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`NOTE: This disposition is nonprecedential.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.
`
`
`

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`Case: 22-2276 Document: 46 Page: 2 Filed: 04/05/2024
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`2
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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` 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 lurasidone1 (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:
`the patient
`to
`administering orally
`(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
`
`
`is
`lurasidone
`that
`is no dispute
`1 There
`(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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`Case: 22-2276 Document: 46 Page: 3 Filed: 04/05/2024
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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`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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`Case: 22-2276 Document: 46 Page: 4 Filed: 04/05/2024
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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`(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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`Case: 22-2276 Document: 46 Page: 5 Filed: 04/05/2024
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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`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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`Case: 22-2276 Document: 46 Page: 6 Filed: 04/05/2024
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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`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.
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`Case: 22-2276 Document: 46 Page: 7 Filed: 04/05/2024
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`SUMITOMO PHARMA CO., LTD. v. VIDAL
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`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
`
`