IN THE 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.1
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`__________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`1 Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as a party 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.
`
`
`____________________
`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.1
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`__________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`1 Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as a party 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.
`
`
`
`TABLE OF CONTENTS
`
`Page
`Dr. Chyall’s Experiments ................................................................................ 3
`Merck’s Objection to EX2225 is Untimely ..................................................... 4
`EX2225 Is Admissible at least under FRE 801(d)(2)(B) and FRE 807 .......... 5
`EX1030 Is Admissible ..................................................................................... 9
`EX2225 and EX1030 Are Inextricably Part of this Proceeding Under Rule
`§ 42.51(b)(1)(iii) ............................................................................................10
`Any Alleged Prejudice Merck Faces is a Product of its Own Inaction .........12
`Many of Merck’s Criticisms Go to the Weight Not Admissibility ...............13
`No Paragraph In EX1035 Should be Excluded .............................................15
`
`i
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Avocent Redmond Corp. v. Rose Elecs.,
`2012 U.S. Dist. LEXIS 162177 (W.D. Wash. Nov. 13, 2012) ....................... 6, 15
`Caterpillar, Inc. v. Wirtgen Am., Inc.,
`IPR2018-01091, Paper 49 (P.T.A.B. Nov. 27, 2019) ........................................... 1
`Cephalon, Inc. v. Watson Pharm., Inc.,
`769 F. Supp. 2d 761 (D. Del.), aff'd, 446 F. App'x 306 (Fed. Cir.
`2011) ..................................................................................................................... 1
`Gillette Co. v. Energizer Holdings, Inc.,
`405 F.3d 1367 (Fed. Cir. 2005) ............................................................................ 8
`Nichia Corp. v. Emcore Corp.,
`IPR2012-00005, Paper 19 (PTAB Mar. 26, 2013) ............................................. 10
`Pfizer Inc. v. Teva Pharm. USA, Inc.,
`No. 04-cv-00754, 2006 WL 3041102 (D.N.J. Oct. 26, 2006) .............................. 6
`Pfizer, Inc. v. Chugai Pharm. Co. Ltd.,
`IPR2017-01357, Paper 56 (PTAB. Nov. 28, 2018) ............................................ 11
`Tanabe Seiyaku Co. v. U.S. Int’l Trade Comm’n,
`109 F.3d 726 (Fed. Cir. 1997) .............................................................................. 8
`Unified Patent LLC v. Mobilepay LLC,
`IPR2019-00466, Paper 36 (PTAB Jul. 29, 2020) ................................................. 4
`Rules
`Fed. R. Evid. 801(d)(2) .............................................................................................. 6
`Fed. R. Evid. 801(d)(2)(B) ................................................................................. 2, 5, 6
`Fed. R. Evid. 807 ................................................................................................... 2, 5
`Fed. R. Evid. 807(a) ................................................................................................... 7
`
`ii
`
`
`
`Fed. R. Evid. 807(a)(3) .............................................................................................. 7
`Regulations
`37 C.F.R. § 42.51(b)(1)(iii) ...................................................................... 9, 10, 11, 12
`37 C.F.R. § 42.64 ....................................................................................................... 9
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 4
`37 C.F.R. § 42.65 ..................................................................................................... 10
`37 C.F.R. § 42.65(b) ................................................................................................ 10
`
`iii
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`
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`Merck and its expert Dr. Matzger—not Mylan—introduced and relied upon
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`Dr. Chyall’s work in EX2225. Specifically, Dr. Matzger relied on (1) the methanol
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`experiment of which Merck now complains (EX2103, ¶126 (citing EX2225, ¶¶23-
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`25)) and (2) a solubility study related to pH (EX2103, ¶131 (citing EX2225 at ¶69)).
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`Dr. Matzger fully understood Dr. Chyall’s methanol experiments since he even
`
`provided a brief summary. EX2103, ¶126. Mylan’s expert Dr. Chorghade’s reliance
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`on the same methanol experiments that Merck relied on is entirely proper. EX1035,
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`¶10; see also EX1035, ¶¶11-44. What is good for the goose is good for the gander.
