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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioners,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`IPR2020-000401
`Patent 7,326,708
`__________________
`
`PATENT OWNER’S REPLY IN SUPPORT OF
`MOTION TO EXCLUDE
`
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`1 Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as
`parties to this proceeding via a Motion for Joinder in IPR2020-01060; and Sun
`Pharmaceuticals Industries Ltd. was joined as a party to this proceeding via Motion
`for Joinder in IPR2020-01072.
`
`
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`
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`IPR2020-00040 | Patent 7,326,708
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`Mylan’s Opposition (Paper 83, “Opp.”) proceeds from the startling premise
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`that if an exhibit is in evidence for one purpose, the exhibit is in evidence for all
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`purposes. That is not how the rules of evidence work. “If the court admits
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`evidence that is admissible against a party or for a purpose—but not against
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`another party or for another purpose—the court . . . must restrict the evidence to its
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`proper scope.” Fed. R. Evid. 105. Just such a “restrict[ion]” is required here.
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`Mylan undisputedly relies on Dr. Chyall’s declaration, EX2225, for its truth and
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`for Dr. Chyall’s conclusions as an expert witness. It even begins its Reply with his
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`opinion, which it claims EX2225 “establishes”: that “there is only one possible
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`molecular ratio, a 1:1 ratio . . . of . . . sitagliptin [DHP].” Reply 1. Mylan’s use of
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`the disputed exhibits must comply with Daubert and Fed. R. Evid. 702—and does
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`not. Similarly, Mylan’s use of EX2225 and EX1030 (including indirectly through
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`Dr. Chorghade in EX1035) must comport with the hearsay rule—and does not.
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`Fed. R. Evid. 702. To begin with, the Board should limit the evidence, as
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`Merck’s motion (Paper 91, “Mot.”) requests, based on Rule 702 alone. Mylan
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`never even attempts to defend Dr. Chyall’s statements—including his assertion
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`about what stoichiometries are “possible” (e.g., Reply 1)—as admissible expert
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`opinions on the relevant question for inherency: whether 1:1 sitagliptin DHP is the
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`only salt that can form upon combining sitagliptin and phosphoric acid. Sur-Reply
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`5–9; see Mot. 9. Mylan also does not dispute that Dr. Chyall never considered, let
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`1
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`IPR2020-00040 | Patent 7,326,708
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`alone opined about, WO498. Because Dr. Chyall’s statements neither address the
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`relevant legal standard, nor even Mylan’s new Reply theory that the POSA would
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`seek to replicate WO498’s Example 7 (modified to use phosphoric acid), they are
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`not admissible expert opinions under Rule 702 and must be disregarded. In re
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`Paoli R.R. Yard PCB Litig., 35 F.3d 717, 743 (3d Cir. 1994); Mot. 8.
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`Dr. Chorghade’s hindsight-driven assertion that Dr. Chyall’s experiments
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`anticipate because they are a “reproduction” of WO498, Opp. 14, even though they
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`differ from anything in it, also is unreliable and must be excluded. According to
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`Dr. Chorghade, the POSA would modify the starting material from BOC-protected
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`sitagliptin, the acid from hydrochloric to phosphoric, and myriad other parameters
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`(see Mot. 8; Opp. 14), but not the solvent—no, never the solvent—and thus would
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`arrive at Dr. Chyall’s experimental methods, which he undisputedly selected for a
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`different purpose. Because that opinion has no basis other than Dr. Chorghade’s
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`say-so and is completely disconnected from the law of inherent anticipation, it fails
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`to meet the bar of Rule 702. Mot. 7–9. It must also be disregarded.
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`Mylan’s Use of Hearsay. Separately, Mylan defends its blatant reliance on
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`hearsay using a “goose/gander” argument that Merck cited EX2225 already. The
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`elephant in the room is that Mylan does not dispute that Merck did not rely on
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`EX2225 for its truth, but cited it because Dr. Chyall’s work motivated Dr.
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`Matzger’s experiments. Mot. 4. Given that, it simply is not a response to say
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`2
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`IPR2020-00040 | Patent 7,326,708
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`Merck cited it first, given the hornbook principle that evidence may be admissible
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`“only for a particular purpose” and “not generally against all parties or for all
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`purposes.” 1A Fed. Jury Prac. & Instr. § 11:09 (6th ed.); Tennessee v. Street, 471
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`U.S. 409, 413–15 (1985). That Merck cited and filed the exhibit is thus irrelevant,
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`as are Mylan’s cases (Opp. 1–2) where two parties each cited the same transcript
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`for its truth. The Board can and should limit consideration of Dr. Chyall’s
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`declaration to non-hearsay purposes. See Mylan Pharms. Inc. v. Sanofi‐Aventis
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`Deutschland GmbH, IPR2018‐01676, Paper 84, at 46 (P.T.A.B. May 29, 2020).
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`What is sauce for the goose may not be sauce for the elephant.
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`Timeliness. The distinction between different uses of EX2225 also answers
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`Mylan’s assertion that Merck’s objection is untimely. Opp. 4–5. Merck could not
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`have foreseen Mylan’s improper uses of EX2225, and it timely objected to them.
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`Paper 68. It is no answer for Mylan to argue that Merck knew what was in the
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`document. Mylan used Dr. Chyall’s statements as though they were testimony
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`after it affirmatively represented that it would not use Dr. Chyall as an expert
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`witness in the case. Mot. 5–6. Mylan’s Opposition completely ignores this point,
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`even though it is reason alone to exclude Mylan’s reliance on his work. Id. Merck
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`can hardly be faulted for failing to predict that Mylan would go back on its word.
