Trials@uspto.gov
`571-272-7822
`
` Paper 7
`
`Entered: December 9, 2020
`
`
`
`
`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
`RICHARD J. SMITH, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`571-272-7822
`
` Paper 7
`
`Entered: December 9, 2020
`
`
`
`
`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
`RICHARD J. SMITH, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`IPR2020-01053
`Patent 9,815,827 B2
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`
`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 (Ex. 1001, “the ’827 patent”). Sumitomo Dainippon
`Pharma Co., Ltd. (“Patent Owner”) filed a Preliminary Response (Paper 6
`(“Prelim. Resp.”)).
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). On April 24, 2018,
`the Supreme Court held that a decision under § 314 may not institute review
`on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu,
`138 S. Ct. 1348, 1355–56 (2018). In addition, the Federal Circuit has
`interpreted the statute to require “a simple yes-or-no institution choice
`respecting a petition, embracing all challenges included in the petition.” PGS
`Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018).
`For the reasons provided below, we determine Petitioner has satisfied
`the threshold requirement set forth in 35 U.S.C. § 314(a). Thus, based on the
`information presented, we institute an inter partes review of claims 1–75 of
`the ’827 patent on all grounds.
`A. Related Matters
`According to the parties, the ’827 patent is the subject of the
`following district-court litigations: 2:18-cv-02065 (NJD); 1:18-cv-00256
`(DED); 2:18-cv-02620 (NJD); 1:18-cv-02107 (NYSD); 1:18-cv-01444
`(NYED); 1:18-cv-00185 (NCMD); 1:18-cv-00369 (DED); 2:18-cv-13478
`
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`(NJD); 2:18-cv-13833 (NJD); 2:18-cv-14787 (NJD). Pet. 64; Paper 5, 2.
`Petitioner is not a party to any of those cases. Pet. 19. Patent Owner
`represents that “[n]one of the litigations is pending.” Paper 5, 2.
`B. The ’827 Patent
`The ’827 patent is titled “[a]gent for treatment of schizophrenia.”
`Ex. 1001, Code (54). It relates to “a method for improving schizophrenia
`without being accompanied by extrapyramidal symptoms by orally
`administering a prescribed dose of a specific bicycloheptane dicarboximide
`derivative once a day, and a therapeutic agent used in said method.” Id. at
`1:15–20.
`According to the ’827 patent, schizophrenia is mainly treated with
`medication, and the treatment should be continued for a long time. Id. at
`1:37–39. Thus, “any side effects of medication may always be serious
`problems, and based on this perspective, it has been desired to develop a
`medicine being suitable for prolonged medication.” Id. at 1:42–45.
`The ’827 patent explains that antipsychotics have been used to treat
`schizophrenia, but the conventional antipsychotics have various drawbacks.
`Id. at 1:46–67. As a result, “it has been desired to develop a safe medicament
`which exhibits an excellent effect on various schizophrenia as an
`antipsychotic without causing side effects such as extrapyramidal
`symptoms.” Id. at 2:1–4.
`The ’827 patent states that prior art teaches a genus of imide
`derivatives that “may be useful as an antipsychotic (c.f., neuroleptic agent,
`antiaxiety, etc.), especially as an agent for treatment of schizophrenia, senile
`
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`insanity, manic depressive psychoses, and nervous breakdown.” Id. at
`2:5–39 (citing Ex. 10091).
`According to the ’827 patent, its inventors found that a compound in
`this genus, (1R,2S,3R,4S)-N-[(1R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1-
`piperazinylmethyl]-1-cyclohexylmethyl]-2,3-bicyclo[2.2.1]heptane-
`dicarboximide or a pharmaceutically acceptable salt thereof, “is effective for
`relieving the wide-ranging symptoms of schizophrenia, and may treat
`schizophrenia quite safely without being accompanied by extrapyramidal
`symptoms by orally administering a prescribed dose thereof once a day.” Id.
`at 2:50–3:6. The parties agree that this compound is lurasidone. Pet. 15;
`Prelim. Resp. 1.
`The ’827 patent contains results from a Phase II clinical trial where
`patients with schizophrenia were treated with SM-13496, i.e., lurasidone
`hydrochloride. Ex. 1001, 4:47–10:25.