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`Merck’s effort to exclude only Mylan’s use of Dr. Chyall’s experiments while
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`unabashedly contending that it have unfettered discretion to rely on those
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`experiments smacks of unfairness. Merck’s Motion to Exclude (“Motion”) at 15
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`(“The Board should exclude the portions of EX2225 on which only Mylan relies,
`
`and should limit its consideration of EX2225 to the non-hearsay uses in Merck’s
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`submissions.”). The PTAB has refused to entertain Patent Owner’s wielding of the
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`proverbial sword while shielding Petitioner’s use of the same material. Caterpillar,
`
`Inc. v. Wirtgen Am., Inc., IPR2018-01091, Paper 49, at 71 (P.T.A.B. Nov. 27, 2019)
`
`(“We will not endorse Patent Owner’s attempt to use the transcript as a sword for its
`
`purposes, and our rules as a shield to prevent Petitioner from using the same
`
`transcript to rebut Patent Owner’s contentions.”); Cephalon, Inc. v. Watson Pharm.,
`
`Inc., 769 F. Supp. 2d 761, 772 (D. Del.), aff’d, 446 F. App’x 306 (Fed. Cir. 2011)
`
`1
`
`
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`(denying motion to strike where party opened the door to the evidence and attempted
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`to use such testimony as “a shield” but restrict the other party’s use as a “sword”).
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`Well before Mylan cited Dr. Chyall’s experiments, Merck represented to the
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`PTAB that Dr. Chyall had, in fact, run these very experiments and generated the very
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`data that it now complains about. Merck’s Opposition to Teva’s Joinder Motion,
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`IPR2020-01045, Paper 9 at 6 (“Dr. Leonard Chyall[] generated non-privileged data
`
`and analysis relating to the feasibility of sitagliptin accepting a second proton and
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`creating non-1:1 dihydrogenphosphate salts of sitagliptin.”). Even Merck’s Motion
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`does not deny that the methanol experiments in EX2225 were, in fact, done. Motion
`
`at 15 (“Dr. Chyall, who performed those experiments and rendered those opinions”).
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`Further, to support the admission of EX2225, Merck’s attorney explained EX2225
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`is an official record of the Israeli Patent Office and is a “true and correct” copy.
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`EX1028, ¶¶3, 9. Merck’s counsel even directly stated to this Panel, without any
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`qualifications, that EX2225 “bear[s] on an issue that is already in this proceeding
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`whether this 1:1 salt is inherently[] anticipated.” EX2041, 15:7-14. Mylan agrees.
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`EX2225, including the portions discussing the methanol testing, is non-
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`hearsay both because Merck affirmatively introduced this exhibit into evidence and
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`because it is an adoptive admission of Merck. FRE 801(d)(2)(B). It is also
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`admissible under Rule 807 (as is EX1030), given the substantial guarantees of
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`trustworthiness surrounding this document, not the least of which is Merck’s reliance
`
`2
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`
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`on it and failure to even suggest Dr. Chyall’s data is either unreliable or inaccurate.
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`Even if it were deemed inadmissible, Dr. Chorghade may rely on Dr. Chyall’s salt
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`data because it is exactly the kind of information on which experts routinely rely—
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`experimental data regarding salt formation, and which goes to an issue on which he
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`opines: the anticipation of a 1:1 DHP salt in light of the prior art.
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`Dr. Chyall’s Experiments
`
`Before even filing its Response, Merck represented to the PTAB that “in prior
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`patent office proceedings in Israel … Dr. Leonard Chyall[] generated non-privileged
`
`data and analysis relating to the feasibility of sitagliptin accepting a second proton
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`and creating non-1:1 dihydrogenphosphate salts of sitagliptin.” IPR2020-01045,
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`Paper 9 at 6. Mylan agrees that Dr. Chyall’s experiments show this; in fact, they
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`show that when sitagliptin and excess phosphoric acid are contacted in methanol (or
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`methanol-based aqueous solutions), only the 1:1 DHP salt was produced.
`
`As Dr. Chorghade’s Reply Declaration then noted, Dr. Chyall had, for all
`
`purposes, reproduced Example 7 of WO ‘498 where excess phosphoric acid was
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`substituted for excess hydrochloric acid. (EX1035, ¶¶ 24-28). Dr. Chyall’s testing
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`is probative of anticipation: whether the claimed 1:1 DHP salt was anticipated by
`
`the prior art process, not “whether non-1:1 sitagliptin phosphate salts” may “exist”
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`under any possible experimental condition as Merck alleges. Motion at 3. Dr.
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`Matzger, while relying on the same paragraphs in Dr. Chyall’s declaration, offered
`
`3
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`
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`no rebuttal to them, nor did he challenge the accuracy of the data. EX2103, ¶126
`
`(citing EX2225, ¶23-25). This is where the record stands today.