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`Fed. R. Evid. 801(d)(2)(B). Contrary to Mylan’s suggestion, it is not true
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`that a document becomes an “adoptive admission” under Rule 801(d)(2)(B) simply
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`3
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`IPR2020-00040 | Patent 7,326,708
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`because a party cites it. Merck’s limited use of Dr. Chyall’s declaration and
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`notebook do not come close to an adoption of their entire contents. Mylan’s
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`authorities do not suggest otherwise. Pfizer Inc. v. Teva Pharma. USA, Inc.
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`involved documents created by a party’s own experts and submitted by that party
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`as testimony in another forum. No. 04-cv-00754, 2006 WL 3041102, at *5 (D.N.J.
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`Oct. 26, 2006). And Avocent Redmond Corp. v. Rose Elecs. involved schematics
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`depicting a party’s own devices that the party had produced. 2012 U.S. Dist.
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`LEXIS 162177, *6–9 (W.D. Wash. Nov. 13, 2012). Neither is anything like
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`Merck’s non-hearsay citation of an opposing party’s work.
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`Fed. R. Evid. 807. As to Rule 807, Mylan entirely ignores one prong of the
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`rule, providing that it would only apply if the evidence were “more probative” than
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`“any other evidence” Mylan could obtain with “reasonable effort.” Fed. R. Evid.
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`807(a)(2). Mylan cannot possibly meet that standard. Rule 807 is unavailable
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`where a party “could have retained its own expert.” N5 Tech. LLC v. Capital One
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`N.A., 56 F. Supp. 3d 755, 765 (E.D. Va. Jan. 30, 2014). Mylan did so, but unlike
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`Merck elected to rely on Dr. Chyall’s experiments instead of performing its own.
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`Mylan also unilaterally resisted offering expert testimony from Dr. Chyall, even
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`though its co-Petitioner Teva retained him for this proceeding. Mot. 5–6.
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`Mylan’s supposed “guarantees of trustworthiness,” moreover, indicate at
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`most that Dr. Chyall performed experiments and that some of his experimental
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`4
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`IPR2020-00040 | Patent 7,326,708
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`conditions yielded a 1:1 sitagliptin DHP salt. Opp. 7–8. That does not mean that
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`Mylan can rely on all of his results for their truth, let alone introduce hearsay
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`expert opinions that go far beyond those experimental results. For similar reasons,
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`the supposed lack of a dispute about the authenticity of Dr. Chyall’s notebook
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`(EX1030) has nothing to do with whether it is hearsay or meets the Board’s rules
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`on use of technical data. The authenticating declaration (EX1036) does nothing to
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`cure these problems. And Mylan cannot meet 37 C.F.R. § 42.65’s requirement for
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`an “affidavit” substantiating technical data, nor evade the hearsay rules, simply by
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`having its expert (who had nothing to do with the experiments) cite and repeat Dr.
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`Chyall’s out-of-court statements. Mot. 11; see EX1035 ¶ 64 n.32.
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`37 C.F.R. § 42.51(b)(1)(iii). Finally, contrary to Mylan’s arguments, 37
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`C.F.R. § 42.51(b)(1)(iii) is wholly irrelevant. Rule 42.51 relates to discovery of
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`evidence, not admissibility, as does the one case Mylan cites; Mylan has not
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`moved for any discovery relief. See 37 C.F.R. § 42.62 (admissibility governed by
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`the Federal Rules of Evidence). Moreover, the allegation that Merck “withheld
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`EX2225 and EX1030 in an effort to prevent Institution” is entirely unfounded.
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`Merck introduced EX2225 into this proceeding. It did not introduce EX1030
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`because it had no reason to. And as Merck discusses at length in its Sur‐Reply
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`(and Motion to Exclude), Dr. Chyall’s experiments are not inconsistent with
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`Merck’s positions, so Merck had no obligation to produce them. Sur‐Reply 6–12.
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`5
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`IPR2020-00040 | Patent 7,326,708
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`
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`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`David M. Krinsky (Reg. No. 72,339)
`Elise M. Baumgarten (Pro Hac Vice)
`Alexander S. Zolan (Pro Hac Vice)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`sfisher@wc.com
`bgenderson@wc.com
`dkrinsky@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`
`
`6
`
`Date: February 3, 2021
`
`
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`
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`IPR2020-00040 | Patent 7,326,708
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on February 3, 2021, by delivering a
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`copy via electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`Jovial Wong
`Charles B. Klein
`Claire A. Fundakowski
`Zachary B. Cohen
`WINSTON & STRAWN LLP
`1901 L. Street, N.W.
`Washington, D.C. 20036
`(202) 282-5000
`Sunipr@winston.com
`
`
`
`
`
`
`
`
`
`
`
`Russell W. Faegenburg
`Tedd W. Van Buskirk
`Michael H. Teschner
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK, LLP
`20 Commerce Drive
`Cranford, New Jersey 07016
`(908) 518-6367
`Rfaegenburg.ipr@ldlkm.com
`Tvanbuskirk@lernerdavid.com
`litigation@lernerdavid.com
`MTeschner.ipr@ldlkm.com
`
`
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`
`
`7
`
`
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