(By Balaseshan) AstraZeneca Plc (NYSE: AZN), a global biopharmaceutical company, said it has received favorable decision in patent appeal for Crestor (rosuvastatin calcium) that is used to treat high cholesterol and high triglycerides in the blood.
The Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the substance patent protecting Crestor (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 (NASDAQ: MYL), Par (NYSE: PRX), Sandoz, Sun, Teva (NYSE: 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.
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The Federal Circuit also held that Apotex Corp. was liable as a submitter and is therefore bound by the District Court's decision.
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Beginning in 2007, nine generic drug manufacturers filed ANDAs along with Paragraph IV certifications of non-infringement, invalidity, or unenforceability with respect to the CRESTOR ‘314 substance patent.
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.
In June 2010, the US District Court for the District of Delaware found the ‘314 patent valid and enforceable and infringed by the eight generic defendants.
AZN is trading up 0.36% at $47.63 on Friday. The stock has been trading between $39.72 and $49.27 for the past 52 weeks.