From:
`To:
`
`Cc:
`Subject:
`Date:
`
`Malik, Jitty
`Baumgarten, Elise; Faegenburg, Russell W.; Fisher, Stanley; Mahaffy, Shaun; Pacchioli, Alissa M.; West,
`Christopher W.; Radeke, Heike Simone; Pacchioli, Alissa M.; Van Buskirk, Tedd W.; Teschner, Michael H.; Wong,
`Jovial; Fundakowski, Claire (CFundakowski@winston.com); Fischer, Sarah; Zullow, Keith A
`Merck-Sitagliptin
`RE: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
`Thursday, July 2, 2020 6:09:26 PM
`
`Counsel,
` 
`To be clear,  Merck and joinder Petitioners are free to agree to whatever conditions they see fit
`amongst themselves.  However, no agreement between Merck and joinder Petitioners will bind
`Mylan.  As an illustrative example, below it states: “Merck understands that each party reserves the
`right to present arguments related to party-specific discovery issues.  In other words, Teva will
`present argument if Merck seeks discovery from Teva; no other party will present argument on an
`issue specific to another party.”  As lead Petitioner in an instituted IPR, Mylan always reserves the
`right to interject and speak on any issue. 
` 
`Thanks and I hope everybody stays safe over the holiday weekend,
` 
`Jitty
` 
`Jitendra (“Jitty”) Malik Ph.D.
`Partner
`Katten
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900 | Charlotte, NC 28202-4213
`direct +1.704.344.3185
`jitty.malik@katten.com | katten.com
` 
`From: Baumgarten, Elise <EBaumgarten@wc.com> 
`Sent: Thursday, July 2, 2020 1:45 PM
`To: Faegenburg, Russell W. <rfaegenburg@lernerdavid.com>; Fisher, Stanley <SFisher@wc.com>;
`Malik, Jitty <jitty.malik@katten.com>; Mahaffy, Shaun <SMahaffy@wc.com>; Pacchioli, Alissa M.
`<alissa.pacchioli@katten.com>; West, Christopher W. <christopher.west@katten.com>; Radeke,
`Heike Simone <heike.radeke@katten.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; Van
`Buskirk, Tedd W. <tvanbuskirk@lernerdavid.com>; Teschner, Michael H.
`<mteschner@lernerdavid.com>; Wong, Jovial <JWong@winston.com>; Fundakowski, Claire
`(CFundakowski@winston.com) <CFundakowski@winston.com>; Fischer, Sarah
`<SFischer@goodwinlaw.com>; Zullow, Keith A <KZullow@goodwinlaw.com>
`Cc: Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
` 
`EXTERNAL EMAIL – EXERCISE CAUTION
`Russ,
`
` I
`
` write in response to your email dated July 1 on behalf of Teva, Watson, DRL, and Sun.  Merck would
`like to clarify a few points raised in your email. 
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 1
`
`

