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District Court Denies Regeneron’s Motion For Preliminary Injunction To Block Amgen’s Eylea Biosimilar
10/22/2024On September 23, 2024, Judge Kleeh of the Northern District of West Virginia denied Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) motion for a preliminary injunction against Amgen Inc. (“Amgen”) related to Amgen’s filing of an abbreviated Biologics License Application (“BLA”) seeking authorization to commercialize “ABP 938,” a biosimilar version of Regeneron’s Eylea.
Regeneron filed a patent infringement action against Amgen, alleging that Amgen’s ABP 938 would infringe U.S. Patent No. 11,084,865, (the “ʼ865 patent”) directed to an aflibercept formulation useful for treating Age-Related Macular Degeneration (“AMD”). In denying Regeneron’s motion for a preliminary injunction, the court found that Regeneron did not demonstrate a reasonable likelihood of success on the merits of its patent infringement claim.
The central dispute was whether the claims of the ʼ865 patent required the “VEGF antagonist” and the “buffer” to be separate and distinct components of the formulation. The court concluded that the claims required these components to be separate. This conclusion was based largely on the intrinsic evidence, including (1) the express language of the claims, which listed the “VEGF antagonist” and “buffer” separately, thus creating a presumption that they are distinct components; (2) the specification, which consistently described the “VEGF antagonist” and “buffer” as separate components in every example and embodiment; and (3) the dependent claims, which used different units of measurement for the “VEGF antagonist” and “buffer.” The construction was also consistent with the court’s prior rulings in related cases.
Given the court’s construction of the claims, Amgen's product, ABP 938, which does not contain a separate buffer, raised a substantial question of noninfringement that did not warrant a preliminary injunction. Although the court did not explicitly address the other three factors (irreparable harm, balance of hardships, and public interest) in detail, it noted that the failure to demonstrate a likelihood of success on the merits outweighed any other basis for preliminary injunctive relief.
Regeneron also argued that Amgen’s product infringed under the Doctrine of Equivalents (“DOE”). However, the court found that Regeneron’s DOE theory would vitiate the “buffer” limitation by eliminating it entirely, which is not permissible.
The ʼ865 patent has been the subject of other patent infringement lawsuits against Mylan and Biocon Biologics Inc. (“Biocon”); Samsung Bioepis Co., Ltd. (“Samsung”); Celltrion, Inc. (“Celltrion”); and Formycon AG (“Formycon”). Following a bench trial in June 2023, the court granted a permanent injunction against Mylan and Biocon. The Court also granted preliminary injunctions against Samsung, Celltrion, and Formycon.
