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The week isn’t even half over and it’s already shaping up to be one of the toughest we can remember for generic drug makers fighting to get their versions of bestselling drugs on the market. On Monday, both Bristol-Myers Squibb and Eli Lilly beat back patent challenges, winning separate rulings against competitors hoping to sell generic versions of blockbuster antipsychotic and cancer treatment drugs in the U.S. After nearly four years of litigation and a three-week bench trial in August, Bristol-Myers and its partner Otsuka Pharmaceutical Co. finally convinced a federal district court judge in New Jersey to block Apotex, Novartis, Sun, and Teva from selling generic versions of the antipsychotic Abilify, which generated nearly $2 billion in sales in the first nine months of 2010. Otsuka, which developed Abilify and markets the drug in partnership with Bristol-Myers, sued the generics for patent infringement in early 2007, after they or their predecessor companies filed applications with the U.S. Food & Drug Administration to sell generic versions of Abilify in the U.S. The generics challenged the underlying patent for the drug, claiming that it was obvious, that it was indistinct from another Otsuka patent, and that it was unenforceable because Otsuka failed to disclose information on its development to the U.S. Patent and Trademark Office. But in a 71-page opinion and a separate order issued Monday, Trenton, N.J., federal district court judge Mary Cooper ruled that the patent was valid and infringed, giving Otsuka’s lawyers at Pepper Hamilton everything they asked for in their original complaint. If the decision holds up, the generics will not be able sell their versions of Abilify in the U.S. until an Otsuka patent on the drug expires in 2015. Eli Lilly, meanwhile, won a ruling Monday in Wilmington, Del., federal district court that upholds a patent for one of the company’s top-three bestselling brands, Alimta, a chemotherapy drug used to treat lung cancer. Lilly has earned more than $1.64 billion so far this year from Alimta sales. Represented by Williams & Connolly and Richards, Layton & Finger, Lilly sued Teva in June 2008, after the generic manufacturer applied for FDA approval to market its version of Alimta before Lilly’s patent expires in 2016. At the close of a five-day bench trial, Chief Judge Gregory Sleet ruled from the bench that Lilly’s patent is valid, rejecting Teva’s claims that it was unenforceable due to obviousness and double-patenting (sound familiar?). Otsuka and Bristol-Myers were represented in the Abilify case by Pepper’s John Brenner. Among the firms representing the generic drug makers were Lite DePalma Greenberg; Kenyon & Kenyon; and Husch Blackwell Sanders. Williams & Connolly’s Bruce Genderson and Frederick Cottrell of Richards Layton represented Lilly in the Alimta trial. Teva had Goodwin Procter and Young Conaway Stargatt & Taylor. We left messages with Pepper’s Brenner and Genderson of W&C but didn’t hear back.

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