IPR2020-01060
`U.S. Patent No. 7,326,708
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`Attorney Docket No. REDDY 7.1R-024
`
`
`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.
`
`U.S. Patent No. 7,326,708 to CYPES et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`
`Inter Partes Review No. IPR2020-01060
`
`
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`U.S. Patent No. 7,326,708
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`Attorney Docket No. REDDY 7.1R-024
`
`
`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.
`
`U.S. Patent No. 7,326,708 to CYPES et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`
`Inter Partes Review No. IPR2020-01060
`
`
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`STATEMENT OF RELIEF REQUESTED ...................................................... 1
`STATEMENT OF REASONS FOR RELIEF REQUESTED .......................... 2
`A.
`Legal Standards ........................................................................................ 2
`B. DRL’s Motion is Timely .......................................................................... 3
`C.
`Joinder is Appropriate .............................................................................. 3
`1. No New Grounds of Unpatentability in the Petition ....................... 5
`2. No Impact on the Schedule for the Existing IPR Proceeding ......... 6
`3.
`Briefing and Discovery Will be Simplified .................................... 7
`4. No Prejudice to Patent Owner ......................................................... 8
`III. CONCLUSION ................................................................................................. 8
`
`
`
`
`
`
`
`2
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`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`
`I.
`STATEMENT OF RELIEF REQUESTED
`Petitioners Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories,
`
`Ltd. (collectively “DRL” or “Petitioner”) respectfully request joinder of the
`
`concurrently filed petition for inter partes review of U.S. Patent No. 7,326,708
`
`(“the ’708 Patent”) (IPR2020-01060) with Mylan Pharmaceuticals Inc. v. Merck
`
`Sharp & Dohme Corp., IPR2020-00040, filed October 30, 2019, and instituted
`
`May 12, 2020 ( “the Mylan IPR”). (See IPR2020-00040, Paper 21.) The instant
`
`Petition is substantially the same as the Mylan IPR: it involves the same patent,
`
`same claims, same grounds of unpatentability, and the same evidence (including
`
`the same prior art combinations) as the Mylan IPR. If joined, as discussed further
`
`below, DRL will assume a “silent understudy” role and will not take an active role
`
`in the inter partes review proceeding unless the Mylan Petitioner ceases to
`
`participate in the instituted IPR.
`
`While the instant Petition includes the declaration of Dr. Fortunak (“DRL
`
`Declarant”), this declaration presents nearly identical expert testimony to that put
`
`forth by Dr. Chorghade (“Mylan Declarant”) in the Mylan IPR. If Mylan allows
`
`DRL to use the Mylan Declarant, then DRL will withdraw the DRL Declarant, and
`
`rely only the Mylan Declarant. The PTAB has acknowledged that such concessions
`
`are sufficient to minimize the impact on the original proceeding. SAP Am. Inc. v.
`
`Clouding IP, LLC, IPR2014-00306, Paper 13, at 4 (May 19, 2014). Thus, the
`1
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`
`
`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`proposed joinder will neither unduly complicate the Mylan IPR nor delay its
`
`schedule. As such, the joinder will promote judicial efficiency in determining
`
`patentability in the Mylan IPR without prejudice to Patent Owner.
`
`Although DRL is not otherwise time barred pursuant to 37 C.F.R.
`
`§ 42.101(b), this Motion for Joinder, and accompanying Petition, are timely
`
`because they are filed less than one month after a decision instituting trial in the
`
`Mylan IPR. 37 C.F.R. § 42.122(b) (“no later than one month after the institution
`
`date of any inter partes review for which joinder is requested.”). Accordingly,
`
`DRL respectfully requests that the Board grant this Motion for Joinder.
`
`II.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`A.
`Legal Standards
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review (IPR) proceedings. Joinder is governed by 35 U.S.C. § 315(c), which states:
`
`(c) JOINDER. – If the Director institutes an inter partes review, the
`
`Director, in his or her discretion, may join as a party to that inter partes
`
`review any person who properly files a petition under section 311 that the
`
`Director, after receiving a preliminary response under section 313 or the
`
`expiration of the time for filing such a response, determines warrants the
`
`institution of an inter partes review under section 314.
`
`
`
`2
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`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`
`A motion for joinder should “(1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Dell Inc. v. Network-1 Sec. Solutions, Inc., IPR2013-00385,
`
`Paper 17 (PTAB July 29, 2013); Hyundai Motor Co. v. Am. Vehicular Scis. LLC,
`
`IPR2014-01543, Paper 11, at 3 (Oct. 24, 2014); Macronix Int’l Co. v. Spansion,
`
`IPR2014-00898, Paper 15, at 4 (Aug. 13, 2014) (quoting Kyocera Corp. v.
