`571.272.7822
`
`Paper8
`Date: January 30, 2024
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CELLTRION,INC.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`Before SUSAN L. C. MITCHELL, ROBERT A. POLLOCK,and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`DECISION
`Granting Institution of /nter Partes Review
`Granting Motion for Joinder
`35 US.C. § 314; 35 USC. $ 315(c); 37 CER. § 42.122
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`I.
`
`INTRODUCTION
`
`Regeneron Pharmaceuticals, Inc. (“Patent Owner” or “Regeneron”’)is
`
`the ownerof U.S. Patent 11,253,572 B2 (“the °572 patent”). Paper 5,1. On
`
`December 14, 2023, Celltrion, Inc. (“Petitioner” or “Celltrion’”’) filed a
`
`Petition for inter partes review challenging the patentability of claims 1—30
`
`(all claims) of the 572 patent. Paper 1 (“Pet.’’). The same day, Petitioner
`
`filed a Motion for Joinder, seeking that this proceeding be joined with
`
`pending inter partes review IPR2023-00884 (“IPR’884”). Paper 3
`
`(“Motion”or “Mot.”). On January 26, 2024, a conference call was held
`
`between the Panel, Celltrion, Biocon Biologics Inc. (“Biocon,” the petitioner
`
`in related IPR2024-00298), Samsung Bioepis Co., Ltd. (“Samsung,” the
`
`petitioner in related IPR’884), and Regeneron. See Paper 7. Atthis
`
`conference call, Regeneron indicated that it did not oppose Celltrion’s
`
`Motion and waivedits right to file a preliminary response in this proceeding.
`
`Td.
`
`Under 37 C.F.R. § 42.4(a), we have authority to determine whetherto
`
`institute trial in an inter partes review. We mayinstitute an inter partes
`
`review if the information presented in the petition filed under 35 U.S.C.
`
`§ 311, and any preliminary responsefiled under § 313, showsthat there is a
`
`reasonablelikelihood that Petitioner would prevail with respect to at least
`
`one of the claims challenged in the petition. 35 U.S.C. § 314.
`
`Asdiscussed below, we concludePetitioner demonstrates a
`
`reasonablelikelihood it would prevail in showingthat at least one
`
`challenged claim of the °572 patent is unpatentable under the presented
`
`grounds. Therefore, we grant institution of inter partes review. Further, we
`
`grant Petitioner’s unopposed Motion to join this proceeding with IPR’884.
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`A.
`
`REAL PARTIES-IN-INTEREST
`
`Petitioner states, “[t]he real part[ies]-in-interest for Petitioner [are]
`
`Celltrion Inc., Celltrion Healthcare Co. Ltd. [a]nd Celltrion Healthcare
`
`U.S.A., Inc.” Pet. 16. Patent Owneridentifies itself, Regeneron,as the real
`
`party-in-interest. Paper 3, 1.
`
`B.
`
`RELATED MATTERS
`
`Regarding related matters, Petitionerstates:
`
`Apotex filed an IPR Petition on September 9, 2022 asserting
`five grounds for invalidating the non-DME claimsof the 7572
`patent, all of which recite “results limitations.” Ex.1008
`(“Apotex Petition”). Grounds 1-4 of Apotex’s petition were
`based on anticipation: (1) anticipation of claims 1-5, 8-11, 14,
`and 26-30 based on Dixon;(2) anticipation of claims 1-5, 8-11,
`14, and 26-30 based on a May8, 2008 Regeneron Press
`Release; (3) anticipation of claims 1-5, 8-11, 14, and 26-30
`based on NCT-795 (1.¢., VIEW 1 ClinicalTrials.gov entry); and
`(4) anticipation of claims 1-5, 8-11, 14, and 26-30 based on
`NCT-377 (1.e., VIEW 2 ClinicalTrials.gov entry). Ex.1008, 12.
