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Nicley stated Alm,
Any proposition has the right to be made but not blindly adopted without rigorous examination especially by a judge in a patent court.
Thank you Raf but I am so sick of this it’s all obvious nonsense...
True I agree
Money talks Bouf-- I get it totally
HK
LTHRO,
Since you are playing Devil's Advocate , I will prosecute.
Value
I am not sure. Patent extension is being discouraged because of the prevalent belief that every dog (including the generics) must have their day under prevailing H-W philosophy.
Value
I am not sure. Patent extension is being discouraged because of the prevalent belief that every dog (including the generics) must have their day under prevailing H-W philosophy.
Iryo
check tomorrow they have either deleted it or or considering it to see if it is too "controversial"
jasbg
I am starting to think that Amarin is in fact a riddle wrapped in a mystery inside an enigma. In true DaVinci code fashion, I now think Amarin's future is determined by mathematical and legal mysticism that revolves around multiples of 6: Rule 36 , Rule 24 and Rule 60..
HK
marjac,
IF our brief is dismissed on a technicality or using an escape conveniently provided by an "out" within the Law, we all will have done our duty as responsible citizens and shareholders, to bring out the truth honestly and openly. There is only one reason to dismiss this brief without diligent investigation, and that can be summarized in three key words: Ego Bias and Coverup.
HK
Lemmi
The phrase Lies, Damn Lies and Statistics" was attributed by Twain to Benjamin Disraeli (British PM) and was in fact made by Leonard H. Courtney, in New York in 1895:
'After all, facts are facts, and although we may quote one to another with a chuckle the words of the Wise Statesman (presumably Disraeli), "Lies - damn lies - and statistics," still there are some easy figures the simplest must understand, and the astutest cannot wriggle out of.
The last part seems as apropos to the Nevada court's statistical problem as the first...
HK
sts see my post comparing what HIKMA wrote and what Judge Du wrote--
For sts and others interested in the pacer timeline of statements of Post-trial findings of fact and the final bench order as well as what Amarin -Covington had to say about Kurabayashi in the post-trial final findings of fact and post-trial brief, this is everything I could find. It is clear they were focused on EPA-estradiol being an invalid control group, and EPA bein studied in essentially a normal TG cohort and do point out that the USPTO had considered Kurabayshi citing patent '728 at 8. No mention of the statistical horrors enacted by Heinecke or that Kurabayashi itself stated there was "no effect of EPA on ApoB".
For those interested in the details of the Kurabayshi Heinecke/HIKMA assertions in the Post-Trial Findings of Fact and what exactly was copied across into Judge Du's Bench Order and the comparison to what Kurabayshi et al thought of their own ApoB findings and the flaws in the analysis pointed out by our expert Dr Jarvis, I have compiled a summary:
"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."
This should read:
"In light of the statistically-NON-SIGNIFICANT difference in effects reported between the EPA and control groups, a POSA would have attributed only a lack of detectable effect of EPA on Apo B."
Dr. Jarvis our statistical expert explains it beautifully:
Someone should look at Pacer carefully--as I understand it both parties individually filed their post-trial findings of fact and then the Judge ruled in the bench order.
HK
It was the two yutes that did it your honor...
LTRO
Zip,
I fear I must disagree--not necessarily because you are legally wrong but because there are two separate principles at stake here. The first is the legal construct of Graham and its inappropriate construction by the lower courts. The second is the issue of fraud and mistake. If the SC grants certiorari and reverses the Nevada and CAFC decisions it is true that a legal mistake will have been righted. But what then of the ethical and procedural errors in evidence admission? Who will correct that and ensure that that it never again stains the records of the judicial system anywhere? The issue of true evidentiary admission based on sound science and real POSA standards is the greater principle at stake here.
Hk
Something i wrote for the Amicus:
or is that Hara Kuri (yabashi)?
sts alm LTRO,
This student ethics lecture could vanish and we would still have more than ample evidence that Janus Jay Heinecke knew full well he was committing multiple scientific and ethical faux pas when he cooked the statistical books. Why? First, he is supposed to be a qualified POSA otherwise his opinion matters, not a whit. He is an NIH researcher and a PhD tenured university science professor--if he doesn't understand basic statistical method then who does?
