`
`
`
`
`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
`
`___________
`
`Case No. IPR2018-00126
`U.S. Patent No. 9,284,342
`
`___________
`
`
`
`PETITIONER’S REQUEST FOR REHEARING
`
`
`
`I.
`
`
`
`INTRODUCTION
`
`Petitioner Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
`
`(“Petitioner”) respectfully requests rehearing of the Board’s Decision Denying
`
`Institution of Inter Partes Review (“IPR”) of Gilead Pharmasset LLC’s (“Gilead”)
`
`U.S. Patent 9,284,342 (“the ’342 patent”) (“Decision”; Paper 7) because the Board
`
`misapprehended or overlooked Petitioner’s evidence of motivation to pursue
`
`alternative crystalline forms that would lead a POSA to the ‘342 patent’s claims.
`
`II. LEGAL STANDARD
`
`A party may request rehearing of a denial of institution by, “identify[ing] all
`
`matters the party believes the Board misapprehended or overlooked, and the place
`
`where each matter was previously addressed in a motion, an opposition, or a
`
`reply.” 37 C.F.R. § 42.71(d). The Board reviews its decision for “abuse of
`
`discretion,” Id. at § 42.71(c), which includes basing the decision on, “an erroneous
`
`conclusion of law or clearly erroneous factual finding.” PPG Indus., Inc. v.
`
`Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988).
`
`III. PETITIONER’S EVIDENCE IS NOT CUMULATIVE AND INDEED
`DIRECTLY REBUTS THE EXAMINER’S UNSUPPORTED SOLE
`REASON FOR ALLOWANCE
`
`
`
`In denying institution, the Board stated in the Decision that, “the argument
`
`that a POSA could have prepared the Sp-4 compound having that structure is
`
`unpersuasive because ‘obviousness concerns whether a skilled artisan not only
`
`1
`
`
`
`could have made but would have been motivated to make the combinations or
`
`modifications of prior art to arrive at the claimed invention.’” Paper 7, 17 (citing
`
`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)) (emphasis in
`
`original). However, the Board misapprehended or overlooked Petitioner’s evidence
`
`of motivation to make alternative crystalline forms that would lead a POSA to the
`
`‘342 patent’s claims.
`
`
`
`For one, the Board did not address Petitioner’s argument that:
`
`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.
`
`Ex. 1002, ¶ 95. Thus, the toxicity of the dichloromethane solvate of PSI-7977 as
`
`revealed by comparison of the level of dichloromethane exposure in a typical daily
`
`dose and the recommended maximum human exposure allowable according to the
`
`ICH Guidelines, Ex. 1022, would have motivated a POSA to pursue additional
`
`crystalline structures. As Dr. Fortunak explained:
`
`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).
`
`Ex. 1002, ¶ 94. The known crystalline form in the prior art was therefore
`
`2
`
`
`
`unacceptable for human use because of the toxicity of the dichloromethane
`
`contained in such crystalline form. In making this argument, Petitioner provided
`
`additional evidence of motivation for a POSA to pursue alternative crystalline
`
`forms:
`
`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.
`
`Ex. 1002, ¶ 95 n1.
`
`
`
`Petitioner also provided additional evidence of why a POSA would have
`
`been motivated, indeed obligated, to investigate the effects of water and humidity
`
`on the properties of an Active Pharmaceutical Ingredient (API) as a requirement
`
`for filing an Investigational New Drug Application to utilize PSI-7977 for human
`
`dosing. Ex. 1002, ¶ 96. In the course of doing so, a POSA would have naturally
`
`discovered the crystalline forms claimed in the ‘342 patent. Ex. 1002, ¶ 96. The
`
`Board in its Decision did not identify, much less address, this evidence of
`
`motivation for a POSA to pursue additional crystalline forms.
`
`
`
`In short, while claiming Petitioner’s evidence is conclusory, the Board did
`
`not address all of Petitioner’s evidence.
`
`
`
`In addition, the Board also erroneously dismissed Petitioner’s evidence,
`
`including Dr. Fortunak’s opinions, because they were stated verbatim in the
`
`Petition. Paper 7, 13. The fact that an expert’s opinion testimony is cited
`
`3
`
`
`
`unchanged in a Petition is not a basis to ignore it. Indeed, one would hope a
`
`Petition would repeat expert testimony rather than rephrase it in ways that could
`
`have scientific consequences. No where did the Board cite any evidence
`
`contradicting Dr. Fortunak’s opinions. The Board’s decision to give it no weight
`
`was, thus, an abuse of discretion, especially since even Patent Owner did not
`
`dispute Dr. Fortunak’s credentials.
`
`
`
`The Board’s only other criticism of Dr. Fortunak’s testimony is that it was
`
`supposedly “without citing evidentiary support.” Paper 9, 10, 13 and 15. However,
`
`many of the cited paragraphs of Dr. Fortunak’s declaration absolutely do cite
`
`evidence. See, e.g., Paper 7, 13 (describing Ex. 1002, ¶ 137 as “without citing
`
`evidentiary support,” when that paragraph of Dr. Fortunak’s declaration directly
`
`cites Sofia ‘634 and Ma). Regardless, Dr. Fortunak’s testimony is itself evidence.
`
`Patent Owner does not dispute Dr. Fortunak is an expert with substantial education
`
`and decades of experience underlying his opinions. To dismiss his opinions as
`
`baseless contradicts centuries of American jurisprudence giving substantial weight
`
`to the opinions of experts, especially when they are unrebutted and unimpeached as
`
`here.
`
`
`
`Patent Owner provides, and the Board cites, no evidence to contradict the
`
`evidence provided by Petitioner showing there was motivation to achieve the
`
`claims of the ‘342 patent. That evidence is substantial and supports a finding that
`
`4
`
`
`
`Dated: June 25, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Petitioner has a reasonable likelihood that it will prevail in showing the
`
`unpatentability of the ‘342 patent’s claims.
`
`IV. CONCLUSION
`
`
`
`For the foregoing reasons, Petitioner respectfully requests that the Board
`
`rehear its decision denying institution and institute a trial on all challenged claims.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
`
`Counsel for Petitioner
`
`5
`
`
`
`V. CERTIFICATE OF SERVICE
`
`
`
`I certify that on the date indicated below I caused a true and correct copy of
`
`the foregoing PETITIONER’S REQUEST FOR REHEARING to be served on
`
`counsel for Patent Owner by filing through the PTAB – E2E system as well as by
`
`electronic mail to the following email addresses:
`
`david.cavanaugh@wilmerhale.com
`emily.whelan@wilmerhale.com
`whelan@fr.com
`kane@fr.com
`shear@fr.com
`PTABInbound@fr.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Daniel B. Ravicher/
`Daniel B. Ravicher (Reg. No. 47,015)
`RAVICHER LAW FIRM PLLC
`
`Counsel for Petitioner
`
`
`
`Dated: June 25, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
