On November 8, Regeneron Pharmaceuticals filed a patent infringement complaint against Celltrion in the U.S. District Court for the Northern District of West Virginia. The complaint accuses Celltrion of infringing on thirty-eight patents related to Regeneron’s EYLEA (aflibercept) under the Biologics Price Competition and Innovation Act (BPCIA). According to the complaint, the alleged infringements are tied to Celltrion’s submission of an abbreviated Biologics License Application (aBLA) for CT-P42 – a proposed biosimilar of EYLEA – and Celltrion’s provision of Notice of Commercial Marketing with respect to the same product.
EYLEA, a medication for different eye diseases, notably ager-related macular degradation, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy, has been a key product for Regeneron. This lawsuit emphasizes Regeneron’s determination to protect its rights and interests in what is undoubtedly one of its flagship products.
The introduction of biosimilars into the market has prompted significant patent litigation in the pharmaceutical sector in recent years. This case offers another example of the complexities of intellectual property rights and competition in the pharmaceutical industry where large-scale investments and public health interests are often at stake.
Read full details of the lawsuit on JD Supra.