Amarin Corp Plc (AMRN)

[HDGabor]

First of all:
- I don’t have clue what I’m talking about but this is my opinion!!
- Excuse me for cluttering board with theories that are off point …
(Hopefully I did not forget any required statement … )

As I see / think (now):

The appeal will focus on three (main) topic (to make it clear I do not say that other things will not be included):

1.) Different patient population (different MOA)
2.) Procedural error
3.) “Unexpected benefit / result”

1.) Different patient population (different MOA)

Amarin –most likely correctly - argued that patients with severe TG levels metabolize drugs any differently than those with lower TG levels. The Judge saw it differently, her factual finding is (could be) wrong. However, it is a longshot …

a.) The Federal Circuit will technically defer to the Judge, and therefore only search for whether the Judge’s factual finding on this issue was clearly erroneous
b.) The USPTO had the same conclusion as the Judge.

I do not think the FC will come to different conclusion than the Judge and the USPTO … more likely will defer to the Judge’s finding.

2.) Procedural error

Did the Judge apply the Graham 1-3 and later the G4? Did she handled (considered) the secondary considerations correctly?

It is definitely a stronger argument than 1. (e.g.) the FC could not defer to the Judge, since it is a legal – and is not a factual – issue, however, is not B&W.

a.) Based on how the district court drafted its opinion, it is not necessarily clear that the Judge Du did not weigh the evidence of secondary considerations collectively with the first three Graham factors.
b.) There appears to be disagreement among the judges at the FC over whether it is improper for a district court to first determine that a prima facie case of obviousness exists before assessing secondary considerations … the opinion of the FC – looks like – will depend on the “mix” (of the 3 judges)
c.) As a “nature” of secondary considerations, these could not favor obviousness … lack of a given SC does not support obviousness, SCs could not have a negative weight. The Judge determined two SCs – “long felt need” “and “commercial” success” – and considered both as strong. The rest – the lack of the rest – are not relevant. The question: Are these two strong enough to balance the prima facie obviousness? Taken everything together (all Graham factors): Is there a “clear and convincing” evidence regarding obviousness? … The answer cold be a “NO” … but 3.) is important, relevant.

This argument is promising … but far from certain, applying the correct method … the outcome could be the same.

3.) “Unexpected benefit / result”

I see it as the most important thing.

a.) if it does not exist: make the prima facie obviousness stronger … but if exist: does not count for prima facie and makes SCs stronger … 3 instead of 2 … and it it the strongest, most relevant SC
b.) Meanwhile it is a factual findings, the FC could defer to the Judge, no way that the FC will not find / determine that Judge finding – “the Patent Office’s examiner did not consider Kurabayashi“ - was not clearly erroneous.

Why – most likely – the “unexpected benefit / result” exists … and strong?

a.) “the Patent Office’s examiner did not consider Kurabayashi“

Based on available information it could not be any doubt that Amarin submitted Kurabayashi b to the USPTO … listed as a considered study. If it is B&W: why the Judge said / determined it was not considered?
Most likely, she mixed the consideration with citation … the Patent Office’s examiner did not cite Kurabayashi … most likely, because he did not find it relevant, did not think it teaches anything … in the Office Action(s).

b.) “In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA.”

I could be very off – since I am an ESL – and it does not affect the core argument (below) but it is a very “tricky” sentence (worded by the generics), as it could be read: “In light of the statistically-significant differential effects reported between the EPA and control groups … the EPA arm was SS, meanwhile the control was NS - a POSA would have attributed the reduction in Apo B to EPA.” … and the Judge “missed” it, she read it as a SS different EPA vs control.

The reality – directly from Kurabayashi – “there was no significant difference between the groups”. Estriol (E3) and ethyl icosapentate + E3 2 differential effect on Apo-B could not be determined.
Furthermore, Kurabayashi did not say anything about Apo-B nor in the “Result”, nor in the “Conclusion”, nor in the “Discussion” sections.

Meanwhile I am not a POSA, I could not imagine that a NS (not significant) result of a study teach, suggest or motivate anybody (any POSA) ever.

Sum:
- Amarin has the best chance if win argument 3.)
- Argument 3.) will affect argument 2.)

Best,
G