MYLAN, PFIZER WILL HEAD TO TRIAL OVER NORVASC PATENT
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.
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