Fed Circ invaded jury’s role in Repatha case, says Amgen

Amgen has urged the US Supreme Court to wade into its legal wrangle with Sanofi and Regeneron Pharmaceuticals over patents covering a cholesterol drug, Repatha (evolocumab).

Amgen filed the petition for a writ of certiorari on November 18, and SCOTUS is expected to respond by December 22.

The petition comes in the wake of a ruling by the US Court of Appeals for the Federal Circuit in February that held that patents covering Repatha were invalid because they were too broad and lacked enablement.

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

The patents, US numbers 8,829,165 and 8,859,741, cover antibodies that target PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is an enzyme that binds to and causes certain liver cell receptors to be destroyed, reducing the capacity and effectiveness of the liver cell jury.

In its petition, Amgen wrote that the federal circuit’s decision defied more than a century of precedent and that SCOTUS has long held that whether a patent satisfies an “enablement” requirement is “a question of fact to be determined by the jury”.

The generic maker 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.

The dispute emerged in 2014 when Amgen sued Sanofi and Regeneron for patent infringement after they collaborated to create a competitor to Repatha, called Praluent. Both Repatha and Praulent are used to treat adults whose cholesterol cannot be controlled by diet and statin treatment.

Sanofi countered that the Amgen patents were void through litigation at the US District Court for the District of Delaware.

The Delaware court found in favour of this argument, leading to Amgen’s appeal to the Federal Circuit.

But the Federal Circuit panel opined 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.

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