Trials@uspto.gov
`571-272-7822
`
`Paper 7
`Date: February 9, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2022-00298
`Patent 9,254,338 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 7
`Date: February 9, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.,
`Petitioner,
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`IPR2022-00298
`Patent 9,254,338 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L. C. MITCHELL, Administrative Patent Judges.
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
`
`
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`
`I.
`INTRODUCTION
`Apotex, Inc. (“Petitioner”) timely filed a Petition (“Apotex Petition”)
`requesting an inter partes review of claims 1, 3–11, 13, 14, 16–24, and 26 of
`U.S. Patent No. 9,254,338 B2 (Ex. 1001, “the ’338 patent”). Paper 1
`(“Pet.”). Petitioner also timely filed a Motion for Joinder (“Joinder
`Motion”) to join this proceeding with Mylan Pharms., Inc. v. Regeneron
`Pharms, Inc., IPR2021-00881, filed May 5, 2021, and instituted on
`November 10, 2021 (the “Mylan IPR”). Paper 3 (“Mot.”); see Mylan IPR,
`Paper 21. In an email to the Board on December 20, 2021, Regeneron
`Pharmaceuticals, Inc. (“Patent Owner”)1 communicated that it waives filing
`a Preliminary Response to the Petition. Ex. 3001.
`For the reasons set forth below, we (1) institute inter partes review
`based on the same grounds as instituted in the Mylan IPR, and (2) grant
`Petitioner’s Joinder Motion, subject to the conditions detailed herein.
`II.
`INSTITUTION OF INTER PARTES REVIEW
`In the Mylan IPR, we instituted trial on the following six grounds:
`
`Claims Challenged
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`
`35 U.S.C. § Reference(s)
`102
`Dixon2
`
`102
`
`Adis3
`
`
`1 In its Mandatory Notices, Patent Owner identifies itself as the real party-in-
`interest. Paper 6, 2.
`2 James A. Dixon et al., “VEGF Trap-Eye for the treatment of neovascular
`age-related macular degeneration,” 18(10) Expert Opin. Investig. Drugs
`1573–1580 (2009) (Ex. 1006, “Dixon”)).
`3 Adis Data Information BV, “Aflibercept,” 9(4) Drugs R&D 261–269
`(2008) (Ex. 1007, “Adis”).
`
`2
`
`
`
`35 U.S.C. § Reference(s)
`102
`Regeneron 20084
`
`102
`
`102
`
`NCT-7955
`
`NCT-3776
`
`IPR2022-00298
`Patent 9,254,338 B2
`Claims Challenged
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`1, 3–11, 13, 14, 16–24, 26
`
`Mylan IPR, Paper 21, 6, 40. Apotex’s Petition is substantially identical to
`Mylan’s Petition, 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 supported by the same expert declaration) as
`the Mylan IPR. See Mot. 1. Petitioner seeks only institution of the same
`claims and grounds for which the Board instituted in the Mylan IPR. Id.
`Patent Owner has waived filing a Preliminary Response in this
`proceeding. Ex. 3001. Therefore, at this stage and in this proceeding, Patent
`Owner has not raised any arguments in response to the substantive grounds
`of the Mylan Petition. Petitioner undertakes, if the Petition and Joinder
`
`103
`
`Dixon, Papadopoulos,7 Dix8
`
`
`4 Press Release, Regeneron, “Bayer and Regeneron Dose First Patient in
`Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular
`Degeneration” (May 8, 2008) (Ex. 1013, “Regeneron 2008”).
`5 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of
`Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
`(VIEW1), NCT00509795, ClinicalTrials.gov (Apr. 28, 2009),
`https://clinicaltrials.gov/ct2/show/NCT00509795 (Ex. 1014, “NCT-795”).
`6 VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD
`(VIEW2), NCT00637377, ClinicalTrials.gov (Mar. 17, 2008),
`https://clinicaltrials.gov/ct2/show/NCT00637377 (Ex. 1015, “NCT-377”).
`7 Papadopoulos et al., US 7,374,758 B1, issued May 20, 2008, (Ex. 1010,
`“Papadopoulos”).
`8 Dix et al., US 2006/0217311, issued Sept. 28, 2006 (Ex. 1033, “Dix”).
`
`3
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`Motion are granted, to assume a “silent understudy” role, and will not take
`an active role in the inter partes review proceeding unless the Mylan
`Petitioner ceases to participate in the instituted IPR. Pet. 3. Petitioner
`contends that the proposed joinder will neither unduly complicate the Mylan
`IPR nor delay its schedule. Id. As such, Petitioner asserts, the joinder will
`promote judicial efficiency in determining patentability of the ’388 patent in
`the Mylan IPR without prejudice to Patent Owner. Id.
