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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`CELLTRION, INC.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2024-00260
`____________________________________________________________
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`PATENT OWNER’S MANDATORY NOTICES
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`
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`IPR2024-00260
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`Patent Owner, Regeneron Pharmaceuticals, Inc., hereby files mandatory
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`notices pursuant to 37 C.F.R. § 42.8(a)(2).
`
`A. Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
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`The real party-in-interest is Regeneron Pharmaceuticals, Inc.
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`B. Related Matters (37 C.F.R. § 42.8(b)(2))
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`
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`In accordance with the Office Patent Trial Practice Guide (77 Fed. Reg.
`
`48756, at 48759-60 (Aug. 14, 2012)), Patent Owner identifies the following related
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`matters:
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`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
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`patent is also currently being challenged in Samsung Bioepis Co., Ltd. v.
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`Regeneron Pharmaceuticals, Inc., Case No. IPR2023-00884 (P.T.A.B), and
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`Biocon Biologics Inc. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2024-
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`00298.
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`Related U.S. Patent No. 10,888,601 is being challenged in Mylan
`
`Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2022-
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`01226 (P.T.A.B.), in Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc., Case No.
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`IPR2023-00533 (P.T.A.B.) and Samsung Bioepis Co., Ltd. v. Regeneron
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`Pharmaceuticals, Inc., Case No. IPR2023-00566 (P.T.A.B.), which have been
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`joined with IPR2022-01226. U.S. Patent No. 10,888,601 is also being challenged
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`1
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`IPR2024-00260
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`in Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc., Case No.
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`IPR2023-00739 (P.T.A.B.) and in Biocon Biologics Inc. v. Regeneron
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`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-
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`01225 (P.T.A.B.) and in Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc., Case
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`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-
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`00880 (P.T.A.B.) and in Mylan Pharmaceuticals Inc. v. Regeneron
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`Pharmaceuticals, Inc., Case No. IPR2021-00881 (P.T.A.B.), respectively.
`
`IPR2021-00880 was joined with IPR2022-00257 and IPR2022-00301. IPR2021-
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`00881 was joined with IPR2022-00258 and IPR2022-00298. Patent Owner has
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`appealed the Board’s decisions in those cases to the Federal Circuit, in Regeneron
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`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-1395 (Fed. Cir.)
`
`and Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 2023-
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`1396 (Fed. Cir.), respectively.
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`2
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`IPR2024-00260
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`U.S. Patent No. 11,253,572 and related patents have been asserted in
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`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 1:22-cv-
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`00061-TSK (N.D. W.Va.); Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc., No.
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`1:23-cv-00089-TSK (N.D. W.Va.); Regeneron Pharmaceuticals, Inc. v. Samsung
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`Biopeis, Co., Ltd., No. 1:23-cv-00094-TSK (N.D. W.Va.); and Regeneron
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`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
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`Kanghong Biotechnology Co. v. Regeneron Pharms., Inc., Case No. PGR2021-
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`00035 (P.T.A.B.) (proceeding terminated) regarding related U.S. Patent No.
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`10,828,345.
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`Out of abundance of caution, Patent Owner further identifies Apotex Inc. v.
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`Regeneron Pharmaceuticals, Inc., Case No. IPR2023-00099 (P.T.A.B.)
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`(proceeding terminated), regarding U.S. Patent No. 10,857,205, which was related
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`to U.S. Patent No. 11,253,572 and which Regeneron disclaimed.
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`Patent Owner does not concede that the identified matters would affect, or
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`be affected by, a decision in the present Inter Partes Review of U.S. Patent No.
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`11,253,572.
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`3
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`IPR2024-00260
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`Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
`
`C.
`
`
`Lead Counsel
`
`Backup Counsel
`
`Adam R. Brausa
`Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`Fax: (415) 268-7522
`ABrausa@mofo.com
`
`Rebecca Weires
`Reg. No. 77,895
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6028
`Fax: (415) 268-7522
`RWeires@mofo.com
`
`Backup Counsel
`
`Backup Counsel
`
`Kira A. Davis
`(pro hac vice to be filed)
`MORRISON & FOERSTER LLP
`707 Wilshire Blvd., Suite 6000
`Los Angeles, California 90017
`Tel: (213) 892-5654
`Fax: (213) 892-5454
`KiraDavis@mofo.com
`
`
`
`Daralyn J. Durie
`(pro hac vice to be filed)
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6055
`Fax: (415) 268-7522
`DDurie@mofo.com
`
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`A Power of Attorney is being filed concurrently with these Mandatory
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`Notices.
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`D.
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`Service Information (37 C.F.R. § 42.8(b)(4))
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`Please direct all correspondence regarding this proceeding to the counsel at
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`the addresses listed above. Patent Owner also consents to electronic service by
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`email to Regeneron-MoFo-IPR@mofo.com.
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`The Patent Trial and Appeal Board is hereby authorized to charge any fees
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`associated with this proceeding to Deposit Account 03-1952.
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`4
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`IPR2024-00260
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`Dated: January 3, 2024
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`
`
` By: /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`Counsel for Patent Owner
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`
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`5
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`IPR2024-00260
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached PATENT OWNER’S MANDATORY
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`NOTICES and PATENT OWNER’S POWER OF ATTORNEY UNDER 37
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`C.F.R. § 42.10(b) were served as of the below date via email on the Petitioner (by
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`agreement) at the following correspondence address:
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`Lora Green (Reg. No. 43,541)
`Yahn-Lin Chu (Reg. No. 75,946)
`Robert Cerwinski (to be admitted pro hac vice, pending)
`Aviv Zalcenstein (to be admitted pro hac vice, pending)
`Brigid Morris (to be admitted pro hac vice, pending)
`Gemini Law LLP
`40 W 24th Street, Suite 6N
`New York, NY 10010
`lgreen@geminilaw.com
`fchu@geminilaw.com
`rcerwinski@geminilaw.com
`azalcenstein@geminilaw.com
`bmorris@geminilaw.com
`
`
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`Dated: January 3, 2024
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
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`6
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