Court Opinion

ID: 9957760
Source: CourtListenerOpinion
Date Created: 2024-04-05 13:00:58.918476+00
Date Added: 2024-06-11T08:18:37.450354
License: Public Domain

Case: 22-2276   Document: 46     Page: 1   Filed: 04/05/2024

        NOTE: This disposition is nonprecedential.

   United States Court of Appeals
       for the Federal Circuit
                 ______________________

           SUMITOMO PHARMA CO., LTD.,
                   Appellant

                            v.

  KATHERINE K. VIDAL, UNDER SECRETARY OF
  COMMERCE FOR INTELLECTUAL PROPERTY
    AND DIRECTOR OF THE UNITED STATES
      PATENT AND TRADEMARK OFFICE,
                  Intervenor
            ______________________

                       2022-2276
                 ______________________

     Appeal from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in No. IPR2020-
 01053.
                  ______________________

                 Decided: April 5, 2024
                 ______________________

     THOMAS SAUNDERS, Wilmer Cutler Pickering Hale and
 Dorr LLP, Washington, DC, argued for appellant. Also rep-
 resented by EMILY R. WHELAN, Boston, MA; JOHN A.
 DRAGSETH, SARAH JACK, MICHAEL J. KANE, Fish & Richard-
 son P.C., Minneapolis, MN; NITIKA GUPTA FIORELLA, Wil-
 mington, DE; TIMOTHY RAWSON, San Diego, CA.
Case: 22-2276     Document: 46     Page: 2    Filed: 04/05/2024

 2                        SUMITOMO PHARMA CO., LTD. v. VIDAL

     MARY L. KELLY, Office of the Solicitor, United States
 Patent and Trademark Office, Alexandria, VA, argued for
 intervenor. Also represented by PETER J. AYERS, KAKOLI
 CAPRIHAN, MAI-TRANG DUC DANG, FARHEENA YASMEEN
 RASHEED.
                 ______________________

     Before TARANTO, HUGHES, and CUNNINGHAM, Circuit
                        Judges.
 TARANTO, Circuit Judge.
      Sumitomo Pharma Co., Ltd. (formerly Sumitomo Dain-
 ippon Pharma Co., Ltd.), owns U.S. Patent No. 9,815,827,
 titled “Agent for Treatment of Schizophrenia.” The patent
 claims detail dosing regimens for treating certain psychotic
 disorders with lurasidone 1 (or a salt thereof), further spec-
 ifying an absence-of-weight-gain result of following the reg-
 imens—weight gain being a recognized adverse side-effect
 of many antipsychotic drugs, J.A. 3216. Claim 1 is repre-
 sentative for current purposes:
     1. A method for treating schizophrenia in a patient
     without a clinically significant weight gain, com-
     prising:
         administering orally to the patient
         (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-benzo-
         isothiazol-3-yl)-1-piperazinylmethyl]-1-cy-
         clohexylmethyl]-2,3-
         bicyclo[2.2.1]heptanedicarboximide or a
         pharmaceutically acceptable salt thereof at
         a dose of from 20 to 120 mg/day such that

     1    There is no dispute that lurasidone is
 (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-
 piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicy-
 clo[2.2.1]heptanedicarboximide.
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 SUMITOMO PHARMA CO., LTD. v. VIDAL                           3

         the patient does not experience a clinically
         significant weight gain.
 ’827 patent, col. 10, lines 51–59.
      Slayback Pharma LLC successfully petitioned for an
 inter partes review (IPR) of the ’827 patent, and the Patent
 Trial and Appeal Board eventually held all 75 claims of the
 ’827 patent to be unpatentable for obviousness over a single
 prior-art reference, U.S. Patent No. 5,532,372 (Saji). Slay-
 back Pharma LLC v. Sumitomo Dainippon Pharma Co.,
 No. IPR2020-01053, 2022 WL 212259 (P.T.A.B. Jan. 20,
 2022). For present purposes, we note key aspects of the
 Board’s reasoning, without being complete even as to claim
 1, let alone the other claims also held unpatentable.
      The Board construed “a patient” (and “the patient”) to
 have its “ordinary and customary meaning of ‘one or more
 patients,’ as opposed to a ‘patient population.’” Id. at *4.
 The Board then addressed the claim limitations defining
 the required steps to be performed, finding that Saji suffi-
 ciently taught or suggested the use of lurasidone, at the
 dosages and frequencies of administration claimed in the
 ’827 patent’s claims, to treat the claimed psychotic disor-
 ders. Id. at *5–9. With regard to the claimed absence-of-
 weight-gain property, the Board did not find that Saji (or
 any other prior-art reference) affirmatively disclosed the
 claimed result for a patient so treated, but it noted a sug-
 gestion of favorable weight-gain effects for lurasidone
 made in an article by Horisawa and others. Id. at *9–10.
 Ultimately, though, the Board concluded that the claimed
 weight-gain property was inherent in the claimed method
 of treatment, seemingly because its undisputed claim con-
 struction of “a patient” as “one or more patients” meant
 that administering lurasidone in the claimed amounts to
 even one covered patient who subsequently did not gain
 weight would meet the claim limitation and because Sumi-
 tomo acknowledged that “‘there will always be some outli-
 ers’” in side-effects in a pool of patients. Id. at *10
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 4                        SUMITOMO PHARMA CO., LTD. v. VIDAL

