Paper 23
`
`
`Trials@uspto.gov
` Entered: March 19, 2020
`
`
`571.272.7822
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`HYBRIGENICS SA.
`Petitioner,
`v.
`FORMA THERAPEUTICS, INC.
`Patent Owner.
`____________
`
`PGR2018-00098
`Patent 9,840,491 B2
`____________
`
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`DECISION
`Final Written Decision
`35 U.S.C. § 328
`
`
`
`
`
`
`
`
`

`

`PGR2018-00098
`Patent 9,840,491 B2
`
`
` INTRODUCTION
`Hybrigenics SA (“Petitioner” or “Hybrigenics”) filed a Petition
`requesting a post grant review of claims 1–17 of U.S. Patent No. 9,840,491
`B2 (Ex. 1001, “the ’491 patent”).1 Paper 4 (“Pet.”). Forma Therapeutics,
`Inc. (“Patent Owner” or “Forma”) filed a Preliminary Response to the
`Petition. Paper 9 (Prelim. Resp.).2 We determined, based on the
`information presented in the Petition and Preliminary Response, that there
`was a reasonable likelihood that Petitioner would prevail in showing that at
`least one of the challenged claims was unpatentable. Pursuant to 35 U.S.C.
`§ 324, the Board instituted trial on March 20, 2019. Paper 10 (“Institution
`Decision” or “Inst. Dec.”).
`Patent Owners filed a Response to the Petition (Paper 16, “PO
`Resp.”), Petitioner filed a Reply to Patent Owners’ Response (Paper 19,
`“Reply”), and Patent Owner filed a Sur-Reply (Paper 21, “Sur-Reply”).
`Neither party request an oral hearing.
`We have jurisdiction under 35 U.S.C. § 6. We issue this Final Written
`Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on
`the record before us, we conclude that Petitioner has demonstrated by a
`preponderance of the evidence that claims 1–15 and 17 of the ’491 patent are
`unpatentable but has not demonstrated that claim 16 is unpatentable.
`Related Proceedings
`A.
`Petitioner represents that it is unaware of any other matters related to
`the ’491 patent. Pet. 1. Patent Owner identifies several patent applications
`as related to the ’491 patent, including Patent Cooperation Treaty
`
`1 Petitioner identifies Hybrigenics SA as the real party in interest. Pet. 1.
`2 Patent Owner identifies Forma Therapeutics, Inc. as the real party in
`interest. Paper 6, 2.
`
`2
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`PGR2018-00098
`Patent 9,840,491 B2
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`Application No. PCT/US2016/016542, US Patent Application No.
`62/112,487, US Patent Application No. 15/837,393, US Patent Application
`16/179,061, US Patent Application No. 16/179,071, US Patent Application
`No. 16/179,099, US Patent Application 16/179,111, US Patent Application
`16/179,117, US Patent Application No. 16/179,125, and US Patent
`Application No. 16/694,500. Paper 6, 2; Paper 7; Paper 22.
`The ’491 Patent (Ex. 1001)
`B.
`The ’491 patent issued December 12, 2017, identifying Stephanos
`Ioannidis, Adam Charles Talbot, Bruce Follows, Alexandre Joseph
`Buckmelter, Minghua Wang, Ann-Marie Campbell, and David R. Lancia Jr.
`as joint inventors. Ex. 1001 code (72). The patent “relates to inhibitors of
`USP7 [ubiquitin-specific protease 7].” Id. at Abstract.
`
`The ’491 patent teaches that “USP7 deubiquitinates a variety of
`cellular targets involved in different processes related to cancer and
`metastasis, neurodegenerative diseases, immunological disorders,
`osteoporosis, arthritis inflammatory disorders, cardiovascular diseases,
`ischemic diseases, viral infections and diseases, and bacterial infections and
`diseases.” Ex. 1001, 1:62–2:2. The ’491 patent also teaches that
`“[i]nhibition of USP7 with small molecule inhibitors . . . has the potential to
`be a treatment for cancers and other disorders.” Id. at 3:1–3.
