Trials@uspto.gov Paper No. 10
`571.272.7822
`
` Filed: May 21, 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.
`____________
`
`IPR2018-00121
`Patent 8,334,270 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 21, 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.
`____________
`
`IPR2018-00121
`Patent 8,334,270 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)
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00121
`Patent 8,334,270 B2
`
`
`I. INTRODUCTION
`Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
`(“Petitioner”) requests an inter partes review of claims 1, 2, 10–18, and 20–
`25 of U.S. Patent 8,334,270 B2 (Ex. 1001, “the ’270 patent”). Paper 2
`(“Pet.”). Gilead Pharmasset LLC (“Patent Owner”) filed a Preliminary
`Response. Paper 9 (“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 ’270 patent, IPR2018-00122. Pet., 2; Paper 4, 3. Patent
`Owner also identifies additional petitions for inter partes review of
`additional patents: IPR2018-00119 and IPR2018-00120 for U.S. Patent No.
`7,964,580 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.
`
`2
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`IPR2018-00121
`Patent 8,334,270 B2
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`
`B. The ’270 Patent (Ex. 1001)
`The ’270 patent is directed to, inter alia, phosphoramidate prodrugs of
`a nucleoside derivative for treatment of viral infections in mammals, its
`ester, or a stereoisomer thereof. Ex. 1001, Abstract. The ’270 patent also
`addresses methods of treatment, uses, and processes for preparing such
`compounds. Id. The ’270 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 application” and “the ’309 application.” Ex. 1001,
`1:4–9.
`C. Illustrative Claims
`Independent claims 1 and 16, each reciting a number of different
`phosphoramidate nucleoside derivatives, are reproduced below in part:
`
`A compound selected from among
`
`1.
`. . .
`(S)-isopropyl 2-(((S)-(2R,3R,4R, 5R)-5-(2,4-dioxo-3,4-
`dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyl[-]
`tetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)
`amino)propanoate . . . .
`
`16. A compound or its stereoisomer thereof selected from
`among
`. . .
`(S)-2-{[(2R,3R,4R,5R)-5-(2,4-Dioxo-3,4-dihydro-2H-
`pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahy-dro-
`furan-2-ylmethoxy]-phenoxy-phosphorylamino}-propionic acid
`isopropyl ester . . . .
`Ex. 1001, 605:35, 52–55, 607:58–59, 608:58–61.
`
`3
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`IPR2018-00121
`Patent 8,334,270 B2
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`
`The compound set forth by name in the reproduced portion of
`claim 1 above is the Sp stereoisomer of a phosphoramidate nucleoside
`derivative, known as sofosbuvir, which structure is depicted below:
`
`
`
`Prelim. Resp. 3–4. The figure depicts the chemical structure of sofosbuvir
`with stereochemistry and identifies the compound’s phosphoramidate
`prodrug moiety, modified sugar, and natural uracil base. Id. at 4. Claim 16
`likewise, in setting forth a compound or stereoisomer of compounds
`identified by name, including that reproduced above, encompasses the Sp
`stereoisomer, the Rp stereoisomer, and mixtures of the two. Id. at 3–4, 12;
`see also Pet. 28–29.
`D. The Asserted Grounds of Unpatentability
`Petitioner contends that “[e]ach and every feature of claims 1, 2, 10-
`18 and 20-25 can be found in the prior art reference[s] identified below.”1
`
`
`1 Although Petitioner contends “[e]ach and every feature . . . can be found”
`in the cited references (Pet. 27), the analysis that follows of “exemplary
`disclosure of the cited references” (id.) is effectively limited to consideration
`of a single compound—the 5′-phosphate (phosphoramidate) prodrug of the
`uridine analog (2′R)-2′-deoxy-2′-fluoro-2′-C-methyluridine, wherein the
`
`4
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`IPR2018-00121
`Patent 8,334,270 B2
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`Pet. 27 (citing Ex. 1002 ¶ 92). More particularly, Petitioner asserts that
`claims 1, 2, 10–18, and 20–25 are unpatentable based on each of the
`following grounds. Pet. 3, see also id. at 27–55.
`
`
`References
`Sofia2
`Sofia and Perrone3
`Ma4 and Perrone
`
`
`
`Statutory Basis
`§ 102
`§ 103
`§ 103
`
`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 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
`
`
`5′-phosphate group is the (phenyl)(isopropyl-L-alaninyl)phosphate group (id.
`at 27–55).
`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).
`
`5
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`IPR2018-00121
`Patent 8,334,270 B2
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`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
`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 occur. 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
`
`6
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`Patent 8,334,270 B2
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`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 term 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 ‘270 [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
`
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`Patent 8,334,270 B2
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`statements. The petitioner must instead articulate specific reasoning, based
`on evidence of record, to support the legal conclusion of obviousness.” In re
`Magnum 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 application does not describe the specific compounds claimed by the
`’270 patent in that “it does not discuss the specific compounds and
`stereochemistry around the phosphorous atom claimed.” Pet. 22; see also id.
