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Federal Circuit Decision Clarifies Obviousness-Type Double Patenting and Patent Term Adjustments In Allergan v. MSN Laboratories

By Maia H. Harris and Emma C. Mann
September 01, 2024

On August 13, the Federal Circuit issued a precedential ruling in Allergan USA Inc. et al. v. MSN Laboratories Private Ltd. et al., Case Number 24-1061, U.S. Court of Appeals for the Federal Circuit. This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re: Cellect LLC to invalidate a claim in an earlier-filed parent application over admittedly patentably indistinct claims in later-filed (and earlier-expired) child patents. This decision has resolved some substantial questions about the application of obviousness-type double patenting (ODP) that had been raised by last year's In re Cellect decision.

Case Background

Allergan, Janssen, and Eden Biodesigns (collectively, Allergan) asserted patent infringement against Sun Pharmaceuticals Industries (Sun) after Sun filed an abbreviated new drug application (ANDA) seeking U.S. Food and Drug Administration (FDA) approval to market and sell a generic version of Allergan's bowel treatment drug, Viberzi.

Following a three-day bench trial focusing on the Viberzi patents, the district court held that the asserted claim in parent patent 7,741,356 (the '356 Patent) was invalid for ODP over claims of two later-filed child patents. ODP is a judicially created rule that, in the absence of a terminal disclaimer, prevents the same inventor from obtaining multiple patents for a single invention. See, Manual of Patent Examining Procedure (MPEP) § 804. The doctrine's primary goal is to prevent an unjustified extension of patent exclusivity beyond the life of a patent. (Opinion at 11.)

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