`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`BIOCON BIOLOGICS INC.,
`Petitioner,
`
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`IPR2024-00298
`Patent 11,253,572 B2
`
`
`
`Petitioner’s Amended Mandatory Notices
`
`
`
`
`
`
`
`
`
`
`
`
`Biocon Biologics Inc. (“Petitioner”) submits the following amended
`
`mandatory notices to identify additional related matters and to update back-up
`
`counsel information.
`
` REAL PARTIES-IN-INTEREST (37 C.F.R. § 42.8(b)(1)).
`Petitioner Biocon Biologics Inc., Biocon Limited, Biocon Biologics Limited,
`
`Biocon Biologics UK Limited, and Biosimilar Collaborations Ireland Limited are
`
`real parties-in-interest (“RPIs”) to the current Petition. Biocon Biologics Limited is
`
`a subsidiary of Biocon Limited, a publicly traded company. Biocon Biologics UK
`
`Limited is a wholly owned subsidiary of Biocon Biologics Limited, and Biosimilar
`
`Collaborations Ireland Limited and Biocon Biologics Inc. are wholly owned
`
`subsidiaries of Biocon Biologics UK Limited.
`
`Further RPIs include Mylan Pharmaceuticals Inc. (“Mylan”) and Johnson &
`
`Johnson. Viatris Inc. and Mylan Inc. are parent companies of Mylan Pharmaceuticals
`
`Inc. Accordingly, Viatris Inc., Mylan Inc., and Mylan Pharmaceuticals Inc. are
`
`identified as RPIs to the current Petition. Momenta Pharmaceuticals, Inc. and
`
`Janssen Research & Development LLC are wholly-owned subsidiaries of Johnson
`
`& Johnson, a publicly held company. Momenta Pharmaceuticals, Inc., Janssen
`
`Research & Development LLC, and Johnson & Johnson are also RPIs to the current
`
`Petition.
`
`No other parties exercised or could have exercised control over this Petition;
`
`
`
`no other parties funded, directed, and controlled this Petition. See Trial Practice
`
`Guide, 15-16 (November 2019).
`
` RELATED MATTERS (37 C.F.R. § 42.8(b)(2)) (AMENDED).
`Petitioner identifies Samsung Bioepis Co., Ltd. v. Regeneron Pharms., Inc.,
`
`IPR2023-00884 (P.T.A.B.), Mylan Pharms. Inc. v. Regeneron Pharms., Inc., No.
`
`IPR2022-01225 (P.T.A.B.), and Mylan Pharms. Inc. v. Regeneron Pharms., Inc.,
`
`No. IPR2022-01226 (P.T.A.B.). Petitioner also identifies Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., No. IPR2021-00880 (P.T.A.B.), Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., No. IPR2021-00881 (P.T.A.B.), Mylan Pharms. Inc. v.
`
`Regeneron Pharms., Inc., No. IPR2023-00099 (P.T.A.B.), Biocon Biologics Inc. v.
`
`Regeneron Pharms., Inc., No. IPR2024-00201 (P.T.A.B.), Regeneron Pharms., Inc.
`
`v. Mylan Pharms. Inc., No. 2023-1395 (Fed. Cir.), Regeneron Pharms., Inc. v. Mylan
`
`Pharms. Inc., No. 2023-1396 (Fed. Cir.), Regeneron Pharms., Inc. v. Mylan Pharms.
`
`Inc., 1:22-cv-00061-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v. Celltrion, Inc.,
`
`1:23-cv-00089-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v. Samsung Bioepis,
`
`Co. Ltd., 1:23-cv-00094-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v. Formycon
`
`AG, 1:23-cv-00097-TSK (N.D.W. Va.); Regeneron Pharms., Inc. v. Samsung
`
`Bioepis, Co. Ltd., 1:23-cv-00106-TSK (N.D.W. Va.); and Regeneron Pharms., Inc.
`
`v. Amgen Inc., 2:24-cv-00264-JAK-E (C.D. Cal.). To the best of Petitioner’s
`
`knowledge, the following are additional judicial or administrative matters that would
`
`2
`
`
`
`affect, or be affected by, a decision in this proceeding: Cel/trion, Inc. v. Regeneron
`
`Pharms.,
`
`Inc., No.
`
`IPR2024-00260 (P.T.A.B.), Apotex Inc.
