Celltrion, Inc. vs. Regeneron Pharmaceuticals, Inc.

Explore the PTAB proceeding IPR2025-00456 filed by Celltrion, Inc. on 2025-01-15. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00456

Filing Date

2025-01-15

Accorded Filing Date

2025-01-15

Institution Decision Date

2025-06-25

Last Modified Date

2025-07-26

Proceeding Type

IPR

Termination Date

2025-06-25

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Celltrion, Inc.

Represented By

Green, Loraet al

Patent Owner / Respondent

Regeneron Pharmaceuticals, Inc.

Represented By

Berl, Davidet al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 16739559

Respondent Patent Number 11084865

External Links

Espacenet

Google Patents

Respondent Inventor Eric FURFINE et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

23 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name A&P - Regeneron (Prosecution)

Customer Number 191459

Address 601 Massachusetts Ave., NW, Washington, DC, 20001-3743, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
41408	David Marsh	202-942-5068
48001	Thomas Triolo	914-847-1612
48921	Stephen Gaudet	914-847-7376
50370	Neil Miyamoto	914-847-7175
50437	Frank Cottingham	914-593-1116
58583	Brian Cocca	914-847-1421
58714	Ilona Gont	914-847-1304
59668	Brandon Schurter	914-847-7000
60281	Aparna Patankar	914-847-5571
61391	Yonghao Hou	914-839-2555
61915	Yongjin Choi	914-847-5384
65789	Margarita Zippin	914-847-5589
65957	Lisa Flanagan	914-847-8175
67881	Eileen Woo	914-847-1246
68046	Elysa Goldberg	914-847-1280
68059	David Mellman	720-391-8767
68136	Christopher Westberg	914-847-7912
71406	Gabriele Amodeo	914-847-3578
73212	Trisha Agrawal	914-313-7694
74751	Casey Donahoe	814-931-8622
76829	Michael Lewis	202-942-6728
77536	Alyson Nickols	640-448-3073
81783	Alice Ho	202-942-6753

Proceeding Documents

Director Discretionary Decision: Deny RESPONSE

2025-06-25 FILING PARTY: BOARD

Download

Patent Owner’s Surreply in Support of Preliminary Patent Owner Response OTHER

2025-06-03 FILING PARTY: PATENT OWNER

Download

2022

Celltrion’s Motion to Dismiss for Lack of Personal Jurisdiction, or Alternatively, to Transfer Venue, 23-cv-89, Dkt. 68 (N.D.W. Va. Jan. 17, 2024) Exhibit

2025-06-03 FILING PARTY: PATENT OWNER

Download

Petitioner’s Surreply to Patent Owner’s Discretionary Denial Reply OTHER

2025-05-30 FILING PARTY: PETITIONER

Download

Petitioner's Reply to Patent Owner Preliminary Response OTHER

2025-05-27 FILING PARTY: PETITIONER

Download

Celltrion, Inc. vs. Regeneron Pharmaceuticals, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Celltrion, Inc.

Represented By

Patent Owner / Respondent

Regeneron Pharmaceuticals, Inc.

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Director Discretionary Decision: Deny RESPONSE

Patent Owner’s Surreply in Support of Preliminary Patent Owner Response OTHER

Celltrion’s Motion to Dismiss for Lack of Personal Jurisdiction, or Alternatively, to Transfer Venue, 23-cv-89, Dkt. 68 (N.D.W. Va. Jan. 17, 2024) Exhibit

Petitioner’s Surreply to Patent Owner’s Discretionary Denial Reply OTHER

Petitioner's Reply to Patent Owner Preliminary Response OTHER

Patent Owner's Discretionary Denial Reply OTHER

Email Correspondence Exhibit

EX1062 - Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, The White House (May 12, 2025), https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients Exhibit

EX1063 - Nonconfidential Opening Brief for Defendant-Appellant Samsung Bioepis Co., Ltd., Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, No. 24-1965 (Fed. Cir. July 17, 2024) Exhibit

Order Setting Briefing Schedule on Motions to Dismiss and Setting Schedule for Preliminary Injunction Proceedings, Dkt. 61 (N.D.W. VA.) Exhibit

J.L. Fast et al., Physical Instability of a Therapeutic Fc Fusion Protein: Domain Contributions to Conformational and Colloidal Stability, 48 Biochem. 11724 (2009) Exhibit

EX1055 - Exhibit 1122 (Email from Williams & Connolly LLP Regarding Alvotech), Formycon AG, v. Regeneron Pharmaceuticals, Inc., IPR2025-00233 (Apr. 18, 2025) Exhibit

Regeneron Pharmaceuticals, Inc.’s Memorandum in Support of its Motion for Alternative Service, Dkt. 43-1 (N.D.W. Va.) Exhibit

Defendant Celltrion, Inc.’s Response to Plaintiff’s Motion For Alternative Service, Dkt. 52 (N.D.W. Va.) Exhibit

EX1056 - Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, Federal Register (Apr. 15, 2025), https://www.federalregister.gov/documents/2025/04/18/2025-06837/lowering-drug-prices-by-once-again-putting-americans-first Exhibit

