Amarin Corp Plc (AMRN)

[HDGabor]

The USPTO found in case of all patents that “prima facie” case of obviousness exists but finally granted based on secondary considerations … based on:
1- Unexpected results (Apo-B reduction) and
2- Long felt unmet medical need

The Judge found that “1- Unexpected results” does not exist as
- “Kurabayashi suggested that EPA reduced Apo B levels.”
- “Patent Office’s examiner did not consider Kurabayashi. … the PTO did not have all material facts before it, its considered judgment may lose significant force”
She agreed with the “2- Long felt unmet medical need” and found that “3- Commercial Success” also exists.

(I) “1- Unexpected result”

It is more a legal than a scientific question. A study about an x population does not prove anything about y population scientifically it is not acceptable but legally in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art prima facie case of obviousness exists … and it is ‘worse”: prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.

Let’s accept Amarin statement that the USPTO saw and considered Kurabayashi. The question: who – the USPTO or the Judge - considered correctly – from a legal aspect – Kurabayashi.
The scientific answer is plain and simple … the legal is …
Is the statistically significant Apo-B reduction (compared to the baseline) in the EPA arm within the “close enough” category?

(II) 1+2 > or = or < 2 +3 (1 > or = or < 3)

Secondary considerations do not have the same weight, importance. Most likely unexpected result (1) is the most prevalent form of evidence of nonobviousness ... commercial success (3) has less weight, relevance, could not “balance” (counter) the lack of unexpected result.


Meanwhile (II) could be a basis of an overturn I do not think it is likely, the appeal will be decided based on “Apo-B reduction (compared to the baseline) in the EPA arm” confirms or not the prima facie case of obviousness.

Definitely is not a simple question …

Best,
G