Trials@uspto.gov Paper 7
`571-272-7822 Date: March 22, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEIUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00532
`Patent 10,130,681 B2
`____________
`
`
`Before JOHN G. NEW, SUSAN L.C. MITCHELL, and
`ROBERT A. POLLOCK, 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: March 22, 2023
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEIUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2023-00532
`Patent 10,130,681 B2
`____________
`
`
`Before JOHN G. NEW, SUSAN L.C. MITCHELL, and
`ROBERT A. POLLOCK, 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
`
`
`
`
`
`
`
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`
`I. INTRODUCTION
`Celltrion, Inc. (“Petitioner”) has timely filed a Petition (“Celltrion
`Petition”) requesting an inter partes review of claims of U.S. Patent No.
`10,130,681 B2 (Ex. 1001, “the ’681 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.,
`IPR2022-01225, 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
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`
`Ground
`
`1
`
`2
`
`3
`
`4
`
`Claim(s)
`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
`
`35 U.S.C. §
`1022
`
`Reference(s)/Basis
`Dixon3
`
`102
`
`102
`
`103
`
`Adis4
`
`Regeneron 20085
`
`Dixon alone or in view of
`Papadopoulos6 and/or
`Wiegand7
`
`
`2 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125
`Stat. 284 (2011), amended 35 U.S.C. §§ 102 and 103, effective March 16,
`2013. Because the application from which the ’601 patent issued has an
`effective filing date after that date, the AIA versions of §§ 102 and 103
`apply.
`3 J.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) (“Dixon”) Ex. 1006.
`4 Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE0005, VEGF
`Trap – Regeneron, VEGF Trap (R1R2), VEGF Trap-Eye, 9(4) DRUGS R D
`261–269 (2008) (“Adis”) Ex. 1007.
`5 Press Release, Regeneron and Bayer HealthCare Announce Encouraging
`32-Week Follow-Up Results from a Phase 2 Study of VEGF Trap-Eye in
`Age-Related Macular Degeneration, April 28, 2008 (“Regeneron 2008”)
`Ex. 1012.
`6 Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopoulos”)
`Ex. 1010.
`7 Wiegand et al. (US 7,531,173 B2, May 12, 2009) (“Wiegand”) Ex. 1007.
`3
`
`
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`
`Ground
`
`5
`
`6
`
`Claim(s)
`Challenged
`1, 3–11, 13, 14,
`16–24, 26
`
`35 U.S.C. §
`103
`
`1, 3–11, 13, 14,
`16–24, 26
`
`103
`
`Reference(s)/Basis
`Dixon in combination with
`Rosenfeld-20068, and if
`necessary, Papadopoulos
`and/or Wiegand
`Dixon in combination with
`Heimann-2007, and if
`necessary, Papadopoulos
`and/or Wiegand
`
`
`Mylan IPR, Paper 21, 4–5, 28.
`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
`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
`
`8 P.J. Rosenfeld et al., Ranibizumab for Neovascular Age-Related Macular
`Degeneration, 355 (14) N. ENGL. J. MED. 1419–31; Suppl. App’x 1–17
`(2006) (“Rosenfeld”) Ex. 1058.
`
`
`
`4
`
`
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`IPR2023-00532
`Patent 10,130,681 B2
`
`schedule. Id. As such, Petitioner asserts, the joinder will promote judicial
`efficiency in determining patentability of the ’681 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:
`(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
`
`
`
`5
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`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.
`
`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
`
`
`
`6
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`grounds:
`Ground 1: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 102 as anticipated by
`Dixon.
`
`
`Ground 2: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 102 as anticipated by Adis.
`
`
`Ground 3: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 102 as anticipated by
`Regeneron 2008.
`
`
`Ground 4: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 103 as obvious over Dixon
`alone or in view of Papadopoulos and/or Wiegand.
`
`
`Ground 5: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 103 as being obvious over
`Dixon in combination with Rosenfeld-2006, and if
`necessary, Papadopoulos and/or Wiegand.
`
`
`Ground 6: Claims 1, 3–11, 13, 14, 16–24, and 26 of the ’681
`patent under 35 U.S.C. § 103 as being obvious over
`Dixon in combination with Heimann-2007, and if
`necessary, Papadopoulos and/or Wiegand.
`
`
`FURTHER ORDERED that Petitioner’s Unopposed Motion for
`Joinder with IPR20221-01225 is GRANTED;
`
`
`
`7
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`
`FURTHER ORDERED that IPR2023-00532 is terminated and joined
`with IPR2022-01225, 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
`IPR2022-01225, 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 IPR2022-01225;
`FURTHER ORDERED that the case caption in IPR2022-01225 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 IPR2023-00532 to that proceeding, as shown in the
`attached sample case caption; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2022-01225.
`
`
`
`
`
`
`
`
`
`8
`
`
`
`IPR2023-00532
`Patent 10,130,681 B2
`
`FOR PETITIONER:
`
`Lora M. Green
`GEMINI LAW LLP
`lgreen@geminilaw.com
`
`Yahn Lin Chu
`WILSON SONSINI GOODRICH & ROSATI
`ychu@wsgr.com
`
`
`FOR PATENT OWNER:
`
`Deborah E. Fishman
`David A. Caine
`David S. Denuyl
`Alice S. Ho
`ARNOLD & PORTER KAYE SCHOLER LLP
`deboarh.fishman@arnoldporter.com
`david.caine@arnoldporter.com
`david.denuyl@arnoldporter.com
`alice.ho@arnoldporter.com
`
`
`
`9
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`
`
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`
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`
`Joined Case Caption
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS, INC. and CELLTRION, INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2022-001225
`Patent 10,130,681 B2
`____________
`
`
`
`
`
`
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