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

District court’s finding that plaintiff demonstrated a likelihood of success on the merits was reversed on the basis of (i) specification disclaimer and (ii) issue preclusion.

November 20, 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 2018-2167, 2018 U.S. App. LEXIS 32776 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, Lourie, and Stoll; Opinion by Stoll, J.) (Appeal from D.N.J., McNulty, J.) 

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

Nature of Case and Issue(s) Presented: 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.

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.” The District Court concluded that the claims of the ’305 patent, which lacked an express “drying” method, did not exclude any particular drying method. To this end, the District Court declined to import a drying step into the “continually cast” limitation, and thus found that Indivior demonstrated a reasonable likelihood of proving infringement. The Federal Circuit found that Indivior had not demonstrated a likelihood of success on the merits, and reversed.

Why Dr. Reddy’s Prevailed:  Specifically, the Federal Circuit found that (i) specification disclaimer and (ii) claim preclusion likely prevented a finding of infringement.

With regard to specification disclaimer, the Federal Circuit concluded that the ’305 patent specification disclaims using solely conventional top air drying to produce films with the claimed content uniformity. The patent distinguishes these “conventional methods” from the invention claimed in the ’305 patent and “disparages their use, stating that these methods result in films that do not have content uniformity—a key feature of the invention.” Due to statements in the specification, including examples, the Federal Circuit concluded that the patentee expressly disclaimed the sole use of conventional air drying to produce the claimed films.     

As to claim preclusion, the Federal Circuit noted that a terminal disclaimer does not conclusively show that the claim scope of a parent patent and a child patent are the same, but nevertheless it is a strong indicator that a patent examiner, and, by concession, the applicant, thought the claims in the continuation lacked a patentable distinction over the parent patent. The Federal Circuit went on to explain that the “only difference between the ’305 patent claims asserted [in the instant action] and the ’514 patent claims asserted in the Delaware Case is that the ’305 patent claims contain the term ‘continually cast’ in place of ‘dried’ and ‘drying.’” The Federal Circuit concluded that this was a “patentably indistinct” difference and found that Indivior had not demonstrated a reasonable likelihood of proving infringement.

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