Replies to post #241445 on Amarin Corp Plc (AMRN)

[Bouf]

Less than 12 weeks for any new medicine seems like a short period, and hopefully the judge has good enough common sense to get this.

[ggwpq]

According to the Sanofi case which was brought up by poster Orkafit (can moderator kindly stickied his fine post):

"The Sanofi Court concluded that Defendants' labels would encourage SOME physicians to prescribe the drug to patients with risk factors, and will thus inevitably lead to infringing uses. The Court expressly stated: "[e]ven if [Defendant] were correct that the [language in the label] may be applied to other dosing regimens, the language ... would inevitably lead some consumers to practice the claimed method." The Sanofi decision clearly emphasizes the legal standard, i.e., that the proposed label would inevitably lead SOME physicians to infringe."

[HDGabor]

r- & Whalatane

Someone please give me a scenario in which a reasonable doctor prescribes V for < 12 weeks.

Dr Reddy seems to me to be making the argument that Vascepa can be prescribed for less then 12 wks for a patient at risk of pancreatitis … Thats my take on Dr Reddy's argument

The 12 weeks is not relevant anymore … it was relevant for contributory infringement claim but that was closed / decided by the summary judgement. There is no real dispute that Vascepa — and therefore Defendants’ ANDA drugs — are, and can be for legitimate reasons, prescribed for fewer than 12 weeks. That means that reducing triglycerides in less than 12 weeks using Defendants’ ANDA drugs is a substantial non-infringing use of those drugs. The existence of this substantial non-infringing use for Defendants’ ANDA drugs therefore defeats Plaintiffs’ contributory infringement claim. Because there is no genuine dispute of material fact on this issue, the Court granted Defendants summary judgment that, they do not contributorily infringe Plaintiffs’ Asserted Claims.

The current claim (the topic during the trial): inducement … 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).

Best,
G

[jessellivermore]

raf...

More to the point...The "Marine" label make absolutely no claims for clinical benefit...It is an outlier label...Basically says it is for very high trigs with lifestyle changes...but states very clearly there is no proof of clinical benefit...For high trigs or anything else...

All it really says is this stuff can lower high trigs...there is no clear proof this will make your condition better...

I'm not sure how this label justifies using it for CVD...Only the post R-I
label justifies use for CVD and that would be long term use....

":>) JL