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Orexigen Therapeutics Inc. fended off Teva Pharmaceuticals Inc.'s attempt to introduce a generic version of Contrave, a weight loss drug that is Orexigen’s sole product ( Orexigen Therapeutics, Inc. v. Actavis Labs. FL, Inc. , 2017 BL 367903, D. Del., No. 15-451, 10/13/17 ).
The U.S. District Court for the District of Delaware held Oct. 13 the generic drug infringes patents covering Contrave and the patents are valid. Orexigen sued Actavis Laboratories FL Inc. in 2015 over the proposed generic, and Israeli generics giant Teva Pharmaceuticals Inc. acquired Actavis in 2016.
Orexigen, based in La Jolla, Calif., won U.S. approval for Contrave in 2014. The drug, a naltrexone hydrochloride and bupropion hydrochloride extended-release tablet, is the company’s only product. (It markets the drug as Mysimba outside of the U.S.) Orexigen, which isn’t profitable, is counting on the drug to get it out of the red. The company reported a $24.5 million net loss in 2016, and a $68.7 million loss in 2015, according to its latest annual report. Orexigen noted in a press release its court victory is key to turning that performance around.
“As we progress on our path to profitability by 2019, we expect that exclusivity through 2030 will provide many valuable years of growing profitability for Contrave,” Orexigen President and Chief Executive Officer Michael Narachi said in the release.
The FDA approved Contrave for treating obese or overweight adults who also suffer from a weight-related condition, such as type 2 diabetes or hypertension. Orexigen says the drug likely acts on the brain’s “hunger system” and “reward center” but that its exact mechanism isn’t known.
Orexigen filed suit after Actavis filed an abbreviated new drug application with the FDA seeking approval of its Contrave generic. Orexigen alleged the generic infringed U.S. Patent Nos. 7,462,626, 7,375,111, and 8,916,195, and that the patents are valid. Judge Richard G. Andrews presided over a three-day trial in June and issued a 36-page decision Oct. 13. The court ruled the generic infringed the patent claims at issue and the patents were not invalid due to insufficient description or obviousness under U.S. Patent law, as Actavis had argued.
“This was a tremendous win for Orexigen,” company attorney Chad Peterman told Bloomberg Law in an Oct. 16 email. “The court’s opinion demonstrates a thoughtful analysis of the infringement and validity issues, including a careful assessment of the credibility of the trial testimony.”
“We are disappointed with the result and we’re considering our options on appeal,” Teva spokeswoman Elizabeth DeLuca told Bloomberg Law in an Oct. 16 email.
Paul Hastings LLP and Morris Nichols Arsht & Tunnell LLP represented Orexigen. Greenberg Traurig LLP and Young Conaway Stargatt & Taylor LLP represented Actavis.
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