Orexigen and Takeda take Actavis to the courts over Contrave patents

US obesity speciality Orexigen Therapeutics (Nasdaq: OREX) and partner, Japan’s Takeda Pharma (TYO: 4502) have filed a law suit in the US District Court for the District of Delaware against generics major Actavis (NYSE: ACT).

The law suit was filed in response to an Abbreviated New Drug Application, filed by Actavis (The Pharma Letter April 22). In its application, Actavis seeks to market and sell generic versions of the currently approved doses of weight management drug 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. Takeda and Orexigen filed the lawsuit on the basis that Actavis' proposed generic products infringe each of these patents.

In accordance with the Hatch-Waxman Act, as a result of having filed a law suit within 45 days of the Paragraph IV certification notice, FDA approval of the ANDA will be stayed until the earlier of (i) 30 months from Takeda's receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.