`__________________
`
`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 MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`IPR2020-00040 | Patent 7,326,708
`
`Petitioner Mylan Pharmaceuticals Inc.’s (“Mylan’s”) Reply argued (for the
`
`first time) that the anticipation inquiry should focus on “methanol-based
`
`experiments” rather than other potential ways of making phosphoric acid salts of
`
`sitagliptin. Reply 1–2, 5–10.2 Mylan then argued that the methanol-based
`
`experiments in Dr. Chyall’s first declaration (Exhibit 2225) “[p]roduce[d] 1:1
`
`[s]itagliptin DHP [e]very [t]ime,” which according to Mylan means that the
`
`claimed 1:1 sitagliptin DHP salt is inherently anticipated. E.g., Reply 5. In its
`
`Sur-Reply, Patent Owner Merck Sharp & Dohme Corp. (“Merck”) explained why
`
`this argument is both incorrect and untimely. Sur-Reply 6–11.
`
`In addition to the argument’s substantive deficiencies, the evidence on which
`
`Mylan relies to support it is inadmissible. Dr. Chyall is not a witness in this
`
`proceeding, and Exhibit 2225 is not direct testimony under 37 C.F.R. § 42.53. Yet
`
`Mylan relies on Dr. Chyall’s declaration for the truth of the matters asserted and as
`
`though he were an expert in this case. Exhibit 2225 is thus inadmissible hearsay
`
`under FRE 802.
`
`
`2 As in prior briefs, Merck refers collectively to Petitioners, including the various
`
`remaining Joinder Petitioners, as “Mylan.”
`
`
`
`2
`
`
`
`
`
`Independently, Exhibit 2225 also is inadmissible as expert testimony
`
`IPR2020-00040 | Patent 7,326,708
`
`because it is not reliable under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579
`
`(1993), and FRE 702. The relevant question for inherent anticipation is whether
`
`non-1:1 sitagliptin phosphate salts exist. Sur-Reply 5. Dr. Chyall’s salt screen,
`
`which tested various quantities of sitagliptin freebase and phosphoric acid in
`
`methanol (and only methanol) is not a scientifically valid way of answering—and
`
`did not even purport to answer—that question.
`
`Two additional exhibits are inadmissible to the extent that they rely on Dr.
`
`Chyall’s work in ways that violate the rules of evidence. Exhibit 1030, Dr.
`
`Chyall’s lab notebook, is hearsay and has not been properly authenticated. And
`
`Exhibit 1035, the reply declaration of Mylan’s expert Dr. Chorghade, is
`
`(1) inadmissible hearsay to the extent it recapitulates Dr. Chyall’s statements, and
`
`(2) improper expert testimony under FRE 702 when it relies on Dr. Chyall’s
`
`litigation testimony, as that is not the kind of material on which an expert in his
`
`field ordinarily would rely. Mylan cannot back-door Dr. Chyall’s conclusions
`
`through these other exhibits.
`
`Accordingly, and for the reasons below, Merck hereby moves to exclude
`
`Exhibit 2225 to the extent Mylan relies on it; to exclude Exhibit 1030 in its
`
`entirety; and to exclude Exhibit 1035 to the extent it addresses Exhibit 1030 or
`
`
`
`3
`
`
`
`
`
`Exhibit 2225. Merck timely filed objections to these exhibits on November 24,
`
`IPR2020-00040 | Patent 7,326,708
`
`2020, Paper 68.
`
`II. EXHIBIT 2225 IS INADMISSIBLE FOR THE TRUTH OF THE
`MATTERS IT ASSERTS AND AS EXPERT TESTIMONY
`
`A. Mylan’s Use of Exhibit 2225 Is Hearsay
`
`Exhibit 2225 is a declaration prepared by Dr. Chyall for a proceeding in
`
`Israel. Merck, not Mylan, submitted it in this proceeding. But Merck did not cite
`
`it for the truth of Dr. Chyall’s testimony. Rather, Merck’s expert Dr. Adam
`
`Matzger performed his own experimental work; he made and characterized non-1:1
`
`phosphate salts of sitagliptin, the existence of which rebuts Mylan’s inherent
`
`anticipation case. See POR 15–18; EX2103 ¶¶ 123–76. Dr. Matzger merely cited
`
`Exhibit 2225 because he considered it when designing his experiments—
`
`specifically, as a model of, and motivation for, Dr. Matzger’s experimental
`
`conditions. EX2103 ¶¶ 126, 131.
