U.S. Patent Expired? Why Not Grow Revenue Globally, Says Amarin

By Ben Comer, Chief Editor, Life Science Leader

If you have worked in the pharmaceutical industry for at least 10 years, you will remember the curious case of Amarin Corp and its highly purified prescription fish oil product, Vascepa. An omega- 3 fatty acid, the drug was first approved in 2012 for patients with high triglyceride levels to help reduce the risk of cardiovascular events. After the FDA rejected a product label expansion in 2014, saying it needed to wait for results from the 8,000-person REDUCE-IT trial, Amarin filed a lawsuit in May 2015 that argued for the company’s right to promote the drug off label, saying its promotional messages met the First Amendment standard of being “truthful and nonmisleading.” To the great surprise of many, a federal court ruled in favor of the company.