Trials@uspto.gov
`571.272.7822
`
`
` Paper 8
`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 Inter Partes Review
`Granting Motion for Joinder
`35 U.S.C. § 314; 35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`

`

`IPR2024-00260
`Patent 11,253,572 B2
`
`
`INTRODUCTION
`I.
`Regeneron Pharmaceuticals, Inc. (“Patent Owner” or “Regeneron”) is
`the owner of 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. At this
`conference call, Regeneron indicated that it did not oppose Celltrion’s
`Motion and waived its right to file a preliminary response in this proceeding.
`Id.
`
`Under 37 C.F.R. § 42.4(a), we have authority to determine whether to
`institute trial in an inter partes review. We may institute an inter partes
`review if the information presented in the petition filed under 35 U.S.C.
`§ 311, and any preliminary response filed under § 313, shows that there is a
`reasonable likelihood that Petitioner would prevail with respect to at least
`one of the claims challenged in the petition. 35 U.S.C. § 314.
`As discussed below, we conclude Petitioner demonstrates a
`reasonable likelihood it would prevail in showing that 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.
`
`2
`
`

`

`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 Owner identifies itself, Regeneron, as the real
`party-in-interest. Paper 3, 1.
`RELATED MATTERS
`B.
`Regarding related matters, Petitioner states:
`Apotex filed an IPR Petition on September 9, 2022 asserting
`five grounds for invalidating the non-DME claims of the ’572
`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 May 8, 2008 Regeneron Press
`Release; (3) anticipation of claims 1-5, 8-11, 14, and 26-30
`based on NCT-795 (i.e., VIEW 1 ClinicalTrials.gov entry); and
`(4) anticipation of claims 1-5, 8-11, 14, and 26-30 based on
`NCT-377 (i.e., VIEW 2 ClinicalTrials.gov entry). Ex.1008, 12.
`With respect to 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 obviousness to 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 was solely
`directed to the “isotonic solution” limitation in dependent
`claims 6 and 12 and the “nonionic surfactant” limitation in
`dependent claims 7 and 13—not the “results limitations.”
`Ex.1008, 68-71.
`In its Institution Decision, the Board determined that the
`“results limitations” were entitled to patentable weight.
`
`3
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`

`

`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 same as that
`described in the ’572 patent. Id, 30-36. It therefore denied
`institution. Id.
`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 Board instituted 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
`November 9, 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.
`Mylan filed a petition requesting IPR of the ’681 patent
`on July 1, 2022 (IPR2022-01225) (“Mylan ’681 IPR”). The
`Mylan ’681 IPR was instituted 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., IPR2023-00532, Papers 2-3.
`The petition was granted on March 22, 2023. See id. Paper 7.
`Samsung Bioepis filed a petition against the ’681 patent on
`January 6, 2023 (IPR2023-00442) asserting different grounds
`of invalidity than in the Mylan ’681 IPR. The Board instituted
`review on July 19. 2023.
`Mylan filed a petition requesting IPR of the non-DME
`claims of the ’601 patent on July 1, 2022. See IPR2022-01226
`
`4
`
`

`

`IPR2024-00260
`Patent 11,253,572 B2
`
`
`(“Mylan ’601 IPR”). The Mylan 601 IPR was instituted 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 Bioepis filed 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. Id., Paper 10.
`Samsung Bioepis filed a petition requesting IPR of the
`DME claims of 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,
`i.e., formulations of aflibercept. Review was instituted on July
`20, 2023. Samsung Bioepis filed a “copycat” IPR petition on
`August 18, 2023. See, Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., IPR2023-01312, Papers 1-2. The Board
`instituted Samsung Bioepis’ IPR petition and granted its motion
`for joinder on December 11, 2023 in IPR2023-01312. Id.,
`Paper 30.
`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 States v.
`Regeneron Pharms., Inc., No. 1:20-cv-11217-FDS (D. Mass.).
`Pet. 16–20.
`Regarding related matters, Patent Owner states:
`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 is also currently
`
`5
`
`

`

`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. IPR2023-00532
`(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 was joined 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.
`
`6
`
`