`

` 
`2.  You state that Joinder Petitioners will “withdraw their respective experts once Dr. Chorghade has
`submitted all necessary declarations.” 
`Merck understands that each Joinder Petitioner will withdraw any expert declaration from
`their expert immediately after Dr. Chorghade is deposed.  Once Dr. Chorghade is deposed on
`his currently submitted declaration, Ex. 1002, Merck expects that the Joinder Petitioners will
`immediately withdraw all currently filed expert declarations in this case.    
`Please confirm that Joinder Petitioners withdrawal of their experts will not be discretionary. 
`In other words, once Dr. Chorghade is deposed, Joinder Petitioners agree to immediately
`withdraw their own experts. 
`
` 
`5.c.  Joinder Petitioners state that each Joinder Petitioner reserves the right to address any party-
`specific issues with its own evidence. 
`Merck understands that each party reserves the right to present arguments related to party-
`specific discovery issues.  In other words, Teva will present argument if Merck seeks discovery
`from Teva; no other party will present argument on an issue specific to another party. 
`Merck also understands that each Joinder Petitioner reserves the right to address
`substantively any party-specific discovery.  For example, if Merck obtains discovery from Teva,
`Teva reserves the right to request to address that discovery in a substantive written
`submission.  Merck reserves the right to request additional briefing to address any such
`arguments. 
`Merck understands that these are the only party-specific issues that the Joinder Petitioners
`may raise.
`
` 
`As to other conditions that Merck sought from Joinder Petitioners to ensure that they served the
`true role of a silent understudy (see, e.g., 5.d.i., 5.d.iii, 5.d.vii, 5.d.viiii), Merck understands that,
`unless otherwise indicated in its email, Joinder Petitioners agree with the conditions outlined in its
`June 26 letter. 
` 
`
`Joinder Petitioners appear to have taken the position that Merck is not entitled to party
`discovery.  Merck believes that any formal request for party discovery (and Joinder Petitioners’
`substantive position in response) is premature.  Currently, the issue is whether joinder is
`appropriate.  As such, Merck seeks to ensure that it will have sufficient opportunity and time to seek
`any party discovery to which it believes it is entitled if joinder occurs.  It is Joinder Petitioners’
`burden to show that joinder is appropriate, and they must account for the schedule in so doing. 
` 
`
`In the interest of transparency, Merck previewed some of the discovery it intends to seek
`should joinder be granted.  That Merck referenced certain patent office filings is not surprising, as
`those  are  the  documents  to  which  Merck  has  access  at  this  time.    Merck  will  have  specific,
`particularized requests related to that work (which include multiple declarations submitted by Teva’s
`declarant here Len Chyall), and can further confer with Teva on the inconsistencies and pertinence
`of the discovery in due course.  If needed, Merck can file an application for discovery.  However, at
`this stage, an application is premature because Teva is not a party to any instituted IPR.  Similarly,
`Merck  will  have  requests  for  DRL  and  Sun,  but  saw  (and  still  sees)  it  as  premature  to  raise  them
`before institution.  For example, as to DRL and Sun, their own patents and related publications, on
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 2
`
`

`

`salts  and  polymorphs  of  sitagliptin  (e.g.,  U.S.  Patent  No.  8,309,724  and  WO2013001457A1),
`characterizes the relevant disclosures of the ’871 patent, which is the subject of several Grounds, in
`a manner that is inconsistent with the positions taken in the Petitions.  Merck believes it is entitled
`to discovery relevant to these inconsistencies as a matter of right, and alternatively, if not of right, to
`request  discovery  related  to  these  issues  if  the  Board  orders  joinder.    If  joinder  is  ordered,  the
`parties  can  confer  on  the  appropriateness  of  specific  discovery  requests  related  to  these
`inconsistencies and, if no agreement is reached, Merck will seek authorization from the Board for
`such discovery.      
`
`  Please  let  us  know  immediately  if  Merck’s  statements  above  do  not  align  with  Joinder
`Petitioners’ understanding. 
`
`Thanks,
` 
`Elise
` 
`Elise M. Baumgarten
`Williams & Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`(P) 202-434-5894 | (F) 202-434-5029
`ebaumgarten@wc.com | www.wc.com/ebaumgarten
` 
`From: Faegenburg, Russell W. <rfaegenburg@lernerdavid.com> 
`Sent: Wednesday, July 1, 2020 12:23 PM
`To: Fisher, Stanley <SFisher@wc.com>; Malik, Jitty <jitty.malik@katten.com>; Mahaffy, Shaun
`<SMahaffy@wc.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; West, Christopher W.
`<christopher.west@katten.com>; Radeke, Heike Simone <heike.radeke@katten.com>; Pacchioli,
`Alissa M. <alissa.pacchioli@katten.com>; Van Buskirk, Tedd W. <tvanbuskirk@lernerdavid.com>;
`Teschner, Michael H. <mteschner@lernerdavid.com>; Wong, Jovial <JWong@winston.com>;
`Fundakowski, Claire (CFundakowski@winston.com) <CFundakowski@winston.com>; Fischer, Sarah
`<SFischer@goodwinlaw.com>; Zullow, Keith A <KZullow@goodwinlaw.com>
`Cc: Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
` 
`Stan,
`
`This is in response to your June 26, 2020 letter concerning the joinder motions
`filed by Teva, DRL and Sun (“Joinder Petitioners”). Our firm represents DRL,
`but I write on behalf of all three Joinder Petitioners.
`
`Joinder Petitioners agree to a “silent understudy” role as previously stated, and
`with respect to items 2, 5 and 6 of your letter, Joinder Petitioners agree as
`follows:
`
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 3
`
`

