News Feature | March 13, 2014

Pfizer To Appeal Court Decision On Celebrex Reissue Patent

By Estel Grace Masangkay

Pfizer Inc. announced it will appeal the court decision regarding blockbuster painkiller Celebrex reissue patent.

In its press release, Pfizer confirmed the decision of the United States District Court for the Eastern District of Virginia invalidating the company’s reissue patent (U.S. Patent No. RE44, 048) covering methods of osteoarthritis treatment and other approved conditions with the active ingredient in Celebrex, celecoxib.

“Pfizer disagrees with the ruling and will pursue all available remedies, including an immediate appeal of the court’s decision,” the company stated.

A trial is scheduled to start in the third week of March for alleged infringement of Pfizer’s reissue patent by generic companies Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Watson Laboratories, Inc., Lupin Pharmaceuticals USA, Apotex Corp., and Apotex Inc.

The company stated its generic competitors filed applications before its reissue patent is set to expire. “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.”

If the company doesn’t stop its generic rivals from gaining an early entry in the U.S. market for Celebrex it could lose $3 billion in revenue by the end of 2015, according to analysts.

Celebrex is a non-steroidal anti-inflammatory drug indicated for osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain, and primary dysmenorrhea. The drug has annual global sales of about $3 billion; including $2 billion in the U.S. Celebrex is the fourth biggest bestseller for Pfizer.

The drug’s basic chemical patent will expire on May 30, 2014. Teva and Mylan are among the generic companies which have submitted applications in anticipation of entering the drug’s market.