Amarin Corp Plc (AMRN)

[HDGabor]

A layman summary of the patent case (Part 3; See Part 1 here and Part 2 here)
[Mod - who sticked Part 2 - please replace with this]

Generics bear the burden of proving patents are obvious.
Generics have to prove with “clear-and-convincing-evidence(s)”* that ALL patents are obvious.
* The evidence presented by a party during the trial must be highly and substantially more probable to be true than not and the trier of fact must have a firm belief or conviction in its factuality. It is a higher level of burden of persuasion than "preponderance of the evidence"

Amarin bear the burden of proving patent infringement.
Amarin has to prove with “burden of proof”** that Generics will induce infringement of (at least) ONE claim.
** The standard is met if the proposition is more likely to be true than not true. The standard is satisfied if there is greater than fifty percent chance that the proposition is true (preponderance of the evidence).

The Patents-In-Suit (Asserted Claims)

6 patents … 10 Claims are the topic.

U.S. Patent No. 8,293,728 (“the ‘728 Patent”), Claim 1 & Claim 16
U.S. Patent No. 8,318,715 (“the ‘715 Patent”), Claim 14
U.S. Patent No. 8,357,677 (“the ‘677 Patent”), Claim 1 & Claim 8
U.S. Patent No. 8,367,652 (“the ‘652 Patent”), Claim 1
U.S. Patent No. 8,431,560 (“the ‘560 Patent”), Claim 4 & Claim 17
U.S. Patent No. 8,518,929 (“the ‘929 Patent”), Claim 1 & Claim 5

(i) All Claims are subject of “at least 12 weeks”;
(ii) 8 Claims (‘728 Patent Claim 1, ‘715 Patent Claim 14, ‘677 Patent Claim 1 & Claim 8, ‘652 Patent Claim 1, ‘560 Patent Claim 4 & Claim 17, ‘929 Patent Claim 5) are subject of “achieve the lipid effects required”
(iii) 3 Claims (‘728 Patent Claim 1 & Claim 16, ‘715 Patent Claim 14) are subject of “without concurrent lipid altering therapy”
arguments.

For simplicity let’s assume that Amarin could not prove inducement regarding “achieve the lipid effects required” and “without concurrent lipid altering therapy” … Generics’ labels do not encourage, recommend, or promote administering GV to achieve the lipid effects … Generics’ labels do not encourage, recommend, or promote administering GV without concurrent lipid altering therapy.

The remaining claim is the ‘929 Patent Claim 1:

A method of reducing triglycerides in a subject having fasting triglycerides of at least 500 mg/dl comprising, orally administering to the subject daily for at least about 12 weeks a pharmaceutical composition comprising about 4 g ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids.

‘929 Patent Claim 1 is not a subject of the (ii) and (iii) arguments … it is the subject of the (i) “at least 12 weeks” argument only.

I detailed (here) why I think Amarin will prevail in case of inducement … why Generics’ labels encourage, recommend, or promote administering GV for at least 12 weeks.

However I do not represent of expertise from various fields of scientific endeavor, is not offering a comprehensive analysis of companies in the healthcare sector … It is IMHO only.

So let’s see what is the conclusion by somebody who is “A representation of expertise from various fields of scientific endeavor, offering a comprehensive analysis of companies in the healthcare sector.” and who could not be chargeable with bias in favor of Amarin …

Our takeaway on these points is that Judge Du will find Defendants’ ANDA labels as inducing infringement regarding the “for at least 12-weeks” mention in the Vascepa patent claims.

ANDA labels show intent to induce infringement of the “12-weeks” limitation at all (its clearly obvious)

Conclusion: Amarin has to prove with “burden of proof” that Generics will induce infringement of (at least) ONE claim … Generics will induce infringement of (at least) ‘929 Patent Claim 1.

Best,
G