Trials@uspto.gov Paper No. 7
`571.272.7822
`
` Filed: May 4, 2018
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`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.
`____________
`
`IPR2018-00119
`Patent 7,964,580 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: May 4, 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.
`____________
`
`IPR2018-00119
`Patent 7,964,580 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)
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00119
`Patent 7,964,580 B2
`
`
`I. INTRODUCTION
`Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
`(“Petitioner”) requests an inter partes review of claims 1–14 of U.S. Patent
`7,964,580 B2 (Ex. 1001, “the ’580 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 a concurrently-filed, second petition for inter
`partes review of the ’580 patent, IPR2018-00120. Pet., 2; Paper 4, 3. Patent
`Owner also identifies additional petitions filed by Petitioner for inter partes
`review of other patents owned by Patent Owner: IPR2018-00121 and
`IPR2018-00122 for U.S. Patent No. 8,334,270 B2; IPR2018-00103 for U.S.
`Patent No. 7,429,572 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. Paper 4, 3.
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`Patent 7,964,580 B2
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`B. The ’580 Patent (Ex. 1001)
`The ’580 patent is directed to, inter alia, a phosphoramidate prodrug
`of a nucleoside derivative for treatment of viral infections in mammals, its
`ester, or a stereoisomer thereof. Ex. 1001, Abstract, 493:42–45. The ’580
`patent also addresses methods of treatment, uses, and processes for
`preparing such compounds. Id., Abstract.
`By way of a certificate of correction (Ex. 3001), the ’580 patent
`claims the benefit of priority of two earlier-filed provisional applications,
`60/909,315 filed on March 30, 2007 (Ex. 2013), and 60/982,309 filed on
`October 24, 2007 (Ex. 2014), (respectively, “the ’315 provisional” and “the
`’309 provisional”). 1
`C. Illustrative Claims
`Independent claims 1 and 8—reproduced below—are illustrative of
`the claimed subject matter.
`
`(S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-
`1.
`pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydro-furan-
`2-ylmethoxy]-phenoxy-phosphorylamino}-propionic acid
`isopropyl ester or a stereoisomer thereof.
`8.
`(S)-isopropyl 2-(((S)-(2R,3R,4R, 5R)-5-(2,4-dioxo-3,4-
`dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-meth-
`yltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)
`amino)propanoate.
` Ex. 1001, 493:42–45, 495:27–30.
`Claim 8 is directed to the Sp stereoisomer (i.e., sofosbuvir),
`whereas claim 1 covers the Sp stereoisomer, the Rp stereoisomer, and
`
`1 Petitioner does not contest that the ’580 patent claims the benefit of priority
`to both the ’315 provisional and the ’309 provisional (Pet. 5), but rather, as
`discussed below, contests that the ’580 patent is entitled to the claimed
`benefit of priority to the ’315 provisional (id. at 23, 25).
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`IPR2018-00119
`Patent 7,964,580 B2
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`mixtures of the two. Prelim. Resp. 3–4, 12; see also Pet. 28–29. The
`structure of sofosbuvir, as annotated by Patent Owner, is depicted
`below:
`
`
`Prelim. Resp. 4. 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.
`D. The Asserted Grounds of Unpatentability
`Petitioner asserts that claims 1–14 of the ’580 patent are unpatentable
`based on the following grounds. Pet. 3.
`
`
`References
`Sofia2
`Sofia and Perrone3
`Ma4 and Perrone
`
`Statutory Basis
`§ 102
`§ 103
`§ 103
`
`
`
`2 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. 1004).
`3 Perrone et al., 50 J. MED. CHEM. 1840–1849 (2007) (Ex. 1008).
`4 Ma et al., 282 J. BIOL. CHEM. 29812–29820 (2007) (Ex. 1005).
`
`4
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`IPR2018-00119
`Patent 7,964,580 B2
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`Petitioner supports the Petition with the testimony of Joseph M.
