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rafunrafun

10/29/19 10:45 PM

#221786 RE: jessellivermore #221784

JL - The judge isn't allowing this 12 week thing. It was only a hypothetical example used by him.

Hamoa

10/29/19 11:02 PM

#221788 RE: jessellivermore #221784

Appreciate your concern, but judging by today's ruling, it is, in my view, highly unlikely that doctors will be seeing a generic Vascepa any time before 2029. Generics will simply not be able to get past the induced infringement barrier in Vascepa's patents. Virtually all prescriptions for Vascepa will be for the purpose of treating chronic conditions. And any generic is legally required to have essentially the same label as the brand name drug. As such, there is no way the generic manufacturers can successfully argue that doctors will not, in most cases, prescribe the drug for more than 12 weeks based on that label, and based on what the drug is proven to treat.

As much as people might distrust the legal system, our courts are in fact rooted in fairness, reasonability and logic. The courts language today demonstrated a clear understanding of Amarin's arguments and support for the notion that a generic company shouldn't be allowed to sneak into the market through a loophole if the real world result is that a patent gets violated. Bottom line is that, between now and 2029, if doctors are going to widely use purified EPA for treating chronic conditions, it will, by law, have to be in the form of Amarin-manufactured Vascepa.

Older/Poorer/Wiser

10/29/19 11:13 PM

#221791 RE: jessellivermore #221784

What he (JL) said....

Any crack in the door for generics will be the end of the branded V franchise. Like he said, there aren't any interests (FDA, insurers) in the room who care to police the duration of a Rx, and Amarin isn't going to be in the business of prosecuting their direct or indirect clients.

And I am very long this stock. Feeling rather queasy right now. Hope the judge's body English about the reality of prescribing for chronic conditions carries the day at trial.

On the 5% question - - - I don't know where 5% is substantial other than in large population studies. Some cable TV networks would kill for a 5% share. However if V is as good as it seems to be, that 5% might be an awful lot of people. There has to be prior case law on both of these issues.

In fact - what about the dosage itself? Isn't it possible that some portion of that 5% cohort that showed a rapid decrease in TG's were simply smaller (in size) than the rest? High TG's doesn't mean you have a large body. Easy to see how somebody who weighs 120 lbs vs. somebody 240 lbs., on the same 4gr/day dosage, would have a more rapid response due to double the dose/lb. This seems almost too simple a point to raise, but wouldn't AMRN have some observations about that?? I have not seen anything about body-mass dependent dosing of Vascepa.