Amarin Corp Plc (AMRN)

[Number sleven]

Tatsumaki, Hatch Waxman did create the "skinny label" in section 8. It is legal to obtain an ANDA approval through this pathway. FDA doesn't police those labels for infringement. That has been left to the courts. Hatch Waxman isn't a safe harbor that allows generic infringement without consequences. The court doesn't have the authority to mandate a label change. Take a look at the ruling in GSK v Teva.
Sleven,