Mylan Laboratories announced today that the U.S. District Court for the Western District of Pennsylvania has granted its motion to dismiss U.S. Patent No. 4,572,909 from its case against Pfizer concerning Mylan's ANDA for generic Norvasc (amlodipine besylate). Pfizer's U.S. Patent No. 4,879,303 is still in the case. According to Mylan's press release, the court decision has "far-reaching implications for the generic drug industry."
The district court granted Mylan's motion to dismiss simply because the '909 patent had expired, and therefore the court lacked subject matter jurisdiction to decide whether the '909 patent was valid and infringed. Pfizer wanted the court to keep the '909 patent in the case as a sort of insurance policy in case the '303 patent, which does not expire until March, 2007, is held invalid or unenforceable at trial. A bench trial in the case is scheduled to begin on November 28th.
How an expired patent could be valuable to Pfizer is a bit complicated. Although the '909 expired on July 31, 2006, Pfizer is entitled to 6 mos. of pediatric exclusivity on the patent, essentially extending the life of the patent to January 31, 2007. Mylan has received final approval to market its generic version of Norvasc (Pfizer's 30-month stay has expired), but Mylan has not yet launched its product. Pfizer believed that if the court were to find the '909 patent valid and infringed, then the FDA would revoke Mylan's final approval, changing Mylan's ANDA status back to tentative approval until the pediatric exclusivity on the '909 patent ran out at the end of next January.
Based on its two previous victories on the '303 patent (which we reported in this post last month), Pfizer still appears to be in a good position. If Pfizer wins the upcoming trial, it would hold onto its exclusive rights to market Norvasc through September, 2007, when Pfizer's pediatric exclusivity on the '303 patent will expire. It would be another big win for Pfizer, since Norvasc has annual sales of $2.7 billion in the U.S.
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