US 11084865

US Patent 11,084,865, titled "VEGF antagonist formulations suitable for intravitreal administration," was issued to Regeneron Pharmaceuticals Inc. on August 10, 2021, from an application filed on January 10, 2020. The inventors are Eric Furfine, Daniel Dix, Kenneth Graham, and Kelly Frye.

Abstract:
The patent describes ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist that are suitable for intravitreal administration to the eye. These formulations include both stable liquid formulations and lyophilizable formulations. The preferred protein antagonist has an amino acid sequence of SEQ ID NO:4.

Plain-Language Overview of Independent Claims:

• Claim 1 (Vial containing formulation): This claim describes a vial that holds an ophthalmic formulation intended for injection into the vitreous of the eye. The formulation contains a VEGF antagonist fusion protein (specifically one that is glycosylated and includes amino acids 27-457 of SEQ ID NO:4), an organic co-solvent, a buffer, and a stabilizing agent. A key characteristic is the stability of the VEGF antagonist, with at least 98% of it retaining its native form after two months of storage at 5° C., as measured by size exclusion chromatography.

• Claim 26 (Pre-filled syringe containing formulation): Similar to Claim 1, this claim describes a pre-filled syringe containing an ophthalmic formulation for intravitreal administration. The formulation again includes a glycosylated VEGF antagonist fusion protein (amino acids 27-457 of SEQ ID NO:4), an organic co-solvent, a buffer, and a stabilizing agent. Like the vial, the formulation in the syringe must maintain the VEGF antagonist in at least 98% native conformation after two months of storage at 5° C.

• Claim 51 (Specific ophthalmic formulation): This claim defines a particular ophthalmic formulation suitable for intravitreal administration. It specifies the concentration of the glycosylated VEGF antagonist fusion protein (40 mg/ml, comprising amino acids 27-457 of SEQ ID NO:4), the organic co-solvent (0.03% to 0.1% polysorbate), the buffer (5-40 mM sodium phosphate buffer, pH between 5.8-7.0), and includes sucrose as a stabilizing agent. This formulation also requires the VEGF antagonist to be at least 98% in its native conformation after two months of storage at 5° C.

CAFC 2026 Dockets:
While the Google Patents link for US11084865 lists several CAFC cases filed in 2024 and mentions litigation activity continuing into 2025 (e.g., appeals upheld in January and March 2025, and PTAB IPR denials in June 2025), a direct search for "CAFC 2026 dockets US11084865" did not yield specific 2026 docket numbers for the Federal Circuit. However, it is evident that the patent has been extensively litigated. Regeneron has asserted the patent in BPCIA litigations against multiple biosimilar manufacturers, including Mylan, Samsung Bioepis, Celltrion, Formycon, and Amgen. There have been preliminary injunctions granted and upheld on appeal against Samsung Bioepis, Formycon, and Celltrion, preventing their biosimilar launches, with these decisions occurring in early 2025. PTAB panels have also denied institution of several inter partes review (IPR) petitions against the patent, citing advanced parallel district court proceedings. Fresenius Kabi filed IPR petitions against claims of this patent in July 2025. The ongoing nature of this litigation suggests that proceedings related to this patent may extend into 2026, even if specific CAFC 2026 docket numbers are not explicitly returned by the search.