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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. IPR2018-00125
`U.S. Patent No. 8,633,309
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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 8,633,309 (“the ’309 patent”) (“Decision”; Paper 9) regarding the
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`asserted ground of obviousness over Sofia ‘634 and Congiatu, because Congiatu
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`and Dr. Fortunak’s declaration are substantial evidence that is not cumulative of
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`the evidence of record during prosecution and that in fact overcomes the
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`Examiner’s express reason for allowance that the claimed compound was
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`unexpectedly more potent. There is no evidence of record to support the
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`Examiner’s finding, and Petitioner’s new additional evidence directly rebuts it.
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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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`1
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`III. CONGIATU AND DR. FORTUNAK’S DECLARATION ARE NOT
`CUMULATIVE TO THE EVIDENCE OF RECORD DURING
`PROSECUTION, AND INDEED DIRECTLY REBUT THE
`EXAMINER’S UNSUPPORTED SOLE REASON FOR ALLOWANCE
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`
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`In denying institution of asserted Ground 2, the Board stated in the Decision
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`that, “Petitioner [] relies on Congiatu for teachings that are substantially the same
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`as Sofia ‘634, such that the alleged teachings of Congiatu are cumulative to the
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`alleged teachings of Sofia ‘634.” Paper 9, 17. However, the Board overlooked
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`several of Congiatu’s teachings that are not present in Sofia ‘634 and are thus
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`materially additive over the evidence that was of record during prosecution.
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`First, Congiatu
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`taught
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`the correct stereochemical assignments of
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`phosphorous diastereomers, which is lacking in Sofia ‘634. Ex. 1006, 3. Sofia ‘634
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`teaches separating the diastereomers and testing them separately. It does not teach
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`the assignment of which diastereomer is R- or S-. Ex. 1005, 694 (“The absolute
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`stereochemistry of the P-chiral center of the diastereomers were not determined.”)
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`The Table cites the diastereomers as “fast moving” and “slow moving” by
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`chromatography without stereochemical assignment. Id.
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`Second, Congiatu cited the previous work of Saboulard (1999) and Siccardi
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`(2004) that taught why a POSA would expect differences in activity between
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`different phosphorous diastereomers. Ex. 1006, 2. While Sofia ‘634 taught
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`diastereomers may have substantially different antiviral activity, Paper 9, 17 (citing
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`arguments made in the Petition), Congiatu provided additional teaching that the
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`2
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`difference in activity was not only possible, but would be expected. This is
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`substantially more than what was taught by Sofia ‘634.
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`Third, Congiatu actually found that an Sp diastereomer was more active than
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`an Rp diastereomer, just like the nucleoside phosphoramidates claimed in the ‘309
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`patent. Ex. 1006, 3. The Sofia evidence of record during prosecution did not show
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`that the Sp diastereomer was more potent, only that one diastereomer at
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`Phosphorous could be more potent than the other, without an assignment or
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`understanding of which diastereomer was more potent. Ex. 1005, 694. Thus,
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`Congiatu provides additional evidence above and beyond Sofia ‘634 that such
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`result was not unexpected.
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`Fourth, Congiatu taught that a POSA would look to the specific disease state
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`or tissues of interest in assessing the potential of phosphoramidate prodrugs.
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`Ex. 1006, 2. Thus, Congiatu taught that “Nucleoside analogues represent an
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`extremely effective tool for the treatment of cancer and viral infections.” Id., 1.
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`Congiatu further taught (as Sofia ‘634 does not) that phosphoramidate prodrugs of
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`nucleoside analogues were widely used (by their research group and others) to
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`overcome general limitations of nucleoside analogues. Congiatu discloses the
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`general knowledge (additive to Sofia) that phosphoramidates were used to: 1)
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`improve lipophilicity and cell penetration; and 2) bypass the limitations of
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`intracellular activation of nucleoside analogues by kinases. Id. Congiatu discloses
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`3
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`(as Sofia ‘634 does not) that this approach had been advanced into human
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`treatment. Id., 2. Congiatu also
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`taught (as Sofia ‘634 does not)
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`that
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`phosphoramidates are activated intracellularly by the action of esterases and
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`phosphoramidases and, thus, a POSA would expect a ProTide prodrug to have an
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`activity pattern that is heavily dependent upon the target tissue, and not so much by
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`the particular nucleoside structure. Id.
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`Further, Congiatu cites to, and explains (as Sofia ‘634 does not) the findings
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`of Saboulard (1999) and Siccardi (2004), e.g., that Saboulard found that hydrolysis
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`of the carboxyl ester group “…is a fundamental step for the activation of
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`phosphoramidates.” Id. Congiatu also taught that Siccardi’s teaching: “Enzymatic
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`stability in the extracellular environment and in different cellular preparations was
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`found
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`to be stereospecific with
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`large and unpredictable differences
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`in
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`stereoselective metabolic rate noted by Siccardi et al.” Id. This teaching in
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`Congiatu reveals the motivation of a POSA to separate the phosphoramidate
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`diastereomers of such nucleosides prodrugs. It also reveals why a POSA would not
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`find it unexpected that these diastereomers might have large differences in activity.
