Amarin Corp Plc (AMRN)

[Hamoa]

Additionally, anything Amarin might have said to the FDA in 2019 is by definition retrospective with respect to JELIS/REDUCE-IT learnings. Amarin likely was arguing that, combined, the two studies solidified the proven CV benefit of purified EPA.

Any argument Dr. Reddy’s would put forward would have to be, by definition, prospective, arguing that in a pre-Marine timeframe, a person practiced in the art could have looked at JELIS results and accurately predicted all the REDUCE-IT outcomes, obviating the need for REDUCE-IT.

Those are two very different arguments, the first being accurate on its face, the second being highly unlikely.

Furthermore, as the inventor, Amarin’s point of view at any time is irrelevant to the obviousness discussion, as invention typically begins with non-obvious, speculative theory on the part of the inventor, that becomes obvious only through invention.