`
`Merck’s Objection to EX2225 is Untimely
`
`At the outset, Merck’s objection to EX2225 is untimely. According to PTAB
`
`E2E, EX2225 was served August 21, 2020. Merck does not dispute that it filed its
`
`objection on November 24, 2020. Motion at 4. To the extent Merck wanted to object
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`to any part of EX2225, it should have done so by August 28, 2020. Rule 42.64(b)(1)
`
`(“any objection must be filed within five business days of service of evidence to
`
`which the objection is directed”); Unified Patent LLC v. Mobilepay LLC, IPR2019-
`
`00466, Paper 36 at 10-11 (PTAB Jul. 29, 2020). Nothing in the plain text of Rule
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`42.64(b)(1) prevents a party from objecting to its own exhibit.
`
`Merck cannot plead ignorance as to the contents of its own exhibit. EX2225
`
`is from a proceeding in Israel that Merck actively participated in. Merck’s expert
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`Dr. Matzger reviewed this exhibit, cited and relied on it in his August 21, 2020
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`declaration, including the same methanol experiments that Mylan cites in its Reply.
`
`EX2103, ¶126 (citing EX2225, ¶23-25), ¶¶130-131. Even before that, on July 15,
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`2020, about a month before it filed its Response, Merck doubled down on the
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`relevance of EX2225: it “bear[s] on an issue that is already in this proceeding,
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`whether this 1:1 salt is inherently[] anticipated.” EX2041, 15:7-14 (transcript of
`
`hearing). Likewise, on July 9, 2020, in its Opposition to Teva’s Joinder Motion,
`
`4
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`
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`Merck again pointed to Dr. Chyall’s experiments. IPR2020-01045, Paper 9 at 6.
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`Given Merck’s multiple reviews of EX2225 and Dr. Matzger’s discussion of
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`and reliance on this exhibit, including Dr. Chyall’s methanol experiments, Merck
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`was fully aware of Dr. Chyall’s methanol experiments when it filed its Response in
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`August and repeatedly represented to the Board EX2225’s import to this matter.
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`And yet, despite this knowledge, Merck only objected to EX2225 on November 24,
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`2020 after Mylan addressed EX2225. If any part of EX2225 was objectionable, it
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`would have been objectionable months earlier when Merck filed its Response. As
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`previously noted, of course Merck could have objected to its own exhibit. It did not.
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`Rather, it was buried in over 200 exhibits Merck served. Merck’s failure to timely
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`object to EX2225 is inexcusable, and Mylan’s pointing out that EX2225 undermines
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`Merck’s arguments does not serve as a basis for Merck to now object.
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`EX2225 Is Admissible at least under FRE 801(d)(2)(B) and FRE 807
`
`Merck argues “statements in a declaration submitted in a different proceeding,
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`relied on for the truth, are hearsay unless they fall into an exclusion or exception”
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`(Motion at 6). However, Merck put EX2225 into evidence by relying on it, including
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`the portions regarding the methanol experiments (EX2103, ¶¶126, 131), and Mylan
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`may rely on an exhibit that is already in evidence. As Merck’s own Motion admits
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`“Dr. Chyall…performed those experiments and rendered those opinions.” Motion
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`at 15. EX2225 is also an adoptive admission because Merck submitted, and
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`5
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`
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`affirmatively relied on, the entire Chyall declaration. Merck’s Response (IPR2020-
`
`00040) Paper 41 at 17 (providing an unqualified citation to “EX2225”).
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`Under FRE 801(d)(2)(B), a statement is not hearsay if it is an opposing party’s
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`admission, which includes “adoptive admissions,” i.e., statements that the opposing
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`party effectively “adopted.” Courts have routinely rejected attempts by a party to use
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`the rules of evidence as a shield against an opponent, but as a sword in advancing its
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`own interest. Pfizer Inc. v. Teva Pharm. USA, Inc., No. 04-cv-00754, 2006 WL
`
`3041102, at *5 (D.N.J. Oct. 26, 2006) (“Teva argues that the affidavits are
`
`admissible under section (B) of Rule 801(d)(2) . . . because Pfizer manifested an
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`adoption or belief in the truth of the affidavits by relying on them in the briefs it
`
`submitted to the European Patent Office. . .The Court agrees. . . .Pfizer cannot use
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`the expert affidavits to support its European patent application and then deny that it
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`accepts the truth of the information contained therein.”); Avocent Redmond Corp. v.
