Provided are compositions comprising one or more polyunsaturated fatty acids or derivatives thereof, a source of phospholipid, and optionally one or more additional emulsifiers, as well as methods of using the same to treat various diseases. In some embodiments, provided is a lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA) and methods of using the same to increase EPA uptake in tissues and to treat various diseases including cardiopulmonary diseases, renal diseases, neurological diseases, and cancer.
The LR-EtEPA patent is designed to be a life-cycle management tool to fend off generic competition. With Vascepa, Amarin’s patents were method-of-use focused (for triglyceride reduction and CV risk reduction) and proved vulnerable to attack and to “skinny labeling” workarounds by generics. In contrast, the LR-EtEPA patent focuses on the drug formulation itself, making it harder for generics to circumvent. A generic manufacturer cannot simply omit an indication to avoid infringing – they would have to either wait until patent expiry or engineer a non-infringing formulation (which is challenging if the patent claims are broad). This positions LR-EtEPA as a branded alternative that physicians could prescribe to regain the benefits of a protected product. Notably, Amarin’s U.S. patent application claims priority from nine provisional filings in early 2022, signaling that Amarin moved swiftly to stake out this intellectual property. By being first to file, Amarin has the earliest priority date on this invention, which is critical for establishing dominance if other companies were exploring similar enhanced EPA delivery technologies.
Amarin will apply for its patent’s claims while being able to use all data backing EPA.
Lastly, given that Amarin’s patent extends to broad disease treatment claims (including areas like cancer or neurology) FDA might require that those claims are fully supported by data. The University of Leeds EMT2 trial of EPA in patients undergoing liver surgery for colorectal cancer liver metastasis here becomes of utmost importance. SDL will soon be expanding on this on Stocktwits.
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