UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2023-00533
`U.S. Patent No. 10,888,601 B2
`_____________________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 325(c)
`AND 37 C.F.R. §§42.22 AND 42.222(b)
`
`
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`Case No. IPR2023-00533
`U.S. Patent No. 10,888,601 B2
`_____________________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 325(c)
`AND 37 C.F.R. §§42.22 AND 42.222(b)
`
`
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner, Celltrion, Inc. (“Celltrion” or “Petitioner”), respectfully requests
`
`joinder of the concurrently filed petition for inter partes review of U.S. Patent No.
`
`10,888,601 (“the ’601 Patent”) (IPR2023-00533) with Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., IPR2022-01226 (P.T.A.B.), filed July 21, 2022, and
`
`instituted on January 11, 2023 (“the Mylan IPR”). (See IPR2022-01226, Paper 22.)
`
`Celltrion has conferred with Mylan, and Mylan, including the real parties-in-
`
`interest identified in its petition, does not oppose this Motion for Joinder.
`
`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 supported by the same expert
`
`declarations) as the Mylan IPR. If joined Celltrion 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.
`
`Thus, the 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 Celltrion 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
`
`-1-
`
`
`
`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,
`
`Celltrion respectfully requests that the Board grant this Motion for Joinder.
`
`II.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`A.
`
`Legal Standard
`
`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.
`
`The AIA’s legislative history makes clear that joinder is to be liberally
`
`granted. 157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl).
`
`As joinder should be liberally granted, the factors General Plastic Indus. Co. Ltd.
`
`v. Canon Kabushiki Kaisha, IPR2016-01357, Pap. 19 at 16 (Sept. 6, 2017) favor
`
`-2-
`
`
`
`institution, as Celltrion has not previously filed a petition challenging the same
`
`claims of the ’601 patent.1
`
`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)).
`
`1 The other factors are either also positive or neutral. For example, Factor 6,
`
`which is the “finite resources of the Board,” favors institution as Celltrion is
`
`advancing the same challenges, arguments, and evidence relied upon in the Mylan
`
`IPR. For the same reason, Regeneron’s Preliminary Response was not used as a
`
`roadmap for this Petition. And as discussed in the Motion, joinder would have no
`
`impact on the trial schedule for the Mylan IPR.
`
`-3-
`
`
`
`B.
`
`Celltrion’s Motion for Joinder 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 Celltrion 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 Celltrion’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). Celltrion’s Petition is substantially
`
`identical to the petition in the Mylan IPR, challenging the same claims of the ’601
`
`Patent on the same grounds and relying on the same expert testimony. Thus, the
`
`only difference between Celltrion’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.
`
`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.
`
`-4-
`
`
`
`1.
`
`No New Grounds of Unpatentability in the Petition
`
`Celltrion’s Petition does not assert any new grounds of unpatentability. It
`
`challenges the same claims (1-9, 34-39, 41-43, and 45) of the ’601 Patent based on
`
`the same arguments and analysis, prior art, evidence (including expert
`
`declarations), and five grounds of unpatentability as the Mylan IPR. See, e.g.,
`
`Hyundai, IPR2014-01543, Paper 11, at 2-4; Dell, IPR2013-00385, Paper 17, at 6-
`
`10.
`
`2.
`
`No Impact on the Schedule For the Existing IPR Proceeding
`
`Because Celltrion’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]”). Celltrion will adhere to all applicable deadlines set in the
`
`Scheduling Order for the Mylan IPR.
`
`As discussed further below, Celltrion 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 Celltrion intend to
`
`“step into the shoes” of the dismissed petitioner and materially participate in the
`
`-5-
`
`
`
`joined proceedings. Accordingly, for the reasons stated above, joinder of Celltrion
`
`to the Mylan IPR will not affect the Board’s ability to complete its review and final
`
`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,” Celltrion 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 Celltrion in the joined proceeding be consolidated with
`
`the filings of Mylan, unless a filing solely concerns issues that do not involve
`
`Mylan;
`
`(b) Celltrion 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, Celltrion 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.”).
`
`-6-
`
`
`
`Celltrion also is willing to abide by any additional conditions 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
`
`eliminates the need for the Patent Owner to participate in multiple, staggered inter
`
`partes review proceedings instituted upon identical grounds of unpatentability.2
`
`III. Conclusion
`
`For the foregoing reasons, Celltrion respectfully requests that its Petition for
`
`inter partes review of the ’601 patent be granted and that the proceeding be joined
`
`with IPR2022-01226.
`
`Dated: February 10, 2023
`
`Respectfully submitted,
`
` /Lora M. Green/
`Lora M. Green, Lead Counsel
`Reg. No. 43,541
`
`2 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)
`
`-7-
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), this is to certify that I
`
`caused to be served a true and correct copy of the foregoing Motion for Joinder by
`
`overnight courier (Federal Express or UPS), on this 10th day of February, 2023, on
`
`the Patent Owner at the correspondence address of the Patent Owner as follows:
`
`Regeneron – Bozicevic Field & Francis LLP 201
`Redwood Shores Parkway
`Suite 200
`Redwood City, CA 94065
`
`Regeneron Pharmaceuticals, Inc.
` 770 Old Saw Mill River Road
`Tarrytown, NY 10591
`And additional copies have been delivered to counsel for Patent Owner in
`
`IPR2022-01226, as follows:
`
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, CA 94306
`RegeneronEyleaIPRs@arnoldporter.com
`
`And to counsel for Petitioner Mylan Pharmaceuticals, Inc. in IPR2022-01226,
`
`as follows:
`
`-8-
`
`
`
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`MYL_REG_IPR@rmmslegal.com
`
`Dated: February 10, 2023
`
`Respectfully submitted,
`
` /Lora M. Green/
`Lora M. Green, Lead Counsel
`Reg. No. 43,541
`
`-9-
`
`
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