Trials@uspto.gov
`571-272-7822
`
`Paper No. 35
`Date: July 26, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`v.
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of
`Final Written Decision
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`571-272-7822
`
`Paper No. 35
`Date: July 26, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SLAYBACK PHARMA LLC,
`Petitioner,
`v.
`SUMITOMO DAINIPPON PHARMA CO., LTD.,
`Patent Owner.
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`
`
`
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and JAMIE T. WISZ,
`Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of
`Final Written Decision
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`INTRODUCTION
`I.
`Slayback Pharma LLC (“Petitioner”) filed a Petition (Paper 2
`(“Pet.”)), seeking an inter partes review of claims 1–75 of U.S. Patent
`No. 9,815,827 B2. Sumitomo Dainippon Pharma Co., Ltd. (“Patent Owner”)
`filed a Preliminary Response (Paper 6 (“Prelim. Resp.”)). We instituted trial
`to review the challenged claims. Paper 7 (“Inst. Dec.”). Thereafter,
`Sumitomo Dainippon Pharma Co., Ltd. (“Patent Owner”) filed a Response
`to the Petition (Paper 14, “PO Resp.”), Petitioner filed a Reply (Paper 21),
`and Patent Owner filed a Sur-reply (Paper 25).
`At the conclusion of the trial, we issued a Final Written Decision,
`determining that Petitioner has established the unpatentability of the
`challenged claims. Paper 29 (“Decision” or “Dec.”). Patent Owner timely
`filed a Request for Rehearing of the Decision. Paper 30 (“Reh’g Req.”).
`Patent Owner also timely filed a request for Precedential Opinion Panel
`(POP) review. Paper 31; Ex. 3002. The POP panel denied that request and
`instructed this panel to consider Patent Owner’s rehearing request.
`Paper 33, 2.
`For the reasons explained below, we deny Patent Owner’s Request for
`Rehearing.
`
`II. STANDARD OF REVIEW
`The party challenging a decision in a request for rehearing bears the
`burden of showing the decision should be modified. 37 C.F.R. § 42.71(d). A
`request for rehearing “must specifically identify all matters the party
`believes the Board misapprehended or overlooked, and the place where each
`matter was previously addressed.” Id.
`
`2
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`III. ANALYSIS
`In our Decision, we determined that Petitioner showed claims 1–75
`were unpatentable as obvious over Saji1, as asserted in Ground 3 of the
`Petition. Dec. 12–35. Because we determined that all of the claims were
`unpatentable as obvious over Saji, we did not reach Grounds 1 and 2 of the
`Petition. Id. at 36. In the Request for Rehearing, Patent Owner contends that
`(1) the Board relied on a new ground of unpatentability, and (2) the Board
`erred in its analysis of Grounds 1 and 2 in the Institution Decision. Reh’g
`Req. 2–3. We address each of Patent Owner’s arguments below.
`A. The Board Did Not Rely on A New Ground of Unpatentability
`Patent Owner argues that the Board misapplied the law by finding the
`claims obvious based on a new ground of unpatentability. Reh’g Req. 2
`(citing Pet. 14; Dec. 22, 25). Specifically, Patent Owner argues that the
`Petition alleged that claims 1–75 would have been obvious over Saji alone,
`but the Board relied on Saji and Horisawa2 to conclude that the claims are
`unpatentable. Id. at 4–6 (citing Pet. 50–55; Dec. 20–22). Patent Owner
`argues that “[t]he Board’s decision to rely on Horisawa, and to treat it as
`prior art in its obviousness analysis, represented an improper new ground of
`unpatentability.” Id. at 6. Patent Owner further argues that it was deprived of
`a full and fair opportunity to address Horisawa. See id. at 6–7 (citing
`
`
`1 U.S. Patent No. 5,532,372, issued July 2, 1996 (Ex. 1009, “Saji”).
`2 Horisawa et al. Pharmacological Characteristics of the Novel
`Antipsychotic SM-13496: Evaluation of Action on Various Receptors in the
`Brain, 19 JPN. J. NEUROPSYCHOPHARMACOL. 363 (1999). Petitioner submits
`Exhibit 1028, which includes a certified English translation of Horisawa.
