`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
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`
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`
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`
`
`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
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`
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`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
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`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
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`
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`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
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`(IPR2020-01045), DRL (IPR2020-01060), and Sun (IPR2020-01072) (collectively
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`“Joinder Petitioners”) fails to undermine the legitimate bases for joinder set forth
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`in Joinder Petitioners’ respective motions. Patent Owner has manufactured
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`disputes where none exist in an attempt to derail joinder and the schedule in the
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`underlying proceeding. For the reasons set forth in the joinder motions and below,
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`Joinder Petitioners’ Motions for Joinder should be granted.
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`I.
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`Joinder Petitioners Are True Me-Too Petitioners
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`Merck asserts that Joinder Petitioners have not agreed to a “true understudy
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`role” (Paper 9 at 11), but the record shows otherwise. Joinder Petitioners rely on the
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`same prior art and arguments as Mylan, submitted substantially identical petitions
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`and identical expert testimony, and agreed to raise no new arguments. Joinder
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`Petitioners have agreed that Mylan will serve as lead counsel, submit substantive
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`briefs, provide the expert testimony, take and defend any depositions, and argue at
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`hearings. Joinder Petitioners are classic “me-too” petitioners, having agreed to
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`conditions consistent with the grant of joinder. Br. 7–8; Ex. 2029, 1–2; Ex. 2038, 1.
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`Merck incorrectly argues that there are joinder conditions to which Joinder
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`Petitioners did not agree. Paper 9 at 12–13. Correspondence already of record
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`1 For convenience, all references are to the joinder briefs and exhibits filed in
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`IPR2020-01045 (“Teva IPR”). All emphasis is supplied unless otherwise noted.
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`1
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`
`
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`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
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`Joinder Petitioners’ Position
`“Mylan will be Lead Petitioner [and] file all
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`for a single party when filing
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`substantive written submissions . . . . Joinder
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`papers on behalf of itself and
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`petitioners will not file additional pages to
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`Joinder Petitioners.
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`Mylan’s papers.” Ex. 2029, 1.
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`Joinder Petitioners will obtain
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`Joinder Petitioners reserve the right to address
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`prior Board authorization to file
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`party-specific issues, but “will seek Board
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`any paper or to take any action on
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`authorization to file any such paper or to
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`its own in the Mylan IPR.
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`take any action on its own.” Id., 2.
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`Joinder Petitioners will not serve
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`“Joinder
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`petitioners . . . will not
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`serve
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`discovery requests in connection
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`discovery requests in the Mylan IPR.” Id., 1.
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`with the Mylan IPR.
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`Joinder Petitioners’ counsel will
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`“Mylan will be Lead Petitioner, file all
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`not participate in a speaking role
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`substantive written
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`submissions,
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`[and]
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`in Board teleconferences or oral
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`conduct all argument at hearings . . . .”
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`argument before the Board in the
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`Id., 1.
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`Mylan IPR.
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` Joinder Petitioners also agreed to rely on Mylan’s expert, Dr. Chorghade,
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`and to “withdraw their respective opening expert declarations once Dr. Chorghade
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`2
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`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
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`appropriately only reserved the right to offer their own expert if Mylan settles or
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`otherwise ceases participation before reply briefs and depositions are completed.
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`Exs. 2029, 2038.
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`In fact, Merck recently conceded that the parties “are in agreement” on all
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`but one of Merck’s conditions of joinder. Ex. 1019. While Joinder Petitioners
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`disagree that it is appropriate to address discovery at this stage, they will also agree
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`to Merck’s final condition: Joinder Petitioners agree not to seek discovery from
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`Merck even if Merck seeks discovery from them (id. item e), and will abide by any
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`additional conditions the Board deems necessary. Thus, no unmet joinder
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`conditions support denial of joinder.
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`Contrary to Merck’s suggestion (Paper 9 at 15), joinder will significantly
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`enhance administrative and party efficiency, because DRL is not time-barred
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`(Ex. 1020), and a separate IPR proceeding involving DRL would needlessly
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`duplicate efforts with multiple briefs, experts and hearings on the same patent
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`claims and grounds already being litigated. Including Teva and Sun in the same
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`proceeding further serves efficiency, given their “me-too” stance.
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`II.
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`Purported “Routine Discovery” From
`Me-Too Petitioners Should Not Preclude Joinder
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`As the Board has already noted, it makes sense to “resolve the joinder issue
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`fast” before reaching “whether the [requested] discovery is or is not appropriate.”
`3
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`
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`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
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`should not preclude joinder. And the alleged “routine discovery” Merck intends to
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`seek is a manufactured dispute engineered solely to undermine valid joinder and
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`unnecessarily delay the schedule.
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`Me-too joinder petitions are routinely instituted and joined to original IPR
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`proceedings without need for any schedule adjustments upon joinder, even where
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`additional party-specific discovery is later sought. Amneal Pharma. LLC v.
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`Almirall, LLC, IPR2019-00207, Paper 39. In arguing otherwise, Merck relies on
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`two factually distinct cases. See Paper 9 at 4–5. In Unified Patents, Inc., the
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`discovery at issue related to the identity of the real parties-in-interest (“RPIs”),
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`which the Board determined would inject a new substantive party-specific issue.