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`Accordingly, Congiatu
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`teaches
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`the separation of phosphoramidate
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`diastereomers (at phosphorous) by chromatography. Congiatu also reveals a
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`substantial difference in activity between the more-active Sp diastereomer and the
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`less-active Rp diastereomer. Id., 2-3.This is again more than what Sofia ‘634
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`4
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`taught and highly material to the validity of the ‘309 patent’s claims because it
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`goes to the heart of the issues of suggestion, motivation and expectation of result.
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`In addition to misapprehending and overlooking the teachings of Congiatu,
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`the Board also erroneously misapprehended and overlooked Dr. Fortunak’s expert
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`testimony. The only stated basis for the Board’s dismissal of Dr. Fortunak’s
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`opinions was that they were stated verbatim in the Petition. Paper 9, 17. The fact
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`that an expert’s opinion testimony is cited unchanged in a Petition is not a basis to
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`ignore it. Indeed, one would hope a Petition would repeat expert testimony rather
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`than rephrase it in ways that could have scientific consequences. Nowhere did the
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`Board cite any evidence contradicting Dr. Fortunak’s opinions. The Board’s
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`decision to give it no weight was, thus, an abuse of discretion, especially since
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`even Patent Owner did not 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, 17. However, the cited
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`paragraph of Dr. Fortunak’s declaration, Ex. 1002, ¶ 124, was a concluding
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`paragraph at the end of a detailed and lengthy section that cited several references,
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`including Sofia ‘634 and Congiatu. The fact that Dr. Fortunak provided a summary
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`of his analysis without repeating cites to previously referenced evidence does not
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`mean his opinions were “without evidentiary support.” Regardless, Dr. Fortunak’s
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`testimony is itself evidence. Patent Owner does not dispute Dr. Fortunak is an
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`5
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`expert with substantial education and decades of experience underlying his
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`opinions. To dismiss his opinions as baseless contradicts centuries of American
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`jurisprudence giving substantial weight to the opinions of experts, especially when
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`they are unrebutted and unimpeached as here.
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`Rather than give weight to Dr. Fortunak’s testimony, the Board instead cites
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`Patent Owner’s argument during prosecution history of unexpected results. Paper
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`9, 13, 16. However, that evidence was merely conclusory attorney argument.
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`Ex. 1004, 24. It was not supported by a declaration of an expert in the field like
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`Dr. Fortunak, or even any declaration at all. If anything lacks evidentiary support,
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`it is Patent Owner’s “unexpected results” argument during prosecution history, not
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`Dr. Fortunak’s testimony that the difference in activity was in fact to be expected.
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`Evidence that there was a difference in activity does not support a conclusion that
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`such a difference was unexpected, any more than saying the temperature in January
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`being different than the temperature in July is unexpected. Patent Owner’s baseless
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`“unexpected results” argument is also contradicted by Dr. Fortunak and the
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`evidence he cites, including Congiatu. The Board’s dismissal of Dr. Fortunak’s
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`unrebutted expert testimony was clearly erroneous and should be reversed.
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`Lastly, the Board misapprehended the Examiner’s finding in the Notice of
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`Allowance that, “Applicant has discovered that the Sp enantiomer of the claimed
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`compound is unexpectedly more potent in inhibiting HCV replication.” Paper 9, 14
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`6
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`(citing Ex. 1004, 56). There was absolutely no evidence submitted during
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`prosecution
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`to rebut Petitioner’s evidence (Congiatu and Dr. Fortunak’s
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`Declaration) that the Sp enantiomer being more potent was not unexpected. That
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`evidence was thus not cumulative to the evidence of record during prosecution.
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`Indeed, it addresses exactly the reason the Examiner found critical in allowing the
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`‘309 patent’s claims, Patent Owner’s supposed “unexpected results.” Congiatu and
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`Dr. Fortunak’s declaration could not be more additive over the evidence of record
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`during prosecution history nor could they be more relevant to the validity of the
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`‘309 patent’s claims. The evidence here shows that the difference in activity was
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`not unexpected.
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`In light of the additional evidence provided by Petitioner in the form of
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`Congiatu and Dr. Fortunak’s declaration and the fact that this new evidence
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`directly rebuts the Examiner’s sole reason for allowance, the Board should not
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`have exercised its 325(d) discretion to deny institution.
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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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`7
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`Dated: June 25, 2018
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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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`8
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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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`Dated: June 25, 2018
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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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`9
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