Amarin Corp Plc (AMRN)

[HinduKush]

"While the district's court language is imperfect, the presumption of validity does not relieve the patentee of any responsibility to set forth evidence in opposition to a challenger’s prima facie case which, if left unrebutted, would be sufficient to establish obviousness."

In Zup the CAFC panel lays out how the burden of proof should fall:

Any concerns regarding improper burden allocation
can be quickly dismissed. Our precedent is clear that “the
burden of persuasion remains with the challenger during
litigation because every issued patent is entitled to a
presumption of validity[.” Novo Nordisk A/S v. Caraco
Pharm. Labs., Ltd., 719 F.3d 1346, 1353 (Fed. Cir. 2013).While this burden of persuasion remains with the challenger,
a patentee bears the burden of production with
respect to evidence of secondary considerations of nonobviousness.
Here, the district court adhered to our
precedent in analyzing the evidence presented. Although
ZUP takes issue with the court’s statement that “ZUP has
failed to establish either that a long-felt but unresolved
need existed in the water recreational device industry or
that its product somehow solved any such need,”

I agree with Zip's conclusions:
1. The Generics can't persuasively negate the clear error in the law by judge Du in weighing negative vs. positive S.C.
2. the Generics can't persuasively negate the clear errors of fact made in Mori and Kura by judge Du.
3. The Generics have to fall back on arguments that the effect of the S.C. was unimportant in this case...and that the errors of fact in the prima facie evidence "were not really (serious) errors".
4. these arguments by the Generics are not convincing.

For me as non-legal reader these patent appeal cases are very interesting, because each one turns on a different analytical point e.g in either prima facie obviousness analysis errors, or lack of one of several secondary objective indicia. For example in Zup the absence of demonstrable unresolved long felt unmet need was the determinitive issue. In Amrn's case, it is the the Unexpected Benefit which is/will be the clincher and IS the reason why you cannot assign a point system to the SC objective indicia, becuase the relative weighting of the SC's varies with the facts of each case. One cannot simply assign points add, subtract, and play off each other to get the answer. Unless your are a simpleton.....