Replies to post #323946 on Amarin Corp Plc (AMRN)

[rosemountbomber]

Does anyone know how Du arrived at that conclusion when it is false?

[Bouf]

ST—

I do not believe K was a big part of the court’s decision on what prior art taught a POSA. The K study is only mentioned in passing in the court’s conclusions, which rely primarily on the teachings from Lovaza and Mori. The K study is by no means the lynchpin of the decision.

B

[HinduKush]

IMO Kurabayashi was critical. Why? Let me count the ways:
(1) The patent was granted for ApoB lowering without elevation of LDL and then for TG>500. Therefore if you are going to invalidate the MARINE patents, you must show obviousness in the prior art for (a) EPA lowering LDL and (b) EPA lowering ApoB. The lowering of ApoB is thus a sine qua non for invalidation. Judge Du recognizes this in the concluding paragraphs of her judgement.

As explained above as to Defendants’ prima facie obviousness case, Mori found that EPA did not raise LDL-C levels, and Kurabayashi suggested that EPA reduced Apo B levels.Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious. (ECF No. 373 at 76-80, 246-47.)

Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, considered judgment may lose significant force” See i4i, 564 U.S. at “Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favour of finding the Asserted Claims nonobvious.”

(2) The patent examiner during the notice of allowance explained that the ApoB findings were key to the ascertainment of unexpected benefit (and long-felt need)

Applicant was able to demonstrate that, under the specific conditions of the instant claim, significant reduction 8.5% of Apo-B levels in the patients being treated was observed. This reduction of Apo-B was observed at the 4g per day dose but not at the 2g per day dose see MARINE trial (Bays et al Am Cardiol 2011 108682- 690 Figure on page 684). Apo-B is especially important clinical marker for coronary heart disease (see Bays declaration dated 05/16/2012 topics 28 through 32 on pages and see also Bays et al Am Cardiol 2011 108, 682-690-page 689 left column second paragraph).
The prior art is either silent or teaches that there is no statistically significant change in Apo-B levels when patients with TG levels less than 150 mg/dl or between 150-499 mg/dl are treated with either 96% pure ethyl-EPA or mixture of ethyl-EPA and DHA or when mixture of ethyl-EPA and DHA was administered to patients with TG levels above 500 mg/dl…

(2) The way in which Kurabaysahi was manipulated by Hikma, was by saying that Kurabayshi actually showed that EPA lowered ApoB (and that the whole world, including the authors of K, and the patent examiner totally missed this!):

Further, while the Patent Office found that a decrease in Apo B was an unexpected benefit constituting a valid secondary consideration, the Patent Office’s examiner did not consider Kurabayashi. (Id. at 246-47.) Where “the PTO did not have all material facts before it, its considered judgment may lose significant force[.]” See i4i, 564 U.S. at 95. Thus, the Court finds that the unexpected benefits secondary consideration does not weigh in favor of finding the Asserted Claims nonobvious.

Heinecke's chutzpah is incredible. It's one thing to say that the USPTO may not have looked at the paper. Quite another to school the authors (who underwent scientific peer review prior to publication) and the USPTO that they didn't understand basic statistical analysis...All this while lying boldface to the court about the statistical analysis of the results of Table 3 Kurabayshi, cropping out any embarrassing telltale legends that state otherwise, and setting up the Judge to buy a lie.
In fact, the truth is the USPTO saw the paper, cited it in its review of references and then discarded it from further discussions it was an entirely inconclusive/negative and therefore irrelevant paper to the adjudication of obviousness. Is that truth stranger than the Hikma fiction?
HK