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Bristol-Myers Sues Novartis to Block Proposed Generic Baraclude

By Peter Loftus Bristol-Myers Squibb Co. (BMY) has filed a lawsuit seeking to block a Novartis AG (NVS) unit from selling a generic version of hepatitis B drug Baraclude before its U.S. patent expires. Bristol-Myers filed the patent-infringement lawsuit against Novartis's Sandoz unit in U.S. District Court in Delaware in June, Bristol-Myers disclosed in a quarterly report filed with the Securities and Exchange Commission Wednesday. New York-based Bristol-Myers said its U.S. patent for Baraclude expires in 2015. Baraclude, which was introduced in the U.S. in 2005, generated $682 million in global sales for the first half of 2012, up 20% from the year-earlier period. U.S. sales were $114 million. Sandoz notified Bristol-Myers in May that it had applied for U.S. Food and Drug Administration approval to market a generic version of Baraclude prior to the expiration of the patent. Sandoz challenged the validity of certain claims in the patent and said it was unenforceable. Bristol-Myers said in its lawsuit that Sandoz's proposed generic Baraclude product would infringe upon its patent, which was issued in 1993. The lawsuit seeks a court order barring sale of generic Baraclude until the patent expires in 2015. A Novartis spokeswoman declined to comment. Bristol-Myers previously filed a similar lawsuit in 2010 against Teva Pharmaceutical Industries Ltd. (TEVA) to block Teva's bid to sell generic Baraclude. That triggered a 30-month delay in any FDA approval of Teva's application, under federal law governing drug patent challenges. A trial in the Teva lawsuit is expected in the fourth quarter of this year, Bristol-Myers said in its SEC filing. Write to Peter Loftus at peter.loftus@dowjones.com Subscribe to WSJ: http://online.wsj.com?mod=djnwires

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