Replies to post #260139 on Amarin Corp Plc (AMRN)

[BaaBaa45]

Interesting, another UK lawyer. Like me you’re probably also scratching your head wondering why the US doesn’t have specialist courts, with specialist judges (.....cough) for patent litigation like we have in the UK. Like putting a kid in charge of a firearm.

Good to know that, not surprisingly, she has likely cocked this up!

[oneragman]

alm2, I am certainly not defending the judge and have not looked at Mori stats. All I will say is this is a case about the MARINE patents and that drug trial was 12 weeks. So on it's face, is it appropriate to compare a 6 week trial to a 12 week trial? Note, I am only commenting on point 7 not any other points you brought up. Now, the judge allowed RI results to be included in the case, so does that mean 6 week trial was predictive of a 6 year trial and should have been the comparison? The question I have is she found some those secondary considerations to be valid, so is that enough?

[jessellivermore]

alm...

I am rethinking this...There are two issues here..The first is the how EPA effects other lipids...An issue that Mori partially addresses...The second issue is how EPA effects CVD event risk and Mori does not address that issue. Mori was a pure lipids study with no pretense of evaluating CVD or any other benefits..

So Mori might be germaine as far as the MARINE indication...ie very high trigs..but it says nothing about the REDUCE-IT indication which is reducing CD event risk..I can not speak as lawyer because I am not a lawyer..I can only speak as a clinical physician and a medical scientist..Mori says absolutely nothing about EPA's effects on CVD or any other medical condition it only addresses serum lipid levels..

The point being the real value of Vascepa lies in its ability to lower CVD and other clinical risks. Even so..Mori does not render Obvious the fact that lowering trigs without increasing LDL will benefit those with very high trigs The most obvious case is lowering very high trigs, in the 500 mg/dl.. to decrease the risk of acute pancreatitis.but the FDA does not agree with Judge DU and the last time I checked the Marine label it says there is no proof that Vascepa will provide clinical benefit those with very high trigs.

FDA as the leading clinical drug authority must have thoroughly considered Mori in determining the label and it is clear they do not think Mori makes it obvious that EPA will be beneficial for treating high trigs. .As I am not a lawyer Judge DU is not a doctor or a medical scientist and if she were she would understand..assuming something is obvious in medicine can be very dangerous..The history of medicine is rife with ideas that seemed obvious and turned out to be wrong...Medicine and physiology are far away from mathematics...if you are trying to get from A to C in medicine making an assumption on B can be very dangerous. That is why the FDA requires these long expensive trials...because FDA does not rely on "Obvious"...In the 1500s it was obvious cauterising amputation stumps would save lives..Phlebotomy almost killed George the third...though it was the obvious choice of his doctors at the time..Minot and Murphy were awarded the Nobel Prize in Medicine for their work in establishing the Folic Acid
deficiency cause Pernicious Anemia...Later William Castle proved the Pernicious Anemia was actually caused by Vit B-12 deficiency. Castle never got a Nobel Prize.
An old statement in medicine...one that Judge Du does not know because Judge Du is not an MD or a medical scientist is the statement "The questions in Medicine never change...Only the answers do..

As I have posted before.. regardless of the legal definition of obviousness. Medicine and medical science seldom lays things out in the neat rows that the law would have you believe...Organic life forms and biology..the very definition of "living" is defined by the high level of complexity more than any other factor...And this is something I learned from Jerry Lettvin..a Nobel prize winner and a very bright guy. Complexity does not go hand and hand with Obviousness...Quite the opposite..

The fact Mori determined the effects of EPA and DHA on other blood lipids in a narrow range...does not render any clinical benefit Obvious it only speaks to changing lipid levels and God knows how controversial that whole subject is..Is Judge Du in the least bit aware of all the conflicting Meta analysis..Surrounding Omega threes..Doesn't Judge Du wonder why FDA made Amarin conduct a multi year multi million dollar trial to determine if Vascepa had any meaningful benefit on CVD..And prior to the reported results of the trial..90% of cardiologists at the 2018 Annual Scientific Meeting of the AHA has serious doubts about Vascepa and expected the trial would show no significant clinical benefit..Is Mori really more important than R-I...Is that what Du and the lawyers think...That is insanity...

":>) JL

[sts66]

if I was pushing this appeal I would want suitable experts to take apart everything on the Mori trial and other trials the judge used to back her position

AMRN does not get the opportunity to introduce new evidence or have new testimony presented at the court of appeals - they can only use documents and testimony that were part of the bench trial.