Amarin Corp Plc (AMRN)

[HDGabor]

N-

Hikma is not an impossible position. That is why the magistrate recommend that the case proceed. Take a look at the ruling in GSK v Teva. This ruling blurred the law on infringment.

IIRC there - GSK v Teva - was an "explicit" promotion of the off-label use. I am not aware of the full details of the Hikma case, so could not say or deny it is the "same" or different situation but I am sure an "explicit" promotion by Hikma should be exist to win the case. The gV availability, market size, etc. is not enough in this case.

The FDA position on off label prescriptions has nothing to do with patent law

I did not say it do ... but the logic (and the topic: off-label use) behind it is the same as in case of infringement.
promotion = resulted in off-label use, violation of the FDA law / patent law
no promotion = off-label use is exist but the manufacturer does not liable for it, does not violate the FDA law / patent law

Best,
G