Legal And Regulatory Briefs: Evista, Norvir, Gene Therapy
Executive Summary
Court upholds Lilly's Evista patents: In a Sept. 1 decision, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court ruling that Evista's method-of-use patents are valid. The patents provide the osteoporosis drug with patent protection through March 2014. Teva had appealed a district court ruling that it infringed claims in four Lilly patents (1"The Pink Sheet," Oct. 5, 2009). The Federal Circuit also affirmed the district court's finding that Evista (raloxifene) patents covering particle size distribution are invalid for lack of enablement. Separately, in an Aug. 31 order, the Federal Circuit granted Lilly's request for an injunction to prevent Teva and other generic manufacturers from launching generic versions of Strattera (atomoxetine) while Lilly appeals a district ruling that a key patent on the attention-deficit/hyperactivity disorder drug is invalid. The federal court in New Jersey ruled that the patent, set to expire in May 2017, is invalid for lack of enablement (2"The Pink Sheet" DAILY, Aug. 13, 2010)