SCOTUS agrees to hear Amgen revival bid

The dispute centres on a section of the Patent Act concerning 'enablement' | The US government had urged the court to deny the petition.

The  US Supreme Court has agreed to hear  Amgen’s attempt to revive patents on its cholesterol drug  Repatha (evolocumab) that were invalidated amid a legal wrangle with  Sanofi and  Regeneron.

On Friday, November 4, the Supreme Court agreed to review the case concerning section 112 of the  US Patent Act (which covers patent enablement), just over a month after the US government  urged the court to deny the petition.

Amgen filed its  petition for a writ of certiorari in November last year, following a finding from the  US Court of Appeals for the Federal Circuit that the patents covering Repatha were invalid because they were too broad and lacked enablement.

An invention must be enabled for an application to be considered complete, under US patent law. The disclosure must explain enough about the invention so that someone skilled in the art can both make and use the invention.

The Federal Circuit had concluded that the Amgen patents raised the bar for enablement and the patents would still require “substantial” experimentation by people of ordinary skill in the art to meet the claimed embodiments.

Eight-year dispute

The clash began back in 2014, when Amgen took Sanofi and Regeneron to court after the pair collaborated to create a  Praluent, a competitor to Repatha. Both Repatha and Praulent are used to treat adults whose cholesterol cannot be controlled by diet and statin treatment.

In response, Sanofi claimed that the Amgen patents were invalid, an argument that found favour before the US District Court for the District of Delaware. Amgen appealed against the decision, but the Federal Circuit sided with Sanofi.

Amgen, in its petition to the Supreme Court, claimed that the Federal Circuit’s ruling defied more than a century of precedent by the Supreme Court, which holds that whether a patent satisfies an “enablement” requirement is “a question of fact to be determined by the jury”.

Amgen insisted that by deciding enablement as a question of law, the Federal Circuit had invaded the jury’s role.

“It sows uncertainty, as that court creates new and ever-mutating tests while deciding successive cases,” said Amgen in its brief.

The Federal Circuit requirement that the specification “allow skilled artisans ‘to reach the full scope of claimed embodiments’” is devastating to innovation, particularly for biotech and pharmaceutical innovations, argued Amgen.

An amicus brief—filed in support of Amgen—by companies including  Biogen,  Bristol Myers Squibb, and  Merck Sharp & Dohme, claimed that the decision “could slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large”.

It added: “Innovators, faced with this artificially elevated and uncertain standard, will be compelled to divert precious resources away from making new discoveries or advancing the one already made to market, devoting them instead to making and testing additional examples of their invention and adding information already known to skilled artisans to their patent applications. The harm of diverting those resources can be profound.”