CRESTOR® US Patent Upheld by Court of Appeals for the Federal Circuit
WILMINGTON, Del. -- December 14, 2012
AstraZeneca (NYSE: AZN) 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 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.
The Federal Circuit also held that Apotex Corp. was liable as a submitter and
is therefore bound by the District Court’s decision.
NOTES TO EDITORS
About the Trial
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
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