Paper No. 10
`
`
`Trials@uspto.gov
` Entered: March 20, 2019
`
`
`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.
`____________
`
`Case 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
`Granting Institution of Post Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
` Entered: March 20, 2019
`
`
`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.
`____________
`
`Case 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
`Granting Institution of Post Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`
`
`PGR2018-00098
`Patent 9,840,491 B2
`
`
`I. 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
`Institution of post grant review is authorized by statute only when “the
`information presented in the petition . . . demonstrate[s] that it is more likely
`than not that at least 1 of the claims challenged in the petition is
`unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the
`Petition, the Preliminary Response, and the cited evidence, we conclude that
`Petitioner has satisfied the burden under 35 U.S.C. § 324 to show that it is
`more likely than not that at least 1 of the claims challenged in the petition 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
`Application No. PCT/US2016/016542, US Patent Application No.
`62/112,487, and US Patent Application No. 15/837,393. Paper 6, 2.
`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.
`
`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.
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`Patent 9,840,491 B2
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`as joint inventors. Ex. 1001. 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 3:1–2.
`The ’491 patent discloses “compounds of Formula (I):
`
`and pharmaceutically acceptable salts, hydrates, solvates, prodrugs,
`stereoisomers, and tautomers thereof.” Id. at 3:7–23.
`C. Challenged Claims
`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);
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`3
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`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;
`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 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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`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
`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
`
`
`4 Colland et al., US Patent No. 9,546,150 B2, issued Jan. 17, 2017 (Ex.
`1003, “the ’150 patent”).
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`243. 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 hetercycloalkyl 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
`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
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`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. 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
`’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
`
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`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
`piperidine amide in the compounds of 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:
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`Ground Basis
`
`Claims
`Challenged
`1–17
`
`1–17
`
`1
`
`2
`
`3
`
`1–15 and 17
`
`35 U.S.C. § 103(a) – obvious over the
`’150 patent
`35 U.S.C. § 112(a) – failure to comply
`with the enablement requirement
`35 U.S.C. § 112(a) – failure to comply
`with the written description requirement
`Petitioner submits the Declaration of Dr. Rémi Delansorne (Ex. 1004)
`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.
`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.
`
`
`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.”)
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`At this stage in the proceeding, Patent Owner does not challenge Petitioner’s
`definition. 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).
`Claim Construction
`G.
`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
`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;
`Prelim. Resp. 21–26. Accordingly, at this stage of the proceeding, we
`
`
`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.
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`determine that no explicit construction of any claim term is necessary to
`determine whether to institute a trial in 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’”).
`
`II. REAL PARTY IN INTEREST
`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.” The Petition identifies only Hybrigenics SA as a real party in
`interest (“RPI”). Pet. 1. Patent Owner contends that Petitioner should also
`have named as real parties in interest Servier Laboratories (“Servier”), a
`third party with whom Hybrigenics has collaborated on USP inhibitors, as
`well as Hybrigenics Corp. and Hybrigenics Pharma Inc., two U.S.
`subsidiaries of Hybrigenics. Prelim. Resp. 10–19. Patent Owner introduces
`various publicly available documents to support its position. We have
`reviewed Patent Owner’s assertions, as well as the evidence of record, and,
`for the reasons discussed below, we conclude that the present record does
`not support Patent Owner’s assertion that Servier, Hybrigenics Corp, and/or
`Hybrigenics Pharma Inc. should have been named as real parties in interest.
`“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
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`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,
`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 an RPI, “[t]he point is . . . to probe the extent to
`which [the non-party] has an interest in and will benefit from [the
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`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.
`Analysis of Servier Laboratories as a Potential
`A.
`Real Party in Interest
`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.” Prelim. Resp. 11. Patent
`Owner cites a number of publicly available press releases, corporate
`presentations and financial reports that collectively show that Hybrigenics
`collaborates with Servier on “DUB7 identification and validation, screening
`and profiling of development candidates in oncology, neurology, psychiatry,
`rheumatology, ophthalmology, diabetes and cardiovascular diseases.” See,
`Ex. 2006 at 25, 29; see also, Ex. 2009, 4. These sources also show that
`Hybrigenics collaborated with Servier to develop a ubiquitin specific
`protease and received a milestone payment of €1.5 million as a part of that
`collaboration. See, Ex. 2002, 1; see also, Ex. 2006, 3, 25; Ex. 2007, 3, 27;
`Ex. 2008, 1, 4, 6, and 20; and Ex. 2009, 4. The publicly available
`documents also show that Servier has taken responsibility for future
`development of the USP that is the subject of the Servier/Hybrigenics
`collaboration, and that Hybrigenics stands to receive an additional €12
`million if the USP achieves certain unidentified additional milestones. Id.
