U.S. District Court Invalidates Amgen Patents Over Cholesterol Med


In an ongoing battle between Regeneron Pharmaceuticals and Sanofi versus Amgen over PCSK9 inhibitors to treat high cholesterol, a U.S. district court invalidated Amgen’s patents for Repatha.

In July 2016, Amgen’s Repatha (evolocumab) and Regeneron and Sanofi’s Praluent (alirocumab) were approved within two weeks of each other. Both drugs decrease the so-called “bad” LDL cholesterol by blocking PCSK9. The drugs later demonstrated their ability to decrease the risk of heart attacks.

Lawsuits have been ongoing between the companies for about five years. Both drugs are antibodies that target PCSK9. Amgen sued Sanofi and Regeneron in 2014, alleging that Pralunet infringed on its intellectual property. In 2016, a jury affirmed those patents and Amgen briefly won an injunction against sales of Praluent, although that decision eventually was stayed.

Sanofi and Regeneron then appealed, which partially reversed the earlier finding and a new trial was called. In February, the court validated three of Amgen’s five claims about two patents. Which this latest decision now overturned.

Judge Richard Andrews of the U.S. District Court for the District of Delaware ruled that Amgen’s claims didn’t meet a legal standard known as enablement. Basically, this meant that Amgen didn’t prove a person “skilled in the art” would be able to make the drug based on the patent without “undue experimentation.”

“Even taking the testimony in the light most favorable to plaintiffs, the testimony of plaintiffs’ own experts indicates that the experimentation necessary to enable the full scope of the claims would take a substantial amount of time and effort,” Judge Andrews wrote in his decision. In this case, Amgen is the plaintiff.

However, Sanofi and Regeneron’s request for a new trial was conditionally denied. Also, their attempt to invalidate Amgen’s patents on the basis of a “written description” legal standard was denied.

“We disagree with the Court’s decision in reversing the jury verdict on enablement and will seek review by the appellate court,” Amgen told BioPharma Dive. “We are disappointed with today’s decision, and we look forward to presenting our case to uphold the jury’s verdict.”

For their part, Regeneron and Sanofi seem reasonably happy with the decision, although more legal battles are on the horizon.

“Today’s decision by the U.S. District Court for the District of Delaware validates our position that Amgen’s patents are overly broad and invalid,” stated Joseph LaRosa, executive vice president, General Counsel and Secretary, Regeneron. “Praluent was developed using Regeneron’s proprietary science and technology and the judge has confirmed our position by issuing this ruling.”

Neither Repatha nor Praluent has gained the sort of traction in the market the companies hoped for when approved. They have largely been used for patients who have extremely high cholesterol levels that can’t be modified by diet, exercise and the more common statin medications. Even though the PCSK9 inhibitors have proven effective at lowering LDL cholesterol by as much as 50% to 60% in patients already taking statins, the initial price of both drugs was about $14,000 a year, while statins are typically about $50 per month. As a result, insurers have been reluctant to reimburse for the drugs.

Since initial sales, both drugs’ prices have been dropped to around $6,000 a year, which is still ten times more expensive than statins. Generally, Repatha sales are better, having sold $152 million in the second quarter of 2019 compared to Praluent’s $74 million in the same period.

This week, The Medicines Company announced that its PCSK9 inhibitor inclisiran hit its primary and secondary endpoints in its Phase III clinical trial. One of the advantages of inclisiran, if it gets approved, is that it is dosed twice a year.

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