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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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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`CIPLA LTD.,
`Patent Owner.
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`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
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`Inter Partes Review No.: IPR2017-00807
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`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`I. Reliance On The Malhotra Declaration For Its Truth Should Be Precluded
`Petitioner’s motion made clear that it does not seek to entirely exclude the
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`Malhotra Declaration, but rather only to preclude Patent Owner and its experts
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`from relying on it—as they have—for hearsay purposes. See Mot, 7-8. Patent
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`Owner’s attempts to recharacterize those uses now cannot avoid the hearsay rule.
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`A. The Malhotra Declaration Is Hearsay As Used By Patent Owner
`And Its Experts
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`Referring to the Malhotra Declaration as part of what the Examiner was told
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`during prosecution may have some nonhearsay relevance to this proceeding, and
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`therefore is not a hearsay use of the document. What is hearsay, however, is Patent
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`Owner’s repeated attempts to refer to the Malhotra Declaration for its truth—i.e.,
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`that Dr. Malhotra actually did test Cramer’s Example III and actually did encounter
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`problems with it. See POR, 9 (“However, attempts to recreate, and testing of,
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`Cramer Example III revealed that the formulation exhibited: (1) unacceptable
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`osmolality, which would have caused irritation to patients…. These problems
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`rendered Cramer Example III unsuitable for use” (citing EX1002, 284-87)). These
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`representations are necessarily premised on Dr. Malhotra’s out-of-court statements
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`being true.
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`While the declaration, as a part of the prosecution history, need not be
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`excluded from the record altogether, Patent Owner misstates its relevance in this
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`context when arguing that it was part of the Examiner’s reasoning for allowing the
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`1
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`claims. Opp., 3-4 (“…and accepted by the Examiner”). There is zero evidence in
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`the prosecution history that the Examiner relied in any way on the declaration. See
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`EX1002, 137-47 (Not. of Allowance). Instead, the Examiner relied on three other
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`declarations relating to other secondary considerations, but, significantly, the
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`Examiner did not rely the Malhotra Declaration. Id.
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`Patent Owner also ignores its own arguments in the POR, where the results
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`of Dr. Malhotra’s alleged efforts were stated as truthful definitive evidence
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`concerning reasonable expectations of success. See POR, 28 (“[A] POSA
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`following the prior art guidance of Cramer and Segal would not have arrived at a
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`formulation that was ‘suitable for nasal administration.’ Multiple formulators,
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`acting as a POSA in 2002, all failed….”). While the Malhotra Declaration is not
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`directly cited, the mention of “Multiple formulators, acting as a POSA in 2002”
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`certainly suggests reliance on the Malhotra Declaration, especially since Dr.
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`Govindarajan’s report decidedly does not support this allegation. See CIP2030,
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`¶¶11-15; EX1145, ¶¶34-40.
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`This same section of the POR later makes the disjunctive statement that
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`“Example III of Cramer … was not shown to be ‘suitable for nasal administration’
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`both during original prosecution and again in litigation” (POR, 33 (citing
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`EX1002, 286) (emphasis added)), which cannot be read as anything other than
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`relying on the contents of the Malhotra Declaration for its substantive truth.
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`2
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`Additionally, the comparison testing of Drs. Govindarajan and Herpin that Patent
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`Owner asserts found the same results as Dr. Malhotra also require the Malhotra
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`Declaration to be truthful.1,2 While it may be a nonhearsay purpose for Dr. Herpin
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`to say that he attempted to reproduce the experiment that Dr. Malhotra said she
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`carried out, such reliance crosses over into an impermissible hearsay use where
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`Patent Owner tries to claim that other experts “confirmed” Dr. Malhotra’s results,
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`as here (see, e.g., CIP2176, ¶38 (citing EX1002, 286-87)). Such alleged
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`“confirmation” is only relevant if the results in the Malhotra Declaration are taken
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`as true, which is what makes Patent Owner’s reliance a prohibited hearsay use.
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`As for Patent Owner’s experts, their declarations mimic the content of the
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`POR, and similarly rely on the Malhotra Declaration for its truth. See CIP2147,
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`1 Patent Owner’s assertion that Dr. Govindarajan arrived at the same results as Dr.
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`Malhotra is completely incorrect. See CIP2030, ¶¶11-15; EX1145, ¶¶34-40
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`(discussing physical stability recreations). Nevertheless, for purposes of the
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`hearsay analysis, what is relevant is Patent Owner’s considerations and how those
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`are advanced for a hearsay purpose, as the Malhotra Declaration is here.
