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Pfizer Wins Patent Ruling, Exclusive Sales for Lyrica

Pfizer Inc., the world’s largest drugmaker, convinced a U.S. judge that its patents for the pain-drug Lyrica are valid and infringed, giving it exclusive sales rights until 2018.

Pfizer, based in New York, sued competitors including Teva Pharmaceuticals USA in federal court in Wilmington, Delaware, in April 2009, contending their sales of generic Lyrica would infringe the patents and cause irreparable harm.

“The defendants are enjoined, based on this infringement, from commercially manufacturing, using, offering for sale, or selling” their product, and the U.S. Food and Drug Administration is prohibited from approving the generic drug applications until the patents expire, U.S. District Judge Gregory M. Sleet wrote in a 133-page opinion released yesterday.

“The court’s decision recognizes the infringement and validity of our Lyrica patents and affirms the value of Lyrica as a distinct and important innovation for patients,” Amy Schulman, Pfizer’s general counsel, said in a statement. “Protecting our intellectual property is vital to our ability to develop new medicines that save and enhance patients’ lives.”

FDA Approval

Lyrica, approved by the FDA in 2004 to treat pain, also has been used by doctors to treat anxiety, epilepsy and restless-leg syndrome. Pfizer logged $3.7 billion in Lyrica sales last year.

Denise Bradley, a spokeswoman for defendant Teva Pharmaceutical Industries Ltd., the world’s biggest generic drugmaker, said in an e-mailed statement that the Israeli company had no comment on the ruling.

Watson Pharmaceuticals Inc., the parent company of Bonita Springs, Florida-based defendant Cobalt Laboratories, hasn’t decided whether it will appeal, Charlie Mayr, a spokesman for Watson, said in an interview.

Uday Baldota, a spokesman for Mumbai-based defendant Sun Pharma Industries Ltd., wasn’t immediately available to respond to a phone call and e-mail seeking comment.

Wockhardt USA

Andrew Watson, a spokesman for Parsippany, New Jersey-based defendant Wockhardt USA LLC, wasn’t immediately available to comment on yesterday’s decision.

A phone call to Morristown, New Jersey-based Actavis Inc.’s media relations office seeking comment on the decision wasn’t immediately returned.

Nina Devlin, a spokeswoman for Mylan Inc., of Canonsburg, Pennsylvania, parent of a defendant, didn’t immediately return a call for comment.

Caryn C. Borg-Breen, defense attorney for Baltimore-based Lupin Pharmaceuticals Inc., didn’t immediately return a call for comment.

The case is Pfizer Inc. v. Teva Pharmaceuticals USA, 09-cv-307, U.S. District Court, District of Delaware (Wilmington).

To see the patents in the lawsuit, click: 5,563,175; 6,001,876; 6,197,819.

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