FDAnews
www.fdanews.com/articles/169730-pfizer-facing-another-generic-celebrex-delay-lawsuit

Pfizer Facing Another Generic Celebrex Delay Lawsuit

January 28, 2015

Pfizer is again being accused of having illegally prolonged market exclusivity on its blockbuster arthritis drug Celebrex.

The Allied Services Division Welfare Fund, an Illinois-based health benefit fund, is seeking class action status in a lawsuit filed Jan. 20 in the U.S. District Court for the Eastern District of Virginia.

The lawsuit closely mirrors claims brought against Pfizer in similar cases, where plaintiffs argue they’ve been forced to shell out for branded Celebrex (celecoxib) at supracompetitive prices because cheaper generics were artificially blocked from the market.

The plaintiffs in this latest case claim that Pfizer used deception to obtain a reissued patent that had been invalidated in 2008 during Hatch-Waxman proceedings on Celebrex. That ruling cut the drug’s exclusivity from December 2015 to May 2014.

Reissued patent in hand, Pfizer once again sued generics makers that were seeking to compete with the brandmaker’s own generic versions of Celebrex, the complaint says. But before a final judgment was rendered in those suits, Pfizer settled with the generics makers, eliciting promises from them not to market their versions of the drug until December 2014, even though Celebrex lost its patent protection at the end of May.

Pfizer rejected the charges of antitrust violations involving Celebrex, maintaining that its patent process was lawful.

Multiple generic competitors hit the market with their own versions of Celebrex last month, although several are authorized generics. At the time, the companies cited IMS Health data attributing about $2.5 billion in annual U.S. sales to the therapy. — Bryan Koenig