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District Court Finds Regeneron Eylea® (aflibercept) Formulation Patent Valid and Infringed by Mylan, but Infringed MOT Patent Claims Invalid

Dec 27, 2023

Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents.  The Court published a short form judgment and concluded that:

  • Mylan infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the formulation patent no. 11,084,865;
  • Mylan would induce infringement of claims 6 and 25 of method of treatment patent no. 11,253,572 and claims 11 and 19 of patent no. 10,888,601;
  • the relevant claims of ‘865 were valid (Mylan’s arguments they were invalid for lack of novelty, inventive step, written description, enablement or indefiniteness failed);
  • claims 6 and 25 of ‘572 and claims 11 and 19 of ‘601 lacked inventive step.

The valid ‘865 patent expires in the US on 14 June 2027.  Detailed reasons for the findings are under seal.  Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®.  On 27 April 2023, Regeneron filed a stipulation to narrow the case to the above three patents.  Regeneron’s Complaint asserts that the FDA notified Mylan of acceptance of its aBLA on 28 December 2021.