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Innovative Legal Strategies for a Branded Drug

Press Releases

Fish & Richardson Affirms Patent Infringement Win for Allergan Over Generic LUMIGAN® 0.01% at the Federal Circuit

August 6, 2015

Press Releases

Fish & Richardson Affirms Patent Infringement Win for Allergan Over Generic LUMIGAN® 0.01% at the Federal Circuit

August 6, 2015

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Fish & Richardson has announced that the Federal Circuit yesterday affirmed a patent infringement win for client Allergan, Inc. (NYSE:AGN) in its suit against Sandoz Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Hi-Tech Pharmacal Co., Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. over Allergan’s popular LUMIGAN® 0.01% glaucoma treatment.  The decision affirms the E.D. Texas ruling of January 14, 2014 that the defendants’ proposed products would infringe five of Allergan’s patents, and that the companies could not sell their generic versions of Allergan’s LUMIGAN® 0.01% until Allergan’s last patent expires in 2027.

LUMIGAN® (bimatoprost ophthalmic solution) 0.01 is a leading treatment for elevated eye pressure in people with glaucoma or ocular hypertension.  LUMIGAN® 0.01% was first approved by the FDA in 2010.

In an opinion that was a complete victory for Allergan, the Federal Circuit upheld the district court’s determination that the asserted claims are not invalid for obviousness or for lack of adequate written description and enablement.  The decision keeps the district court’s permanent injunction in place that prevents the defendants from the commercial manufacture, use, offer to sell and/or sale of their proposed generic products in, as well as the import of those products into, the U.S. or its territories.

The Fish appellate team was led by principal Juanita Brooks, who argued the case at the Federal Circuit and led the trial below; principal Craig Countryman, who led the briefing effort; and principal Jonathan Singer, who leads Fish’s Life Sciences Litigation practice.  “Hatch-Waxman litigation requires expertise across a wide range of legal areas, including everything from pre-suit investigations to PTO actions, Orange Book tactics, Title I strategies, ANDA filings (especially certification requirements pursuant to Paragraph IV), and FDA affairs.  We are pleased that Fish was able to bring all of that expertise to bear to win this case for Allergan,” said Singer.

Under Hatch-Waxman, drug companies may file a so-called abbreviated new drug application (ANDA) with the FDA to seek approval for generic versions of already-approved drugs by submitting bioequivalence studies instead of clinical studies, which is a much cheaper method than the normal FDA process.  Branded companies that own the patents and believe the generic will infringe must then sue to enforce their patent rights to attempt to prevent the approval of the infringing generic.

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