Petitioner's Opposition to Patent Owner's Discretionary Denial Brief RESPONSE

EX1052 - Reply to Patent Owner’s Preliminary Response, Formycon AG, v. Regeneron Pharmaceuticals, Inc., IPR2025-00233 (Apr. 23, 2025) Exhibit

Order Granting Motions for Alternative Service, Dkt. 219 (N.D.W. Va.) Exhibit

EX1054 - Stipulation and Order Vacating Permanent Preliminary Injunction, In re: Aflibercept Patent Litigation, No. 1:24-MD-3103-TSK (N.D.W.Va. 2025) Exhibit

Appellant Celltrion's Reply Brief, Dkt. 33 (Fed. Cir.) Exhibit

Summons, Proof of Service of Complaint, Dkt. 223 (N.D.W. Va.) Exhibit

EX1058 - Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices, The White House (Apr. 15, 2025), https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices Exhibit

EX1053 - Decision, Adverse Judgment After Institution of Trial, Celltrion Inc. v. Regeneron Pharmaceuticals, Inc., IPR2023-00462 (Feb. 21, 2024) Exhibit

EX1057 - Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices, The White House (Apr. 15, 2025), https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices/ Exhibit

Patent Owner's Preliminary Response POPR

Returned Summons, Dkt. 224 (N.D.W. Va.) Exhibit

Regeneron v. Mylan, 22-cv-61, Trial Transcript (Public Excerpts) (N.D.W. Va.) Exhibit

EX1050 - Summons in a Civil Action, Regeneron Pharmaceuticals, Inc. v. Celltrion, No. 1:23-CV-89 (N.D.W.Va. 2023) Exhibit

EX1061 - The U.S. Generic & Biosimilar Medicines Savings Report, Association for Accessible Medicines (Sept. 2024). Exhibit

EX1051 - Petitioner’s Reply to Patent Owner’s Preliminary Response, Samsung Bioepis Co., Ltd., v. Regeneron Pharmaceuticals, Inc., IPR2025-00176 (Apr. 23, 2025) Exhibit

Celltrion Redacted PI Decision, 24-md-3103, Dkt. 248 (N.D.W. Va.) Exhibit

Celltrion’s Reply in Support of Celltrion’s Motion for Status Conference, 24-md-3103, Dkt. 504 (Fed. Cir.) Exhibit

Mylan Redacted Trial Decision, 22-cv-61, Dkt. 692 (N.D.W. Va.) Exhibit

Patent Owner's Discretionary Denial Brief RESPONSE

SB Appeal Decision, 24-1965, Dkt. 76 (Fed. Cir.) Exhibit

Notice: Extending Deadline for Discretion Briefing NOTICE

Formycon Redacted PI Decision, 24-md-3103, Dkt. 247 (N.D.W. Va.) Exhibit

Celltrion Appeal Decision, 24-2058, Dkt. 62 (Fed. Cir.) Exhibit

Formycon Appeal Decision, 24-2009, Dkt. 67 (Fed. Cir.) Exhibit

Regeneron Pharmaceuticals, Inc.’s Response to Defendant Samsung Bioepis Co., Ltd.’s Motion for Entry of Scheduling Order Pursuant to Rule 16 or, in the Alternative, a Status Conference, 24-md-3103, Dkt. 483 (N.D.W. Va.) Exhibit

SB Redacted PI Decision, 24-md-3103, Dkt. 194 (N.D.W. Va.) Exhibit

Celltrion’s Opening Appeal Brief, 24-2058, Dkt. 25 (Fed. Cir.) Exhibit

Exhibit A, Samsung Bioepis’s Proposed Schedule, 24-md-3103, Dkt. 478-1 (N.D.W. Va.) Exhibit

Notice: Notice filing date accorded NOTICE

Notice: Mandatory Notice NOTICE

Notice: Power of Attorney NOTICE

EX1001 - US 11,084,865 B2 Exhibit

EX1006 - 16_739559 File History (Full) Exhibit

EX1041 - Mahler (2005) Exhibit

EX1017 - Wulff (2002) Exhibit

EX1005 - Sigl (WO2017129685A1) Exhibit

EX1003 - Tessier CV Exhibit

EX1040 - Mimura (2000) Exhibit

EX1044 - Wiegand (U.S. Publication No. 2005_0175610) Exhibit

EX1030 - Ferrara (2005) Exhibit

EX1045 - Yumioka (2009) Exhibit

EX1012 - 13_914996 File History (Excerpts) Exhibit

EX1032 - Jefferis (2005) Exhibit

EX1007 - 16_582486 File History (Full) Exhibit

EX1013 - 13_329770 File History (Excerpts) Exhibit

EX1011 - 14_330096 File History (Excerpts) Exhibit

Petition: as filed PETITION

EX1020 - Andya (2003) Exhibit

EX1037 - Panka (1997) Exhibit

EX1047 - Gandhi (2017) Exhibit