2012年12月14日星期五
AstraZeneca announced today that the Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the US substance patent protecting CRESTOR (rosuvastatin calcium) (RE37,314 – the ‘314 patent) is valid and enforceable. The defendants may seek a rehearing and/or review by the U.S. Supreme Court. Absent a reversal of this decision, none of the Abbreviated New Drug Applications (ANDAs) filed by Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent may be approved by the FDA prior to expiration of the ‘314 patent. The ‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR.
联邦电路还持有Apotex Corp.作为提交者承担责任，因此由地区法院的决定束缚。
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关于试验
从2007年开始，九个仿制药制造商提起ANDAS以及第四段认证，无侵权，无效或无可收算不可以责任，涉及Crestor'314物质专利。AstraZeneca and Shionogi (the owner of the ‘314 patent) filed patent infringement suits against eight manufacturers (various parent or subsidiary entities of Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the ‘314 substance patent. These suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the U.S. District Court, District of Delaware. Trial commenced on February 22, 2010 before Judge Farnan and ended on March 3, 2010.
2010年6月，特拉华州地区的美国地区法院发现了“八个普通被告有效和强制执行的314专利权和侵犯。
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