`
`Mylan’s extensive use of Exhibit 2225, in contrast, is plainly as hearsay.
`
`See, e.g., Reply 1, 4, 6–7, 10, 12. Dr. Chyall is not a witness in this proceeding.
`
`No party adduced his testimony as direct testimony under 37 C.F.R. § 42.53, and
`
`Merck had no opportunity to cross-examine him. Yet Mylan quotes Exhibit 2225
`
`for what it supposedly “establishes,” “shows,” and “demonstrates,” and even the
`
`“conclusions reached in” it—in other words, for the truth of what it says—over and
`
`over. Id. Mylan relies on Dr. Chyall’s description of twelve experiments in
`
`
`
`4
`
`
`
`IPR2020-00040 | Patent 7,326,708
`
`
`
`Exhibit 2225 that, he says, resulted in a 1:1 sitagliptin DHP salt. See Reply at 1, 4,
`
`10, 12. Mylan also relies on Dr. Chyall’s conclusion that “there is only one
`
`possible molecular ratio, a 1:1 ratio.” Reply 1, 6. Each of these uses relies on the
`
`truth of Dr. Chyall’s statements. Exhibit 2225 is probative of Mylan’s arguments
`
`only if Dr. Chyall’s description of his experiments and observations are true or his
`
`conclusions are accepted as correct.
`
`Mylan’s use of Dr. Chyall’s declaration is especially inappropriate because
`
`Mylan insisted that it would not rely on his testimony. Dr. Chyall originally was
`
`an expert witness in one of the joined proceedings; Joinder-Petitioner Teva
`
`Pharmaceuticals, Inc. filed a declaration from Dr. Chyall. That declaration
`
`parroted the conclusions of Mylan’s expert, Dr. Chorghade; it did not disclose the
`
`experiments or conclusions in Exhibit 2225. IPR2021-01045, Exhibit 1002. But
`
`even so, Merck raised the question of whether it would have the opportunity to
`
`depose him. In response, Mylan emphasized that Dr. Chyall was not Mylan’s
`
`expert. In the words of Mylan’s counsel, “To the extent Merck wants to depose
`
`Dr. Chyall, enter into a stipulation regarding Dr. Chyall, or do anything else
`
`with connection with Dr. Chyall, I remind you that Mylan’s expert in
`
`IPR2020-00040 is Dr. Chorghade not Dr. Chyall.” EX2285. After Dr.
`
`Chorghade’s deposition, Teva withdrew its reliance on Dr. Chyall’s testimony, and
`
`Mylan confirmed to the Board that “Mylan is not intending to rely on Dr. Len
`
`
`
`5
`
`
`
`
`
`Chy[a]ll.” EX1018, 9–10; id. at 13 (“As Mr. Fisher notes, our expert is Dr.
`
`Torgotti [phonetic for ‘Chorghade’].”); see Paper 44 (Teva/Watson Joinder
`
`IPR2020-00040 | Patent 7,326,708
`
`Decision) at 5 (“Petitioner also cites the declaration of Dr. Leonard Chyall (Ex.
`
`1002), but has indicated that it will withdraw Dr. Chyall’s declaration, and will
`
`rely instead on the testimony of Mylan’s declarant, Dr. Mukund Chorghade, in the
`
`Mylan IPR if permitted.”).3
`
`That was then. In Mylan’s Reply, Dr. Chyall reappears—as an expert
`
`witness, rendering conclusions on which Mylan relies—in Exhibit 2225.
`
`It is hornbook law that statements in a declaration submitted in a different
`
`proceeding, relied on for their truth, are hearsay unless they fall into an exclusion
`
`or exception, which Exhibit 2225 does not. FRE 801(c); Rose v. Frazer, Int. No.
