SCOTUS allows early notice from biosimilar applicants
The US Supreme Court has ruled that biosimilar applicants may provide notice to the manufacturer before obtaining a licence from the Food and Drug Administration (FDA) for their biosimilars.
Today, June 12, the court handed down its opinion in the dispute between Amgen and Sandoz, partly vacating and remanding the case for further proceedings.
At issue in the dispute was whether a 180-day notice of commercial marketing must be given to the reference product sponsor (RPS) after the biosimilar product is licensed by the FDA.
Amgen claimed that a biosimilar applicant must wait until its product is approved by the FDA before giving notice, while Sandoz argued that notice may be given prior to approval.
Backing Sandoz, the Supreme Court said that an applicant may provide notice before obtaining a licence.
The US Court of Appeals for the Federal Circuit had previously ruled that a biosimilar applicant must wait until its drug has been approved before giving the RPS 180 days’ notice of the biosimilar product’s launch.
The case between the two parties arose after Amgen and Sandoz disagreed over the interpretation of the Biologics Price Competition and Innovation Act (BPCIA).
Amgen and Sandoz claimed different interpretations of the statute, which states 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.
Sandoz claimed that the wording “shall” means that providing the information is optional, as opposed to Amgen, which interpreted the meaning as mandatory.
Amgen had also asked the Supreme Court to clarify whether a biosimilar applicant has to provide the information and, if it does not, whether the RPS’s only option is to launch a declaratory judgment and/or a patent infringement action.
According to the court, no injunction is available under federal law to force compliance with the ‘patent dance’, but the court remanded the issue for the Federal Circuit to determine whether a state law injunction is available.
The Supreme Court agreed with the Federal Circuit that an injunction under federal law is not available, although it clarified that it did so “for slightly different reasons than those provided by the court below”.
“The flaw in the Federal Circuit’s reasoning is that Sandoz’s failure to disclose its application and manufacturing information was not an act of artificial infringement, and thus was not remediable under section 271(e)(4),” said the Supreme Court in its opinion.
The court added: “Submitting an application constitutes an act of artificial infringement.”
In the opinion, the Supreme Court said that because Sandoz had fully complied with the BPCIA when it first gave notice in July 2014, the Federal Circuit erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio (filgrastim-sndz) until 180 days after licensure.
Amgen’s Neupogen (filgrastim) has been marketed since 1991; in May 2014, Sandoz filed an application at the FDA for approval of a biosimilar under the brand name Zarxio.
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