Trials@uspto.gov Paper No. 12
`571.272.7822
`
` Filed: July 3, 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 Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
` Filed: July 3, 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 Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`IPR2018-00121
`Patent 8,334,270 B2
`
`
`I. INTRODUCTION
`Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
`(“Petitioner”) filed a Petition (Paper 2 (“Pet.”)) to institute an inter partes
`review of claims 1, 2, 10–18, and 20–25 of U.S. Patent No. 8,334,270 B2
`(Ex. 1001 (“the ’270 patent”)). Gilead Pharmasset LLC (“Patent Owner”)
`filed a Preliminary Response. Paper 9 (“Prelim. Resp.”). Having considered
`the Petition, the Preliminary Response, and the evidence of record, and
`applying the standard set forth in 35 U.S.C. § 314(a), which requires that
`Petitioner demonstrate a reasonable likelihood that it would prevail with
`respect to at least one challenged claim; we denied Petitioner’s request and
`did not institute an inter partes review. Paper 10, 13 (“Decision” or “Dec.”).
`Petitioner filed a Request for Rehearing (Paper 11 (“Reh’g Req.”)),
`requesting reconsideration of the Decision denying institution of inter partes
`review. Petitioner contends that we “misapprehended or overlooked that a
`provisional application to which the ‘270 patent claims priority failed to
`satisfy the written description requirement.” Reh’g Req. 1.
`We have considered Petitioner’s Request for Rehearing, and, for the
`reasons set forth below, Petitioner’s Request is denied.
`
`
`II. STANDARD OF REVIEW
`37 C.F.R. § 42.71(d) provides that:
`A party dissatisfied with a decision . . . may file a request for
`rehearing, without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each
`
`2
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`IPR2018-00121
`Patent 8,334,270 B2
`
`
`matter was previously addressed in a motion, opposition, or a
`reply.
`See Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012).
`Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a
`panel will review the decision for an abuse of discretion.” An abuse of
`discretion occurs when a “decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
`PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565,
`1567 (Fed. Cir. 1988) (citations omitted).
`
`
`III. DISCUSSION
`In contending that we “misapprehended or overlooked that a
`provisional application to which the ‘270 patent claims priority failed to
`satisfy the written description requirement” (Reh’g Req. 1), Petitioner
`maintains its argument that while the ’315 provisional discusses broad
`genera of compounds, it does not discuss the specific compounds and
`stereochemistry claimed in the ’270 patent (id. at 3–4).
`Petitioner further contends that “[n]either Patent Owner in its
`Preliminary Response, nor the Board in its Decision, dispute I-MAK’s
`assertion that the ‘315 application fails to identify the specific compounds
`and stereochemistry around the phosphorous atom and at the amino acid
`ester (i.e., R3a and R3b) as claimed in the ‘270 patent.” Id. at 3.
`Emphasizing the large number of compounds identified in the ’315
`provisional, Petitioner argues that the “two lines cited by the Board . . . do
`not, ‘reasonably convey[] to those skilled in the art that the inventor had
`possession’ of the compounds with the stereochemistry claimed in the ‘270
`
`3
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`IPR2018-00121
`Patent 8,334,270 B2
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`patent.” Id. at 3–4 (quoting Ariad Pharms. v. Eli Lilly, 598 F.3d 1336, 1351
`(Fed. Cir. 2010) (en banc). Citing various portions of the ’315 provisional
`as support for certain R groups not being disclosed, Petitioner further
`contends that “the structures of many of the compounds claimed in
`challenged claims 16, 17 and 18 are not even disclosed in any of the ‘315
`application’s tables.” Id. at 5–6. Petitioner further argues we
`misapprehended or overlooked that the only evidence of record is Dr.
`Fortunak’s opinion (id. at 6–7, 9–10), that we erred in our application of
`relevant case law to this case (id. at 7–9), and that our reasoning is
`inconsistent with that in our decision denying institution in related IPR2018-
`00120 (id. at 11). Petitioner further cites to a European Patent Office (EPO)
`decision, dated October 31, 2016 (Exhibit 1015), filed with the Request for
`Rehearing, and argues it came to an opposite conclusion than we did (id. at
`12–13).
