Tag Archives: patent holder

Patent Holders May Not Use Federal Law To Issue Injunctions Against Applicants For Biosimilar Products

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated process for the FDA to approve drugs that are biosimilar to already licensed biological products. The Act, in part, requires an applicant for a biosimilar product to provide its application and manufacturing information to the patent holder within 20 days of the date the FDA notifies the applicant... Read More >