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HDGabor

01/11/20 8:30 PM

#240178 RE: Hamoa #240175

H-

In this case, there won’t be a person in that courtroom who does not fully grasp that Defendants’ intentions are to gain ill-gotten access to as much of the CV market

Meanwhile Defendants’ intentions could be (is) as you say … as of "today" (now), it could not be at the time of the ANDA (2016) … or anytime before 9/24/2018 (12/13/2019).

Best,
G
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Lemmiwinks

01/11/20 8:32 PM

#240179 RE: Hamoa #240175

That my friend, is the case in a nutshell!!!!!!
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Older/Poorer/Wiser

01/11/20 8:47 PM

#240180 RE: Hamoa #240175

I hope you are right, but sometimes people/companies/entities just fall into money for no reason at all. Nothing to do with their skill or predictive powers.

Generics didn't know R-IT results. They ended up with unchallenged rights (to a <12 week indication) that happens to have enormous profits for the CV indication when written off-label, as a great many Vascepa Rx's have been written the past year.

There is a distinct possibility they will just fall into the money pile here, through nothing to do with their business acumen. Careful evaluation of prior carve-out situations will likely play a large role in the Judge's thinking. Sanofi was more cut and dry because the generics included in the label some of the patent-protected drug administration details. Generics are lucky their ANDA was filed before R-IT, so they couldn't even imagine a label that would step into those AMRN patents. They seem careful to sidestep any MARINE/TG patent claims, as well.

I'd like to think the Judge sees this as potentially precedent-setting for discouraging patent workarounds. But in narrow terms it doesn't, because the generics didn't know about the new indication. They fell into it. Perhaps if some evidence or a line of argument can be introduced that all of the drama around the SPA and ANCHOR induced them (no pun intended) to put in a speculative ANDA just in case R-IT amounted to something, then this could be evidentiary rationale against them.

I'd rather be lucky than smart, but so far I haven't been either with Vascepa, and I hope the generics switch spots with me - but it will be a close call.