Amarin Corp Plc (AMRN)

[Hamoa]

I thought it might be helpful to post some thoughts regarding Amarin's possible strategy on appeal. The issues arising from the district court's decision seem to be fairly clear at this point. Do note, however, that we do not yet have the benefit of the trial transcript, which will likely be a source of significant additional information relating to Judge Du's decision. The trial transcript should be available via PACER in early May. Also note that issues relating to the "Graham" vs. "prima facie-rebuttal" approaches to obviousness, which will likely be central to this appeal, remain unsettled in the Federal Circuit. While Amarin will likely argue for a traditional Graham approach to determining obviousness in this case (which would put Judge Du's approach very much at odds with that standard), the composition of the Federal Circuit panel hearing the appeal could either work for or against Amarin based on leanings of panel judges. (This link provides a good overview of the Graham vs. prima-facie rebuttal issue: https://www.dlapiper.com/en/us/insights/publications/2018/12/federal-circuit-judges-disagree/

My personal view is that the procedural issues could be very helpful to Amarin, but given the unsettled nature of the Federal Circuit's approach to those issues, it would be hard to venture a guess as to the likelihood of success on procedural grounds. The errors of fact, however, provide a very strong line of attack on appeal, as they are quite clear, well substantiated, and very consequential to the outcome.  

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Amarin's strategy on appeal is helped by the fact that Judge Du relied so heavily on her interpretation of the results of the Kurabayashi study in reaching her finding of obviousness. By making Kurabayashi the lynchpin of her obviousness argument, Judge Du provided Amarin with a very clear target for a reversal argument.

The structure of Judge Du's obviousness finding looked like this:

1) Prior art renders Amarin's claims prima facie obvious
2) The USPTO also found Amarin's claims prima facie obvious
3) Despite its finding of prima facie obviousness, the USPTO granted the patents-in-suit based on secondary considerations that included "unexpected benefit". However, the USPTO did not consider Kurabayashi in its determination of non-obviousness
4) The entirety of Defendants' Kurabayashi argument is accepted by this court, and the court finds that "In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA."
5) With the removal of "unexpected benefit" from secondary considerations, and weighing Plaintiff's two acknowledged secondary considerations against Plaintiff's weaker secondary considerations arguments, in the section of her decision titled "Weighing These Secondary Considerations", the court finds that the secondary considerations do not overcome the court's finding of prima facie obviousness, and finds all patents-in-suit to be invalid due to obviousness. 

On appeal, Amarin will likely argue the following:

1) Judge Du employed a procedurally flawed methodology for her finding of prima facie obviousness, as she failed to factor secondary considerations into her analysis before reaching a prima facie obviousness finding, in contravention of the Graham vs. John Deere standard for evaluating obviousness. The Federal Circuit has generally held that, in cases of issued patents, where the patent holder enjoys a presumption of validity, a "prima facie" structure of analysis, which weighs the first 3 Graham factors to determine prima facie obviousness, then subsequently considers whether secondary considerations overcome prima facie obviousness, is not appropriate. As the Federal Circuit has stated, "...it is error to reach a conclusion of obviousness until all those (4 Graham) factors are considered." (Apple Inc. vs. Samsung)

2) Not disputed, but Plaintiff's maintain that the USPTO erred in its finding of prima facie obviousness

3) Judge Du's assertion that the USPTO did not consider Kurabayashi is a clear error of fact. Kurabayashi was indisputably considered by the USPTO in the prosecution of the patents-n-suit. This fact is clearly supported by the patent record and by the trial record, including by Defendants' expert witness, Dr. Heinecke, who wrote in trial document #234, at 131, "Kurabayashi was published in 2000 and I understand is prior art to the patents-in-suit." 

Kurabayashi was likely not cited by the USPTO examiner in his decision because: 

a) Reductions in Apo B levels between the EPA and control groups were not statistically-significant, as was clearly stated in the study author's findings, and as is clearly illustrated in Table 3, which Judge Du included in her decision, and which was included in its entirety, along with the study author's findings, in documents submitted to the court by Defendants. 

b) The statistically-significant reduction in Abo B levels, from baseline, that was observed in the EPA group, viewed in isolation, does not clear the claim hurdle found in asserted claim 8 of Plaintiff's '677 patent-in-suit: "The method of claim 1, comprising administering to the subject about 4 g of the pharmaceutical composition daily for a period of at least about 12 weeks to effect reduction in apolipoprotein B compared to placebo control." 

4) Judge Du's wholesale acceptance of Defendants' Kurabayashi argument, which was copied verbatim into her decision from Defendants' Findings of Fact, without added analysis or commentary from Judge Du, was a clear error of fact. The results of the Kurabayashi study related to Abo B reduction clearly indicate the very opposite of Judge Du's findings. That is, as was stated by the Kurabayashi study's author in his findings, "The apolipoprotein B level in the eicosapentaenoic acid group was significantly lower at week 48 compared with the baseline level, but there was no significant difference between the groups", as compared to Judge Du's finding that "In light of the statistically-significant differential effects reported between the EPA and control groups, a POSA would have attributed the reduction in Apo B to EPA."

Were one to attempt to explain away this apparent error of fact on Judge Du's part with a claim that her finding was in fact based on the difference between the statistically-significant reduction in Apo B levels in the EPA group versus the non-significant reduction in the control group, and not the difference between groups, again, that argument fails, as the Apo B reduction in the EPA group from baseline, in isolation, does not overcome the requirement of asserted claim 8 of Plaintiff's '677 patent-in-suit, which requires that the reduction in Apo B level be compared to a control group. Judge Du cannot have it both ways. Either her finding was based on an erroneous reading of the Kurabayashi results ("differential effects reported between EPA and control groups"), in which case she committed an error of fact, or her finding was based on an erroneous determination that the Apo B reduction in the EPA group alone was adequate to satisfy the requirements of all the asserted claims, in which case she committed a different error of fact.

In both cases, the error of fact would have wrongfully led Judge Du to find that the results of the Kurabayashi study eliminated Apo B reduction as an unexpected benefit of Plaintiff's asserted claims. Were "unexpected benefit" to be restored as a secondary consideration for Plaintiff's, it's probable that Judge Du would have found Plaintiff's claims to be non-obvious, likely leading the district court to also find that Plaintiff's patents-in-suit were valid. 

5) Here Judge Du committed two significant procedural errors. Firstly, Judge Du applied a procedurally flawed methodology in "weighing" secondary considerations against each other as part of her obviousness analysis, as is clearly evidenced by her titling a section of her decision, "Weighing These Secondary Considerations". The discounting of the power of one  secondary consideration by way of a comparison to a weaker secondary consideration is a fanciful methodology not based in any law, and as such, it is likely to lead to a flawed conclusion. Secondly, Judge Du inappropriately shifted the burden of proof away from Defendants and on to Plaintiffs by employing secondary considerations in a "rebuttal capacity" against the district court's prima facie obviousness finding, a practice explicitly discouraged by the Federal Circuit in obviousness cases involving issued patents. The law dictates that the burden of proof of obviousness is borne by exclusively by the Defendant, and never shifts to the Plaintiff.