Shameless plug for cash to support motion 60 filing, read:
The EPA Drug Initiative II (EPADI II) is seeking to raise the funds needed to file a Rule 60 Motion in the U.S. District Court in Nevada. A Rule 60 Motion is used to seek relief from an already issued judgment or order when matters previously unknown to the Court subsequently come to light - such as legal error, fraud or misrepresentation, new evidence, or other factors. The deadline to file this Motion is March 29, 2021.
On March 30, 2020, U.S. District Court Judge Miranda Du issued an order invalidating certain patents previously granted by the US Patent Trading Office to Amarin Corporation. After her order was issued, it was discovered, among other things, that the science and testimony presented to the Court by Hikma Pharmaceuticals and its counsel was extremely problematic; and adding to the concern was Judge Du’s high reliance upon it to derive at her decision to invalidate the patents. The impact for Amarin has been very negative in that it has allowed generic manufacturers to enter the market and has cast doubt on Amarin’s ability to capitalize fully on other emerging market opportunities.
Setting aside the disappointing outcomes after Judge Du’s March 2020 decision (the denial of a Rule 36 Motion without an explanation by a three judge panel at the D.C. Federal Court of Appeals, the denial of an Amicus filed by EPADI II, a refusal by the same D.C. Court to hear the case en banc in spite of the inconsistent application of case law, and the curious legal strategy of Amarin), it is the view of the members of EPADI II that a Rule 60 Motion is particularly appropriate and will offer a fast and cost effective/high potential upside path to correcting the matter. Should this initiative be successful, we anticipate it will have the potential to effectively restore the depressed share price as well as reduce additional obstacles to other market opportunities. Another possible benefit of a Rule 60 Motion is that Judge Du will be required to speak to the rationale of her actions.
Some have expressed concern that the funding target of $100,000 for this initiative is significantly higher than the funds raised for the 2020 Amicus. In the following, to help to allay such concerns, we provide context to our strategy, an update as to the progression of this initiative, as well as impacts and alternatives depending on the level of funding actually achieved:
· Given what most of us believe to be the upside potential for Vascepa (treatment for Cardiovascular Disease, Inflammation caused by Diabetes, possible Covid-19 and Alzheimer’s treatments) and the competitive environment it faces, the goal of EPADI II is to mount the most robust and aggressive Rule 60 effort possible. In this regard, expert testimony will be very helpful, and the known cost for say two ‘world-class’ subject matter experts - if available - would consume a very significant portion of the funding target. We are hopeful of some corporate contributions; however, this is yet to be confirmed and the matter is extremely fluid. In the end, we will be able to ‘get what we pay for ‘.
· The individuals preparing the Motion are highly motivated and have now been working on it for months; and none expects a market scale compensation for time and effort. However, some provision that provides recognition is considered appropriate. Examples of activities to date include reviewing Court records and testimony and other related studies/reports; reviewing case law, researching, interviewing and negotiating with potential experts; strategic planning; and drafting of key deliverables of the overall Motion, which will include a ‘Rule 60 Intervention’, a ‘Pro Hac Vice’ associated briefs and, an expert(s) testimony report.
· The ‘bare bones’ cost to undertake this initiative with a reasonable expectation of a desirable outcome is about $23,000. Some of the more significant components of this amount (some of which have already been borne by the team) are presented in the following table, excluding taxes.
Estimated Minimal Cost for Rule 60 Motion
Item/Description
Estimated Cost
One ‘reasonable’ expert to review matters and prepare a fairly basic and specific report. (This cost could be higher if funding and individuals are available. )
$6,000 (semi-hard)
Committed costs for preliminary studies/reports and documentation
$2,500 (semi-hard)
Essential filing fees including temporary Nevada Bar and required local counsel costs
$3,000 (semi-hard)
Provision for other miscellaneous and unforeseen such as courier and potential travel
$1,500 (to be developed further)
Subtotal
$13,000
Provision to recognize professional services provided
$10,000
Grand Total
$23,000
Cognizant of the approaching deadline, we will realistically fine-tune the initiative according to the level of funding available. A higher level of funding can be expected to result in enhancements, up to and including two world-class experts providing testimony.
EPADI II hopes that the preceding comments will address any lingering concerns regarding this initiative and that we can count on your support both financially and to spread the word. Please use #AmarinRule60Fund on Twitter and track progress on the PACER site.