`Fortunak, Ph.D. (Ex. 1002). Based on Dr. Fortunak’s statement of
`qualifications (id. ¶¶ 1–20) and curriculum vitae (Ex. 1003), on this record,
`we determine that he is qualified to opine from the perspective of a person of
`ordinary skill in the art.
`
`
`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 ¶ 35).
`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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`Patent 7,964,580 B2
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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).
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`Petitioner contends that “there is no reason to give any of the terms of
`the claims of the ‘580 [patent] a meaning other than their ordinary and
`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 prior art to the challenged
`claims under a relevant subsection of § 102. “To satisfy its burden of
`proving obviousness, a petitioner cannot employ mere conclusory
`statements. The petitioner must instead articulate specific reasoning, based
`on evidence of record, to support the legal conclusion of obviousness.” In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016).
`Petitioner contends that Sofia and Ma are both prior art because
`the ’315 provisional does not describe the specific compounds claimed by
`the ’580 patent in that “it does not discuss the specific compounds and
`stereochemistry around the phosphorous atom claimed.” Pet. 23, 25;
`Ex. 1002 ¶ 73. The relied on declaration testimony, reproduced below in
`full, states:
`The ‘315 provisional application does not include a description
`of the specific compounds claimed by the ‘580 patent. While
`the ‘315 provisional discusses broad genera of compounds, it
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`IPR2018-00119
`Patent 7,964,580 B2
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`does not discuss the specific compounds and stereochemistry
`around the phosphorous atom claimed in the ‘580 patent.
`Ex. 1002 ¶ 73.
`Patent Owner contends the ’580 patent is entitled to the benefit of
`priority of the ’315 provisional, and that Petitioner fails to meet its burden of
`producing evidence that the ’580 patent is not entitled to its earliest priority
`date. Prelim. Resp. 15. Patent Owner contends that “neither [Petitioner] nor
`its expert has presented a legitimate priority analysis.” Id.
`Citing specific disclosure from the ’315 provisional, Patent Owner
`offers a detailed explanation how the ’315 provisional supports Patent
`Owner’s contention that the claims of the ’580 patent are entitled to the
`priority benefit of the ’315 provisional. Id. at 16–20. Patent Owner
`addresses chemical structure, stereochemistry, and synthesis. Id.
`Patent Owner relies on the ’315 provisional’s disclosure of IX-25-2
`(Ex. 2013, 195), a compound according to Structure IX (id. at 187), in which
`particular constituents in Structure IX, i.e., R1, R2, R3a, R3b, R4, R5, R6, X, Y,
`R7, and R8, are specified in Table IX-25 (id. at 195). Patent Owner
`reproduces Structure IX and Table IX-25 (with emphasis), as depicted
`below:
`
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`Prelim. Resp. 17–18; see also Ex. 2013, 87 (Structure IX), 195 (Table IX-
`25). Structure IX itself discloses the stereochemistry for most of the
`structure, but does not depict the stereochemistry at the potentially chiral
`centers at the carbon substituted with R3a and R3b and at the phosphorus (P).
`Patent Owner directs us to disclosure in the ’315 provisional that
`identifies both chiral configurations at the potentially chiral centers at both
`the carbon substituted with R3a and R3b and at the phosphorus (P) for each
`compound, including IX-25-2. Prelim Resp. 18–20 (citing Ex. 2013, 63–
`64). In particular, as to the carbon center, the compounds disclosed by
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`IPR2018-00119
`Patent 7,964,580 B2
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`reference to the depicted structures, including Structure IX, and the tables,
`including Table IX-25, include those in which “R3a projects towards the
`viewer while R3b projects away from the viewer” and those in which “R3a
`projects away from the viewer while R3b projects towards the viewer.” Id. at
`18–19 (emphasis omitted) (citing Ex. 2013, 63). And, as to the phosphorus
`(P), the compounds disclosed include those in which “the oxo-substituent
`projects towards the viewer while the OR1 substituent projects away from
`the viewer, and vice versa.” Id. at 19–20 (citing Ex. 2013, 63–64).