`The ’491 patent discloses “compounds of Formula (I):
`
`and pharmaceutically acceptable salts, hydrates, solvates, prodrugs,
`stereoisomers, and tautomers thereof.” Id. at 3:7–23.
`
`3
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`PGR2018-00098
`Patent 9,840,491 B2
`
`
`Challenged Claims
`C.
`Petitioner challenges claims 1–17 of the ’491 patent. Claims 1 and 16
`are representative and are reproduced below.
`
`1.
`
`A compound of Formula (I):
`
`or a pharmaceutically acceptable salt, stereoisomer, and tautomer
`thereof,
`wherein:
`X1 is C, S, or S(O);
`Y1 is N or CH;
`Y2 is N or CR5;
`Y3 is N or CR6;
`Y4 is N or CR7;
`. . . R2 is (C1-C6) alkyl, (C6-C14) aryl, 5- or 6- membered
`heteroaryl comprising 1 to 3 heteroatoms selected from O, N,
`and S, (C5-C8) cycloalkyl, 3- to 7-membered heterocycloalkyl
`comprising 1 to 3 heteroatoms selected from O, N, and S, or —
`NR10R11, wherein the alkyl, aryl, heteroaryl, cycloalkyl, and
`heterocycloalkyl are optionally substituted with one to three R8;
`. . . wherein R5, R6, and R7 and not all simultaneously H;
`. . . provided that when R2 is optionally substituted alkyl, R5 is
`H, and R7 is H, then R6 is not chloro.3
`
`16. A compound selected from:
`3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl) methyl)-7-
`methoxyquinazolin-4(3H)-one;
`3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl) methyl)-8-
`methylquinazolin-4(3H)-one;
`
`3 Claim 1 also includes limitations further limiting R substituents, and
`further limiting m, n, and q, but those limitations are not relevant to the
`dispositive issues in this Petition and so are not reproduced herein.
`4
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`

`

`PGR2018-00098
`Patent 9,840,491 B2
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`
`7-amino-3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4–
`yl)methyl)quinazolin-4(3H)-one;
`N-(3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)-
`4-oxo-3,4-dihydroquinazolin-7-yl)acetamide;
`(R)-3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)-
`7-methoxyquinazolin-4(3H)-one;
`(R)-3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)-
`8-methylquinazolin-4(3H)-one;
`3-((1-(1-benzylindoline-5-carbonyl)-4-hydroxypiperidin-4-
`yl)methyl)-7- methylquinazolin-4(3H)-one;
`3-((1-benzoyl-4-hydroxypiperidin-4-yl)methyl)-7-
`phenylquinazolin-4(3H)-one;
`3-((1-benzoyl-4-hydroxypiperidin-4-yl)methyl)-8-
`phenylquinazolin-4(3H)-one;
`3-((1-(4-fluorobenzoyl)-4-hydroxypiperidin-4-yl)methyl)-8-(4-
`fluorophenoxy)quinazolin-4(3H)-one;
`3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)
`pyrido[2,3-d]pyrimidin-4(3H)-one;
`3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)
`pyrido[3,4-d]pyrimidin-4(3H)-one; or
`3-((4-hydroxy-1-(3-phenylbutanoyl)piperidin-4-yl)methyl)
`pyrido[3,2-d]pyrimidin-4(3H)-one.
`
`
`
`D. The Prosecution History
`We discuss the prosecution history of the ’491 patent for context
`because one of the prior art references asserted in this proceeding, the ’150
`patent,4 was cited by the Examiner during prosecution and because
`Petitioner challenges material added by amendment as lacking written
`description support.
`The application that issued as the ’491 patent (Application
`No. 15/015,571), was filed on February 4, 2016. Ex. 1001. In an Office
`Action dated September 29, 2016, the Examiner rejected claims
`
`
`4 Colland et al., US Patent No. 9,546,150 B2, issued Jan. 17, 2017
`(Ex. 1003, “the ’150 patent”).