`
`Rose Elecs., 2012 U.S. Dist. LEXIS 162177, *7-9 (W.D. Wash. Nov. 13, 2012) (3rd
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`party schematic documents produced by defendant as representative of its products
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`held non-hearsay under FRE 801(d)(2)).
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`Merck not only submitted the Chyall declaration, it affirmatively relies on the
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`entire declaration to advance its own arguments. Merck’s Response (IPR2020-
`
`00040) Paper 41 at 17 (providing an unqualified citation to “EX2225”). Merck’s
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`expert relied on Chyall (and his methanol experiments) to substantively support his
`
`6
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`
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`argument about how a POSA should conduct testing and to contradict Dr. Chorghade
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`on this point. EX2103, ¶126. Further, Merck explicitly argued to the Board that
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`EX2225 “bear[s] on an issue that is already in this proceeding, whether this 1:1 salt
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`is inherently[] anticipated.” EX2041, 15:7-14. Merck’s attempt to rely on EX2225,
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`while claiming that Mylan cannot, should be rejected.
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`EX2225 also falls into the residual hearsay exception of FRE 807, given the
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`substantial guarantees of trustworthiness that Merck’s own use of the exhibit
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`demonstrates. See FRE 807(a). Significantly, Merck has repeatedly stated to the
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`PTAB that Dr. Chyall, in fact, ran the methanol experiments and generated the data
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`contained therein: “Dr. Leonard Chyall[] generated non-privileged data and analysis
`
`relating to the feasibility of sitagliptin accepting a second proton and creating non-
`
`1:1 dihydrogenphosphate salts of sitagliptin.” Teva Opposition at 6; Motion at 15
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`(“Dr. Chyall…performed those experiments and rendered those opinions”); Motion
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`at 8 (same). Further, Dr. Matzger reviewed EX2225 and relied on it for propositions
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`he sought to advance. EX2103, ¶126 (“See EX2225 (Chyall First Decl., August 3,
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`2010) at ¶¶23–25”), ¶131”). Dr. Matzger never challenged the reliability of Dr.
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`Chyall’s data, and that data is probative of the relevant issue because it uses process
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`conditions recited in the prior art, for example, methanol solvent and ambient
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`temperature conditions. See FRE 807(a)(3).
`
`In addition to EX2225, Merck cited other declarations from the Israeli
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`7
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`
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`proceeding (which it does not seek to exclude) as accurately reporting Dr. Chyall’s
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`work. EX2103, ¶131; Response (Paper 41) at 17. As Merck’s Israeli attorney
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`explains, EX2225, along with other documents, are “true and correct copies of
`
`documents submitted by the parties and their experts—Dr. Leonard J. Chyall for
`
`Teva and Dr. Jerry Atwood for Merck—in the forgoing Israeli patent opposition
`
`proceedings.” EX2225, ¶¶3, 9. As an Official Record on the Israeli Patent Office,
`
`the PTAB should consider it. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d
`
`1367, 1374 (Fed. Cir. 2005); Tanabe Seiyaku Co. v. U.S. Int’l Trade Comm’n, 109
`
`F.3d 726, 733 (Fed. Cir. 1997).
`
`EX2225 also includes an attestation to the truth by Dr. Chyall. EX2225, at
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`27. Merck, through its expert, Dr. Atwood, had the opportunity to challenge the
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`content of EX2225. See, e.g., EX2221, ¶50 et seq. But Dr. Atwood did not dispute
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`that Dr. Chyall had, in fact, made the 1:1 DHP salt in his methanol experiments.
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`EX2221, ¶72 (“In the remaining five experiments (4063-03-01, 4063-19-01, 4063-
`
`32-01, 4063-50-01, 4063-56-01), Dr. Chyall used a molar excess of phosphoric
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`acid”); see also EX2192, ¶55 (“Despite varying conditions, solvents and molar ratios
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`of starting materials, every salt that I obtained was determined to be sitagliptin
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`dihydrogenphosphate salt (a 1:1 salt). Indeed, Prof. Atwood does not dispute the
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`results of these experiments”). In addition, Merck had the opportunity to seek
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`testimony from Dr. Chyall in the Israeli proceeding and even put an excerpt from
`
`8
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`
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`such testimony into this record. EX2227. To the extent Merck wanted to discuss
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`anything with Dr. Chyall in connection with his work in the Israeli Proceeding, or
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`submit any other testimony it received from Dr. Chyall to the PTAB, clearly it had
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`a full and fair opportunity to do so. For all the above reasons, EX2225 is admissible.