`
`
`7 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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`Patent Owner contends that this evidence shows that Servier “stands
`to benefit from Petitioner’s attempt to invalidate the ’491 patent through this
`Petition” because, “[i]f a jointly developed USP inhibitor product were
`found to infringe the ’491 patent, then Servier’s substantial investment in
`milestone payments and product development would be in jeopardy.”
`Prelim. Resp. 15.
`At this stage of the proceeding, and based on the current record, we
`are persuaded that Petitioner has carried its burden of complying with 35
`U.S.C. § 322 by identifying Hybrigenics SA as a real party in interest. The
`current record is not sufficient to support Patent Owner’s contention that
`Servier should have been named as a real party in interest. Patent Owner has
`not directed us to persuasive evidence suggesting that Servier controlled,
`directed, financed, or participated in any way in the filing of this Petition.
`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.’” Prelim. Resp. 15. While we
`acknowledge the evidence reflecting that “Servier will take charge of” a
`“R&D program” “focused on one USP especially relevant to oncology” (Ex.
`2002, 1), Patent Owner has not identified persuasive evidence suggesting
`that future control of an R&D program includes control over the present
`legal proceedings directed against a third party patent. Nor has Patent
`Owner directed us to evidence specifically identifying the USP inhibitor
`whose R&D program Servier controls, making it unclear to what extent
`Servier benefits from the filing of this Petition.
`Even if we were to assume that the ’491 patent would cover the USP
`that was the subject of the Servier/Hybrigenics collaboration, Patent
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`Owner’s contention that Servier is a real party in interest amounts to little
`more than an assertion that Servier had a preexisting, established
`relationship with Petitioner and is a beneficiary of the Petition. This is
`insufficient to establish that Servier should have been named as a real party
`in interest. See Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC,
`IPR2018-00883 (PTAB Nov. 27, 2018 (Public Version)) (Paper 36, 14–15)
`(“We agree with Petitioner that Patent Owner is overextending the reasoning
`of AIT [Applications in Internet Time]. The RPI analysis set out in AIT and
`the common law require more than simply confining the analysis to
`determining whether a party benefits generally from the filing of this
`Petition and also has a relationship with the Petitioner.”). If the sole
`requirement for being named a real party in interest were that a party might
`benefit from the filing of a petition, as suggested by Patent Owner, it would
`ensnare third parties, such as suppliers and contract research organizations,
`with no connection to the Petition.
` In sum, the current record does not tend to support that Servier
`exercised, or could have exercised, control over Petitioner’s participation in
`this proceeding. Nor does the current record tend to support that the Petition
`was filed at the behest of Servier or that Servier “desires review” of the ’491
`patent. Accordingly, based on the record before us at this stage of the
`proceeding, we do not find Petitioner’s identification of the real party in
`interest deficient for failing to identify Servier.
`Analysis of Hybrigenics Corp. and Hybrigenics Pharma Inc. as
`B.
`Potential Real Parties in Interest
`Patent Owner asserts that “Hybrigenics Corp. and/or Hybrigenics
`Pharma Inc., control U.S. activities of Petitioner.” Prelim. Resp. 15.
`According to Patent Owner, “[b]ecause Petitioner’s U.S. entities potentially
`
`15
`
`
`
`PGR2018-00098
`Patent 9,840,491 B2
`
`benefit from the Petition, it is also critical to ‘assure proper application of
`the statutory estoppel provisions’ to these entities with respect to Petitioner’s
`decision to file the Petition.” Id. at 15–16.
`Patent Owner cites a number of publicly available documents that
`show that Hybrigenics Corp. “is the American subsidiary of [Petitioner]”
`(Ex. 2001, 2), “represent[s 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.” Ex.
`2003, 1. The documents also show that Hybrigenics Pharma Inc., is a U.S.
`subsidiary of Petitioner. Ex. 2004, 2.
`Patent Owner argues that Hybrigenics’ U.S. subsidiaries should have
`been named as real parties in interest because they would hold the New Drug
`Application (“NDA”) should Hybrigenics seek to commercialize a drug
`product containing a USP inhibitor compound that infringes the ’491 patent.
`Prelim. Resp. 16–17. According to Patent Owner, Hybrigenics’ U.S.
`subsidiaries would thus have the ability to sell an infringing product. Id.
