Trials@uspto.gov
`9571.272.7822
`
`
`Paper 9
`Date: January 31, 2024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIOCON BIOLOGICS INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2024-00298
`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
`
`
`
`
`

`

`IPR2024-00298
`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 18, 2023, Biocon Biologics Inc. (“Petitioner” or “Biocon”) 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 2
`(“Motion” or “Mot.”). On January 26, 2024, a conference call was held
`between the Panel, Biocon, Celltrion, Inc. (“Celltrion,” the petitioner in
`related IPR2024-00260),1 Samsung Bioepis Co., Ltd. (“Samsung,” the
`petitioner in related IPR’884), and Regeneron. See Paper 8. 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
`
`
`1 IPR2024-00260 has been joined with IPR2023-00884.
`
`2
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`grounds. Therefore, we grant institution of inter partes review. Further, we
`grant Petitioner’s unopposed Motion to join this proceeding with IPR’884.
`A. REAL PARTIES-IN-INTEREST
`Petitioner states, Petitioner Biocon Biologics Inc., Biocon
`Limited, Biocon Biologics Limited, Biocon Biologics UK
`Limited, and Biosimilar Collaborations Ireland Limited are real
`parties-in-interest (“RPIs”) to the current Petition. Biocon
`Biologics Limited is a subsidiary of Biocon Limited, a publicly
`traded company. Biocon Biologics UK Limited is a wholly
`owned subsidiary of Biocon Biologics Limited, and Biosimilar
`Collaborations Ireland Limited and Biocon Biologics Inc. are
`wholly owned subsidiaries of Biocon Biologics UK Limited.
`Further RPIs include Mylan Pharmaceuticals Inc.
`(“Mylan”) and Johnson & Johnson. Viatris Inc. and Mylan Inc.
`are parent companies of Mylan Pharmaceuticals Inc.
`Accordingly, Viatris Inc., Mylan Inc., and Mylan
`Pharmaceuticals Inc. are identified as RPIs to the current
`Petition. Momenta Pharmaceuticals, Inc. and Janssen Research
`& Development LLC are wholly-owned subsidiaries of Johnson
`& Johnson, a publicly held company. Momenta
`Pharmaceuticals, Inc., Janssen Research & Development LLC,
`and Johnson & Johnson are also RPIs to the current Petition.
`No other parties exercised or could have exercised
`control over this Petition; no other parties funded, directed, and
`controlled this Petition. See Trial Practice Guide, 15-16
`(November 2019).
`Paper 7, 1–2. Patent Owner identifies itself, Regeneron, as the real party-in-
`interest. Paper 5, 1.
`B. RELATED MATTERS
`Regarding related matters, Petitioner states:
`Petitioner identifies Samsung Bioepis Co., Ltd. v.
`Regeneron Pharms., Inc., IPR2023-00884 (P.T.A.B.), Mylan
`Pharms. Inc. v. Regeneron Pharms., Inc., No. IPR2022-01225
`(P.T.A.B.), and Mylan Pharms. Inc. v. Regeneron Pharms.,
`
`3
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`
`Inc., No. IPR2022-01226 (P.T.A.B.). Petitioner also identifies
`Mylan Pharms. Inc. v. Regeneron Pharms., Inc., No. IPR2021-
`00880 (P.T.A.B.), Mylan Pharms. Inc. v. Regeneron Pharms.,
`Inc., No. IPR2021-00881 (P.T.A.B.), Mylan Pharms. Inc. v.
`Regeneron Pharms., Inc., No. IPR2023-00099 (P.T.A.B.),
`Biocon Biologics Inc. v. Regeneron Pharms., Inc., No.
`IPR2024-00201 (P.T.A.B.), Regeneron Pharms., Inc. v. Mylan
`Pharms. Inc., No. 2023-1395 (Fed. Cir.), Regeneron Pharms.,
`Inc. v. Mylan Pharms. Inc., No. 2023-1396 (Fed. Cir.),
`Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-
`00061-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v.
`Celltrion, Inc., 1:23-cv-00089-TSK (N.D.W. Va.); Regeneron
`Pharms., Inc. v. Samsung Bioepis, Co. Ltd., 1:23-cv-00094-
`TSK (N.D.W. Va.); Regeneron Pharms., Inc. v. Formycon AG,
`1:23-cv-00097-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v.
`Samsung Bioepis, Co. Ltd., 1:23-cv-00106-TSK (N.D.W. Va.);
`and Regeneron Pharms., Inc. v. Amgen Inc., 2:24-cv-00264-
`JAK-E (C.D. Cal.). To the best of Petitioner’s knowledge, the
`following are additional judicial or administrative matters that
`would affect, or be affected by, a decision in this proceeding:
`Celltrion, Inc. v. Regeneron Pharms., Inc., No. IPR2024-00260
`(P.T.A.B.), Apotex Inc. v. Regeneron Pharmaceuticals, Inc.,
`No. IPR2022-01524 (P.T.A.B.), Samsung Bioepis Co., Ltd. v.
`Regeneron Pharms., Inc., IPR2023-00442 (P.T.A.B.), Samsung
`Bioepis Co. Ltd. v. Regeneron Pharms., Inc., No. IPR2023-
`00739 (P.T.A.B.), United States v. Regeneron Pharms., Inc.,
`No. 1:20-cv-11217-FDS (D. Mass.), and Horizon Healthcare
`Servs., Inc. v. Regeneron Pharms., Inc., No. 1:22-cv-10493-
`FDS (D. Mass.).
`U.S. Patent Nos. 9,254,338 B2; 9,669,069 B2;
`10,857,205 B2; 10,828,345 B2; 10,130,681 B2; 10,888,601 B2;
`11,559,564 B2; 11,707,506 B2; and 11,730,794 B2; and U.S.
`Patent Application Nos. 17/072,417; 17/112,063; and
`18/496,472 each claim the benefit of the ’572 patent's purported
`priority date.
`Paper 7, 2–3. 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.
`
`4
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`
`IPR2022-01524 (P.T.A.B.). The ’572 patent is also currently
`being challenged in Samsung Bioepis Co., Ltd. v. Regeneron
`Pharmaceuticals, Inc., Case No. IPR2023-00884 (P.T.A.B),
`and Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc., Case
`No. IPR2024-00260.
`Related U.S. Patent No. 10,888,601 is being challenged
`in Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals,
`Inc., Case No. IPR2022-01226 (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. IPR2022-01225 (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. IPR2021-00880 (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. IPR2021-00881 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.
`2023-1396 (Fed. Cir.), respectively.
`
`5
`
`