`Patent Owner disputes the accuracy of this translation and provides
`Exhibit 2040, “a correct translation” of Horisawa that “the parties agreed
`to.” PO Resp. 44 n.144.
`
`3
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`EmeraChem Holdings, LLC v. Volkswagen Group of America, Inc., 859 F.3d
`1341 (Fed. Cir. 2017)). We are not persuaded.
`In our Decision, we determined that Petitioner has shown, by a
`preponderance of the evidence, that “Saji teaches or suggests each limitation
`of the challenged claims,” and “an ordinarily skilled artisan would have had
`a reason to modify the dose range taught in Saji, and would have had a
`reasonable expectation of success when doing so.” Dec. 13. Specifically, we
`found that Saji teaches lurasidone as a preferred embodiment for treating
`schizophrenia and manic depressive psychosis and its preferred dosage range
`overlaps with the claimed dosage range. Id. at 13–20. We noted Patent
`Owner’s argument that, despite the overlap, the claimed dosing regimen was
`unobvious because it unexpectedly “does not cause weight gain.” Id. at 20
`(citing PO Resp. 39–40). In addressing that argument, we considered the
`evidence of record, including Horisawa. Id. at 20–25. Thus, considering
`Horisawa to determine whether the lack of weight gain was unexpected does
`not deviate from the theory of obviousness set forth in the Petition.
` The Federal Circuit has “made clear that the Board may consider a
`prior art reference to show the state of the art at the time of the invention,
`regardless of whether that reference was cited in the Board’s institution
`decision.” Genzyme Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm. Inc.,
`825 F.3d 1360, 1369 (Fed. Cir. 2016); see also Anacor Pharm., Inc. v.
`Iancu, 889 F.3d 1372, 1381 (Fed. Cir. 2018) (stating the Board may consider
`additional references “as evidence of the knowledge that a skilled artisan
`would bring to bear in reading [the asserted references] even though those
`additional references were not cited in the petition”).
`
`4
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`In the instant case, our Decision was based on the ground set forth in
`the Petition, that is, the challenged claims would have been obviousness over
`Saji. See Genzyme, 825 F.3d at 1366 (affirming the Board’s final written
`decisions because they were “based on the same combinations of references
`that were set forth in its institution decisions,” and “the Board found the
`claims at issue unpatentable based on those same grounds and no others”).
`We considered Horisawa to determine whether an ordinarily skilled artisan
`would have expected a lack of weight gain. Dec. 20. Patent Owner has not
`shown it is improper for us to do so. See Anacor, 889 F.3d at 1381 (holding
`“it was not improper for the Board to rely on those [additional] references to
`show what a person of skill in the art would believe about” the effectiveness
`of a therapeutic compound).
`We also are not persuaded by Patent Owner’s argument that it did not
`receive adequate notice of Horisawa in our obviousness analysis. Reh’g
`Req. 2–3. According to Patent Owner, our treatment of Horisawa is contrary
`to the Federal Circuit case law holding that “broad, general statements
`regarding a reference in the Petition did not provide adequate notice for
`purposes of relying on the reference to support an obviousness ground.” Id.
`(citing EmeraChem, 859 F.3d at 1348–49). The facts in our case, however,
`are distinguishable from those in EmeraChem.
`In EmeraChem, the Federal Circuit emphasized “the specificity with
`which the petition’s claim chart and the Institution Decision’s list of claims
`expressly identified particular references’ disclosures for some claims and
`not for others.” 859 F.3d at 1349. It was in this context that the court stated
`that “[w]here the petitioner uses certain prior art references to target specific
`claims with precision, or the Board does the same in its decision to
`
`5
`
`
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`IPR2020-01053
`Patent 9,815,827 B2
`
`institute,” “it cannot be the case that the general statements [the petitioner]
`relies upon provided sufficient notice that [those prior art references] could
`be applied to all claims.” Id.
`In contrast, here, Petitioner discussed Horisawa (Ex. 1028) in detail in
`the Petition.3 See Pet. 51–53. Specifically, when asserting all challenged
`claims would have been obvious over Saji, Petitioner cited Horisawa to
`show that an ordinarily skilled artisan would not have expected weight gain.
`Id. at 51–53, 55–57, 59.
