“US Supreme Court Invalidates Amgen’s Patents, Sparks Concern Among Legal Experts”

US Supreme Court Invalidates Two Amgen Patents, Sparks Concern Among Legal Experts

The US Supreme Court ruling on 18 May, which invalidated two of Amgen’s patents related to the cholesterol drug Repatha (evolocumab), has raised eyebrows among legal experts. The court’s nine justices unanimously upheld a lower court’s decision that Amgen had failed to provide sufficient information to allow others to recreate the full scope of its claimed innovation. This decision effectively ends the long-running litigation between Amgen and Sanofi–Regeneron.

Amgen’s Patent Dispute with Sanofi

Amgen discovered a viable antibody binding site and generated antibodies engineered to help reduce levels of harmful LDL cholesterol, explains Matt Jonsen, a partner at the law firm Dorsey & Whitney in Denver. However, Sanofi developed an antibody that a jury said essentially did the same thing. In 2014, Amgen sued Sanofi, accusing the company of infringing multiple patents by using Amgen’s roadmap to create Praluent (alirocumab), a competing antibody. In March 2016, a jury determined that the patents were valid. But a federal appeals court later reversed the jury’s decision, and the supreme court has now upheld that reversal.

Implications of the Supreme Court Ruling

Amgen’s patent applications had described 26 antibodies, identified by their amino acid sequences, as well as detailed instructions for generating additional related antibodies. This information covered roughly 400 pages and included electronic data of the x-ray crystallographic coordinates of the company’s two lead antibodies. However, the question remains, if all of that is not enough, then what is enough? This question was not answered, says US patent attorney Gene Quinn, who founded the law blog IPWatchdog.

Quinn emphasises that the law has always recognised that a patent doesn’t need to be a complete blueprint or an engineering or manufacturing document, but rather enough information for a skilled person to recreate the invention. He warns that this decision appears to throw that into doubt.

Jonsen too anticipates that the ruling will have reverberations for sectors such as chemicals, pharmaceuticals and polymers. It will be felt in any field where someone wants to protect a class of compounds, just like Amgen wanted to protect a class of antibodies.

Reactions to the Ruling

Amgen expressed disappointment in the ruling, but vowed to continue to fight for patent laws and policies that provide meaningful patent protection needed to foster breakthrough innovation. In contrast, Sanofi described the ruling as representing an unequivocal win for America’s innovation economy, its scientists and researchers. The supreme court prevented a move that would have blocked progress for entire classes of molecules, deterred innovative competition, and led to potential increases of drug prices, the company said.

The ruling has sparked a debate about the sufficiency of information required for a patent and its implications on various industries. It remains to be seen how this will affect future patent applications and the innovation landscape in the US.