`As set forth in the Decision (see Dec. 7–8, 11), we fully considered
`Petitioner’s contention that the ’315 provisional “does not include a
`description of the specific compounds” in that “it does not discuss the
`specific compounds and stereochemistry around the phosphorous atom
`claimed in the ‘270 patent,” even if it “discusses broad genera of
`compounds” (Pet. 21–22 (citing Ex. 1002 ¶ 72)).
`Petitioner now builds on its original contention, raising arguments and
`relying on evidence not included in the Petition. Compare Reh’g Req. 2–13,
`to Pet. 22. Arguments raised and evidence provided for the first time in a
`Request for Rehearing, however, do not identify any matter that we
`misapprehended or overlooked in denying institution because those
`arguments and that evidence were not before us.
`
`4
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`IPR2018-00121
`Patent 8,334,270 B2
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`Petitioner’s contention that “[n]either Patent Owner . . . nor the Board
`. . . dispute[d its] assertion that the ‘315 application fails to identify the
`specific compounds and stereochemistry” (Reh’g Req. 3) does not identify
`any misapprehended or overlooked matter. Patent Owner did contend that
`the ’270 patent is entitled to the benefit of priority of the ’315 provisional in
`stating, for example, that Petitioner’s “conclusory assertion regarding
`priority is wrong” (Prelim. Resp. 13) and that “[a] review of the ’315
`application . . . reveals that the ’315 provisional application discloses both
`the specific compounds and the stereochemistry . . . [of] the compounds
`claimed in the Sofia ’270 patent” (id. at 15). But, although noting Patent
`Owner’s contention that the ’270 patent is entitled to the benefit of priority
`of the ’315 provisional (Dec. 8), the Decision is grounded on “Petitioner
`fail[ing] to sufficiently demonstrate that the ’270 patent is not entitled to the
`priority benefit of the ’315 provisional” (id. at 11).
`Petitioner’s further arguments that various R groups are not
`adequately disclosed in the ’315 provisional to constitute written description
`support similarly fails to identify any matter misapprehended or overlooked.
`Petitioner bears the burden required to support institution of inter partes
`review. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir.
`2016). No effort to remedy that failure in the Request is persuasive that we
`misapprehended or overlooked any matter. See 37 C.F.R. § 42.22(a)(2) (a
`petition must include “[a] full statement of the reasons for the relief
`requested”); cf. 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.”).
`
`5
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`IPR2018-00121
`Patent 8,334,270 B2
`
`
`Petitioner’s further arguments that we misapplied relevant case law
`and that our reasoning is inconsistent with our decision denying institution
`in IPR2018-00122 are grounded on the ’315 provisional effectively
`disclosing broad genera rather than providing written description support for
`particular compounds claimed. It follows that these do not identify any
`matter misapprehended or overlooked where we fully considered the
`contentions in the Petition as to what the ’315 provisional discloses.
`Also, contrary to Dr. Fortunak’s opinion being the only evidence of
`record as to what the ’315 provisional describes, the ’315 provisional
`(Ex. 2013) is itself evidence of what it describes. Cf. 37 C.F.R. § 42.61(c)
`(“A specification or drawing of a United States patent application . . . is
`admissible as evidence only to prove what the specification or drawing
`describes.”).
`On this record, Petitioner neither persuades us that we overlooked or
`misapprehended any matter, nor sufficiently shows that denying inter partes
`review of claims 1, 2, 10–18, and 20–25 represents an abuse of discretion.
`
`
`IV. ORDER
` Accordingly, it is hereby:
`ORDERED that Petitioner’s Request for Rehearing is denied.
`
`
`6
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`
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`IPR2018-00121
`Patent 8,334,270 B2
`
`PETITIONER:
`
`Daniel Ravicher
`RAVICHER LAW FIRM PLLC
`dan@ravicher.com
`
`PATENT OWNER:
`
`Dorothy Whelan
`Mike Kane
`Chad Shear
`FISH & RICHARDSON P.C.
`whelan@fr.com
`kane@fr.com
`shear@fr.com
`
`David Cavanaugh
`Emily Whelan
`WILMER HALE
`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
`
`
`
`
`7
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