`C. Prosecution History
`The ’827 patent issued from Application No. 14/471,919 (“the ’919
`application”), filed on August 28, 2014. Ex. 1001, codes (21), (22). The ’919
`application is a continuation of application No. 10/525,021 (“the ’021
`application”), filed on August 20, 2003, now U.S. Patent No. 9,174,975 B2.
`Id., code (63). The ’827 patent also claims priority to provisional application
`No. 60/404,927, filed on August 22, 2002. Id., code (60). The parties agree
`
`
`1 U.S. Patent No. 5,532,372, issued July 2, 1996 (Ex. 1009, “Saji”). Saji is
`one of the prior-art references asserted in this proceeding.
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`that the specifications of all three applications “are identical in all relevant
`respects.” See Prelim. Resp. 8–9.
`On August 28, 2014, the filing date of the ’919 application, the
`applicant filed an amendment, canceling the originally filed claims 1–19 and
`adding claims 20–27. Ex. 1020, 3–4.2 Both the canceled claims and the
`newly added claims were limited to a method of treating schizophrenia. Id.
`The newly added claim 20, the sole independent claim, reads as follows:
` A method for treating schizophrenia in a patient, without
`20.
`causing a clinically significant weight gain in the patient, the
`method comprising administering to the patient a dose of 5 mg
`to 120 mg of the active compound: (1R,2S,3R,4S)—[sic]N-
`[(1R,2R)-2-[4-(1,2-benzoisothiazol-3-yl)-1- piperazinylmethyl]-
`1-cyclohexylmethyl]-2,3- bicyclo[2.2.1]heptanedicarboximide
`or a pharmaceutically acceptable salt thereof.
`Id. at 3.
` On October 5, 2015, the applicant amended pending claim 20 to
`recite a “method for treating schizophrenia or manic depressive psychoses.”
`Ex. 1006, 2. The applicant also added dependent claim 28, reciting “wherein
`the method is for treating manic depressive psychoses.” Id. at 3. For written-
`description support, the applicant relied on the following language in the
`’919 application:
`On the other hand, it has been known that the imide derivative of
`the following formula, which was found by the co-workers of the
`present inventors, may be useful as an antipsychotic (c.f.,
`neuroleptic agent, antiaxiety, etc.), especially as an agent for
`
`
`2 Unless otherwise noted, we use the pagination provided by the parties for
`the exhibits.
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`treatment of schizophrenia, senile insanity, manic depressive
`psychoses, and nervous breakdown.
`Id. at 4; Ex. 1003, 5:26–6:1.
`The examiner rejected all pending claims as obvious over prior art.
`Ex. 1033, 3–5. In response, the applicant made arguments to overcome the
`rejection. Ex. 1034, 14–21. The applicant also amended the pending claims
`to recite treating either schizophrenia or manic depressive psychosis, and
`added claims reciting treating a patient “with an antipsychotic.” Id. at 2–13.
`Thereafter, the examiner allowed all pending claims. Ex. 1046, 181.
`The examiner pointed out that in the clinical studies described in the
`Specification, “either body weight gain, bulimia, impotence, erectile
`dysfunction or convulsion was not observed.” Id. at 182. According to the
`examiner, “[t]hese results are significant and unexpected because
`conventional antipsychotic drug caused serious side effects such as
`undesired metabolic changes (e.g., hyperglycemia and dyslipidemia) and
`cardiovascular adverse reaction, which were considered as closely linked
`with a weight gain.” Id.
`
`D. Illustrative Claims
`Petitioner divides the challenged claims into two groups:
`(1) claims comprising treating manic depressive psychosis (“manic
`depressive claims”), including claims 8–18, 25–28, 30, 31, 33–44, 46,
`48–60, 62, 64, 66, 67, 69, 71, 73, and 75; and (2) claims limited to
`treating schizophrenia (“schizophrenia claims”), including claims 1–7,
`19–24, 29, 32, 45, 47, 61, 63, 65, 68, 70, 72, and 74. Pet. 13. Patent
`Owner adopts these groupings. See Prelim. Resp. 16–17 (discussing
`“manic depressive claims”). For consistency, we do the same.
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`Claim 1 is illustrative of the schizophrenia claims, and is
`reproduced below:
`A method for treating schizophrenia in a patient without a
`1.
