On Friday December 14th, the Court of Appeals for the Federal Circuit announced that it had upheld the District Court in Delaware's finding that biopharmaceutical business AstraZeneca's substance patent protecting Crestor is valid and enforceable.
The ruling follows legal wranglings dating back five years. In 2007, nine generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs) 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 who had challenged the '314 substance patent. The suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the U.S. District Court, District of Delaware.
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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.
Following last week's decision, the defendants may seek a rehearing and/or review by the U.S. Supreme Court.
AstraZeneca's share price was down 0.05% to 2,922.50p at 11:45 on Monday morning.
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