UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`DR. REDDY’S LABORATORIES INC., and
` DR. REDDY’S LABORATORIES LTD.,
`Petitioners,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-01060
`U.S. Patent 7,326,708
`__________________
`
`PATENT OWNER’S OPPOSITION TO MOTION FOR JOINDER
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`
`
`I.
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`TABLE OF CONTENTS
`
`LEGAL STANDARD ..................................................................................... 2
`
`II.
`
`ARGUMENT ................................................................................................... 3
`
`A.
`
`Joinder Necessitates an Order Providing for an Orderly Party
`Discovery Process. ................................................................................ 4
`
`B.
`
`Joinder Necessitates an Adjustment to the Schedule. ........................... 9
`
`C.
`
`Joinder Requires that Joinder Petitioners Serve the Role of True
`Understudies. ....................................................................................... 11
`
`D.
`
`In the Absence of Needed Safeguards, Merck Opposes Joinder. ....... 13
`
`
`
`
`
`
`
`
`i
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`TABLE OF AUTHORITIES
`
`
`Aurobindo Pharma U.S.A. Inc. v. Astrazeneca AB,
`IPR2016-01117, Paper 12 (P.T.A.B. Oct. 21, 2016) .......................................... 12
`
`Central Security Grp. – Nationwide, Inc., v. Ubiquitous Connectivity, LP,
`IPR2019-01610, Paper 12 (P.T.A.B. Feb. 26, 2020) .......................................... 13
`
`Clear-vu Lighting LLC v. University of Strathclyde,
`IPR2019-00588, Paper 14 (P.T.A.B. Apr. 19, 2019) ........................................... 9
`
`Dr. Reddy’s v. Horizon, Inc.,
`IPR2018-01341, Paper 21 (P.T.A.B. Apr. 19, 2019) ................................... 12, 13
`
`Ericsson Inc., v. Unicloc
`2017 LLC, IPR2020-00376, Paper 16 (P.T.A.B. May 22, 2020) ....................... 12
`
`Garmin International, Inc. v. Cuozzo Speed Techs, LLC,
`IPR2012-00001, Paper 26 (P.T.A.B. Mar. 5, 2013) ............................................. 5
`
`Harmonix Music Systems, Inc. v. Princeton Digital Image Corp,
`IPR2015-00271, Paper 15 (P.T.A.B. June 2, 2015) ............................................. 2
`
`Kyocera Corp. v. SoftView LLC,
`IPR2013-0004, Paper 15 (P.T.A.B. Apr. 24, 2013) ............................................. 2
`
`Maxlinear, Inc. v. Cresta Tech Corp.,
`IPR2015-00594, Paper 35 (P.T.A.B. Jan. 27, 2016) ............................................ 8
`
`Mylan Pharmaceuticals, Inc., v. Janssen Oncology, Inc.,
`IPR2016-01332, Paper 21 (P.T.A.B. Jan. 10, 2017) .................................... 13, 14
`
`Samsung Electronics, Co. Ltd., v. Evolved Wireless, LLC,
`IPR2017-00106, Paper 14 (P.T.A.B. Feb. 23, 2017) ............................................ 3
`
`Taro Pharms. U.S.A., Inc. v. Apotex Techs., Inc.,
`IPR2017-01446, Paper 33 (P.T.A.B. May 11, 2018) ........................................... 8
`
`Teva Pharmaceuticals USA Inc. v. Eli Lilly & Co.,
`IPR2016-01340, Paper 8 ..................................................................................... 12
`
`Unified Patents Inc. v. Finjan, Inc.,
`IPR2019-01611, Paper 6 (P.T.A.B. Dec. 23, 2019) ............................................. 9
`
`ii
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`Unified Patents, Inc. v. Personalweb Techs. et al.,
`IPR2014-00702, Paper 12 (P.T.A.B. July 24, 2014) .................................. 2, 4, 14
`
`ZTE Corp. v. Adaptix, Inc.,
`IPR2015-01184, Paper 10 (P.T.A.B. July 24, 2015) ............................ 5, 7, 14, 15
`
`35 U.S.C. §103(c) .................................................................................................... 10
