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NOTE: This disposition is nonprecedential.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

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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 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. Case: 22-2276 Document: 46 Page: 3 Filed: 04/05/2024

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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 Case: 22-2276 Document: 46 Page: 4 Filed: 04/05/2024

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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 Case: 22-2276 Document: 46 Page: 5 Filed: 04/05/2024

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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 Case: 22-2276 Document: 46 Page: 6 Filed: 04/05/2024

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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. Case: 22-2276 Document: 46 Page: 7 Filed: 04/05/2024

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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