Federal Circuit vacates Amgen injunction in Sanofi suit

The US Court of Appeals for the Federal Circuit has vacated a permanent injunction awarded to Amgen in its dispute with Sanofi and Regeneron.

In January this year, Sanofi and Regeneron were ordered to stop selling cholesterol-lowering medicine Praluent (alirocumab) after Amgen obtained an injunction against the companies.

Amgen had sued the pair in October 2014 for infringing two of its patents covering the drug Repatha (evolocumab): US numbers 8,829,165 and 8,859,741.

Evolocumab is a monoclonal antibody that targets PCSK9 (a naturally occurring protein) to prevent it from destroying liver cell receptors.

Sanofi and Regeneron’s appeal to suspend the injunction was denied in January by the US District Court for the District of Delaware.

However, Sanofi and Regeneron secured a stay of the injunction from the Federal Circuit while they appealed against an earlier order.

LSIPR reported that a number of doctors had filed amicus briefs backing Sanofi and Regeneron in their bid to fight the injunction.

The doctors claimed that removing the drug from the market would have immediate detrimental effects on patients, while others argued that pulling the drug would increase the risk of major cardiovascular problems for their patients.

Yesterday, October 5, the Federal Circuit handed down a precedential ruling on the dispute.

Sanofi and Regeneron argued that the district court had improperly excluded evidence regarding written description and enablement, and had improperly instructed the jury on written description.

The Federal Circuit agreed with Sanofi and Regeneron’s arguments, and it reversed in-part and remanded for a new trial on written description and enablement, while reversing the injunction.

Chief Judge Sharon Prost, speaking on behalf of the court, said that the district court’s instruction was not legally sound and was not based on any binding precedent so that the instruction was “improper”.

The district court instructed the jury that written description can be satisfied “by the disclosure of a newly-characterised antigen … if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that production of antibodies against such an antigen was conventional or routine”.

According to Prost, the instructions effectively permitted the jury to “dispense with the required finding of a ‘written description of the invention’”.

“A jury would naturally understand the instruction to permit it to deem any antibody within the claim adequately described merely because the antibody could easily be ‘produced’ (and, implicitly, used as an antibody),” said Prost.

The schedule for the new trial has not yet been determined, said Sanofi and Regeneron in a press release, adding that they don’t expect any new trial proceedings to begin in 2017.

Karen Linehan, executive vice president and general counsel at Sanofi, said: “We are pleased with the Federal Circuit’s decision to remand for a new trial that allows us to present our complete evidence to the jury.”

A spokesperson for Amgen said the company was disappointed by the decision.

“We firmly believe in the validity of our patents and we look forward to reasserting our rights in court,” they said.

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