`In view of these representations by Petitioner, and having reviewed
`the Apotex Petition, we determine that, under the current circumstances, it is
`appropriate to exercise our discretion to institute inter partes review of the
`challenged claims based upon the same ground authorized and for the same
`reasons discussed in our Institution Decision in the Mylan IPR. See Mylan
`IPR, Paper 21.
`III.
`JOINDER OF INTER PARTES REVIEWS
`An inter partes review may be joined with another inter partes
`review, subject to the provisions 35 U.S.C. § 315(c), which governs joinder
`of inter partes review proceedings:
`(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.
`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: set forth the reasons joinder is appropriate; identify any new
`grounds of unpatentability asserted in the petition; and explain what impact
`(if any) joinder would have on the trial schedule for the existing review. See
`
`4
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`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).
`Petitioner timely filed its Joinder Motion within one month of the
`institution of the Mylan IPR, as required by 37 C.F.R. § 42.122(b). In the
`Joinder Motion, Petitioner explains that it will:
`assume a “silent understudy” role and will not take an active role
`in the inter partes review proceeding unless the Mylan Petitioner
`ceases to participate in the instituted IPR. Thus, the proposed
`joinder will neither unduly complicate the Mylan IPR nor delay
`its schedule. As such, the joinder will promote judicial efficiency
`in determining patentability in the Mylan IPR without prejudice
`to Patent Owner.
`
`Mot. 3, 1. As discussed in the Institution Decision, Section II supra, the
`instituted grounds in this proceeding are the same as that instituted in the
`Mylan IPR.
`Having considered the unopposed Joinder Motion, and our decisions
`to institute the same grounds in the Mylan IPR, we determine that Petitioner
`Apotex has established persuasively that joinder is appropriate and will have
`little to no impact on the timing, cost, or presentation of the trial on the
`instituted ground. Thus, in consideration of the foregoing, and in the manner
`set forth in the following Order, the Joinder Motion is granted.
`
`5
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`
`IV. 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, 3–11, 13, 14, 16–24, and 26 of U.S. Patent No.
`9,254,338 B2 is instituted in IPR2022-00298 on the six grounds asserted in
`the Petition, and set forth above in Section II:
`FURTHER ORDERED that Petitioner’s Unopposed Motion for
`Joinder with IPR2021-000881 is granted;
`FURTHER ORDERED that IPR2022-00298 is terminated and joined
`with IPR2021-00881, pursuant to 37 C.F.R. §§ 42.72, 42.122, wherein
`Apotex will maintain a secondary role in the proceeding, unless and until
`Mylan ceases to participate as a petitioner in the inter partes review;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2021-00881, along with modifications appropriately stipulated to by the
`parties, shall govern the joined proceeding;
`FURTHER ORDERED that all future filings in the joined proceeding
`are to be made only in IPR2021-00881;
`FURTHER ORDERED that the case caption in IPR2021-00881 for all
`further submissions shall be changed to add Apotex, Inc. as a named
`Petitioner after the Mylan Petitioner, and a footnote shall be added to
`indicate the joinder of IPR2022-00298 to that proceeding, as shown in the
`attached sample case caption;9 and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2021-00881.
`
`
`9 The attached sample caption includes Petitioner Celltrion, based on our
`concurrently decided decision granting institution and granting the motion
`for joinder in IPR2022-00258.
`
`6
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`FOR PETITIONER:
`
`Teresa Stanek Rea
`Deborah H. Yellin
`Shannon M. Lentz
`CROWELL & MORING LLP
`trea@Crowell.com
`dyellin@Crowell.com
`slentz@Crowell.com
`
`
`FOR PATENT OWNER:
`
`Deborah E. Fishman
`David A. Caine
`Alice S. Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`deboarh.fishman@arnoldporter.com
`david.caine@arnoldporter.com
`alice.ho@arnoldporter.com
`
`
`
`
`
`7
`
`
`
`IPR2022-00298
`Patent 9,254,338 B2
`
`
`
`Joined Case Caption
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS, INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2021-0088110
`Patent 9,254,338 B2
`____________
`
`
`
`
`
`
`
`
`
`
`10 IPR2022-00258 and IPR 2022-00298 have been joined with this
`proceeding.
`
`8
`
`
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