`
`STANLEY E. FISHER
`(202) 434-5289
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`sfisher@wc.com
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`Via Email
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`June 26, 2020
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`Jitendra Malik, Ph.D.
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`
`Keith A. Zullow
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`kzullow@goodwindprocter.com
`
`
`
`Russell W. Faegenburg
`Lerner, David, Littenberg, Krumholz &
`Mentlik, LLP
`20 Commerce Drive,
`Cranford, New Jersey 07016
`rfaegenburg@lernerdavid.com
`
`Jovial Wong
`Winston & Strawn LLP
`1901 L STREET, NW
`Washington, DC 20036
`JWong@winston.com
`
`Re: Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040;
`Teva Pharmaceuticals USA, Inc. et al. v. Merck Sharp & Dohme Corp., IPR2020-
`01045; Dr. Reddy’s Laboratories, Inc. et al. v. Merck Sharp & Dohme Corp.,
`IPR2020-01060; Sun Pharmaceuticals Industries Ltd. v. Merck Sharp & Dohme
`Corp., IPR2020-01072
`
`Dear Counsel,
`
`I write in connection with the motions filed by (1) Teva Pharmaceuticals USA, Inc. and
`Watson Laboratories, Inc. (“Teva”), (2) Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
`Laboratories, Ltd. (“DRL”), and (3) Sun Pharmaceutical Industries, Ltd. (“Sun”) (collectively,
`“Joinder Petitioners”) requesting joinder with Mylan Pharmaceuticals Inc. (“Mylan”) in Mylan
`Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040 (“Mylan IPR”)
`(collectively, “Petitioners”). Merck has considered the Joinder Petitioners’ briefs as well as
`Petitioners’ positions on joinder submitted to the Board on June 23, 2020. In the interest of
`advancing the conferral process, this letter outlines several issues on which Merck seeks clarity as
`it evaluates its position.
`
`
`
`Merck Sharp & Dohme Corp. Exhibit 2028
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 1
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`

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`June 26, 2020
`Page 2
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`As I previewed on our June 23 call, Merck believes that it is entitled to party discovery
`from one or more of the Joinder Petitioners. While we continue to evaluate the record and reserve
`all rights, at this time, Merck believes that it is entitled to discovery as a matter of right under 37
`C.F.R. § 42.51(b)(1)(iii) because Joinder Petitioners’ arguments and/or evidence in its newly filed
`Petition papers (which would become “adoptive positions” if joined to the Mylan IPR) are
`inconsistent with documents, data, or testimony in their possession. Merck also may seek
`discretionary discovery related to one or more of these issues under Garmin v. Cuozzo, Case
`IPR2012-00001, Paper No. 26 (Mar. 5, 2013).
`
`By way of example, Teva performed testing and 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 in prior patent office proceedings. Merck believes that
`the data and testimony provided by Teva in that prior proceeding and within Teva’s possession is
`inconsistent with Teva’s and the other Petitioners’ position and expert declaration that sitagliptin
`can only be mono-protonated and form 1:1 dihydrogenphosphate salts. Merck believes it is
`entitled to discovery relevant to these inconsistencies as a matter of right, and alternatively, to
`request discovery from the Board related to these issues “in the interests of justice” if the Board
`orders joinder.
`
`Petitioners may disagree that Merck is entitled to such discovery under the governing
`standards. However, Merck seeks clarification from Petitioners as to how trial would proceed, in
`the case of joinder, when Merck seeks such discovery. Specifically:
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`1. Will the Petitioners confirm that, if the Board grants the joinder motions, Merck would be
`legally entitled to party discovery from Joinder Petitioners, just like Mylan, in the event
`the discovery standards are satisfied? If Petitioners dispute this, please explain why.
`
`2. Will the Joinder Petitioners confirm that their position with respect to experts is that they
`will withdraw their respective experts once Dr. Chorghade is deposed and, even if they do
`not retain Dr. Chorghade, they intend to rely solely on Dr. Chorghade’s opinions and
`testimony for purposes of trial?
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`3. Merck intends to seek party discovery from Joinder Petitioners in advance of Dr.
`Chorghade’s deposition, so Merck has the opportunity to use that material in his deposition.