`
`With respectto the “results limitations” in these claims,
`Apotex argued that they (1) were not entitled to patentable
`weight (id., 17-20); or (2) were inherently anticipated by
`practice of the claimed method (id., 35-68). Notably, Apotex
`did not rely on obviousnessto address the visual acuity
`limitations in any of the claims.
`
`Apotex only asserted obviousness for claims 6, 7, 12, and
`13 in its Ground 5. For those claims, Apotex relied on any of
`the above anticipatory references in view of Hecht. Ex.1008,
`12. Apotex’s obviousness argument in Ground 5 wassolely
`directed to the “isotonic solution”limitation in dependent
`claims 6 and 12 and the “nonionic surfactant” limitation in
`dependent claims 7 and 13—notthe “results limitations.”
`Ex.1008, 68-71.
`
`In its Institution Decision, the Board determined that the
`“results limitations” were entitled to patentable weight.
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`Ex.1004 (“Apotex *°572 ID”), 14-18. The Board then went on
`to determine that the prior art did not inherently disclose the
`“results limitations” for at least two reasons: (1) less than all of
`the patients in the VIEW 1/2 trials achieved the claimed visual
`acuity limitations; and (2) the patient population reported in the
`prior art as achieving the recited gains was not the sameasthat
`described in the *572 patent. /d, 30-36. It therefore denied
`institution.
`/d.
`
`The *572 patent is in the same family as U.S. Patent Nos.
`9,254,338 (“°338 patent”), 9,669,069 (“069 patent”),
`10,130,681 (“681 patent”), and 10,888,601 (‘’601 patent’).
`Ex.1001.
`
`In May 2021, Mylan Pharmaceuticals Inc. filed petitions
`requesting inter partes review of the °338 and ’069 patents. See
`IPR2021-00881 (338 IPR”) and IPR2021-00880 (069
`IPR”). The Boardinstituted review for the °338 and °069
`patents, and Celltrion filed joinder petitions to both of those
`proceedings—IPR2022-00258 and IPR2022-00257,
`respectively. The Board found all challenged claims of those
`patents unpatentable in Final Written Decisions issued on
`November9, 2022. See Ex.1011, ’338 IPR, Paper 94 (*°338
`FWD”); ’069 IPR, Paper 89. Regeneron appealed the Board’s
`Final Written Decisions to the Court of Appeals for the Federal
`Circuit—Consolidated Appeal Nos. 2023-1395 and -001396.
`
`Mylanfiled a petition requesting IPR of the 681 patent
`on July 1, 2022 (IPR2022-01225) (“Mylan °681 IPR”). The
`Mylan 681 IPR wasinstituted on January 11, 2023. Ex.1012
`(681 ID”). Celltrion filed a “copycat” petition and a motion
`for joinder on February 10, 2023. See, Celltrion, Inc. v.
`Regeneron Pharmaceuticals, Inc., {PR2023-00532, Papers 2-3.
`The petition was granted on March 22, 2023. See id. Paper7.
`Samsung Bioepis filed a petition against the 681 patent on
`January 6, 2023 (IPR2023-00442) asserting different grounds
`of invalidity than in the Mylan 7681 IPR. The Board instituted
`review on July 19. 2023.
`
`Mylanfiled a petition requesting IPR of the non-DME
`claims of the ’601 patent on July 1, 2022. See IPR2022-01226
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`(“Mylan *601 IPR”). The Mylan 601 IPR wasinstituted on
`January 11, 2023. Ex.1013 (601 ID). Celltrion filed a
`“copycat” petition and a motion for joinder on February 10,
`2023. See, Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.,
`IPR2023-00533, Papers 2-3. The petition was granted on
`March 22, 2023. See id. Paper 7. Samsung Bioepisfiled a
`“copycat” IPR petition on February 10, 2023. See, Samsung
`Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.,
`IPR2023-00566, Papers 2-3. The Board instituted Samsung
`Bioepis’ IPR petition and granted its motion for joinder on
`March 22, 2023 in IPR2023-00566. /d., Paper 10.
