UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`AQUESTIVE THERAPEUTICS, INC.,
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`Petitioner,
`
`v.
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`NEURELIS, INC.,
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`Patent Owner.
`
`_____________________________
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`Case IPR2019-00451
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`U.S. Patent No. 9,763,876
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`_____________________________
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`NEURELIS, INC.’S REPLY TO PETITIONER’S OPPOSITION TO
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`AQUESTIVE THERAPEUTICS, INC.,
`
`Petitioner,
`
`v.
`
`NEURELIS, INC.,
`
`Patent Owner.
`
`_____________________________
`
`Case IPR2019-00451
`
`U.S. Patent No. 9,763,876
`
`_____________________________
`
`NEURELIS, INC.’S REPLY TO PETITIONER’S OPPOSITION TO
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`
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`TABLE OF CONTENTS
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`I.
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`Documents Not Cited in the Petition or Reply Should be
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`Excluded ................................................................................................ 1
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`II.
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`EX1013 and Dr. Peppas’ Reliance Thereon Should be Excluded ........ 1
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`III. Dr. Peppas’ Non-Expert Opinions Should be Excluded ....................... 2
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`IV. Belated and Unauthenticated EX1069 Should be Excluded ................. 2
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`V.
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`VI.
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`EX1080 and EX1081 Should be Excluded ........................................... 3
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`EX1150 Should be Excluded in its Entirety ......................................... 4
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`
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`Each exhibit in Neurelis’s Motion to Exclude (“Motion”) (Paper 35) should
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`be excluded for failure to comply with the FRE. Aquestive fails to show otherwise.
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`Documents Not Cited in the Petition or Reply Should be Excluded
`I.
`Aquestive asserts that the uncited exhibits might have been relevant “[i]f PO
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`filed a Motion to Amend,” effectively conceding irrelevance because “PO did not
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`file a Motion to Amend.” Paper 38, 1. FRE 403 requires exclusion and Aquestive
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`proves no exception to the rule. Pages 86-88 of EX1149 (discussing uncited-
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`EX1065) should be excluded for the same reason.
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`EX1013 and Dr. Peppas’ Reliance Thereon Should be Excluded
`II.
`Aquestive fails to show why EX1013—a document that is cited only in
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`support of a non-instituted ground—(and Dr. Peppas’ discussion thereof, EX1041,
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`¶¶171-191, 264-362, Appendix A (pp. 197-224), and EX1050) is relevant to the
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`instituted grounds. Aquestive’s assertion that EX1013 shows the state-of-the art is
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`disingenuous given that Dr. Peppas’ extensive discussion of EX1013 relates to it
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`being allegedly invalidating prior art. Moreover, Aquestive’s reliance on Ariosa
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`Diagnostics v. Verinata Health, Inc. and Genzyme Therapeutic Prod. Ltd. v.
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`Biomarin Pharm. Inc. is misplaced as neither addressed the relevance of an exhibit
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`submitted in support of a non-instituted ground. 805 F.3d 1359, 1364 (Fed. Cir.
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`2015); 825 F.3d 1360, 1365-69 (Fed. Cir. 2016). Thus, EX1013 and Dr. Peppas’
`
`testimony regarding EX1013 (including EX1050) should be excluded.
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`Dr. Peppas’ Non-Expert Opinions Should be Excluded
`III.
`Aquestive fails to address Dr. Peppas’ admission that he is not an expert in
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`patent prosecution—the subject of EX1041 ¶¶29-63 and 167-168. These
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`conclusory, non-expert opinions are of no value, and should be excluded.
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`Belated and Unauthenticated EX1069 Should be Excluded
`IV.
`Any purported relevance of EX1069—which Neurelis continues to
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`dispute—is outweighed by the manifest prejudice to Neurelis caused by the belated
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`submission of EX1069. Aquestive’s reliance on Genzyme Therapeutic and/or
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`Ariosa Diagnostics is disingenuous given that neither of those decisions involved
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`the lack of notice, and resultant prejudice, that is present here. Paper 38 at 3, citing
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`Genzyme Therapeutic, 825 F.3d at 1365 n.2 (exhibits were cited in institution
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`decision); Ariosa Diagnostics, 805 F.3dat 1365 (exhibit included in petition).1
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`Additionally, Aquestive cites no actual evidence authenticating EX1069.
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`Instead, Aquestive offers only the conclusory declaration of its own counsel, Mr.
`
`1 Aquestive relies on the same decisions to argue relevance of EX1122, but they
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`are inapplicable for the same reason—as EX1122 was not part of the petition.
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`IPR2019-00451
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`-2-
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`U.S. Patent No. 9,763,876
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`Chakansky.2 EX1152. The declaration does not provide any “personal knowledge”
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`as required by FRE 901(b)(1), or any other evidence that EX1069 is what
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`Aquestive purports it to be—a manual available to, and followed by, medical
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`technicians in Florida prior to the priority date. Phigenix, Inc. v. ImmunoGen, Inc.,
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`845 F.3d 1168, 1175 n.6 (Fed. Cir. 2017) (reciting authentication standards for
`
`declaration). Moreover, whether “counsel was offered the opportunity to inspect
`
`the original” (Paper 38, 5) is not an authentication standard. Multilayer Stretch
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`Cling v. Berry Plastics Corp., 831 F.3d 1350, 1365 (Fed. Cir. 2016) (discovery
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`sufficiency). EX1069 should be excluded, and pages 24-27 of EX1149 (discussing
`
`EX1069) should be excluded for the same reasons.