`
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`Patent 9,840,491 B2
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`corresponding to the claims at issue under 35 U.S.C. § 112(a) as indefinite
`because the claims “defined variables (where applicable) as heterocycle,
`heteroaryl, heterocyclic, and/or aryl” but the “specification does not define
`the ring size, heteroatom, number and nature of substituents, and the exact
`point of contact with the atom(s) for the substituents.” Ex. 1002, 186. The
`Examiner also rejected these claims under 35 U.S.C. § 112(a) for failure to
`comply with the enablement requirement. Id. at 187. The pending claims
`were drawn to compounds of Formula I “or a pharmaceutically acceptable
`salt, hydrate, solvate, prodrug, stereoisomer, and tautomer thereof.” Id. at
`241. The Examiner found that “the specification, while being enabling for
`specific compounds disclosed in the specification, does not reasonably
`provide enablement for hydrates, solvates and prodrugs of those
`compounds and composition[s] containing same.” Id. at 187.
`In response to the September 29, 2016, Office Action, Patent Owner
`amended the claims by deleting the terms “hydrate,” “solvate,” and
`“prodrug.” Id. at 142, 178. Patent Owner also amended the limitations
`relating to the R2, R3, R6–R11, R13, R14, R17, R21–R24, R26, and R27
`substituents by narrowing the recited heteroaryl and heterocycle to a “5- or
`6- membered heteroaryl comprising 1 to 3 heteroatoms selected from O, N,
`and S” and a “3- to 7- membered heterocycloalkyl comprising 1 to 3
`heteroatoms selected from O, N, and S.” Id. at 142–148. The portion of the
`claim relating to the R2 substituent, as amended, is representative and reads
`as follows:
`R2 is (C1-C6) alkyl, (C6-C14) aryl, 5- or 6-membered heteroaryl
`comprising 1 to 3 heteroatoms selected from O, N, and S, (C5-
`C8) cycloalkyl, 3- to 7-membered heterocycloalkyl comprising
`1 to 3 heteroatoms selected from O, N, and S, -NR10R11, or –
`OR10, wherein the alkyl, aryl, heteroaryl, cycloalkyl, and
`
`6
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`PGR2018-00098
`Patent 9,840,491 B2
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`
`heterocycloalkyl are optionally substituted with one to three or
`more R8;
`
`
`Ex. 1002, 142 (underlined text reflects material added by amendment,
`strikeout text reflects material deleted by amendment). Patent Owner
`asserted that this amendment was supported by paragraphs 32, 33, and 41 of
`the Specification, was well as by pages 54–63. Id. at 177.
`
`In an April 19, 2017 Office Action, the Examiner found that the
`pending enablement and indefiniteness rejections had “been obviated by
`Applicant’s Amendment.” Id. at 127. However, the Examiner entered six
`new rejections over the prior art. Of particular relevance here, the Examiner
`rejected the pending claims as anticipated by and as obvious over the ’150
`patent. Id. at 128–133, 135–136. With respect to the obviousness rejection
`over the ’150 patent, the Examiner stated:
`The claims differ from the reference by reciting specific species
`and a more limited genus than the reference. However, it would
`have been obvious to one having ordinary skill in the art at the
`time of the invention to select any of the species of the genus
`taught by the reference, including those instantly claimed,
`because the skilled chemist would have the reasonable
`expectation that any of the species of the genus would have
`similar properties, and thus, the same use as taught for the
`genus as a whole. One of ordinary skill in the art would have
`been motivated to select the claimed compounds from the genus
`in the reference since such compounds would have been
`suggested by the reference as a whole. A prior art disclosed
`genus of useful compounds is sufficient to render prima facie
`obvious a species falling within a genus. Thus, Applicant’s
`claims are obvious, and therefore, rejected under 35 U.S.C. 103.
`Id. at 135.
