Amarin Corp Plc (AMRN)

[HDGabor]

H-

I don’t think the timing of the ANDA filing relative to REDUCE-IT results is material. In the case of either RI indication or MARINE, Defendants are attempting to make a specious argument to gain access to a very small market that conveniently sits beside a much larger market that should be legally off limits.

The Hatch-Waxman Act supports this approach … Section 505(j)(2)(A)(viii) of the Food, Drug, and Cosmetic Act, aka the “Section VIII Statement,” protects generic drug companies from infringement lawsuits filed by innovator drug companies - as long as the ANDA applicant’s drug uses are not covered by the innovator patent(s). New ANDAs - if any … I do not expect any if Amarin will prevail in the current litigation - could be submitted for MARINE only with P VIII notice.

The current ANDAs requested everything that was possible at the time of their filing.

Best,
G