SCOTUS Reverses Federal Circuit Court Decision in Sandoz v Amgen on 180-Day Rule

In a big win for Sandoz, the US Supreme Court ruled today that a manufacturer of a biosimilar product can provide a notice of commercial marketing either before or after FDA approval of the drug to the reference drug developer. The court also rejected the Circuit court’s 2-tier timing interpretation for the 180-day marketing notices to the FDA.

In its decision today, which was delivered by Justice Thomas on behalf of the Supreme Court, the court also said that there is no injunction available under federal law to force compliance with the patent dance, but it might be available under state law—a question that the Circuit Court could address.

The lawsuit filed by Amgen—which developed and markets filgrastim (Neupogen)—against Sandoz, which has developed the biosimilar filgrastim-sndz (Zarxio), states that Sandoz did not exchange patent and manufacturing information with Amgen about it’s biosimilar. Sandoz’s attorney Julia Pike, the company decided to forego the patent dance and tried to speed the process of resolving any patent issues related to marketing Zarxio.

“The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Carol Lynch, Global Head of Biopharmaceuticals, Sandoz, in a statement. “As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine. The results of this Supreme Court case reinforce that the work we are doing every day has meaning to the patients and customers we are here to help.”

The pharmacy benefit manager Express Scripts also expressed support for the federal court’s decision, saying that the ruling will allow affordable access to medicine. “At a time when the cost of complex biologic specialty drugs is growing at double-digit rates, payers need every tool in their arsenal to bring cost-effective solutions to market. Express Scripts continues to champion for a clear pathway to expand the appropriate use of biosimilars. This ruling should help expand access and lower prescription drug costs for employers, health plans, labor unions, and Medicare,” according to the statement. Express Scripts also noted that, by its estimate, the United States "wasted more than $45 million for every month that the Sandoz biosimilar Zarxio (filgrastim-sndz) was delayed from coming to market as a result of the notice of commercial marketing issue argued in Sandoz v. Amgen."

Sandoz, the manufacturer of the first biosimilars to be applied for and launched in the United States, as well as the first company to have 2 biosimilars approved by the FDA, said in its press release related to the ruling, "America spent $323 billion in 2016 on prescription medicines, and biologics are estimated to account for 28% of drug spending by 2020. One analysis predicted that biosimilars could deliver up to $44 billion in savings to the US healthcare system by 2024 while driving healthy competition and innovation."