Appeals Court Strikes Down Teva’s Generic Celebrex Exclusivity

Teva’s first-filer rights to generic Celebrex are in doubt after a federal appeals court struck down a lower court’s decision upholding an FDA finding that the Israeli drugmaker was entitled to exclusivity on the blockbuster arthritis therapy.

The U.S. Court of Appeals for the Fourth Circuit found that the FDA inappropriately granted Teva exclusivity rights to generic Celebrex (celecoxib) in April.

That exclusivity should have come and gone when Teva first knocked down some of Pfizer’s patent protections on the therapy in 2008, the appellate court found. The decision sends the case back to the District Court in West Virginia to be adjudicated based on the new findings.

   
The ruling represents a win for Teva’s generic competitors, Mylan, Lupin and Actavis, who had filed a lawsuit against the FDA arguing that any claim by Teva to exclusivity expired in 2008. The FDA had countered that Teva was entitled to extended exclusivity claims because Pfizer successfully won a reissue of the invalidated patent, a position upheld at the district court level.

The appellate court, however, found that the reissuance of the patent effectively nullified any existing first-filer rights to it. 

How much of a difference the appellate decision makes remains unclear. All four generics makers have already announced product launches on their versions of Celebrex. Teva launched under its exclusivity while Mylan, Lupin and Actavis subsidiary Watson all boast authorized generic versions.

Lupin said that the decision would have no impact on its supply of authorized generic Celebrex in the U.S. Teva declined a request for comment. Mylan and Actavis did not respond to queries by press time. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.