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Wyeth Defeats Australian Generic Challenge Over Effexor Patent

Wyeth, a unit of Pfizer Inc., beat back a challenge from generic drug makers against the patent on the extended-release form of its antidepressant Effexor in Australia.

Federal Court Judge Jayne Jagot dismissed the challenge by Sigma Pharmaceuticals Ltd., Alphapharm Ltd. and Generic Health Ltd. in a judgment released yesterday, ruling that Wyeth’s patent was valid.

“The applicants have not established any ground” under the law to justify revoking the patent, Jagot wrote.

Sigma, which had a net loss of A$218.5 million ($221 million) for the six months ended July 31, and the other generic drug makers are prohibited under the ruling from selling copies of Effexor. The drug was Wyeth’s best-selling antidepressant, with sales of $3.9 billion in 2008, until cheaper U.S. generic versions were released this year. Effexor sales dropped to $175 million in the third quarter.

Sigma fell 0.5 cents to 45 cents in Australian Stock Exchange trading at 10:17 a.m. Pfizer declined 0.8 percent yesterday in New York.

Jagot also ordered Sigma and the other generic drug makers to destroy any copies of Effexor they have. She suspended the order for 14 days, or until the ruling is upheld on appeal.

Sigma began selling a copy of Effexor, called Evelexa, in Australia in May 2009. A month later, Wyeth won a court-ordered prohibition on the sale of the copy until trial.

Sue Morgan-Dethick, Sigma’s general counsel, didn’t immediately respond to a request for comment.

The case is Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth, VID195/2009, Federal Court of Australia, Sydney.

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