Amarin Corp Plc (AMRN)

[HinduKush]

Eight thanks as always for all your information which I find valuable..much appreciated by all.
Infact I took your intial Du errors post and filled in my DD on scientific/medical evidence for my statement of error in generics obviousness story, and Du's shamefaced copying and reiterating a barefaced lie.
Here it is in entirety (was sent to Singer) if anyone wants to go through it, though I recommend a stiff one before ploughing in. "Nullius in verba"
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:5331b67a-f335-43af-b9c9-a0be2d344e14

When I think of it now and in reflection of all the data, one has to focuses on that key word Obviousness which has been in the English lexicon since the Oxford English Dictionary documents its use in 1663 by the scientist (&Natural Philosopher) Robert Hooke who was the the First President of the Royal Society (the first group of Scientific thinkers using scientific thinking that revolutionized our modern world ..Newton Boyle Hooke...(a great background read is "The Clockwork Universe : Isaac Newton, the Royal Society, and the Birth of the Modern World" by Edward Dolnick Harper Collins).
Hooke says in his preface to his great Magnum Opus Micrographia: "The good success of all these great Men (he cites several great men including Galileo and Harvey), and many others, and the now seemingly great obviousness of most of their and divers other Inventions, which from the beginning of the world have been, as 'twere, trod on, and yet not minded till these last inquisitive Ages."
These precient insights illustrate what we are dealing with: It is likely true there were inadequately done studies (with no placebo controls, no direct comparison of EPA to DHA and inadequate numbers for staistical power or those that studied the wrong TG level population) that showed some suggestion or glimpse that EPA may reduce high TG without LDL elevation buy none showed anything with adequate scientific rigor to conclude anything.So Amarin did the due diligence and went that extra mile to show just that, in completing both MARINE (2011) and ANCHOR (2012) to illustrate that with or without a statin, and in TG>500mg/dl alone or TG (200-500 mg/dl with statin),Vascepa could profoundly reduce TG's, lower LDL, and lower ApoB and that it did so at a very specific dose of 4 g/day and proved it incontrovertibly with a placebo, in adequate staistical power. Who else showed that? No one and the USPTO recognized it fairly:

USPTO examiner
Applicant was able to overcome the above 103 obviousness rejection by showing: 1- Unexpected results, and 2- Long felt unmet medical need. 1- Unexpected results: Applicant was able to demonstrate that under the specific conditions of the instant claims a significant reduction (8.5%) of Apo-B levels in the patients being treated was observed. This reduction of Apo-B was observed at the 4 g per day dose bot not at the 2 g per day dose (see MARINE trial, Bays et. al. Am. J. Cardiol. (2011) 108:682- 690, Figure 3 on page 684). Apo-B is a very important marker for coronary heart disease...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 a mixture of ethyl-EPA and DHA, or when a mixture of ethyl-EPA and DHA was administered to patients with TG levels above 500 mg/dl ...When combined with the fact that the levels of Apo-B are also decreased, this treatment: the administration of 4 g daily of 96% pure ethyl EPA for a period of at least 12 weeks to patients with TG above 500 mg/dl that are not on concomitant lipid altering therapy, becomes the only one available that, besides significantly lowering TG levels, also does not increase LDL-C levels and decreases apolipoprotein B levels, two important markers strongly associated with increase in cardiovascular diseases. The above justifies the allowance of the instant claims in their full scope."

If Newton wanted to patent his prism for the separartion of light into multiple colors, he might have been rebuffed right away by Judge Du saying it was obvious to do so because so many others did this and that.(could have-should have-would have-people). In fact, Newton being honest admitted as much in writing to Hooke his greatest rival in fame: "What Descartes did was a good step. You have added much several ways, and especially in taking the colours of thin plates into philosophical consideration. If I have seen a little further it is by standing on the shoulders of Giants." could anyone denythat it was Newton who connected the dots, then assembled the facts into a new Law of Light and Optics and found new discovery from the waste of "obviousness", using what eluded others before him? In a final irony, Newton may have borrowed or paraphrased from a thesis on Logic by John salisbury in 1159 called the Metalogicon who said:
"We are like dwarfs sitting on the shoulders of giants. We see more, and things that are more distant, than they did, not because our sight is superior or because we are taller than they, but because they raise us up, and by their great stature add to ours."
It was ever the same, it is so now. It doesn't detract from what Amarin showed convincingly for the first time in MARINE. So now, who will say what is obvious?
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