`To:
`
`Cc:
`Subject:
`
`Date:
`Attachments:
`
`Malik, Jitty
`Baumgarten, Elise; Fundakowski, Claire; Zullow, Keith A; Faegenburg, Russell W.; Wong, Jovial; Pacchioli, Alissa
`M.; West, Christopher W.; Radeke, Heike Simone; Van Buskirk, Tedd W.; Teschner, Michael H.; Rapalino, Emily
`L.; Fischer, Sarah
`Fisher, Stanley; Mahaffy, Shaun; Zolan, Alexander; Genderson, Bruce; Sheh, Anthony; Merck-Sitagliptin
`RE: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck); IPR2020-01072 (Sun
`v. Merck)
`Monday, August 3, 2020 5:20:09 PM
`image002.jpg
`
`Counsel,
`
`Speaking only on behalf of Mylan: To the extent Merck wishes to introduce any exhibit into
`IPR2020-00040, Mylan reserves the right to object at that time in accordance with the applicable
`PTAB rules. Mylan will not be taking any position on exhibits that Merck has not properly introduced
`into IPR2020-00040. Nothing in this communication should be viewed as an acquiescence on
`Mylan’s part that any discovery requests to joinder petitioners are even proper. Obviously, that is
`something the parties will deal with when the time is right.
`
`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. To support its IPR positions, Mylan has the right to rely on the expert
`of its choosing, not the expert of Merck’s choosing. Mylan is aware of no authority to the contrary.
`If you have any such authority, Mylan asks that you provide it. At this time, Mylan will oppose any
`effort to introduce the alleged opinions of Dr. Chyall.
`
`Finally, Mylan will not agree to any further extension of the schedule. Mylan has already agreed to
`extend the schedule once as an accommodation to Merck. As a further accommodation to Merck to
`allow Merck to stay on schedule, Mylan has not objected to the recognition of three pro hac vice
`counsel even though Mylan could have objected to any more than two pro hac vice counsel. Apotex
`Inc. v. Alcorn Pharms, Ltd, IPR2013-00012, Paper 39 at 2 (PTAB Jan. 18, 2013) (“The admission of two
`attorneys pro hac vice was determined to be reasonable by the Board”).
`
`Thanks,
`
`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
`
`
`Merck Exhibit 2285, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`From: Baumgarten, Elise
`Sent: Friday, July 31, 2020 12:27 PM
`To: Fundakowski, Claire ; Malik, Jitty ; Zullow, Keith A ; Faegenburg, Russell W. ; Wong, Jovial ;
`Pacchioli, Alissa M. ; West, Christopher W. ; Radeke, Heike Simone ; Van Buskirk, Tedd W. ; Teschner,
`Michael H. ; Rapalino, Emily L. ; Fischer, Sarah
`Cc: Fisher, Stanley ; Mahaffy, Shaun ; Zolan, Alexander ; Genderson, Bruce ; Sheh, Anthony ; Merck-
`Sitagliptin
`Subject: RE: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck);
`IPR2020-01072 (Sun v. Merck)
`
`EXTERNAL EMAIL – EXERCISE CAUTION
`Counsel,
`
`Unless Merck is misunderstanding Joinder Petitioner’s position in its Reply brief, the parties appear
`to now be in agreement on all the conditions of the understudy role of Joinder Petitioners.
`Assuming that’s the case (and a brief conferral this afternoon could confirm that), Merck believes
`that it is worth bringing that agreement to the Board’s attention expeditiously (given the 8/6 expert
`deposition and the POR deadlines on 8/14) and getting any further guidance from the Board on
`timing of a decision on joinder, in view of Merck’s previously raised concerns regarding the
`sequencing and timing of any party discovery necessitated by joinder. As to specifics of discovery,
`while formal discovery requests are premature in advance of a joinder order, in the interest of
`advancing the conferral process, Merck would seek the following discovery from specific Joinder
`Petitioners, if they are joined:
`
`
`- Teva: Len Chyall’s declarations and testimony in the Israel proceeding regarding the
`potential creation of a non-1:1 dihydrogenphosphate salt of sitagliptin, including but not
`limited to his attempts to create such salts and attempts to duplicate the experiments
`conducted by Jerry Atwood;
`- The underlying lab notebooks, documents, and other data associated with Len Chyall’s
`experiments, declarations, and testimony in the Israel proceeding regarding the potential
`creation of a non-1:1 dihydrogenphosphate salt of sitagliptin, including but not limited to his
`attempts to create such salts and attempts to duplicate the experiments conducted by Jerry
`Atwood, whether or not produced in the Israel proceeding.
