Fresenius Kabi SwissBioSim GmbH et al. vs Regeneron Pharmaceuticals, Inc. - IPR2025-01268

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

Case Details

Proceeding Number: IPR2025-01268
Filing Date: Jul 14, 2025
Petitioner: Fresenius Kabi SwissBioSim GmbH et al.
Respondent: Regeneron Pharmaceuticals, Inc.
Status: Pending
Respondent Application Number: 16739559
Respondent Tech Center: 1600
Respondent Patent Number: 11084865

Proceeding Decision New

Decision documents related to this case provide insights into the outcomes of proceedings. These documents are crucial for understanding the legal determinations and implications for the parties involved.

Document Name	Filing Date	Category	Filing Party
Mylan Redacted Trial Decision, 22-cv-61, Dkt. 692 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
SB Redacted PI Decision, 24-md-3103, Dkt. 194 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Formycon Redacted PI Decision, 24-md-3103, Dkt. 247 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Celltrion Redacted PI Decision, 24-md-3103, Dkt. 248 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
SB Appeal Decision, 24-1965, Dkt. 76 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Formycon Appeal Decision, 24-2009, Dkt. 67 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Celltrion Appeal Decision, 24-2058, Dkt. 62 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.

Show Exhibit Documents

Document Name	Filing Date	Category	Filing Party
Alert me when new update on this case
Regeneron's Preliminary Patent Owner Response (IPR2025-01268)	Oct 24, 2025	PAPER	PATENT OWNER
Zaltrap® Label	Oct 24, 2025	EXHIBIT	PATENT OWNER
Regeneron v. Mylan, 22-cv-61, Trial Transcript (Public Excerpts) (N.D.W. Va.)	Oct 24, 2025	EXHIBIT	PATENT OWNER
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”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
Regeneron v. Mylan, 22-cv-61, Trial Ex. DTX-3619A, Fusion Proteins Disclosed in Papadopoulos	Oct 24, 2025	EXHIBIT	PATENT OWNER
International Publication No. WO 00/75319 (“WO 00/75319”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
U.S. Patent Application Pub. No. 2006/0058234 A1 (“Daly”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
W. Wang, Protein Aggregation and Its Inhibition in Biopharmaceutics, 289 INT. J. PHARM. 1 (2005) (“Wang 2005”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
J. Gaudreault et al., Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration, 46(2) INVEST OPHTHALMOL VIS SCI. 726 (2005) (“Gaudreault”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
Thomas et al., Comparative Effectiveness of Aflibercept for the Treatment of Patients with Neovascular Age-Related Macular Degeneration, 7 CLINICAL OPHTHALMOLOGY 495 (2013) (“Thomas”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
International Publication No. WO 2005/102303 A2 (“Peyman”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
M.R. Marmour, Retinal detachment from hyperosmotic intravitreal injection, 18(12) INVEST OPHTHALMOL VIS SCI. 1237 (1979) (“Marmour ”)	Oct 24, 2025	EXHIBIT	PATENT OWNER
Declaration of Kenneth S. Graham, dated April 18, 2024	Oct 24, 2025	EXHIBIT	PATENT OWNER
Excerpts of File History of U.S. Patent No. 11,084,865	Oct 24, 2025	EXHIBIT	PATENT OWNER
Petitioner's Opposition to Patent Owner's Request for Discretionary Denial	Oct 23, 2025	PAPER	PETITIONER
Ex. 1009	Oct 23, 2025	EXHIBIT	PETITIONER
Ex. 1010	Oct 23, 2025	EXHIBIT	PETITIONER
Ex. 1011	Oct 23, 2025	EXHIBIT	PETITIONER
Patent Owner's Discretionary Denial Brief	Sep 23, 2025	PAPER	PATENT OWNER
Mylan Redacted Trial Decision, 22-cv-61, Dkt. 692 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
SB Redacted PI Decision, 24-md-3103, Dkt. 194 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Formycon Redacted PI Decision, 24-md-3103, Dkt. 247 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Celltrion Redacted PI Decision, 24-md-3103, Dkt. 248 (N.D.W. Va.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
SB Appeal Decision, 24-1965, Dkt. 76 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Formycon Appeal Decision, 24-2009, Dkt. 67 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Celltrion Appeal Decision, 24-2058, Dkt. 62 (Fed. Cir.)	Sep 23, 2025	EXHIBIT	PATENT OWNER
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	Sep 23, 2025	EXHIBIT	PATENT OWNER
Email from D. Berl to S. Gibson re Scheduling Conference (Sept. 12, 2025)	Sep 23, 2025	EXHIBIT	PATENT OWNER
Notice: Power of Attorney	Aug 4, 2025	PAPER	PATENT OWNER
Notice: Mandatory Notice	Aug 4, 2025	PAPER	PATENT OWNER
Notice: Notice filing date accorded	Jul 23, 2025	PAPER	BOARD
Petitioner Fresenius Kabi SwissBiosim, GmBH Power of Attorney	Jul 14, 2025	PAPER	PETITIONER
Fresenius Kabi SwissBiosim, GmBH Petition for IPR of USP11,084,865	Jul 14, 2025	PAPER	PETITIONER
Ex. 1001	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1002	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1003	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1004	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1005	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1006	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1007	Jul 14, 2025	EXHIBIT	PETITIONER
Ex. 1008	Jul 14, 2025	EXHIBIT	PETITIONER