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Richter, James
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Intellectual Property
Patent Litigation
Litigation
Bayer Schering Pharma AG, et al. v. Barr Pharmaceuticals, Inc., et al.
Teva North America
In one of the more significant cases Winston has litigated for Barr/Teva North America, the company filed an ANDA seeking FDA approval to market its generic equivalent of the oral contraceptive pill Yasmin® (drospirenone and ethinyl estradiol). We took the case through fact and expert discovery, argued the case during a four-week bench trial, and argued the appeal before the Federal Circuit in 2009. Bayer Schering had asserted patent infringement claims against Barr related to U.S. Patent No. 6,787,531 covering Yasmin®, which had annual U.S. sales of $575 million in 2008. On behalf of Barr, our team developed an obviousness defense, as well as additional defenses, to challenge the validity and enforceability of the Yasmin® patent. The court held that the asserted claims of Bayer Schering’s ‘531 patent are invalid due to obviousness, paving the way for Barr Laboratories to market and launch the first generic version of Yasmin®. Bayer Schering appealed this decision to the Federal Circuit. On August 5, 2009, the Federal Circuit affirmed, and on October 26, 2009, denied a petition for rehearing en banc. Bayer Schering filed a petition for certiorari on February 23, 2010, which the U.S. Supreme Court denied on May 3, 2010.