`- A deposition of Len Chyall in the Mylan proceeding, unless all Petitioners stipulate to waive
`evidentiary objections to use of those materials.
`
`
`(Note: Joinder Petitioners take the position in their Reply brief that Merck itself should produce
`these materials, alleging they are inconsistent with Merck’s position. While the parties obviously
`disagree on the interpretation of these materials, it seems, now, that both Joinder Petitioners and
`Merck agree the material is relevant and there should be some production. Merck believe the
`parties should confer regarding whether all such materials were produced in the Israel proceeding,
`work to jointly create an index of those materials (counsel for Merck is not confident Merck is in
`possession of all relevant materials, as we understand a number of such documents were produced
`during the Israel trial itself), agree on a production date, and confer on a stipulation to potentially
`obviate a Chyall deposition).
`
`Merck Exhibit 2285, Page 2
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`
`
`- DRL: The final research and development report(s) associated with U.S. Patent No.
`8,309,724 (DRL Patent) (Ex.2032) (patent on salts of sitagliptin, which characterized the
`disclosure of the ’871 patent).
`- Sun: The final research and development report(s) associated with WO2013001456 (Sun
`Application) (Ex. 2033) (application on salts of sitagliptin, which characterized the disclosure
`of the ’871 patent).
`
`
`Merck is willing to proceed with the Chorghade deposition on 8/6 (in advance of a joinder order and
`production of these materials) for the convenience of all parties, and will not object to the
`attendance by Joinder Petitioners, even in advance of a joinder order. However, as a condition to
`Merck’s withdrawing its objections to joinder, Merck requests that (1) Joinder Petitioners and Merck
`agree on a prompt schedule for party discovery, and (2) Mylan and the Joinder Petitioners consent
`to (or not oppose), subject to approval of the Board, a minor schedule adjustment in the Mylan IPR
`to allow Merck an extra 1-2 weeks to submit its Patent Owner Response and supporting evidence.
`This would allow Merck additional time to provide its expert any such discovery and efficiently
`address this evidence in its POR.
`
`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: Fundakowski, Claire <CFundakowski@winston.com>
`Sent: Thursday, July 30, 2020 9:32 PM
`To: Baumgarten, Elise <EBaumgarten@wc.com>; Malik, Jitty <jitty.malik@katten.com>; Zullow, Keith
`A <KZullow@goodwinlaw.com>; Faegenburg, Russell W. <rfaegenburg@lernerdavid.com>; Wong,
`Jovial <JWong@winston.com>; Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; West,
`Christopher W. <christopher.west@katten.com>; Radeke, Heike Simone
`<heike.radeke@katten.com>; Van Buskirk, Tedd W. <tvanbuskirk@lernerdavid.com>; Teschner,
`Michael H. <mteschner@lernerdavid.com>; Rapalino, Emily L. <ERapalino@goodwinlaw.com>;
`Fischer, Sarah <SFischer@goodwinlaw.com>
`Cc: Fisher, Stanley <SFisher@wc.com>; Mahaffy, Shaun <SMahaffy@wc.com>; Zolan, Alexander
`<AZolan@wc.com>; Genderson, Bruce <BGenderson@wc.com>; Sheh, Anthony <ASheh@wc.com>;
`Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck);
`IPR2020-01072 (Sun v. Merck)
`
`Elise,
`
`Merck Exhibit 2285, Page 3
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`
`Similar to Mylan, Joinder Petitioners would like to better understand what issues Merck intends to
`raise with the Board, and why Merck believes the Board may be able to help the parties reach an
`expedited resolution on joinder, given that the matter is fully briefed and the parties’ positions set
`forth.
