Amarin hit on third citizen petition to invalidate key Vascepa patent

Amarin (AMRN -5.1%) is down on more than double normal volume in what appears to be profit-taking after its 33% rally since late June.

Many observers are attributing today’s drop to the filing of a third Citizen Petition by Medical Research Collaborative, LLC requesting that the company’s U.S. Patent No. 8,188,146 covering the composition of highly purified ethyl eicosapentaenoic acid (EPA) and other EPA derivatives, be removed from the FDA’s Orange Book (ultra-pure omega-3 fatty acid is the active ingredient in Vascepa).

On May 31, 2016, the FDA awarded Amarin five years of New Chemical Entity (NCE) exclusivity for Vascepa, meaning that icosapent ethyl should not contain any active moiety previously approved by the agency. As the patent title states, though, icosapent ethyl is an ethyl ester of EPA. GlaxoSmithKline’s Lovaza (omega-3-acid ethyl esters) is a combination of seven ethyl esters of omega-3 fatty acids so many have argued that the agency erred in granting NCE exclusivity for Vascepa, the removal of which would open the floodgates for competitors.

https://seekingalpha.com/news/3476611-amarin-5-percent-third-citizen-petition-invalidate-key-vascepa-patent