`
`EX1080 and EX1081 Should be Excluded
`V.
`Aquestive’s attempt to authenticate EX1080 and EX1081 through EX1152
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`fails for the same reasons as detailed, supra. §II.D.
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`As for hearsay, Aquestive’s argument that EX1080 is evidence of the
`
`“composition and characteristics of Valium®” (Paper 38, 6) confirms that
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`Aquestive indeed submits the hearsay document to prove the truth of the matter
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`2 Aquestive discusses the “Fire Chiefs” website (Paper 38, 5), but fails to identify
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`any link or relationship between said website and EX1069 that would satisfy the
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`FRE 902 self-authentication requirements.
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`
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`asserted (that Valium® contained ethanol and benzyl alcohol). E.g., EX1150,
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`¶¶146-156. Moreover, Aquestive’s argument that EX1081 is “not used to prove
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`the actual cost of the drugs” directly contradicts Dr. Wermeling’s reliance on
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`EX1081. E.g., id., ¶67 (comparing drug prices as an economic consideration).
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`EX1150 Should be Excluded in its Entirety
`VI.
`EX1150 is unduly prejudicial because it is replete with claim construction
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`contentions and prior art that were not presented in Aquestive’s petition. Even if
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`Aquestive’s argument that Dr. Wermeling’s testimony responds to Neurelis’s
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`arguments were true—Aquestive cannot escape the fact that EX1150 improperly
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`cites new references and presents new obviousness arguments (e.g., Dr.
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`Wermeling’s heavy reliance on newly cited-EX1069). Intelligent Bio-Sys., Inc. v.
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`Illumina Cambridge Ltd., 812 F.3d 1359, 1369 (Fed. Cir. 2016) (new declaration
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`rejected for citing several non-patent literature references and arguing obviousness
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`for reasons other than those described in the originally relied-upon prior art).3
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`3 Aquestive’s cited authority simply emphasizes that the Board should base its
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`decision on only the combination of references offered in the Petition. Paper 38
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`at 8-9 (citing case law, e.g., Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1079
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`(Fed. Cir. 2015) (“prior art itself, together with the Petition, sufficed to supply a
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`prima facie case of obviousness.”)).
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`IPR2019-00451
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`U.S. Patent No. 9,763,876
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`Separately, Dr. Wermeling’s experience in drug development does not
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`qualify him to provide expert opinions on economics and/or regulatory procedures.
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`Aquestive block cites portions of Dr. Wermeling’s testimony in support of the
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`alleged “expertise”—but, a closer look at the testimony reveals that he (1) is
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`merely “familiar with economic principles” (EX2031, 8:19-22) and otherwise
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`collaborated with trained economists for his written work (id., 10:2-14); (2) has
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`never worked at, or received any formal certifications related to, FDA practice and
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`procedure (id., 10:22-11:7); (3) has limited experience with pricing (id., 77:2-7)
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`and could not make any pricing decisions on his own (id., 79:24-80:81:5), and; (4)
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`is only “pretty familiar” with the 505(b)(2) pathway and would need to consult the
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`“regulatory person at the company” for the answer to a complex question on the
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`same (id., 85:6-86:13). Because he is not an expert in economics or regulatory
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`procedures, Dr. Wermeling’s opinions on these matters are no more than
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`“unsupported speculation” and should be excluded. Daubert v. Merrell Dow
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`Pharm., Inc., 509 U.S. 579, 590 (1993).
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`Finally, Aquestive’s argument that EX1025 (as cited in EX1150) is not used
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`for the truth of the matter asserted—and thus is not hearsay—is contradicted by Dr.
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`Wermeling’s reliance on its experiments and results. E.g., EX1150, ¶192.
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`IPR2019-00451
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`-5-
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`U.S. Patent No. 9,763,876
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`
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`Dated: May 5, 2020
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`Respectfully submitted,
`
`
`/Jeffrey W. Guise/
`Jeffrey W. Guise, Lead Counsel
`Reg. No. 34,613
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`IPR2019-00451
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`-6-
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`U.S. Patent No. 9,763,876
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`
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`CERTIFICATE OF SERVICE
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`This is to certify that I caused to be served true and correct copies of the
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`foregoing Neurelis, Inc.’s Reply to Petitioner’s Opposition to Patent Owner’s
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`Motion to Exclude Evidence on this 5th day of May, 2020, on the
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`Petitioner at the correspondence address of the Patent Owner as follows:
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`Daniel A. Scola, Jr.
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`dscola@hbiplaw.com
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`Michael I. Chakansky
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`
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`mchakansky@hbiplaw.com
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`James F. Harrington
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`jharrington@hbiplaw.com
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`Matthew J. Solow
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`msolow@hbiplaw.com
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`John T. Gallagher
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`jgallagher@hbiplaw.com
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`HOFFMANN & BARON, LLP
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`876IPR@hbiplaw.com
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`Dated: May 5, 2020
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`Respectfully submitted,
`
`
`/Jeffrey W. Guise/
`Jeffrey W. Guise, Lead Counsel
`Reg. No. 34,613
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`IPR2019-00451
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`-7-
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`U.S. Patent No. 9,763,876
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`
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