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 and her selective and inconsistent application of case law 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 an appeal using Rule 36 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 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.
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 cost to undertake this initiative with a reasonable expectation of a desirable outcome is about $23,000. 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. A summary of the budget follows:
Expert witness - $6,000
Committed costs for preliminary studies/reports and documentation - $2,500
Essential filing fees, temporary Nevada Bar and required local counsel - $3,000
Other miscellaneous and unforeseen such as courier and potential travel - $1,500
Subtotal - $13,000
Provision to recognize professional services provided - $10,000
Subtotal - $10,000
Grand Total - $23,000
We hope that the preceding comments will address any questions or 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.
- Elvis Rodriguez
- Randy Vance
- John F. Thero
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