Sumitomo Pharma Co., Ltd. v. Katherine K. Vidal, Under Secretary of Commerce for Intellectual Property

N OTE: This disposition is nonprecedential.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
______________________
T HOMAS SAUNDERS , Wilmer Cutler Pickering Hale and
Dorr LLP, Washington, DC, argued for appellant. Also rep-
resented by EMILY R. WHELAN, Boston, MA; J OHN A.
D RAGSETH , SARAH J ACK, MICHAEL J. K ANE, Fish & Richard-
son P.C., Minneapolis, MN; N ITIKA G UPTA F IORELLA, Wil-
mington, DE; T IMOTHY RAWSON, San Diego, CA.
Case: 22-2276 Document: 46 Page: 1 Filed: 04/05/2024

-- 1 of 7 --

SUMITOMO PHARMA CO., LTD. v. VIDAL 2
MARY L. K ELLY , Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
intervenor. Also represented by P ETER J. AYERS , K AKOLI
CAPRIHAN, MAI-T RANG D UC D ANG, F ARHEENA YASMEEN
RASHEED.
______________________
Before T ARANTO, HUGHES , and CUNNINGHAM , Circuit
Judges.
T ARANTO, 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:
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: 2 Filed: 04/05/2024

-- 2 of 7 --

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

-- 3 of 7 --

SUMITOMO PHARMA CO., LTD. v. VIDAL 4
(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: 4 Filed: 04/05/2024

-- 4 of 7 --

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

-- 5 of 7 --

SUMITOMO PHARMA CO., LTD. v. VIDAL 6
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: 6 Filed: 04/05/2024

-- 6 of 7 --

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

-- 7 of 7 --