`
`In response to the April 17, 2017, Office Action, Patent Owner argued
`that the ’150 patent did not anticipate the claimed compounds because the
`
`7
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`Patent 9,840,491 B2
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`’150 patent teaches a “4-quinazolinone compound . . . that is substituted by
`an alkoxy group at the 6-carbon corresponding to R5 in Formula I” while the
`definition of R5 in the claims “does not contemplate an alkoxy group.” Id. at
`87. In addition, Patent Owner argued that claim 1 specifies that “R6 is not
`chloro” and that “R5, R6, and R7 are not all simultaneously H” and, thus, the
`compounds disclosed in the ’150 patent did not fall within the scope of the
`pending claims. Id. at 88–91.
`
`Patent Owner similarly argued that the compounds of the ’150 patent
`did not render the claimed compounds obvious because the phenyl portion of
`the quinazolinone ring system in the fourteen exemplified compounds of the
`’150 patent exhibited only three substitution patterns “(i) no substitution; (ii)
`chloro substitution at C7; or (iii) alkoxy substitution at C6 and C7.” Id. at
`96. According to the Patent Owner, the ordinary artisan “motivated by a
`desire to arrive at an effective inhibitor of USP7, would have likely selected
`a compound with one of those three substitution patterns as a lead compound
`for further modification along with a substituted alkyl amide.” Id.
`Accordingly, rather than modify one of the three quinazolinone ring systems
`exemplified in the ’150 patent, the skilled artisan would “modify the
`substituted alkyl group bound to the piperidine amide.” Id. Patent Owner
`also asserted that Examples 13 and 14 of the ’150 patent “demonstrated the
`lowest inhibitory concentration of USP7, and would therefor likely be
`selected as lead compounds.” Id. at 96–97. Since these compounds do not
`have quinazolinone rings that fall within the scope of the claims, and,
`according to the Patent Owner, the ordinary artisan would modify the
`substituted alkyl group bound to the piperidine amide in the compounds of
`
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`Patent 9,840,491 B2
`
`the ’150 patent rather than the quinazolinone ring, the claimed compounds
`would not have been obvious. Id. at 97.
`
`The Examiner evidently found these arguments persuasive, allowing
`the claims because the “prior art does not teach or suggest the compositions
`and compounds substituted in the manner claimed by the Applicant.” Id. at
`37.
`
`The Asserted Ground of Unpatentability
`E.
`Petitioner challenges the patentability of claims 1‒17 of the
`’491 patent on the following grounds:
`Claim(s) Challenged
`35 U.S.C. §
`1–17
`§ 103(a)
`1–17
`§ 112(a)
`1–15, 17
`§ 112(a)
`
`Reference(s)/Basis
`’150 patent
`Enablement
`Written Description
`
`Petitioner submits two Declarations of Dr. Rémi Delansorne
`(Ex. 1004 and Ex. 1029) in support of institution of post grant review.5
`F. Person of Ordinary Skill in the Art
`Factual indicators of the level of ordinary skill in the art include “the
`various prior art approaches employed, the types of problems encountered in
`the art, the rapidity with which innovations are made, the sophistication of
`the technology involved, and the educational background of those actively
`working in the field.” Jacobson Bros., Inc. v. U.S., 512 F.2d 1065, 1071 (Ct.
`
`
`5 Dr. Delansorne is Petitioner’s Chief Executive Officer and Chairman of its
`Board of Directors (Ex. 1004, 1) and thus has an interest in this proceeding,
`which may diminish the persuasiveness of his testimony. Ashland Oil, Inc.
`v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)
`(“While the opinion testimony of a party having a direct interest in the
`pending litigation is less persuasive than opinion testimony by a
`disinterested party, it cannot be disregarded for that reason alone and may be
`relied upon when sufficiently convincing.”).
`9
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`Cl. 1975); see also Orthopedic Equip. Co., v. U.S., 702 F.2d 1005, 1011
`(Fed. Cir. 1983) (quoting with approval Jacobson Bros.).