`
`35 U.S.C. § 315(b) ................................................................................................... 15
`
`35 U.S.C. § 315(c) ..................................................................................................... 2
`
`35 U.S.C. § 316(a)(11) ............................................................................................... 3
`
`37 C.F.R. § 42.5(c)(2) ................................................................................................ 3
`
`37 C.F.R. § 42.20(c) ................................................................................................... 2
`
`37 C.F.R. § 42.51(b)(1)(iii) ........................................................................................ 5
`
`37 C.F.R. § 42.122 ..................................................................................................... 2
`
`
`
`
`
`iii
`
`

`

`
`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
`
`(collectively, “DRL”) seek joinder with Mylan Pharmaceuticals Inc. (“Mylan”) in
`
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040
`
`(“Mylan IPR”). Paper 2. In separate proceedings, Teva Pharmaceuticals USA,
`
`Inc. and Watson Laboratories, Inc. (collectively, “Teva”), IPR2020-01045, Paper
`
`4, and Sun Pharmaceutical Industries, Ltd. (“Sun”), IPR2020-01072, Paper 2, also
`
`seek to join the Mylan IPR.
`
`Pursuant to the Board’s June 18, 2020 Order in IPR2020-01045, Paper 5,
`
`Merck conferred with Teva, DRL, Sun (“Joinder Petitioners”), and Mylan (Mylan,
`
`collectively with Joinder Petitioners, “Petitioners”), to determine what, if any,
`
`issues related to joinder remain in dispute. Merck sought (1) Petitioners’
`
`agreement to structure any joined proceedings such that Merck would have an
`
`opportunity to seek and receive party discovery from Joinder Petitioners before
`
`deposing Mylan’s sole expert and before submitting its Patent Owner’s Response;
`
`and (2) Joinder Petitioners’ agreement to serve a true understudy role in the Mylan
`
`IPR, including by withdrawing each of their experts once Mylan’s expert was
`
`deposed.
`
`Petitioners have not agreed to these conditions. Joinder therefore threatens
`
`to deprive Merck of its discovery rights because the current Mylan IPR schedule
`
`does not allow time for Merck to seek and receive discovery and make use of it in
`
`1
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`the IPR. Indeed, although Joinder Petitioners indicate that they will abide by
`
`whatever schedule adjustment the Board orders in the Mylan IPR, Mylan plans to
`
`oppose any adjustment to the schedule. See EX2027. In addition, Merck opposes
`
`joinder because Joinder Petitioners have not unequivocally committed to dropping
`
`their additional experts or abide by numerous limitations commonly imposed on
`
`joinder petitioners by the Board.
`
`Unless these issues are resolved in Merck’s favor, joinder is inefficient and
`
`prejudicial to Merck. The Board should therefore deny joinder.
`
`I.
`
`LEGAL STANDARD
`
`The decision to grant joinder is discretionary. 35 U.S.C. § 315(c); 37 C.F.R.
`
`§ 42.122. Even in the context of identical, “me too” petitions, joinder is not a
`
`“matter of right.” Unified Patents, Inc. v. Personalweb Techs. et al., IPR2014-
`
`00702, Paper 12 at 4 (P.T.A.B. July 24, 2014). The burden is on Joinder
`
`Petitioners to establish they are entitled to joinder. 37 C.F.R. § 42.20(c).
`
`The Board determines whether to grant joinder on a “case-by-case basis,
`
`taking into account the particular facts of each case.” Harmonix Music Systems,
`
`Inc. v. Princeton Digital Image Corp, IPR2015-00271, Paper 15 at 3 (P.T.A.B.
`
`June 2, 2015). The Board specifically considers any prejudice to patent owner, id.
