Judge Rules That Sanofi-Regeneron’s PCSK9 Cannot be Sold in the U.S., Saying it Infringes on Amgen’s Patent

Sanofi SA and Regeneron Pharmaceuticals, who partnered to make a new cholesterol-fighting drug called Praluent, cannot sell their product in the United States, a federal judge ruled yesterday. As the Wall Street Journal reports, the permanent injunction helps Amgen, which sells Repatha, another cholesterol-fighting drug. The judge ruled that the injunction begins in 30 days, which gives Sanofi SA and Regeneron Pharmaceuticals time to appeal the decision, which officials at the two drugmakers vow they will do right away.  

Karen Linehan, Sanofi’s general counsel, tells the newspaper: “It is our longstanding position that Amgen’s patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”

Amgen CEO Robert A. Bradway fired back. “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.”

The drugs are PCSK9s and they’re expensive. Repatha costs about $14,000 a year. That makes them somewhat problematic for health insurance plans. As the Wall Street Journal notes: “Their sales have proved disappointing as health insurers have resisted paying the high prices, though analysts expect the drugs will eventually be big sellers.”

Steve Miller, the CMO of the PBM Express Scripts, has been called a gatekeeper, judge and jury, cost-fighting ninja, and “among the most feared” people by pharma. He’s kept an eye on the PCSK9 situation. He told Managed Care in 2015 that, “There are 71 million people with high cholesterol in the U.S. And cardiovascular disease and stroke are the top killers. So, it’s a really important category, which potentially is going to add a lot of spend.”

Source: Wall Street Journal