`Moreover, in EmeraChem, “neither party addressed in briefing or
`argument” the application of the reference-at-issue to the claims-at-issue.
`859 F.3d at 1351. According to the court, this fact “helps make the point that
`neither party was on notice that [the reference-at-issue] was at issue as to
`those challenged claims.” Id. at 1351–52.
`In contrast, here, both parties thoroughly addressed issues related to
`Horisawa throughout trial. Indeed, in its Preliminary Response, when
`arguing that the challenged claims are patentable over Saji, Patent Owner
`contended that “Horisawa does not establish that lack of weight gain was
`expected.” Prelim. Resp. 25–27. In our decision to institute, when discussing
`obviousness over Saji, we specifically noted the parties’ disagreement over
`the significance of Horisawa with regard to expectation of no weight gain.
`Inst. Dec. 20–21 (citing Pet. 21; Paper 6, 25–27). We encouraged the parties
`to “fully develop the record during trial” on this issue. Id. at 22.
`
`
`3 The fact that Horisawa was introduced in the Petition also makes our case
`stronger than Genzyme and Anacor, where the references-at-issue were
`introduced after the respective petitions. See Genzyme, 825 F.3d at 1367;
`Anacor, 889 F.3d at 1381.
`
`6
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`The parties did exactly that. In fact, Patent Owner disputed the
`accuracy of the translated Horisawa submitted by Petitioner (Ex. 1028), and
`submitted its own version (Ex. 2040).4 PO Resp. 44 n.144. In its Response,
`Patent Owner again argued that “Horisawa does not establish that lack of
`weight gain was expected.” Id. at 41–44; see also Ex. 2131 ¶¶ 127–139
`(Patent Owner’s expert testifying the same).
`In the Reply, Petitioner again pointed to Horisawa for supporting “the
`conclusion that lurasidone’s allegedly favorable profile for cardiac and
`weight gain side effects was not unexpected.” Paper 21, 26–27 (citing
`Ex. 1002 ¶ 118). In the Sur-reply, Patent Owner argued that Petitioner and
`its expert “tacitly admitt[ed] that [Patent Owner] is correct” on the
`implication of Horisawa’s teaching. Paper 25, 15–16. Finally, during the oral
`hearing, counsel for both Petitioner and Patent Owner argued at length about
`Horisawa’s teachings as related to the expectation of no weight gain.
`See Paper 28, 12:7–14, 14:20, 32:22–35:8.
`Considering the record as a whole, we find that Patent Owner had
`actual notice of Petitioner’s reliance on Horisawa for showing lack of weight
`gain is not unexpected. Patent Owner also had ample opportunities to
`respond, and indeed, had repeatedly countered Petitioner’s arguments as
`related to Horisawa. Accordingly, we are not persuaded that we erred in
`relying on Horisawa in our Decision to determine whether an ordinarily
`skilled artisan would have expected a lack of weight gain.
`
`
`4 In our Decision, we relied on Exhibit 2040, the alleged “correct
`translation” that “the parties agreed to.” Dec. 20 n.6 (quoting PO Resp. 44
`n.144).
`
`7
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`B. The Board Is Not Obligated to Address All the Grounds
`in the Final Written Decision
`In its Request for Rehearing of the Final Written Decision, Patent
`Owner asks us to dismiss Grounds 1 and 2 for lack of jurisdiction. Reh’g
`Req. 9–10. For the reasons explained below, we decline this invitation.
`In the Petition, Petitioner asserted under Grounds 1 and 2 that a subset
`of the challenged claims (“the manic depressive claims”) are unpatentable as
`anticipated by or obvious over certain references, including Latuda
`Information.5 Pet. 23–49. The central issue for Grounds 1 and 2 is the
`prior-art status of Latuda Information. Petitioner argued the claims-at-issue
`cannot claim priority before the August 28, 2014, filing date of the ’827
`patent application, because the priority application does not provide
`sufficient written-description support for using lurasidone to treat manic
`depressive psychosis. Id. at 23–31. Thus, Petitioner concluded that Latuda
`Information qualifies as prior art. Id. at 31, 38.
