UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.
`AND SUN PHARMACEUTICAL INDUSTRIES, INC.,
`
`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 IPR2024-00107
`
`_______________
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 35 U.S.C. § 315(c) and
`37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`SUN PHARMACEUTICAL INDUSTRIES LTD.
`AND SUN PHARMACEUTICAL INDUSTRIES, INC.,
`
`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 IPR2024-00107
`
`_______________
`
`PETITIONER’S MOTION FOR JOINDER
`UNDER 35 U.S.C. § 315(c) and
`37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`IPR2024-00107 (U.S. Patent No. 10,335,462)
`
`Motion for Joinder
`
`I.
`
`A STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries Inc.
`
`(“Sun” or “Petitioners”) submit, concurrently with this motion, a petition for inter
`
`partes review (the “Sun Petition”) of claims 1–10 of U.S. Patent No. 10,335,462
`
`(“the ’462 patent”) (Ex. 1001), assigned to Novo Nordisk A/S (“Patent Owner”).
`
`Sun respectfully requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R.
`
`§ 42.122(b) of the concurrently filed Petition with a pending inter partes review filed
`
`by Mylan Pharmaceuticals, Inc. (“Mylan”), Mylan Pharmaceuticals Inc. v. Novo
`
`Nordisk A/S, IPR2023-00724 (the “Mylan IPR”). Joinder is appropriate because
`
`Sun’s request is timely and it will promote an efficient and consistent resolution of
`
`the validity of a single patent and will not prejudice any of the parties to the Mylan
`
`IPR. 37 C.F.R. § 42.122(b).
`
`II. BACKGROUND
`
`On March 16, 2023, Mylan filed a petition for inter partes review challenging
`
`claims 1–10 of U.S. Patent No. 10,335,462 (“the ’462 patent”), which was assigned
`
`Case No. IPR2023-00724. On October 4, 2023, the Board instituted review of claims
`
`1–10 on five grounds: (1) Claims 1–3 of the ’462 patent as anticipated by WO421;
`
`(2) Claims 1–3 of the ’462 patent as anticipated by Lovshin; (3) Claims 1–10 of the
`
`’462 patent as obvious over WO421 and the ’424 Publication; (4) Claims 1–10 of
`
`the ’462 patent as obvious over WO537 and Lovshin; and (5) Claims 1–10 of the
`
`2
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`’462 patent as obvious over NCT657, NCT733, and the ’424 Publication. IPR2023-
`
`00724, Paper 10.
`
`Today, concurrent with the instant motion for joinder, Sun filed the Sun
`
`Petition, Case No. IPR2024-00107, that 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) instituted in the Mylan
`
`IPR.
`
`III. ARGUMENT
`
`A.
`
`Legal Standard
`
`The Board has authority to join as a party any person who properly files a
`
`petition
`
`for
`
`inter partes
`
`review
`
`to an
`
`instituted
`
`inter partes
`
`review.
`
`35 U.S.C. § 315(c). A motion for joinder must be filed within one month of
`
`institution of any inter partes review for which joinder is requested. 37 C.F.R.
`
`§ 42.122(b). In deciding whether to grant a motion for joinder, the Board considers
`
`several factors including: (1) the reasons why joinder is appropriate; (2) whether the
`
`party to be joined has presented any new grounds of unpatentability; (3) what impact,
`
`if any, joinder would have on the trial schedule for the existing review; and (4) how
`
`briefing and discovery may be simplified. See, e.g., Hyundai Motor Co. v. Am.
`
`Vehicular Sciences LLC, IPR2014-01543, Paper 11 at 3 (Oct. 24, 2014); Macronix
`
`3
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`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.
`
`The Relevant Factors Weigh in Favor of Joinder
`
`Each of the four factors considered by the Board weighs in favor of joinder.
`
`1.
`
`Joinder Is Appropriate
`
`Joinder with the Mylan IPR is appropriate because the Sun Petition is limited
`
`to the same grounds instituted in Mylan’s IPR2023-00724 petition. It also relies on
`
`the same prior art analysis and expert analysis submitted by Mylan. Indeed, the
`
`Petition raises grounds identical to those raised in the IPR2023-00724 petition and
`
`does not include any new grounds not raised in that petition. As such, the Sun
`
`Petition does “not present issues that might complicate or delay” Mylan’s IPR. See
`
`Enzymotec Ltd. v. Neptune Techs & Bioresources, Inc., IPR2014-00556, Paper 19
`
`(PTAB July 9, 2014).
