The United States Patent and Trademark Office (USPTO) has issued a notice of allowance for US Patent Application Serial Number 13/282,145, titled "Method of Treating Hypertriglyceridemia," to Amarin Corporation plc.
The application includes claims intended to protect the Vascepa (icosapent ethyl) indication approved in July 2012 by the US Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results. 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 term that expires no earlier than in 2030. After issuance, Amarin plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
“This notice of allowance is based upon showings that the clinical results for Vascepa in Amarin's MARINE trial were surprising and unexpected, key factors considered by the USPTO in granting a patent," stated Joseph Zakrzewski, chairman and CEO of Amarin. "Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity and trade secrets and by taking advantage of manufacturing barriers to entry. The issuance of this Notice of Allowance is a significant step toward achieving this goal."
This application is part of an expanding patent portfolio for Amarin with seven patent applications now either issued, allowed or in advanced stages of prosecution with the USPTO and over 25 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.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids.