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`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.
`
`NOVO NORDISK A/S,
`Patent Owner
`
`U.S. Patent No. 10,335,462 to Jensen
`Issue Date: July 2, 2019
`Title: Use Of Long-Acting Glp-1 Peptides
`
`Inter Partes Review No. IPR2024-00009
`
`PETITIONERS’ MOTION FOR JOINDER
`UNDER 35 U.S.C. § 315(c) and 37 C.F.R.
`§§ 42.22 AND 42.122(b)
`
`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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`TABLE OF CONTENTS
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`I.
`II.
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`STATEMENT OF RELIEF REQUESTED ....................................................... 1
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................... 2
`A. Legal Standards ......................................................................................... 2
`B. DRL’s Motion is Timely ........................................................................... 3
`Joinder is Appropriate ............................................................................... 3
`C.
`1. No New Grounds of Unpatentability in the Petition ........................ 5
`2. No Impact on the Schedule for the Existing IPR Proceeding .......... 6
`Briefing and Discovery Will be Simplified ..................................... 7
`3.
`4. No Prejudice to Patent Owner ......................................................... 8
`III. CONCLUSION .................................................................................................. 8
`
`2
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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`
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`IPR2024-00009 (U.S. Patent No. 10,335,462)
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`
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`I.
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`STATEMENT OF RELIEF REQUESTED
`Petitioners Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories,
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`Ltd. (collectively “DRL” or “Petitioners”) respectfully request joinder of the
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`concurrently filed petition for inter partes review of U.S. Patent No. 10,335,462
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`(“the ’462 Patent”) (IPR2023-00724) with Mylan Pharmaceuticals, inc. v. Novo
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`Nordisk, A/S, IPR2023-00724, instituted October 4, 2023 ( “the Mylan IPR”). (See
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`IPR2023-00724, Paper 10.) The instant Petition is substantially the same as the
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`Mylan IPR: it involves the same patent, same claims, same grounds of
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`unpatentability, and the same evidence (including the same prior art combinations)
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`as the Mylan IPR. If joined, as discussed further below, DRL will assume a “silent
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`understudy” role and will not take an active role in the inter partes review
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`proceeding unless the Mylan Petitioner ceases to participate in the instituted IPR.
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`While the instant Petition includes the declarations of Drs. Randall M.
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`Zusman, John P. Fruehauf, and Maureen D. Donovan (“DRL Declarants”), these
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`declarations presents substantially identical expert testimony to that put forth by
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`Drs. John Bantle, William J. Jusko, and Paul Dalby (“Mylan Declarant(s)”) in the
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`Mylan IPR. If Mylan allows DRL to use the Mylan Declarants, then DRL will
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`withdraw the DRL Declarants, and rely only the Mylan Declarants. The PTAB has
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`acknowledged that such concessions are sufficient to minimize the impact on the
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`original proceeding. SAP Am. Inc. v. Clouding IP, LLC, IPR2014-00306, Paper
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`2
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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`
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`IPR2024-00009 (U.S. Patent No. 10,335,462)
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`13, at 4 (May 19, 2014). Thus,
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`the proposed joinder will neither unduly
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`complicate the Mylan IPR nor delay its schedule. As such, the joinder will promote
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`judicial efficiency in determining patentability in the Mylan IPR without prejudice
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`to Patent Owner.
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`Finally, this Motion for Joinder, and accompanying Petition, are timely
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`because they are filed less than one month after a decision instituting trial in the
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`Mylan IPR. 37 C.F.R. § 42.122(b) (“no later than one month after the institution
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`date of any inter partes review for which joinder is requested.”). Accordingly,
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`DRL respectfully requests that the Board grant this Motion for Joinder.
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`II.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED
`A. Legal Standards
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review (IPR) proceedings. Joinder is governed by 35 U.S.C. § 315(c), which states:
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`(c) JOINDER. – If the Director institutes an inter partes review, the
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`Director, in his or her discretion, may join as a party to that inter partes
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`review any person who properly files a petition under section 311 that the
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`Director, after receiving a preliminary response under section 313 or the
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`expiration of the time for filing such a response, determines warrants the
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`institution of an inter partes review under section 314.
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`2
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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`A motion for joinder should “(1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Dell Inc. v. Network-1 Sec. Solutions, Inc., IPR2013-00385,
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`Paper 17 (PTAB July 29, 2013); Hyundai Motor Co. v. Am. Vehicular Scis. LLC,
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`IPR2014-01543, Paper 11, at 3 (Oct. 24, 2014); Macronix Int’l Co. v. Spansion,
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`IPR2014-00898, Paper 15, at 4 (Aug. 13, 2014) (quoting Kyocera Corp. v.
