"Amarin's response brief noted that seven other manufacturers sell the same generic drug using materially identical skinny labels and that Amarin has not sued any of them because they confined their marketing to unpatented indications."
"The Court granted certiorari in January, after Hikma Pharmaceuticals petitioned for review of the CAFC's June 2024 ruling."
"According to Amarin's response brief, the United States Food and Drug Administration (FDA) originally approved Vascepa in 2012 as a treatment for severe hypertriglyceridemia."
"Amarin thereafter invested more than $300 million and several years into the Reduce It clinical trial, which monitored more than 8,000 patients and demonstrated that Vascepa reduces the risk of major adverse cardiovascular events by up to 30 percent."
The U.S. Supreme Court is considering a case involving Amarin Pharma and Hikma Pharmaceuticals regarding induced patent infringement related to the cardiovascular drug Vascepa. Amarin's response brief highlights that other manufacturers use similar skinny labels without legal action due to their marketing practices. The case questions whether labeling a product as a generic while referencing the branded drug's sales constitutes infringement. Amarin's investment in clinical trials for Vascepa, which demonstrated significant cardiovascular benefits, is also emphasized in the context of the patent claims.
Read at IPWatchdog.com | Patents & Intellectual Property Law
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