`
`at 7, and “what impact (if any) joinder would have on the trial schedule for the
`
`2
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`existing review,” Kyocera Corp. v. SoftView LLC, IPR2013-0004, Paper 15 at 4
`
`(P.T.A.B. Apr. 24, 2013).
`
`Separately, the Board has discretion to extend time for good cause, 37
`
`C.F.R. § 42.5(c)(2), and, if necessary, to extend the one-year period for issuing a
`
`decision by up to six months in the case of joinder, 35 U.S.C. § 316(a)(11). The
`
`Board may adjust a scheduling order concurrently with a grant of joinder. See,
`
`e.g., Samsung Electronics, Co. Ltd., v. Evolved Wireless, LLC, IPR2017-00106,
`
`Paper 14 at 4–5 (P.T.A.B. Feb. 23, 2017).
`
`II. ARGUMENT
`
`Merck agrees that in some “me too” contexts, there could be efficiencies to
`
`joinder—for example, the Board’s ability to resolve all issues with all petitioners in
`
`one trial based on all available evidence—but here, Merck opposes joinder to the
`
`extent it precludes Merck from discovery to which it is otherwise entitled from
`
`Joinder Petitioners, and if Joinder Petitioners are not properly confined to a true
`
`“silent understudy” role.
`
`The Board should therefore order: (1) that Merck be provided a period to
`
`seek discovery from Joinder Petitioners (including time to resolve any discovery
`
`disputes and to receive and analyze any such discovery) in the Mylan IPR before
`
`deposing the sole expert testifying in support of Mylan’s petition and submitting its
`
`3
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`Patent Owner’s Response1; and (2) confine Joinder Petitioners to a true understudy
`
`role. Without that relief, the proceeding will deprive Merck of its rights to
`
`discovery and be less efficient, and, in that circumstance, Merck opposes joinder.
`
`A.
`
`Joinder Necessitates an Order Providing for an Orderly Party
`Discovery Process.
`
`The parties have conferred and agree on several conditions for which Joinder
`
`Petitioners will proceed in a “silent understudy” role. See EX2028; EX2029.
`
`However, the parties have not agreed on how party discovery from Joinder
`
`Petitioners would take place in the event of joinder. Joinder Petitioners have taken
`
`the position that Merck has not demonstrated its entitlement to party discovery and
`
`are therefore unwilling to engage on sequencing of discovery. EX2029. Mylan
`
`opposes any change to the current schedule, and has not explained how Merck
`
`could take party discovery under this schedule. EX2027.
`
`Joinder Petitioners put the cart before the horse by requiring that Merck
`
`show entitlement to party discovery before discussing the process for seeking any
`
`such discovery.2 Clearly, Merck has the right to seek routine and additional
`
`
`1 Contemporaneously with this Opposition, Merck will seek authorization to file a
`
`motion to adjust the Scheduling Order in the Mylan IPR if joinder is ordered.
`
`2 Joinder Petitioners argue that Merck has not identified specific documents or
`
`testimony that it is seeking. EX2029. While Merck has previewed the nature of
`
`4
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`discovery from all parties to the proceeding, including Joinder Petitioners. ZTE
`
`Corp. v. Adaptix, Inc., IPR2015-01184, Paper 10 at 4–5 (P.T.A.B. July 24, 2015).
`
`Neither Mylan nor Joinder Petitioners have disputed this basic proposition. But
`
`until Joinder Petitioners are joined as parties in the Mylan IPR, Merck has no right
`
`to seek party discovery, or if there is a dispute, move to compel it.
`
`This dispute related to discovery from Joinder Petitioners is not merely
`
`academic. Merck believes it has a good faith basis to seek discovery from Joinder
`
`Petitioners. See 37 C.F.R. § 42.51(b)(1)(iii) (“a party must serve relevant
`
`information that is inconsistent with a position advanced by the party during the
`
`proceeding”); Garmin International, Inc. v. Cuozzo Speed Techs, LLC, IPR2012-
`
`00001, Paper 26 (P.T.A.B. Mar. 5, 2013). Although it is not Merck’s burden to
`
`show it is entitled to discovery from Joinder Petitioners at this stage—and Merck
`
`does not intend to take on that burden here—Merck provides the following detail
`
`related to each Joinder Petitioner in the interest of transparency and to demonstrate
`
`why joinder without a schedule adjustment prejudices Merck.