`
`EX1030 Is Admissible
`
`As explained below, Merck should have produced EX1030 under Rule
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`42.51(b)(1)(iii). Putting Rule 42.51(b)(1)(iii) aside, EX1030 is also admissible
`
`under FRE807. The record is replete with references to this very Notebook 4063.
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`For example, a search of EX2221 shows 53 references to it, and EX2225 shows 38
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`references to it. The contents of EX1030 are easily corroborated by matching them
`
`to the 91 references to Notebook 4063 in EX2221 and EX2225.
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`Merck’s argument concerning the authenticity of EX1030 also fails. Mylan
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`need only demonstrate that the document is what it purports to be, and there is no
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`doubt or uncertainty that EX1030 is Dr. Chyall’s genuine laboratory notebook (No.
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`4063), given that Merck itself has introduced and relied upon evidence (such as
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`EX2221 and EX2225) that repeatedly refers to Notebook 4063 and corroborates that
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`EX1030 contains the information that Mylan purports it contains. Furthermore,
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`Mylan files concurrently with this Paper supplemental evidence pursuant to
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`Rule 42.64 from Noam Blei, counsel for Teva Pharmaceuticals Industries Ltd. in the
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`Israeli proceeding which involved Merck. See EX1036, ¶1. As Mr. Blei explains,
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`9
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`
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`“Exhibit No. 1030, and it is a true and correct copy of Notebook No. 4063 from Dr.
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`Leonard J. Chyall, which was produced by Teva to Merck and submitted by the latter
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`in the foregoing Israeli patent opposition proceedings.” EX1036, ¶3.
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`Merck’s contention that EX1030 does not comply with 37 C.F.R. § 42.65 is
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`also incorrect. Motion 11-12. Both Dr. Chorghade’s declaration and Dr. Chyall’s
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`declaration meet the requirements of this rule with respect to the tests conducted in
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`EX1030. Dr. Chorghade explained in detail how Dr. Chyall’s salt experiments were
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`run, and how XRPD, NMR, DSC, and elemental analysis, techniques well regarded
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`in the art (and used by Merck’s own ’708 Patent, EX1001), were used to generate
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`the data and determine the salt that had been formed. EX1035 ¶¶16-23; Rule
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`42.65(b). Likewise, Dr. Chyall’s declaration explains the same information in detail.
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`EX2225, ¶¶22-52. EX1030 (and EX2225) meet the requirements of Rule 42.65.
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`EX2225 and EX1030 Are Inextricably Part of this Proceeding Under
`Rule 42.51(b)(1)(iii)
`Merck’s Motion does not address the requirements of Rule 42.51(b)(1)(iii).
`
`Rule 42.51(b)(1)(iii) states, “[u]nless previously served, a party must serve relevant
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`information that is inconsistent with a position advanced by the party during the
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`proceeding concurrent with the filing of the documents or things that contains the
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`inconsistency.” Rule 42.51(b)(1)(iii) is self-executing and does not require
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`assistance from the PTAB. Nichia Corp. v. Emcore Corp., IPR2012-00005, Paper
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`19 at 2 (PTAB Mar. 26, 2013). EX2225 and EX1030 should have been served by
`
`10
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`
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`Merck when it filed its POPR. Rule 42.51(b)(1)(iii). And Merck can hardly feign
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`ignorance of Rule 42.51(b)(1)(iii) given it stated when filing its POPR it “ha[d] been
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`mindful of its duty to ‘serve relevant information that is inconsistent with [its]
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`position.’ 37 C.F.R. § 42.51(b)(1)(iii).” Paper 14 at 7 n.1. Clearly not. Merck
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`withheld EX2225 and EX1030 in an effort to prevent Institution. EX2225 and
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`EX1030 are inseparably part of this proceeding under Rule 42.51(b)(1)(iii).
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`And Merck can hardly dispute that it had EX2225 in its possession since
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`Merck introduced EX2225 into this proceeding. Likewise, EX1030 has always been
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`in Merck’s possession. EX1036, ¶3 (explaining EX1030 “was produced by Teva to
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`Merck and submitted by the latter in the foregoing Israeli patent opposition.”).