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`2 Patent Owner’s claim that “Dr. Govindarajan sought to recreate the experiment
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`described in the Malhotra Declaration” (Opp., 4.) is also wrong, as Dr.
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`Govindarajan sought to and did reproduce Cramer’s Example 3, not Dr. Malhotra’s
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`experiments. See CIP2030, ¶¶7-10.
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`3
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`¶27 (Carr); CIP2176, ¶¶ 23, 31, 36, 38, 40-43 (Smyth (public)). Their attempt to
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`use the Malhotra Declaration to allegedly show a lack of expectation of success
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`(see, e.g., CIP2176, ¶36) can only be relying on the declaration for its truth.
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`B. Hearsay Uses Of The Malhotra Declaration Can And Should Be
`Precluded
`Patent Owner claims that REG Synthetic Fuels, LLC v. Neste Oil Oyj, 841
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`F.3d 954 (Fed. Cir. 2016), is dispositive, and compels denial of Petitioner’s motion
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`to exclude. Opp., 6. Patent Owner is wrong. The relevance of REG Synthetic
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`Fuels, and the reason Petitioner cited this case in its motion, was to show that
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`evidence can be “admitted” into the proceeding for one purpose (i.e., a nonhearsay
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`use), even while other uses (i.e., hearsay) remain prohibited. 841 F.3d at 963-65.
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`Thus, it is not that the Malhotra Declaration should be stricken from the
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`proceeding altogether, but rather that the parties’ and the Board’s reliance on it
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`should be restricted to nonhearsay purposes.
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`C.
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`Patent Owner And Its Experts’ Reliance Does Not Fit Within A
`Hearsay Exception
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`The exceptions to the hearsay rule Patent Owner identifies are not applicable
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`to their and their expert’s reliance on the Malhotra Declaration. Specifically, FRE
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`803(15) states that “unless later dealings with the property are inconsistent with the
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`truth of the statement or the purport of the document,” which directly implicates
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`that fact that Dr. Govindarajan’s testing efforts directly contract those of Dr.
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`4
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`Malhotra, as explained above. See supra, FN 1. Patent Owner has not cited any
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`authority to show how FRE 803(15) is even applicable to a declaration submitted
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`during prosecution.
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`As for the alleged FRE 807 exception, Patent Owner pays lip service to the
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`“including the declarant’s name and address” portion of the residual exception,
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`without actually addressing the “so that the party has a fair opportunity to meet it”
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`portion of the same rule. Here, Patent Owner is conveniently forgetting that a
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`cross-examination deposition was requested and denied by Patent Owner. See
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`Mot., 5-6. As such, Patent Owner’s reliance on the Malhotra Declaration does not
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`fit within the residual exception—otherwise, virtually any sworn declaration would
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`be admissible without cross-examination, which is certainly not the Board’s
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`practice. US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR2015-
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`00019 (Paper 54), at *38-42 (P.T.A.B. Dec. 28, 2016) (refusing to admit a
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`declaration under FRE 807 (residual exception)).
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`II. Conclusion
`For these reasons, Petitioner respectfully requests that the Board preclude
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`Patent Owner from relying on the factual assertions in Dr. Malhotra’s declaration
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`contained in Exhibit 1002 at pages 284-287 as if true.
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`Dated: April 30, 2018
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`Respectfully submitted,
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`By: /Michael Houston/
`Michael Houston
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`5
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`Registration No. 58,486
`FOLEY & LARDNER LLP
`321 North Clark Street, Suite 2800
`Chicago, Illinois 60654
`Telephone: 312-832-4500
`Facsimile: 312-832-4700
`mhouston@foley.com
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`Counsel for Petitioner
`Argentum Pharmaceuticals LLC
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`6
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing
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`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION TO
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`PETITIONER’S MOTION TO EXCLUDE was served on April 30, 2018, on
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`Counsel for Patent Owner via electronic mail to the following:
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`Dated: April 30, 2018
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`dvarughe-PTAB@skgf.com
`dsterlin-PTAB@skgf.com
`alarock-PTAB@skgf.com
`ueverett-PTAB@skgf.com
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`By: /Michael Houston/
`Michael Houston
`Registration No. 58,486
`Counsel for Petitioner
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