White & Case Scores for Pfizer in Lyrica Patent Row

, The Litigation Daily


Pfizer Inc. and its lawyers at White & Case fended off a major challenge from generic rivals on Thursday, persuading an appeals court that patents for the painkiller Lyrica give the company exclusive rights to sell the drug through the end of 2018.

A group of eight drugmakers had sought to make their own versions of the pain and antiseizure medication, which generated $3.7 billion in revenue for Pfizer in 2011. But the U.S. Court of Appeals for the Federal Circuit upheld a lower court ruling that patents are valid and infringed by the proposed copycat drugs.

Pfizer tapped a White & Case team led by Dimitrios Drivas to sue the generic drug companies in U.S. district court in Delaware in 2009. Pfizer maintained that the patents protecting Lyrica, which were held by Northwestern University and exclusively licensed to Pfizer, were valid and infringed by the proposed generic versions. The defendants included Teva Pharmaceuticals Ltd., Actavis Inc., Mylan Pharmaceuticals Inc. and Cobalt laboratories Inc.

As we previously reported, U.S. District Judge Gregory Sleet in Wilmington held a bench trial in the case in October 2011, and in July 2012 issued a 133-page decision siding with Pfizer.

On appeal at the Federal Circuit, Mylan counsel Timothy Kratz of McGuireWoods argued that one of the underlying patents was invalid because it didn't enable others to make and use the drug as required. Sun Pharmaceuticals, which was represented at the Federal Circuit by Winston & Strawn's James Hurst, argued that the patent didn't include an adequate written description.

Neither position got any traction with the Federal Circuit panel. In dismissing the generics' enablement argument, Judge Sharon Prost wrote that "the inventors were not required to provide a detailed recipe for preparing every conceivable permutation of the compound they invented." As to Sun's argument that the invention wasn't adequately described, Prost wrote that the patent's written description was "sufficient for persons of ordinary skill in the art to recognize that the inventor invented what is claimed."

The panel also denied the generic companies' joint argument that the Lyrica patent was obvious because of prior inventions.

Kratz of McGuireWoods didn't respond to our call. Winston's Hurst was at trial on another case and unavailable to comment.

White & Case's Drivas, who represented Pfizer at trial and at the Federal Circuit, referred us to his client. In a statement, Pfizer senior VP and associate general counsel Michael Parini said the company was pleased with the decision.

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