, and provide helpful strategies for patent owners and challengers contemplating or anticipating concurrent ANDA litigation and post-grant review.