FDAnews
www.fdanews.com/articles/63552-pfizer-s-expired-patent-dismissed-from-lawsuit-against-generic-firm

PFIZER'S EXPIRED PATENT DISMISSED FROM LAWSUIT AGAINST GENERIC FIRM

October 30, 2006

A district court granted Mylan Laboratories' motion to dismiss a patent from a lawsuit Pfizer brought against the company over a generic version of the blood pressure drug Norvasc.

The U.S. District Court for the Western District of Pennsylvania removed Pfizer's '909 patent from the lawsuit because it had already expired, Mylan announced Oct. 19. Because the patent has expired, the court said it does not have subject matter jurisdiction to decide whether the patent was infringed.

One patent still remains in the infringement litigation, which is scheduled to go to trial Nov. 28. Pfizer filed the lawsuit against Mylan in 2002, when both patents on its Norvasc Tablets were still valid. The second patent does not expire until September 2007.

Last year, the FDA granted final approval for Mylan's Amlodipine Besylate Tablets, a generic version of Norvasc. Since Mylan was the first company to receive approval for its generic drug, it has 180 days of exclusivity before other generics can enter the market. That period will begin when Mylan launches the product or when the court reaches a final decision on the patent litigation.

According to IMS Health, Norvasc sales for the 12-month period ending June 30 reached approximately $2.7 billion.