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Legal Briefs: September Is a Mixed Bag For Brand Pharma Patents

Executive Summary

Former InterMune CEO convicted of wire fraud for misleading press release: A California jury convicted W. Scott Harkonen of wire fraud for the creation and dissemination of false and misleading information about the efficacy of InterMune's Actimmune (interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis. The information was included in a press release the company issued in 2002 announcing the results of a clinical trial. The jury acquitted him of a misbranding charge of promoting the drug for an unapproved use. A grand jury indicted Harkonen for fraudulent promotion in 2008, two years after InterMune entered a deferred prosecution agreement with the Department of Justice and agreed to pay $36.9 million to resolve criminal charges and civil liabilities for fraudulent promotion (1"The Pink Sheet" DAILY, March 18, 2008). The government has prosecuted pharma execs in the past but has largely been unsuccessful in winning verdicts against them. Eight executives of TAP were acquitted in a 2001 case over pricing and marketing of the prostate cancer drug Lupron (leuprolide) and several Serono executives were acquitted in a case over marketing of the AIDS drug Serostim (somatropin) (2"The Pink Sheet," March 31, 2008)

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Legal And Regulatory Briefs: Evista, Norvir, Gene Therapy

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)

Legal And Regulatory Briefs: Evista, Norvir, Gene Therapy

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)

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