`

`2. Joinder Petitioners will withdraw their respective experts once Dr.
`Chorghade has submitted all necessary declarations (including any reply
`declaration) and has been deposed with respect to all of them. In that
`instance, Joinder Petitioners intend to rely solely on Dr. Chorghade’s
`opinions and testimony. (Joinder Petitioners have the same comments in
`response to item 5.b.)
`
`5.a. Joinder Petitioners will not raise any new grounds not already
`instituted by the Board in the Mylan IPR.
`
`5.c. Joinder Petitioners will not present any additional arguments or IPR
`briefs. To the extent there is a party-specific issue, each Joinder
`Petitioner reserves the right to address that issue with its own evidence.
`
`5.d. Mylan will be Lead Petitioner, file all substantive written
`submissions, conduct all argument at hearings and examine and defend
`witness depositions. Joinder petitioners will not file additional pages to
`Mylan’s papers. The deposition timeframes for one party will apply.
`Joinder petitioners will be bound by discovery agreements between
`Mylan and Merck. Joinder petitioners will not serve objections to
`discovery requests served on Mylan and will not serve discovery requests
`in the Mylan IPR.
`
`All of these conditions regarding item 5.d. apply other than with respect
`to party discovery on Joinder Defendants or any issue involving a Joinder
`Petitioner that is specific to that Petitioner. For example, although
`Joinder Petitioners generally agree not to file substantive papers in the
`Mylan IPR, each Joinder Petitioner reserves the right to file papers
`relating to any party-specific issue that applies to that Petitioner, and will
`seek Board authorization to file any such paper or to take any action on
`its own. Likewise, if Merck were to seek party discovery from one of the
`Joinder Petitioners, that Petitioner would reserve the right to respond
`appropriately, including by resisting such discovery and by issuing its
`own request for discovery.
`
`6. Joinder Petitioners confirm that if Mylan is no longer a party, they will
`meet and confer to select a new Lead Petitioner to step into Mylan’s
`shoes and Joinder Petitioners will be bound by the same conditions
`already in place.
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 4
`
`

`

`
`With respect to items 1, 3 and 4 of your letter, Joinder Petitioners disagree that
`Merck has identified any basis to seek party discovery, and the discovery
`matters you discuss are, therefore, premature and not pertinent to the joinder
`inquiry.
`
`You have only purported to identify a basis for discovery from Teva, not from
`either DRL or Sun. Even as to Teva, you have not identified specifically what
`you are seeking beyond documents and testimony readily available from public
`patent office proceedings, or even how any of the information from such
`proceedings is inconsistent with Teva’s invalidity arguments in the present
`IPR. Teva is willing to further meet and confer with Merck to understand the
`specific discovery Merck will be seeking from Teva.
`
`Given that Merck has not yet established any right to party discovery, and its
`ability to obtain party discovery is speculative, Merck has not established a
`basis to alter the schedule in the Mylan IPR based on proposed joinder. As
`stated above, and in Joinder Petitioners’ motion papers, Joinder Petitioners are
`“me too” Petitioners and have agreed to the same “understudy” conditions on
`which the Board has previously relied in permitting joinder. If Merck wishes to
`pursue discovery, either now or at some time in the future, it is free to make a
`motion for discovery and, if it chooses, to make an application to extend the
`IPR schedule. Joinder Petitioners, if joined, will comply with any change that
`the Board orders with respect to the schedule in the Mylan IPR.
`
`Sincerely yours,
`
`Russ
`
`From: Fisher, Stanley [mailto:SFisher@wc.com]
`Sent: Wednesday, July 1, 2020 8:54 AM
`To: Malik, Jitty; Mahaffy, Shaun; Pacchioli, Alissa M.; West, Christopher W.; Radeke, Heike Simone;
`Pacchioli, Alissa M.; Van Buskirk, Tedd W.; Teschner, Michael H.; Faegenburg, Russell W.; Wong, Jovial;
`Fundakowski, Claire (CFundakowski@winston.com); Fischer, Sarah; Zullow, Keith A
`Cc: Merck-Sitagliptin
`Subject: RE: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
` 
`[EXTERNAL E-MAIL]
`Counsel,
` 
`Merck reserves all rights to oppose joinder, and if joinder is ordered, to seek party discovery in
`advance of the deposition of Dr. Chorghade, along with a reasonable adjustment to the schedule to
`accommodate party discovery.  Do any of the other Petitioners (Teva, Sun, or DRL) intend to respond
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 5
`
`