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`Unified Patents v. Personalweb Techs, IPR2014-00702, Paper 12 at 5. The Board
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`denied joinder on that basis, and because (a) the joinder petitioner did not address
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`how joinder would impact the schedule of five interrelated copending IPRs and
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`(b) a pending Federal Circuit decision could moot the entire proceeding. Id. at 6–7.
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`None of those issues is present here. Similarly, in ZTE, joinder was denied because
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`the joinder petitioner did not file an identical petition, did not rely on the same
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`expert declarant even after the declarant’s deposition, and did not address these
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`differences in the joinder motion. See ZTE Corp. v. Adaptix, Inc., IPR2015-01184,
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`Paper 10 at 4–6. These factors are not present here and ZTE does not control.
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`4
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`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`Moreover, Joinder Petitioners each already provided routine discovery with
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`their petitions, including information about RPIs. Paper 3, 6; IPR2020-01060,
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`Paper 2, 6; IPR2020-01072, Paper 3, 6. Merck’s insistence that it requires
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`additional “routine discovery” is merely a delay tactic, and Merck has fallen short
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`of demonstrating a “good faith basis” to seek such discovery. With respect to the
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`Teva Israeli Opposition proceeding on the Israeli counterpart to the ’708 patent, all
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`of the non-work product documents associated with that proceeding are either
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`available on the public docket or are already in Merck’s possession from its
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`participation in that proceeding. No Protective Order precludes Merck from relying
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`on those documents in this IPR.
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`Moreover, if the Teva documents from the Israeli Opposition are routine
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`discovery from any party in this proceeding, they are routine discovery that Merck,
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`not Teva, must produce in the context of this IPR. The declarations and testimony
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`from Teva’s expert, Dr. Chyall, in that proceeding are inconsistent with Merck’s
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`position in this IPR, and are entirely consistent with Teva’s me-too petition.
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`Indeed, the Israeli Patent Office invalidated the Merck counterpart patent on the
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`basis of Dr. Chyall’s testimony in those proceedings. Ex. 1021 ¶ 36 (Opponent
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`claims that the DHP salt “is the only [salt] that can be formed by reacting
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`sitagliptin as a free base and the phosphoric acid”); ¶ 74 (finding that claim 1 of the
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`Israeli counterpart application lacks novelty because, among other things, the DHP
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`5
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`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
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`cursory review of the full versions of the documents Merck clip quotes shows that
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`Dr. Chyall’s statements were consistent with the position that the only salt that
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`forms
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`from
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`crystallizing
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`sitagliptin
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`using
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`phosphoric
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`acid
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`is
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`the
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`dihydrogenphosphate (“DHP”) salt, which has a 1:1 ratio of sitagliptin to
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`phosphoric acid. See Ex. 1022 ¶ 30 (“I therefore remain fully convinced that the
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`only pharmaceutically suitable stable salt that will result from a reaction of
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`sitagliptin free base and phosphoric acid is the DHP Salt, a salt containing a 1:1
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`ratio of sitagliptin to phosphoric acid.”). On that basis, the Israeli Patent Office
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`invalidated Merck’s counterpart to the ‘708 patent at issue here. Ex. 1021 ¶¶ 87–
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`89.
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`Merck’s bid for discovery from DRL and Sun is similarly flawed. Merck
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`cites statements in a DRL patent and a Sun application that the ’871 Patent
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`generally discloses a list of “pharmaceutically acceptable salts” (Paper 9 at 7; Ex.
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`2032, 1:39–42; Ex. 2033, 1:13–15), but none of these is inconsistent with any of
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`DRL’s or Sun’s arguments. Both parties acknowledge in their petitions that the
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`’871 Patent lists multiple salts, one of which is the phosphoric acid salt, which is
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`particularly preferred. IPR2020-01060, Paper 2, 16–19; IPR2020-01072, Paper 3,
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`16–19. Nothing in the cited patent documents warrants further discovery.
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`6
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`U.S. Patent No. 7,326,708
`IPR Nos. 2020-01045, 2020-01060, 2020-01072
`III. “Routine Discovery” Would Not Disrupt This Proceeding
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`Even if Merck were entitled to additional “routine discovery”—which it is
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`not—there is no reason that such discovery would disrupt this proceeding. As the
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`Board recognized, while a discovery dispute “may take longer than some people
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`think, . . . that wouldn’t necessarily derail the schedule from where it is right now.”
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`IPR2020-00040, Ex. 2041 at 20:2–9. And even if such discovery required an
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`extension to the existing schedule, Merck can subsequently explain why “a modest
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`change in the briefing schedule is justified given the circumstances post joinder.”
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`Id. at 34:15–35:6. Neither of these scenarios justify precluding joinder.
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`Nor will Joinder Petitioners interfere with extensions to the existing
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`schedule. Again, as true understudies, Joinder Petitioners will not oppose minor
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`adjustments to the schedule—instead, Mylan will file “all substantive written
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`submissions, [and] conduct all argument at hearings . . . .” Ex. 2029, 1. Joinder
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`Petitioners have also already explained that, if joined, Joinder Petitioners would
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`“comply with any change that the Board orders with respect to the schedule in the
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`Mylan IPR.” Id. Any argument that joinder discovery would derail this proceeding
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`lacks support and is at best speculative.
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`IV. Conclusion
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`For the reasons stated above, Petitioners’ Motions for Joinder should be
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`granted.
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`7
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`Dated: July 29, 2020
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`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
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`
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`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
`
`
`
`
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`
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`9
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`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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