`Petitioner contends that the person of ordinary skill would have “the
`equivalent of at least a Ph.D. in biochemistry, organic chemistry,
`pharmacology or related science and has post-Ph.D. work in the field for at
`least three years including either as a post-doc or in industry.” Pet. 4. In our
`Institution Decision, we accepted this definition. Inst. Dec. 9. Patent Owner
`does not challenge Petitioner’s definition or our acceptance thereof. PO
`Reply 3 (“For the purposes of this Response, Patent Owner does not dispute
`the Board’s finding on the level of ordinary skill.”). Accordingly, for
`purposes of this Decision and based on the present record, we accept
`Petitioner’s definition, which is consistent with the level of skill reflected in
`the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350,
`1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of
`ordinary skill in the art).
`
`G. Claim Construction
`We interpret claims of an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent in which
`[they] appear[].” 37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs., LLC
`v. Lee, 136 S. Ct. 2131, 2144–46 (2016).6 Under the broadest reasonable
`construction standard, claim terms are generally given their ordinary and
`
`
`6 The broadest reasonable interpretation (“BRI”) construction standard
`applies to post grant reviews filed before November 13, 2018. 77 Fed. Reg.
`48727 (Aug. 14, 2012) (codified at 37 C.F.R. § 42.100(b)), as amended at 81
`Fed. Reg. 18766 (Apr. 1, 2016); see also 83 Fed. Reg. 51340 (Oct. 11, 2018)
`(changing the standard for interpreting claims in inter partes reviews filed
`on or after November 13, 2018). Because the Petition was filed prior to this
`date, on September 12, 2018, the BRI construction standard applies.
`10
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`customary meaning as would be understood by one of ordinary skill in the
`art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249,
`1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning,
`the PTO should only limit the claim based on the specification . . . when [it]
`expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320,
`1325 (Fed. Cir. 2004).
`Neither Petitioner nor Patent Owner proposes any specific
`constructions for any of the terms in the claims at issue. See, Pet. 12–13; PO
`Resp. 3. Accordingly, at this stage of the proceeding, we determine that no
`explicit construction of any claim term is necessary to resolve this case. See
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d
`1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in
`controversy, and only to the extent necessary to resolve the controversy’”
`(quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
`1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent
`necessary to resolve the controversy’”).
` REAL PARTY IN INTEREST
`Patent Owner argues that Servier Laboratories, Hybrigenics Corp.,
`and Hybrigenics Pharma Inc. are real parties in interest (“RPI”) with respect
`to the Petition, and that Petitioner, Hybrigenics SA, failed to identify them as
`required by 35 U.S.C. § 322(a)(2). PO Resp. 24–40. Patent Owner further
`argues that, because Petitioner did not identify these parties within nine
`months of the issuance of the ’491 patent, the Petition must be dismissed as
`time barred under 35 U.S.C. § 321(c). Id. at 24. For the reasons discussed
`below, we do not find Patent Owner’s arguments persuasive.
`
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`
`A.
`
`Background Regarding the Relationship Between Hybrigenics
`SA and Servier Laboratories
`Dr. Delansorne, Petitioner’s Chief Executive Officer, testifies that
`from October 2011 to September 2016, “Hybrigenics screened and profiled
`Servier’s compounds as potential USP7 inhibitors.” Ex. 1029 ¶ 2.7
`Dr. Delansorne’s testimony on this point is consistent with the record. See,
`Ex. 2012 (January 2015 Hybrigenics press release announcing “the
`extension of [Hybrigenic’s] partnership with Servier to discover new drugs
`which inhibit Ubiquitin-Specific Proteases (USPs)”); Ex. 2016, 23 (February
`2017 Hybrigenics “Bio-CEO and Investor” presentation stating that
`Hybrigenics pioneer research position on DUBs8 included a “[s]uccessful
`partnership with Servier for validation of one USP in oncology, screening of
`its lead inhibitors and profiling of development candidates”); Ex. 2017, 27
`(January 2016 Hybrigenics “Corporate presentation” including similar
`statement as quoted from Ex. 2016); Ex. 2018, 27 (September 2016
`Hybrigenics “Corporate presentation” including similar statement as quoted
`from Ex. 2016).
