Saturday, November 27, 2021


The outcome:

Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”) petitioned for inter partes review of U.S. Patent 9,687,454 (the “’454 patent”), owned by Indivior UK Limited (“Indivior”). The United States Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) held that claims 1–5, 7, and 9–14 are unpatentable as anticipated, but that DRL failed to demonstrate that claim 8 is anticipated. See Dr. Reddy’s Lab’ys S.A. v. Indivior UK Ltd., No. IPR2019-00329, 2020 WL 2891968 (P.T.A.B. June 2, 2020) (“Decision”). Indivior appeals from the Board’s decision holding that claims 1–5, 7, and 9–14 are unpatentable, and DRL cross-appeals the Board’s decision holding that DRL failed to demonstrate unpatentability of claim 8. For the reasons detailed below, we affirm.

The law

We review the Board’s legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review its factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938). Whether a claim satisfies the written description requirement is a question of fact. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Anticipation is also a question of fact. In re Rambus, Inc., 753 F.3d 1253, 1256 (Fed. Cir. 2014).

Dr. Reddy's cross-appeal

DRL argues that the Board erred in finding that the ’571 application contains written description support for claim 8. DRL asserts that a person of ordinary skill in the art would not have immediately discerned that the ’571 application discloses a polymer component comprising 48.2 wt % of a film because the tables do not state the total polymer weight of various formulations. Indivior contends that the Board’s determination was supported by substantial evidence. Indivior states that the Board’s finding was based on Tables 1 and 5 but also supported by admissions of DRL and its expert. The Board upheld the validity of claim 8, which recites “about 48.2 wt %” as the amount of polymer. We affirm that determination, even though, as DRL argues, the number “48.2 wt %” is not explicitly set forth in the ’571 application. We do so out of deference to the Board’s factfinding, even though one might see some inconsistency between this result and our above holding concerning the principal appeal. But, given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board’s decision concerning claim 8. Accordingly, we affirm the Board’s decision that the ’571 application provides written description support for claim 8 and that, since claim 8 is entitled to the ’571 application’s filing date, DRL failed to demonstrate that Myers anticipates claim 8.


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