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29 April 2021AmericasAlex Baldwin

GSK claims Amgen v Sanofi decision “threatens” innovation

GlaxoSmithKline (GSK) has submitted an amicus  brief to the Court of Appeals for the Federal Circuit claiming that the ruling on Amgen v Sanofi could “threaten incentives to invest in future discoveries.”

The pharmaceutical giant submitted it’s brief in support of Amgen’s petition to rehear the case yesterday, requesting that the court take up the petition en banc in order to “reaffirm the availability and viability” of genus claims for patents—which it claims are being obstructed in recent rulings.

“Genus claims protect continued innovation in the chemical, pharmaceutical, and biotechnological industries. But the panel in Amgen joins other recent panels in upending such protections. That development is bad policy, as it disincentivises innovation,” the brief claimed.

“A patent system that provides protection to inventors consistent with the scope of their inventions is critical to ensuring continued investment in research and development,” it added.

Several US courts have held recently that genus claims to small molecules are invalid, including in Wyeth and Idenix. These recent rulings, including in Amgen, have “effectively imposed limits on the number of species that can exist in an enabled genus claim”, according to the brief.

“[This] sea change threatens to devastate the incentives for companies like GSK to invest billions of dollars and hundreds of thousands of research hours in discovering breakthrough drugs,” the brief concluded.

Case background

Amgen owned two patents, US numbers 829,165 and 8,859,741, related to elevated lowering low-density lipoprotein (LDL) cholesterol to prevent heart disease.

Amgen filed a lawsuit against Sanofi and Regeneron (collectively Sanofi) in October 2014 alleging infringement of multiple patents, including the ‘165 and ‘741 patents. Amgen and Sanofi both stipulated infringement but Sanofi disputed the validity of both patents in 2016.

During the trial, the district court granted a judgment on a matter of law (JMOL) of nonobviousness and of no willful infringement. The jury had determined that patents were not invalid for lack of enablement and written description.

This led Sanofi to appeal to the Federal Circuit, which found that the district court erred in its evidentiary rulings and jury instructions and issued a new trial on those issues. The remanded trial also found Sanofi had failed to prove claims in Amgen’s patents were invalid. It then submitted another JMOL for lack of enablement which was then granted.

Upon its second appeal to the Federal Circuit, Judge Lourie ruled that the asserted claims of the patents were invalid for lack of enablement.

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More on this story

Americas
25 November 2021   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.
Generics
9 December 2021   Following a substantial push from generics companies to reverse the GSK v Teva “skinny” label ruling, GlaxoSmithKilne has added its response to the petition to rehear the case yet again.
Americas
4 January 2022   The US Court of Appeals for the Federal Circuit has rejected several bids from French pharma giant Sanofi to revive claims in its Lantus SoloStar insulin pen patents.

More on this story

Americas
25 November 2021   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.
Generics
9 December 2021   Following a substantial push from generics companies to reverse the GSK v Teva “skinny” label ruling, GlaxoSmithKilne has added its response to the petition to rehear the case yet again.
Americas
4 January 2022   The US Court of Appeals for the Federal Circuit has rejected several bids from French pharma giant Sanofi to revive claims in its Lantus SoloStar insulin pen patents.