`
`Softview LLC, IPR2013-00004, Paper 15, at 4 (April 24, 2013)).
`
`B. DRL’s Motion Is Timely
`A motion for joinder is timely if the moving party files within one month of
`
`institution of the inter partes review for which joinder is requested. 37 C.F.R.
`
`§ 42.122(b). Because DRL files this motion within one month after a decision on
`
`the institution of the Mylan IPR, this motion is timely.
`
`C.
`Joinder Is Appropriate
`Joinder is appropriate because DRL’s Petition does not raise any new
`
`grounds of unpatentability and does “not present issues that might complicate or
`
`delay” the Mylan IPR. See Enzymotec Ltd. v. Neptune Techs & Bioresources, Inc.,
`
`IPR2014-00556, Paper 19 (PTAB July 9, 2014). DRL’s Petition is substantially
`
`identical to the petition in the Mylan IPR, challenging the same claims of the
`
`
`
`3
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`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`’708 Patent on the same grounds and relying on substantially identical expert
`
`testimony. The primary difference between DRL’s Petition and the petition filed in
`
`the Mylan IPR are the sections on Real Party-In-Interest, Related Matters, and
`
`Counsel, which have been appropriately updated.
`
`To simplify this proceeding, DRL will rely on the Mylan Declarant, should
`
`Mylan permit it. If Mylan allows DRL to do so, DRL will withdraw the DRL
`
`Declarant and rely on the declaration and testimony of the Mylan Declarant.
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`DRL’s proposal is identical to the procedure proposed by other petitioners when
`
`they sought joinder. Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789, Motion
`
`for Joinder, Paper 2, at 4-5 (Mar. 5, 2019); Teva Pharm. USA, Inc. v. Eli Lilly &
`
`Co., IPR2016-01343, Mot. for Joinder, Paper 3, at 8 (July 1, 2016) (offering same
`
`procedure); Argentum Pharms. LLC v. Janssen Oncology, Inc., IPR2016-01317,
`
`Mot. for Joinder, Paper 3, at 6-7 (June 29, 2016) (same); Argentum Pharms.
`
`LLC, v. Cosmo Techs., Ltd.., IPR2016-01317, Mot. for Joinder, Paper 3, at 4-5
`
`(Oct. 20, 2017) (same). Such concessions on the part of a joining party are
`
`sufficient to minimize the impact on the original proceeding. SAP, IPR2014-00306,
`
`Paper 13, at 4.
`
`Even if, despite its best efforts with Mylan, DRL were required to proceed
`
`with its own Declarant, there would be no impact on the Board’s ability to
`
`complete its review in a timely manner, in light of the substantially identical
`
`
`
`4
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`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`testimony between the DRL Declarant and the Mylan Declarant. In such a
`
`situation, there would be at most a modest impact on the Patent Owner given that
`
`little additional preparation would be needed for the deposition of the DRL
`
`Declarant beyond that required for the deposition of the Mylan Declarant. Still
`
`further, in the event that Mylan does not agree to allow DRL to retain the Mylan
`
`Declarant, DRL would agree to withdraw the DRL Declarant if the Mylan
`
`Declarant has already been deposed based on his declarations in the Mylan IPR
`
`and the deposition transcripts have been made of record. In that case, DRL would
`
`rely on
`
`the declarations and
`
`testimony of
`
`the Mylan Declarant. Teva,
`
`IPR2016-01343, Mot. for Joinder, Paper 3, at 9, n.2 (offering
`
`the same
`
`concessions).
`
`Joinder would, therefore, have little, if any, impact on the Mylan IPR, the
`
`schedule would not be affected, no additional briefing or discovery would be
`
`required, and no additional burdens would be placed on any party or the PTAB, as
`
`detailed below.
`
`1.
`No New Grounds Of Unpatentability In The Petition
`DRL’s Petition does not assert any new grounds of unpatentability. It
`
`challenges the same claims (1-4, 17, 19, and 21-23) of the ’708 Patent based on the
`
`same arguments and analysis, prior art, evidence, and six grounds of
`
`unpatentability as the Mylan IPR. See, e.g., Hyundai, IPR2014-01543, Paper 11,
`
`
`
`5
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`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`at 2-4; Dell, IPR2013-00385, Paper 17, at 6-10. In addition, the expert declaration
`
`of DRL’s expert is substantively identical to the expert declaration of Mylan’s
`
`expert.
`
`2.
`
`No Impact On The Schedule
`For The Existing IPR Proceeding
`Because DRL’s Petition raises no new grounds of unpatentability, and
`
`because a Scheduling Order has been established for the Mylan IPR less than one
`
`month ago, joinder should have no impact on the schedule of the Mylan IPR. See
`
`LG v. Memory Integrity, LLC., IPR2015-01353, Paper 11, at 6 (Oct. 5, 2015)
`
`(granting IPR and motion for joinder where “joinder should not necessitate any
`
`additional briefing or discovery from Patent Owner beyond that already required in
`
`[the original IPR]”). DRL will adhere to all applicable deadlines set in the
`
`Scheduling Order for the Mylan IPR.