`
`
`the discovery it will seek, the current inquiry is whether Merck has a reasonable
`
`basis to seek it. Unified Patents, IPR2014-00702, Paper 12 at 5. If joinder is
`
`ordered, Merck will confer with Joinder Petitioners on specific discovery requests
`
`and, if necessary, seek authorization from the Board to file a motion.
`
`5
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`Teva: In its Petition, Teva takes the position that forming a sitagliptin
`
`phosphate salt “necessarily” forms a salt with a 1:1 ratio of phosphate to
`
`sitagliptin. See IPR2020-01045, EX1002 ¶ 132; see also IPR2020-00040, Paper
`
`21 (describing Mylan’s position, which is mirrored in Teva’s “me too” petition).
`
`Teva, however, participated in prior patent office proceedings in Israel where its
`
`expert, 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. See, e.g., EX2030 at 35–41 (Dr. Chyall
`
`explaining results of solubility experiments that are consistent with non-1:1 salts of
`
`sitagliptin being possible); EX2031 ¶ 12 (“The recovered solids had the same
`
`characteristic XRPD pattern as that of Prof. Atwood’s solids [which Merck argued
`
`showed non-1:1 salts].”).
`
`Merck believes that the data provided by Teva in that prior proceeding is
`
`inconsistent with Teva’s (and other Joinder Petitioners’) position and expert
`
`testimony that sitagliptin can only be mono-protonated and form 1:1
`
`dihydrogenphosphate salts. Indeed, Dr. Chyall, who ran many of the tests in that
`
`prior proceeding, is Teva’s declarant in IPR2020-01045. Presumably because it
`
`was a “me too” declaration, Dr. Chyall did not cite, comment on, or append any of
`
`6
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`that testing to his declaration. If Teva is joined, Merck will serve particularized
`
`requests directed at the testing.3
`
`DRL and Sun: Joinder Petitioners DRL and Sun have patents and
`
`applications related to sitagliptin. These filings characterize the relevant
`
`disclosures of U.S. Patent 6,699,871 (“the ’871 patent”), which is the subject of
`
`several Grounds, in a manner that is inconsistent with the positions taken in their
`
`respective Petitions. Unlike their “me too” Petitions which argue that “the ’871
`
`patent teaches the phosphoric acid salt of sitagliptin,” see, e.g., Paper 2 at 33, their
`
`patent documents, just like Merck’s own ’708 patent, characterize the ’871 patent
`
`as “generally” disclosing “pharmaceutically acceptable salts.” EX2032 (U.S.
`
`Patent No. 8,309,724 (DRL Patent)) at 1:39-42; EX2033 (WO20130014574 (Sun
`
`Application)) at 1:13-15; EX1001 (’708 Patent) at 1:55–59. Put simply, DRL’s
`
`and Sun’s Petitions are inconsistent with the positions DRL and Sun put forth
`
`when seeking their own patents. These statements are also in contrast to the
`
`Board’s institution decision, which preliminarily concluded that the “Examiner
`
`
`3 Merck does not know whether all such testing information is publicly available.
`
`Moreover, Merck may request that a Teva witness answer questions about the
`
`inconsistencies. ZTE, IPR2015-01184, Paper 10 at 5.
`
`4 Patent application assigned to Sun’s subsidiary, Ranbaxy. EX2034.
`
`7
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`simply overlooked WO ’498’s teaching of sitagliptin and a ‘particularly preferred’
`
`phosphoric acid salt form.” IPR2020-00040, Paper 21 at 18. Merck believes it is
`
`entitled to probe those inconsistencies through particularized requests related to
`
`these documents in party discovery.
