Replies to post #272300 on Amarin Corp Plc (AMRN)

[MontanaState83]

Thx HDG

[Will Lar]

HDG - I largely agree with your analysis. IMHO, it all boils down to "the unmet needs", or to me it means Amarin's investment in clinical trials which bear the coveted fruits. If ReduceIt fails, this lawsuit would not happen, period. In the end, it's whether the court or "law" acknowledges Amarin's investment and efforts. Apo-B argument is just a mean to this end. I guess we will see more color of the appeal when Singer's brief is out next week.

Sum: IF (and it is an if) Apo-B / “Kurabayashi” will be counted as unexpected benefit … Amarin will be OK … w/o it the chance is not zero, since Long-felt need (supported by commercial success) could be enough.

[dukesking]

G, Excellent work. Thanks for sharing your thoughts, opinions and research. Much appreciated.

[Number sleven]

HDG, Impressive summary. Thank you.
Sleven,

[ziploc_1]

HDG...Thank you for that even handed and well thought out discussion...I hope Amarin's lawyers see it...I especially liked the part where you discussed..."What could be discussed/argued with a higher chance of success?"

[ilovetech]

HDG, Bravo! Your work deserves our praise and full attention. Your analysis was elegant, interpretations precise, and conclusions
very pursuasive.

Amarin wins the appeal on Du's mishandling of SC. vs. Obvious/Nonobviousness.



ILT

[biowreck]

HDg....”An invention composed entirely of pieces of prior art was nonetheless nonobvious, based largely on the fact that the patented invention fulfilled a long-felt need, achieved commercial success, and was the subject of skepticism on the part of experts, which the court called “strong evidence of nonobviousness. (Envtl. Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 697–98 (Fed. Cir. 1983)) ”

Awesome find, excellent work :)

[north40000]

The Supreme Court, in Graham v. John Deere, coupled “long felt need” and “failure of others” as factual elements to be considered in determining what would have been obvious to one of ordinary skill in the art at the time the invention was made. Those 2 elements are logically considered together.

Were it otherwise, PTO examiners ( and defendants in patent infringement suits) would have found every element or limitation of the patent claims in a single piece of prior art—-findings would have been made 1) that those of skill in the art had not failed and 2) that the invention was not new and lacked novelty. This case then would have evolved under 35 USC 102. That is not this case.

About 95% of issued patents claim inventions the market place ignores—the market place didn’t want them or need them. As the evidence shows, that is not this case either, at least insofar as treatments of patients with trigs elevated above about 500mg/dL are concerned.

[jessellivermore]

G.

Nice synopsis...but you can take all this legal mumbo -jumbo and stick it, because if this Du determination stands then you can say good-bye to the entire FDA marketing process.

Who in their right mind is going to put up the money, millions and millions of dollars and all that time and risk...If some DC judge; who, can not even get her facts correct; can counterfeit the PTO opinion as to patent validity and make an end run around the the Hatch-Waxman legislation.

I am not a lawyer, but if this simple fact does not scream "Unintended
Consequences"; Those consequences being a chilling effect on future medical research. ...AND don't think the FDA, the USPTO, BP, the AHA, the ADA and the AMA are not going to be weighing in with Amicus Curiae(S).

Another thing I may be overlooking in your post is the fact the obligation to prove with clear and overwhelming evidence the patents were obvious is the responsibility of the defendents..But the judge instead charged Amarin with proving the patents were valid and this is clearly a procedural error which can be introduced in the appeal.

IMHO...Focusing on the line items which you have done a great job. Is a situation in which the sum of the total does not reflect the magnitude of the harm that this decision will do..And that is what the AC judges will consider if they are indeed wise..What will be the consequences if Du's opinion is upheld..And of course it is the job of Amarin's legal team to point this out..And Amarin will in all likelihood receive help from the drug and medical community..

The whole episode reminds me of Cyril and Hypatia. And the burning of the great library of Alexandria...

":>) JL

[Invest83838]

Excellent HDG - Thank You

I don't think anyone else on this board has the historical analytical database on Amarin that you do

You must have accumulated a huge book of analytical facts by now

Thank You for your skill, time, and interest to do all of this

and to also share with all of us

[Meowza]

HDGabor--amazing! I always learn a lot from your posts. Even if I don't always agree. And even when your language is too rough for my soft virgin eyes.

[amarininvestor]

thanks HDG nice analysis.

Another way to put it. :

a) DC found erroneously that patent office did not see some of the evidence (K. paper). In other words she assumes that if they did, they would have found the patent to be obvious. FACTUAL ERROR
b) DC looks at SC (with the mind of someone that has already seen the prima facie to be weaken by what is believed to be an oversight of the USPTO). Finds that THE SC ARE NOW EVEN STRONGER THAN THOSE THAT THE USPTO SAW (as we have now commercial success on the bag), but she decides that it does not matter because USTPO did not see all the evidence (FACTUAL ERROR) and some of SC weight against others (PROCEDURAL ERROR)



So What I expect the case for amarin to be build upon is:

-Point out the SC error on K. paper. That should then be seeing by the FC as that USPTO did their job correctly and that should put back the burden of proving invalidity by clear and convicing evidence back to generics
-Correcting the error also indicates that weight of secondaries as saw by USPTO were sufficient at the time....now they are even stronger with comercial success.

In my mind Amarin has a very solid case. I know that we use reference from other trials where things go in one or other way, but as of now, I have not found a ruling from the FC that did not make sense to me once you read the reasoning behind it.

Bottomline, I am not a lawyer but just a layman who after reading all the evidence believe that the chances of amarin to succeed is larger than the 50-50 that some lawyers give. I am not even convinced that this is so dependent on the judges assigned as many believe. That would be the case on a true 50-50 case when the case is very dependent on opinion. In this case there are so many issues, that I believe that regardless of whether you are a judge that likes to follow procedure or not, the issues related to the DC court as so numerous that they may reach a similar conclusion regardless of their style judging.

[Restingzebra]

Excellent post. Thank you very much. Well done as always.

[ggwpq]

HDG, thank you for your insightful analysis. "IF (and it is an if) Apo-B / “Kurabayashi” will be counted as unexpected benefit", then patent 677 would be non-obvious and hence valid, right?

[circuitcity]

Hdg,

Quote:

Second: to treat patients – to reduce TG - having TG above 500 mg/dl with 96% pure ethyl-EPA was prima facie obvious according to the DC and the USPTO … does not worth the effort to challenge it.
—-
Is Singer challenging this in brief? If I remember correctly, you think he did a great job here, right?