(By Balaseshan) Amarin Corporation Plc (NASDAQ: AMRN) said it has received notification of patent allowance for U.S. application related to Vascepa and the U.S. Food and Drug Administration (FDA) approved MARINE indication.
Vascepa, Amarin's first FDA approved product, is a patented, ultra pure omega-3 fatty acid product comprising not less than 96% EPA. The United States Patent and Trademark Office (USPTO) has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/608,775.
This application includes claims intended to protect the Vascepa (icosapent ethyl) indication approved in July 2012 by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.
This application is a continuation of Amarin's U.S. Patent Number 8,293,728 (formerly, the '153 application) and broadens the '728 claims by covering the use of Vascepa with and without other lipid lowering agents, such as statins. The '775 application claims gauge drug effects against placebo control.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
This application is part of an expanding patent portfolio for Amarin with nine patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States.
Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin has announced receipt of an Intention to Grant letter.
AMRN closed Friday's regular session at $10.84. The stock has been trading between $5.99 and $15.96 for the past 52 weeks.