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Lemmiwinks

01/11/20 9:50 PM

#240194 RE: venus537 #240189

high trigs is a chronic condition.....if diet, weight loss, and exercise are already on board...then you gonna have high trigs without medication...period. 99.999% of physicians know this. I know this and I’m an Emergency Medicine physician. Honestly, diet, excercise and weight loss can lead to one no longer needing blood pressure and oral diabetes meds....but high trigs...not so much.....after those three fail it’s mostly about your DNA. It’s more likely to be chronic than high BP or type 2 diabetes by 1000%. And those two are mostly lifelong once ya got em as well.
We loose this and I’m seriously considering moving to another country, albeit in a smaller than envisioned house
Lem-
"Look to my coming, at first light, on MONDAY. At dawn, look to the East."

HDGabor

01/11/20 9:58 PM

#240195 RE: venus537 #240189

v-

a doctor to follow the narrow generic label of prescribing Vascepa for less than 12 weeks

Generic did not request a narrow label (for less than 12 weeks), they requested the same label as V had (prior 12/13/2019) without any (direct) recommendation for treatment duration.

The "less than 12-weeks" was relevant for contributory infringement. Since it is exist (app. 5% of the treatment) Amarin's contributory infringement theory was denied (see summary judgement).

It is beyond any dispute that most of the cases the treatment is longer than 12-weeks, generics do not dispute it. The topic (top of obviousness) is: inducement.
The question: The label encourage, recommend, or promote infringement or do not?

However - based on Sanofi v. Glenmark Pharmaceuticals Inc., USA, case - generics have to prove that labels will NOT encourage ANY physicians to prescribe Vascepa for more than 12 weeks and will NOT lead to infringing uses.

Tough task ....

Best,
G