Amarin Corp Plc (AMRN)

[me33]

Good summary write up on Amarin vs ITC case.

"Final Thoughts

The Federal Circuit Court of Appeals’ decision is not expected until late summer 2018. Despite the somewhat narrow set of facts in the case, the outcome could have implications beyond the fate of concentrated omega-3 products and the supplement industry. If Amarin’s position prevails, companies could decide to use the ITC as a forum to resolve competitive disputes involving FDA-regulated products or potentially pursue Lanham Act cases or similar actions against competitors even though the question at stake may have been traditionally reserved for FDA. However, the choice will depend on the relief sought, since a restriction on imports into the US would be the remedy in such cases. On the other hand, the Lanham Act could offer more broad relief in a case of unfair competition. Likewise, for companies unsatisfied with FDA’s approach to an issue—or the agency’s inaction—and the typically slow pace of litigation, the ITC provides an attractive and more efficient alternative. Regardless of the final decision in the Amarin matter, the regulatory classification of ingredients will continue to receive increased attention from FDA, retailers and other industry stakeholders. It is a worthwhile exercise for all companies to evaluate the regulatory status of their dietary ingredients. For many ingredients, the conclusion is clear. But for others, any questions surrounding those ingredients should be answered sooner rather than later."

https://www.raps.org/news-and-articles/news-articles/2018/7/update-on-the-amarin-itc-case-and-the-issues-at-st