State law can’t compel ‘patent dance’, rules Federal Circuit

State law cannot force drug makers to participate in the ‘patent dance’ provided for by the Biologics Price Competition and Innovation Act (BPCIA).

Yesterday, December 14, the US Court of Appeals for the Federal Circuit handed down its decision in Amgen v Sandoz, after the dispute had been remanded by the US Supreme Court.

In June, the Supreme Court ruled that biosimilar applicants may provide notice to the manufacturer before obtaining a licence from the Food and Drug Administration (FDA) for their biosimilars.

Amgen and Sandoz disagreed over the interpretation of the BPCIA—the statute says that a biosimilar applicant “shall” provide its application and manufacturing information to the reference product sponsor within 20 days of filing its biosimilar drug application (section 262(l)(2)(A)).

Amgen had also requested that the Supreme Court clarify whether a biosimilar applicant has to provide the information and, if it does not, whether the reference product sponsor’s only option is to launch a declaratory judgment and/or a patent infringement action.

The Supreme Court ruled that no injunction is available under federal law to force compliance with the ‘patent dance’, but it asked the Federal Circuit to determine whether a state law injunction is available.

In September, the US Department of Justice voiced its opinion in the clash, arguing that the BPCIA pre-empts additional remedies under state law.

And the Federal Circuit agreed, deciding that a state law injunction is not available in these circumstances.

In July, the court re-opened the appeal and both parties responded with a brief which addressed the question of whether Sandoz waived any pre-emption defence it had to Amgen’s state law claims.

In a unanimous decision, the Federal Circuit ruled that Sandoz didn’t waive its pre-emption defence to Amgen’s state law claims.

The court also concluded that the BPCIA pre-empts state law remedies for an applicant’s failure to comply with section 262(l)(2)(A).

Circuit Judge Alan Lourie, on behalf of the court, said: “As discussed supra, the pre-emption analysis here demonstrates that Amgen’s state law claims conflict with the BPCIA and intrude upon a field, biosimilar patent litigation, that Congress reserved for the federal government.”

Irena Royzman, co-chair of the biotechnology practice at Patterson Belknap Webb & Tyler, said the decision preserves the status quo and may have limited impact in most cases.

“It is now clear that innovators have no recourse in federal or state court to enforce the BPCIA’s disclosure requirements and that the subsequent steps of the patent dance can therefore also be bypassed,” she stated.

However, in the long term, she believes that biosimilar makers will follow the ‘patent dance’ in the majority of cases.

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