Trials@uspto.gov Paper No. 7
`571.272.7822
`
` Filed: June 13, 2018
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.,
`Petitioner,
`
`v.
`
`GILEAD PHARMASSET LLC,
`Patent Owner.
`____________
`
`IPR2018-00123
`Patent 8,735,372 B2
`____________
`
`
`
`Before LORA M. GREEN, GRACE KARAFFA OBERMANN, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`DERRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
` Filed: June 13, 2018
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.,
`Petitioner,
`
`v.
`
`GILEAD PHARMASSET LLC,
`Patent Owner.
`____________
`
`IPR2018-00123
`Patent 8,735,372 B2
`____________
`
`
`
`Before LORA M. GREEN, GRACE KARAFFA OBERMANN, and
`WESLEY B. DERRICK, Administrative Patent Judges.
`
`DERRICK, Administrative Patent Judge.
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00123
`Patent 8,735,372 B2
`
`
`I. INTRODUCTION
`Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
`(“Petitioner”) requests an inter partes review of claims 1 and 2 of
`U.S. Patent No. 8,735,372 B2 (“the ’372 patent”). Paper 2 (“Pet.”). Gilead
`Pharmasset LLC (“Patent Owner”) filed a Preliminary Response. Paper 6
`(“Prelim. Resp.”).
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an
`inter partes review “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). Applying that standard, for the reasons
`set forth below, we decline to institute an inter partes review because the
`Petitioner has not shown a reasonable likelihood that it would prevail in
`establishing the unpatentability of any challenged claim.
`
`
`
`
`II. BACKGROUND
`A. Related Proceedings
`The parties identify identifies additional petitions filed by Petitioner
`for inter partes review of other patents owned by Patent Owner: IPR2018-
`00103 for review of U.S. Patent No. 7,429,572 B2; IPR2018-00119 and
`IPR2018-00120 for review of U.S. Patent No. 7,964,580 B2; IPR2018-
`00121 and IPR2018-00122 for U.S. Patent No. 8,334,270 B2; IPR2018-
`00125 for review of U.S. Patent No. 8,633,309 B2; and IPR2018-00126 for
`review of U.S. Patent No. 9,284,342 B2. Pet. 2, Paper 4, 2–3.
`
`2
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`IPR2018-00123
`Patent 8,735,372 B2
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`
`B. The ’372 Patent (Ex. 1001)
`The ’372 patent is directed to a method of treating a human infected
`by hepatitis C virus comprising administering both an NS5a inhibitor and a
`prodrug of a nucleoside derivative. Ex. 1001 Abstract.
`Claims 1 and 2 are reproduced below.
`
`A method of treating a human infected by hepatitis C
`1.
`virus, comprising administering to the subject an effective
`amount of an NS5a inhibitor and an effective amount of a
`compound represented by the following formula:
`
`
`
`
`wherein
`R1 is hydrogen, methyl, ethyl, n-propyl, i-propyl, or a
`substituted or unsubstituted phenyl, where the
`substitutent [sic] of the substituted phenyl is at least one
`of a CH3, OCH3, F, Cl, Br, I, nitro, cyano, and a CH3-qXq,
`where X is F, Cl, Br, or I, and q is 1-3;
`R2 is hydrogen or CH3;
`R3a is H and R3b is H, CH3, CH(CH3)2 , CH2CH(CH3)2,
`CH(CH3)CH2CH3, CH2Ph, CH2 -indol-3-yl,
`–CH2CH2SCH3, CH2CO2H, CH2C(O)NH2,
`CH2CH2COOH, CH2CH2C(O)NH2,
`CH2CH2CH2CH2NH2, —CH2CH2CH2NHC(NH)NH2,
`CH2-imidazol-4-yl, CH2OH, CH(OH)CH3, CH2((4'-
`OH)-Ph), CH2SH, or lower cycloalkyl, or
`
`3
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`IPR2018-00123
`Patent 8,735,372 B2
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`
`R3a is CH3, CH(CH3)2, CH2CH(CH3)2 , CH(CH3)CH2CH3,
`CH2Ph, CH2 -indol-3-yl, —CH2CH2SCH3, CH2CO2H,
`CH2C(O)NH2 , CH2CH2COOH, CH2CH2C(O)NH2,
`CH2CH2CH2CH2NH2, -CH2CH2CH2NHC(NH)NH2,
`CH2-imidazol-4-yl, CH2OH, CH(OH)CH3, CH2(( 4'-
`OH)-Ph), CH2SH, or lower cycloalkyl and R3b is H;
`R4 is hydrogen, CH3, Et, iPr, nPr, nBu, 2-butyl, tBu, benzyl,
`cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, N-
`methyl-aziridin-2-yl, N-methyl-azetidin-3-yl, N-methyl-
`pyrrolidin-3-yl, N-methyl-pyrrolidin-4-yl, N-methyl-
`piperidin-4-yl, lower haloalkyl, or di(lower alkyl)amino-
`lower alkyl; and
`R7 and R8 are independently H, F, Cl, Br, I, OH, OCH3, SH,
`SCH3, NH2, NHCH3, N(CH3)2, CH3, CH3-qXq, where X is
`F, Cl, Br, or I and q is 1 to 3, vinyl, CO2H, CO2CH3,
`CONH2, CONHCH3, or CON(CH3)2, wherein R' is a C1-20
`alkyl; a C1-20 cycloalkyl; a C2-C6 alkenyl, a C2-C6
`alkynyl.