`clinically significant weight gain, comprising:
`administering orally to the patient (1R,2S,3R,4S)-N-[(1R,2R)-2-
`[4-(1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-
`cyclohexylmethyl]-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 the patient does not experience a clinically
`significant weight gain.
`Claim 8 is illustrative of the manic depressive claims, and is
`reproduced below:
`A method for treating manic depressive psychosis in a
`8.
`patient without a clinically significant weight gain, comprising:
`administering orally to the patient (1R,2S,3R,4S)-N-[(1R,2R)-2-
`[4-(1,2-benzoisothiazol-3-yl)-1-piperazinylmethyl]-1-
`cyclohexylmethyl]-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 the patient does not experience a clinically
`significant weight gain.
`
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`E. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability:
`Claims Challenged 35 U.S.C. §3
`References
`8–18, 25–28, 30,
`102
`Latuda Information4
`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
`Saji
`103
`1–75
`In support of the unpatentability challenge, Petitioner relies on the
`Declaration of Thomas R. Kosten, M.D. (Ex. 1002).
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, we construe a claim term “using the same
`claim construction standard that would be used to construe the claim in a
`civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under that
`
`103
`
`Latuda Information, Loebel5
`
`
`3 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29,
`125 Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102, 103, and 112,
`effective March 16, 2013. As explained below, the manic depressive claims
`are not entitled to a priority date earlier than the August 28, 2014, filing date
`of the ’919 application. See infra at II.B. Thus, the AIA version of §§ 102,
`103, and 112 applies.
`4 Latuda, Information published in American Journal of Psychiatry,
`Vol. 170, No. 8, August 2013 (Ex. 1007, “Latuda Information”).
`5 Loebel et al., Lurasidone Monotherapy for the Treatment of Bipolar
`Depression: Results of the 6-Week, Double-blind, Placebo-controlled
`PREVAIL-2 Study, 38 NEUROPSYCHOPHARM. 109–10 (2012) (Ex. 1008,
`“Loebel”).
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`standard, the words of a claim “are generally given their ordinary and
`customary meaning,” which is “the meaning that the term would have to a
`person of ordinary skill in the art in question at the time of the invention, i.e.,
`as of the effective filing date of the patent application.” Phillips v. AWH
`Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc).
`Petitioner proposes the following constructions:
`Term(s)
`Proposed Construction
`“a patient”/“the patient”
`“one or more patients”
`includes both “treating a patient for
`schizophrenia with an
`antipsychotic” and “treating a
`patient for manic depressive
`psychosis with an antipsychotic”
`“bipolar disorder”
`limits the “pharmaceutical
`composition” of claims 40 and 56 to
`a “sole active ingredient”
`
`“manic depressive psychosis”
`“a pharmaceutical composition
`comprising…a sole active
`ingredient” (claims 40 and 56)
`
`“treating a patient with an
`antipsychotic”
`(claims 25, 40, and 56)
`
`Pet. 18–23.
`Patent Owner states that it “does not concede that [Petitioner]
`Slayback’s proposed constructions are correct and submits that no
`construction is necessary at this stage.” Prelim. Resp. 15.
`Based on the current record, we find Petitioner’s proposed
`constructions are supported by intrinsic and extrinsic evidence. See
`Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient”
`should have its ordinary and customary meaning of “one or more patients,”
`as opposed to a “patient population” as Patent Owner has previously argued
`in a district court litigation involving another party. See id. at 19–20. We
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`also agree with Petitioner that the dependent claims requiring treating
`patients with schizophrenia and manic depressive psychosis would tend to
`support the conclusion that “treating a patient with an antipsychotic” means
`treatment of a patient with these particular diseases. See id. at 20–21. On this
`record, we further agree with Petitioner that “manic depressive psychosis”
`would be interpreted by a person or ordinary skill in the art as “bipolar
`disorder,” which includes Bipolar I Disorder, Bipolar II Disorder,
`Cyclothymia and Bipolar Disorder Not Otherwise Specified. See id. at 21–
`22 (citations omitted). Thus, for purposes of this Decision, we adopt
`Petitioner’s proposed constructions.
`On this record and for purposes of this Decision, we see no need to
`construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be
`construed to the extent necessary to resolve the controversy).
