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Fish Wins Patent Infringement Suit for Allergan

16-Jan-2014 | Source : | Visits : 7303
TYLER, TX – Fish & Richardson announced in a press release that it won an important Hatch-Waxman litigation for client Allergan Inc. (NYSE:AGN) in a patent infringement suit against Sandoz Inc., Lupin Ltd., Lupin Pharmaceuticals Inc., Hi-Tech Pharmacal Co., Inc., Watson Laboratories, Inc., Watson Pharmaceuticals, Inc., and Watson Pharma, Inc. On January 14, 2014, the US District Court for the Eastern District of Texas ruled that the defendants could not sell their generic versions of Allergan’s popular LUMIGAN® (bimatoprost ophthalmic solution) 0.01% until Allergan’s last patent expires in 2027.

LUMIGAN® 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.

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.

As part of the ruling, the court permanently enjoined 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 US or its territories.

“We are very pleased for our client Allergan and to have had the privilege of representing them in this case,” said Jonathan Singer, head of the Life Sciences Litigation practice at Fish & Richardson who, along with Juanita Brooks and Douglas McCann, led the litigation and trial effort for Allergan. “This is a victory for all companies that put their R&D dollars into developing new and important products that address the unmet medical needs of patients around the world.”



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