Pfizer has confirmed that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (U.S. Patent No. RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®.
Pfizer disagrees with the ruling and will pursue all available remedies, including an immediate appeal of the court’s decision.
A trial was scheduled to begin on March 19, 2014, for infringement of the reissue patent in the action brought by Pfizer against the generic companies Teva Pharmaceuticals USA, Inc., Mylan Pharmaceuticals Inc., Watson Laboratories, Inc., Lupin Pharmaceuticals, USA, Inc., Apotex Corp., and Apotex, Inc.
Each of these generic companies previously filed an abbreviated new drug application with the United States Food and Drug Administration seeking approval to market a generic form of celecoxib in the United States beginning on May 30, 2014, when Pfizer’s basic Celebrex® compound patent (including the six-month pediatric exclusivity period)expires. This is eighteen months prior to the December 2, 2015 expiration (including the six-month pediatric exclusivity period) of the reissue patent.