`B. Priority Date of the Manic Depressive Claims
`Petitioner argues that the manic depressive claims cannot claim
`priority before the August 28, 2014, filing date of the ’827 patent
`application, because the priority application6 does not provide sufficient
`written-description support for using lurasidone to treat manic depressive
`psychosis. Pet. 23–31. Patent Owner disagrees. Prelim. Resp. 16–20. On this
`
`
`6 In their respective arguments on the priority issue, Petitioner cites the ’021
`application (Ex. 1004), whereas Patent Owner cites the provisional
`application (Ex. 1005). It is undisputed that the specifications of the ’021
`application and the provisional application “are identical in all relevant
`respects.” See Prelim. Resp. 8–9.
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`record, and for the reasons explained below, we find Petitioner’s argument
`more persuasive.
`“[A] patent’s claims are not entitled to an earlier priority date merely
`because the patentee claims priority.” In re NTP, Inc., 654 F.3d 1268, 1276
`(Fed. Cir. 2011). “Rather, for a patent’s claims to be entitled to an earlier
`priority date, the patentee must demonstrate that the claims meet the
`requirements of 35 U.S.C. § 120.” Id. One such requirement is that the
`earlier filed application sufficiently discloses the invention claimed in the
`later filed application to satisfy the written-description requirement. Id. at
`1277.
`
`To satisfy this requirement, the written description must “clearly
`allow persons of ordinary skill in the art to recognize that the inventor
`invented what is claimed.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
`1336, 1351 (Fed. Cir. 2010) (en banc) (internal brackets omitted), see also
`id. (“[T]he test for sufficiency is whether the disclosure of the application
`relied upon reasonably conveys to those skilled in the art that the inventor
`had possession of the claimed subject matter as of the filing date.”).
`In this case, the priority application repeatedly refers to using
`lurasidone to treat schizophrenia as the “present invention.” See, e.g.,
`Ex. 1004, 3:6–12 (Technical Field), 6:5–12 (Disclosure of Invention), 7:4–
`8:17 (Detailed Description of Invention). And it discloses a single clinical
`trial treating schizophrenia with lurasidone. Id. at 9:28–10:3. In contrast, it
`does not describe using lurasidone to treat manic depressive psychoses.
`Instead, it mentions “manic depressive psychoses” only once in the
`“Background Art” section, where it states that a large genus of imide
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`derivatives “may be useful as an antipsychotic (c.f., neuroleptic agent,
`antia[n]xiety, etc.), especially as an agent for treatment of schizophrenia,
`senile insanity, manic depressive psychoses, and nervous breakdown.”
`Ex. 1004, 4:26–5:1; Ex. 1005, 27:21–25.
`We find that this general statement about the large genus, even though
`it includes lurasidone, does not demonstrate that the inventors invented the
`claimed method of treating manic depressive psychosis with lurasidone. This
`is because “one cannot disclose a forest in the original application and then
`later pick a tree out of the forest and say here is my invention. In order to
`satisfy the written description requirement, the blaze marks directing the
`skilled artisan to that tree must be in the originally filed disclosure.” Purdue
`Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000).
`Patent Owner does not point to any other disclosure in the priority
`application to support the manic depressive claims. See Prelim. Resp. 18
`(only citing the language in the “Background Art” section). Instead, Patent
`Owner contends that “during prosecution of the ’827 patent, the Examiner
`was aware of the manic depressive limitations, considered the written
`description and priority issues, and agreed that the manic depressive claims
`were entitled to the August 22, 2002 filing date.” Id.
`According to Patent Owner, when the applicant relied on the same
`language in the “Background Art” section for written-description support for
`the added limitation of “manic depressive psychoses,” “the examiner
`accepted these claim amendments as adequately supported by the ’827
`patent specification,” which is identical to the priority application in all
`relevant respects. Id. at 19. Patent Owner also emphasizes that the examiner
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`“determined multiple times that the ’827 patent should be accorded
`‘pre-AIA’ status.” Id. Because the ’919 application, which matured into the
`’827 patent, was filed post-AIA, whereas the priority application was filed
`pre-AIA, Patent Owner reasons that the examiner must have considered and
`accepted the priority claim of the ’827 patent. Id.
