Amarin Corp Plc (AMRN)

[HinduKush]

Breath,

Specific factual matters do not need to be shown by clear and convincing evidence

Requiring the patients in Mori to have triglycerides greater than 500 mg/dcl before Mori can be considered in an obviousness analysis confuses the patent law concept of anticipation (where a prior art reference must show exactly the same thing as in a patent claim) with obviousness (where a prior art reference need only suggest what is in a patent claim).

The law seems to be an exercise in random subjective obfuscation occasionally punctuated by the need for objectivity, where “ clear and convincing” mutates to whatever suits the cause . A dose of reflection shows us that there are some facts that can be accepted and utilized as they stand ipso facto, even if their scientific basis or explanation is not understood eg “the sun rises in the East and sets in the West“ ( it was ever thus). While on the other hand there are others that need qualification before being accepted unequivocally; “he killed his wife” may be factual, but context needs to be added to determine if it was murder by intent or manslaughter. Context and level of evidence is everything. In the Amarin appeal case the CAFC must somehow be induced to re-examine the Du process of determining prima facie obviousness or risk overlooking the egrey intellectual errors of logic and reasoning that lead to an erroneous conclusion.
So, while it may be anticipated that EPA possibly in mildly hyperlipidemic men ( TG~ 170mg/dl) doesn’t raise LDL, it is by NO means obvious that EPA ( per MARINE indications) doesn’t raise LDL in men and women with TG’s > 500 mg/dl— especially when it is unequivocally known without a shadow of any scientific doubt medically that every available FDA approved TG lowering therapy circa 2000 INCREASED LDL. This logic was not lost on the patent examiners of the USPTO at the time.

If the Law does nothing else it must make sure proper procedures are followed in evaluating and presenting evidence without corruption or scientific compromise, so that the Judge can make an informed determination. After all we wouldn’t let it be otherwise in a murder case, why change standards for patent cases involving life saving medicines?
I rest my opinion. It is also redundant to say that it is morally incumbent on judges to have or obtain decent scientific and statistical knowledge before accepting one side of the argument.
HK