For AMRN, NCE Status May Be Moot Point Given New Patent Allowances

Amarin Corp. (NASDAQ:AMRN) announced Tuesday that the U.S. Patent and Trade Office (PTO) issued a Notice of Allowance for Patent Application 13/282,145, which was based on results from the Phase III MARINE trial (patients with very high triglycerides). Additionally, on the PTO’s website, it appears that two other patent applications based on the MARINE trial (12/702,889 and 13/349,153) have also been granted Notices of Allowance, which when issued, are expected to protect Vascepa through 2030. These soon-to-be issued patents are very important, and may mean that whether or not the FDA grants new chemical entity (NCE) status for Vascepa is becoming a moot point. Patent protection out to 2030 is far more important than the 5 year regulatory exclusivity offered by the FDA (see PropThink’s previous coverage), and as a result, AMRN may be in position to secure a major drug company partnership or sell the company given the improving intellectual property position around Vascepa. Regardless, the next FDA Orange Book update is expected in mid-September, and if NCE status is granted, this could take shares of AMRN up, given the weight that investors have placed on this issue. Essentially, the risk around Vascepa’s U.S. market exclusivity is diminishing, which should continue to reflect in the rising price of the stock.