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`Softview LLC, IPR2013-00004, Paper 15, at 4 (April 24, 2013)).
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`B. DRL’s Motion Is Timely
`A motion for joinder is timely if the moving party files within one month of
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`institution of the inter partes review for which joinder is requested. 37 C.F.R.
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`§ 42.122(b). Because DRL files this motion within one month after a decision on
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`the institution of the Mylan IPR, this motion is timely.
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`Joinder Is Appropriate
`C.
`Joinder is appropriate because DRL’s Petition does not raise any new
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`grounds of unpatentability and does “not present issues that might complicate or
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`delay” the Mylan IPR. See Enzymotec Ltd. v. Neptune Techs & Bioresources, Inc.,
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`IPR2014-00556, Paper 19 (PTAB July 9, 2014). DRL’s Petition is substantially
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`identical to the petition in the Mylan IPR, challenging the same claims of the
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`3
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
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`’462 Patent on the same grounds and relying on substantially identical expert
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`testimony. The primary difference between DRL’s Petition and the petition filed in
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`the Mylan IPR are the sections on Real Party-In-Interest, Related Matters, and
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`Counsel, which have been appropriately updated.
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`To simplify this proceeding, DRL will rely on the Mylan Declarants, should
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`Mylan permit it. If Mylan allows DRL to do so, DRL will withdraw the DRL
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`Declarants and rely on the declaration and testimony of the Mylan Declarants.
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`DRL’s proposal is identical to the procedure proposed by other petitioners when
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`they sought joinder. Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789, Motion
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`for Joinder, Paper 2, at 4-5 (Mar. 5, 2019); Teva Pharm. USA, Inc. v. Eli Lilly &
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`Co., IPR2016-01343, Mot. for Joinder, Paper 3, at 8 (July 1, 2016) (offering same
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`procedure); Argentum Pharms. LLC v. Janssen Oncology, Inc., IPR2016-01317,
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`Mot. for Joinder, Paper 3, at 6-7 (June 29, 2016) (same); Argentum Pharms.
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`LLC, v. Cosmo Techs., Ltd.., IPR2016-01317, Mot. for Joinder, Paper 3, at 4-5
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`(Oct. 20, 2017) (same). Such concessions on the part of a joining party are
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`sufficient to minimize the impact on the original proceeding. SAP, IPR2014-00306,
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`Paper 13, at 4.
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`Even if, despite its best efforts with Mylan, DRL were required to proceed
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`with its own Declarants, there would be no impact on the Board’s ability to
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`complete its review in a timely manner, in light of the substantially identical
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`4
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
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`testimony between the DRL Declarants and the Mylan Declarants. In such a
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`situation, there would be at most a modest impact on the Patent Owner given that
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`little additional preparation would be needed for the deposition of the DRL
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`Declarants beyond that required for the depositions of the Mylan Declarants. Still
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`further, in the event that Mylan does not agree to allow DRL to retain the Mylan
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`Declarants, DRL would agree to withdraw the DRL Declarants if the Mylan
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`Declarants have already been deposed based on their declarations in the Mylan IPR
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`and the deposition transcripts have been made of record. In that case, DRL would
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`rely on the declarations and
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`testimony of
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`the Mylan Declarants. Teva,
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`IPR2016-01343, Mot. for Joinder, Paper 3, at 9, n.2 (offering the same
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`concessions).
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`Joinder would, therefore, have little, if any, impact on the Mylan IPR, the
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`schedule would not be affected, no additional briefing or discovery would be
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`required, and no additional burdens would be placed on any party or the PTAB, as
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`detailed below.
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`No New Grounds Of Unpatentability In The Petition
`1.
`DRL’s Petition does not assert any new grounds of unpatentability. It
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`challenges the same claims (1-10) of the ’462 Patent based on the same arguments
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`and analysis, prior art, evidence, and five grounds of unpatentability as the Mylan
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`IPR. See, e.g., Hyundai, IPR2014-01543, Paper 11, at 2-4; Dell, IPR2013-00385,
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`5
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
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`Paper 17, at 6-10. In addition, the expert declarations of DRL’s experts are
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`substantively identical to the expert declarations of Mylan’s experts.
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`2.
