January 12, 2017

“Is it in the public’s interest to have two similar cholesterol drugs on the market?” STAT, January 6, 2017

As Sanofi prepares a do-or-die appeal to continue selling a pricey cholesterol drug, a key issue may turn on the extent to which patient access to the medicine is considered to be in the public interest.

The drug maker and its partner, Regeneron Pharmaceuticals, lost a stunner when a federal court judge late Thursday issued a permanent injunction preventing the companies from marketing their Praluent injectable cholesterol medicine. The judge did so in response to a jury verdict last year that found the product infringed patents held by Amgen on its own drug, which is called Repatha. A lawsuit1 had been filed in 2014.

Both drugs, which are known as PCSK9 inhibitors, became available in 2015 to treat patients who struggle to control their cholesterol using statins, particularly those with an inherited disorder known as familial hypercholesterolemia. The medicines cost about $14,000 annually, before rebates, and doctors and investors are awaiting study data on whether the drugs can lower cardiovascular risks.

“This is a close call. They’re both equally important factors,” said Leanne Rakers, a Principal at the Harness IP law firm, who specializes in pharmaceutical patent litigation. “In this case, I think Sanofi has strong arguments and can possibly win the appeal, because monetary damages should be adequate to compensate Amgen. Why isn’t that sufficient, especially when there is a public interest?”

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Reposted with permission from STAT.