Sandoz Petitions Supreme Court to Rule on Biosimilars

Posted 17 February 2016 By Zachary Brennan


Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market.

The petition for the Supreme Court’s review 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 because of a Federal Circuit ruling on a provision in the Biologics Price Competition and Innovation Act (BPCIA), which was signed into law in 2010 as part of the Affordable Care Act.

“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 argues.

Sandoz, the biosimilar and generic arm of Novartis, claims 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.”

“The Federal Circuit’s erroneous interpretation will delay the availability of all biosimilars for 180 days more than Congress intended—even if the sponsor has no valid patent claims and even if the sponsor already has had the opportunity to pursue any valid claims,” Sandoz says.

The Sandoz petition comes as the Federal Circuit in October declined to rehear its decision on the notice provision.

Amgen v. Apotex

Amgen is also dealing with another lawsuit against Apotex, which previously argued that by complying with the manufacturing and patent information exchanges, which are part of the so-called “patent dance” established by the BPCIA, Apotex was allowed to opt out of providing Amgen with the 180-day notice of marketing.

A little more than a month ago, the Generic Pharmaceutical Association’s Biosimilars Council sided with Apotex, arguing that Congress never meant for the 180-day notice provision to add six months of exclusivity to biologics.

In its ruling, the Federal Circuit said that the patent dance is optional, though 180-days’ pre-marketing notice can only be applied after a 351(k) application has been approved by FDA.

On 4 February, Amgen filed its reply brief, which is currently on appeal before the Federal Circuit. In it, Amgen noted that the 180-day period is designed to allow the reference product sponsor that the biosimilar is based on, a discrete period in which to seek preliminary injunctive relief.

“Apotex cannot avoid the requirement of a statute by the specifics of this particular case. Sandoz, too, touted the peculiarities of its own position as a reason not to give 180 days’ notice, but the panel majority rejected this: ‘A statute must be interpreted as it is enacted, not especially in light of particular, untypical facts of a given case,’” Amgen said.

“The 180-day notice period would apply to Apotex even if it were right that Amgen had no additional patents on which to seek a preliminary injunction. It is, as this Court held in Amgen v. Sandoz, a standalone provision,” Amgen said.

Industry group BIO also filed an amicus curiae brief Tuesday in support of Amgen, noting: “The BPCIA’s provision requiring biosimilar applicants to provide notice of commercial marketing following FDA approval is an integral part of the balance achieved by the BPCIA, and it furthers Congress’ goal of ensuring that the parties can resolve any patent disputes prior to the launch of the biosimilar product. The commercial marketing notice provision cannot meaningfully serve its intended function, however, if, as Apotex argues in this case, applicants are in many circumstances free to ignore it.”

Next Steps

According to the Big Molecule Watch blog, the Supreme Court is likely to rule on the Sandoz petition before its summer recess, but if it grants the case, it likely won’t hear it until next fall and likely won’t make a decision until 2017.

“Under the Supreme Court’s rules, it is conceivable that Amgen could file a ‘conditional cross-petition’ – a petition asking that, if (and only if) the Court takes up Sandoz’s petition, it also take up the issue on which Sandoz won and Amgen lost in the Federal Circuit: whether the BPCIA’s information disclosure provisions are ‘mandatory.’ Conditional cross-petitions are rarely granted; if the Court takes such a cross-petition, it generally does to ensure that its review of an issue is not unduly circumscribed by the question as drafted by the petitioner,” the blog noted.

Sandoz Petition for a Writ Certiorari

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Categories: Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

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