`
`Samsung Bioepis filed a petition requesting IPR of the
`DME claimsof the °601 patent on March 26, 2023. See
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.,
`IPR2023-00739. Institution was granted on October 20, 2023.
`
`In the interest of completeness, Petitioner notes that it
`filed IPR2023-00462, challenging claims 1-18 of US Patent No.
`10,464,992, which claims formulations of VEGF antagonists,
`1.e., formulations of aflibercept. Review wasinstituted on July
`20, 2023. Samsung Bioepis filed a “copycat” IPR petition on
`August 18, 2023. See, Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., {PR2023-01312, Papers 1-2. The Board
`instituted Samsung Bioepis’ IPR petition and granted its motion
`for joinder on December 11, 2023 in IPR2023-01312. Id.,
`Paper30.
`
`To the best of Petitioner’s knowledge, the following are
`judicial or administrative matters that potentially would affect,
`or be affected by, a decision in this proceeding: Regeneron
`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., NDWV-
`1-22-cv-00061 (“Mylan Litigation”), United Statesv.
`Regeneron Pharms., Inc., No. 1:20-cv-11217-FDS (D. Mass.).
`
`Pet. 16-20.
`
`Regarding related matters, Patent Ownerstates:
`
`U.S. Patent No. 11,253,572 was previously challenged in
`Apotex Inc. v. Regeneron Pharmaceuticals, Inc., Case No.
`IPR2022-01524 (P.T.A.B.). The ’572 patent 1s also currently
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`being challenged in Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., Case No. IPR2023-00884 (P.T.A.B),
`and Biocon Biologics Inc. v. Regeneron Pharmaceuticals, Inc.,
`Case No. IPR202400298.
`
`Related U.S. Patent No. 10,888,601 is being challenged
`in Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals,
`Inc., Case No. IPR202201226 (P.T.A.B.), in Celltrion, Inc.v.
`Regeneron Pharmaceuticals, Inc., Case No. IPR2023-00533
`(P.T.A.B.) and Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., Case No. IPR2023-00566 (P.T.A.B.),
`which have been joined with IPR2022-01226. U.S. Patent No.
`10,888,601 is also being challenged in Samsung Bioepis Co.,
`Ltd. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2023-
`00739 (P.T.A.B.) and in Biocon Biologics Inc. v. Regeneron
`Pharmaceuticals, Inc., Case No. IPR2024-00201 (P.T.A.B.).
`
`Related U.S. Patent No. 10,130,681 is being challenged
`in Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals,
`Inc., Case No. IPR202201225 (P.T.A.B.) and in Celltrion, Inc.
`v. Regeneron Pharmaceuticals, Inc., Case No. [PR2023-00532
`(P.T.A.B.), which has been joined with IPR2022-01225. U.S.
`Patent No. 10,130,681 is also being challenged in Samsung
`Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc., Case No.
`2023-00442 (P.T.A.B).
`
`Related U.S. Patent Nos. 9,669,069 and 9,254,338 were
`challenged in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., Case No. IPR202100880 (P.T.A.B.) and
`in Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals,
`Inc., Case No. IPR2021-00881 (P.T.A.B.), respectively.
`IPR2021-00880 wasjoined with IPR2022-00257 and
`IPR2022-00301. IPR202100881 was joined with
`IPR2022-00258 and IPR2022-00298. Patent Owner has
`appealed the Board’s decisions in those cases to the Federal
`Circuit, in Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals Inc., No. 2023-1395 (Fed. Cir.) and
`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals
`Inc., No. 20231396 (Fed. Cir.), respectively.
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`U.S. Patent No. 11,253,572 and related patents have been
`asserted in Regeneron Pharmaceuticals, Inc. v. Mylan
`Pharmaceuticals Inc., No. 1:22-cv-00061-TSK (N.D. W.Va.);
`Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc., No. 1:23-
`cv-00089-TSK (N.D. W.Va.); Regeneron Pharmaceuticals, Inc.
`v. Samsung Biopeis, Co., Ltd., No. 1:23-cv-00094-TSK (N.D.
