TalShu
20 hours ago
Please find below some informatin that should clarify the difference between Lr-EtEPA and MND-2119.
Excuse the way am presenting it; I am doing this in a hurry as I have to go out shortly.
LR-EtEPA Patent Timeline
Reference Amarin’s U.S. and international patent applications for an LR-EtEPA technology/invention for “LYMPH-RELEASING COMPOSITION OF FATTY ACIDS AND USES THEREOF FOR LYMPHATIC INCORPORATION AND SYSTEMIC DISEASE TREATMENT.”
Amarin is here claiming, inter-alia, that “Lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA), in some embodiments, increase EPA uptake in tissues and treat various diseases including cardiopulmonary diseases, renal diseases, neurological diseases and cancer.”
A. Applying for patent protection in the U.S.
Being the first applicant for an invention is especially important since there may be other pharmaceutical companies developing similar technologies at once. Since patent rights are granted to the first entity that files a patent application for an invention (assuming all requirements for the issuance of a patent are met), filing an initial United States provisional patent application can allow an applicant to obtain the earliest possible priority date since a provisional application may be prepared in less time and filed in an INFORMAL form.
The benefit of claiming priority is to take advantage of the filing date of the initial provisional patent application and consequently receive protection for the subject matter in the initial patent application.
Consequently, Amarin filed 9 U.S. provisional patent applications as follows:
Patent 63/303,365 filed on 26 January 2022 (01.26.2022)
Patent 63/303,383 filed on 26 January 2022 (01.26.2022)
Patent 63/304,042 filed on 26 January 2022 (01.26.2022)
Patent 63/334,065 filed on 22 April 2022 (04.22.2022)
Patent 63/334,071 filed on 22 April 2022 (04.22.2022)
Patent 63/340,292 filed on 10 May 2022 (05.10.2022)
Patent 63/340,304 filed on 10 May 2022 (05.10.2022)
Patent 63/342,509 filed on 16 May 2022 (0516.2022)
Patent 63/348,908 filed on 03 June 2022 (06.03.2022)
Thanks to StockTwits board member SanDiegoLiving’s post of the 6th instant https://register.epo.org/documentView?number=US.202318472875.A&documentId=LWIIVHGXGREENX5 it is at present known that:
- On 09.22.2023 Amarin proceeded to file a NON-PROVISIONAL or REGULAR patent application under Number 18/472,875.
- USPTO issued a NOTICE OF PUBLICATION OF APPLICATION for
“LYMPH-RELEASING COMPOSITION OF FATTY ACIDS AND USES
THEREOF FOR LYMPHATIC INCORPORATION AND SYSTEMIC
DISEASE TREATMENT” which now has an OFFICIAl Publication No. US-
2024-0165066-A1 and a 05.23.2024 Publication date.
- The patent application now enjoys a “pending” status as certified by the “A1” code at the end of the publication number.
- Accordingly, Amarin is given privileges as if a patent was granted on the date of publication of application. Thus, in case of suit for
infringement, the patent owner can claim damages from the date of publication of patent application or date of infringement whichever
is earlier.
- Publishing a patent application basically announces to the world that innovations in the above-mentioned area of technology may be
covered by patent rights. It puts Competitors on Notice and Discourages New Competitors.
As a reminder, in the United States, examination is requested automatically when filing a regular or non-provisional patent application (done on 09.22.2023). USPTO must accept or reject it within a period not exceeding 12 months. By issuing the 05.23.2024 NOTICE OF PUBLICATION OF APPLICATION USPTO has given the non-provisional application a final/regular status within the legally imposed time framework.
Next, the non-provisional application will be examined by a patent examiner who typically issues at least one Office Action. An examiner’s Office Action is a detailed report that outlines objections to the form of the application and/or the substance of the patent claims. It usually includes citations of prior art, often of 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 (on 09.22.2023). The USPTO may request a new cycle of argumentations that would lead to a second and final Office Action stating allowance or rejection of the patent application.
As a reminder, Amarin has in the past used USPTO’s TRACK ONE Prioritized Examination that allows it to get a final disposition within about twelve months.
B. Applying for patent protection in the rest of the world
The World Intellectual Property Organization’s (WIPO) Patent Cooperation Treaty (PCT) is a mechanism that enables an applicant to file a single regular patent application and have that application flow through to its chosen countries and regions as a regular patent application through either a national or regional phase entry filing made at a later date, once those countries and regions are identified. The time limit for entering the national or regional phase is generally 30 months from the priority date. For the EU it is 31 months.
