Indivior Inc. v. Dr. Reddy’s Labs. S.A.

Case Name: Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 17-7111, 2018 U.S. Dist. LEXIS 116974 (D.N.J. July 13, 2018) (McNulty, J.) 

Drug Product and Patent(s)-in-Suit: Suboxone® film (buprenorphine and naloxone); U.S. Patent No. 9,931,305 (“the ’305 patent”)

Nature of Case and Issue(s) Presented: The ’305 patent is a child of U.S. Patent No. 8,603,514 (“the ’514 patent”). In August 2017, Judge Richard Andrews (D. Del.) held that Indivior failed to meet its burden of showing that Dr. Reddy’s generic Suboxone film infringed the ’514 patent. Specifically, Judge Andrews found that the ’514 patent required the film to be “dried without solely employing conventional convection air drying from the top” and explained that there was insufficient evidence to find that Dr. Reddy’s infringed. In response, Indivior prosecuted the ’305 patent, which replaced the “drying/dried” claim language with a requirement of “a continuously cast film produced on a manufacturing line.”

Indivior holds and practices the ’305 patent for Suboxone film, a rapidly dissolving film that adheres to the underside of a patient’s tongue or the inside of a patient’s cheek. The film contains and is a means of administering buprenorphine and naloxone, which are used in the treatment of opioid addiction. Indivior sought a preliminary injunction after Dr. Reddy’s ANDA product received tentative FDA approval. The court granted Indivior’s motion.

Why Indivior Prevailed: With regard to likelihood of success, the court found that claim preclusion and issue preclusion did not apply. As to the former, the Court explained that “[t]his case centers around a single point of distinction: the meaning of the removal of the terms ‘drying/dried’ form the ’514 parent patent and their replacement with the term ‘continuously cast on the manufacturing line’ in the ’305 child patent.” Although a terminal disclaimer to the ’514 patent was filed during prosecution of the ’305 patent, the court concluded that Indivior was still likely to prevail, as the drying/dried language was replaced with the “continuously cast” claim limitation. In other words, the prior justification for Judge Andrew’s non-infringement opinion did not attach to the ’305 patent. For the same reason, the court explained that Indivior was likely to succeed against Dr. Reddy’s claim of issue preclusion.

The court also found that Indivior would suffer irreparable harm. First, the court explained that Indivior would lose market share currently held by Suboxone film in the buprenorphine-containing transmucosal market. Further, if Dr. Reddy’s were allowed to launch, Indivior would irretrievably lose favorable formulary status among insurance plans. Finally, Indivior would suffer from delays in research and development and suffer reputational harm and loss of goodwill.

In balancing the equities, the court explained that Dr. Reddy’s would no doubt lose months of potential revenue from the sale of its ANDA product. Nevertheless, because it currently had no market share, Dr. Reddy’s losses could more easily be calculated in damages.

Finally, the court concluded that the public interest in protecting Indivior’s property rights outweighed the benefit of a generic Suboxone film entering the market. Specifically, the court concluded that an injunction would not limit access to the API, meaning other non-film generics would remain on the market.