`W.Va.); and Regeneron Pharmaceuticals, Inc. v. Formycon AG,
`No. 1:23-cv-00097-TSK (N.D. W.Va.).
`
`Out of abundance of caution, Patent Ownerfurther
`identifies Chengdu Kanghong Biotechnology Co. v. Regeneron
`Pharms., Inc., Case No. PGR202100035 (P.T.A.B.)
`(proceeding terminated) regarding related U.S. Patent No.
`10,828,345.
`
`Out of abundance of caution, Patent Ownerfurther
`identifies Apotex Inc. v. Regeneron Pharmaceuticals, Inc., Case
`No. IPR2023-00099 (P.T.A.B.) (proceeding terminated),
`regarding U.S. Patent No. 10,857,205, which wasrelated to
`U.S. Patent No. 11,253,572 and which Regeneron disclaimed.
`
`Patent Owner does not concedethat the identified matters
`would affect, or be affected by, a decision in the present /nter
`Partes Review of U.S. Patent No. 11,253,572.
`
`Paper3, 1-3.
`
`C.
`
`THE ’572 PATENT
`
`The *572 patent is summarized in our Institution Decision in IPR’884
`
`(see Paper 13, 4—9, of that proceeding). Therefore, for efficiency’s sake, we
`
`will not restate our summary of the challenged patent and its challenged
`
`claims, but refer to our decision in IPR’884, whichis incorporated by
`
`reference. !
`
`' The parties are not authorized to incorporate arguments or briefing by
`reference in any papers.
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`D.
`
`ASSERTED GROUNDS FOR UNPATENTABILITY
`
`Petitioner, identically to Samsung in IPR’884 (see Paper 2 (the
`
`petition) in that proceeding) asserts the following groundsfor the
`
`unpatentability of claims 1—30 of the °572 patent:
`
`
`
`15, 24
`1-5, 8-11, 16, 17,
`20,21
`a 1-5, 8-11, 26-30
`26-30
`
`102(a)
`
`2009 PR? or Dec. 2010
`PR.‘ individual
`Dec. 2010 PR
`Dixon,° 2006 PR’
`Nov. 2010 PR?
`
`* The priority date to be accorded the ’572 patent is contested (see Pet. 25);
`however, as discussed in our Institution Decision in IPR2023-00884 (Paper
`13,9 n.1, 30-34), we agree with Patent Ownerthat all claims should be
`accordedat least a January 21, 2011, priority date, which is before the AIA
`revisions to 35 U.S.C. §§ 102 and 103 took effect on March 16, 2013.
`35 U.S.C. § 100 (note). Therefore, pre-AIA § 102 and § 103 apply.
`> Regeneron, Enrollment Completed in Regeneron and Bayer HealthCare
`Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular
`Degeneration (Wet AMD)(Sept. 14, 2009) (Ex. 1005, “2009 PR”).
`4 Regeneron, Regeneron and Bayer Report Positive Results for VEGF Trap-
`Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO)and in
`Phase 2 Study in Diabetic Macular Edema (DME)(Dec. 20, 2010)
`(Ex. 1006, “Dec. 2010 PR”).
`> Regeneron, Bayer and Regeneron Report Positive Top-Line Results of
`Two Phase 3 Studies with VEGF Trap-Eye in Wet Age-related Macular
`Degeneration (Nov.22, 2010) (Ex. 1007, “Nov. 2010 PR”).
`© James A. Dixonet al., VEGF Trap-Eye for the treatment ofneovascular
`age-related macular degeneration, 18(10) EXPERT OPIN. INVESTIG. DRUGS
`1573-80 (2009) (Ex. 1009, “Dixon’’).
