US Supreme Court overturns copycat drug delays

A California-based pharmaceutical company cannot use federal law to enforce a rule delaying the sale of a copycat “biosimilar” drug, but may appeal to the federal circuit court to use state law instead, the US Supreme Court ruled unanimously.

Amgen Inc. sued Sandoz, a subsidiary of Swiss-based Novartis AG, for patent infringement and sought to delay them from selling a biosimilar drug until six months after receiving US Food and Drug Administration (FDA) approval and another six months from filing a marketing notice. Sandoz’s drug, Zarxio, would have competed with Amgen’s Neupogen.

Statutory context of the law contains a single 180-day timing requirement, rather than the two requirements posited by the federal circuit court, Justice Clarence Thomas wrote in the decision. Had Congress intended to impose two timing requirements, it would have done so, Thomas noted.

“Amgen’s contrary arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language,” Thomas wrote.

“Sandoz’s failure to disclose was not an act of artificial infringement remediable” under the law, Thomas added. “Submitting an application constitutes an act of artificial infringement; failing to disclose the application and manufacturing information required by §262(l)(2)(A) does not.”

Amgen can try to seek an injunction under state law, the Supreme Court held, but noted that such an injunction might be pre-empted by federal law. Both of those questions were sent back to the federal circuit court for consideration.

Biosimilars are a class of medication that aims to copy biological products made inside living cells. Neupogen, a white blood cell booster, has been on the market since 1991. Zarxio was approved for use in Europe in 2009, and Sandoz began selling it in the US in September 2015.

As part of the Obama administration’s Affordable Care Act (ACA), the Biologics Price Competition and Innovation Act (BPCI Act) of 2009 established an expedited licensing procedure for biological products that are shown to be “biosimilar” or “interchangeable” with a FDA-licensed biological product.

According to the FDA, a biosimilar has “no clinically meaningful differences in terms of safety and effectiveness” from the reference product, and only “minor differences in clinically inactive components” are allowed.