`
`As discussed further below, DRL is willing to limit its participation in this
`
`proceedings to a “silent understudy.” In the event that the Mylan IPR is terminated
`
`with respect to the Mylan Petitioner, only then does DRL intend to “step into the
`
`shoes” of the dismissed petitioner and materially participate in the joined
`
`proceedings. Accordingly, for the reasons stated above, joinder of DRL to the
`
`Mylan IPR will not affect the Board’s ability to complete its review and final
`
`
`
`6
`
`
`
`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`decision within the statutory time limits under 35 U.S.C. § 316(a)(11) and 37
`
`C.F.R. § 42.100(c).
`
`3.
`Briefing And Discovery Will Be Simplified
`As a “silent understudy,” DRL agrees that, if joined, the following
`
`conditions will apply so long as Mylan remains an active party, as previously
`
`approved by the Board in other joinder circumstances:
`
`(a) all filings by DRL in the joined proceeding be consolidated with the
`
`filings of Mylan, unless a filing solely concerns issues that do not involve Mylan;
`
`(b) DRL shall not be permitted to raise any new grounds not instituted by
`
`the Board in the Mylan IPR, or introduce any argument not already introduced by
`
`Mylan;
`
`(c) With regard to taking of testimony, DRL will abide by 37 C.F.R.
`
`§ 42.53 or any agreement between the Patent Owner and Mylan. See DRL Pharms.
`
`Inc. v. Novartis AG, IPR2015-00268, Paper 17, at 5-6 (PTAB Apr. 10, 2015)
`
`(finding the same proposed limitations “are consistent with the ‘understudy’ role
`
`that Petitioner agrees to assume, as well as Petitioner’s assertion that its presence
`
`would not require introducing any additional arguments, briefing, or discovery.”).
`
`DRL also is willing to abide by any additional conditions the Board deems
`
`appropriate.
`
`
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`7
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`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`4.
`No Prejudice To Patent Owner
`Joinder of Petitioner to the Mylan IPR will not create any additional
`
`burden on the Patent Owner. The Patent Owner need not expend any additional
`
`resources above and beyond those required in the current Mylan IPR. Moreover,
`
`joinder eliminates the need for the Patent Owner to participate in multiple,
`
`staggered inter partes review proceedings instituted upon identical grounds of
`
`unpatentability.1
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`III. CONCLUSION
`For the foregoing reasons, DRL respectfully requests that its Petition for
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`Inter Partes Review of the ’708 Patent be granted and that the proceedings be
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`joined with IPR2020-00040.
`
`Dated:
`
`June 11, 2020
`
`
`
`
`
`Respectfully submitted,
`
`By: / Russell W. Faegenburg /
`Russell W. Faegenburg
`Reg. No. 77,876
`
`
`
`
`
`
`1 The argument that joinder may theoretically frustrate settlement between Mylan
`and Patent Owner is not a basis to deny joinder because that same possibility
`exists in every joinder situation. Global Foundries U.S. Inc. v. Godo Kaisha IP
`Bridge 1, IPR2017-00925 and IPR2017-00926, Paper 13, at 10 (June 9, 2017).
`8
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`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies
`that a copy of
`
`the
`
`foregoing
`
`PETITIONER’S MOTION FOR JOINDER UNDER 37 C.F.R. §§ 42.22
`
`AND 42.122(b) was served in its entirety by filing through the PTAB E2E System,
`
`on the Patent Owner’s correspondence address of record:
`
`Philippe Durette
`Merck & Co., Inc.
`P.O. Box 2000
`Rahway, NJ 07065-0907
`
`and at the following addresses for counsel of record listed in Patent Owner’s
`
`Updated Mandatory Notices for the pending IPR2020-00040:
`
`Stanley E. Fisher
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`
`Bruce R. Genderson
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`Anthony H. Sheh
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`
`Jessamyn S. Berniker
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`
`Shaun P. Mahaffy
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`
`
`
`
`
`
`
`
`
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`9
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`
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`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petitioner’s Mot. for Joinder Under §§ 42.22 and 42.122(b)
`
`
`In addition, a courtesy copy of the motion was served upon counsel of
`
`record for Petitioner Mylan in IPR2020-00040 at the following addresses:
`
`Jitendra Malik, Ph.D.
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`
`June 11, 2020
`
`Dated:
`
`
`
`
`
`By:
`
`/ Russell W. Faegenburg /
`Russell W. Faegenburg
`Reg. No. 77, 876
`
`
`
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`10
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