`During this time period, Servier filed two patent applications that,
`according to Patent Owner, disclose compounds that related to the ’491
`patent. Sur-Reply. 16–17. Patent Owner argues that one of these
`
`
`7 As noted above, Dr. Delansorne has an interest in this proceeding, which
`may diminish the persuasiveness of his testimony. However, the factual
`testimony in Dr. Delansorne’s September 3, 2019 Declaration (Ex. 1029) is
`consistent with, and/or not persuasively contradicted by the evidence of
`record. Accordingly, we find Dr. Delansorne’s factual testimony to be
`credible.
`8 USPs, including USP7, are a family of deubiquitinating (“DUB”) enzymes.
`See, e.g., Ex. 1001, at 1:41–42; Ex. 2001 (“The class of USPs is part of the
`wider family of DUBs”).
`
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`applications “discloses a genera of compounds . . . that substantially
`overlaps with the compounds claimed in the ’491 patent” and that the other
`“discloses compounds that are structurally similar to the compounds claimed
`in the ’491 patent.” Id. at 17 (citing, Ex. 2023, and Ex. 2024).9
`Dr. Delansorne testifies that, in September 2016, Hybrigenics and
`Servier entered into an agreement terminating the collaboration during
`which Hybrigenics screened and profiled Servier’s compounds as potential
`USP7 inhibitors. Ex. 1029 ¶ 2. Dr. Delansorne’s testimony on this point is
`consistent with the record and, therefore, credible. See, Ex. 2013 (October
`10, 2016 Hybrigenics press release announcing a “new step in
`[Hybrigenics’] R&D partnership with Servier” and stating that the
`partnership “has now reached its objectives.”); Ex. 2019, 1 (June 2017
`Arrowhead “Dilligence and Valuation Report” stating that “[i]n 2011,
`Hybrigenics collaborated with Servier Laboratories” and that the “R&D
`partnership has now reached its objectives”). Dr. Delansorne also testifies
`that the agreement terminating the partnership between Hybrigenics and
`Servier did not relate to any third party patents, including the ’491 patent.
`Ex. 1029 ¶¶ 4–5. Patent Owner has not provided persuasive evidence
`calling this testimony into question. Accordingly, we credit it.
`Following the termination of its collaboration with Hybrigenics to
`screen compounds as USP7 inhibitors, Servier assumed control of the
`continued development of the USP7 inhibitors Hybrigenics screened.
`
`9 Patent Owner does not provide evidence supporting this assertion. See,
`Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (“Attorneys’
`argument is no substitute for evidence.”); In re Pearson, 494 F.2d 1399,
`1405 (CCPA 1974). Nonetheless, for purposes of this decision, we accept
`Patent Owner’s representation that these two patent applications disclose
`compounds that are related to the compounds claimed in the ’491 patent.
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`Ex. 2013, 1 (October 10, 2016 Hybrigenics press release announcing “new
`step” in Hybrigenics/Servier partnership and stating that “Servier will take
`charge of the continuation of this R&D program in oncology.”); Ex. 2019, 1
`(June 2017 Arrowhead “Dilligence and Valuation Report” stating that
`Servier will “take charge of the continuation of the R&D program in
`oncology” and that Servier will “commercialize the approved drugs” that
`were developed as a result its collaboration with Hybrigenics). Also
`following the termination of the collaboration, Servier filed another patent
`application disclosing compounds that Patent Owner alleges were
`“structurally similar to those claimed in the ’491 patent.” PO Resp. 20.10
`Notwithstanding the termination of the USP screening partnership,
`Hybrigenics “remain[ed] entitled to development milestones in recognition
`of its contribution to the screening and profiling of compounds.” Ex. 1029
`¶ 3; see also, Ex. 2016, 23 (October 10, 2016 Hybrigenics press release
`setting forth milestone schedule including € 6.7 m in payments already
`realized and “[p]otential further milestones until drug registration for a total
`amount of € 12 m”); Ex. 2019, 1 (June 2017 Arrowhead “Dilligence and
`Valuation Report” stating that Hybrigenics’ collaboration with Servier
`entitled Hybrigenics to “preclinical, clinical, and registration milestones
`totaling € 9.5 MM or € 11.5 MM for each target yielding a DUB inhibitor,
`which becomes a commercialized drug” and that Hybrigenics “has already
`reached the first preclinical milestone (€ 500,000) and it has potential offers
`of royalties to the Company on future sales of companion diagnostic kits.”).
