BioCentury
ARTICLE | Company News

Amarin cardiovascular news

September 17, 2012 7:00 AM UTC

Amarin said the U.S. Patent and Trademark Office (PTO) issued a Notice of Allowance for Patent Application No. 13/349,150. The patent covers Vascepa icosapent ethyl (formerly AMR101) to treat hypertriglyceridemia - its approved indication. The company said the notice signifies that the PTO determined that a patent can be granted from the application. Amarin announced earlier this month that the U.S. PTO issued Notices of Allowance for four other patent applications in the company's Vascepa patent portfolio (see BioCentury, Sept. 10).

Additionally, analysts reported that investors are concerned over delays regarding FDA's exclusivity decision in the event Amarin does not secure patent protection for the product. The agency can grant Vascepa either five years of market exclusivity as a new chemical entity or three years as a new product under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. When the NDA was approved in July, the company said such a decision usually comes in the month following NDA approval. The company said in an SEC filing that as of Sept. 10, FDA had not yet made a decision regarding Vascepa's exclusivity (see BioCentury, July 30). ...