`7 Regeneron Pharm., Regeneron Reports Positive Phase 1 Data for the
`VEGFTrap in Age-Related Macular Degeneration, Preliminary results show
`improvements in vision andretinal swelling, VEGF Trap was well tolerated
`
`8
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`
`
`
`6, 7, 12, 13
`
`7
`
`18, 19, 22, 23
`
`103)
`
`103(a)
`
` Ground |
`2009 PR, 2007 ARVO,
`16, 17, 20, 21
`103(a)
`Dixon, 2010 ARVO®
`Dixon, Hecht,'° 2006
`PR, Dec. 2010 PR
`Dec. 2010 PR, Hecht,
`2009 PR, 2007 ARVO,
`Dixon, 2010 ARVO
`Dixon, Dec. 2010 PR,
`
`
`
`
`
`CATT,!! PIER
`; ae Be
`
`9 |ts|tos)|ea 200
`Dixon
`1-5, 8-11, 26-30
`10
`11
`1-5, 8-11, 26-30
`2009 PR
`
`2009 PR, Shams,”
`
`at all dose levels, Company also announcesinitiation of phase 2 trial (May 1,
`2006) (Ex. 1027, “2006 PR”).
`®D.V. Do et al., ARVO Annual Meeting Abstract, Results ofa Phase I Study
`ofIntravitreal VEGF Trap in Subjects with Diabetic Macular Edema: The
`CLEAR-IT DME Study, 48 Investigative Ophthalmology & Visual Sci. 1430
`(May 2007) (Ex. 1030, “2007 ARVO”).
`? J.C. Major, Jr. & D.M. Brown, ARVO Annual Meeting Abstract, DA
`VINCI: DME and VEGF Trap-Eye: Investigation of Clinical Impact: Phase
`2 Study in Patients with Diabetic Macular Edema (DME), 51 Investigative
`Ophthalmology & Visual Sci. 6426 (April 2010) (Ex. 1010, “2010 ARVO”).
`'© Gerald Hecht, PhD, Ophthalmic Preparations, in I] REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY,19" ed., Ch. 89, 1563-76 (Alfonso
`R. Gennaro ed., 1995) (Ex. 1016, “Hecht’’).
`"| CATTand PIERrefer to clinicaltrials concerning ranibizumab and
`bevacizumab, and are described in the Petition as encompassing Exhibits
`1020-1026.
`
`2 WO 2006/047325 Al (published May 4, 2006) (Ex. 1017, “Shams”).
`'S Michael J. Elman et al., Randomized Trial Evaluating Ranibizumab Plus
`Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic
`Macular Edema, 117(6) OPHTHALMOLOGY 1064-77 (June 2010) (Ex. 1018,
`“Elman 2010”).
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`See Pet. 22—24. Weinstituted trial in IPR’884 onall of the above-listed
`
`grounds. See IPR’884 DI.
`
`In support of these grounds for unpatentability Petitioner submits,
`
`inter alia, the Declaration of Christine Kay, MD. Ex. 1002. Petitioner
`
`certifies in its Motion that “[t]he conclusions and underlying reasoning of
`
`[Dr. Kay and Dr. Chaum, Samsung’s declaration witness in IPR’884,] are
`
`identical.” Mot. 1 n.1.
`
`II.
`
`INSTITUTION OF TRIAL
`
`A.
`
`INSTITUTION IS WARRANTED
`
`The Petition here is substantively identical to Samsung’s Petition in
`
`IPR’884, challenging the same patent and claims, based on the same grounds
`
`of unpatentability, and relying upon the same evidence (including the same
`
`prior art combinations and supported by a substantially “identical” expert
`
`declaration). See generally Pet.; see also Mot. | (Petitioner certifies that
`
`“It|he instant Petition is substantially the same as the Samsung IPR[’884]: it
`
`involves the same patent, same claims, same groundsof unpatentability, and
`
`the same evidencel! (including the sameprior art combinations) as the
`
`Samsung IPR[’884].”). Petitioner seeks institution of the same claims and
`
`grounds for which the Boardinstituted trial in IPR’884, stating that the
`
`“Petition does not raise any new groundsof unpatentability” and that the
`
`Petition is substantially identical to the petition in the Samsung
`IPR, challenging the same claims of the ’572 Patent on the
`same grounds and relying on the same testimony from an expert
`declarant. Thus, the only difference between Celltrion’s
`Petition and the petition filed in the Samsung IPR are the
`sections on Real Party-In-Interest, Related Matters, and
`Counsel, which have been appropriately updated.