`
`The method of claim 1, wherein the compound is
`
`2.
`
`
`
` Ex. 1001, 629:64–632:20.
`Claim 2 sets forth a specific compound (i.e., sofosbuvir) for
`administration with an NS5a inhibitor, whereas claim 1 sets forth by
`formula and possible substituents a genus of compounds for
`
`
`
`4
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`IPR2018-00123
`Patent 8,735,372 B2
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`administration with an NS5a inhibitor. Pet. 36–38; Prelim. Resp. 4–5.
`The structure of sofosbuvir, as annotated by Patent Owner, is depicted
`below:
`
`
`
`Prelim. Resp. 4–5. The figure depicts the chemical structure of sofosbuvir
`with stereochemistry and identifies the compound’s phosphoroamidate
`prodrug moiety, modified sugar, and natural uracil base. Id.
`C. The Asserted Ground of Unpatentability
`Petitioner asserts that claims 1 and 2 of the ’372 patent are
`unpatentable based on the following ground. Pet. 3.
`
`References
`Sofia,1 Congiatu,2 and
`Serrano-Wu3
`
`Statutory Basis
`
`§ 103
`
`
`1 Sofia et al., Poster #P-259, presented at the 14th Int’l Symposium on
`Hepatitis C Virus and Related Viruses, Glasgow, Scotland, UK, Sept. 9–13,
`2007 (Ex. 1012).
`2 Congiatu et al., 49 J. MED. CHEM. 452–455 (2006) (Ex. 1011).
`3 Serrano-Wu et al., US 2006/0276511 A1, published December 7, 2006
`(Ex. 1013).
`
`5
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`IPR2018-00123
`Patent 8,735,372 B2
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`
`Petitioner supports the Petition with the testimony of Joseph M.
`Fortunak, Ph.D. (Ex. 1002).
`
`
`III. ANALYSIS
`A. Level of Ordinary Skill in the Art
`Petitioner contends that a person of ordinary skill in the art would
`have held either
`(1) a Ph.D. in chemistry or a closely related field with some
`experience in an academic or industrial laboratory focusing on
`drug discovery or development, and would also have some
`familiarity with antiviral drugs and their design and mechanism
`of action, or
`(2) a Bachelor’s or Master’s degree in chemistry or a closely
`related field with significant experience in an academic or
`industrial laboratory focusing on drug discovery and/or
`development for the treatment of viral diseases.
`Pet. 5–6 (citing Ex. 1002 ¶ 33).
`Patent Owner does not expressly contest the level of ordinary skill.
`See generally Prelim. Resp.
`On this record, we adopt Petitioner’s essentially uncontested
`definition of the level of ordinary skill. We further note that the prior art
`itself demonstrates the level of skill in the art at the time of the invention.
`See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining
`that “specific findings on the level of skill in the art . . . [are not required]
`‘where the prior art itself reflects an appropriate level and a need for
`
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`testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State
`Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
`B. Claim Construction
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to their broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings). Under that standard, we interpret claim terms
`using “the broadest reasonable meaning of the words in their ordinary usage
`as they would be understood by one of ordinary skill in the art, taking into
`account whatever enlightenment by way of definitions or otherwise that may
`be afforded by the written description contained in the applicant’s
`specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “Under
`a broadest reasonable interpretation, words of the claim must be given their
`plain meaning, unless such meaning is inconsistent with the specification
`and prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062
`(Fed. Cir. 2016). If an inventor acts as his or her own lexicographer, the
`definition must be set forth with reasonable clarity, deliberateness, and
`precision. Renishaw PLC v. Marposs Societa′ per Azioni, 158 F.3d 1243,
`1249 (Fed. Cir. 1998). Only those terms which are in controversy need to be
`construed and only to the extent necessary to resolve the controversy. See
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013,
`1017 (Fed. Cir. 2017).