`
`The Board has recognized that the type of discovery Merck seeks here is
`
`discovery to which patent owners are entitled. See, e.g., Maxlinear, Inc. v. Cresta
`
`Tech Corp., IPR2015-00594, Paper 35 at 7 (P.T.A.B. Jan. 27, 2016) (granting
`
`motion to compel production of evidence inconsistent with position advanced as
`
`routine discovery); Taro Pharms. U.S.A., Inc. v. Apotex Techs., Inc., IPR2017-
`
`01446, Paper 33 at 9 (P.T.A.B. May 11, 2018) (granting discovery of documents
`
`“both relevant to, and inconsistent with, positions advanced” by a party).
`
`While Joinder Petitioners may oppose these requests, their refusal to commit
`
`to a process by which Merck could seek discovery in a sequenced fashion once
`
`joinder is ordered puts Merck in an untenable position. On the one hand, Joinder
`
`Petitioners’ reply to this opposition on joinder is not due for one month, and then
`
`presumably the Board will take time to issue an order on joinder. If joinder is
`
`ordered, conferring on and then litigating these discovery requests will take time,
`
`and then, if ordered, Joinder Petitioners will need to produce the discovery, and
`
`Merck needs time to make use of it in deposition or otherwise. On the other hand,
`
`the deposition of the sole expert testifying in support of Mylan’s Petition is
`
`8
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`scheduled to occur in less than a month, EX2035, and Merck’s Patent Owner’s
`
`Response is due in just over a month, IPR2020-00040, Paper 32. As such, Merck
`
`cannot simply wait until joinder is ordered and after the Board adjudicates the
`
`merits of Merck’s discovery requests to seek an adjustment to the scheduling order
`
`in the Mylan IPR.
`
`B.
`
`Joinder Necessitates an Adjustment to the Schedule.
`
`In conjunction with ensuring the schedule is sequenced to permit Merck to
`
`seek discovery prior to depositions and submission of its Patent Owner’s
`
`Response, the Board should find there is “good cause” for an extension of time to
`
`allow for this order of proceedings.
`
`The Board has recognized that parties are entitled to “adequate time for
`
`Petitioner to produce responsive documents, and for Patent Owner to consider the
`
`documents produced.” Clear-vu Lighting LLC v. University of Strathclyde,
`
`IPR2019-00588, Paper 14 at 13 (P.T.A.B. Apr. 19, 2019) (extending due date for
`
`patent owner’s preliminary response to account for additional discovery); see also
`
`Unified Patents Inc. v. Finjan, Inc., IPR2019-01611, Paper 6 at 2 (P.T.A.B. Dec.
`
`23, 2019) (granting extension of time for additional discovery).
`
`Without an adjustment to the schedule in the Mylan IPR, Merck will not
`
`have the opportunity to seek discovery before deposing Mylan’s expert and filing
`
`its response. As described above, the parties will not have sufficient time to confer
`
`9
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`and, if necessary, brief Merck’s request for routine or additional discovery, much
`
`less time for Merck to actually receive and make use of any such discovery in
`
`advance of Merck’s expert deposition and Patent Owner’s Response.
`
`Further, the process of addressing joinder-related issues itself is taking time.
`
`This joinder scenario is unique and complex—and layered on top of the discovery
`
`issues made relevant by joinder, there are multiple grounds of institution, issues
`
`concerning antedating references and 35 U.S.C. §103(c), and anticipation and
`
`obviousness arguments. IPR2020-00040, Paper 21. Merck currently has just over
`
`three months to present the evidence and argument in support of its Patent Owner’s
`
`Response. But with joinder, Merck would have to litigate the propriety of party
`
`discovery against three new Joinder Petitioners (each of whom have reserved the
`
`right to advocate for themselves in a non-understudy role in these disputes) in this
`
`critical period of time. EX2029. Making matters more complicated, Mylan has
`
`reaffirmed that it reserves the right to weigh in on party discovery of Joinder
`
`Petitioners, such that Merck will now be conferring with two parties when it seeks
`
`discovery from a single party. EX2036. Accordingly, Merck would be prejudiced
`
`without an appropriate adjustment to the schedule.
