Replies to post #280463 on Amarin Corp Plc (AMRN)

[MontanaState83]

Hamoa - Thx! Still seems pretty f’d up to me when they discuss different approaches by different panels. They need to get their act together.

That said, in its entirety, this seems positive for us?

[venus537]

It sounds like it would be beneficial for Singer to reference this case as precedent???

[Restingzebra]

Excellent post as always. Thank you. Most informative.

[Bill B]

The district court's error is understandable because this court has inconsistently articulated the burden of proof applicable to an obviousness defense in district court litigation. It was error nonetheless.

That's the key takeaway. That sentence highlights the divide in the court and re emphasises the importance of the judicial panel we draw. Nothing I have read alters that imo.

[HinduKush]

Great explanation Hamoa,
So as I see it there are three major problems:
(1) Assumption of obviousness based on flawed factual and statistical interpretation of data (Mori Kurabayashi) and flawed extrapolation of incomplete data (Hayashi) to entirely different TG>500mg/dl population (considered by Du and flatly rejected). Just because Amrn didn't produce one of the inventors at trial e.g. Mehar Manku in court or did not/could not expressly point out the statistical flaws in generics/Du's interpretation, does not detract from obvious factual error of analysis which stands on itw own merits)
(2) Shifting of burden of proof of obviousness to Amrn which occurred de facto the minute Du used a weighing system of her own creation, to assess a relative importance basis for the secondary objective indicia, without considering them in totality.

....even panels that have used the “prima facie” and “rebuttal” language generally have made clear that a fact finder must consider all evidence of obviousness and nonobviousness before reaching a determination. For example, in Iron Grip Barbell Co. v. USA Sports, Inc., while the panel did hold that “there is no objective evidence to rebut the strong showing of obviousness based on the prior art,” 392 F.3d 1317, 1325 (Fed.Cir.2004), it also cautioned that, in “determining the question of obviousness, inquiry should always be made into whatever objective evidence of nonobviousness there may be.” Id. at 1323 (quoting Vandenberg v. Dairy Equip. Co., 740 F.2d 1560, 1567 (Fed.Cir.1984))

(3) Failure to consider the secondary indicia SIMULTANEOUSLY with the prima facie evidence of obviousness (prior art etc..). Had Du done this honestly, she might have stopped to question her prima facie obviousness construct in the first place.

In Stratoflex, Inc. v. Aeroquip Corp., we held that a fact finder in district court litigation may not defer examination of the objective considerations until after the fact finder makes an obviousness finding:
It is jurisprudentially inappropriate to disregard any relevant evidence on any issue in any case, patent cases included. Thus evidence rising out of the so-called “secondary considerations” must always when present be considered en route to a determination of obviousness· Indeed, evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to have been obvious in light of the prior art was not. It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art.

The premature nature of the court's obviousness finding is apparent. Before it reached the objective considerations, the district court stated that the claimed PK profile “would have been obvious to one of skill in the art at the time of the invention” and that “a person of ordinary skill in the art would have been motivated to take a group of known elements to create an extended release version of cyclobenzaprine, and [would have had] a reasonable expectation of success in doing so.” It was not until after the district court found the asserted claims obvious that it proceeded to analyze the objective considerations, or what it called the “secondary considerations.”