NORVASC PATENT UPHELD IN FEDERAL COURT

A federal court has blocked plans by Mylan Laboratories to launch amlodipine besylate, a generic version of Pfizer's blockbuster drug Norvasc, during the drug's pediatric exclusivity period.

The U.S. District Court for the District of Western Pennsylvania upheld Pfizer's claims that the '303 patent covering its hypertension treatment is valid and enforceable. It said the generic version of the drug, if launched prior to patent expiry, would infringe on Pfizer's hypertension treatment patent.

Mylan disagreed with the court and immediately filed an appeal, a company source said. It sought to market generic amlodipine besylate in 2.5- and 10-mg tablets.

The ruling prohibits the generic firm from launching its version of the drug before Sept. 25, when the pediatric exclusivity for Norvasc expires. The substance patent expires March 25.

The court ruling marks another victory for Pfizer in its effort to keep generic firms from capturing a piece of the Norvasc market, reported to be worth billions.

A ruling by North Carolina's Middle District Court shot down a Norvasc patent challenge by the generic drug manufacturing arm of Synthon, which had also attempted to market generic amlodipine. The court ruled that the generic version would infringe on Pfizer's patent.