2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology.
The fight over proposed Enbrel
® (etanercept) biosimilar Erelzi
certiorari requesting review of the judgement of the Federal Circuit on whether:
[a] patent owner [may] avoid the rule against double patenting by buying all of the substantial rights to a second, later-expiring patent for essentially the same invention, so long as the seller retains nominal ownership and a theoretical secondary right to sue for infringement?
Petition at i. In July 2020, the Federal Circuit considered Sandoz’s arguments that two patents covering Immunex Corp.’s (“Immunex”) Enbrel were invalid for obviousness-type double patenting. The Federal Circuit concluded that the patents-at-issue were not owned by Immunex, and therefore not subject to the alleged obviousness-type double patenting defect.