`
`Merck is amenable to negotiating a revised schedule with the Petitioners that
`
`accounts for the issues raised herein, and that works for the parties and the Board.
`
`As a proposal, Merck suggests that DUE DATE 1 occur two months after joinder
`
`10
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`is ordered, with the remaining due dates adjusted in commensurate fashion.
`
`Merck will seek permission from the Board to file a motion making corresponding
`
`adjustments to the schedule in the Mylan IPR. This proposed schedule adjustment
`
`would address the issues introduced by the Motions for Joinder but still ensure that
`
`a final written decision is issued as soon as possible.
`
`C.
`
`Joinder Requires that Joinder Petitioners Serve the Role of True
`Understudies.
`
`The Board should additionally deny joinder unless Joinder Petitioners are
`
`confined to the role of true silent understudies in the Mylan IPR. Joinder
`
`Petitioners have refused to abide by conditions typically imposed on silent
`
`understudies.
`
`First, Joinder Petitioners have hedged on the withdrawal of their “me too”
`
`experts, stating that they “reserve the right to use their own experts” and then only
`
`provide an “example” of when they may use that reservation. EX2037; EX2038
`
`(emphasis added). Such a reservation of rights is unacceptable. Merck is
`
`concerned that it is going to get sandbagged by an 11th hour attempt to resurrect
`
`one of the “me too” experts after Merck has taken its expert deposition, submitted
`
`its Patent Owner’s Response, and laid bare its trial strategy. That is fundamentally
`
`unfair. Joinder Petitioners should have to commit not to use their own experts after
`
`the deposition of Mylan’s expert, period.
`
`11
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`Second, Joinder Petitioners have refused to limit their participation in the
`
`Mylan IPR in ways that the Board has found necessary in other proceedings. In
`
`the meet and confer process, Merck has asked Joinder Petitioners to commit to the
`
`following:
`
` Mylan will be subject to the word count limits for a single party when filing
`
`papers on behalf of itself and Joinder Petitioners. EX2037 at 3; Aurobindo
`
`Pharma U.S.A. Inc. v. Astrazeneca AB, IPR2016-01117, Paper 12 at 11
`
`(P.T.A.B. Oct. 21, 2016).
`
` Joinder Petitioners must obtain prior Board authorization to file any paper or
`
`to take any action on its own in the Mylan IPR. EX2037 at 3; Ericsson Inc.,
`
`v. Unicloc 2017 LLC, IPR2020-00376, Paper 16 at 10 (P.T.A.B. May 22,
`
`2020).
`
` Joinder Petitioners will not serve discovery requests in connection with the
`
`Mylan IPR. EX2037 at 3; Aurobindo, IPR2016-01117, Paper 12 at 6.
`
` Joinder Petitioners’ counsel will not participate in a speaking role in any
`
`telephonic conference before the Board in the Mylan IPR. EX2037 at 4;
`
`Teva Pharmaceuticals USA Inc. v. Eli Lilly & Co., IPR2016-01340, Paper 8
`
`at 3, Paper 9 at 11 (P.T.A.B. Oct. 6, 2016).
`
`12
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
` Counsel for Joinder Petitioners will not participate in oral argument in the
`
`Mylan IPR. EX2037 at 4; Dr. Reddy’s v. Horizon, Inc., IPR2018-01341,
`
`Paper 21 at 7 (P.T.A.B. Apr. 19, 2019).