`
`104,733, Paper 73 at 2–3 (B.P.A.I. Mar. 29, 2002); see FRE 801, 802, 803, 804. It
`
`is therefore inadmissible for the truth of the matters it asserts. The Board should
`
`exclude it to the extent Mylan relies on it for that purpose, and should not rely on
`
`the portions of Exhibit 2225 that Mylan cites. See, e.g., Mexichem Amanco
`
`
`3 Since that time, Merck settled with Teva, so the proceeding in which Dr. Chyall
`
`originally submitted a declaration has now been terminated. IPR2020-01045,
`
`Paper 22.
`
`
`
`6
`
`
`
`
`
`Holdings S.A. de C.V. v. Honeywell Int’l, IPR2013-00576, Paper 36 at 3 (P.T.A.B.
`
`IPR2020-00040 | Patent 7,326,708
`
`Sept. 5, 2014).
`
`B.
`
`Exhibit 2225 Is Inadmissible as Expert Testimony
`
`Even if Exhibit 2225 did not pose insurmountable hearsay problems, the
`
`Board should exclude Dr. Chyall’s conclusions because they are not helpful or
`
`reliable expert testimony under FRE 702. To be reliable and admissible under
`
`FRE 702, expert testimony must not only be “based on data, a methodology, or
`
`studies” that are “[]adequate to support the conclusions reached,” Amorgianos v.
`
`Nat’l R.R. Passenger Corp., 303 F.3d 256, 266 (2d Cir. 2002), but they must “have
`
`a valid scientific connection to the disputed facts of the case.” Allison v. McGhan
`
`Med. Corp., 184 F.3d 1300, 1312 (11th Cir. 1999). Daubert and FRE 702 require
`
`“a valid scientific connection to the pertinent inquiry as a precondition to
`
`admissibility” and emphasize that “scientific validity for one purpose is not
`
`necessarily scientific validity for other, unrelated purposes.” Daubert, 509 U.S. at
`
`591–92.
`
`Dr. Chyall’s opinions do not come close to meeting that standard. They
`
`were not even intended to address the proposition for which Mylan advances them,
`
`nor to address the relevant standard for inherent anticipation. Mylan asserts
`
`
`
`7
`
`
`
`
`
`(incorrectly4) that WO498 teaches an “earlier known process” for making
`
`IPR2020-00040 | Patent 7,326,708
`
`sitagliptin DHP, and proffers Dr. Chyall’s opinions for the proposition that “when
`
`the earlier known process is reproduced, ‘there is only one possible molecular
`
`ratio, a 1:1 ratio . . . of . . . sitagliptin dihydrogen phosphate.’” Reply 1 (quoting
`
`EX2225 at ¶ 52). But Dr. Chyall’s declaration never suggests that there was an
`
`“earlier known process” for making phosphate salts of sitagliptin. EX2225. Nor
`
`does the declaration address what phosphate salts the POSA might make by
`
`following the teachings of WO498, because it never even mentions WO498. Id. In
`
`fact, as Merck has previously explained, Dr. Chyall’s experiments differed from
`
`WO498’s Example 7 in many respects: starting material, acid base, molar ratio of
`
`acid to sitagliptin, dropwise instead of all-at-once addition of the acid,
`
`concentration of the reactants, use of an aqueous solvent system, use of slurry
`
`crystallization, reaction time, and isolation of reaction products. See Sur-Reply 7–
`
`8. Dr. Chyall’s experiments simply are not a “[r]eproduction of WO498.” Reply
`
`5. And because they are not, Exhibit 2225 does not contain reliable, helpful, or
`
`admissible expert testimony for the proposition that reproducing WO498, or any
`
`“earlier known process,” always leads to a 1:1 sitagliptin DHP salt. See In re Paoli
`
`R.R. Yard PCB Litig., 35 F.3d 717, 743 (3d Cir. 1994) (holding that FRE 702
`
`
`4 See Sur-Reply 6–9.
`
`
`
`8
`
`
`
`
`
`requires “good grounds to extrapolate” from the scientific conclusion of an expert
`
`IPR2020-00040 | Patent 7,326,708
`
`to “knowledge for purposes of the case”).
`
`Mylan may respond that, divorced from WO498, Dr. Chyall did address
`
`whether it is “possible” that non-1:1 phosphoric acid salts of sitagliptin exist.
