Amarin (AMRN) Receives U.S. Patent Allowance on '217 App for Vascepa MARINE Trial
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Amarin Corporation plc (Nasdaq: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/610,217. This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved by the U.S. 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 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.
The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of highly pure icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 4 capsules, each containing about 900 mg to about 1000 mg of EPA, regardless of EPA purity.
"The claims in this allowed application cover the administration of capsules containing EPA within a significant range of EPA concentrations," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents yet another significant step toward Amarin's goal of protecting 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."
This application is part of an expanding patent portfolio for Amarin with 12 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.
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.
The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of highly pure icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 4 capsules, each containing about 900 mg to about 1000 mg of EPA, regardless of EPA purity.
"The claims in this allowed application cover the administration of capsules containing EPA within a significant range of EPA concentrations," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents yet another significant step toward Amarin's goal of protecting 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."
This application is part of an expanding patent portfolio for Amarin with 12 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.
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