The Amarin-Mochida Collaboration
1. Seen from Amarin’s viewpoint:
a. Amarin’s 10-K 2018 states:
“In June 2018, we entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to development and potential subsequent commercialization of drug products and indications based on the active pharmaceutical ingredient in Vascepa, the omega-3 acid, EPA (eicosapentaenoic acid). The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.”
b. From 2019 till 2023 all Amarin’s 10-K have reported the following INVARIABLE text:
“In June 2018, we entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in Vascepa, the omega-3 acid, EPA. Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories. In addition, the parties will collaborate to research and develop new products and indications based on EPA for our commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development. Upon closing of the collaboration agreement, we made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for milestone payments from us upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.”
c. Nota Bene: Amarin 10-K 2019 also confirmed at the end of the above statement: “In January 2020, we achieved certain milestones under the agreement, resulting in payment of $1.0 million to Mochida.’
2. Seen from Mochida’s viewpoint:
a. Mochida Annual Review 2018 stated:
“In June 2018, Mochida also entered an agreement with Amarin Corporation Plc Group to develop and
commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation.”
b. Mochida’s Annual Review 2019 affirmed:
“Mochida also entered into an agreement with Amarin Corporation Plc for the development and commercialization of EPA-based drug products in the United States and certain other territories by Amarin Corporation Plc.”
c. Nota Bene: Mochida’s 2019 wording replaced:
- “high-purity EPA products” by “EPA-based drug products” and,
- “under Mochida’s intellectual properties, including new EPA formulation” by “certain other territories by Amarin Corporation Plc.”
d. Mochida Annual review 2020 specified:
“Mochida also entered into an agreement with Amarin Corporation Plc for the development and commercialization of high-purity EPA formulations in the United States and certain other territories by Amarin Corporation Plc.”
It also listed Amarin as part of its “alliance partner” group.
e. Nota Bene: Mochida went back to using “high-purity EPA formulations” in lieu of “EPA-based drug products” but continued to ignore “under Mochida’s intellectual properties, including new EPA formulation.”
f. Strangely, the Mochida Integrated Report for 2021, 2022, and 2023 NO LONGER MENTIONS Amarin in any way.
3. In summary:
a. It is clear that Mochida had had second thoughts as early as 2019 regarding Amarin’s ability to fulfill its part of the 2018 Agreement “to develop and commercialize high-purity EPA products in the US and certain other countries under Mochida’s intellectual properties, including new EPA formulation.”
b. Mochida has been concerned by Amarin’s inability to promote Vascepa in the U.S. and avoid the erosion of its market share in the face of generics. Cutting off its nascent advertising spending, completely eliminating its sales force, and offering rebates to maintain 75% of the market at the expense of margins only corroborate this assessment. Moreover, declarations by Karim Mikhaïl and Per Wold Olsen that the U.S. market is lost could hardly have reassured the Japanese partner. To the contrary, these will back up future attempts by Mochida to have the 2018 Agreement declared legally void and nil.
c. What concerns Mochida most is the reference to the terms “intellectual property” which were erased in its Integrated reports for 2019 and 2020. Worse, Mochida no longer mentions a word about Amarin altogether since 2021. Gone are the short days when it was looked at as a collaborator and ally.
d. In this perspective, Mochida reasserted its attachment to and defense of its “intellectual property” rights by applying for U.S. patent protection for its MND-2119 (Epadel EM) product on July 17, 2020. The latter was granted on February 27, 2024.
e. Amarin, for its part, insists yearly on stating: “Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories.”
f. Questions impose themselves here:
- What is the state of relationship obtaining between Amarin and Mochida and where is it heading?
- Can the “exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories” be valid if Amarin is unable to put them to good use as well as promote its only product in terms of publicity/awareness (educating doctors, pharmacists, insurers and patients), and sales?
- To what extent is Amarin dependent on Mochida’s R&D capabilities? Does this reliance in a deteriorating relationship explain why Amarin scraped its Fixed Dose Combination program which KM and Executive Vice President, President R&D, Chief Scientific Officer Steve Ketchum had touted so much before?
- To what extent is LR-EtEPA’s development linked to Mochida’s R&D capabilities, and hence affected by this blurred and strained relationship?
- As Mochida obtained U.S. patent approval for Epadel EM who will eventually commercialize this product in the U.S. and “certain other territories”? And with what sales force?
- Mochida’s products being limited to the VHTG indication, can Vascepa’s 4mg compete against Epadel EM one-a-day in this market segment in the U.S., Europe, China and ROW?
- What do “certain other territories” cover?
- Is/are litigation(s) next to clarify the Mochida-Amarin collaboration?
g. For information:
- Mochida has 17,000+ employees.
- Mochida declared in its Integrated Report 2023: “We are also leveraging our alliances to globally expand our EPA drug with high purity in China, Thailand, Vietnam and the United States. In Thailand, the subsidiary of Meiji Seika Pharma Co., Ltd. obtained approval to import and market our EPA drug for the treatment of hypertriglyceridemia in October 2020 and commenced sales in April 2021. In Vietnam, an alliance partner of Meiji Seika Pharma is in the process of applying for approval to import and market our EPA drug.” It is worthwhile noting here Mochida does not identify who are its high-purity EPA drug marketing partners in the U.S. and China.
- Meiji Seika Pharma Co., Ltd (Japan) promotes and sells, inter alia, Mochida’s products overseas through a network of consolidated subsidiaries that cover India, most of the Far East (4 in China), Oceania (Australia & New Zealand), Europe and Africa. Production facilities are also found in India, Thailand and Spain.
- Amarin made the following payments to Mochida:
• “a non-refundable, non-creditable upfront payment of approximately $2.7 million” “upon closing the collaboration agreement” in June 2018.
• $1.0 million for “certain product development milestones achieved under the Agreement” in January 2020.
• $1.0 million for “exercising certain rights under the agreement” in December 2020.
- Amarin filed 9 U.S. provisional patent applications for LR-EtEPA during the period January 26 – June 2, 2022. It could not have done so if LR-EtEPA were the same product as MND-2119 for which Mochida had applied on July 17, 2020 – both priority claim and prior art would have impeded this.
- We do not know the status of these applications. After one year the United States Patent and Trade Mark Office (USPTO) must inform Amarin as quickly as possible if it is allowed, or not, to pursue the process. If allowed, Amarin must file a “final” so-called ‘regular” non-provisional application.
- Once the regular application is examined by a patent examiner, it is typical for the patent examiner to issue at least one Office Action. An examiner’s Office Action is a detailed report that outlines objections to the form of the application or the form or substance of the patent claims. It usually includes citations of prior art, often prior patents and published patent applications, that the examiner alleges to be relevant to the patentability of what’s claimed in the subject patent application.
- An Office Action is usually received by the applicant within 17 months of filing a regular patent application in the United States. The USPTO may request a new cycle of argumentations that would lead to a second final Office Action stating allowance or rejection of the patent application.
- Noteworthy, it took 43 months for Mochida to be granted USPTO protection for its MND-2119.
- As regards the rest of the world, Amarin used the PCT process on January 26, 2023 to ensure worldwide priority claim for LR-EtEPA based on the 9 non-provisional U.S. applications. This became effective with WIPO’s international publication of Amarin’s application on August 3, 2023.
- It is up to Amarin to move forward with applications for patent protection in certain individual countries and/or regional groupings as recognized by the PCT. Unfortunately, we lack total information regarding Amarin’s moves and intentions in this regard.
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