`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`CELLTRION, INC.,
`Petitioner,
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`v.
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`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
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`_____________________________
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`Case No. IPR2022-00258
`Patent No. 9,254,338
`_____________________________
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 325(c)
`AND 37 C.F.R. §§42.22 AND 42.222(b)
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioner, Celltrion, Inc. (“Celltrion” or “Petitioner”), respectfully requests
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`joinder of the concurrently filed petition for inter partes review of U.S. Patent No.
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`9,254,338 (“the ’338 Patent”) (IPR2020-00258) with Mylan Pharms. Inc. v.
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`Regeneron Pharms., Inc., IPR2021-00881 (P.T.A.B.), filed May 5, 2021 and
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`instituted on November 10, 2021 (“the Mylan IPR”). (See IPR2021-00881, Paper
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`21.) Celltrion has conferred with Mylan, and Mylan, including the real parties-in-
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`interest identified in its petition, does not oppose this Motion for Joinder.
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`The instant Petition is substantially the same as the Mylan IPR: it involves
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`the same patent, same claims, same grounds of unpatentability, and the same
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`evidence (including the same prior art combinations supported by the same expert
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`declarations) as the Mylan IPR. If joined Celltrion 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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`Thus, the proposed joinder will neither unduly complicate the Mylan IPR nor delay
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`its schedule. As such, the joinder will promote judicial efficiency in determining
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`patentability in the Mylan IPR without prejudice to Patent Owner.
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`Although Celltrion is not otherwise time barred pursuant to 37 C.F.R.
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`§ 42.101(b), 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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`Celltrion 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
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`A. Legal Standard
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`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)
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`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
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`partes review any person who properly files a petition under section
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`311 that the Director, after receiving a preliminary response under
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`section 313 or the expiration of the time for filing such a response,
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`determines warrants the institution of an inter partes review under
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`section 314.
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`The AIA’s legislative history makes clear that joinder is to be liberally
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`granted. 157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl).
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`As joinder should be liberally granted, the factors General Plastic Indus. Co. Ltd.
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`v. Canon Kabushiki Kaisha, IPR2016-01357, Pap. 19 at 16 (Sept. 6, 2017) favor
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`institution, as Celltrion has not previously filed a petition challenging the same
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`claims of the ’338 patent.1
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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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`1 The other factors are either also positive or neutral. For example, Factor 6,
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`which is the “finite resources of the Board,” favors institution as Celltrion is
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`advancing the same challenges, arguments, and evidence relied upon in the Mylan
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`IPR. For the same reason, Regeneron’s Preliminary Response was not used as a
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`roadmap for this Petition. And as discussed in the Motion, joinder would have no
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`impact on the trial schedule for the Mylan IPR.
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`B. Celltrion’s Motion for Joinder is Timely
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`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
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`C.F.R. 42.122(b). Because Celltrion files this motion within one month after a
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`decision on the institution of the Mylan IPR, this motion is timely.
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`C.
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`Joinder is Appropriate
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`Joinder is appropriate because Celltrion’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). Celltrion’s Petition is substantially
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`identical to the petition in the Mylan IPR, challenging the same claims of the ’338
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`Patent on the same grounds and relying on the same expert testimony. Thus, the
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`only difference between Celltrion’s Petition and the petition filed in the Mylan IPR
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`are the sections on Real Party-In-Interest, Related Matters, and Counsel, which
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`have been appropriately updated.
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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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`1.
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`No New Grounds of Unpatentability in the Petition
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`Celltrion’s Petition does not assert any new grounds of unpatentability. It
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`challenges the same claims (1, 3-11, 13-14, 16-24, and 26) of the ’338 Patent
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`based on the same arguments and analysis, prior art, evidence (including expert
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`declarations), and six grounds of unpatentability as the Mylan IPR. See, e.g.,
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`Hyundai, IPR2014-01543, Paper 11, at 2-4; Dell, IPR2013-00385, Paper 17, at 6-
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`10.
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`2.
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`No Impact on the Schedule For the Existing IPR Proceeding
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`Because Celltrion’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]”). Celltrion 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, Celltrion is willing to limit its participation in
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`this proceedings to a “silent understudy.” In the event that the Mylan IPR is
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`terminated with respect to the Mylan Petitioner, only then does Celltrion intend to
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`“step into the shoes” of the dismissed petitioner and materially participate in the
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`joined proceedings. Accordingly, for the reasons stated above, joinder of Celltrion
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`to the Mylan IPR will not affect the Board’s ability to complete its review and final
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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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`3.
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`Briefing and Discovery Will be Simplified
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`As a “silent understudy,” Celltrion 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)
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`all filings by Celltrion in the joined proceeding be consolidated with
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`the filings of Mylan, unless a filing solely concerns issues that do not involve
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`Mylan;
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`(b) Celltrion shall not be permitted to raise any new grounds not instituted
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`by the Board in the Mylan IPR, or introduce any argument not already introduced
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`by Mylan;
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`(c) With regard to taking of testimony, Celltrion 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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`Celltrion also is willing to abide by any additional conditions the Board deems
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`appropriate.
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`4.
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`No Prejudice to Patent Owner
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`Joinder of Petitioner to the Mylan IPR will not create any additional burden
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`on the Patent Owner. The Patent Owner need not expend any additional resources
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`above and beyond those required in the current Mylan IPR. Moreover, joinder
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`eliminates the need for the Patent Owner to participate in multiple, staggered inter
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`partes review proceedings instituted upon identical grounds of unpatentability.2
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`III. Conclusion
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`For the foregoing reasons, Celltrion respectfully requests that its Petition for
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`inter partes review of the ’338 patent be granted and that the proceeding be joined
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`with IPR2021-00881.
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`Dated: December 9, 2021
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`Respectfully submitted,
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` / Lora M. Green /
`Lora M. Green, Lead Counsel
`Reg. No. 43,541
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`2 The argument that joinder may theoretically frustrate settlement between Mylan
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`and Patent Owner is not a basis to deny joinder because that same possibility exists
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`in every joinder situation. Global Foundries U.S. Inc. v . Godo Kaisha IP Bridge 1,
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`IPR2017-00925 and IPR2017-00926, Paper 13, at 10 (June 9, 2017).
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), this is to certify that I
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`caused to be served a true and correct copy of the foregoing Motion for Joinder by
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`overnight courier (Federal Express or UPS), on this 9th day of December, 2021, on
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`the Patent Owner at the correspondence address of the Patent Owner as follows:
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`Regeneron – Bozicevic Field & Francis LLP
`201 Redwood Shores Parkway
`Suite 200
`Redwood City, CA 94065
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`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591
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`And additional copies have been delivered to counsel for Patent Owner in
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`IPR2021-00881, as follows:
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`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, CA 94306
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`And to counsel for Petitioner Mylan Pharmaceuticals, Inc. in IPR2021-
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`00881, as follows:
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`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
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`Dated: December 9, 2021
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`Respectfully submitted,
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` / Lora M. Green /
`Lora M. Green, Lead Counsel
`Reg. No. 43,541
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