`

`to my June 26 letter, which was an attempt to narrow the issues and potentially obviate an
`opposition to joinder?   
` 
`Assuming the Board denies the joinder motions, Merck has no objection to a remote deposition for
`Dr. Chorghade at the end of July.  July 22 does not work for Merck; we are available the following
`week on any of July 29-31.  Please let me know if one of those days works for Mylan to tentatively
`schedule Dr. Chorghade’s deposition. 
` 
`Thank you,
`Stan
` 
`Stanley E. Fisher
`Williams & Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`(P) 202-434-5289 |(F) 202-434-5029
`SFisher@wc.com | www.wc.com/sfisher
` 
`From: Malik, Jitty <jitty.malik@katten.com> 
`Sent: Monday, June 29, 2020 1:35 PM
`To: Mahaffy, Shaun <SMahaffy@wc.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; West,
`Christopher W. <christopher.west@katten.com>; Radeke, Heike Simone
`<heike.radeke@katten.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; Van Buskirk, Tedd
`W. <tvanbuskirk@lernerdavid.com>; Teschner, Michael H. <mteschner@lernerdavid.com>;
`Faegenburg, Russell W. <rfaegenburg@lernerdavid.com>; Wong, Jovial <JWong@winston.com>;
`Fundakowski, Claire (CFundakowski@winston.com) <CFundakowski@winston.com>; Fischer, Sarah
`<SFischer@goodwinlaw.com>; Zullow, Keith A <KZullow@goodwinlaw.com>
`Cc: Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
` 
`Counsel,
` 
`Mylan is in receipt of your letter.  To that end, and speaking only on behalf of Mylan, Mylan remains
`opposed to any change in the current schedule.  See IPR2020-00040 (Paper 32).  To that end, Dr.
`Chorghade will be made available for his deposition on July 22nd.  Due to the current COVID
`pandemic, and for the health and safety off all concerned, Dr. Chorghade will be made available only
`for a remote deposition.  Please let Mylan know if Merck has any objection to proceeding on this
`date.
` 
`Thanks,
` 
`Jitty
` 
`Jitendra (“Jitty”) Malik Ph.D.
`Partner
`Katten
`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 6
`
`

`

`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900 | Charlotte, NC 28202-4213
`direct +1.704.344.3185
`jitty.malik@katten.com | katten.com
` 
`From: Mahaffy, Shaun <SMahaffy@wc.com> 
`Sent: Friday, June 26, 2020 5:22 PM
`To: Malik, Jitty <jitty.malik@katten.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; West,
`Christopher W. <christopher.west@katten.com>; Radeke, Heike Simone
`<heike.radeke@katten.com>; Malik, Jitty <jitty.malik@katten.com>; Pacchioli, Alissa M.
`<alissa.pacchioli@katten.com>; Van Buskirk, Tedd W. <tvanbuskirk@lernerdavid.com>; Teschner,
`Michael H. <mteschner@lernerdavid.com>; Faegenburg, Russell W.
`<rfaegenburg@lernerdavid.com>; Wong, Jovial <JWong@winston.com>; Fundakowski, Claire
`(CFundakowski@winston.com) <CFundakowski@winston.com>; Fischer, Sarah
`<SFischer@goodwinlaw.com>; Zullow, Keith A <KZullow@goodwinlaw.com>
`Cc: Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: IPR2020-00040, IPR2020-01045, IPR2020-01060, IPR2020-01072
` 
`EXTERNAL EMAIL – EXERCISE CAUTION
`Counsel,
` 
`Please see the attached correspondence.
` 
`Regards,
`Shaun
` 
`Shaun P. Mahaffy
`Associate | Williams & Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`(P) 202-434-5554 | (F) 202-434-5029
`smahaffy@wc.com | www.wc.com
` 
`
`
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`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 7
`
`

`

`the sender, by electronic mail or telephone, of any unintended recipients
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`
`Merck Sharp & Dohme Corp. Exhibit 2036
`Dr. Reddy’s Laboratories Inc. v. Merck Sharp and Dohme Corp.
`IPR2020-01060
`Page 8
`
`