`In sum, the cited disclosure identifies compounds according to
`IX-25-2 that include both stereochemical orientations at the carbon bearing
`the specified R3a and R3b constituents, both stereochemical orientations at the
`phosphorous, and stereochemical orientations elsewhere that are identical to
`those of sofosbuvir. Thus, the cited portions of the ’315 provisional
`constitute disclosure of the Sp stereoisomer (sofosbuvir), as well as the
`stereoisomers having the opposite stereochemical orientation at either (or
`both) the carbon bearing R3a and R3b constituents and the phosphorous.
`Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996) (It is well
`settled that “ipsis verbis disclosure is not necessary to satisfy the written
`description requirement of section 112.”); see also In re Ruschig, 379 F.2d
`990, 994–95 (CCPA 1967) (Analogizing the direction sufficient to identify
`species in a genus as “blaze marks which single out particular trees.”).
`In the face of the ’315 provisional’s disclosure of particular
`compounds according to the claims, we agree with Patent Owner that
`Petitioner fails to sufficiently demonstrate that the ’580 patent is not entitled
`to the priority benefit of the ’315 provisional. We accord little weight to Dr.
`Fortunak’s testimony, because Dr. Fortunak does not identify factual support
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`IPR2018-00119
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`for his opinion and he fails to address portions of the ’315 provisional
`contrary to his position. See Ashland Oil, Inc. v. Delta Resins &
`Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual
`support for expert opinion going to factual determinations” is sufficient to
`“render the testimony of little probative value in a validity determination.”).
`Thus, there is no sound basis for Petitioner’s contentions that Sofia is prior
`art “because it was published by September 13, 2007” (Pet. 23), and that Ma
`is prior art “because it was published on October 12, 2007 (id. at 25).
`D. Alleged Unpatentability of the Challenged Claims
`1. Anticipation by Sofia
`Petitioner asserts that claims 1–14 are anticipated by Sofia. Pet. 28–
`34. The unavailability of Sofia as prior art undermines Petitioner’s
`anticipation ground. Accordingly, we are not persuaded that Petitioner
`establishes a reasonable likelihood of prevailing in showing that the subject
`matter of claims 1–14 is unpatentable over Sofia.
`2. Obviousness over Sofia and Perrone
`Petitioner contends that claims 1–14 are unpatentable as obvious over
`the combination of Sofia and Perrone. Id. at 34–47. The unavailability of
`Sofia undermines Petitioner’s obviousness ground, which relies on Sofia as
`to the nucleoside portion of the claimed prodrug, that is, “the uridine analog
`‘(2’R)-2’-deoxy-2’-fluoro-2’-C-methyluridine.’” Id. at 35. Perrone, relied
`on as to the phosphoramidate portion of the prodrug (id. at 39–43), uses a
`different uridine analog, 4′-azidouridine (Ex. 1008). Accordingly, we are
`not persuaded that Petitioner establishes a reasonable likelihood of
`prevailing in showing that the subject matter of claims 1–14 is unpatentable
`over Sofia and Perrone.
`
`11
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`IPR2018-00119
`Patent 7,964,580 B2
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`3. Obviousness over Ma and Perrone
`Petitioner contends that claims 1–14 are unpatentable as obvious over
`the combination of Ma and Perrone. Pet. 47–59. The unavailability of Ma
`undermines Petitioner’s obviousness ground, which relies on Ma alone as to
`the nucleoside portion of the claimed pro-drug, and on Perrone as to the
`phosphoramidate portion of the prodrug. Id. 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
`Ma and Perrone.
`
`
`IV. CONCLUSION
`Petitioner has not established a reasonable likelihood of prevailing on
`its assertion that claims 1–14 are unpatentable.
`
`
`V. ORDER
`For the reasons given, it is:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’580 patent and no trial is instituted.
`
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`IPR2018-00119
`Patent 7,964,580 B2
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`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
`
`
`
`
`
`
`
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`13
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