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Supreme Court Rules for Biosimilar Applicants under the BPCIA

June 16, 2017

On June 12, 2017, the Supreme Court released a decision in Sandoz Inc. v. Amgen Inc., which involved a case emerging out of the Biologics Price Competition and Innovation Act.

 

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for biosimilar products of already licensed biological products (reference products) to FDA approval.

Under the Act, an applicant of a biosimilar product “shall provide” its application and manufacturing information to the manufacturer of the reference products within 20 days of the FDA notifying acceptance for review. Additionally, it requires an applicant give notice to the reference product manufacturer at least 180 days prior to commercially marketing the biosimilar.

The remedy available under the BPCIA for when an applicant fails to provide its application and manufacturing information or fails to complete a subsequent step is the ability for manufacturers to bring immediate action for declaratory-judgment based on infringement of relevant patents.

In the present case, Amgen sued Sandoz for patent infringement and asserted Sandoz engaged in “unlawful” conduct in violation of California’s unfair competition law because of Sandoz’s alleged violationsof the BPCIA in not providing or disclosing its application and manufacturing information. Amgen sought injunctions and Sandoz counterclaimed for declaratory judgments of patent invalidity, non-infringement, and for no violation of the BPCIA.

The Supreme Court was faced with two issues in this case. First, whether an injunction is available under Federal Law for alleged violations of the BPCIA. Second, whether an applicant may provide notice in regards to the 180 days prior to commercial marketing requirement before obtaining an FDA license.

The Supreme Court ruled for Sandoz on both accounts. First, the Court held that the section requiring an applicant to provide its application and manufacturing information is not enforceable by injunction under federal law, although the Supreme Court left it open to the Federal Circuit to decide on remand whether a state-law injunction is available. Second, the Court held that notice 180 days prior to commercial marketing can be given before obtaining an FDA license.


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