`The current record is not sufficient to support Patent Owner’s
`contention that Hybrigenics’ U.S. subsidiaries should have been named as
`real parties in interest. Patent Owner has not directed us to persuasive
`evidence suggesting that Hybrigenics’ U.S. subsidiaries controlled, directed,
`financed, or participated in any way in the filing of this Petition. Patent
`Owner’s contention that Hybrigenics’ U.S. subsidiaries are real parties in
`interest rests on little more than speculation that the subsidiaries would stand
`to benefit in the event that Hybrigenics seeks to commercialize a drug falling
`within the scope of the ’491 patent. For the reasons discussed in connection
`
`16
`
`
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`PGR2018-00098
`Patent 9,840,491 B2
`
`with Servier, mere status as a potential beneficiary of a Petition is not
`enough to establish an unnamed party as a real party in interest.
`The cases cited by Patent Owner, Cisco Sys., Inc. v. Hewlett Packard
`Enter. Co., IPR2017-01933, (PTAB Mar. 16, 2018) (Paper No. 9) and
`Amazon.com, Inc. v. Appistry, Inc., IPR2015-00480, at 4–6 (PTAB July 13,
`2015) (Paper 18) are not to the contrary. Prelim. Resp. 16. In Cisco, Cisco
`Systems, Inc. (“Cisco”) filed a request for inter partes review. One week
`before the request was filed, Cisco invested $34 million into another
`company, Springpath, and attained “board-level representation” at
`Springpath. Cisco, Paper 9, 14. The record showed that Springpath had
`been accused of infringement in district court litigation, but that none of
`Cisco’s products were accused of infringement. Id. at 15. After the request
`for inter partes review was filed, Cisco acquired Springpath as a wholly-
`owned subsidiary of Cisco. Id. Based on these facts, the Board determined
`that Springpath should have been named as a real party in interest because
`“Cisco [was] representing Springpath’s interest, rather than its own and,
`thus, . . . pursuing its Petition as a proxy for Springpath.” Id. at 14. Unlike
`the record in Cisco, the current record does not include evidence suggesting
`that Petitioner lacks an independent interest in these proceedings or that
`Petitioner was acting as a proxy for its U.S. subsidiaries.
`In Amazon, the evidence showed that “Petitioner AWS [was] a
`wholly-owned subsidiary of AWSHC, which in turn [was] a wholly-owned
`subsidiary of ADS, [which in turn was] a wholly-owned subsidiary of
`Petitioner Amazon.com.” Amazon, Paper 18, 5. The Petition named
`Amazon.com, the ultimate parent, and AWS, the ultimate subsidiary, as real
`parties in interest but failed to name the two intervening wholly owned
`
`17
`
`
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`PGR2018-00098
`Patent 9,840,491 B2
`
`subsidiaries, AWSC and ADS. Id. at 4. The Board accepted Patent Owner’s
`argument that the only way the ultimate parent, Amazon.com, could control
`its ultimate subsidiary, AWS, was by indirectly exercising its control over
`the two unnamed intervening subsidiaries. Id. at 4–6. The Board thus
`concluded that the intervening subsidiaries should have been identified as
`real parties in interest. Id. Unlike Amazon, the current record does not
`suggest that Hybrigenics’ unnamed subsidiaries were intermediaries through
`which a parent that had been identified as a real party in interest exercised
`control over a subsidiary that was also named as a real party in interest.
`III. WRITTEN DESCRIPTION
`Petitioner challenges written description on two bases. First,
`Petitioner argues that during prosecution, Patent Owner narrowed the genus
`of substituents recited in claim 1, and that this narrowing amendment is not
`supported by the Specification. Pet. 55–58. Second, Petitioner argues that
`the Specification does not disclose sufficient species to adequately describe
`the broad genus recited in claim 1, and in the claims depending therefrom.
`Id. at 58–59. Patent Owner contends that these arguments have already been
`considered by the Examiner and thus we should exercise our discretion
`under 35 U.S.C. § 325(d) to deny institution on this ground. Prelim. Resp.
`40–43. Patent Owner also disputes that the claims are not supported by the
`Specification. Id. at 51–56. We have reviewed Petitioner’s and Patent
`Owner’s assertions, as well as the evidence of record, and, for the reasons
`discussed below, we decline to exercise our discretion under 35 U.S.C.
`§ 325(d) and conclude that Petitioner has demonstrated it is more likely than
`not that at least 1 of claims 1–15 and 17 do not comply with the written
`description requirement.
`
`18
`
`
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`PGR2018-00098
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`
`35 U.S.C. § 325(d)
`A.
`We have discretion to deny review when “the same or substantially
`the same prior art or arguments previously were presented to the Office.”
`35 C.F.R. § 325(d). When evaluating whether the same or substantially the
`same prior art or arguments were previously presented to the Office under
`§ 325(d), the Board has considered a number of non-exclusive factors,
`including, for example: (1) the similarity of the assert
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