U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TEVA PHARMACEUTICALS USA, INC. and
`WATSON LABORATORIES, INC.,
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01045
`
`
`
`
`
`
`
`
`
`DR. REDDY'S LABORATORIES, INC., and
`DR. REDDY'S LABORATORIES, LTD.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01060
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01072
`
`U.S. Patent No. 7,326,708 to Cypes et al.
`
`PETITIONERS’ JOINT REPLY IN SUPPORT OF MOTIONS FOR
`JOINDER UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`Mail Stop “PATENT BOARD”
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TEVA PHARMACEUTICALS USA, INC. and
`WATSON LABORATORIES, INC.,
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01045
`
`
`
`
`
`
`
`
`
`DR. REDDY'S LABORATORIES, INC., and
`DR. REDDY'S LABORATORIES, LTD.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01060
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.,
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`
`Inter Partes Review No.: IPR2020-01072
`
`U.S. Patent No. 7,326,708 to Cypes et al.
`
`PETITIONERS’ JOINT REPLY IN SUPPORT OF MOTIONS FOR
`JOINDER UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`Mail Stop “PATENT BOARD”
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Table of Contents
`
`
`I.
`II.
`
`Joinder Petitioners Are True Me-Too Petitioners ........................................... 1
`Purported “Routine Discovery” From Me-Too Petitioners Should Not
`Preclude Joinder ............................................................................................... 3
`“Routine Discovery” Would Not Disrupt This Proceeding ............................ 7
`III.
`IV. Conclusion ....................................................................................................... 7
`
`
`i
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Table of Authorities
`
` Page(s)
`
`Cases
`Amneal Pharma. LLC v. Almirall, LLC,
`IPR2019-00207, Paper 39 ..................................................................................... 4
`Unified Patents v. Personalweb Techs,
`IPR2014-00702, Paper 12 ..................................................................................... 4
`ZTE Corp. v. Adaptix, Inc.,
`IPR2015-01184, Paper 10 ..................................................................................... 4
`
`
`
`ii
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Patent Owner’s opposition to the motions for joinder filed by Teva
`
`(IPR2020-01045), DRL (IPR2020-01060), and Sun (IPR2020-01072) (collectively
`
`“Joinder Petitioners”) fails to undermine the legitimate bases for joinder set forth
`
`in Joinder Petitioners’ respective motions. Patent Owner has manufactured
`
`disputes where none exist in an attempt to derail joinder and the schedule in the
`
`underlying proceeding. For the reasons set forth in the joinder motions and below,
`
`Joinder Petitioners’ Motions for Joinder should be granted.
`
`I.
`
`Joinder Petitioners Are True Me-Too Petitioners
`
`Merck asserts that Joinder Petitioners have not agreed to a “true understudy
`
`role” (Paper 9 at 11), but the record shows otherwise. Joinder Petitioners rely on the
`
`same prior art and arguments as Mylan, submitted substantially identical petitions
`
`and identical expert testimony, and agreed to raise no new arguments. Joinder
`
`Petitioners have agreed that Mylan will serve as lead counsel, submit substantive
`
`briefs, provide the expert testimony, take and defend any depositions, and argue at
`
`hearings. Joinder Petitioners are classic “me-too” petitioners, having agreed to
`
`conditions consistent with the grant of joinder. Br. 7–8; Ex. 2029, 1–2; Ex. 2038, 1.
`
`Merck incorrectly argues that there are joinder conditions to which Joinder
`
`Petitioners did not agree. Paper 9 at 12–13. Correspondence already of record
`
`1 For convenience, all references are to the joinder briefs and exhibits filed in
`
`IPR2020-01045 (“Teva IPR”). All emphasis is supplied unless otherwise noted.
`
`1
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`shows that Joinder Petitioners explicitly agreed to Merck’s conditions:
`
`Condition
`Mylan subject to word count limits
`
`Joinder Petitioners’ Position
`“Mylan will be Lead Petitioner [and] file all
`
`for a single party when filing
`
`substantive written submissions . . . . Joinder
`
`papers on behalf of itself and
`
`petitioners will not file additional pages to
`
`Joinder Petitioners.
`
`Mylan’s papers.” Ex. 2029, 1.
`
`Joinder Petitioners will obtain
`
`Joinder Petitioners reserve the right to address
`
`prior Board authorization to file
`
`party-specific issues, but “will seek Board
`
`any paper or to take any action on
`
`authorization to file any such paper or to
`
`its own in the Mylan IPR.
`
`take any action on its own.” Id., 2.
`
`Joinder Petitioners will not serve
`
`“Joinder
`
`petitioners . . . will not
`
`serve
`
`discovery requests in connection
`
`discovery requests in the Mylan IPR.” Id., 1.
`
`with the Mylan IPR.
`
`Joinder Petitioners’ counsel will
`
`“Mylan will be Lead Petitioner, file all
`
`not participate in a speaking role
`
`substantive written
`
`submissions,
`
`[and]
`
`in Board teleconferences or oral
`
`conduct all argument at hearings . . . .”
`
`argument before the Board in the
`
`Id., 1.
