Fed. Cir. Allows Sales of Generic Opioid Addiction Treatment

Written July 23, 2019

The US Court of Appeals for the Federal Circuit on July 12, 2019, ruled that Dr. Reddy’s Laboratories Ltd. does not have to halt sales of its generic version of the opioid addiction treatment Suboxone Film. Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., Fed. Cir., 17-2587, 7/12/19.

Suboxone Film is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs; it’s absorbed by being placed under the tongue or inside the cheek. The drug is owned by Aquestive Therapeutics Inc. and licensed to Indivior, who fought to keep the Dr. Reddy’s version out of the market.

The two patents at the center of the case relate to ways to ensure that the drug is uniformly attached to the film; the Federal Circuit agreed with the trial court and found that Dr. Reddy’s used a distinct manufacturing process and therefore did not infringe.