`

`IPR2024-00298
`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. PGR2021-00035 (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 5, 1–3.
`THE ’572 PATENT
`C.
`The ’572 patent is summarized in our Institution Decision (“DI”) 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.2
`
`
`2 The parties are not authorized to incorporate arguments or briefing by
`reference in any papers.
`
`6
`
`

`

`2
`3
`4
`
`102(a)
`102(a)
`103(a)
`
`IPR2024-00298
`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:
`
`
`Reference(s)/Basis
`2009 PR4 or Dec. 2010
`PR, 5 individually
`Dec. 2010 PR
`Nov. 2010 PR6
`Dixon, 7 2006 PR8
`
`Ground Claims Challenged 35 U.S.C. §3
`1
`15, 24
`102(a)
`1–5, 8–11, 16, 17,
`20, 21
`26–30
`1–5, 8–11, 26–30
`
`3 The priority date to be accorded the ’572 patent is contested (see Pet. 16–
`17); however, as discussed in our Institution Decision in IPR’884 (DI 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.
`4 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”).
`5 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”).
`6 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”).
`7 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”).
`8 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
`
`7
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`
`Ground Claims Challenged 35 U.S.C. §3
`5
`16, 17, 20, 21
`103(a)
`
`6
`
`7
`
`8
`
`6, 7, 12, 13
`
`18, 19, 22, 23
`
`14
`
`103(a)
`
`103(a)
`
`103(a)
`
`9
`10
`11
`
`Reference(s)/Basis
`2009 PR, 2007 ARVO, 9
`Dixon, 2010 ARVO10
`Dixon, Hecht,11 2006
`PR, Dec. 2010 PR
`Dec. 2010 PR, Hecht,
`2009 PR, 2007 ARVO,
`Dixon, 2010 ARVO
`Dixon, Dec. 2010 PR,
`CATT, 12 PIER,
`2009 PR, Shams,13
`Elman 201014
`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”).
`9 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”).
`10 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”).
`11 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”).
`12 CATT and PIER refer to clinical trials concerning ranibizumab and
`bevacizumab, and are described in the Petition as encompassing Exhibits
`1020–1026.
`13 WO 2006/047325 A1 (published May 4, 2006) (Ex. 1017, “Shams”).
`14 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”).
`
`8
`
`