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`Indeed, even Merck’s other exhibits in this proceeding indicate that Merck itself had
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`possession of EX1030 by making reference to Chyall’s Lab Notebook 4063.
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`EX2221, ¶51, 62, 64, 65, p.367-368. But oddly, Merck never produced Notebook
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`4063 (EX1030)—despite producing another notebook from Dr. Chyall that Merck
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`believed supported its case. EX2226 (#4061).
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`EX2225 and EX1030 are also inconsistent with Merck’s positions. Merck
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`admits this. Motion at 5 (“EX2225 is probative of Mylan’s arguments only if Dr.
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`Chyall’s description of his experiments and observations are true or his conclusions
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`are accepted as correct.”). Merck made no attempt to harmonize its positions with
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`inconsistent information in its possession; Mylan has every right to point out
`
`11
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`
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`Merck’s inconsistent positions to the PTAB. Cf. Pfizer, Inc. v. Chugai Pharm. Co.
`
`Ltd., IPR2017-01357, Paper 56 at 22 (PTAB. Nov. 28, 2018) (noting consistency
`
`with positions taken before the European Patent Office).
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`Any Alleged Prejudice Merck Faces is a Product of its Own Inaction
`Merck complains that it “had no opportunity to cross-examine [Dr. Chyall].”
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`Motion at 4, 12. In truth, Merck did get testimonial evidence from Dr. Chyall and
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`even put a transcript from the Israeli proceeding from him into this proceeding.
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`EX2227. And Merck had a similar motive in the Israeli proceeding to develop Dr.
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`Chyall’s
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`testimony
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`through cross-examination on Dr. Chyall’s methanol
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`experiments, including the opportunity to challenge Dr. Chyall’s data.
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`Merck then cherry picks certain quotes from Mylan regarding Dr. Chyall
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`when Merck was improperly withholding EX2225 and EX1030 contrary to the
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`provisions of Rule 42.51(b)(1)(iii). Where Mylan left things is best reflected in the
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`hearing transcript: “Obviously we will reserve our rights regarding any discovery
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`[Merck] may raise in connection with any of the other Joint Petitioners and Dr.
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`Chy[a]ll . . . . So basically we will cross the remaining bridges when we get to it if
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`and when Merck decides to file any discovery motion.” EX1018 at 13:15-14:2.
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`But more importantly, the PTAB repeatedly explained that to the extent
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`Merck wanted any additional discovery—and specifically making a reference to the
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`Israeli Proceeding—it may pursue it: “Merck is not precluded from pursuing it, and,
`
`12
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`
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`if the parties reach an impasse after exhausting good faith efforts, asking for the
`
`Board’s help in promptly resolving the dispute.” Joinder Orders in IPR2020-
`
`00040, Paper 44 at 9, 10 (“Merck then cites a foreign patent office proceeding”); see
`
`also Paper 45 (DRL) at 9-10; Paper 46 (DRL) at 9-10. As the PTAB explained,
`
`“there is no adequate basis to conclude that such issues cannot be addressed promptly
`
`and fairly within the confines of the current schedule.” Teva Joinder Order at 10.
`
`To the extent Merck complains that it “had no opportunity to cross-examine
`
`[Dr. Chyall]” (Motion at 4) or failed to receive any other discovery, nothing
`
`precluded Merck from making such a request. But Merck has never made any such
`
`request to Mylan or “ask[ed] for the Board’s help in promptly resolving the dispute”
`
`upon Mylan’s refusal to provide any such discovery. Put simply, Mylan has never
`
`refused Merck any discovery. To that end, Mylan has not even filed its own Motion
`
`to Exclude any Evidence. Merck knew about the contents of EX2225 and EX1030
`
`well before Institution. Any prejudice Merck complains about is of its own making.
`
`Many of Merck’s Criticisms Go to the Weight Not Admissibility
`Merck’s challenge under FRE 702 is based exclusively on Merck’s erroneous
`
`assumption that any and all solvents, conditions and methodologies may be
`
`considered in assessing the question of anticipation. The proper question is whether
`
`Dr. Chyall’s testing bears on whether a 1:1 DHP salt is anticipated by the prior art
`
`process (i.e., the one disclosed in WO498). The “fit” of this evidence is pertinent,
`
`13
`
`
`
`regardless of whether Dr. Chyall set out to reproduce Example 7 of WO498.
