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

Explore the PTAB proceeding IPR2025-01269 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

IPR2025-01269

Filing Date

2025-07-14

Accorded Filing Date

2025-07-14

Institution Decision Date

2026-01-09

Last Modified Date

2026-03-09

Proceeding Type

IPR

Termination Date

2026-01-09

Trial Status

Institution Denied

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 16159282

Respondent Patent Number 10828345

External Links

Espacenet

Google Patents

Respondent Inventor George D. Yancopoulos

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

Institution Decision: Deny DECISION

2026-01-09 FILING PARTY: BOARD

Download

Director Discretionary Decision: Refer RESPONSE

2025-11-20 FILING PARTY: BOARD

Download

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

2025-11-05 FILING PARTY: PETITIONER

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

Institution Decision: Deny DECISION

Director Discretionary Decision: Refer RESPONSE

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

Patent Owner's Reply in Support of Discretionary Denial OTHER

Email Correspondence Exhibit

Barbazetto et al., Dosing Regimen and the Frequency of Macular Hemorrhages in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab, 30 RETINA 1376 (2010). Exhibit

U.S. Provisional Application No. 61/432,245 Exhibit

Eylea Label (November 18, 2011) Exhibit

SUSTAIN - Study of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (Dec. 09, 2010), https://www.clinicaltrials.gov/study/ NCT00331864?tab=history&a=10#version-content-panel Exhibit

Regeneron's Preliminary Patent Owner Response (IPR2025-01269) POPR

Expert Declaration of Dr. Neil M. Bressler in Support of Patent Owner Preliminary Response. Exhibit

U.S. Provisional Application No. 61/561,957 Exhibit

Prospective OCT Study with Lucentis for Neovascular AMD (PrONTO study), NCT00344227, ClinicalTrials.gov (June 23, 2006), https://clinicaltrials.gov/study/ NCT00344227?tab=history&a=1#version-content-panel Exhibit

Curriculum Vitae of Dr. Neil M. Bressler, M.D. Exhibit

G.L. Skuta et al, Retina And Vitreous 72-73, 109-114, 121, 128-29 (Section 12, 2009) Exhibit

MACUGEN® Prescribing Information (2006) Exhibit

N. M. Bressler, Antiangiogenic Approaches to Age-Related Macular Degeneration Today, 116 AM. ACAD. OPHTHALMOLOGY S15 (2009) Exhibit

C.D. Regillo et al., Randomized, Double-Masked, ShamControlled Clinical Trial of Ranibizumab for Neovascular Age-Related Macular Degeneration: PIER Study Year 1, 145 AM. J. OPHTHALMOLOGY 145(2): 239-248 (2008) Exhibit

P.J. Rosenfeld et al., Ranibizumab for Neovascular Age Related Macular Degeneration, 355 N. ENG. J. MED. 1419 (2006) Exhibit

A.P. Adamis, Angiogenesis and Ophthalmic Disease, 3 ANGIOGENESIS 9 (1999) Exhibit

U.S. Provisional Application No. 61/434,836 Exhibit

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

Ex. 1057 Exhibit

Ex. 1056 Exhibit

EX2001 - 16159282 File Certified - Part 6 of 6 Exhibit

EX2001 - 16159282 File Certified - Part 4 of 6 Exhibit

EX2005 - Regeneron - the Company that Trump claims cured his Covid Exhibit

EX2002 - Compare Record History ver 9-10 2009-04-28 NCT00509795 Exhibit

EX2006 - Trump calls coronavirus treatment he received a cure Exhibit

EX2001 - 16159282 File Certified - Part 1 of 6 Exhibit

EX2004 - Donald Trump Remarks Transcript October 7th Exhibit

EX2003 - NCT-795 as submitted in App. No. 14-972,560 Exhibit

EX2001 - 16159282 File Certified - Part 3 of 6 Exhibit

EX2001 - 16159282 File Certified - Part 5 of 6 Exhibit

EX2001 - 16159282 File Certified - Part 2 of 6 Exhibit

Patent Owner's Discretionary Denial Brief RESPONSE

Notice: Power of Attorney NOTICE

Notice: Mandatory Notice NOTICE

Notice: Notice filing date accorded NOTICE

Ex. 1027 Exhibit

Ex. 1007 Exhibit

Ex. 1040 Exhibit

Ex. 1009 Exhibit

Ex. 1004 Exhibit

Ex. 1012 Exhibit

Ex. 1011 Exhibit

Ex. 1013 Exhibit

Ex. 1026 Exhibit

Ex. 1032 Exhibit

Ex. 1045 Exhibit

Ex. 1053 Exhibit

Ex. 1028 Exhibit

Ex. 1003 Exhibit

Ex. 1050 Exhibit

Ex. 1018 Exhibit

Ex. 1022 Exhibit

Ex. 1038 Exhibit

Ex. 1043 Exhibit

Ex. 1005 Exhibit

Ex. 1008 Exhibit

Ex. 1037 Exhibit

Ex. 1020 Exhibit

Ex. 1051_Part 2 Exhibit