UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
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`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`IPR2024-00260
`U.S. Patent No. 11,253,572
`_____________________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§42.22 AND 42.122(b)
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`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________________
`
`IPR2024-00260
`U.S. Patent No. 11,253,572
`_____________________________
`
`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§42.22 AND 42.122(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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`11,253,572 (“the ’572 Patent”) (IPR2024-00260) with Samsung Bioepis Co., Ltd.,
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`v. Regeneron Pharms., Inc., IPR2023-00884 (P.T.A.B.), filed April 27, 2023, and
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`instituted on November 17, 2023 (“the Samsung IPR”). (See IPR2023-00884,
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`Paper 13). Celltrion has conferred with Samsung Bioepis (“Samsung”), and
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`Samsung does not oppose this Motion for Joinder.
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`The instant Petition is substantially the same as the Samsung IPR: it involves
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`the same patent, same claims, same grounds of unpatentability, and the same
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`evidence1 (including the same prior art combinations) as the Samsung IPR. If
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`joined, Celltrion will assume a “silent understudy” role and will not take an active
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`role in the inter partes review proceeding unless Samsung ceases to participate in
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`the instituted IPR. Thus, the proposed joinder will neither unduly complicate the
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`1 Celltrion filed a declaration by its expert, Dr. Christine Kay, as part of its petition
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`materials. The conclusions and underlying reasoning of the experts are identical,
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`and therefore present no additional burden on the part of the Patent Owners to
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`address. Dr. Kay will also not have an active role in the IPR unless Samsung
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`ceases to participate.
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`-1-
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`Samsung IPR nor delay its schedule. As such, the joinder will promote judicial
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`efficiency in determining patentability in the Samsung IPR without prejudice to
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`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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`Samsung 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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`-2-
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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 ’572 patent.2
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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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`2 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
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`Samsung IPR. For the same reason, Regeneron’s Preliminary Response was not
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`used as a roadmap for this Petition. And as discussed in the Motion, joinder would
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`have no impact on the trial schedule for the Samsung IPR.
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`-3-
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`
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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. 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 Samsung 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 Samsung IPR. See Enzymotec Ltd. v. Neptune Techs & Bioresources,
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`Inc., IPR2014-00556, Paper 19 (PTAB July 9, 2014). Celltrion’s Petition is
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`substantially identical to the petition in the Samsung IPR, challenging the same
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`claims of the ’572 Patent on the same grounds and relying on the same testimony
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`from an expert declarant. Thus, the only difference between Celltrion’s Petition
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`and the petition filed in the Samsung IPR are the sections on Real Party-In-Interest,
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`Related Matters, and Counsel, which have been appropriately updated.
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`Joinder would, therefore, have little, if any, impact on the Samsung IPR, the
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`schedule would not be affected, no additional briefing or discovery would be
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`-4-
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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 (1-30) of the ’572 Patent based on the same arguments
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`and analysis, prior art, evidence, and eleven grounds of unpatentability as the
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`Samsung IPR. See, e.g., Hyundai, IPR2014-01543, Paper 11, at 2-4; Dell,
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`IPR2013-00385, Paper 17, at 6-10.
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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 Samsung IPR less than
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`one month ago, joinder should have no impact on the schedule of the Samsung
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`IPR. See LG v. Memory Integrity, LLC., IPR2015-01353, Paper 11, at 6 (Oct. 5,
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`2015) (granting IPR and motion for joinder where “joinder should not necessitate
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`any additional briefing or discovery from Patent Owner beyond that already
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`required in [the original IPR]”). Celltrion will adhere to all applicable deadlines set
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`in the Scheduling Order for the Samsung 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 Samsung IPR is
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`terminated with respect to the Samsung Petitioner, only then does Celltrion intend
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`-5-
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`
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`to “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 Samsung IPR will not affect the Board’s ability to complete its review and
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`final 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 Samsung 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 Samsung, unless a filing solely concerns issues that do not involve
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`Samsung;
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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 Samsung IPR, or introduce any argument not already
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`introduced by Samsung;
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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 Samsung. See DRL
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`Pharms. Inc. v. Novartis AG, IPR2015-00268, Paper 17, at 5-6 (PTAB Apr. 10,
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`2015) (finding the same proposed limitations “are consistent with the ‘understudy’
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`role that Petitioner agrees to assume, as well as Petitioner’s assertion that its
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`-6-
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`presence would not require introducing any additional arguments, briefing, or
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`discovery.”). Celltrion is also willing to abide by any additional conditions the
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`Board deems appropriate.
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`4.
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`No Prejudice to Patent Owner
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`Joinder of Petitioner to the Samsung 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 Samsung 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.3
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`3 The argument that joinder may theoretically frustrate settlement between
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`Samsung and Patent Owner is not a basis to deny joinder because that same
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`possibility exists in every joinder situation. Global Foundries U.S. Inc. v . Godo
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`Kaisha IP Bridge 1, IPR2017-00925 and IPR2017-00926, Paper 13, at 10 (June 9,
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`2017)
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`-7-
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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 ’572 patent be granted and that the proceeding be joined
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`with IPR2023-00884.
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`Dated: December 14, 2023
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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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`-8-
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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), on this 14th day of December, 2023, on the
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`Patent Owner at the correspondence address of the Patent Owner as follows:
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`191459 – A&P – Regeneron (Prosecution)
`601 Massachusetts Ave., N.W.
`Washington, DC 20001-3743
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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.
` 770 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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`IPR2023-00884, as follows:
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`Adam R. Brausa
`Rebecca Weires
`MORRISON & FOERSTER LLP
`abrausa@mofo.com
`rweires@mofo.com
`regeneron-mofo-ipr@mofo.com
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`And to counsel for Petitioner in IPR2023-00884, as follows:
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`Raymond N. Nimrod
`Matthew A. Traupman
`Landon Andrew Smith
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`-9-
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`
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`QUINN EMANUEL URQUHART & SULLIVAN LLP
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com
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`
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`DATED: December 14, 2023
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`Respectfully submitted,
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`
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`
`
`/Ashley F. Cheung/
`Paralegal for
`Petitioner’s Counsel
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`-10-
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