`Petitioner contends that “there is no reason to give any of the terms of
`the claims of the ‘372 [patent] a meaning other than their ordinary and
`
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`accustomed meaning.” Pet. 6. Patent Owner does not contest that the claim
`terms should be given their ordinary and accustomed meaning. See
`generally Prelim. Resp. We determine that no claim term requires express
`construction for the purpose of determining whether to institute review.
`C. Prior Art Status
`Under 35 U.S.C. § 311(b), in an inter partes review, a petitioner may
`only challenge the claims of a patent based on “prior art consisting of patents
`or printed publications,” and the petitioner has the initial burden of
`producing evidence to support a conclusion of unpatentability under § 102 or
`§ 103, including that an asserted reference is a printed publication. At this
`stage of the proceeding, Petitioner must establish that there is a reasonable
`likelihood that it will prevail with respect to at least one of the claims
`challenged. 35 U.S.C. § 314(a).
`“Public accessibility” is the touchstone in determining whether a
`reference is a “printed publication.” In re Hall, 781 F.2d 897, 898–99 (Fed.
`Cir. 1986). “Indeed, the key inquiry is whether or not a reference has been
`made ‘publicly accessible.’” In re Klopfenstein, 380 F.3d 1345, 1348 (Fed.
`Cir. 2004). As stated by our reviewing court, “the reference must have been
`sufficiently accessible to the public interested in the art; dissemination and
`public accessibility are the keys to whether a prior art reference was
`‘published.’” In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989) (quoted
`with approval in Klopfenstein, 380 F.3d at 1348).
`“The determination of whether a reference is a ‘printed publication’
`under 35 U.S.C. § 102[] involves a case-by-case inquiry into the facts and
`circumstances surrounding the reference’s disclosure to members of the
`public.” Klopfenstein, 380 F.3d at 1350 (citing Cronyn, 890 F.2d at 1161;
`
`8
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`Hall, 781 F.2d at 899); see also Blue Calypso, LLC v. Groupon, Inc., 815
`F.3d 1331, 1348 (Fed. Cir. 2016) (“Whether a reference qualifies as a
`printed publication is a legal conclusion based on underlying factual
`determinations.”); Voter Verified, Inc. v. Premier Election Sols., Inc., 698
`F.3d 1374, 1380 (Fed. Cir. 2012) (“Public accessibility is a legal conclusion
`based on underlying factual determinations.”). Limited distribution, even to
`those skilled in the art, may not amount to “publication” under the statute
`unless the material is otherwise so situated that “anyone who chooses may
`avail himself of the information it contains.” In re Bayer, 568 F.2d 1357,
`1360, 1362 (CCPA 1978) (quoting 1 W. Robinson, The Law of Patents 327
`at 448 (1890)).
`Petitioner fails to present an adequate basis for the Sofia poster being
`sufficiently accessible to the public interested in the art to be considered a
`“printed publication.” Petitioner contends that “Sofia is prior art under
`35 U.S.C. § 102(a) to the ‘372 patent because it was published by
`September 13, 2007” (Pet. 31) and, similarly, that “the September 2007
`publication of Sofia makes it prior art under [§] 102(a)” (id. at 32).
`Petitioner also contends that “Sofia . . . Poster #P-259, [was] presented at the
`14th International Symposium on Hepatitis C Virus and Related Viruses,
`Glasgow, Scotland, UK, Sep. 9-13, 2007.” Id. at 30 (citing Ex. 1012); see
`also Ex. 1002 ¶ 83 (repeating Petitioner’s contention verbatim). The Sofia
`poster (Exhibit 1012) states, inter alia, “[p]resented at the 14th International
`Symposium on Hepatitis C Virus and Related Viruses, Glasgow, Scotland,
`UK, September 9-13, 2007.” Dr. Fortunak states that he “understand[s] that
`prior art for the ‘372 patent’s claims is anything before March 21, 2008.”
`Exhibit 1002 ¶ 85.