`We are not persuaded by Patent Owner’s arguments. “In the absence
`of an interference or rejection which would require the PTO to make a
`determination of priority, the PTO does not make such findings as a matter
`of course in prosecution.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d
`1299, 1305 (Fed. Cir. 2008). Furthermore, we are “not bound by the
`examiner’s finding in the ex parte application proceeding that the new
`claims were supported by the specification.” Purdue Pharma, 230 F.3d at
`1329.
`
`Patent Owner further argues that, because the manic depressive claims
`were added by amendments filed on October 5, 2015, even if Petitioner is
`correct that these claims lack written-description support in the priority
`application, the claims would not be entitled to even the August 28, 2014,
`filing date of the ’919 application. Prelim. Resp. 17. Rather, Patent Owner
`continues, “they would be invalid under § 112, para. 1 as lacking written
`description in the application as filed.” Id. According to Patent Owner, in
`that case, we also should deny institution because “IPR challenges [are]
`limited to §§ 102 and 103 grounds based on patents or printed publications.”
`Id. We reject this argument.
`First, Petitioner does not argue that the priority date of the claims-at-
`issue is the 2014 filing date. Instead, Petitioner argues that priority date is no
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`earlier than the 2014 filing date. Second, the statute does not prohibit an
`inter partes review of the patentability of a claim based on patents or printed
`publications under sections 102 or 103 that may also be unpatentable for
`lacking written-description support. Cf. Samsung Electronics America, Inc.
`v. Prisua Engineering Corp., 948 F.3d 1342, 1355 (Fed. Cir. 2020) (stating
`the fact that the patentability of a claim may be challenged for indefiniteness
`“does not necessarily preclude the Board from addressing the patentability
`of the claims on section 102 and 103 grounds”).
`In sum, we determine that, based on the record before us, the priority
`application does not provide sufficient written-description support for the
`manic depressive claims. Thus, for purposes of this Decision, those claims
`are not entitled to a priority date earlier than August 28, 2014, filing date of
`the ’919 application.
`C. Anticipation by Latuda Information
`Petitioner argues that Latuda Information anticipates the manic
`depressive claims. Pet. 31–38. Based on this record, we determine Petitioner
`has established a reasonable likelihood that it would prevail in this assertion.
`As an initial matter, we address the public accessibility of Latuda
`Information. In a footnote, Patent Owner argues that “Ex. 1007 [Latuda
`Information] appears to be an insert included in a periodical. Although
`[Petitioner] Slayback goes to great lengths to prove that the periodical was a
`printed publication, there is no evidence that the periodical included this
`particular insert.” Prelim. Resp. 16 n.59. We disagree.
`Petitioner has provided the Declaration of Sylvia D. Hall-Ellis, Ph.D.
`(Ex. 1036, “Librarian’s Affidavit”) to support the argument that Latuda
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`Information was “published and was publicly available more than one year
`before the ‘827 Patent Application’s August 28, 2014 filing date.” Pet. 31
`(citing Ex. 1036 ¶¶ 41–46). Patent Owner does not challenge, and on this
`record, we do not have a reason to doubt, the Librarian’s Affidavit. Thus, we
`are persuaded that Latuda Information qualifies as prior art under § 102(a).
`For claim 8, Petitioner refers to Latuda Information for disclosing the
`approval of Latuda (lurasidone HCl tablets) to treat bipolar depression.
`Pet. 32 (citing Ex. 1007). Petitioner argues that Latuda is administered orally
`at a dose of from 20 to 120 mg/day. Id. at 32–33 (citing Ex. 1007). Petitioner
`asserts that patients taking Latuda do not experience a clinically significant
`weight gain. Id. at 33 (citing Ex. 1007). Petitioner also contends that Latuda
`Information discloses each and every limitation of the other manic
`depressive claims. Id. at 32–38 (citing Ex. 1007). After reviewing the current
`record, and for purposes of this Decision, we agree with Petitioner and adopt
`Petitioner’s mapping of claim 8’s limitations to the disclosures of Latuda
`Information as our own findings. See id. at 32–38.
`Indeed, Latuda Information discloses that Latuda, i.e., lurasidone HCl
`tablets formulated at 20, 40, 80, 120 mg each dose, “is indicated as
`monotherapy for the treatment of patients with major depressive episodes
`associated with bipolar I disorder (bipolar depression). The efficacy of
`LATUDA was established in a 6-week monotherapy study in adult patients
`with bipolar depression.” Ex. 1007, 2, 4. It reports “findings [that] are based
`on the short-term, placebo-controlled premarketing study for bipolar
`depression in which LATUDA was administered at daily doses ranging from
`20 to 120 mg.” Id. at 8.
