US Supreme Court to Review Biosimilar ‘Patent Dance’

Regulatory NewsRegulatory News | 13 January 2017 |  By 

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole.

The decision to take up the issue has caught some by surprise, particularly as so few biosimilars have come to market in the US and because the Supreme Court in December declined to hear a similar dispute between Amgen and Apotex over what's known as the "patent dance" (see explanation below).

New York Law School professor Jacob Sherkow told Focus: “I'm surprised at the High Court's decision to take the Amgen v. Sandoz case. It's a strict matter of statutory interpretation; there's virtually no litigation in the area--less than five cases; the ink isn't even dry on the lower court decision; and I can't think of a compelling public interest in the outcome or a Constitutional principle at stake. I'm just really surprised. Perhaps the Court is going for low-hanging fruit since it's down a justice, but it's tough to tell.”

In early December, Ian Heath Gershengorn, acting US solicitor general and his deputies, wrote in an amicus brief to the Supreme Court in support of taking up the case: “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [Biologics Price Competition and Innovation Act of 2009] and the ability of aBLA [abbreviated biologic license application] applicants promptly to bring their biosimilars to the public. And because the provisions are integrally related, the Court should consider all of the questions presented together. Both the certiorari petition and conditional cross-petition therefore should be granted.”


The BPCIA establishes an expedited process for licensing “biosimilar” versions of licensed biologics. As part of that process, the BPCIA establishes a series of steps for the resolution of potential patent claims by the sponsor of the reference product and the biosimilar applicant, also known as the “patent dance.”

A section of that law says that a biosimilar applicant shall provide the sponsor of the reference biologic a copy of the biosimilar application and information about the product’s manufacturing processes. At issue is whether the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

Last February, Sandoz called on the Supreme Court to hear the case, which deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first biosimilar in the US, the product did not actually come to market until September 2015 because of a Federal Circuit ruling on a provision in the BPCIA.

“The Federal Circuit turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months,” Sandoz argued.

Sandoz, the biosimilar and generic arm of Novartis, also claimed in its petition that not only did it provide Amgen with more than 180 days’ notice of its intent to market Zarxio, giving Amgen time to bring suit (which it did) and seek a patent-based injunction (which it did not), but Amgen’s exclusivity period for Neupogen had expired, as Amgen “already had enjoyed 24 years of exclusivity.”



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