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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`INITIATIVE FOR MEDICINES, ACCESS & KNOWLEDGE (I-MAK), INC.
`Petitioner
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`v.
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`GILEAD PHARMASSET LLC
`Patent Owner
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`___________
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`Case No. IPR2018-00126
`U.S. Patent No. 9,284,342
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`___________
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`PETITIONER’S REQUEST FOR REHEARING
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`I.
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`INTRODUCTION
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`Petitioner Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
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`(“Petitioner”) respectfully requests rehearing of the Board’s Decision Denying
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`Institution of Inter Partes Review (“IPR”) of Gilead Pharmasset LLC’s (“Gilead”)
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`U.S. Patent 9,284,342 (“the ’342 patent”) (“Decision”; Paper 7) because the Board
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`misapprehended or overlooked Petitioner’s evidence of motivation to pursue
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`alternative crystalline forms that would lead a POSA to the ‘342 patent’s claims.
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`II. LEGAL STANDARD
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`A party may request rehearing of a denial of institution by, “identify[ing] all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, or a
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`reply.” 37 C.F.R. § 42.71(d). The Board reviews its decision for “abuse of
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`discretion,” Id. at § 42.71(c), which includes basing the decision on, “an erroneous
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`conclusion of law or clearly erroneous factual finding.” PPG Indus., Inc. v.
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`Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988).
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`III. PETITIONER’S EVIDENCE IS NOT CUMULATIVE AND INDEED
`DIRECTLY REBUTS THE EXAMINER’S UNSUPPORTED SOLE
`REASON FOR ALLOWANCE
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`In denying institution, the Board stated in the Decision that, “the argument
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`that a POSA could have prepared the Sp-4 compound having that structure is
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`unpersuasive because ‘obviousness concerns whether a skilled artisan not only
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`could have made but would have been motivated to make the combinations or
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`modifications of prior art to arrive at the claimed invention.’” Paper 7, 17 (citing
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`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)) (emphasis in
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`original). However, the Board misapprehended or overlooked Petitioner’s evidence
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`of motivation to make alternative crystalline forms that would lead a POSA to the
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`‘342 patent’s claims.
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`For one, the Board did not address Petitioner’s argument that:
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`Because the amount of residual dichloromethane in a standard dose of
`PSI-7977 as the dichloromethane solvate, known as of 2010 to be
`either 200 or 400 mg/day of active drug, EX1023, was several times
`greater than the Permissible Daily Exposure limit of 6 mg, a POSA
`would have been compelled to create alternative crystalline forms of
`PSI-7977 for human use.
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`Ex. 1002, ¶ 95. Thus, the toxicity of the dichloromethane solvate of PSI-7977 as
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`revealed by comparison of the level of dichloromethane exposure in a typical daily
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`dose and the recommended maximum human exposure allowable according to the
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`ICH Guidelines, Ex. 1022, would have motivated a POSA to pursue additional
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`crystalline structures. As Dr. Fortunak explained:
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`A POSA would also have known that dichloromethane is a “class II”
`solvent whose exposure to a patient should be limited due to inherent
`toxicity. “Specifications: Test Procedures and Acceptance Criteria For
`New Drug Substances and New Drug Products: Chemical
`Substances,” ICH (Q6A) Harmonised Tripartite Guideline, October 6,
`1999 (“ICH”; EX1022).
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`Ex. 1002, ¶ 94. The known crystalline form in the prior art was therefore
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`unacceptable for human use because of the toxicity of the dichloromethane
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`contained in such crystalline form. In making this argument, Petitioner provided
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`additional evidence of motivation for a POSA to pursue alternative crystalline
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`forms:
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`The dichloromethane solvate of PSI-7977 contains approximately
`13.8% of dichloromethane by weight. Thus, a 200mg daily dose of
`active PSI-7977 would contain 32mg of dichloromethane – several
`times the acceptable limit for daily exposure.
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`Ex. 1002, ¶ 95 n1.
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`Petitioner also provided additional evidence of why a POSA would have
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`been motivated, indeed obligated, to investigate the effects of water and humidity
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`on the properties of an Active Pharmaceutical Ingredient (API) as a requirement
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`for filing an Investigational New Drug Application to utilize PSI-7977 for human
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`dosing. Ex. 1002, ¶ 96. In the course of doing so, a POSA would have naturally
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`discovered the crystalline forms claimed in the ‘342 patent. Ex. 1002, ¶ 96. The
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`Board in its Decision did not identify, much less address, this evidence of
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`motivation for a POSA to pursue additional crystalline forms.
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`In short, while claiming Petitioner’s evidence is conclusory, the Board did
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`not address all of Petitioner’s evidence.
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`In addition, the Board also erroneously dismissed Petitioner’s evidence,
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`including Dr. Fortunak’s opinions, because they were stated verbatim in the
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`Petition. Paper 7, 13. The fact that an expert’s opinion testimony is cited
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`unchanged in a Petition is not a basis to ignore it. Indeed, one would hope a
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`Petition would repeat expert testimony rather than rephrase it in ways that could
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`have scientific consequences. No where did the Board cite any evidence
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`contradicting Dr. Fortunak’s opinions. The Board’s decision to give it no weight
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`was, thus, an abuse of discretion, especially since even Patent Owner did not
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`dispute Dr. Fortunak’s credentials.
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`The Board’s only other criticism of Dr. Fortunak’s testimony is that it was
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`supposedly “without citing evidentiary support.” Paper 9, 10, 13 and 15. However,
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`many of the cited paragraphs of Dr. Fortunak’s declaration absolutely do cite
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`evidence. See, e.g., Paper 7, 13 (describing Ex. 1002, ¶ 137 as “without citing
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`evidentiary support,” when that paragraph of Dr. Fortunak’s declaration directly
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`cites Sofia ‘634 and Ma). Regardless, Dr. Fortunak’s testimony is itself evidence.
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`Patent Owner does not dispute Dr. Fortunak is an expert with substantial education
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`and decades of experience underlying his opinions. To dismiss his opinions as
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`baseless contradicts centuries of American jurisprudence giving substantial weight
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`to the opinions of experts, especially when they are unrebutted and unimpeached as
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`here.
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`Patent Owner provides, and the Board cites, no evidence to contradict the
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`evidence provided by Petitioner showing there was motivation to achieve the
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`claims of the ‘342 patent. That evidence is substantial and supports a finding that
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`Dated: June 23, 2018
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`Petitioner has a reasonable likelihood that it will prevail in showing the
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`unpatentability of the ‘342 patent’s claims.
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`IV. CONCLUSION
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`For the foregoing reasons, Petitioner respectfully requests that the Board
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`rehear its decision denying institution and institute a trial on all challenged claims.
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`Respectfully submitted,
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`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
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`Counsel for Petitioner
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`V. CERTIFICATE OF SERVICE
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`I certify that on the date indicated below I caused a true and correct copy of
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`the foregoing PETITIONER’S REQUEST FOR REHEARING to be served on
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`counsel for Patent Owner by filing through the PTAB – E2E system as well as by
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`electronic mail to the following email addresses:
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`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
`whelan@fr.com
`kane@fr.com
`shear@fr.com
`PTABInbound@fr.com
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`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
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`Counsel for Petitioner
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`Dated: June 23, 2018
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`6
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