Pfizer files patent suit against Lupin, 5 other pharma firms

NEW DELHI: US-based pharma giant Pfizer Inc today said it has filed suit against six firms, including India's Lupin, over patent infringement of celecoxib, the active ingredient of its branded drug Celebrex used for treating osteoarthritis.

The development follows the United States Patent & Trademark Office granting Pfizer a reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib.

"Pfizer filed suit today against Teva Pharmaceuticals USA, Inc, Mylan Pharmaceuticals Inc, Watson Laboratories Inc, Lupin Pharmaceuticals, USA, Inc, Apotex Corp, and Apotex Inc in the United States District Court for the Eastern District of Virginia for infringement of the reissue patent," Pfizer said in a statement on its website.

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 US beginning in May 2014, prior to the December 2, 2015 expiration of the reissue patent, it added.

The company said the reissue patent, which will expire on December 2, 2015, includes six months of pediatric exclusivity.

The basic patent for celecoxib expires on May 30, 2014, which also includes six months of pediatric exclusivity.

Pfizer Executive Vice President and General Counsel Amy Schulman said: "We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our intellectual property rights through December 2, 2015."