The U.S. District Court for the District of New Jersey has granted Indivior PLC a temporary restraining order forcing Dr. Reddy’s Laboratories Ltd. to immediately cease its launch activities related to Suboxone Film.
The move came shortly after Dr. Reddy’s received final approval from the U.S. Food and Drug Administration to launch the Buprenorphine and Naloxone Sublingual Film in the U.S. market.
The temporary restraining order will remain in place pending a hearing on the preliminary injunction motion filed by Indivior. The hearing, through which Indivior will seek to extend the cessation of launch activities pending the outcome of a recently filed patent litigation against Dr. Reddy’s, has been scheduled for June 28, 2018. The proceeding only involves one patent, U.S. Patent No. 9,931,305.
The court order issued Friday prevents Dr. Reddy’s from sales and commercialization of Buprenorphine and Naloxone Sublingual Film within the U.S., but does not include a prohibition on commercial manufacturing of the product.
Indivior will be required to post a bond or other security totaling $18 million to satisfy any losses or damages incurred by Dr. Reddy’s during the period of the temporary restraining order.
“We are pleased that the court has granted our request for a temporary restraining order,” Indivior CEO Shaun Thaxter said. “This order will stop Dr. Reddy’s launch activities before the court has had a chance to rule on the preliminary injunction motion. We will continue to pursue all legal avenues against Dr. Reddy’s to protect our Suboxone Film patent estate.”
Dr. Reddy’s, in a statement, said it remains confident in its legal positions on this patent and believes it will prevail on the issues raised with respect to the application for injunction.