Samsung Bioepis Co., Ltd. vs. Regeneron Pharmaceuticals, Inc.

Explore the PTAB proceeding IPR2025-00176 filed by Samsung Bioepis Co., Ltd. on 2024-11-20. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00176

Filing Date

2024-11-20

Accorded Filing Date

2024-11-20

Institution Decision Date

2025-06-02

Last Modified Date

2025-08-18

Proceeding Type

IPR

Termination Date

2025-06-02

Trial Status

Institution Denied

Parties & Counsel

Petitioner

Samsung Bioepis Co., Ltd.

Represented By

Nimrod, Raymondet 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

178

Notice: refund approved NOTICE

2025-08-18 FILING PARTY: BOARD

Download

Request for Refund OTHER

2025-08-15 FILING PARTY: PETITIONER

Download

Institution Decision: Deny DECISION

2025-06-02 FILING PARTY: BOARD

Download

2035

Email from D. Berl to District Court Exhibit

2025-05-07 FILING PARTY: PATENT OWNER

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PATENT OWNER’S SURREPLY IN SUPPORT OF PRELIMINARY RESPONSE OTHER

2025-05-07 FILING PARTY: PATENT OWNER

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Samsung Bioepis Co., Ltd. vs. Regeneron Pharmaceuticals, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Samsung Bioepis Co., Ltd.

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

Notice: refund approved NOTICE

Request for Refund OTHER

Institution Decision: Deny DECISION

Email from D. Berl to District Court Exhibit

PATENT OWNER’S SURREPLY IN SUPPORT OF PRELIMINARY RESPONSE OTHER

'992 IPR Decision Exhibit

Email regarding Updated Case Management Order Exhibit

First District Court Complaint Exhibit

Proposed Case Management Order Exhibit

'681 IPR Decision Exhibit

'601 Disclaimer Exhibit

'601 IPR Decision Exhibit

Summons in District Court Exhibit

'601 IPR Decision Exhibit

ID in Celltrion '992 IPR Exhibit

Mylan Stipulation of Dismissal Exhibit

Second District Court Complaint Exhibit

Email re Proposed Scheduling Order Exhibit

'601 Disclaimer Exhibit

Reply to POPR OTHER

'572 Disclaimer Exhibit

Regeneron May 10 Submission Exhibit

'992 Disclaimer Exhibit

Motion for Entry of Scheduling Order Exhibit

'572 IPR Decision Exhibit

'601 Disclaimer Exhibit

ORDER Conduct of the Proceeding Granting Request for Additional Briefing ORDER

Ex. 3001 Exhibit

D. Ghate & H.F. Edelhauser, Ocular Drug Delivery (2006) Exhibit

Regeneron Pharmaceuticals, Inc.’s Response, 24-md-3103, Dkt. 483 (N.D.W. Va.) Exhibit

OPUVIZ™ Label Exhibit

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

Stedmans Medical Dictionary 265360 Exhibit

N. Ferrara et al., Development of Ranibizumab, an Anti–Vascular Endothelial Growth Factor Antigen Binding Fragment, as Therapy for Neovascular Age-Related Macular Degeneration (2006) Exhibit

T.L. Jackson et al., Human Retinal Molecular Weight Exclusion Limit and Estimate of Species Variation (2003) Exhibit

J.A. Marinaro et al., O-glycosylation Delays the Clearance of Human IGF-Binding Protein-6 from the Circulation (2000) Exhibit

FDA Guidance for Industry, Stability Testing Exhibit

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

W. Wang, Instability, Stabilization, and Formulation of Liquid Protein Pharmaceuticals (1999) Exhibit

U.S. Patent Application Publication No. 2003/0113316 Exhibit

U.S. Patent Application Publication No. 2001/0014326 Exhibit

WO 2006/047325 Exhibit

Eylea® Label Exhibit

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

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

N. Ferrara et al., Discovery and Development of Bevacizumab, an Anti-VEGF Antibody for Treating Cancer (2004) Exhibit

Regeneron's Preliminary Patent Owner Response (IPR2025-00176) POPR

R.L. Shields et al., High Resolution Mapping of the Binding Site on Human IgG1 for FcγRI, FcγRII, FcγRIII, and FcRn and Design of IgG1 Variants with Improved Binding to the FcγR* (2001) Exhibit

A.M. Sinclair & S. Elliott, Glycoengineering: The Effect of Glycosylation on the Properties of Therapeutic Proteins (2005) Exhibit

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

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

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

P.J. Rosenfeld et al., Maximum Tolerated Dose of a Humanized Anti–Vascular Endothelial Growth Factor Antibody Fragment for Treating Neovascular Age-Related Macular Degeneration (2005) Exhibit

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

Declaration of Kenneth S. Graham, dated April 18, 2024 Exhibit

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

W. Wang, Protein Aggregation and Its Inhibition in Biopharmaceutics (2005) Exhibit

Thomas et al., Comparative Effectiveness of Aflibercept for the Treatment of Patients with Neovascular Age-Related Macular Degeneration (2013) Exhibit

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

Regeneron v. Mylan, 22-cv-61, Trial Ex. DTX-3619A, Fusion Proteins Disclosed in Papadopoulos Exhibit

Notice: Updated Mandatory Notice NOTICE

Notice: Updated Power of Attorney NOTICE

Notice: Notice filing date accorded NOTICE

Notice : Power of Attorney NOTICE

Notice : Mandatory Notice NOTICE