`
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`
`Petitioner’s relevant contentions and showing, detailed above in full,
`include no evidence indicating that Sofia was published in print or electronic
`form, but only that it was presented as a poster. As to its presentation as a
`poster at the symposium, Petitioner provides nothing further as to, for
`example, how long it was posted, whether it was sufficiently publicized to,
`or placed in front of a sufficient number of, those interested in the subject
`matter, or as to the freedom of those viewing the poster to take notes or to
`copy the poster. See generally Pet.; Ex. 1002, Ex. 1012. Petitioner, thus,
`fails to provide a sufficient showing as to the “facts and circumstances
`surrounding the reference’s disclosure to members of the public” necessary
`to identify it as a “printed publication.” Klopfenstein, 380 F.3d at 1350–51;
`see also Blue Calypso, 815 F.3d at 1348–50; Voter Verified, 698 F.3d at
`1380–81; Cronyn, 890 F.2d at 1160–61; Hall, 781 F.2d at 898–99; Bayer,
`568 F.2d at 1360–62.
`We accord little weight to Dr. Fortunak’s statement that he
`“understand[s] that prior art for the ‘372 patent’s claims is anything before
`March 21, 2008” (Ex. 1002 ¶ 85), because it is a legal opinion inapposite to,
`and lacking a factual basis as to, the relevant issue, that is, whether the Sofia
`poster is, in particular, a patent or printed publication, on which inter partes
`review can be instituted (35 U.S.C. § 311(b)). Cf. Brooke Group Ltd. v.
`Brown & Williamson Tobacco Corp., 509 U.S. 209, 242 (1993) (“When an
`expert opinion is not supported by sufficient facts to validate it in the eyes of
`the law, . . . it cannot support a jury’s verdict.”); Integra Lifesciences I, Ltd.
`v. Merck KGaA, 496 F.3d 1334, 1342 (Fed. Cir. 2007) (holding that “when
`an expert witness’ statement of the law is incorrect, that view of the law
`cannot be relied upon to support the verdict.”). As discussed above, the
`
`10
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`IPR2018-00123
`Patent 8,735,372 B2
`
`issue is not merely whether Sofia was earlier in time than March 21, 2008,
`but rather, whether it was a printed publication. Dr. Fortunak’s expressed
`opinion grounded on a contrary understanding fails to bear the weight
`required of Petitioner’s showing.
`D. Alleged Unpatentability of Claims
`Petitioner contends that claims 1 and 2 are unpatentable as obvious
`over the combination of Sofia, Congiatu, and Serrano-Wu, identified as prior
`art by Petitioner. Pet. 31–46. The unavailability of Sofia undermines
`Petitioner’s obviousness ground, which relies on Sofia alone as to the
`nucleoside portion of the claimed pro-drug. Id.
`Petitioner thus fails to bear the burden required to support institution
`of inter partes review. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356,
`1363 (Fed. Cir. 2016) (“In an [inter partes review], the petitioner has the
`burden from the onset to show with particularity why the patent it challenges
`is unpatentable.”). Petitioner should not expect the Board to search the
`record to piece together what may support a challenge. See 37 C.F.R.
`§ 42.22(a)(2) (a petition must include “[a] full statement of the reasons for
`the relief requested”); DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th
`Cir. 1999) (“A brief must make all arguments accessible to the judges, rather
`than ask them to play archaeologist with the record.”); cf. In re Magnum Oil
`Tools Int’l, Ltd., 829 F.3d 1364, 1380–81 (Fed. Cir. 2016) (rejecting an
`argument that the Board properly “ma[de] an obviousness argument on
`behalf of [petitioner]” that “could have been included in a properly drafted
`petition,” because “petitioner . . . bears the burden of proof”).
`
`11
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`IPR2018-00123
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`Accordingly, we are not persuaded that Petitioner establishes a
`reasonable likelihood of prevailing in showing that the subject matter of any
`challenged claim is unpatentable over Sofia, Congiatu, and Serrano-Wu.
`
`
`IV. CONCLUSION
`Petitioner has not established a reasonable likelihood of prevailing on
`its assertion that claims 1 and 2 are unpatentable.
`
`
`V. ORDER
`For the reasons given, it is:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’372 patent and no trial is instituted.
`
`
`
`12
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`IPR2018-00123
`Patent 8,735,372 B2
`
`PETITIONER:
`Daniel B. Ravicher
`Ravicher Law Firm PLLC
`dan@ravicher.com
`
`
`PATENT OWNER:
`Dorothy P. Whelan
`Michael J. Kane
`W. Chad Shear
`FISH & RICHARDSON P.C.
`whelan@fr.com
`kane@fr.com
`shear@fr.com
`
`David L. Cavanaugh
`Emily R. Whelan
`WILMER HALE
`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
`
`
`
`
`
`13
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`
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