Indivior Uk Limited v. Dr. Reddy"s Laboratories S.A.

CourtCourt of Appeals for the Federal Circuit
DecidedNovember 24, 2021
Docket20-2073
StatusPublished

This text of Indivior Uk Limited v. Dr. Reddy"s Laboratories S.A. (Indivior Uk Limited v. Dr. Reddy"s Laboratories S.A.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Indivior Uk Limited v. Dr. Reddy"s Laboratories S.A., (Fed. Cir. 2021).

Opinion

Case: 20-2073 Document: 45 Page: 1 Filed: 11/24/2021

United States Court of Appeals for the Federal Circuit ______________________

INDIVIOR UK LIMITED, Appellant

v.

DR. REDDY'S LABORATORIES S.A., DR. REDDY'S LABORATORIES, INC., Cross-Appellants ______________________

2020-2073, 2020-2142 ______________________

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2019- 00329. ______________________

Decided: November 24, 2021 ______________________

RICHARD L. RAINEY, Covington & Burling LLP, Wash- ington, DC, argued for appellant. Also represented by JEFFREY B. ELIKAN, NICHOLAS LANE EVOY, MATTHEW AARON KUDZIN; PETER P. CHEN, Palo Alto, CA.

KEVIN PAUL MARTIN, Goodwin Procter LLP, Boston, MA, argued for cross-appellants. Also represented by ELAINE BLAIS, EDWINA CLARKE, ROBERT FREDERICKSON, III; IRA J. LEVY, ALEXANDRA D. VALENTI, New York, NY. ______________________ Case: 20-2073 Document: 45 Page: 2 Filed: 11/24/2021

2 INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.

Before LOURIE, LINN, and DYK, Circuit Judges. Opinion for the court filed by Circuit Judge LOURIE. Opinion concurring in part and dissenting in part filed by Circuit Judge LINN. LOURIE, Circuit Judge. Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Labora- tories, 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 Pa- tent and Trademark Office Patent Trial and Appeal Board (the “Board”) held that claims 1–5, 7, and 9–14 are un- patentable as anticipated, but that DRL failed to demon- strate 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 ap- peals 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. BACKGROUND Indivior owns the ’454 patent, which generally de- scribes orally dissolvable films containing therapeutic agents. The ’454 patent issued as the fifth continuation of U.S. Patent Application 12/537,571 (the “’571 application”), which was filed on August 7, 2009. This appeal involves the question whether Indivior can get the benefit of that 2009 filing date for the claims at issue. DRL petitioned for inter partes review of claims 1–5 and 7–14. DRL alleged that the polymer weight percentage limitations, added to the claims by amendment, do not have written description support in the ’571 application as filed and thus are not entitled to the benefit of its filing date. DRL argued that claims 1–5 and 7–14 were Case: 20-2073 Document: 45 Page: 3 Filed: 11/24/2021

INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A. 3

anticipated by U.S. Patent Publication 2011/0033541 (“My- ers”), the February 10, 2011 publication of the ’571 appli- cation. Indivior had argued that the polymer weight percentage limitations were supported by the ’571 applica- tion and that the claims were therefore entitled to the ’571 application’s priority date. Indivior did not dispute that, if the ’571 application lacked written description of the claims and hence that Myers was deemed prior art, Myers would anticipate claims 1–5 and 7–14. Indivior contended that Myers was not prior art to the ’454 patent, and there- fore that DRL failed to demonstrate anticipation. Claims 1, 7, 8, and 12 of the ’454 patent are specifically relevant to this appeal because they include the polymer weight percentage limitations at issue. 1. An oral, self-supporting, mucoadhesive film comprising: (a) about 40 wt % to about 60 wt % of a water- soluble polymeric matrix; (b) about 2 mg to about 16 mg of buprenorphine or a pharmaceutically acceptable salt thereof; (c) about 0.5 mg to about 4 mg of naloxone or a pharmaceutically acceptable salt thereof; and (d) an acidic buffer; wherein the film is mucoadhesive to the sublingual mucosa or the buccal mucosa; wherein the weight ratio of (b):(c) is about 4:1; wherein the weight ratio of (d):(b) is from 2:1 to 1:5; and wherein application of the film on the sublingual mucosa or the buccal mucosa results in differing absorption between buprenorphine and naloxone, with a buprenorphine Cmax from about 0.624 ng/ml to about 5.638 ng/ml and a buprenorphine AUC Case: 20-2073 Document: 45 Page: 4 Filed: 11/24/2021

4 INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A.

from about 5.431 hr*ng/ml to about 56.238 hr*ng/ml; and a naloxone Cmax from about 41.04 pg/ml to about 323.75 pg/ml and a naloxone AUC from about 102.88 hr*pg/ml to about 812.00 hr*pg/ml. ’454 patent col. 24, ll. 25–46 (emphasis added). 7. The film of claim 1, wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix. Id. at col. 24, ll. 57–59 (emphasis added). 8. The film of claim 7, wherein the film comprises about 48.2 wt % of the water soluble polymeric matrix. Id. at col. 24, ll. 60–61 (emphasis added). 12. The film of claim 1, wherein the weight ratio of (d):(b) is from about 1:1 to 1:5; wherein the weight ratio of (b):(a) is from about 1:3 to about 1:11.5; and wherein the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix. Id. at col. 25, ll. 3–7 (emphasis added). In its review, the Board analyzed whether the chal- lenged claims have written description support in the ’571 application. Regarding claim 8’s polymer weight percent- age limitation of “about 48.2 wt %,” the Board found that Tables 1 and 5 in the ’571 application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art. Decision at *27. The Board determined that DRL did not establish that the ’571 application lacked written description of claim 8’s pol- ymer weight percentage limitation and thus did not show that claim 8 is anticipated by Myers. Id. at *35. Case: 20-2073 Document: 45 Page: 5 Filed: 11/24/2021

INDIVIOR UK LIMITED v. DR. REDDY'S LABORATORIES S.A. 5

In contrast, claims 1, 7, and 12 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 appli- cation does not “discuss or refer to bounded or closed ranges of polymer weight percentages.” Id. at *33. It found some of Indivior’s expert’s testimony regarding written descrip- tion support for ranges to be not credible. Id. at *31. The Board also found that a person of ordinary skill would have been led away from a particular bounded range by the ’571 application’s teaching that “[t]he film may contain any de- sired level of self-supporting film forming polymer.” Id. The Board determined that claims 1–5, 7, and 9–14 do not have written description support in the ’571 application. Id. at *34. It therefore determined that Myers is prior art to claims 1–5, 7, and 9–14 because the claims have an ef- fective filing date of no earlier than June 21, 2013, the date of the ’454 patent’s next oldest application in the series. Id. The Board then evaluated Myers, noted that Indivior did not contest DRL’s anticipation arguments, and found that DRL showed that claims 1–5, 7, and 9–14 are anticipated by Myers. Id. at *34–36. Indivior appealed, and DRL cross-appealed. The valid- ity questions hinge on whether each of the ’454 patent claims is entitled to the benefit of the ’571 application’s fil- ing date. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

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