`
`We understand that Merck has separately requested a meet and confer with each Joinder Petitioner
`to discuss each Joinder Petitioner’s “production of documents in this proceeding.” To make any
`meet and confer productive, please send each Joinder Petitioner Merck’s proposed discovery
`requests. We need this information in advance of our call to understand the scope of the discovery
`being requested, so we can meaningfully discuss Merck’s discovery requests and raise any issues
`with our clients.
`
`Subject to the above, Joinder Petitioners are available during the proposed call times with the Board,
`except we are not available on Tuesday 11-12 pm ET. In addition, Teva and Sun are generally
`available for a meet and confer tomorrow after 12 pm ET. DRL is unavailable tomorrow as counsel
`will be in depositions.
`
`Kind regards,
`Claire
`
`
`Claire Fundakowski
`Winston & Strawn LLP
`
`D: +1 202-282-5347
`
`winston.com
`
`From: Baumgarten, Elise <EBaumgarten@wc.com>
`Sent: Thursday, July 30, 2020 5:44 PM
`To: Malik, Jitty <jitty.malik@katten.com>; Zullow, Keith A <KZullow@goodwinlaw.com>; Faegenburg,
`Russell W. <rfaegenburg@lernerdavid.com>; Wong, Jovial <JWong@winston.com>; Pacchioli, Alissa
`M. <alissa.pacchioli@katten.com>; West, Christopher W. <christopher.west@katten.com>; Radeke,
`Heike Simone <heike.radeke@katten.com>; Van Buskirk, Tedd W. <tvanbuskirk@lernerdavid.com>;
`Teschner, Michael H. <mteschner@lernerdavid.com>; Fundakowski, Claire
`<CFundakowski@winston.com>; Rapalino, Emily L. <ERapalino@goodwinlaw.com>; Fischer, Sarah
`<SFischer@goodwinlaw.com>
`Cc: Fisher, Stanley <SFisher@wc.com>; Mahaffy, Shaun <SMahaffy@wc.com>; Zolan, Alexander
`<AZolan@wc.com>; Genderson, Bruce <BGenderson@wc.com>; Sheh, Anthony <ASheh@wc.com>;
`Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck);
`IPR2020-01072 (Sun v. Merck)
`
`Jitty,
`
`
`Merck Exhibit 2285, Page 4
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`The purpose and need for a call is already outlined in the transcript cited in my email below. On that
`call, the Board clearly stated “there’s a willingness on the panel’s behalf to help the parties work
`through those issues so that we can get a faster resolution on the joinder issue.” IPR2020-00040,
`EX2041 at 37; id. at 33 (expressing that the Board would “help” facilitate joinder in a way “that’s
`least disruptive to the present schedule”). Now that the Joinder Petitioners’ reply brief has been
`submitted, Merck has additional clarity on Joinder Petitioners’ positions on understudy conditions
`and party discovery. We thus think it makes sense to pursue the Board’s offer to help reach an
`expedited resolution on joinder. We’ve conferred on these issues multiple times, and Merck may
`continue to confer with particular Petitioners on specific issues.
`
`We do think it makes sense for Mylan to join the call with the Board, as Mylan’s views may be
`elicited. As the Board repeatedly indicated that it would like to expedite resolution of joinder issues,
`please provide your availability for a call on Monday or Tuesday as soon as possible.
`
`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: Malik, Jitty <jitty.malik@katten.com>
`Sent: Thursday, July 30, 2020 4:21 PM
`To: Baumgarten, Elise <EBaumgarten@wc.com>; Zullow, Keith A <KZullow@goodwinlaw.com>;
`Faegenburg, Russell W. <rfaegenburg@lernerdavid.com>; Wong, Jovial <JWong@winston.com>;
`Pacchioli, Alissa M. <alissa.pacchioli@katten.com>; West, Christopher W.
