Amarin Corp Plc (AMRN)

[HDGabor]

MontanaState83 & amarinbullfromchicago & rosemountbomber (ps.: Biobillionair & Relic & ziploc_1)

If the question on inducement comes down to whether or not the label could be the cause, how does one prove that one way or the other?

Wouldn’t all hell break loose if she dismissed the induced infringement?

The last description of Day 2 posted by HDG sure does not instill mounds of confidence in the outcome.

The question comes down to whether or not the label could be the cause, since that is the way how the generics could commit inducement.

In this type of Hatch-Waxman Act patent litigation, where Defendants have filed ANDAs, the question of whether Defendants may be held liable for inducing infringement turns on whether Defendants “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” in a way that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the label encourages, recommends, or promotes infringement.” Id. (citation omitted). And because the Asserted Claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” Id. (citation omitted).

Since Amarin has to win both argument (inducement & obviousness) the Judge has to grant Amarin inducement theory to avoid generics' entry. [I see obviousness as the easier part. Meanwhile generics could refer to small studies, small pieces these are - maximum - good to raise questions, to establish theory but these are not (far away from) a “clear-and-convincing-evidence”].

Inducement: Meanwhile it is still "in the air", Defendants failed two times
(i) Summary Judgement was denied as

Plaintiffs’ proffered expert testimony creates a genuine issue of material fact inappropriate for resolution at summary judgment as to “whether the label encourages, recommends, or promotes infringement.”

“The purpose of summary judgment is to avoid unnecessary trials when there is no dispute as to the facts before the court.” … The Court finds it more appropriate to consider expert testimony from both sides as to whether induced infringement may be inferred from the labelling at the upcoming bench trial, and resolve the meaning of the labelling at trial.

(ii) Generics' Motion to immediately dismiss the induced infringement claim was denied as "the plaintiff has met the initial burden of proof."

Let's see what will be the Judge's conclusion (if any) after the examination of the defense's expert cardiologist witness. She was not convinced by generics previously as / due to

The Court finds this argument intuitively persuasive—chronic conditions require indefinite treatment.

Defendants primarily rely on Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp., … The Court is not persuaded. There is a meaningful distinction between the labelling in this case and the labelling at issue in Takeda … Therefore, Plaintiffs’ proffered expert testimony supplements a plausible interpretation of the labelling, instead of providing an explanation of the labelling not consistent with the labelling, like the expert testimony did in Takeda.

I was not aware of the possibility that Judge could rule during the trial …
After the examination of the defense's expert cardiologist witness the Defendants could request (again) to immediately dismiss the induced infringement claim … and if it will be denied (or without Ds' Motion) Amarin could request to immediately grant the induced infringement claim.

IF the Judge grant induced infringement claim (today / tomorrow ?) the likehood of settlement will increase significantly.

Best,
G

ps.:

Biobillionair: Just check out the full docket and please give your opinion

I won't check … see relocatedmetsfan's posts (#241133 and #241144. It is not about "change in Trig levels to 135" … no way that generics request TG 136, meanwhile V did not get it.

Relic: how would generics get around the EPA purification method patents?

I do not opine on purification (or on composition) patents … but according to my best knowledge these are not a topic in the current case and I do not see any good reason (on Amarin side) to leave it out if these could stop - with 100% certainty - the entry of the generics

ziploc_1: It would be naive to think that in 2014 when the Generics filed their ANDA...they did not see the potential for a wider market than Marine and this played into their motive for filing the ANDA.

Do you think R-IT was obvious? Everybody saw / expected the huge indication / market potential?
How about ANDAs for Lovaza ("MARINE" label)? Do you think generics expected that GSK will make an outcome trial and that will be successful?
Your view isn't naive, but is a biased / "wishful" thinking without any basis and rational.