`

`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 Owner further
`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 Owner further
`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 was related to
`U.S. Patent No. 11,253,572 and which Regeneron disclaimed.
`Patent Owner does not concede that the identified matters
`would affect, or be affected by, a decision in the present Inter
`Partes Review of U.S. Patent No. 11,253,572.
`Paper 3, 1–3.
`THE ’572 PATENT
`C.
`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, which is incorporated by
`reference.1
`
`
`1 The parties are not authorized to incorporate arguments or briefing by
`reference in any papers.
`
`7
`
`

`

`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 grounds for the
`unpatentability of claims 1–30 of the ’572 patent:
`
`
`35 U.S.C. §2
`102(a)
`
`Reference(s)/Basis
`2009 PR3 or Dec. 2010
`PR,4 individually
`Dec. 2010 PR
`Nov. 2010 PR5
`Dixon,6 2006 PR7
`
`Ground Claims Challenged
`1
`15, 24
`1–5, 8–11, 16, 17,
`20, 21
`26–30
`1–5, 8–11, 26–30
`
`2 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 Owner that all claims should be
`accorded at 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.
`3 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”).
`5 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”).
`6 James A. Dixon et al., VEGF Trap-Eye for the treatment of neovascular
`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
`VEGF Trap in Age-Related Macular Degeneration, Preliminary results show
`improvements in vision and retinal swelling, VEGF Trap was well tolerated
`
`2
`3
`4
`
`102(a)
`102(a)
`103(a)
`
`8
`
`

`

`IPR2024-00260
`Patent 11,253,572 B2
`
`
`Ground Claims Challenged
`5
`16, 17, 20, 21
`
`6
`
`7
`
`8
`
`6, 7, 12, 13
`
`18, 19, 22, 23
`
`14
`
`35 U.S.C. §2
`103(a)
`
`103(a)
`
`103(a)
`
`103(a)
`
`9
`10
`11
`
`Reference(s)/Basis
`2009 PR, 2007 ARVO,8
`Dixon, 2010 ARVO9
`Dixon, Hecht,10 2006
`PR, Dec. 2010 PR
`Dec. 2010 PR, Hecht,
`2009 PR, 2007 ARVO,
`Dixon, 2010 ARVO
`Dixon, Dec. 2010 PR,
`CATT,11 PIER,
`2009 PR, Shams,12
`Elman 201013
`Dixon
`2009 PR
`
`103(a)
`102(a)
`102(a)
`
`25
`1–5, 8–11, 26–30
`1–5, 8–11, 26–30
`
`at all dose levels, Company also announces initiation of phase 2 trial (May 1,
`2006) (Ex. 1027, “2006 PR”).
`8 D.V. Do et al., ARVO Annual Meeting Abstract, Results of a Phase I Study
`of Intravitreal 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”).
`9 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”).
`10 Gerald Hecht, PhD, Ophthalmic Preparations, in II REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY, 19th ed., Ch. 89, 1563–76 (Alfonso
`R. Gennaro ed., 1995) (Ex. 1016, “Hecht”).
`11 CATT and PIER refer to clinical trials concerning ranibizumab and
`bevacizumab, and are described in the Petition as encompassing Exhibits
`1020–1026.
`12 WO 2006/047325 A1 (published May 4, 2006) (Ex. 1017, “Shams”).
`13 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”).
`
`9
`
`

`

`A.
`
`IPR2024-00260
`Patent 11,253,572 B2
`
`
`See Pet. 22–24. We instituted trial in IPR’884 on all 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.
`INSTITUTION OF TRIAL
`II.
`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. 1 (Petitioner certifies that
`“[t]he instant Petition is substantially the same as the Samsung IPR[’884]: it
`involves the same patent, same claims, same grounds of unpatentability, and
`the same evidence[] (including the same prior art combinations) as the
`Samsung IPR[’884].”). Petitioner seeks institution of the same claims and
`grounds for which the Board instituted trial in IPR’884, stating that the
`“Petition does not raise any new grounds of 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
`
`
`We explained 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. The present Petition advances identical arguments, challenging the same
`claims over the same combinations of prior art. We consequently adopt the
`same reasoning here as in our IPR’884 Institution Decision, and conclude
`that Petitioner is similarly likely to prevail in demonstrating the
`unpatentability of the same challenged claims. Id. 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. See id.
`Based on the record before us, we determine that the Petition warrants
`institution of inter partes review on all claims and all grounds asserted in the
`Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board
`will authorize the review to proceed on all 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).
`III. JOINDER WITH IPR2023-00884
`LEGAL STANDARD FOR JOINDER
`The Patent Act, 35 U.S.C. § 315(c), governs joinder of inter partes
`review proceedings and 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
`
`A.
`
`11
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`

