The United States Court of Appeals for the Federal Circuit, by a 2-1 majority, has ruled drug maker Dr. Reddy’s Laboratories did not infringe two patents pertaining to British drug maker Indivior’s opioid dependence treatment drug Suboxone.
Friday’s ruling is expected to come as a booster shot for the Hyderabad-headquartered firm in continuing with the sale of its generic version, something Indivior had sought to stop by appealing against a U.S. district court order. The appeal involved issues of infringement and invalidity of four patents covering pharmaceutical films and methods of making them. However, the parties’ substantive disputes focus on only two of the four, the Court of Appeals for the Federal Circuit said. Besides Dr. Reddy’s, the defendants in the case included Watson Laboratories, Actavis Laboratories and Teva Pharmaceuticals, which originally owned DRL’s Abbreviated New Drug Application (ANDA).
Affirming the district court’s judgment that DRL does not infringe the ‘514 patent’, while Watson does, the ruling said Watson, Teva, and DRL, however, failed to prove that Indivior’s patent is invalid. Likewise, DRL does not infringe the ‘150 patent’, but failed to prove that it is invalid.
Dr. Reddy’s in February, soon after the U.S. Supreme Court turned down a plea for stay filed by Indivior, re-launched its generic version of Suboxone. It had first started sale of the generic version in June last year for a while before a U.S. court passed a temporary restraining order on the sale in response to a plea by Indivior.
