A U.S. District Court has issued a judgment in favour of Dr. Reddy’s Laboratories, ruling that the proposed generic version of Suboxon. Inte (buprenorphine and naloxone) sublingual film does not infringe the patents as asserted by Indivior.
Suboxone is indicated for the maintenance treatment of opioid dependence.
The proposed generic version “does not infringe US Patent nos. 8,017,150; 8,603,514 and 8,900,497 as asserted by Indivior,” Dr.Reddy’s said in a release announcing the U.S. District Court of Delaware judgment of August 31.
Shares surge
The development saw Dr. Reddy’s shares on Friday gaining 9.75% to close ₹2,217.35 on the BSE. Intra-day the stock touched a high of ₹2,230.20.
“We are pleased with the verdict... the judgment reiterates our commitment to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world,” the release from Dr. Reddy’s Laboratories said quoting an unnamed spokesperson.
Reckitt Benckiser had developed Suboxone sublingual film using MonoSol Rx’s PharmFilm technology.
In December 2014, Reckitt Benckiser de-merged its pharmaceuticals business as Indivior. The USFDA approved Suboxone film in four strengths, the release said.
Indivior to appeal
Indivior intends to appeal against the judgment. In a communication, filed with the London Stock Exchange, the company’s CEO Shaun Thaxter described the news as “disappointing to Indivior given the belief that the company has in its intellectual property for Suboxone film. We will appeal the ruling and defend our intellectual property.”
However, unless and until the court’s ruling is reversed on appeal, and in the absence of other judicial relief, the company 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, Indivior said.
The financial guidance for FY 2017, updated on July 27 in its H1 results, assumed no generic film launch. Clearly, as a result of the court ruling, the risk to the guidance related to the launch of a generic Suboxone film has significantly increased, Indivior said.
