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www.fdanews.com/articles/89604-mylan-loses-u-s-norvasc-patent-challenge

MYLAN LOSES U.S. NORVASC PATENT CHALLENGE

February 28, 2007

Pfizer announced yesterday that a federal court in the Western District of Pennsylvania has upheld the company's U.S. patent covering the active ingredient in Norvasc, a hypertension drug. Generic drugmaker Mylan had challenged the patent.

The judge ruled that the patent covering amlodipine besylate is valid and enforceable, and that it would be infringed on by Mylan's product. The decision, which is subject to appeal, prohibits Mylan from launching a generic version of Norvasc until September.

The ruling is the latest in a series of favorable decisions for Pfizer involving its Norvasc patent. Last year a federal court in the Northern District of Illinois ruled against Canadian generic firm Apotex, and 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, according to Pfizer.

Mylan said it plans to appeal the most recent ruling.