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Pfizer Wins U.S. Ruling to Block Generic Lyrica Until 2018 (1)

February 06, 2014

Pfizer Inc., the world’s biggest drugmaker, won a court ruling that will block generic versions of its No. 1 product, Lyrica, in the U.S. until December 2018.

Teva Pharmaceutical Industries Ltd. (TEVA), Actavis Plc (ACT:US) and Lupin Ltd. (LPC) are among the generic-drug makers that would infringe a valid patent on the pain medicine, the U.S. Court of Appeals for the Federal Circuit in Washington said in an opinion today on its website. The other generic-drug makers in the case were Sun Pharmaceutical Industries Ltd., Wockhardt Ltd. and Mylan Inc.

Lyrica has become increasingly important to Pfizer’s earnings since the New York-based company lost patent protection on its cholesterol pill Lipitor, which once generated almost $13 billion a year. Sales of Lyrica, used to treat shingles, fibromyalgia, epilepsy, and hot flashes, reached $4.6 billion last year, accounting for 9 percent of Pfizer’s total revenue.

The appeal centered on a single aspect of a patent covering the active ingredient, pregabalin. The generic-drug makers argued that the patent didn’t adequately describe a new invention, and was an obvious variation of other compounds. They conceded that, if the patent claim was upheld, they had no chance at winning on that or a second patent.

“We perceive no error in the district court’s construction” of what the patent claim covers, the three-judge panel wrote.

The case is Pfizer Inc. (PFE:US) v. Teva Pharmaceuticals USA Inc., 12-1576, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 09cv307, U.S. District Court for the District of Delaware (Wilmington).

To contact the reporter on this story: Susan Decker in Washington at

To contact the editor responsible for this story: Bernard Kohn at

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