`
`EX2225 ¶ 52. Dr. Chyall’s opinion is unreliable, and is thus inadmissible under
`
`FRE 702, on that point as well. Dr. Chyall did a limited salt screen. He combined
`
`sitagliptin and phosphoric acid in various different proportions and at different
`
`temperatures, to see what different phosphate salts might form. EX2225 ¶¶ 13, 24.
`
`But as Mylan itself emphasizes (trying to make lemonade from lemons), Dr.
`
`Chyall did all of these experiments using a methanol-based solution. Id. ¶ 24; see
`
`Reply 1 (“EX2225 contains 12 methanol-based experiments”). Nowhere did Dr.
`
`Chyall opine that his screen was exhaustive or that his use of methanol (and only
`
`methanol) was representative. He simply said that his experiments “represent
`
`common and reasonable attempts” to make other salt forms—a standard that was
`
`apparently applicable to whatever issues were presented in Israeli proceeding, but
`
`bears no connection to U.S. inherent anticipation law. EX2225 ¶ 52; see, e.g., U.S.
`
`Water Services, Inc. v. Novozymes A/S, 843 F.3d 1345, 1350 (Fed. Cir. 2016).
`
`Conducting a series of experiments that all use methanol is not a reliable
`
`way to determine the relevant inherency question here: whether a 1:1 sitagliptin
`
`DHP “always result[s]” when crystallizing a salt from a solution of sitagliptin and
`
`
`
`9
`
`
`
`
`
`phosphoric acid. U.S. Water Servs., 843 F.3d at 1350–51. Dr. Chyall never
`
`suggested that his methanol-based experiments answer this question. On the
`
`IPR2020-00040 | Patent 7,326,708
`
`contrary, it is undisputed that the solvent matters. Mylan emphasizes as much,
`
`stating that “methanol and isopropanol are not equivalent solvents” and arguing
`
`that “[h]ad [Dr. Matzger] used methanol,” the other parameters he explored would
`
`have yielded a 1:1 salt. Reply 10. Mylan does not dispute that using an
`
`isopropanol solution, Dr. Matzger in fact made non-1:1 phosphoric acid salts of
`
`sitagliptin. Sur-Reply 5; see Reply 8–10. Given these undisputed facts, Mylan
`
`cannot contend that Dr. Chyall’s opinions in Exhibit 2225 are reliable and
`
`admissible evidence to somehow address whether non-1:1 sitagliptin phosphate
`
`salts exist. Dr. Chyall’s work simply did not determine that.
`
`For all these reasons, even if it were proper, non-hearsay testimony, Dr.
`
`Chyall’s declaration is not helpful or reliable expert testimony. Exhibit 2225 fails
`
`to satisfy the requirements of FRE 702 and should be excluded.
`
`III. EXHIBIT 1030 IS INADMISSIBLE
`
`Exhibit 1030 is a lab notebook purporting to belong to Dr. Chyall. Mylan
`
`does not cite it in Reply. As will be discussed further below, its expert, Dr.
`
`Chorghade, uses it to perform a supposed “[i]ndependent [r]eview” of “the
`
`methanol experiments in EX2225.” EX1035 ¶ 63.
`
`
`
`10
`
`
`
`
`
`To begin with, Exhibit 1030 is inadmissible because it is neither sufficiently
`
`authenticated under FRE 901, Linear Tech. Corp. v. Micrel, Inc., 275 F.3d 1040,
`
`IPR2020-00040 | Patent 7,326,708
`
`1055–56 (Fed. Cir. 2001), nor compliant with the heightened requirements for
`
`substantiating technical data under 37 C.F.R. § 42.65. If Mylan had submitted
`
`direct testimony from Dr. Chyall, he could have authenticated his laboratory
`
`notebook and explained his experiments as the rules require. But in using his
`
`Israeli declaration as an end-run around the usual rules on expert testimony, Mylan
`
`left his laboratory notebook without the requisite support. As an initial matter, Dr.