`<christopher.west@katten.com>; Radeke, Heike Simone <heike.radeke@katten.com>; Van Buskirk,
`Tedd W. <tvanbuskirk@lernerdavid.com>; Teschner, Michael H. <mteschner@lernerdavid.com>;
`Fundakowski, Claire <CFundakowski@winston.com>; Rapalino, Emily L.
`<ERapalino@goodwinlaw.com>; Fischer, Sarah <SFischer@goodwinlaw.com>
`Cc: Fisher, Stanley <SFisher@wc.com>; Mahaffy, Shaun <SMahaffy@wc.com>; Zolan, Alexander
`<AZolan@wc.com>; Genderson, Bruce <BGenderson@wc.com>; Sheh, Anthony <ASheh@wc.com>;
`Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: RE: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck);
`IPR2020-01072 (Sun v. Merck)
`
`Elise,
`
`Thank you for your email. Mylan just read Joinder Petitioners’ Joint Reply Paper and would like to
`get a better idea of what Merck considers are the “remaining issues concerning joinder,” including
`whether the issues that planned to be discussed with the Board directly involve Mylan or whether
`
`Merck Exhibit 2285, Page 5
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`the purpose of the call is for joinder petitioners and Merck to continue their discussion about joinder
`conditions (this time with the guidance of the Panel). To that end, I remind you that the parties are
`expressly directed to confer before sending any email to the Board for a conference call. See
`Consolidated Trial Practice Guide (November 2019) at page 9 (“Prior to making a request for a
`conference call, the parties should meet and confer to resolve any disputes. If attempts to resolve
`the dispute fail, a party may request a conference call with the Board.”).
`
`Thanks,
`
`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 30, 2020 1:06 PM
`To: Zullow, Keith A <KZullow@goodwinlaw.com>; Faegenburg, Russell W.
`<rfaegenburg@lernerdavid.com>; Wong, Jovial <JWong@winston.com>; 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>; Van Buskirk,
`Tedd W. <tvanbuskirk@lernerdavid.com>; Teschner, Michael H. <mteschner@lernerdavid.com>;
`Fundakowski, Claire <CFundakowski@winston.com>; Rapalino, Emily L.
`<ERapalino@goodwinlaw.com>; Fischer, Sarah <SFischer@goodwinlaw.com>
`Cc: Fisher, Stanley <SFisher@wc.com>; Mahaffy, Shaun <SMahaffy@wc.com>; Zolan, Alexander
`<AZolan@wc.com>; Genderson, Bruce <BGenderson@wc.com>; Sheh, Anthony <ASheh@wc.com>;
`Merck-Sitagliptin <MerckSitagliptin@wc.com>
`Subject: IPR2020-01045 (Teva v. Merck); IPR2020-01060 (Dr. Reddy’s Laboratories v. Merck);
`IPR2020-01072 (Sun v. Merck)
`
`EXTERNAL EMAIL – EXERCISE CAUTION
`All,
`
`We have received Joint Petitioners’ reply in support of their Motions for Joinder. In view of the reply
`and Merck and Mylan’s last call with the Board, we intend to send the following. Please provide
`Petitioners’ availability for the call:
`
`Your Honors,
`
`Yesterday, Joint Petitioners filed a joint reply in support of their Motions for Joinder in IPR Nos.
`2020-01045, 2020-01060, and 2020-01072. In view of the reply and the Board’s call with Merck and
`
`Merck Exhibit 2285, Page 6
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`Mylan on July 15, 2020, Merck requests a call with the Board to discuss and to expedite resolution of
`any remaining issues concerning joinder. IPR2020-00040, EX2041 at 33-37.
`
`The parties are available for such a call on Monday other than 1-2:30, and Tuesday other than 1-1:30
`or 4-5 pm.
`
`
`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
`
`
`
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`
`Merck Exhibit 2285, Page 7
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`