Indivior To Appeal Ruling To Defend Intellectual Property For Suboxone Film

(RTTNews) - Indivior PLC (INDV.L) announced a US District Court has found the asserted claims of U.S. Patent Nos. 8,017,150; 8,603,514; 8,900,497 valid, but that Dr. Reddy's does not infringe any asserted claims of these patents, and that Watson (Actavis) and Par do not infringe the asserted claim of the '497 Patent. Indivior believes that it has grounds to appeal the ruling.

The Group noted that the the Court's prior ruling enjoining marketing approval and sale of Watson's and Par's proposed generic products until the expiration of the '514 Patent in 2024 remains in place. However, Watson and Par are now able to pursue their respective appeals at the US Court of Appeals for the Federal Circuit. Unless and until the Court's ruling is reversed on appeal, and in the absence of other judicial relief, the company said it will not be able to rely on the '514, '150, and '497 Patents to prevent Dr. Reddy's from manufacturing and marketing a generic film alternative in the US.

The company said it recognizes the significant challenges that an "at risk" generic film launch would present to its Suboxone Film business in the US based on industry analogs in the near-term. As such, the company has prepared contingency plans based on various potential generic film launch scenarios.

Indivior said its financial guidance for 2017 assumed no generic film launch. The company will continue to monitor market conditions and will update financial guidance if appropriate.