`
`In order to further simplify the proceeding, Sun will rely on the same
`
`declarants as Mylan, Dr. John Bantle, Dr. William J. Jusko, and Dr. Paul Dalby
`
`(collectively, the “Mylan Declarants”), should Mylan permit it. If Mylan allows Sun
`
`to use the Mylan Declarants, then Sun will withdraw the declarations of Dr. Melissa
`
`Weinberg, Dr. Craig Dyar, and Dr. Alekha K. Dash (the “Sun Declarants”) and rely
`
`solely on the declarations and testimonies of the Mylan Declarants. Given Sun’s
`
`reliance on Mylan’s IPR Petition and Declarants, the primary difference between
`
`4
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`Sun’s and Mylan’s Petitions are the sections on Real Party-In-Interest, Related
`
`Matters, and Counsel, which have been appropriately updated.
`
`The Board has previously acknowledged that such concessions on the part of
`
`a party seeking to join are sufficient to minimize the impact on the original
`
`proceeding. 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). Further, the declarations of the Sun Declarants submitted in support
`
`of the present Petition present substantively identical testimony to that of the Mylan
`
`Declarants, thus streamlining the issues for trial even if Mylan does not permit Sun
`
`to rely directly on the Mylan Declarants.
`
`Even if, despite its best efforts with Mylan, Sun were required to proceed with
`
`its own Declarants, there would be no impact on the Board’s ability to complete its
`
`review in a timely manner, in light of the substantially identical testimony between
`
`the Sun Declarants and the Mylan Declarants. 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 Sun Declarants beyond that required for
`
`5
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`the depositions of the Mylan Declarants. Still further, in the event that Mylan does
`
`not agree to allow Sun to rely on the Mylan Declarants, Sun would agree to withdraw
`
`the Sun Declarants if the Mylan Declarants have already been deposed based on their
`
`declarations in the Mylan IPR and the deposition transcripts have been made of
`
`record. In that case, Sun would rely on the declarations and testimony of the Mylan
`
`Declarants. Teva, IPR2016-01343, Mot. for Joinder, Paper 3, at 9, n.2 (offering the
`
`same concessions).
`
`In view of the above, joinder will promote the just, speedy, and inexpensive
`
`resolution of patentability issues, including the determination of validity of the
`
`challenged claims of the ’462 patent. For example, a final written decision on the
`
`validity of the ’462 patent has the potential to minimize issues and potentially
`
`resolve any litigation altogether with respect to the ’462 patent.
`
`2.
`
`No New Grounds Are Presented
`
`The Sun Petition does not present any new ground of unpatentability. As
`
`above, the Petition presents for review only grounds from the petition in the Mylan
`
`IPR that have been instituted. The present Petition is based on the same prior art
`
`analysis submitted by Mylan, and the Sun Declarants’ testimony in support of these
`
`grounds is substantively identical to that of the Mylan Declarants in the Mylan IPR,
`
`which further weighs in favor of joinder. See, e.g., Hyundai, IPR2014-01543, Paper
`
`11 at 2–4; Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495,
`
`6
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`Paper 13 at 5–9 (Sep. 16, 2013); Dell Inc. v. Network-1 Solutions, Inc., IPR2013-
`
`00385, Paper 17 at 6–10 (Jul. 29, 2013); Motorola Mobility LLC v. Softview LLC,
`
`IPR2013-00256, Paper 10 at 4–10 (June 20, 2013).
`
`Because the Sun Petition raises no new grounds of unpatentability than those
`
`already presented in the Mylan IPR, joinder will have no substantial effect on the
`
`parties or have a negative impact on the schedule of the Mylan IPR, much less
`
`prevent the Board from issuing a final written decision in a timely manner. 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”). Sun will adhere to all applicable
`
`deadlines set in the Scheduling Order for the Mylan IPR.
`
`Moreover, as discussed below, Sun is willing to limit its participation in the
`
`proceeding as a “silent understudy” to Mylan, only assuming an active role in the
`
`event of termination of Mylan as a party. Sun does not anticipate that any extension
`
`of the trial schedule will be required as a result of joinder.