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`According to Latuda Information, monotherapy data from the short-
`term study show that the mean weight gain was 0.29 kg for Latuda-treated
`patients compared to -0.04 kg for placebo-treated patients. Id. at 6. “The
`proportion of patients with a ≥ 7% increase in body weight (at Endpoint)
`was 2.4% for LATUDA-treated patients versus 0.7% for placebo-treated
`patients.” Id.
`Patent Owner does not address Petitioner’s arguments on anticipation
`at this stage of the proceeding, except asserting that the manic depressive
`claims are entitled to the 2002 priority date, an argument that we have
`rejected as set forth above. See Prelim. Resp. 16–20; supra at II.B. As a
`result, based on the current record, we are persuaded that Petitioner has
`shown a reasonable likelihood of establishing that Latuda Information
`anticipates the manic depressive claims.
`Thus, we institute an inter partes review as to all challenges raised in
`the Petition. See SAS, 138 S. Ct. at 1355–56; see also Patent Trial and
`Appeal Board Consolidated Trial Practice Guide 64 (Nov. 2019)7 (“The
`Board will not institute on fewer than all claims or all challenges in a
`petition.”). We nevertheless offer the following observations on the
`remaining grounds.
`D. Obviousness over Latuda Information and Loebel
`As an alternative, Petitioner argues that the manic depressive claims
`would have been obvious over Latuda Information and Loebel. Pet. 41–49.
`
`
`7 Available at https://www.uspto.gov/sites/default/files/documents/
`tpgnov.pdf.
`
`16
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`Based on the current record, we determine Petitioner has established a
`reasonable likelihood that it would prevail in this assertion.
`Loebel describes the results of a 6-week, double-blind, placebo-
`controlled study of using luradison monotherapy for the treatment of bipolar
`depression. Ex.1008, 109. In that study, “monotherapy with lurasidone,
`flexibly dosed at 20-60 mg/day or 80-120 mg/day, significantly reduced
`depressive symptoms in patients with bipolar I depression compared with
`placebo.” Id. at 110. Loebel also reports that “[m]inimal changes in weight,
`lipids and measures of glycemic control were observed.” Id.
`Petitioner argues that an ordinarily skilled artisan would have been
`motivated to combine the teachings of Latuda Information and Loebel.
`Pet. 41. Petitioner also provides a limitation-by-limitation analysis of this
`ground. Id. at 41–49. Patent Owner, again, does not address Petitioner’s
`arguments, except asserting that the manic depressive claims are entitled to
`the 2002 priority date, an argument that we rejected as set forth above. See
`Prelim. Resp. 16–20; supra at II.B.
`After reviewing the current record, we agree with Petitioner and, for
`purposes of this Decision, adopt Petitioner’s mapping of the claim
`limitations to the disclosures of Latuda Information and Loebel as our own
`findings. See Pet. 41–49. As a result, based on the current record, we are
`persuaded that Petitioner has shown a reasonable likelihood of establishing
`that the manic depressive claims would have been obvious over Latuda
`Information and Loebel.
`
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`E. Obviousness over Saji
`Petitioner argues that claims 1–75 of the ’827 patent would have been
`obvious over Saji. Pet. 50–63.
`Saji teaches an imide compound of the formula:
`
`
`
`The figure above shows the chemical structure of compound (I) of Saji.
`Ex. 1009, 3:3–8. Saji further specifies the formula of groups Z, D, and Ar of
`compound (I). Id. at 3:10–44.
`Saji teaches that the novel imide compounds and their acid addition
`salts of its invention can be used “as anti-psycotic agents (neuroleptic
`agents, anti-anxiety agents), especially for therapy of schizophrenia, senile
`insanity, manic-depressive psychosis, neurosis, etc.” Id. at 1:8–12.