 (emphasis added by the Board) (quoting Patent Owner’s
 Sur-Reply before the Board).
     After unsuccessfully seeking rehearing and a Prece-
 dential Opinion Review, Sumitomo timely appealed. Su-
 mitomo has argued, among other things, that the Board did
 not properly consider certain safety-related evidence or the
 Horisawa suggestion and that it made an erroneous, or at
 least unclear, use of inherency doctrine in addressing at
 least the motivation-to-modify, reasonable-expectation-of-
 success, and unexpected-results components of the obvi-
 ousness analysis. Slayback did not appear on appeal, but
 the Director of the Patent and Trademark Office inter-
 vened to defend the Board’s decision. We have statutory
 jurisdiction under 35 U.S.C. § 141(c) and 28 U.S.C.
 § 1295(a)(4)(A).
     Just before oral argument, the ’827 patent expired.
 The court therefore asked about the issue of mootness at
 the outset of oral argument. Counsel for Sumitomo ex-
 plained various facts, and Sumitomo’s position, relating to
 the issue. Oral Arg. at 0:54–1:37.
     “On appeal . . . a case becomes moot ‘when the issues
 presented are no longer “live” or the parties lack a legally
 cognizable interest in the outcome.’” ABS Global, Inc. v.
 Cytonome/ST, LLC, 984 F.3d 1017, 1020 (Fed. Cir. 2021)
 (quoting Already, LLC v. Nike, Inc., 568 U.S. 85, 91 (2013)).
 A “case remains live ‘[a]s long as the parties have a con-
 crete interest, however small, in the outcome of the litiga-
 tion.’” MOAC Mall Holdings, LLC v. Transform Holdco
 LLC, 598 U.S. 288, 295 (2023) (alteration in original) (quot-
 ing Chafin v. Chafin, 568 U.S. 165, 172 (2013)); Chafin, 568
 U.S. at 173 (“[T]he parties must continue to have a per-
 sonal stake in the ultimate disposition of the lawsuit”
 (cleaned up)); cf. TransUnion LLC v. Ramirez, 594 U.S.
 413, 422–30 (2021) (ruling, in the related area of standing,
 that a case or controversy requires more than a dispute
 over a statute-based legal right—it requires a concrete
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 SUMITOMO PHARMA CO., LTD. v. VIDAL                       5

 interest in that right). Here, the case is moot if Sumitomo
 no longer has a concrete interest in the exclusionary right
 granted by the ’827 patent.
     We conclude that Sumitomo no longer has such an in-
 terest. Given the expiration of the patent, Sumitomo has
 no interest in any forward-looking exclusion based on the
 patent. But that does not end the inquiry: As we have ex-
 plained, a patentee may have a concrete interest in pursu-
 ing damages for pre-expiration infringement. See, e.g.,
 Sony Corp. v. Iancu, 924 F.3d 1235, 1238–39 n.1 (Fed. Cir.
 2019). In this case, however, Sumitomo lacks any such con-
 crete interest, as made clear in the colloquy with Sumi-
 tomo’s counsel at oral argument.
      Given the opportunity to discuss such an interest, Su-
 mitomo expressed no interest in seeking damages for direct
 infringement from any persons who engaged in pre-expira-
 tion use of the claimed methods, including those who may
 have acquired lurasidone from a firm that had not labeled
 it for a use covered by the ’827 patent’s claims. Oral Arg.
 at 0:34–0:54, 41:10–41:28. With respect to firms that
 might have sold lurasidone in a way that could have con-
 stituted indirect infringement if unlicensed—e.g., a firm
 that “jumped the gun,” “a compounding pharmacy,” Oral
 Arg. at 41:10–41:27—Sumitomo noted that there was only
 a theoretical possibility that such firms even existed: Su-
 mitomo did not affirmatively conjecture that there were
 any such firms. Oral Arg. at 41:27–41:39. To the contrary,
 it stated that, as far as it knew, the only firms marketing
 lurasidone with relevant instructions were firms already
 under license to Sumitomo, pursuant to settlement agree-
 ments with it. See Oral Arg. at 0:33–0:41. It made clear,
 moreover, that, in contrast to what would often be true in
 different kinds of markets, it was very unlikely that there
 were such unlicensed firms unknown to it, given the regu-
 latory entry and other requirements in this area. See Oral
 Arg. at 0:28–0:34, 0:42–0:54, 1:04–1:12, 41:10–41:39. The
 existence of such firms, in this case, presents only “a
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 6                        SUMITOMO PHARMA CO., LTD. v. VIDAL

