Trials@uspto.gov Paper 7
`571-272-7822 Date: February 9, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEIUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2022-00257
`Patent 9,969,069 B2
`____________
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L.C. MITCHELL, Administrative Patent Judges.
`
`NEW, 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 Date: February 9, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEIUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2022-00257
`Patent 9,969,069 B2
`____________
`
`
`Before ERICA A. FRANKLIN, JOHN G. NEW, and
`SUSAN L.C. MITCHELL, Administrative Patent Judges.
`
`NEW, 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
`
`
`
`
`
`
`
`
`IPR2022-00257
`Patent 9,969,069 B2
`
`
`I. INTRODUCTION
`Celltrion, Inc. (“Petitioner”) has timely filed a Petition (“Celltrion
`Petition”) requesting an inter partes review of claims 1 and 8–12 of
`U.S. Patent No. 9,969,069 B2 (Ex. 1001, “the ’069 patent”). Paper 2
`(“Pet.”). Petitioner also timely filed a Motion for Joinder (the “Motion” or
`“Mot.,” Paper 3) to join this proceeding with Mylan Pharms. Inc. v.
`Regeneron Pharms., Inc., IPR2021-00880, filed May 5, 2021, and instituted
`on November 10, 2021 (the “Mylan IPR”). See Mylan IPR, Paper 21. In an
`email to the Board on December 20, 2021, Patent Owner Regeneron
`Pharmaceuticals Inc. (“Patent Owner”)1 communicated that it waives filing a
`Preliminary Response to the Petition. See 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 Motion for Joinder, subject to the conditions detailed herein.
`
`
`II. INSTITUTION OF INTER PARTES REVIEW
`In the Mylan IPR, we instituted trial on the following grounds:
`
`
`
`
`1 In its Mandatory Notices, Patent Owner identifies itself as the real party-in-
`interest. Paper 6, 2.
`
`
`
`
`
`2
`
`
`
`IPR2022-00257
`Patent 9,969,069 B2
`
`
`Ground
`
`I
`II
`III
`
`IV
`
`V
`
`Claims
`Challenged
`1, 9–12,
`1, 9–12
`1, 9–12
`
`1, 8–12
`
`1, 8–12
`
`35 U.S.C. §
`102
`102
`102
`
`Reference(s)
`Dixon2
`Heier 20093
`Regeneron I4
`
`102/103
`
`Dixon
`
`103
`
`Heier 2009, Mitchell5 or
`Dixon, optionally
`Papadopolous6 or Dix7
`
`
`Mylan IPR, Paper 21, 3, 4, 49.
`Celltrion’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
`
`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”)).
`
`
`3J.S. Heier, Intravitreal VEGF Trap for AMD: An Update, October 2009
`RETINA TODAY 44–45 (2009) (“Heier 2009”) Ex. 1020.
`
` 4
`
` 5
`
` 6
`
` 7
`
` Press Release, Bayer and Regeneron Extend Development Program for
`VEGF Trap-Eye to Include Central Retinal Vein Occlusion, April 30, 2009
`(“Regeneron I”) Ex. 1028.
`
` P. Mitchell et al., Ranibizumab (Lucentis) in Neovascular Age-Related
`Macular Degeneration: Evidence from Clinical Trials, 94(2) Br. J.
`Ophthalmol. 2–13 (2010) (“Mitchell”) Ex. 1030.
`
` Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopolous”)
`Ex. 1010.
`
` Dix et al., (US 2006/0217311 A1, May 20, 2008) (“Dix”) Ex. 1033.
`3
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`
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`IPR2022-00257
`Patent 9,969,069 B2
`
`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 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 ’069 patent in the Mylan IPR
`without prejudice to Patent Owner. Id.
`In view of these representations by Petitioner, and having reviewed
`the Celltrion 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 grounds 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:
`
`
`
`4
`
`
`
`IPR2022-00257
`Patent 9,969,069 B2
`
`
`(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
`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
`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.
`
`
`
`
`5
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`
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`IPR2022-00257
`Patent 9,969,069 B2
`
`Mot. 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 motion for joinder, and our decision
`to institute the same grounds in the Mylan IPR, we determine that Petitioner
`Celltrion 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 Motion for Joinder is GRANTED.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that trial is instituted in IPR2022-00257 on the following
`grounds:
`Ground I: Claims 1 and 9–12 of the ’069 patent under 35
`U.S.C. § 102 as anticipated by Dixon.
`
`
`Ground II: Claims 1 and 9–12 of the ’069 patent under 35
`U.S.C. § 102 as anticipated by Heier 2009.
`
`
`Ground III: Claims 1 and 9–12 of the ’069 patent under 35
`U.S.C. § 102 as anticipated by Regeneron I.
`
`
`Ground IV: Claims 1 and 8–12 of the ’069 patent under 35
`U.S.C. §§ 102 and or 103 as anticipated by or
`obvious over Dixon.
`
`
`Ground V: Claims 1 and 8–12 of the ’069 patent under 35
`U.S.C. § 103 as being obvious over Heier 2009 and
`Mitchell or Dixon, and optionally, Papadopolous or
`Dix.
`
`
`
`6
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`
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`IPR2022-00257
`Patent 9,969,069 B2
`
`
`
`FURTHER ORDERED that Petitioner’s Unopposed Motion for
`Joinder with IPR2021-000880 is GRANTED;
`FURTHER ORDERED that IPR2022-00257 is terminated and joined
`with IPR2021-00880, pursuant to 37 C.F.R. §§ 42.72, 42.122, wherein
`Celltrion 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
`IPR2021-00880, 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 IPR2021-00880;
`FURTHER ORDERED that the case caption in IPR2021-00880 for all
`further submissions shall be changed to add Celltrion, Inc. as a named
`Petitioner after the Mylan Petitioner, and a footnote shall be added to
`indicate the joinder of IPR2022-00257 to that proceeding, as shown in the
`attached sample case caption;8 and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2021-00880.
`
`
`
`
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`
`
`8 The attached sample caption includes Petitioner Apotex, based on our
`concurrently decided decision granting institution and granting the motion
`for joinder in IPR2022-00301.
`
`7
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`IPR2022-00257
`Patent 9,969,069 B2
`
`FOR PETITIONER:
`
`Lora M. Green
`Yahn-Lin Chu
`WILSON SONSINI GOODRICH & ROSATI
`lgreen@wsgr.com
`ychu@wsgr.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
`
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`8
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`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.
`____________
`
`IPR2021-008801
`Patent 9,969,069 B2
`____________
`
`
`
`
`1 IPR2022-00257 and IPR 2022-00301 have been joined with this
`proceeding.
`
`
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