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LILLY'S PATENT ON PMS TREATMENT UPHELD

August 8, 2005

Eli Lilly's patent on premenstrual syndrome (PMS) treatment Sarafem was recently upheld by a federal appeals court, which rejected a patent challenge by Israeli generic firm Teva Pharmaceutical.

The decision by the U.S. Court of Appeals for the Federal Circuit upheld an August 2004 ruling by the U.S. District Court for the Southern District of Indiana. The case centered on Eli Lilly's '998 patent, which covers a method of treating PMS by administering fluoxetine, according to court documents.

In its appeal to the federal circuit, Teva challenged the district court's claim construction interpreting the statement that the drug must be administered "prior to the onset of [a woman's] menstrual period," according to court documents. The district court construed the claim to mean treatments that go on continuously before, during and after a woman's period. Teva argued that the district court had erred in including continuous dosing regimens in the claim construction.