`
`Mylan IPR.
`
`
` Joinder Petitioners also agreed to rely on Mylan’s expert, Dr. Chorghade,
`
`and to “withdraw their respective opening expert declarations once Dr. Chorghade
`
`2
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`is deposed on his opening declaration.” Ex. 2038, 1. Joinder Petitioners have
`
`appropriately only reserved the right to offer their own expert if Mylan settles or
`
`otherwise ceases participation before reply briefs and depositions are completed.
`
`Exs. 2029, 2038.
`
`In fact, Merck recently conceded that the parties “are in agreement” on all
`
`but one of Merck’s conditions of joinder. Ex. 1019. While Joinder Petitioners
`
`disagree that it is appropriate to address discovery at this stage, they will also agree
`
`to Merck’s final condition: Joinder Petitioners agree not to seek discovery from
`
`Merck even if Merck seeks discovery from them (id. item e), and will abide by any
`
`additional conditions the Board deems necessary. Thus, no unmet joinder
`
`conditions support denial of joinder.
`
`Contrary to Merck’s suggestion (Paper 9 at 15), joinder will significantly
`
`enhance administrative and party efficiency, because DRL is not time-barred
`
`(Ex. 1020), and a separate IPR proceeding involving DRL would needlessly
`
`duplicate efforts with multiple briefs, experts and hearings on the same patent
`
`claims and grounds already being litigated. Including Teva and Sun in the same
`
`proceeding further serves efficiency, given their “me-too” stance.
`
`II.
`
`Purported “Routine Discovery” From
`Me-Too Petitioners Should Not Preclude Joinder
`
`As the Board has already noted, it makes sense to “resolve the joinder issue
`
`fast” before reaching “whether the [requested] discovery is or is not appropriate.”
`3
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`IPR2020-00040, Ex. 2041 at 24:2–7. In any event, routine discovery requests
`
`should not preclude joinder. And the alleged “routine discovery” Merck intends to
`
`seek is a manufactured dispute engineered solely to undermine valid joinder and
`
`unnecessarily delay the schedule.
`
`Me-too joinder petitions are routinely instituted and joined to original IPR
`
`proceedings without need for any schedule adjustments upon joinder, even where
`
`additional party-specific discovery is later sought. Amneal Pharma. LLC v.
`
`Almirall, LLC, IPR2019-00207, Paper 39. In arguing otherwise, Merck relies on
`
`two factually distinct cases. See Paper 9 at 4–5. In Unified Patents, Inc., the
`
`discovery at issue related to the identity of the real parties-in-interest (“RPIs”),
`
`which the Board determined would inject a new substantive party-specific issue.
`
`Unified Patents v. Personalweb Techs, IPR2014-00702, Paper 12 at 5. The Board
`
`denied joinder on that basis, and because (a) the joinder petitioner did not address
`
`how joinder would impact the schedule of five interrelated copending IPRs and
`
`(b) a pending Federal Circuit decision could moot the entire proceeding. Id. at 6–7.
`
`None of those issues is present here. Similarly, in ZTE, joinder was denied because
`
`the joinder petitioner did not file an identical petition, did not rely on the same
`
`expert declarant even after the declarant’s deposition, and did not address these
`
`differences in the joinder motion. See ZTE Corp. v. Adaptix, Inc., IPR2015-01184,
`
`Paper 10 at 4–6. These factors are not present here and ZTE does not control.
`
`4
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Moreover, Joinder Petitioners each already provided routine discovery with
`
`their petitions, including information about RPIs. Paper 3, 6; IPR2020-01060,
`
`Paper 2, 6; IPR2020-01072, Paper 3, 6. Merck’s insistence that it requires
`
`additional “routine discovery” is merely a delay tactic, and Merck has fallen short
`
`of demonstrating a “good faith basis” to seek such discovery. With respect to the
`
`Teva Israeli Opposition proceeding on the Israeli counterpart to the ’708 patent, all
`
`of the non-work product documents associated with that proceeding are either
`
`available on the public docket or are already in Merck’s possession from its
`
`participation in that proceeding. No Protective Order precludes Merck from relying
`
`on those documents in this IPR.
`
`Moreover, if the Teva documents from the Israeli Opposition are routine
`
`discovery from any party in this proceeding, they are routine discovery that Merck,
`
`not Teva, must produce in the context of this IPR. The declarations and testimony
`
`from Teva’s expert, Dr. Chyall, in that proceeding are inconsistent with Merck’s
`
`position in this IPR, and are entirely consistent with Teva’s me-too petition.
