Supreme Court rules in Hikma's favor in 'skinny' label case

WASHINGTON — The Supreme Court has unanimously ruled that Hikma Pharmaceuticals' generic version of Amarin’s cardiovascular drug Vascepa (icosapent ethyl) does not infringe on the branded drug maker's patents. 

The 9-0 decision validates “skinny” labels, which allow generics to be marketed for certain indications as long as they don’t infringe on other patented uses. The law enabling skinny labeling is designed to speed patients' access to lower-cost medications.

In 2020, Hikma launched icosapent ethyl for non-patented use only. Amarin sued the generic manufacturer, alleging it was marketing the product for both patented and non-patented uses. A U.S. district court dismissed the suit, but a federal appeals court overturned that ruling and allowed the case to proceed. Hikma then appealed to the high court.

“Hikma took this fight to the Supreme Court to ensure patients have ongoing access to generic medicines, especially those medicines that have appropriately carved out patented indications,” said Hikma general counsel Sam Park. “Amarin’s lawsuit sought to limit legitimate generic competition, despite long-established legal frameworks governing generic medicines in the U.S. We are very pleased the U.S. Supreme Court has ended this litigation, which will have a beneficial impact on all Americans.”

“Hikma has long fought for patients and their access to safe, high-quality, and affordable medicines,” added Park. “We welcome the United States Supreme Court’s decision, which allows us to continue providing millions of American patients with generic medicines that improve health and save lives.

“Our more than 2,300 US employees and their Hikma colleagues around the world remain hard at work developing, manufacturing and distributing essential generic medicines that have become a cornerstone of the U.S. health care system and that serve the needs of hospitals, doctors, pharmacists and patients nationwide.”