`As I mentioned on our June 23, 2020 call, to allow time for such discovery (and/or to
`resolve any disputes) before Dr. Chorghade’s deposition, Merck may need an extension of
`the current schedule, and the current August 14, 2020 due date for its Patent Owner
`Response and supporting evidence, and any Motion to Amend. As I further mentioned on
`that call, in the case of joinder, the Board has discretion to adjust the trial schedule. See 35
`U.S.C. §§ 316(a)(11). Mylan suggested on that call that it would likely oppose an extension
`request and elicited the Joinder Petitioners agreement not to seek an extension. Merck is
`willing to work with Mylan and the Joinder Petitioners to propose a revised schedule to the
`Board that accounts for these issues and works for the parties and counsel. Will Petitioners
`
`
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`Merck Sharp & Dohme Corp. Exhibit 2028
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 2
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`June 26, 2020
`Page 3
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`reconsider their position and negotiate a revised schedule with Merck to propose to the
`Board?
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`4. Merck understands that Petitioners agree that Joinder Petitioners will assume a “silent
`understudy” role in the Mylan IPR. Could Petitioners please explain how the process
`will work with respect to party discovery?
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`5. Merck understands that Joinder Petitioners will otherwise proceed as follows:
`
`a. Joinder Petitioners have not raised and will not raise any new grounds not already
`instituted by the Board in the Mylan IPR.
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`b. Joinder Petitioners will withdraw the “me too” expert declarations filed in support
`of their Petitions once Mylan’s expert is deposed, and Joinder Petitioners will rely
`solely on the declaration and testimony of Mylan’s expert.
`
`c. Joinder Petitioners will not present any additional argument, briefing, or evidence.
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`d. As long as Mylan is a party, Mylan will be Lead Petitioner, file all substantive
`written submissions, and conduct all argument and examination of witnesses.
`Mylan alone is responsible for all petitioner filings in the Mylan IPR unless and
`until Mylan is terminated as a party. Additionally and/or specifically, other than
`with respect to party discovery on the Joinder Petitioners:
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`i. Joinder Petitioners will not file additional pages to Mylan’s papers. Mylan
`will be subject to the word count limits for a single party.
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`ii. Joinder Petitioners will not file any papers or exhibits in the Mylan IPR,
`except for pro hac vice motions, updated mandatory notices, and similar
`administrative filings that do not constitute argument or evidence relating
`to the merits.
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`iii. Joinder Petitioners must obtain prior Board authorization to file any paper
`or to take any action on its own in the Mylan IPR.
`
`iv. Joinder Petitioners will be bound by any agreement between Mylan and
`Merck concerning discovery and depositions.
`
`v. Joinder Petitioners will not serve objections to discovery requests served
`on Mylan in the Mylan IPR. Joinder Petitioners will not serve discovery
`requests in connection with the Mylan IPR.
`
`vi. Counsel for Joinder Petitioners will not conduct the cross-examination or
`redirect of any witness, and will not defend any witness deposition in the
`
`
`
`Merck Sharp & Dohme Corp. Exhibit 2028
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 3
`
`

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`
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`June 26, 2020
`Page 4
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`Mylan IPR. Cross-examination and redirect will occur within the
`timeframe that the rules allow for one party.
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`vii. Counsel for Joinder Petitioners will not participate in any speaking role in
`any telephonic conference before the Board in the Mylan IPR.
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`viii. Counsel for Joinder Petitioners will not participate in oral argument in the
`Mylan IPR.
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`6. Will the Joinder Petitioners please also confirm that, in the event Mylan is no longer a
`party, Joinder Petitioners shall meet and confer with the remaining joined parties, if any,
`to select a new Lead Petitioner, and thereafter any such new Lead Petitioner will
`effectively take Mylan’s place in this proceeding and Joinder Petitioners will continue to
`be bound to the present agreement.
`
`*****
`
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`Please let me know your availability to discuss the issues raised in this letter. I look forward
`to conferring with you further in an attempt to narrow the issues in advance of the due date for
`Merck’s opposition to joinder.
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`If you have any questions, please feel free to contact me.
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` Best Regards,
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`/Stanley E. Fisher/
` Stanley E. Fisher
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`Merck Sharp & Dohme Corp. Exhibit 2028
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 4
`
`