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`No Impact On The Schedule
`For The Existing IPR Proceeding
`Because DRL’s Petition raises no new grounds of unpatentability, and
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`because a Scheduling Order has been established for the Mylan IPR less than one
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`month ago, joinder should have no impact on the schedule of the Mylan IPR. See
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`LG v. Memory Integrity, LLC., IPR2015-01353, Paper 11, at 6 (Oct. 5, 2015)
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`(granting IPR and motion for joinder where “joinder should not necessitate any
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`additional briefing or discovery from Patent Owner beyond that already required in
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`[the original IPR]”). DRL will adhere to all applicable deadlines set in the
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`Scheduling Order for the Mylan IPR.
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`As discussed further below, DRL is willing to limit its participation in this
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`proceedings to a “silent understudy.” In the event that the Mylan IPR is terminated
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`with respect to the Mylan Petitioner, only then does DRL intend to “step into the
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`shoes” of the dismissed petitioner and materially participate in the joined
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`proceedings. Accordingly, for the reasons stated above, joinder of DRL to the
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`Mylan IPR will not affect the Board’s ability to complete its review and final
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`6
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
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`decision within the statutory time limits under 35 U.S.C. § 316(a)(11) and 37
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`C.F.R. § 42.100(c).
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`Briefing And Discovery Will Be Simplified
`3.
`As a “silent understudy,” DRL agrees that, if joined, the following
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`conditions will apply so long as Mylan remains an active party, as previously
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`approved by the Board in other joinder circumstances:
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`(a) all filings by DRL in the joined proceeding be consolidated with the
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`filings of Mylan, unless a filing solely concerns issues that do not involve Mylan;
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`(b) DRL shall not be permitted to raise any new grounds not instituted by
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`the Board in the Mylan IPR, or introduce any argument not already introduced by
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`Mylan;
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`(c) With regard to taking of testimony, DRL will abide by 37 C.F.R.
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`§ 42.53 or any agreement between the Patent Owner and Mylan. See DRL Pharms.
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`Inc. v. Novartis AG, IPR2015-00268, Paper 17, at 5-6 (PTAB Apr. 10, 2015)
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`(finding the same proposed limitations “are consistent with the ‘understudy’ role
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`that Petitioner agrees to assume, as well as Petitioner’s assertion that its presence
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`would not require introducing any additional arguments, briefing, or discovery.”).
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`DRL also is willing to abide by any additional conditions the Board deems
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`appropriate.
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`7
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
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`No Prejudice To Patent Owner
`4.
`Joinder of Petitioner to the Mylan IPR will not create any additional
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`burden on the Patent Owner. The Patent Owner need not expend any additional
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`resources above and beyond those required in the current Mylan IPR. Moreover,
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`joinder eliminates the need for the Patent Owner to participate in multiple,
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`staggered inter partes review proceedings instituted upon identical grounds of
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`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 ’462 Patent be granted and that the proceedings be
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`joined with IPR2023-00724.
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`Dated: October 20, 2023
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`
`Respectfully Submitted,
`
`/Jovial Wong/
`Jovial Wong (lead counsel)
`Reg. No. 60,115
`Scott M Border (backup counsel)
`Reg. No. 77,744
`Sharon Lin McIntosh (backup counsel)
`(pro hac vice to be submitted)
`WINSTON & STRAWN LLC
`1901 L Street, N.W.
`Washington, D.C. 20036
`T: 202-282-5100
`sborder@winston.com
`jwong@winston.com
`slin@winston.com
`
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`8
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
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`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).
`
`9
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00011
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on this 20th day of October,
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`2023, I caused to be served a true and correct copy of PETITIONERS’MOTION
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`FOR JOINDER UNDER 37 C.F.R.§§ 42.22AND 42.122(b) by federal express on
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`the Patent Owner’s correspondence address of record:
`
`Novo Nordisk Inc.
`Intellectual Property Department
`800 Scudders Mill Road
`Plainsboro, NJ 08536
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`With a courtesy copy emailed to Patent Owner’s Litigation Counsel at:
`
`
`J. Steven Baughman - steve.baughman@groombridgewu.com
`
`Megan Raymond - megan.raymond@groombridgewu.com
`
`Novo-Semaglutide-IPR@groombridgewu.com
`
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`
`
`Respectfully Submitted,
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`Dated: October 20, 2023
`
`/Jovial Wong/
`Jovial Wong (lead counsel)
`Reg. No. 60,115
`Scott M Border (backup counsel)
`Reg. No. 77,744
`Sharon Lin McIntosh (backup counsel)
`(pro hac vice to be submitted)
`WINSTON & STRAWN LLC
`1901 L Street, N.W.
`Washington, D.C. 20036
`T: 202-282-5100
`sborder@winston.com
`10
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00012
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`jwong@winston.com
`slin@winston.com
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`11
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00013
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`12
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00014
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`13
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`Novo Nordisk Exhibit 2545
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00015
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