`
`Chyall’s declaration is not testimony at all—merely an inadmissible collection of
`
`hearsay statements—and cannot be the required “affidavit” under § 42.65, nor can
`
`it be relied upon for the truth of what Exhibit 1030 is. See supra § II.A. But even
`
`if it were treated as testimony, it makes no attempt to comply with the
`
`requirements of § 42.65. For example, while it sets forth experimental procedures
`
`for making samples, EX2225 ¶¶ 33–45, it then simply announces conclusions
`
`about XPRD, NMR, and DSC analyses without explanation as to “[h]ow the test
`
`was performed and the data was generated.” 37 C.F.R. § 42.65(b)(3); EX2225
`
`¶¶ 29, 46–47. Dr. Chorghade also cannot authenticate Exhibit 1030 or provide any
`
`of the required information about the experiments it contains because he has no
`
`firsthand personal knowledge to attest to its contents. EX2283, 15:18–17:3. And
`
`while Mylan served a declaration from Noam Blei, counsel for Teva in the Israeli
`
`
`
`11
`
`
`
`IPR2020-00040 | Patent 7,326,708
`
`
`
`proceeding, as supplemental evidence purportedly to authenticate Exhibit 1030, it
`
`does nothing to solve these problems because Mr. Blei lacks personal knowledge
`
`about the technical tests and data in the notebooks, and his declaration does not
`
`come close to complying with the requirements of § 42.65.
`
`Additionally, the Board should exclude Exhibit 1030 because it is
`
`inadmissible hearsay under FRE 801 and 802. Mylan seeks to use the statements
`
`in Exhibit 1030 to prove the truth of the matter asserted—i.e., that Dr. Chyall
`
`performed certain experiments and what the results of those experiments were. See
`
`EX1035 at 35–37. Exhibit 1030 is only probative if its statements are true, and
`
`Merck was not given an opportunity to cross-examine Dr. Chyall. Exhibit 1030
`
`also does not fall under any exceptions to the hearsay rule in FRE 803.
`
`Exhibit 1030 is therefore inadmissible and should be excluded in its entirety.
`
`IV. EXHIBIT 1035 IS INADMISSIBLE TO THE EXTENT IT CITES OR
`RELIES ON EXHIBITS 1030 AND 2225
`
`Exhibit 1035 is a Reply Declaration by Mylan’s expert Dr. Chorghade.
`
`Unlike Merck’s expert Dr. Matzger, Dr. Chorghade performed no experiments of
`
`his own. Instead, large portions of Dr. Chorghade’s Reply Declaration rely on
`
`and/or parrot the inadmissible experiments and conclusions of Dr. Chyall in
`
`Exhibits 2225 and 1030. See EX1035 at 1–29, 35–38. To the extent Dr.
`
`Chorghade relies on Dr. Chyall’s work, his Reply Declaration also is inadmissible.
`
`
`
`12
`
`
`
`IPR2020-00040 | Patent 7,326,708
`
`
`
`To begin with, Dr. Chorghade’s reliance on Dr. Chyall’s declaration and
`
`notebook is inadmissible hearsay under FRE 801 and 802. As discussed above,
`
`Exhibits 2225 and 1030 are inadmissible hearsay, which Mylan relies on for the
`
`truth of the matters asserted. Mylan cannot cure their evidentiary deficiencies by
`
`using Dr. Chorghade as a conduit for inadmissible hearsay evidence. See Williams
`
`v. Illinois, 567 U.S. 50, 80 (2012). Dr. Chorghade has no personal knowledge
`
`about the experiments that Dr. Chyall conducted and cannot testify to their
`
`accuracy. EX2283, 15:18–17:3. The experiments were conducted a decade ago,
`
`without his involvement; he simply read the inadmissible exhibits and then relayed
`
`their contents. EX1035 ¶¶ 8, 16–19, 21–26, 44, 64–67. That testimony is just the
`
`sort of back-door attempt to introduce evidence that the hearsay rules prohibit.
`
`Dr. Chorghade’s status as an expert also does not change this analysis. An
`
`expert witness may rely on inadmissible facts or data if—but only if—“experts in
`
`the particular field would reasonably rely on those kinds of facts or data in forming
`
`an opinion on the subject.” FRE 703. Dr. Chyall’s declaration does not meet that
`
`standard. Much of Dr. Chorghade’s declaration consists simply of repeating the
`
`contents of Dr. Chyall’s declaration, not rendering independent opinions. EX1035
`
`¶¶ 8, 16–19, 21–26, 44, 64–67. Moreover, while Dr. Chorghade states that he “has
`
`spent decades reviewing other people’s experimental data and manuscripts,”
`
`EX1035 ¶ 15, FRE 703 demands more than just familiarity with a general class of
`
`
`
`13
`
`
`
`
`
`documents. Dr. Chorghade admitted that in his work in the pharmaceutical
`
`IPR2020-00040 | Patent 7,326,708
`
`industry, he has never relied on litigation-related opinions. EX2283, 18:18–21.
