Amarin Corp Plc (AMRN)

[HDGabor]

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