`
`Mot. 4, 5.
`
`10
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`Weexplained in our Institution Decision in IPR’884 why we conclude
`
`that Samsung demonstrated a reasonable likelihood of prevailing at trial in
`
`showing that the challenged claims are unpatentable. See generally IPR’884
`
`DI. Thepresent Petition advances identical arguments, challenging the same
`
`claims over the same combinationsof prior art. We consequently adopt the
`
`same reasoning here as in our IPR’884Institution Decision, and conclude
`
`that Petitioner is similarly likely to prevail in demonstrating the
`
`unpatentability of the same challenged claims.
`
`/d. We incorporate our
`
`previous analysis regarding the asserted grounds of unpatentability and
`
`conclude that Petitioner demonstrates a reasonable likelihood of prevailing
`
`at trial with respect to at least one claim of the *572 patent challenged in the
`
`Petition for the same reasons as in IPR’884. Seeid.
`
`Based onthe record before us, we determine that the Petition warrants
`
`institution of inter partes review onall claims and all groundsasserted in the
`
`Petition. 37 C.F.R. § 42.108(a) (“Wheninstituting .
`
`.
`
`. review, the Board
`
`will authorize the review to proceed onall of the challenged claims and on
`
`all grounds of unpatentability asserted for each claim.”’); see also SAS Inst.
`
`Inc. v. Iancu, 138 S. Ct. 1348, 1359-60 (2018).
`
`IN. JOINDER WITH IPR2023-00884
`
`A.
`
`LEGAL STANDARD FOR JOINDER
`
`The Patent Act, 35 U.S.C. § 315(c), governs joinderof inter partes
`
`review proceedings andstates:
`
`(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 whoproperly files a
`petition under section 311 that the Director, after receiving a
`preliminary response undersection 313 or the expiration of the
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`11
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`IPR2024-00260
`Patent 11,253,572 B2
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`time for filing such a response, determines warrants the
`institution of an inter partes review undersection 314.
`
`Joinder may be authorized when warranted, but the decision to grant
`
`joinderis discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. We
`
`determine whether to grant joinder on a case-by-case basis, taking into
`
`accountthe particular facts of each case, substantive and procedural issues,
`
`and other considerations. When exercising that discretion, we are mindful
`
`that patent trial regulations, including the rules for joinder, must be
`
`construed to secure the just, speedy, and inexpensive resolution of every
`
`proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b).
`
`Asthe movingparty, Petitioner bears the burden of proving that it is
`
`entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder
`
`should: (1) set forth the reasons joinder is appropriate; (2) identify any new
`
`grounds of unpatentability asserted in the petition; and (3) explain what
`
`impact (if any) joinder would have onthetrial schedule for the existing
`
`review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4
`
`(PTAB Apr. 24, 2013); see also, USPTO, America Invents Act (AIA)
`
`Frequently Asked Questions,” available at: uspto.gov/patents/laws/america-
`
`invents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partes-
`
`review_3244(last visited February 2, 2022).
`
`B.—JOINDER IS WARRANTED
`
`Petitioner filed its Petition and Motion for Joinder on December14,
`
`2023, which was within one month of our IPR’884 DI (entered Nov. 17,
`
`2023), thus, the Motion is timely. 37 C.F.R. § 42.122(b).
`
`Petitioner certifies and we agree that the Petition is substantively
`
`identical to that of IPR’884, where we found Samsung had metits burden to
`
`show a reasonable likelihood it would prevail at trial in establishing at least
`
`12
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`
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`IPR2024-00260
`Patent 11,253,572 B2
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`one challenged claim unpatentable under the asserted grounds. Mot. 5; see
`
`generally IPR’884 DI. Petitioner also certifies, and we agree, thatit relies
`
`on the same evidencehere as in IPR’884. Mot. 5. Patent Owner waivesits
`
`rightto file a preliminary responsein this proceeding, for the sake of
`
`efficiency. See Paper7, 2.