`IPR2024-00260
`Patent 11,253,572 B2
`
`
`time for filing such a response, determines warrants the
`institution of an inter partes review under section 314.
`Joinder may be authorized when warranted, but the decision to grant
`joinder is 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
`account the 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).
`As the moving party, 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 on the trial 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).
`JOINDER IS WARRANTED
`B.
`Petitioner filed its Petition and Motion for Joinder on December 14,
`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 met its burden to
`show a reasonable likelihood it would prevail at trial in establishing at least
`
`12
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`

`IPR2024-00260
`Patent 11,253,572 B2
`
`one challenged claim unpatentable under the asserted grounds. Mot. 5; see
`generally IPR’884 DI. Petitioner also certifies, and we agree, that it relies
`on the same evidence here as in IPR’884. Mot. 5. Patent Owner waives its
`right to file a preliminary response in this proceeding, for the sake of
`efficiency. See Paper 7, 2.
`Petitioner also certifies that it will be a “silent understudy” to
`Samsung in IPR’884 if the proceedings are joined, thus, there will be no
`impact to the schedule of that instituted trial. Mot. 5–6. Moreover,
`Petitioner asserts that, structured in this way, the joined proceeding will
`simplify briefing and discovery (i.e., they will be singular, rather than
`occurring in two proceedings). Id. at 6–7.
`Petitioner asserts that Patent Owner will not be prejudiced by joinder.
`Id. at 7. As noted above, Patent Owner does not oppose the motion and, so,
`does not expressly disagree. Paper 7.
`Here, institution is warranted, and joining this proceeding with
`IPR’884 will provide a more just, speedy, and inexpensive resolution of the
`proceeding(s). We conclude the circumstances warrant the joinder of this
`proceeding with IPR’884.
`
`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 grounds authorized 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
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`

`

`IPR2024-00260
`Patent 11,253,572 B2
`
`does not constitute a final decision regarding the patentability of any
`challenged claim.
`
`V. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–30 of U.S. Patent 11,253,572 B2 is instituted with
`respect to all grounds and challenged claims as set forth in the Petition and
`shall commence on the entry date of this Decision, and notice is hereby
`given of the institution of trial;
`FURTHER ORDERED that Petitioner’s Motion for Joinder with
`IPR2023-00884 (Paper 3) is granted, IPR2024-00260 is terminated, and this
`proceeding is hereby joined with IPR2023-00884;
`FURTHER ORDERED that the Scheduling Order entered in
`IPR2023-00884 (see Papers 14 and 18, and see also Paper 28 (stipulated
`modifications in that proceeding) shall govern the trial schedule;
`FURTHER ORDERED that Petitioner’s role in IPR2023-00884 shall
`be limited as stated by Petitioner in the Motion for Joinder (Paper 3) unless
`and until Samsung is terminated from that proceeding;
`FURTHER ORDERED that the case caption in IPR2023-00884 shall
`be changed, and a footnote added, to reflect joinder of Celltrion Inc. as a
`petitioner in accordance with the attached example;
`FURTHER ORDERED that a copy of this Decision will be entered
`into the record of IPR2023-00884; and
`FURTHER ORDERED that all further filings shall be made in
`IPR2023-00884.
`
`
`
`
`14
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`

`

`IPR2024-00260
`Patent 11,253,572 B2
`
`
`FOR PETITIONER
`
`Lora Green
`Yahn Lin Chu
`GEMINI LAW LLP
`lgreen@geminilaw.com
`fchu@geminilaw.com
`
`FOR PATENT OWNER
`
`Adam Brausa
`Rebecca Weires
`MORRISON & FOERSTER LLP
`abrausa@mofo.com
`rweires@mofo.com
`
`
`
`
`15
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`

`

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`
`
`[joined case caption]
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD., and CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-008841
`Patent 11,253,572 B2
`____________
`
`
`
`
`
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`
`
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`
`
`
`
`
`
`_________________________
`
` IPR2024-00260 has been joined with IPR2023-00884.
`
` 1
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`