`
`3.
`
`Discovery and Briefing Will Be Simplified
`
`As a “silent understudy,” Sun 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:
`
`7
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`(a) All filings by Sun in the joined proceeding will be consolidated with
`
`the filings of Mylan, unless a filing solely concerns issues that do not involve Mylan;
`
`(b)
`
`Sun 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; and
`
`(c) With regard to taking of testimony, Sun 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.”). Sun is also willing
`
`to abide by any additional conditions that the Board deems appropriate.
`
`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
`
`8
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`eliminates the need for the Patent Owner to participate in multiple, staggered inter
`
`partes review proceedings instituted upon identical grounds of unpatentability.1
`
`IV. CONCLUSION
`
`For the foregoing reasons, Sun respectfully requests that its Petition for Inter
`
`Partes Review of claims 1–10 of the ’462 patent be granted on the same grounds
`
`and for the same reasons discussed in the Institution Decision of IPR2023-00724,
`
`and that this proceeding be joined therewith.
`
`
`
`
`
`Dated: November 2, 2023
`
`
`
`
`Respectfully submitted,
`
`
`
` /s/ Brian Sodikoff
`Brian Sodikoff
`
`
`
`
`
`
`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
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`
`
`IPR2024-00107 (U.S. Patent No. 10,335,462)
`
`Motion for Joinder
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that I caused to be
`
`served a true and correct copy of the foregoing: PETITIONER’S MOTION FOR
`
`JOINDER, by Federal Express (or equivalent) Next Business Day Delivery on this
`
`day on the Patent Owner’s correspondence address of record for the subject patent
`
`as follows:
`
`Novo Nordisk Inc.
`Intellectual Property Department
`800 Scudders Mill Road
`Plainsboro, NJ 08536
`
`Courtesy copies of the Petition for Inter Partes Review of U.S. Patent No.
`
`10,335,462 and any accompanying exhibits and materials have been sent by Federal
`
`Express (or equivalent) Next Business Day Delivery on this day to Patent Owner’s
`
`counsel of record as follows:
`
`J. Steven Baughman
`Groombridge, Wu, Baughman & Stone LLP
`801 17th Street, NW, Suite 1050
`Washington, DC 20006
`
`with courtesy copies sent via electronic means to:
`
`•
`
`•
`
`•
`
`J. Steven Baughman at steve.baughman@groombridgewu.com;
`
`Megan Raymond at megan.raymond@groombridgewu.com; and
`
`Novo-Semaglutide-IPR@groombridgewu.com.
`
`
`
`A courtesy copy of the foregoing has been sent by Federal Express (or
`
`equivalent) Next Business Day Delivery on this day to Mylan Pharmaceuticals,
`
`Inc.’s counsel of record as follows:
`
`10
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`
`
`IPR2024-00107
`
`Motion for Joinder
`
`Brandon M. White
`Perkins Coie LLP
`700 13th Street, NW, Suite 800
`Washington, DC 20005
`
`with courtesy copies by electronic means to:
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Brandon M. White: White-ptab@perkinscoie.com
`
`Emily J. Greb: Greb-ptab@perkinscoie.com
`
`Courtney Prochnow, PhD: Prochnow-ptab@perkinscoie.com
`
`Christopher D. Jones: Jones-ptab@perkinscoie.com
`
`Jonathan I. Tietz, PhD: Tietz-ptab@perkinscoie.com
`
`Matthew A. Lembo: Lembo-ptab@perkinscoie.com
`
`
`
`A courtesy copy of has been sent by Federal Express (or equivalent) Next
`
`Business Day Delivery on this day to Doctor Reddy’s Laboratories, Inc.’s counsel
`
`of record as follows:
`
`Jovial Wong
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`
`with courtesy copies by electronic means to:
`
`•
`
`•
`
`•
`
`Jovial Wong: jwong@winston.com
`
`Scott Border: sborder@winston.com
`
`Sharon Lin McIntosh: slin@winston.com
`
`
`
`
`Dated: November 2, 2023
`
` /s/ Brian Sodikoff
`Brian Sodikoff
`
`
`
`
`
`
`
`
`
`11
`
`Novo Nordisk Exhibit 2546
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00011
`
`
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