`at 24; Ex. 1002 ¶ 72. The relied on declaration evidence, reproduced below
`in full, states:
`The ‘315 provisional application does not include a description
`of the specific compounds claimed by the ‘270 patent. While
`the ‘315 provisional discusses broad genera of compounds, it
`does not discuss the specific compounds and stereochemistry
`around the phosphorous atom claimed in the ‘270 patent.
`Ex. 1002 ¶ 72.
`Patent Owner contends the ’270 patent is entitled to the benefit of
`priority of the ’315 provisional, and that Petitioner wholly fails to meet its
`burden of producing evidence that the ’270 patent is not entitled to its
`earliest priority date.5 Prelim. Resp. 14–15. Patent Owner contends that
`“neither [Petitioner] nor its expert has presented a legitimate priority
`analysis.” Id. at 14.
`As to the 5′-phosphate (phosphoramidate) prodrug of the uridine
`analog (2′R)-2′-deoxy-2′-fluoro-2′-C-methyluridine, wherein the
`5′-phosphate group is the (phenyl)(isopropyl-L-alaninyl)phosphate group,
`
`
`5 Patent Owner “also submits that the Petition should be stayed pending
`disposition of the Oil States appeal” before the Supreme Court relating to the
`constitutionality of IPR proceedings. Prelim. Resp. 37–38. The request is
`moot, however, in light of our decision denying institution.
`
`8
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`IPR2018-00121
`Patent 8,334,270 B2
`
`the focus of Petitioner’s anticipation and obviousness analysis (Pet. at 27–
`55), Patent Owner offers a detailed explanation addressing chemical
`structure, stereochemistry, and synthesis (Prelim. Resp. 15–19).
`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:
`
`
`
`
`
`9
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`IPR2018-00121
`Patent 8,334,270 B2
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`
`Prelim. Resp. at 16–17; 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 as 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. 17–18 (citing Ex. 2013, 63–
`64). In particular, as to the carbon center, the compounds disclosed by
`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
`17–18 (emphasis omitted) (citing Ex. 2013, 63). And, as to the phosphorus
`(P), the compounds disclosed includes those in which “the oxo-substituent
`projects towards the viewer while the OR1 substituent projects away from
`the viewer, and vice versa.” Id. at 18 (citing Ex. 2013, 63–64).
`In sum, the cited disclosure discloses 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. As such, 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
`
`10
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`IPR2018-00121
`Patent 8,334,270 B2
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`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, including even
`disclosure of the particular compound relied on in Petitioner’s contentions of
`anticipation and obviousness, we agree with Patent Owner that Petitioner
`fails to sufficiently demonstrate that the ’270 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
`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 basis for Petitioner’s contentions that Sofia is prior art
`“because it was published by September 13, 2007” (Pet. 22), and that Ma is
`prior art “because it was published on October 12, 2007” (id. at 24).
`D. Alleged Unpatentability of the Challenged Claims
`1. Anticipation by Sofia
`Petitioner asserts that claims 1, 2, 10–18, and 20–25 are anticipated by
`Sofia. Pet. 27–32. The unavailability of Sofia as prior art undermines
`Petitioner’s anticipation ground. Accordingly, we are not persuaded the
`record before us establishes a reasonable likelihood that Petitioner will
`prevail in showing that the subject matter of claims 1, 2, 10–18, and 20–25 is
`unpatentable over Sofia.
`
`11
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`IPR2018-00121
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`2. Obviousness over Sofia and Perrone
`Petitioner contends that claims 1, 2, 10–18, and 20–25 are
`unpatentable as obvious over the combination of Sofia and Perrone. Id. at
`32–44. The unavailability of Sofia undermines Petitioner’s obviousness
`ground, which relies on Sofia as to the nucleoside portion of a prodrug
`according to the claims, that is, “the uridine analog ‘(2’R)-2’-deoxy-2’-
`fluoro-2’-C-methyluridine.’” Id. at 33. Perrone, relied on as to the
`phosphoramidate portion of the prodrug (id. at 37–42), uses a different
`uridine analog, 4′-azidourdine (Ex. 1008). Accordingly, we are not
`persuaded the record before us establishes a reasonable likelihood that
`Petitioner will prevail in showing that the subject matter of claims 1, 2, 10–
`18, and 20–25 is unpatentable over Sofia and Perrone.
`3. Obviousness over Ma and Perrone
`Petitioner contends that claims 1, 2, 10–18, and 20–25 are
`unpatentable as obvious over the combination of Ma and Perrone. Pet. 44–
`55. The unavailability of Ma undermines Petitioner’s obviousness ground,
`which relies on Ma 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 the record before us establishes a
`reasonable likelihood that Petitioner will prevail in showing that the subject
`matter of claims 1, 2, 10–18, and 20–25 is unpatentable over Ma and
`Perrone.
`
`
`12
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`IPR2018-00121
`Patent 8,334,270 B2
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`
`IV. CONCLUSION
`Petitioner has not established a reasonable likelihood of prevailing on
`its assertion that claims 1, 2, 10–18, and 20–25 are unpatentable.
`
`
`V. ORDER
`For the reasons given, it is:
`ORDERED that the Petition is denied as to all challenged claims of
`the ’270 patent and no trial is instituted.
`
`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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