Replies to post #240182 on Amarin Corp Plc (AMRN)

[Older/Poorer/Wiser]

Hamoa,

I wish I knew how to embed quotes into a post in order to maintain the continuity of the discussion. My apologies for that.

The problem here is that defendants didn't know the larger market existed when they filed the ANDA for the relatively inconsequential market.

They fell into it. I hope the Judge infers some nefarious intent to pursue that market in part due to defendants assessment of the possibility the R-IT trial amounted to something.

[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

[Restingzebra]

Well done again. Thanks.