`
`
`10 Again, Patent Owner does not provide evidence supporting this assertion.
`Nonetheless, for purposes of this decision, we accept Patent Owner’s
`representation that these two patent applications disclose compounds that are
`related to the compounds claimed in the ’491 patent.
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`Dr. Delansorne, testifies that “Hybrigenics has always worked with
`Servier as an independent contractor,” that there is “no overlap between the
`management of Hybrigenics and the management of Servier,” that
`Hybrigenics “has received no instruction regarding the ’491 patent prior to
`implementation of PGR2018-00098,” and that “Hybrigenics has received no
`instructions from Servier regarding PGR2018-00098.” Ex. 1029 ¶¶ 6–9.
`Patent Owner has not provided persuasive evidence calling this testimony
`into question. Accordingly, we credit it.
`B.
`Background Regarding the Relationship Between Petitioner,
`Hybrigenics Corp., and Hybrigenics Pharma
`Dr. Delansorne testifies that “Hybrigenics Corp. is 100% owned by
`
`Hybrigenics Services SAS” and that Petitioner is “only a 19.99% minority
`shareholder of Hybrigenics Services SAS,” which, under French law,
`precludes Petitioner from exerting control over Hybrigenics Services SAS.
`Ex. 1029 ¶¶ 12, 15. Patent Owner has not provided persuasive evidence
`calling this testimony into question. In its Response, Patent Owner cites a
`January 2015 press release that states that “Hybrigenics Corp. . . . is the
`American subsidiary of [Petitioner],” and a September 2013 press release
`that states that Hybrigenics Corp. “will represent [Petitioner] for R&D,
`regulatory and business development matters” “[i]n the American territory,”
`and may “facilitate future R&D interactions with the U.S. Food and Drug
`Administration.” PO Resp. 36–37 (citing Ex. 2012, and Ex. 2014). These
`statements are consistent with Dr. Delansorne’s testimony. See, Ex. 2029 ¶¶
`13–14 (testifying that Hybrigenics Corp. was “set up in 2013 as a subsidiary
`of [Petitioner]” but “sold to Hybrigenics Services SAS in December 2016”).
`Accordingly, we credit Dr. Delansorne’s testimony that “Hybrigenics Corp.
`is 100% owned by Hybrigenics Services SAS” and that Petitioner is “only a
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`Patent 9,840,491 B2
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`19.99% minority shareholder of Hybrigenics Services SAS.” Ex. 1029 ¶¶
`12, 15.
`
`Dr. Delansorne also testifies that “Hybrigenics Pharma Inc. is 100%
`owned by [Petitioner]” and that it was set up “exclusively . . . to manage the
`clinical study of inecalcitol in the U.S.” Ex. 1029 ¶¶ 16–17. We credit this
`testimony as it is consistent with the other evidence of record. See Ex. 2015,
`2 (May 2017 press release stating that “Hybrigenics Pharma Inc. . . . is the
`U.S. subsidiary of [Petitioner].”).
`Analysis
`C.
