Amarin has patent protection for Vascepa® out to 2030, including protection related to the possible expanded Reduce-It trial label.
Two U.S. formulation patents and 22 U.S. Vascepa® Patents expire between 1/27/20 and 4/29/30, with 21 of 22 expiring in 2030.
Two of the 22 method of use Vascepa® Patents are relevant to the possible expanded label from the Reduce-It trial.
The number of Vascepa® Patents is likely to grow in coming years as additional patents issue.
Investors are cautioned that this info is largely based on info provided by Amarin in the FDA Orange Book for Vascepa® and there is pending litigation related to some of these patents, and risks with every issued patent of patent validity and scope.
In this article, we discuss Amarin's (NASDAQ:AMRN) U.S. patents on Vascepa®. From an investor's perspective, the high level story is promising, with protection apparently out to 2030 for 21 of 22 Orange-Book-listed patents. The Vascepa® patents include 2 formulation patents and 2 method of use patents that appear to be relevant even in view of the possible expanded indication related to the sNDA that Amarin is filing from the Reduce-It trial results.
However, as U.S. patent attorneys, we also see that like all issued U.S. patents, there are risks of validity and scope of coverage in the Amarin patent portfolio. The risks are more real in this situation because the active ingredient for Vascepa® was likely known for related indications before Amarin filed their patent applications, and there is pending generic drug-type litigation related to these patents, facts that are also fairly common for biopharma patents. Below, we provide much more detail about the Amarin Vascepa® patents and pose questions and comments related to some of the risks.
Disclosure: This article is NOT legal or investment advice. More information regarding the authors and their patent law practice can be found at doublehelixlaw.com.