DMC8,
Management has repeatedly asserted, particularly under Patrick Holt’s watch, that Intellectual Property Rights is the foundational element of Amarin’s business.
In addition to what SDL has stated, one should also keep in mind the guarded 2018 Collaboration Agreement signed with Mochida Pharmaceutical Company as part of Amarin’s IP moat. As a reminder, Mochida launched Epadel Capsule 300, the world’s first high-purity EPA preparation, in 1990 and Epadel EM (MND-2119), the world’s first one-a-day self-emulsifying formulation of highly-purified EPA, in 2022.
Moreover, the LR-EtEPA patent application is designed to cover not just the active ingredient (icosepentethyl) but also the novel formulation and uses: “lymph-releasing composition” comprising EPA ethyl ester with a phospholipid emulsifier (e.g. lecithin), and optionally other emulsifiers, to enhance lymphatic absorption, thereby increasing EPA uptake in tissues. The claims extend to treat a broad range of diseases – cardiopulmonary, renal, neurological diseases, and cancer – using this formulation. In practical terms, the patent would protect any extended-release or self-emulsifying EPA formulations similar to MND-2119 in the U.S., and key global markets. This broad scope helps insulate Amarin from would-be generic competitors trying to introduce improved EPA products. Generic drug could still sell regular icosepoentethyl capsules, but they could not copy the LR-EtEPA formulation (EPA + specific phospholipid/emulsifier system) without infringing. Thus, if Amarin can convert patients to the new formulation, generics of old Vascepa would be less threatening.
The LR-EtEPA patent is also devised 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” workaround 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 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 in the U.S. and through the World Intellectual Property Organization, Amarin has the earliest priority date on this invention worldwide, which is critical to establishing dominance if other companies were exploring similar enhanced EPA delivery technologies.
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