`
`35 U.S.C. § 322(a)(2) requires that a petition for post grant review
`“may be considered only if . . . the petition identifies all real parties in
`interest.” It is Petitioner’s burden here to demonstrate that it has correctly
`identified itself as the only real party. Worlds Inc. v. Bungie, Inc., 903 F.3d
`1237, 1242 (Fed. Cir. 2018)
`“Determining whether a non-party is a ‘real party in interest’ demands
`a flexible approach that takes into account both equitable and practical
`considerations, with an eye toward determining whether the non-party is a
`clear beneficiary that has a preexisting, established relationship with the
`petitioner.” Applications in Internet Time v. RPX Corp., 897 F.3d 1336,
`1351 (Fed. Cir. 2018). Whether an entity that is not named as a participant
`in a given proceeding constitutes a “real party in interest” is a highly fact-
`dependent question that takes into consideration how courts generally have
`used that term to “describe relationships and considerations sufficient to
`justify applying conventional principles of estoppel and preclusion.” Office
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012)
`(“Trial Practice Guide”). According to the Trial Practice Guide,
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`
`the spirit of that formulation as to . . . PGR proceedings means
`that, at a general level, the “real party-in-interest” is the party that
`desires review of the patent. Thus, the “real party-in-interest”
`may be the petitioner itself, and/or it may be the party or parties
`at whose behest the petition has been filed.
`
`Id.
`
`As stated in the Trial Practice Guide, there are “multiple factors
`relevant to the question of whether a non-party may be recognized as” a real
`party in interest. Id. (citing Taylor v. Sturgell, 553 U.S. 880, 893–895, 893
`n.6 (2008)). There is no “bright line test.” Id. Considerations may include,
`for example, whether a non-party exercises control over a petitioner’s
`participation in a proceeding, or whether a non-party is funding the
`proceeding or directing the proceeding. Id. at 48,759–60. “[T]he two
`questions lying at [the] heart” of the RPI inquiry are “whether a non-party
`‘desires review of the patent’ and whether a petition has been filed at a non-
`party’s ‘behest.’” Applications in Internet Time, 897 F.3d at 1351 (quoting
`Trial Practice Guide, 77 Fed. Reg. at 48,759). In assessing a petitioner’s
`alleged failure to identify a RPI, “[t]he point is . . . to probe the extent to
`which [the non-party] has an interest in and will benefit from [the
`petitioner’s] actions, and inquire whether [the petitioner] can be said to be
`representing that interest after examining its relationship with [the non-
`party].” Id. at 1353.
`Servier Laboratories
`Patent Owner contends that Servier is “a clear beneficiary” that has a
`“preexisting, established relationship” with Hybrigenics and that Servier has
`an “actual measure of control or opportunity to control that might reasonably
`be expected between two formal coparties.” PO Resp. 29. Patent Owner
`cites a number of publicly available press releases, corporate presentations
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`financial reports, and patent applications to support its position. Petitioner
`contends that Patent Owner’s evidence “amounts to little more than an
`assertion that Servier had a preexisting, established relationship with
`Petitioner and is a beneficiary of the Petition” and that “[t]his is clearly
`insufficient to establish that Servier should have been named as a real party
`in interest.” Reply. 2 (emphasis omitted). Based on our review of the
`record, and the parties’ arguments regarding the same, we find that
`Petitioner has met its burden to demonstrate that Servier is not a real party in
`interest.
`As discussed above, “the two questions lying at [the] heart” of the RPI
`inquiry are “whether a non-party ‘desires review of the patent’ and whether
`a petition has been filed at a non-party’s ‘behest.’” Applications in Internet
`Time, 897 F.3d at 1351 (quoting Trial Practice Guide, 77 Fed. Reg. at
`48,759). Here, the record does not support that the Petition was filed at the
`behest of Servier or that Servier desires review of the ’491 patent.
`The evidence of record supports that the Petition was not filed at
`Servier’s behest. Ex. 1029 ¶¶ 4–5, and 8–9. Patent Owner contends that
`“[b]y controlling and funding the development of Petitioner’s USP
`inhibitors, it is evident that Servier ‘exercised or could have exercised
`control over the proceeding.’” PO Resp. 35. But the record does not include
`evidence that Servier controlled, directed, financed, or participated in any
`way in the filing of the Petition. We acknowledge the evidence that
`following the termination of the collaboration between Servier and
`Hybrigenics, Servier assumed control of R&D and commercialization for the
`USP7 inhibitors that Hybrigenics screened. Ex. 1029 ¶ 2; Ex. 2013, 1;
`Ex. 2019, 1. However, the record does