The US District Court for the District of Delaware has issued a claim construction (Markman) ruling governing patent litigation brought by Orexigen Therapeutics (NYSE: OREX) and partner Japan’s Takeda Pharmaceutical (TYO: 4502) against Andrx and Actavis (now Allergan) companies.
The lawsuit was filed in response to an Abbreviated New Drug Application, filed by Actavis. In its application, Actavis seeks to market and sell a generic version of the currently approved dose of Contrave (naltrexone HCl/bupropion HCl extended release) tablets prior to the expiration of US Patents listed in the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. There are 10 Contrave patents listed in the Orange Book, the last of which expires in 2032.
Orexigen and Takeda filed the lawsuit on the basis that Actavis' proposed generic product infringes the Contrave patents. In a Markman ruling, also known as a claim construction ruling, the Court determines the meaning of disputed patent claim terms at issue in patent litigation. The Markman hearing for the Actavis litigation was held on May 24, 2016. In a June 6, 2016 Markman ruling, Judge Richard Andrews adopted Orexigen's proposed constructions for the majority of the disputed claim terms.
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