Friday, October 1 2021   \  Published by Kluwer Patent Blog.

U.S. District Court Adopts Expansive Definition of aBLA “Submitter”

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 "artifical act of infringement" for which the biologic's patent owner may file suit.  Read more

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