US District Court Rules Against Pfizer in Celebrex Patent Case

By Pharma News - DCAT Publisher

March 12, 2014

Pfizer Inc. reports that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (US 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, according to a company statement.  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-drug 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 FDA 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.

Source: Pfizer