Tuesday, April 1, 2008

Court Upholds Ortho-McNeil's Topamax Patent

A federal appeals court on Monday upheld a ruling that prevents generic drug maker Mylan (MYL.N: Quote, Profile, Research) from pursuing efforts to market a version of the epilepsy drug Topamax until Ortho-McNeil Pharmaceutical Inc's patent expires.

The U.S. Court of Appeals for the Federal Circuit found that a District Court in New Jersey district was correct in siding with Ortho-McNeil, a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research).

Ortho-McNeil said on its web site that the Topamax patent expires in September.

Under the Hatch-Waxman Act to encourage generic versions of drugs to be marketed quickly after a patent expires, Mylan had filed an application with the Food and Drug Administration saying it intended to bring out a version of Topamax. As part of that application, Mylan said Ortho-McNeil's patent was invalid.

But Ortho-McNeil disagreed, and filed a lawsuit saying its patent rights had been infringed.

http://www.cafc.uscourts.gov/opinions/07-1223.pdf

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