`
`Merck’s baseless criticisms go, if anything, to the weight of the evidence. For
`
`example, Merck suggests that Mylan is not relying on methanol in WO ‘498. Motion
`
`at 2, 9. Mylan and its expert expressly identified methanol and the temperature
`
`conditions of Example 7 of WO ‘498 to meet the express claim limitations. Pet. at
`
`28 (“WO ‘498 discloses using methanol”), 30, 37, 38, 45, 58; EX1002, ¶¶98, 101,
`
`116, 117, 134, 135, 161; EX1035, ¶26 (“Experiment 4063-19-01 uses 1:5.01 molar
`
`ratio of sitagliptin to phosphoric acid. The reaction was done in methanol (like
`
`Example 7) and at ambient temperatures”). As to Merck’s other alleged differences
`
`(Motion at 8), Dr. Chorghade addressed these upfront and explained why they would
`
`have no bearing and why the POSA would consider Dr. Chyall’s work a
`
`reproduction of Example 7 when phosphoric acid was used in the place of HCl:
`
`Merck’s Motion at 8
`
`“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”
`
`Dr. Chorghade (Representative
`Citations)
`EX1035, p.4, n.3, p.14, n.11; see also
`EX2283, 93:9-94:15
`EX1035, ¶¶26, 27, 46; see also
`EX2283, 92:5-93:7
`EX1035, ¶¶26-28; see also EX2283,
`92:5-93:7
`EX1035, ¶¶36-37
`
`EX1035, ¶¶28, 34-35, 41-42
`EX1035, ¶27 (“phosphoric acid always
`contains water”), ¶56; EX2283, 34:12-
`17, 35:2-8, 59:15-19, 94:19-96:1
`EX1035, ¶¶38-39; see also EX2283,
`
`14
`
`
`
`“Reaction time”
`“Isolation of reaction products”
`
`97:4-16
`EX1035, ¶¶29-31
`EX1035, ¶40
`
`Merck never points to how its perceived differences would impact the results
`
`of Dr. Chyall’s work. The results of Dr. Chyall’s experiments are clear: no matter
`
`how the process conditions were changed by Dr. Chyall’s 12 experiments, if
`
`phosphoric acid contacted sitagliptin in methanol, only a 1:1 DHP salt was formed.
`
`No Paragraph In EX1035 Should be Excluded
`Merck also seeks to preclude Dr. Chorghade from relying on EX2225 and
`
`EX1030 in his Declaration. For all the above reasons, EX2225 and EX1030 are
`
`admissible and therefore Dr. Chorghade may rely on EX2225 and EX1030.
`
`Furthermore, as FRE 703 explains, “an expert may base an opinion on facts or data
`
`in the case that the expert has been made aware of….If experts in the particular field
`
`would reasonably rely on those kinds of facts or data in forming an opinion on the
`
`subject, they need not be admissible for the opinion to be admitted.” As
`
`Dr. Chorghade explained, Dr. Chyall’s work is the kind of work an expert would
`
`reasonably rely on to form an opinion. EX1035, ¶15; Avocent, 2012 U.S. Dist.
`
`LEXIS 162177, at *9-10. Dr. Matzger also relied on this work without raising any
`
`concerns, corroborating Dr. Chorghade’s opinion that it represents the kind of work
`
`an expert would rely on to form an opinion. EX2103, ¶126 (“See EX2225 (Chyall
`
`First Decl., August 3, 2010) at ¶¶ 23–25”); ¶131.”).
`
`15
`
`
`
`Date: January 27, 2021
`
`RESPECTFULLY SUBMITTED,
`
`Katten Muchin Rosenman LLP
`
`/ Jitendra Malik /
`
`Jitendra Malik (Reg. No. 55,823)
`
`Lead Counsel for Petitioner
`
`16
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on January 27, 2021, a complete copy of the foregoing Paper,
`
`Supplemental Exhibit List, and Exhibit 1036, were served via email to the Patent
`
`Owner by serving the correspondence address of record and joinder Petitioners:
`
`sfisher@wc.com
`
`jberniker@wc.com
`
`smahaffy@wc.com
`
`asheh@wc.com
`
`bgenderson@wc.com
`
`ebaumgarten@wc.com
`
`azolan@wc.com
`
`jwong@winston.com
`
`ZCohen@winston.com
`
`CKlein@winston.com
`
`Cfundakowski@winston.com
`
`rfaegenburg@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`mteschner@lernerdavid.com
`
`17
`
`
`
`Respectfully submitted,
`
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
`
`18
`
`
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