Recent Federal Circuit Decisions on Obviousness-Type Double Patenting May Shape Life Science Patent Portfolio Management

May 17, 2019

The U.S. Court of Appeals for the Federal Circuit recently decided two appeals, Novartis AG v. Ezra Ventures LLC1 (Ezra) and Novartis Pharms. Corp. v. Breckenridge Pharm. Inc.2 (Breckenridge) that both relate to the effect of obviousness-type double patenting (ODP) on pharmaceutical patents that received patent term extension (PTE) for Food and Drug Administration (FDA) regulatory delays per 35 U.S.C. § 156(c). Both cases concern pairs of patents where the primary patent was filed before implementation of the Uruguay Round Agreements Act (URAA)3 and the reference patent asserted as the basis for ODP was filed after URAA implementation. The Ezra opinion, in particular, may help clarify some issues relating to the effect of ODP on life sciences patenting strategies, but also leaves some important ODP-related issues unresolved. The analysis that follows reviews the state of ODP law following Ezra and Breckenridge and highlights considerations for patent portfolio management when ODP is a concern, particularly for patents that have PTE-extended terms.

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