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)

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 (Also see "Legal Briefs: September Is a Mixed Bag For Brand Pharma Patents" - Pink Sheet, 5 Oct, 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 (Also see "Without Strattera, Will Lilly Merge?" - Pink Sheet, 13 Aug, 2010.)).

Public Patent Foundation questions Norvir patents: A nonprofit group affiliated with Benjamin N. Cardozo School of Law has asked the U.S. Patent and Trademark Office to reexamine eight patents on Abbott's HIV/AIDS drug Norvir (ritonavir). The patents were listed in FDA's Orange Book for a new heat-stable formulation of the drug that was approved by FDA in February. PUBPAT said it has submitted prior art proving that the patents, which were also listed for other formulations of the drug, should not have been granted. PUBPAT contends that the patents were anticipated or rendered obvious by Norvir patent No. 5,142,056, which expired in August 2009. Abbott said it is confident in the validity of the patents and expects they will be upheld.

FDA workshop on cell and gene therapy trials: FDA is holding a public workshop on Nov. 2 to exchange information on the best practices in conducting cell and gene therapy clinical trials in pediatric populations. The agency is seeking information from Institutional Review Boards, clinical researchers and other stakeholders on such issues as identifying and minimizing risks associated with administration of novel cell and gene therapy products, obtaining informed consent and conducting continuing review. The workshop will be held in Bethesda, Md.