NUVO PHARMACUETICALS v. DR. REDDY’S LABORATORIES INC.

NUVO PHARMACUETICALS v. DR. REDDY’S LABORATORIES INC., Appeal No. 2017-2473 (Fed. Cir. May 15, 2019).  Before Prost, Clevenger, and Wallach.  Appealed from D.N.J. (Judge Cooper). (Written Description)

Background:

Nuvo sued Dr. Reddy’s for infringement of patent claims covering its pain relief drug, Vimovo®, after Dr. Reddy’s filed an ANDA seeking to market a generic version of the drug.  The drug is a combination of a non-steroidal anti-inflammatory drug (NSAID) for treating pain and an acid inhibitor for reducing acidity in the gastrointestinal tract.  In order to prevent gastrointestinal problems thought to be caused by the combination of the NSAID and acid in the stomach and upper small intestine, the drug is designed to release the acid inhibitor first to increase the pH in the gastrointestinal tract to a desired level before the NSAID is released.

Dr. Reddy’s stipulated to infringement, but alleged that the patent claims were invalid on various grounds, including lack of an adequate written description.  The district court disagreed, finding that the claims satisfied the written description requirement.  Dr. Reddy’s appealed.

Issue/Holding:

Did the district court err by holding that the claims satisfied the written description requirement?  (continue reading)

Summary by: Megan Doughty

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