Last week, a 2-1 majority in the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent Trial and Appeal Board’s (“Board”) inter partes review (“IPR”) decision that Indivior’s challenged patent claims would have been anticipated. Indivior UK Limited v. Dr. Reddy’s Laboratories S.A., Dr. Reddy’s Laboratories, Inc., 2020-2073, 2020-2142 (November 24, 2021).
Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) had petitioned for an IPR of U.S. Patent 9,687,454 (“’454 patent”), owned by Indivior UK Limited (“Indivior”). The ‘454 patent, which generally describes films containing therapeutic agents, issued as the fifth continuation of U.S. Patent Application 12/537,571 (“’571 application”), which was filed on August 7, 2009. Claims of the ‘454 patent recite polymer weight percentage limitations as ranges: “about 40 wt % to about 60 wt %” (claim 1) and “about 48.2 wt % to about 58.6 wt %” (claims 7 and 12). The Board found that the ’571 application does not discuss or refer to bounded or closed weight percentage ranges. Therefore, those range limitations lacked adequate written description in the ‘571 priority application, and the ‘454 patent was not entitled to its August 7, 2009, priority date. As such, the range claims of the ‘454 patent were anticipated by U.S. Patent Publication 2011/0033541 (“Myers”), the February 10, 2011 publication of the ’571 application.
The Federal Circuit agreed with the Board noting “[t]he validity questions hinge on whether each of the ’454 patent claims is entitled to the benefit of the ’571 application’s filing date”. In this regard, the Court also noted that the test for written description “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date”, citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In this case, the Federal Circuit found that two different ranges (“at least 25%” and “at least 50%.”) disclosed in the ‘571 application, and two discrete aggregate polymer percentages (48.2% and 58.6%) from its examples, were insufficient to support the later claimed bounded or closed ranges.