Pfizer Wins Challenge to Norvasc Patent by Mylan

Pfizer Inc said today that a federal court in the Western District of Pennsylvania (Pittsburgh) has upheld the company's U.S. patent covering the active ingredient in Norvasc, the world's most-prescribed branded medicine for treating hypertension. The patent had been challenged by the generic manufacturer Mylan.

Judge Terrence F. McVerry ruled that the patent (U.S. Patent No. 4,879,303) covering amlodipine besylate is valid, enforceable and would be infringed by Mylan's product. The decision, which is subject to appeal, prohibits Mylan from launching a generic version of amlodipine until September 2007.

"The court decision is another important victory for medical innovators who invest in high-risk research to develop life saving medicines, as well as for the patients who benefit from those medicines," said Allen Waxman, Pfizer's general counsel.

Today's ruling is the latest in a series of favorable decisions for Pfizer and against generics manufacturers who have sought to invalidate Norvasc's U.S. patent covering amlodipine besylate. In January 2006, a federal court in the Northern District of Illinois ruled against Canadian generic manufacturer Apotex; and in August 2006, a federal court in the Middle District of North Carolina rejected a challenge by Dutch generic manufacturer Synthon. Both of those decisions have been appealed.