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14 September 2017Americas

DoJ weighs in on Amgen v Sandoz biosimilar clash

The US Department of Justice (DoJ) has voiced its opinion on the biosimilar dispute between Amgen and Sandoz.

DoJ filed an amicus brief on Monday, September 11. It was unsealed the following day.

According to the DoJ, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) pre-empts additional remedies under state law.

In a highly-anticipated decision, handed down in June, the US 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 had also asked the Supreme Court to 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.

Under section 262(l)(2)(A) of the BPCIA, applicants are required to disclose their application and manufacturing process within 20 days of filing the biosimilar drug application.

The court held that no injunction is available under federal law to force compliance with the ‘patent dance’, because Congress had deliberately omitted injunctive relief from the BPCIA’s remedies for noncompliance with the provision.

However, the Supreme Court remanded the issue for the Federal Circuit to determine whether a state law injunction was available.

“Allowing additional state law remedies also would impair important objectives the BPCIA’s patent-related provisions are designed to achieve”, said the DoJ in its brief.

It added that “section 262(l) and other federal statutes occupy the field of federal patent litigation, precluding states from regulating the procedures concerning such litigation”.

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