Amarin proceeded with an application for LR-EtEPA on 01.26.2023.
WIPO/PCT issued an International Publication on 08.11.2023 with a priority date of 01.26.2022 corresponding to the first provisional application made in the US.
It remains Amarin’s strategic decision to designate the countries or regions in which it would like to proceed with filing a national or regional phase entry patent application, and to choose the paths to fast-track the processes and reduce their costs.
While a provisional patent application does not provide any immediate legal protection from infringers, it can preserve Amarin’s future patent rights in the United States and in foreign countries by establishing an earlier priority filing date.
In short, Amarin had secured priority claim for its LR-EtEPA technology/invention in the US and the remaining 156 members states of the Patent Cooperation Treaty. Yet, whether Amarin has proceeded with national and regional applications or not remains an unknown given the BOD’s silence.
In fact, much to shareholders’ regrets, Amarin has never talked about LR-EtEPA. Were it not for poster Laurent Maldague’s due diligence they wouldn’t know of its very existence. And were it not for the DD poster SanDiegoLiving digged up regarding the 05.23.2024 NOTICE OF PUBLICATION OF APPLICATION shareholders would not know where LR-EtEPA application stands today on the patent allowance timeline.
Sincere appreciation and thanks to both Laurent and SDL.
Finally, all that shareholders can hope for is that Amarin has extra diligent patent lawyers helping BOD and management in devising Amarin’s strategy. According to the above exposé Amarin appears to be very close to the U.S. finish line and must have initiated patent applications in the ROW before the WIPO/PCT deadlines come into effect.
How important is this correspondence in the BOD’s decision-making matrix remains to be seen.
All of the above is IMHO. I am not a lawyer. Any corrections are most welcome.
Best.
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Mochida Pharmaceuticals’ MND-2119 (Epadel EM) is a self-emulsifying formulation of highly purified EPA to treat cholesterol and triglyceride. It also prevents blood from clotting and suppresses blood clod sticking to the vessel walls.
Mochida presents it as follows:
Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The product is available in Epadel Capsules, Epadel S, and Epadel EM Capsules forms. Epadel S is indicated for "Hyperlipidemia" and "Ulcer, pain and chilliness associated with arteriosclerosis obliterans" in Japan. The active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and mass production capability. Since its launch in 1990, it has been taken by many patients.
For your information:
A. Announcement of Submission of New Drug Application for Epadel in China
This material is an English translation of the press release to be issued on July 2, 2024 in Japanese, and the Japanese release is given priority regarding content and interpretation.
July 2, 2024 Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. (Head office: Tokyo, Japan, President: Naoyuki Mochida, hereinafter: Mochida) announced that Mochida submitted a New Drug Application to the China National Medical Products Administration (NMPA) for Epadel S (development code: MND-21), a highly purified eicosapentaenoic acid (EPA) ethyl ester formulation that is being jointly developed in China by Mochida and Sumitomo Pharma (Suzhou) Co., Ltd., a Chinese subsidiary of Sumitomo Pharma Co., Ltd.
As the clinical phase III trial conducted in patients with severe hypertriglyceridemia in China has shown positive results, Mochida has submitted a New Drug Application for Epadel S.
Additionally, Mochida has entered into a distribution agreement for Epadel S in China with Meiji Seika Pharma Co., Ltd. (hereinafter: Meiji) in 2024. After approval, Mochida will supply the product to Meiji, which will distribute it through its affiliated partner in China, MAXMIND Bio-Technology (Hainan) Co., Ltd.
Mochida is committed to contributing to the improvement of the quality of life for Chinese patients with hypertriglyceridemia through Epadel S.
B. “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.”
C. Since 2020 Mochida dropped its prior reference to Amarin as a strategic partner. In fact, it no longer mentions it at all.
D. Meanwhile, Amarin continues to mention its collaboration with Mochida in its SEC reports.
E. Mochida started commercialzing Epadel EM in Japan in 2022.
F. Questions arise:
- who will commercialize it in the U.S.?
- how will Epadel EM compete with Vascepa/Vaskepa in China?
As a reminder, Mochida has never claimed a CVD indication.