`
`Without providing their reasoning, Joinder Petitioners have refused to agree
`
`to the above conditions. EX2038 (writing on behalf of “Joinder Petitioners Teva,
`
`Sun and DRL”: “[O]ur silence should not be construed as an agreement to any
`
`particular condition”). The Board has required these covenants as a condition of
`
`joinder, because these conditions ensure the efficient and orderly resolution of the
`
`proceedings. Dr. Reddy’s v. Horizon, IPR2018-01341, Paper 21 at 7. Joinder
`
`Petitioners’ refusal to agree to them is unjustified and is a basis to deny joinder.
`
`Mylan Pharmaceuticals, Inc., v. Janssen Oncology, Inc., IPR2016-01332, Paper 21
`
`at 10–11 (P.T.A.B. Jan. 10, 2017).
`
`D.
`
`In the Absence of Needed Safeguards, Merck Opposes Joinder.
`
`The Board has the discretion to and should order that party discovery occur
`
`in advance of key deadlines imposed on Merck and, to accomplish that, extend the
`
`schedule in the Mylan IPR for good cause. The Board should also ensure that
`
`Joinder Petitioners are true understudies in the Mylan IPR. Absent those
`
`accommodations, Merck opposes joinder as it would be prejudiced, and joinder
`
`would not “ensure the just, speedy, and inexpensive resolution of every
`
`13
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`proceeding.” Central Security Grp. – Nationwide, Inc., v. Ubiquitous Connectivity,
`
`LP, IPR2019-01610, Paper 12 at 6 (P.T.A.B. Feb. 26, 2020).
`
`The Board has denied joinder in cases such as this one where joinder would
`
`spur the need for additional discovery and thereby affect the schedule. See, e.g.,
`
`Unified Patents, IPR2014-00702, Paper 12 at 5–6; ZTE, IPR2015-01184, Paper 10
`
`at 4–5. The Board has also denied joinder in circumstances, like the one here,
`
`where the petitioner did not “offer a practical way to accommodate the additional
`
`discovery without inconveniencing all involved or delaying the due dates.”
`
`Janssen Oncology, IPR2016-01332, Paper 21 at 11.
`
`Joinder Petitioners’ assertion that “joinder will neither unduly complicate the
`
`Mylan IPR nor delay its schedule,” Paper 3 at 2; see also IPR2020-01045, Paper 4
`
`at 2; IPR2020-01072, Paper 3 at 7, is without basis. As outlined above, the parties
`
`need time to conduct party discovery prior to Merck’s deadline to file its Patent
`
`Owner’s Response and depose Mylan’s sole expert. This complicates the schedule
`
`and introduces additional issues into the Mylan IPR. See Unified Patents,
`
`IPR2014-00702, Paper 12 at 5–6 (“[The] potential for additional discovery
`
`presents a new substantive issue beyond what is already before us [] and, as a
`
`result, weighs in favor of denying [the] Motion for Joinder.”). Further, Joinder
`
`Petitioners’ refusal to serve the role of true understudies, including by
`
`unconditionally withdrawing their own declarants after the deposition of Mylan’s
`
`14
`
`

`

`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`declarant, further complicates the trial. ZTE, IPR2015-01184, Paper 10 at 5 (“We
`
`agree with Patent Owner that the new issues raised by reliance on the different
`
`declarant in the instant Petition would adversely impact the IPR ’1525 trial.”).
`
`
`
` Without the requested safeguards, the Board should deny joinder.
`
`
`Date: July 10, 2020
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice
`motion to be submitted)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Alexander S. Zolan (Pro Hac Vice
`motion to be submitted)
`Elise M. Baumgarten (Pro Hac Vice
`motion to be submitted)
`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
`jberniker@wc.com
`azolan@wc.com
`ebaumgarten@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`
`15
`
`

`

`
`
`
`
`Case IPR2020-01060 | U.S. Patent 7,326,708
`
`CERTIFICATE OF SERVICE
`
`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 July 10, 2020, by delivering a
`
`copy via electronic mail on the following attorneys of record:
`
`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
`MTeschner.ipr@ldlkm.com
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
`
`
`
`
`
`
`
`
`
`
`
`
`
`16
`
`