Naproxen & Esomeprazole – USA

On  June 27, 2017 a  United States District Court for the District of New Jersey upheld the validity of two patents owned by a subsidiary of Aralez and licensed to Horizon Pharma plc covering VIMOVO® (naproxen/esomeprazole magnesium), and that Dr. Reddy's Laboratories Inc. and Dr. Reddy's Laboratories Ltd. ("Dr. Reddy's"), Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd., and Mylan Inc. ("Mylan"), and Lupin Ltd. and Lupin Pharmaceuticals Inc. ("Lupin") would infringe at least one of the two patents with their proposed generic naproxen/esomeprazole magnesium products.

On April 21, 2011, July 25, 2011, and June 28, 2013, an Aralez subsidiary filed patent infringement lawsuits in District Court against Dr. Reddy's, Lupin, and Mylan, respectively, related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market generic versions of VIMOVO.  The lawsuits claim infringement of U.S. Patent Nos. 8,557,285 ('285 patent) and 6,926,907 ('907 patent) titled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," which cover VIMOVO.  The District Court's decision was made based on the validity of the '285 and '907 patents for VIMOVO and the Court's judgment will prevent Dr. Reddy's, Mylan, and Lupin from launching generic versions of VIMOVO in the United States until at least the expiration of the relevant patent.

VIMOVO has 14 Orange Book listed patents with terms that extend to 2031. Other ANDA filers include Anchen pharma & Watson. Coalition for Affordable Drugs filed 4 different Inter Partes Reviews (IPR) on US 6,926,907; US 8,858,996; US 8,852,636 & US 8,945,621 patents. PTAB denied institution of all IPRS except one which is related to US’621. In final decision w.r.t US’621 patent, Board upheld the claims as patentable. No appeal was taken.