Indivior Inc. v. Dr. Reddy's Laboratories, S.A., No. 17-2587 (Fed. Cir. 2019)Annotate this Case
Indivior markets and holds the New Drug Application (NDA) for Suboxone® sublingual film, an opioid addiction treatment that combines two active ingredients: the opioid buprenorphine and the opioid antagonist naloxone. Suboxone Film is applied below a patient’s tongue, where it then rapidly dissolves to release the active ingredients. In 2010, the FDA approved Indivior’s film product, the first such product to gain FDA approval. Previously, Indivior sold buprenorphine/naloxone only in a tablet form. These appeals involve issues of infringement and invalidity of four patents covering pharmaceutical films and methods of making them, particularly two patents that claim pharmaceutical films and are listed in the Orange Book2 as covering Suboxone Film. The district court concluded that the asserted claims of three patents are not invalid as obvious; that one patent is not invalid as indefinite and that Watson infringes that patent; and that DRL and Alvogen do not infringe either of two patents. The court found certain claims in a fourth patent invalid. The Federal Circuit vacated, as moot, the holding that those claims were invalid as obvious but otherwise affirmed. In a parallel inter partes review proceeding, the Patent Trial and Appeal Board had held the claims unpatentable as anticipated and obvious, and the Federal Circuit affirmed.