`

`A.
`
`IPR2024-00298
`Patent 11,253,572 B2
`
`
`See Pet. 14–16. We instituted trial in IPR’884 on all of the above-listed
`grounds. See generally IPR’884 DI.
`In support of these grounds for unpatentability Petitioner submits,
`inter alia, the Declaration of Edward Chaum, MD. Ex. 1002. Petitioner
`certifies in its Motion that this is “the same expert declaration” as filed by
`Samsung in IPR’884. Mot. 3.
`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 the same expert declaration). See
`generally Pet.; see also Mot. 5 (Petitioner certifies that the Petition here and
`that of the Samsung IPR’884 are “Substantively Identical”). Petitioner seeks
`institution over the same claims and under the same grounds for which the
`Board instituted in IPR’884, stating that “[t]he instant petition for IPR filed
`by Biocon challenges the same patent claims, contains the same grounds of
`unpatentability, and is the same in all substantive aspects as the Samsung
`IPR[‘884], aside from minor non-substantive edits to accommodate word
`count.” Mot. 5.
`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
`
`9
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`that Petitioner is 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.
`Therefore, 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
`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
`
`A.
`
`10
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`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 18,
`2023, which was within one month of our IPR’884 DI (entered Nov. 17,
`2023), thus, the Motion is timely (December 17, 2023, a Sunday, was a non-
`business day). 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
`one challenged claim unpatentable under the asserted grounds. Mot. 5–6, 8;
`see generally IPR’884 DI. Petitioner also certifies and we agree that it relies
`on the same evidence here as in IPR’884. Mot. 5–6. Patent Owner waives
`its right to file a preliminary response in this proceeding, for the sake of
`efficiency. See Paper 8, 2.
`
`11
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`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`
`Petitioner also certifies that it will take on a “limited understudy role”
`with respect 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 n.2, 7–9.
`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 7.
`Petitioner asserts that Patent Owner will not be prejudiced by joinder.
`Id. at 9–10. As noted above, Patent Owner does not oppose the motion and,
`so, does not expressly disagree. See Paper 8.
`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
`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
`
`12
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`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 2) is granted, IPR2024-00298 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 2) 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 Biocon Biologics 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.
`
`
`
`
`13
`
`

`

`IPR2024-00298
`Patent 11,253,572 B2
`
`
`FOR PETITIONER
`
`Paul Molino
`Jeffrey Marx
`Neil McLaughlin
`Steven Birkos
`Deanne Mazzochi
`Thomas Ehrich
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`paul@rmmslegal.com
`jmarx@rmmslegal.com
`nmclaughlin@rmmslegal.com
`sbirkos@rmmslegal.com
`dmazzochi@rmmslegal.com
`tehrich@rmmslegal.com
`
`
`FOR PATENT OWNER
`
`Adam Brausa
`Rebecca Weires
`MORRISON & FOERSTER LLP
`abrausa@mofo.com
`rweires@mofo.com
`
`14
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`[joined case caption]
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-008841
`Patent 11,253,572 B2
`____________
`
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`_________________________
`
` 1
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` IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
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