Amarin Corp Plc (AMRN)

[HinduKush]

Zup vs NASH is in a different basket than the Amrn case, because the prima facie obviousness analysis was the ultimate determinant and there were no real secondary objective indicia considerations of import to debate by the CAFC who then focussed on the evidence for prima facie obviousness mostly:

Here, there appears to be no dispute with respect to
the content of the prior art or the differences between the
prior art and the ’681 patent. And, the parties agree that
the relevant level of skill in the art is “a person with at
least 3–5 years’ experience in the design and manufacture
of water recreational devices or [who has] a bachelor’s
degree in mechanical engineering.” ZUP, 229 F. Supp. 3d
at 438; Appellant’s Br. 13. The only issues raised on
appeal pertain to (1) whether a person of ordinary skill in
the art would have been motivated to combine the prior
art references in the way claimed in the ’681 patent, and
(2) whether the district court properly evaluated ZUP’s
evidence of secondary considerations.

Here, the CAFC outlines how to think about secondary objective criteria where the prima facie evidence appears to be overwhlemingly "obvious":

Secondary considerations “help inoculate
the obviousness analysis against hindsight.” Mintz v.
Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir.
2012); see also Graham, 383 U.S. at 36. As explained
below, however, ZUP’s minimal evidence of secondary
considerations does not create a genuine dispute of fact
sufficient to withstand summary judgment on the question
of obviousness.

Here the CAFC states its view on the burden of proof for each party:

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,”

Judge Du should have given the USPTO patent at least a presumption of validity and then sought tangible evidence of factual oversight before invalidating the patent especially when the USPTO examiner goes to great pains to explain why (scinetifically) the patent was granted (the unique ApoB lowering effects in the context of the TG>500mg/dl necessity. Apart from stating that the USPTO did not discuss Kurabayashi (though acknowledging that it was cited in the references), no scientific basis for negating the patents was provided by Judge Du, other than the flawed satistical analysis of Kurabayashi)

In the case of the Amrn MARINE patents, by these standards of precedential opinion that Chief Judge Prost lays out (remember Judge Prost is a prima facie first protagonist), Singer et al will clearly have to show:
(1) The prima facie evidence never amounted to a level of outright obviousness by Zup criteria ,and that what Judge Du mistook for prior art, was not only NOT representative of the MARINE TG>500 population, the data presented never even showed scientifically what it was purported to show by the generics-c.f. Bhatt Nature paper(noting that Mori and Kurabayashi were a bust scientifically even by TG<150 mg/dl standards)
(2) The secondary objective criteria were wrongly applied and their pari passu use in negating each other and/or confirming the prima facie case was not only absurd but not warranted by prior SC opinion or any prior CAFC case opinion precedent.
(3) Where the prima facie evidence for obviousness is so marginal and contentious, the secondary objective criteria of obviousness are the decider; in this case, because there is a very clear motivation to combine (to effectively treat TG>500 while not raising LDL and lowering ApoB) generating an equally demonstrable long felt and truly unmet need, and further a long succession of failed attempts which never pulled a single therapeutic success bythe above mentiopned criteria for over two decades of trying including every Lovaza trial out there.
(4) Hindisght bias combined with clear and demonstrable factual errors corrupted the prima facie analysis of obviousness, while improper procedure in analyzing secondary objective indicia, compounded the problem by improper shifting of the burden of proof to the patentee.
HK