Judge Orders Halt to Praluent Sales in Patent Dispute

The judge's ruling allows 30 days for an appeal but encourages the parties to work out a settlement. The case involves competing, expensive drugs to control cholesterol.

A federal judge stunned Sanofi and Regeneron Thursday by ordering them to stop selling the PCSK9 inhibitor alirocumab (Praluent) because it infringes on patents of rival cholesterol-fighter evolocumab (Repatha), made by Amgen.

US District Judge Sue Robinson ruled that Praluent sales had to be halted for 12 years, but her order will not take effect for 30 days to give Sanofi and Regeneron time to appeal. The order, which came after a March 2016 ruling that upheld Amgen’s patents, could be the first step toward a settlement between the 2 pharmaceutical giants, and Robinson called on the parties “to reach an appropriate business resolution,” in her order.

Besides the potential lack of competition in a costly new drug class, Sanofi and Regeneron asserted that the ruling could mean fewer choices for patients, since Praluent is available in 2 different doses and Repatha is currently available in 1 dose.

In a statement, Amgen praised the ruling and said it was ready to work with patients who wanted to switch from Praluent to Repatha. “We are pleased with today’s decision that recognizes Amgen is entitled to an injunction against further infringement of our patent rights,” said Robert A. Bradway, chairman and CEO at Amgen.

“Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases,” he said.

Competition has been fierce between Sanofi-Regeneron and Amgen for the market for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, injectable drugs that sharply reduce levels of low-density lipoprotein cholesterol in patients at high risk of cardiovascular events or who have genetic conditions that elevate cholesterol.

FDA approved the competing drugs in July and August 2015, but sales have fallen short of expectations, with most blaming the cost—wholesale prices for both topped $14,000 a year. Bloomberg reported that the loss could cost Sanofi and Regeneron up to $2 billion through 2020, while current forecasts for Amgen’s Repatha sales are just above $1 billion for 2018.

Sanofi and Regeneron vowed to appeal both Thursday’s order and the original ruling on Amgen’s patents, saying in a statement that, “the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”

Amgen first unveiled studies on evolocumab that wowed attendees of the 2014 meeting of the American College of Cardiology in Washington, DC. But Sanofi countered in January 2015, spending $67.5 million on a priority review voucher that allowed alirocumab to jump ahead in the FDA queue by a month. While FDA approved both drugs, the labels’ scope falls short of what European regulators allowed, which has required patients seeking PCSK9 inhibitors to meet strict protocols to gain access.

The ruling comes less than a month after Sanofi cut its US diabetes and cardiovascular sales forces by 20%, amid pushback from payers and pharmacy benefit managers on drug prices. This week, Sanofi announced Wednesday that a recently approved insulin combination therapy, Soliqua, is now available in the United States. The injectable therapy combines the basal insulin Lantus with lixisenatide, a glucagon-like peptide-1 receptor agonist.