Amarin (AMRN) Receives Notice of Allowance for '450 Patent
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Amarin Corporation plc (Nasdaq: AMRN) 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 13/623,450. 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 regardless of the drug's effect on LDL-C levels.
"This allowance is significant in that it would broaden our currently issued MARINE method of use claims to cover the use of Vascepa (and other highly pure EPA formulations) without regard to LDL-C levels," stated Joseph Zakrzewski, Chairman and CEO 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 11 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.
The 13/623,450 Notice of Allowance has not yet been posted on the USPTO public PAIR website. Amarin has posted this Notice of Allowance and related claims in the Press Release section of its corporate website.
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 regardless of the drug's effect on LDL-C levels.
"This allowance is significant in that it would broaden our currently issued MARINE method of use claims to cover the use of Vascepa (and other highly pure EPA formulations) without regard to LDL-C levels," stated Joseph Zakrzewski, Chairman and CEO 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 11 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.
The 13/623,450 Notice of Allowance has not yet been posted on the USPTO public PAIR website. Amarin has posted this Notice of Allowance and related claims in the Press Release section of its corporate website.
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