Skip to content

Regeneron wins a patent ruling to extend Eylea protection but two other patents were deemed invalid. 

According to the US District Court for the Northern District of West Virginia, US, a Regeneron patent (#11,084,865) has been successfully defended for certain ophthalmic formulations of Eylea.  Regeneron sued Mylan in August 2022, arguing that a biosimilar of Eylea infringed certain intellectual property and this outcome for Regeneron will now extend Eylea’s commercial protection.  The biosimilar, from Viatris’ Mylan unit, was the first to file for an Eylea biosimilar in 2021 and the subsequent biosimilar was then sold by Viatris to Biocon Biologics in a $3.33 billion cash-and-stock deal.  Biocon’s biosimilar, termed “YESAFILI” has comparable efficacy, safety and quality to the reference product Eylea (aflibercept), which received marketing authorization approval from the European Medicines Agency (EMA) last year.


Yesafili (also previously referred to MYL-1701P) has been developed and authorized via the Centralised Procedure in the European Union under the Anatomical Therapeutic Chemical (ATC) classification system, as an ocular anti-neovascularisation agent.   Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.  In Eylea, the active pharmacologic agent, aflibercept, acts as a soluble decoy receptor that binds to VEGF-A and PlGF, and thereby inhibits the binding and activation of their cognate receptors VEGFR-1 and VEGFR-2, which are expressed on the surface of endothelial cells. Activation through VEGFR-1 and VEGFR-2 is associated with neovascularization and vascular permeability, while inhibition of activation by Eylea (aflibercept) has been demonstrated to reduce both processes, with clinical benefit in the indicated disorders.


Yesafili is indicated for adults for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).  In follow up to the court decision, Biocon Ltd stated that, “[in] the matter of Regeneron Pharmaceuticals, Inc. v Mylan Pharmaceuticals Inc. and Biocon Biologics Inc. (Case No. 22-061), the U.S. District Court for the Northern District of West Virginia issued a mixed decision pertaining to three of Regeneron’s patents purporting to cover certain formulations and methods of treatment relating to the ophthalmic product, EYLEA® (aflibercept) Injection. The court decided that certain claims of the method of treatment patents (U.S. Patent Nos. 10,888,601 and 11,253,572) were invalid, while certain claims of the formulation patent (U.S. Patent No. 11,084,865) were held valid and infringed.  Biocon Biologics is an innovation-driven company and will continue to aggressively pursue its mission of bringing high-quality affordable biosimilars to patients in the United States”.