`
`Indeed, the Israeli Patent Office invalidated the Merck counterpart patent on the
`
`basis of Dr. Chyall’s testimony in those proceedings. Ex. 1021 ¶ 36 (Opponent
`
`claims that the DHP salt “is the only [salt] that can be formed by reacting
`
`sitagliptin as a free base and the phosphoric acid”); ¶ 74 (finding that claim 1 of the
`
`Israeli counterpart application lacks novelty because, among other things, the DHP
`
`5
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`salt “is the only salt formed from reacting sitagliptin and phosphoric acid”). Even a
`
`cursory review of the full versions of the documents Merck clip quotes shows that
`
`Dr. Chyall’s statements were consistent with the position that the only salt that
`
`forms
`
`from
`
`crystallizing
`
`sitagliptin
`
`using
`
`phosphoric
`
`acid
`
`is
`
`the
`
`dihydrogenphosphate (“DHP”) salt, which has a 1:1 ratio of sitagliptin to
`
`phosphoric acid. See Ex. 1022 ¶ 30 (“I therefore remain fully convinced that the
`
`only pharmaceutically suitable stable salt that will result from a reaction of
`
`sitagliptin free base and phosphoric acid is the DHP Salt, a salt containing a 1:1
`
`ratio of sitagliptin to phosphoric acid.”). On that basis, the Israeli Patent Office
`
`invalidated Merck’s counterpart to the ‘708 patent at issue here. Ex. 1021 ¶¶ 87–
`
`89.
`
`Merck’s bid for discovery from DRL and Sun is similarly flawed. Merck
`
`cites statements in a DRL patent and a Sun application that the ’871 Patent
`
`generally discloses a list of “pharmaceutically acceptable salts” (Paper 9 at 7; Ex.
`
`2032, 1:39–42; Ex. 2033, 1:13–15), but none of these is inconsistent with any of
`
`DRL’s or Sun’s arguments. Both parties acknowledge in their petitions that the
`
`’871 Patent lists multiple salts, one of which is the phosphoric acid salt, which is
`
`particularly preferred. IPR2020-01060, Paper 2, 16–19; IPR2020-01072, Paper 3,
`
`16–19. Nothing in the cited patent documents warrants further discovery.
`
`6
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`III. “Routine Discovery” Would Not Disrupt This Proceeding
`
`Even if Merck were entitled to additional “routine discovery”—which it is
`
`not—there is no reason that such discovery would disrupt this proceeding. As the
`
`Board recognized, while a discovery dispute “may take longer than some people
`
`think, . . . that wouldn’t necessarily derail the schedule from where it is right now.”
`
`IPR2020-00040, Ex. 2041 at 20:2–9. And even if such discovery required an
`
`extension to the existing schedule, Merck can subsequently explain why “a modest
`
`change in the briefing schedule is justified given the circumstances post joinder.”
`
`Id. at 34:15–35:6. Neither of these scenarios justify precluding joinder.
`
`Nor will Joinder Petitioners interfere with extensions to the existing
`
`schedule. Again, as true understudies, Joinder Petitioners will not oppose minor
`
`adjustments to the schedule—instead, Mylan will file “all substantive written
`
`submissions, [and] conduct all argument at hearings . . . .” Ex. 2029, 1. Joinder
`
`Petitioners have also already explained that, if joined, Joinder Petitioners would
`
`“comply with any change that the Board orders with respect to the schedule in the
`
`Mylan IPR.” Id. Any argument that joinder discovery would derail this proceeding
`
`lacks support and is at best speculative.
`
`IV. Conclusion
`
`For the reasons stated above, Petitioners’ Motions for Joinder should be
`
`granted.
`
`
`
`7
`
`
`
`
`Dated: July 29, 2020
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Respectfully submitted,
`
`/s/ Keith A. Zullow
`Keith A. Zullow
`(Reg. No. 37,975)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`kzullow@goodwinlaw.com
`
`Counsel for Petitioners Teva
`Pharmaceuticals USA, Inc. and Watson
`Laboratories, Inc.
`
`/s/ Russell W. Faegenburg
`Russell W. Faegenburg
`(Reg. No. 77,876)
`Lerner, David, Littenberg, Krumholz &
`Mentlik, LLP
`20 Commerce Drive
`Cranford, NJ 07016
`Tel: 908-654-5000
`Fax: 908-654-7866
`rfaegenburg@lernerdavid.com
`
`Counsel for Petitioners Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s
`Laboratories, Ltd.
`
`/s/ Jovial Wong
`Jovial Wong
`(Reg. No. 60,115)
`Winston & Strawn LLP
`1901 L St NW
`Washington, DC 20036
`Tel: 202-282-5000
`
`8
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Fax: 202-282-5100
`SunIPR@winston.com
`
`Counsel for Petitioner Sun Pharmaceutical
`Industries Ltd
`
`
`
`
`
`
`
`9
`
`
`
`
`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`CERTIFICATION OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
`
`“PETITIONERS’ JOINT REPLY IN SUPPORT OF MOTIONS FOR JOINDER
`
`UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)” was served electronically via e-mail
`
`on July 29, 2020 on the following counsel of record:
`
`Stanley E. Fisher
`Bruce R. Genderson
`Jessamyn S. Berniker
`Alexander S. Zolan
`Elise M. Baumgarten
`Shaun P. Mahaffy
`Anthony H. Sheh
`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
`MerckSitagliptin@wc.com
`
`
`Dated: July 29, 2020
`
`
`
`
`/s/ Keith A. Zullow
`Keith A. Zullow
`
`10
`
`
`
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