`In our decision to institute, based on the then-current record, we
`agreed with Petitioner on this issue. Inst. Dec. 13–14. In the Final Written
`Decision, however, we did not reach the challenges raised in Grounds 1
`and 2 because we determined all challenged claims would have been
`obvious over Saji. Dec. 36. We explained that the Board “need not address
`issues that are not necessary to the resolution of the proceeding.” Id.
`(quoting Bos. Sci. Scimed, Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990
`(Fed. Cir. 2020)).
`Patent Owner argues that our “analysis of priority was contrary to
`law.” Reh’g Req. 3. According to Patent Owner, the Board lacked
`
`5 Latuda, Information published in American Journal of Psychiatry,
`Vol. 170, No. 8, August 2013 (Ex. 1007, “Latuda Information”).
`
`8
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`jurisdiction to consider Grounds 1 and 2 of the Petition, and thus, should
`dismiss those grounds. Id. We are not persuaded.
`As Patent Owner recognizes, in our Decision, we did not rule on the
`merits of Grounds 1 and 2. Dec. 36. Decisions from both the Supreme Court
`and the Federal Circuit permit this approach. See SAS Inst. Inc. v. Iancu, 138
`S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final written
`decision addressing all of the claims it has challenged”); Bos. Sci. Scimed,
`809 F. App’x at 990 (stating the Board has “discretion to decline to decide
`additional instituted grounds once the petitioner has prevailed on all its
`challenged claims”); see also Beloit Corp. v. Valmet Oy, 742 F.2d 1421,
`1423 (Fed. Cir. 1984) (holding that once a dispositive issue is decided, there
`is no need to decide other issues).
`In addition, “the Board is not bound by any findings made in its
`Institution Decision” and “[t]he Board is free to change its view of the merits
`after further development of the record.” Trivascular, Inc. v. Samuels, 812
`F.3d 1056, 1068 (Fed. Cir. 2016). Indeed, because the decision to institute
`and the final written decision involve “very different analyses,” the Board
`has an obligation to assess the unpatentability question anew after trial based
`on the totality of the record. See In re Magnum Oil Tools Int’l, Ltd., 829
`F.3d 1364, 1377 (Fed. Cir. 2016). Thus, even though we analyzed the
`priority issue at the institution stage, we do not have to revisit that issue in
`the Final Written Decision.
`Patent Owner does not argue that we misapprehended or overlooked
`any matter in the Decision, or otherwise abused our discretion in disposing
`the case based on Ground 3. We declined to revisit the priority issue in the
`Decision, and we continue to do so now that the trial has ended.
`
`9
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`Latuda
`Information
`
`Latuda
`Information,
`Loebel
`
`Saji
`
`
`103
`
`103
`
`
`Denied
`
`Granted
`
`8–18, 25–28,
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`8–18, 25–28,
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`1–75
`1–75
`
`
`
`
`
`
`
`
`IV. CONCLUSION
`For the foregoing reasons, we deny Patent Owner’s Request for
`Rehearing.
`Outcome of Decision on Rehearing:
`Claims
`35 U.S.C.
`Reference(s)
`
`§
`8–18, 25–28,
`102
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`8–18, 25–28,
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`1–75
`Overall
`Outcome
`Final Outcome of Final Written Decision after Rehearing:
`Claims
`35 U.S.C.
`Reference(s)
`Claims
`
`§
`Shown
`Unpatentable
`
`
`8–18, 25–28,
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`8–18, 25–28,
`30, 31, 33–44,
`46, 48–60, 62,
`64, 66, 67, 69,
`71, 73, 75
`1–75
`Overall
`Outcome
`
`102
`
`Latuda
`Information
`
`Claims Not
`shown
`Unpatentable
`
`
`
`
`1–75
`1–75
`
`103
`
`103
`
`
`Latuda
`Information,
`Loebel
`
`Saji
`
`
`10
`
`
`
`
`
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
`
`
`V. ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`
`
`
`FOR PETITIONER:
`
`Louis Weinstein
`Patrick Pollard
`WINDELS MARX LANE & MITTENDORF, LLP
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
`
`
`FOR PATENT OWNER:
`Dorothy Whelan
`Chad Shear
`FISH & RICHARDSON P.C.
`whelan@fr.com
`shear@fr.com
`
`
`11
`
`
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