The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical marketing. Central to this legal dispute are U.S. Patents 9,700,537 and 10,568,861, owned by Amarin, which describe methods of reducing cardiovascular risk by administering icosapent ethyl, a compound found in the drug Vascepa®. Vascepa® had initially received FDA approval for treating severe hypertriglyceridemia, a condition marked by high levels of triglycerides in the blood. However, Amarin’s continued research into the drug’s benefits led to an expanded FDA approval in 2019, allowing Vascepa® to be marketed for reducing cardiovascular risk in certain patient populations.Continue Reading Federal Circuit Provides Insight on Induced Infringement Claims in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.