`
`Petitioner also certifies that it will be a “silent understudy”to
`
`Samsung in IPR’884 if the proceedingsare joined, thus, there will be no
`
`impact to the schedule ofthat instituted trial. Mot. 5—6. Moreover,
`
`Petitioner asserts that, structured in this way, the joined proceeding will
`
`simplify briefing and discovery (1.e., they will be singular, rather than
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`occurring in two proceedings).
`
`/d. at 6—7.
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`Petitioner asserts that Patent Owner will not be prejudiced by joinder.
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`Id. at 7. As noted above, Patent Owner does not oppose the motion and,so,
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`does not expressly disagree. Paper 7.
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`Here,institution is warranted, and joining this proceeding with
`
`IPR’884 will provide a more just, speedy, and inexpensive resolution of the
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`proceeding(s). We conclude the circumstances warrant the joinder of this
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`proceeding with IPR’884.
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`IV. CONCLUSION
`
`Having reviewed the Petition, as well as Petitioner’s representations in
`
`its Motion for Joinder, which Patent Owner does not oppose, we determine
`
`that, under the circumstances,it is appropriate to institute inter partes review
`
`of the challenged claims based upon the same groundsauthorized and for the
`
`same reasons discussed in our Institution Decision in IPR’884 (see generally
`
`IPR’884 DI) and to grant Petitioner’s Motion for Joinder. This Decision
`
`13
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`does not constitute a final decision regarding the patentability of any
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`challenged claim.
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`V. ORDER
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`In consideration of the foregoing,it is hereby:
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`ORDEREDthat, pursuant to 35 U.S.C. § 314(a), an inter partes
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`review of claims 1—30 of U.S. Patent 11,253,572 B2 is instituted with
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`respect to all grounds and challenged claimsasset forth in the Petition and
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`shall commenceon the entry date of this Decision, and notice is hereby
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`given of the institution of trial;
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`FURTHER ORDEREDthat Petitioner’s Motion for Joinder with
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`IPR2023-00884 (Paper 3) is granted, [PR2024-00260 is terminated, and this
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`proceeding is hereby joined with IPR2023-00884;
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`FURTHER ORDEREDthat the Scheduling Order entered in
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`IPR2023-00884 (see Papers 14 and 18, and see also Paper 28 (stipulated
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`modifications in that proceeding) shall govern the trial schedule;
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`FURTHER ORDEREDthat Petitioner’s role in [PR2023-00884shall
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`be limited as stated by Petitioner in the Motion for Joinder (Paper 3) unless
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`and until Samsungis terminated from that proceeding;
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`FURTHER ORDEREDthat the case caption in IPR2023-00884 shall
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`be changed, and a footnote added,to reflect joinder of Celltrion Inc. as a
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`petitioner in accordance with the attached example;
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`FURTHER ORDEREDthata copy ofthis Decision will be entered
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`into the record of IPR2023-00884; and
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`FURTHER ORDEREDthatall further filings shall be made in
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`IPR2023-00884.
`
`14
`
`
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`FOR PETITIONER
`
`Lora Green
`Yahn Lin Chu
`GEMINI LAW LLP
`iereen(@geminilawcom
`
`ichud@gemimlawcom
`
`
`
`FOR PATENT OWNER
`
`Adam Brausa
`Rebecca Weires
`MORRISON & FOERSTER LLP
`abrausa@@moto com
`
`rweires@moto com
`
`
`15
`
`
`
`[joined case caption]
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SAMSUNGBIOEFPIS CO., LTD., and CELLTRION,INC.,
`Petitioner,
`
`V.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2023-00884!
`Patent 11,253,572 B2
`
`
`
`" IPR2024-00260 has been joined with IPR2023-00884.
`
`