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Court Ruling Invalidates Celebrex Patent

Generic companies get ready to pounce

The U.S. District Court for the Eastern District of Virginia has granted a 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, marketed by Pfizer.

The ruling gives generic rivals an earlier U.S. entry that analysts estimate could cost the company $3 billion in revenue by the end of 2015. Pfizer has announced that it 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 an 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 (ANDA) with the FDA seeking approval to market a generic form of celecoxib in the U.S. beginning on May 30, 2014, when Pfizer’s basic Celebrex compound patent (including the six-month pediatric exclusivity period) expires. This is 18 months prior to the December 2, 2015 expiration (including the six-month pediatric exclusivity period) of the reissue patent.

Celebrex has annual global sales of about $3 billion, including $2 billion in the U.S. It is the fourth-biggest product for Pfizer, which has total annual company sales of about $52 billion.

Sources: Pfizer; March 12, 2014; and Reuters; March 12, 2014.

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