Tuesday, February 12, 2013

Reuters: Regulatory News: UPDATE 2-U.S. court invalidates patent on Bristol hepatitis B drug

Reuters: Regulatory News
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UPDATE 2-U.S. court invalidates patent on Bristol hepatitis B drug
Feb 12th 2013, 15:43

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Tue Feb 12, 2013 10:43am EST

  * Bristol-Myers says considering whether to appeal decision      * Bristol shares slip 0.6 pct, Teva falls 0.4 percent          Feb 12 (Reuters) - A U.S. federal court has invalidated the  U.S. patent on Bristol-Myers Squibb Co's Baraclude  treatment for hepatitis B after a challenge from generic  drugmaker Teva Pharmaceutical Industries Ltd,  Bristol-Myers said on Tuesday.      "We are disappointed with the court's decision and believe  it is incorrect," Bristol-Myers spokeswoman Laura Hortas said.  She said the company is considering whether to appeal the ruling  by the U.S. District Court in Delaware.      Bristol-Myers had filed suit against Israeli drugmaker Teva  in 2010 to block introduction of its generic form of Baraclude.  Hortas said the drug's chemical patent lapses in February 2015,  but declined to comment on whether U.S. regulators might allow  Teva's generic onto the market before then.      Teva officials could not immediately be reached for comment.      ISI Group analyst Mark Schoenebaum said the U.S. Food and  Drug Administration would have to approve Teva's marketing  application before its generic could be introduced, and that it  was unclear when the FDA might act.      Schoenebaum said Baraclude is expected to have U.S. sales  this year of about $260 million. Even if the Teva generic  arrives this year and hurts Baraclude's U.S. sales, he said  Bristol-Myers will probably not need to lower its current  full-year profit forecast.      Shares of Bristol-Myers were down 0.6 percent at $36.69 on  the New York Stock Exchange on Tuesday morning. Teva shares were  down 0.4 percent in Tel Aviv.  

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