U.S. District Court Adopts Expansive Definition of aBLA “Submitter”
Submission of an abbreviated Biologics License Application (“aBLA”), under the Biosimilar Price Competition and Innovation Act of 2009 (“BPCIA”), for a biosimilar version of an already-approved biologic drug constitutes an “artificial act of infringement” for which the biologic’s patent owner may file suit.[1] In the recent AbbVie Inc. v. Alvotech hf.[2] decision, the district court…