Fresenius Kabi SwissBioSim GmbH et al. vs. Regeneron Pharmaceuticals, Inc.

Explore the PTAB proceeding IPR2025-01268 filed by Fresenius Kabi SwissBioSim GmbH et al. on 2025-07-14. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-01268

Filing Date

2025-07-14

Accorded Filing Date

2025-07-14

Institution Decision Date

2025-11-20

Last Modified Date

2026-03-09

Proceeding Type

IPR

Termination Date

2025-11-20

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Fresenius Kabi SwissBioSim GmbH et al.

Represented By

Aly, Imronet 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

Notice: refund approved NOTICE

2026-03-09 FILING PARTY: BOARD

Download

Petitioner's Request for Refund of Post-Institution Fees OTHER

2026-02-26 FILING PARTY: PETITIONER

Download

Order Denying Director Review of Institution Decision REHEARING

2026-02-10 FILING PARTY: BOARD

Download

Authorized Response to Director Review Request OTHER

2026-01-06 FILING PARTY: PATENT OWNER

Download

3103

Patent Owner’s request to submit a response by January 6, 2026 granted Exhibit

2025-12-22 FILING PARTY: BOARD

Download

Fresenius Kabi SwissBioSim GmbH et al. vs. Regeneron Pharmaceuticals, Inc.

Proceeding Overview

Parties & Counsel

Petitioner

Fresenius Kabi SwissBioSim GmbH et al.

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

Petitioner's Request for Refund of Post-Institution Fees OTHER

Order Denying Director Review of Institution Decision REHEARING

Authorized Response to Director Review Request OTHER

Patent Owner’s request to submit a response by January 6, 2026 granted Exhibit

Ex. 3102 Counsel Email for Authorized response Exhibit

Petitioner's Request for Director's Review REQUEST

Director Discretionary Decision: Deny RESPONSE

Petitioner's Sur-Reply in Opposition to Patent Owner's Request for Discretionary Denial OTHER

Ex. 1012 Exhibit

Patent Owner's Reply in Support of Discretionary Denial OTHER

Scheduling Order, Case No. MDL 24-md-3103, ECF No. 663 Exhibit

Email Correspondence 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) (“Fast”) Exhibit

U.S. Patent Application Pub. No. 2006/0058234 A1 (“Daly”) Exhibit

W. Wang, Protein Aggregation and Its Inhibition in Biopharmaceutics, 289 INT. J. PHARM. 1 (2005) (“Wang 2005”) Exhibit

M.R. Marmour, Retinal detachment from hyperosmotic intravitreal injection, 18(12) INVEST OPHTHALMOL VIS SCI. 1237 (1979) (“Marmour ”) Exhibit

Thomas et al., Comparative Effectiveness of Aflibercept for the Treatment of Patients with Neovascular Age-Related Macular Degeneration, 7 CLINICAL OPHTHALMOLOGY 495 (2013) (“Thomas”) Exhibit

International Publication No. WO 2005/102303 A2 (“Peyman”) Exhibit

Excerpts of File History of U.S. Patent No. 11,084,865 Exhibit

International Publication No. WO 00/75319 (“WO 00/75319”) Exhibit

J. Gaudreault et al., Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration, 46(2) INVEST OPHTHALMOL VIS SCI. 726 (2005) (“Gaudreault”) Exhibit

Regeneron's Preliminary Patent Owner Response (IPR2025-01268) POPR

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

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

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

Zaltrap® Label Exhibit

Petitioner's Opposition to Patent Owner's Request for Discretionary Denial RESPONSE

Ex. 1010 Exhibit

Ex. 1011 Exhibit

Ex. 1009 Exhibit

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

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

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

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

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

Email from D. Berl to S. Gibson re Scheduling Conference (Sept. 12, 2025) Exhibit

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

Patent Owner's Discretionary Denial Brief RESPONSE

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

Fresenius, Fresenius to Expand Biopharma Portfolio with a New Licensing Agreement to Commercialize a Proposed Aflibercept Biosimilar (Dec. 20, 2024), https://www.fresenius.com/node/6982 Exhibit

Notice: Power of Attorney NOTICE

Notice: Mandatory Notice NOTICE

Notice: Notice filing date accorded NOTICE

Ex. 1004 Exhibit

Ex. 1006 Exhibit

Ex. 1002 Exhibit

Ex. 1001 Exhibit

Ex. 1007 Exhibit

Ex. 1003 Exhibit

Ex. 1008 Exhibit

Petitioner Fresenius Kabi SwissBiosim, GmBH Power of Attorney NOTICE

Fresenius Kabi SwissBiosim, GmBH Petition for IPR of USP11,084,865 PETITION

Ex. 1005 Exhibit