`
`v. Regeneron
`
`Pharmaceuticals, Inc., No. IPR2022-01524 (P.T.A.B.), Samsung Bioepis Co., Ltd.
`
`v. Regeneron Pharms., Inc., 1PR2023-00442 (P.T.A.B.), Samsung Bioepis Co. Ltd.
`
`v. Regeneron Pharms., Inc., No. IPR2023-00739 (P.T.A.B.), United States v.
`
`Regeneron Pharms.,
`
`Inc., No. 1:20-cv-11217-FDS (D. Mass.), and Horizon
`
`Healthcare Servs., Inc. v. Regeneron Pharms., Inc., No. 1:22-cv-10493-FDS (D.
`
`Mass.).
`
`U:S. Patent Nos. 9,254,338 B2; 9,669,069 B2: 10,857,205 B2; 10,828,345 B2:
`
`10,130,681 B2; 10,888,601 B2; 11,559,564 B2; 11,707,506 B2; and 11,730,794 B2:
`
`and U.S. Patent Application Nos. 17/072,417; 17/112,063; and 18/496,472 each
`
`claim the benefit of the °572 patent’s purported priority date.
`
`C.
`
`LEAD AND BACK-UP COUNSEL AND SERVICE INFORMATION (37
`C.F.R. § 42.8(b)(3)-(4)).
`
`Petitioner identifies its lead and backup counsel below.
`
`
`
`Paul J. Molino (Reg. No. 45,350)
`William A. Rakoczy
`paul@rmmslegal.com
`(pro hac vice to be filed)
`
`wrakoczy@rmmmslegal.com
`
`
`
`
`
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`
`Heinz J. Salmen
`
`
`
`Postal and Hand Delivery Address
`Rakoczy Molino Mazzochi Siwik LLP
`6 West HubbardStreet
`Chicago, IL 60654
`Telephone: (312) 222-6300
`
`
`
`
`
`
`Facsimile: (312) 843-6260
`
`Petitioner consents to email service at:
`MYL_REG_IPR@rmmslegal.com
`
`
`(pro hac vice to be filed)
`hsalmen@rmmslegal.com
`
`Eric R. Hunt
`(pro hac vice to be filed)
`ehunt@rmmslegal.com
`
`Neil B. McLaughlin (Reg. No. 70,810)
`nmclaughlin@rmmslegal.com
`
`Lauren M. Lesko
`(pro hac vice to be filed)
`llesko@rmmslegal.com
`
`L. Scott Beall (Reg. No. 52,601)
`sbeall@rmmslegal.com
`
`Thomas H. Ehrich (Reg. No. 67,122)
`tehrich@rmmslegal.com
`
`Steven J. Birkos (Reg. No. 65,300)
`sbirkos@rmmslegal.com
`
`Jake R. Ritthamel
`(pro hac vice to be filed)
`jritthamel@rmmslegal.com
`
`Postal and Hand Delivery Address
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone: (312) 527-2157
`Facsimile: (312) 843-6260
`
`
`Please direct all correspondence to lead and back-up counsel at the contact
`
`information above.
`
` Petitioner also consents
`
`to service by email at:
`
`MYL_REG_IPR@rmmslegal.com.
`
`4
`
`
`
`Dated: January 18, 2024
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
` /Paul J. Molino/
`Paul J. Molino
`Registration No. 45,350
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 843-6260
`paul@rmmslegal.com
`
`
`Counsel for Petitioner
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`Petitioner’s Amended Mandatory Notices was served on January 18, 2024, via
`
`electronic mail, to the following counsel of record for Patent Owner:
`
`
`
`
`
`Adam R. Brausa (Reg. No. 60,287)
`Rebecca Weires (Reg. No. 77,895)
`Duralyn J. Durie (pro hac vice to be
`filed)
`Morrison & Foerster LLP
`425 Market Street
`San Francisco, CA 94105
`Tel: 415.268,6053
`Tel: 415.268.6028
`Tel: 415.268.6055
`abrausa@mofo.com
`rweires@mofo.com
`ddurie@mofo.com
`
`
`Dated: January 18, 2024
`
`
`
`
`Kira A. Davis (pro hac vice to be filed)
`Morrison & Foerster LLP
`707 Wilshire Blvd., Suite 6000
`Los Angeles, CA 90017
`Tel: 213.892,5654
`kiradavis@mofo.com
`
`Respectfully Submitted,
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`/Paul J. Molino/
`
`6
`
`