UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2023-008841
`____________________________________________________________
`
`PATENT OWNER’S UPDATED MANDATORY NOTICES
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`SAMSUNG BIOEPIS CO., LTD., CELLTRION INC,
`and BIOCON BIOLOGICS INC.
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2023-008841
`____________________________________________________________
`
`PATENT OWNER’S UPDATED MANDATORY NOTICES
`
`1 IPR2024-00260 and IPR2024-00298 are joined with IPR2023-00884.
`
`
`
`IPR2023-00884
`
`
`
`
`
`Patent Owner, Regeneron Pharmaceuticals, Inc., hereby files mandatory
`
`notices pursuant to 37 C.F.R. § 42.8(a)(3).
`
`A. Real Party-in-Interest (37 C.F.R. § 42.8(b)(1)) – unchanged
`
`The real party-in-interest is Regeneron Pharmaceuticals, Inc.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2)) – unchanged
`
`
`
`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
`
`matters:
`
`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.).
`
`Related U.S. Patent No. 10,888,601 was challenged in Mylan
`
`Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2022-
`
`01226 (P.T.A.B.), which was joined with IPR2023-00533 and IPR2023-00566.
`
`Patent Owner has appealed the Board’s decision in IPR2022-01226 to the Federal
`
`Circuit in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No.
`
`24-1567 (Fed. Cir.). 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.), which has been
`
`joined with IPR2023-00739.
`
`
`
`1
`
`
`
`IPR2023-00884
`
`
`
`
`
`Related U.S. Patent No. 10,130,681 was challenged in Mylan
`
`Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2022-
`
`01225 (P.T.A.B.), which was joined with IPR2023-00532. Patent Owner has
`
`appealed the Board’s decision in IPR2022-01225 to the Federal Circuit in
`
`Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., No. 24-1564
`
`(Fed. Cir.). U.S. Patent No. 10,130,681 is also being challenged in Samsung
`
`Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc., Case No. IPR2023-00442
`
`(P.T.A.B.).
`
`Related patents 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.
`
`IPR2021-000880 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.
`
`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-
`
`
`
`2
`
`
`
`IPR2023-00884
`
`
`
`
`
`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.); Regeneron
`
`Pharmaceuticals, Inc. v. Formycon AG, No. 1:23-cv-00097-TSK (N.D. W.Va.);
`
`Regeneron Pharmaceuticals, Inc. v. Samsung Biopeis, Co., Ltd., No. 1:23-cv-
`
`00106-TSK (N.D. W.Va.); and Regeneron Pharmaceuticals, Inc. v. Amgen, Inc.
`
`2:24-cv-00264 (C.D. Cal.).
`
`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 an abundance of caution, Patent Owner further identifies Apotex Inc.
`
`v. Regeneron Pharmaceuticals, Inc., Case No. IPR2023-00099 (P.T.A.B.)
`
`(proceeding terminated), regarding related U.S. Patent No. 10,857,205, 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.
`
`
`
`
`
`
`
`3
`
`
`
`IPR2023-00884
`
`
`
`
`
`Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)) – UPDATED
`
`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, granted)
`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, granted)
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6055
`Fax: (415) 268-7522
`DDurie@mofo.com
`
`
`Backup Counsel (NEW)
`
`Backup Counsel (NEW)
`
`Matthew M. Wilk
`(pro hac vice, to be filed)
`Arnold & Porter Kaye Scholer LLP
`250 West 55th Street
`New York, NY 10019-9710
`Tel: (212) 836-7152
`Fax: (212) 836-8689
`matthew.wilk@arnoldporter.com
`
`
`
`
`
`Jeremy Cobb
`(pro hac vice, to be filed)
`Arnold & Porter Kaye Scholer LLP
`601 Massachusetts Ave, NW
`Washington, DC 20001-3743
`Tel: (202) 942-6828
`Fax: (202) 942-5999
`jeremy.cobb@arnoldporter.com
`
`
`
`4
`
`
`
`IPR2023-00884
`
`
`
`
`
`Backup Counsel (NEW)
`
`David A. Caine
`Reg. No. 52,683
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, CA 94306-3807
`Tel: (650) 319-4710
`Fax: (650) 319-4700
`david.caine@arnoldporter.com
`
`
`
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4)) – unchanged
`
`Please direct all correspondence regarding this proceeding to the counsel at
`
`the addresses listed above. Patent Owner also consents to electronic service by
`
`email to Regeneron-MoFo-IPR@mofo.com.
`
`
`
`
`Dated: March 15, 2024
`
`
`
`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
`
`
`
`
`
`5
`
`
`
`IPR2023-00884
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached PATENT OWNER’S UPDATED
`
`MANDATORY NOTICES was served as of the below date via email on the
`
`Petitioners (by agreement) at the following correspondence address:
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Elliot Choi (pro hac vice granted)
`Zachariah Summers (pro hac vice granted)
`Sarah Cork (pro hac vice to be applied for)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`Email: raynimrod@quinnemanuel.com
`Email: matthewtraupman@quinnemanuel.com
`Email: elliotchoi@quinnemanuel.com
`Email: zachsummers@quinnemanuel.com
`Email: landonsmith@quinnemanuel.com
`Email: qe-samsungbioepis@quinnemanuel.com
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy (pro hac vice to be filed)
`Deanne M. Mazzochi (Reg. No. 50,158)
`Heinz J. Salmen (pro hac vice to be filed)
`Eric R. Hunt (pro hac vice to be filed)
`Neil B. McLaughlin (Reg. No. 70,810)
`Lauren M. Lesko (pro hac vice to be filed)
`L. Scott Beall (Reg. No. 52,601)
`Thomas H. Ehrich (Reg. No. 67,122)
`Steven J. Birkos (Reg. No. 65,300)
`Jake R. Ritthamel (pro hac vice to be filed)
`Rakoczy Molino Mazzochi Siwik LLP
`
`6
`
`
`
`IPR2023-00884
`
`
`
`
`
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone: (312) 527-2157
`Facsimile: (312) 843-6260
`Email: MYL_REG_IPR@rmmslegal.com
`
`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
`Tel.: 917-915-8832
`Email: lgreen@geminilaw.com
`Email: fchu@geminilaw.com
`Email: rcerwinski@geminilaw.com
`Email: azalcenstein@geminilaw.com
`Email: bmorris@geminilaw.com
`
`
`
`Dated: March 15, 2024
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`
`
`
`
`7
`
`
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