FDAnews Drug Daily Bulletin


Nov. 14, 2005

A federal judge has rejected Pfizer's request to throw out Mylan Laboratories' lawsuit challenging the patents on blockbuster blood pressure treatment Norvasc.
The U.S. District Court for the Western District of Pennsylvania recently issued an order denying Pfizer's motion for summary judgment seeking the dismissal of Mylan's inequitable conduct claims in the parties' ongoing patent litigation over Norvasc (amlodipine besylate). Mylan accused Pfizer of inequitable conduct in filing the patents, one of which expires Jan. 31, 2007, and the other on Sept. 25, 2007.

In his ruling, Judge Terrence McVerry stated that "both Pfizer and Mylan have raised a number of persuasive arguments as to the issues of the alleged inequitable conduct by the Pfizer patent applicants."

In a separate ruling, McVerry denied Mylan's motion for partial summary judgment of invalidity of one of the patents. Mylan said it will be able to assert its invalidity defense at trial.

The FDA approved Mylan's abbreviated new drug application (ANDA) for amlodipine besylate in 2.5-, 5- and 10-mg tablets in October. The agency also confirmed that Mylan was the first generic company to file an ANDA on all strengths of Norvasc tablets, making the firm eligible for 180 days of market exclusivity once it launches its product.