The fact that NO peer-reviewed science journal should or would accept such methodology (if detected by a statistical reviewer) because it breaches every principle of statistical canon in data analysis, is ample evidence that he knew that it was wrong.
Second, the fact that he recited the ethical rules of scientific conduct in a lecture to naive students and then broke all the rules himself is as surprising as a politician who lays his hand on the Bible and swears to uphold the constitution and then does what all politicians do --break their own code. It proves that there is nothing new in the world and for mammon, a man will utter any lie and commit any act however unspeakable.
So Dr H knew he was committing dishonesty both scientific and ethical-he reveals it in so many ways but most of all his constant repetition throughout his testimony (almost apologetically if you can believe it) that he did so because the law and claim construction allows him to do so. Since when did expert witnesses get to do claim construction and bend science to fit round pegs in square holes? Since when were the standards of peer-reviewed evidentiary science and POSA thinking subject to ad hoc corruption to suit the convenience of a litigant? Since when did Daubert's gatekeeping standards and Frye's acceptance tests get thrown out the window? Since Nevada 03/30/2020...
HK
LTRO,
Jomama,
Jomama
I beg to disagree. There was already too much evidence that EPA had LDL neutral and/ or lowering effects --eg JELIS itself in 2007--in fact Klein made the valid point that Amarin itself used this evidence in the preamble to their own patent claim constructions and likely new all this stuff well before 2008 through Japanese sources at Mochida and elsewhere and through their own collected lipid database. Now, we can wax eloquent about how Lipoprotein lipase enzyme saturates at around 500mg/dl plus, and how EPA (as opposed to DHA) lowers LDL particularly in the above 500mg/dl hyperTG cohort, but at the end of the day in a court of law the boundary is 500 mg/dl and Hayashi was always going to be the problem link between <500 and >500 and any expert is going to have difficulty saying that Vascepa works differently at 501 than 499 (Toth acknowledged this as proof of what I say). SO, the smarter thing to have done would have been to NOT argue the LDL differences above and below 500mg/dl (as the patent examiner had already declared them obvious), but to argue the uniqueness of the MARINE ApoB findings (acknowledged by the patent examiner as being unexpected results and unmet need) and defend to the death the integrity of the prior art and NOT accept the gibberish mooted by Heinecke on Mori and Kuarbayashi. Now, I respectfully suggest that whoever was directing the science strategy and coordination of the medical expert witnesses of the Nevada trial was asleep at the wheel from the git-go.
HK
I have no doubt this a smart thing to do
DK,
Heinecke has three choices here:
(1) He was naive and got conned into a mistaken representation by his legal team
(2) Consequence of (1) he is actually just incompetent either as a POSA or an expert witness
(3) He knew exactly what he was doing and why he shouldn't do it. In other words, he is a FRAUD
Which choice would he like to take?
LTRO,
Agreed entirely.
Heinecke knew what was right.
He just didn't do right.
tm100,
No doubt because we know he did it
jasbg
I think this was a lecture given by Heinecke to students as to the moral dilemmas that come up in science-all PhD and MD researchers go through a similar question and answer course before being allowed to run or submit a study protocol to the Institutional Review Board of our hospital or university...
HK
Here's one for the students of Ethics:
FRAUD
++You are an eminent scientist and hold several NIH grants leading and teaching students at a famous university
++A lawyer in a contentious patent suit offers you the equivalent of two years salary for some scientific evidence that essentially requires you to stretch the truth
++You look at the data and see that is essentially solid but if some of the prior art is “reworked” that there might be a path to invalidation
++There is a problem the data analysis you propose is essentially wrong by every accepted statistical standard you have use din your own research
++The attorney encourages you and says that science is one thing the law allows you some latitude….
WHAT SHOULD YOU DO?
My wife asked me today what had motivated me to spend the last three months gathering the evidence and sculpting the arguments with Marjac and all the members of EPADI II, when as many say the cause is a forlorn one. I tell you truly I had long given up the thought of recouping my share value loss in any immediate time period, but I really felt what you express:
Lizzy,
I think they wanted nothing to do with this on advisement from Kennedy and his team of auxiliaries. Thero said his hands were tied to me personally.
HK
Alm,
Alm,
Zip,