 hypothetical state of facts,” which is not enough to prevent
 mootness. Chafin, 568 U.S. at 173.
     Those statements, together with Sumitomo’s focus only
 on its concern with the Board’s reasoning, Oral Arg. at
 41:40–41:50, and its representation that it would not op-
 pose vacatur on mootness grounds, Oral Arg. at 41:51–
 42:04, indicate that Sumitomo now lacks a legally cogniza-
 ble interest in the validity of the ’827 patent before its ex-
 piration. These special circumstances properly distinguish
 this case from Sony Corp. v. Iancu, which was not a phar-
 maceutical case and which recited no reason even to doubt
 the reality of the possibility of pre-expiration damages,
 much less to be confident that such a possibility was not a
 real one. See 924 F.3d at 1237, 1238–39 n.1. We conclude
 that the expiration of the patent has extinguished any con-
 crete stake Sumitomo has in a reversal on the merits of the
 patentability ruling. The case before us is therefore moot.
     The Supreme Court, relying on United States v. Mun-
 singwear, Inc., 340 U.S. 36, 39 (1950), has explained that,
 in cases coming from district courts, its “‘ordinary practice
 in disposing of a case that has become moot on appeal is to
 vacate the judgment with directions to dismiss.’” New York
 State Rifle & Pistol Association v. City of New York, 140 S.
 Ct. 1525, 1526 (2020) (quoting Lewis v. Continental Bank
 Corp., 494 U.S. 472, 482 (1990)); accord Azar v. Garza, 584
 U.S. 726, 729 (2018); Arizonans for Official English v. Ari-
 zona, 520 U.S. 43, 71 (1997). In a case involving Mun-
 singwear in the context of a Board order, the Supreme
 Court ordered vacatur, but was silent about dismissal of
 the Board proceeding. PNC Bank National Association v.
 Secure Axcess, LLC, 584 U.S. 974 (2018). We have some-
 times included the direction-to-dismiss aspect of the Mun-
 singwear practice even when the appeal to us came from a
 non-Article III forum. See INVT SPE LLC v. International
 Trade Commission, 46 F.4th 1361, 1370 (Fed. Cir. 2022);
 Apple Inc. v. Voip-Pal.com, Inc., 976 F.3d 1316, 1321 (Fed.
Case: 22-2276     Document: 46     Page: 7     Filed: 04/05/2024

 SUMITOMO PHARMA CO., LTD. v. VIDAL                          7

 Cir. 2020) (from PTAB); Tessera, Inc. v. International
 Trade Commission, 646 F.3d 1357, 1371 (Fed. Cir. 2011).
     Here, we deem it appropriate to vacate the Board order
 in this matter, considering the “conditions and circum-
 stances” that can bear on application of the “equity” prac-
 tice of vacatur. Azar, 584 U.S. at 729 (internal quotation
 omitted); see Acheson Hotels, LLC v. Laufer, 601 U.S. 1, 14–
 16 (2023) (Jackson, J., concurring) (calling for case-specific
 assessment of vacatur). Mootness occurred here “through
 happenstance—circumstances not attributable to the par-
 ties,” so this case does not involve mootness caused by vol-
 untary action such as settlement, and vacatur pursuant to
 the ordinary Munsingwear practice “is in order” here. Ari-
 zonans for Official English, 520 U.S. at 71–72 (distinguish-
 ing mootness by settlement); see also Azar, 584 U.S. at 729
 (mootness by unilateral action). Moreover, even if insub-
 stantiality of the grounds of an appeal might in some cases
 weigh against vacatur, this is not such a case: Although we
 do not decide whether Sumitomo is ultimately correct in
 any of its grounds for seeking to set aside the Board’s deci-
 sion, we conclude that at least some of those grounds are
 substantial. We include the direction to dismiss in this
 case, reserving for another case a full consideration of the
 issue of when such a direction might be inappropriate in a
 case coming from the Board.
     For the foregoing reasons, the decision of the Board is
 vacated, and the case is remanded for the Board to dismiss
 the IPR.
     The parties shall bear their own costs.
                VACATED AND REMANDED