`According to Saji, for the therapeutic use as an anti-psychotic agent, the
`imide compound (I) and its pharmaceutically acceptable salt may be
`formulated into tablets for oral administration. Id. at 11:66–12:6. According
`to Saji,
`its
`imide compound (I) or
`the
`the dosage of
`While
`the
`pharmaceutically acceptable salt varies greatly with
`symptom, age and weight of the patient, the dosage form, the
`administration mode and the like, it may be generally given to an
`adult at a daily dose of from about 1 to 1000 mg, preferably from
`about 5 to 100 mg, in case of oral administration . . . Said dose
`may be applied in a single time or dividedly in two or more times.
`Id. at 12:15–24.
`
`18
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`Claim 14 of Saji is directed to an imide compound with the following
`formula, or an acid addition salt thereof:
`
`
`The figure above shows the chemical structure of compound of claim 14. Id.,
`claim 14. According to Petitioner, the compound of claim 14 is lurasidone.
`Pet. 56.
`Saji also teaches Compound No. 101, which has the following
`structure:
`
`
`
`The figure above shows the chemical structure of compound of Compound
`No. 101. Ex. 1009, col. 30, at the bottom. According to Petitioner,
`Compound No. 101 is lurasidone HCl.8 Pet. 56.
`
`
`8 Patent Owner argues that Compound No. 105 is lurasidone. Prelim.
`Resp. 22. Compound No. 105 is the “(-)-isomer of Compound No. 101 in the
`
`19
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`Petitioner argues that the above disclosures of Saji teach treating
`manic depressive psychosis and schizophrenia by orally administering
`lurasidone or lurasidone HCl at a dose required in the challenged claims.
`Pet. 54–61. For the limitations related to no weight gain (including “no
`clinically significant weight gain” (claims 1, 8, 25, and 40), “no weight gain
`after six weeks of administration” (claims 10, 27, 43, and 59), and “without
`a weight gain” (claim 56)), Petitioner contends that no weight gain “in one
`or more patients is inherent.” Id. at 55, 56, 59.
`Petitioner also relies on other prior art to show that no weight gain
`“was expected because patients are diverse, and because ziprasidone, a
`structurally related compound, was known to cause little or no weight gain.”
`Id. at 55 (citing Ex. 1002 ¶¶ 126, 127; Ex. 10299), 56 (citing Ex. 1002 ¶ 129;
`Ex. 1028), 59 (citing Ex. 1002 ¶ 137; Ex. 1029; Ex. 104110). For example,
`Petitioner argues that Horisawa reports that SM-13496’s “body weight
`increasing action are weak because its bonding affinity to α1, H1 and 5-
`HT2C receptors is low.” Id. at 52 (quoting Ex. 1028). Petitioner further
`asserts that “ziprasidone, a drug structurally related to lurasidone, was an
`
`
`form of hydrochloride.” Ex. 1009, 32:20–21. Thus, it appears to us that
`Compound No. 105 is a lurasidone HCl salt.
`9 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) (Ex. 1029,
`“Horisawa”). Exhibit 1029 is in Japanese. Exhibit 1028 includes a certified
`English translation of Horisawa.
`10 Allison et al., Antipsychotic-Induced Weight Gain: A Comprehensive
`Research Synthesis, 156 AM. J. PSYCHIATRY 1686–96 (1999) (Ex. 1041,
`“Allison”).
`
`20
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`antipsychotic known in the prior art to cause no change in body weight in at
`least some patients.” Id. at 53 (citing Ex. 1002 ¶ 119; Exs. 1041, 1042).
`Patent Owner counters that Saji does not teach the claimed dosing
`regimen. Prelim. Resp. 22. According to Patent Owner, Saji “generically
`states that the compounds covered by its genus may be provided in any of
`four broad dose ranges.” Id. at 23 (citing Ex. 1009, 12:19–22). Patent Owner
`contends that Saji warns that dosing ranges vary greatly with the dosage
`form, the administration mode, and the like. Id. (citing Ex. 1009, 12:15–24).
`And while Saji “says that the dose for these compounds may be applied as a
`single dose,” Patent Owner continues, “it also says it may be divided in two
`or more times.” Id. (citing Ex. 1009, 12:23–24). Thus, Patent Owner asserts
`that Saji does not teach “the ʼ827 patent’s specific dosing range of 20–120
`mg administered orally once a day for any compound, let alone for
`lurasidone.” Id.
`Patent Owner further argues that the claimed dosing regimen
`unexpectedly does not cause weight gain. Id. at 24. According to Patent
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