Vascepa Intellectual Property Justice Fund, organized by Jason Williams
The EPA Drug Initiative II (EPADI II) is seeking to raise the funds needed to file a Rule 60 Motion in the U.S. District Court in Nevada. A Rule 60 Motion is used to seek relief from an already issued judgment or order when matters previously unknown to the Court subsequently come to light - such as legal error, fraud or misrepresentation, new evidence, or other factors. The deadline to file this Motion is March 29, 2021.
On March 30, 2020, U.S. District Court Judge Miranda Du issued an order invalidating certain patents previously granted by the US Patent Trading Office to Amarin Corporation. After her order was issued, it was discovered, among other things, that the science and testimony presented to the Court by Hikma Pharmaceuticals and its counsel was extremely problematic; and adding to the concern was Judge Du’s high reliance upon it to derive at her decision to invalidate the patents. The impact for Amarin has been very negative in that it has allowed generic manufacturers to enter the market and has cast doubt on Amarin’s ability to capitalize fully on other emerging market opportunities.
Setting aside the disappointing outcomes after Judge Du’s March 2020 decision (the denial of a Rule 36 Motion without an explanation by a three judge panel at the D.C. Federal Court of Appeals, the denial of an Amicus filed by EPADI II, a refusal by the same D.C. Court to hear the case en banc in spite of the inconsistent application of case law, and the curious legal strategy of Amarin), it is the view of the members of EPADI II that a Rule 60 Motion is particularly appropriate and will offer a fast and cost effective/high potential upside path to correcting the matter. Should this initiative be successful, we anticipate it will have the potential to effectively restore the depressed share price as well as reduce additional obstacles to other market opportunities. Another possible benefit of a Rule 60 Motion is that Judge Du will be required to speak to the rationale of her actions.
Some have expressed concern that the funding target of $100,000 for this initiative is significantly higher than the funds raised for the 2020 Amicus. In the following, to help to allay such concerns, we provide context to our strategy, an update as to the progression of this initiative, as well as impacts and alternatives depending on the level of funding actually achieved:
· Given what most of us believe to be the upside potential for Vascepa (treatment for Cardiovascular Disease, Inflammation caused by Diabetes, possible Covid-19 and Alzheimer’s treatments) and the competitive environment it faces, the goal of EPADI II is to mount the most robust and aggressive Rule 60 effort possible. In this regard, expert testimony will be very helpful, and the known cost for say two ‘world-class’ subject matter experts - if available - would consume a very significant portion of the funding target. We are hopeful of some corporate contributions; however, this is yet to be confirmed and the matter is extremely fluid. In the end, we will be able to ‘get what we pay for ‘.
· The individuals preparing the Motion are highly motivated and have now been working on it for months; and none expects a market scale compensation for time and effort. However, some provision that provides recognition is considered appropriate. Examples of activities to date include reviewing Court records and testimony and other related studies/reports; reviewing case law, researching, interviewing and negotiating with potential experts; strategic planning; and drafting of key deliverables of the overall Motion, which will include a ‘Rule 60 Intervention’, a ‘Pro Hac Vice’ associated briefs and, an expert(s) testimony report.
· The ‘bare bones’ cost to undertake this initiative with a reasonable expectation of a desirable outcome is about $23,000. Some of the more significant components of this amount (some of which have already been borne by the team) are presented in the following table, excluding taxes.
Estimated Minimal Cost for Rule 60 Motion
Item/Description
Estimated Cost
One ‘reasonable’ expert to review matters and prepare a fairly basic and specific report. (This cost could be higher if funding and individuals are available. )
$6,000 (semi-hard)
Committed costs for preliminary studies/reports and documentation
$2,500 (semi-hard)
Essential filing fees including temporary Nevada Bar and required local counsel costs
$3,000 (semi-hard)
Provision for other miscellaneous and unforeseen such as courier and potential travel
$1,500 (to be developed further)
Subtotal
$13,000
Provision to recognize professional services provided
$10,000
Grand Total
$23,000
Cognizant of the approaching deadline, we will realistically fine-tune the initiative according to the level of funding available. A higher level of funding can be expected to result in enhancements, up to and including two world-class experts providing testimony.
EPADI II hopes that the preceding comments will address any lingering concerns regarding this initiative and that we can count on your support both financially and to spread the word. Please use #AmarinRule60Fund on Twitter and track progress on the PACER site.
Vascepa Intellectual Property Justice Fund, organized by Jason Williams