`
`Neither Mylan nor Dr. Chorghade has established that chemistry experts “would
`
`reasonably rely on” the litigation-driven declaration of another scientist for any
`
`purpose. None of Dr. Chorghade’s use of Exhibit 2225 is admissible.
`
`As to Dr. Chorghade’s use of Exhibit 1030, Dr. Chorghade is explicit that it
`
`adds “no substantive additional details” to Exhibit 2225. EX1035 ¶ 66. Dr.
`
`Chorghade announces a purportedly independent conclusion, but in an entirely
`
`conclusory manner that again simply re-states—and indeed quotes—Dr. Chyall’s
`
`conclusion. EX1035 ¶ 67 (quoting EX2225 ¶¶ 24, 52). Once again, Mylan cannot
`
`evade the hearsay rule simply by having its expert discuss hearsay materials from
`
`another proceeding about which neither he nor any other witness in this proceeding
`
`has personal knowledge. See Williams, 567 U.S. at 80.
`
`Independently, Dr. Chorghade’s declaration should be excluded under FRE
`
`702 to the extent it relies on Exhibits 2225 and Exhibit 1030. All of the FRE 702
`
`arguments discussed above in connection with Exhibit 2225 apply with equal force
`
`to the substantively identical opinions in Exhibit 1035. Whatever exhibit is used to
`
`introduce them, Dr. Chyall’s experiments do not have any “valid scientific
`
`connection to the disputed facts of the case.” Allison, 184 F.3d at 1312. In
`
`addition, Dr. Chorghade has failed to provide any support or reliable methodology
`
`
`
`14
`
`
`
`
`
`that could possibly have led him to the conclusion that one of the exhibits Dr.
`
`IPR2020-00040 | Patent 7,326,708
`
`Chyall performed “is a reproduction of Example 7 of WO498,” when Dr. Chyall
`
`said nothing of the sort and there are significant differences between the
`
`experiments. EX1035 ¶ 67; supra § II.B; Sur-Reply 6–9.
`
`V. CONCLUSION
`
`Exhibits 2225 and 1030, and the portions of Exhibit 1035 that discuss them,
`
`contain litigation-driven experiments performed, and opinions expressed for a
`
`different proceeding, raising different issues, applying different legal standards,
`
`and in a different country. Dr. Chyall, who performed those experiments and
`
`rendered those opinions, has not provided testimony here—and Mylan even
`
`affirmatively disclaimed reliance on him as an expert. Mylan’s attempt to rely on
`
`hearsay statements he presented in that other proceeding, in support of a theory
`
`presented belatedly for the first time in Reply, flouts not only the rules of this
`
`Board but also the Federal Rules of Evidence, and it deprived Merck of the right to
`
`cross-examine him in this proceeding. And Mylan’s efforts to launder Dr. Chyall’s
`
`work through its own expert, Dr. Chorghade, are likewise contrary to the rules.
`
`The Board should exclude the portions of Exhibit 2225 on which only
`
`Mylan relies, and should limit its consideration of Exhibit 2225 to the non-hearsay
`
`uses in Merck’s submissions. It should exclude Exhibit 1030 in its entirety. And it
`
`should exclude Exhibit 1035 to the extent it cites Exhibits 2225 and 1030.
`
`
`
`15
`
`
`
`
`
`Date: January 20, 2021
`
`
`
`
`
`
`
`IPR2020-00040 | Patent 7,326,708
`
`
`
`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.
`
`
`
`
`16
`
`
`
`
`
`IPR2020-00040 | Patent 7,326,708
`
`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
`
`and correct copy of the foregoing was served on January 20, 2021, by delivering a
`
`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
`
`
`
`17
`
`