Replies to post #240118 on Amarin Corp Plc (AMRN)

[johnking29]

HAMOA: Excellent summary of what I believe everyone on this board is trying to say!

THANK YOU!

[rafunrafun]

H - excellent post.

My guess is that the defendants are overplaying their hand because they know that this means everything to Amarin but falsely think that Amarin will cave in to their nonsensical demands.

Amarin probably said that they refuse to be pushovers.

Something like:

Defendants (like terrorists): give us $100 million and we walk away

Amarin: the best we can do is $5 million

Defendants: $95 million

Amarin: see you in trial

[dukesking]

Hamoa, Thank you for your insights and opinions. Much appreciated.

[Restingzebra]

Excellent post. As always, many thanks for your insight. Could you please post your views on the defendants removal of attorneys and the sealed/unsealed issues. All the best...

[couldbebetter]

WoW! Makes me want to stand at attention and salute!

[ziploc_1]

Hamoa...Thank you for the logic of your thoughts and for your clarity in expressing them.

Most discourses on patents are difficult to follow...but your post was as understandable as it was convincing.

[StockLearner2011]

I like your logical post. The ones who simply say bullish/bearish are no more than stereotypes??

[xblkbk]

Thanks Hamoa for your knowledge and expertise in these matters!!

x BLK BK

[Lajit65]

Thank you Hamoa. You're commentary is so on point.

[Biobillionair]

Very good post. Thanks Hamoa
BB

[Bouf]

Hamoa—

Agree with your analysis and would add that trials are on a subconscious level about the decision maker deciding who are the good guys vs. the bad guys. The primary reason Amarin has the advantage in this case is that they occupy the moral high ground. That does not always prevail in this country as is evidenced by, for example, the intense litigation in the 1850s over the fugitive slave act that resulted in the abhorrent Dred Scott decision. But in this case, in my view, it will carry the day. Let’s hope you and I are right.

Bouf

[Older/Poorer/Wiser]

The prior post on the carve-out issue that was illuminated by the Sanofi ruling is what this is going to hinge on. Either Hamoa or HDG provided that, I believe. Thanks - that is the scenario & logic that will be tested here.

Judge stated she was thinking of high TG's as chronic condition and leaning towards assuming LT treatment needed as a result (certainly >12 weeks).

Generics appear to frame many instances where TG's >500mg can be reduced via short-term (<12 weeks) IPE treatment and diet/exercise. (Thanks to whoever posted that partially redacted document, #333, it is a must read).

Seems those differences of impression/opinion on TG treatment duration are going to be slugged out in court. It appears that generics do not violate any patents if prescribed for <12 weeks. Whoever at Amarin filed that patent with a minimum duration of dosing should be shot, as the MARINE trial itself showed a distribution of TG reductions, not a step function at 12 weeks. The Amarin patents provide no protection for <12 wks of treatment, as Amarin has stipulated.

So, it comes down to the indirect inducement question. Judge said R-IT results don't matter much to that (as someone else posted)? I hope they do, because that is the obvious incentive to push generic IPE and pursue this litigation to the ends of the earth. It's not the size of the well-supplied hyper-TG market. Unfortunately, I don't think intent to access the vastly larger CV market can be proven here, absent the discovery of some internal generics document that points to the off-generic-label CV opportunity. In fact, this litigation started before R-IT results emerged.

Hamoa is completely correct about the primacy of strong IP protection to stimulate innovation. However, the judge will rule on the narrow facts & circumstances of this case, guided by precedent. If there has been inadequate development of the patent estate for a given endeavor, that is the company's problem, not the Judge's. She will rule on how the explicit patent language is applied rather than the societal costs of losing patent challenges. Which takes us right back to Sanofi and how that bears on Amarin vs. Generics.

There is that old saying: "The law is an ass". Sometimes it truly is. It is tough to take much comfort in the possiblity that the Judge wants to reward Amarin simply due to the momentousness of the impact of Vascepa for CV disease, and the heck with many of the surrounding details. If their filings prove to not be in order, Amarin has a problem. But the key issue leads back to the Sanofi carve out precedent for the back door to the massive CV market.

[jessellivermore]

Hamoa...

This post of yours is beautifully written and is very compelling...An impressive feat..I only hope Judge DU is half as wise as you are and I hope you are prescient in this case..

The story of Vascepa is a great one and one of the reason why it is a great story is because things were never obvious..Certainly not obvious to the cardiologists who attended the 2018 annual scientific meeting of the AHA..Prior to Dr. Bhatt's presentation of the RI data..The cardiologists were polled on their smart phones as to whether they were would prescribe Vascepa to their patients at risk for CVD and less than 10% said they would..After the presentation the number who said they would jumped to over 90 %...There was a standing ovation after the presentation...Something very rare in clinical presentations..

The FDA did not think the the results of R-I were a foregone conclusion and even went to the extreme of reneging on an SPA...I'm not aware of FDA ever doing that before...FDA did not think V would lower CVD event risk...and insisted on a CVOT (cardio vascular outcomes trial)...A trial that ran eight years and never once did the FDA say "stop the trial"..its obvious....

Thank you for writing one of the best posts I have seen in more than 10 years...

":>) JL

[berryfitRD]

Thank you for your time and analysis. Much appreciated.

[hypo]

Hamoa, WOW!! So Clear.

Cheers

[rosemountbomber]

Excellent post Hamoa. I know that Amarin has an excellent legal team but after reading your post I wish you were on the team.

[irc203]

Hey Hamoa, thank you for your post. I seek out your posts because they add greatly to the discussion and my knowledge. I have a small issue in the following statement:

"Defendants are asking Judge Du to:

1) rule that both the USPTO and FDA "clearly and convincingly" erred in judging the non-obviousness of Amarin's inventions, "

I believe the patent office has sole responsibility in determining whether a patent should be issued. Regardless, the defendants are not asking the judge to rule that both the USPTO and the FDA "clearly and convincingly" erred.

Rather, the defendants have the burden of proof to prove the patent is not valid due to obviousness which means the PTO erred in issuing the patent. The burden in substantial. Most civil suits are decided based on the preponderance of the evidence, which means the trier of fact weighs the evidence to determine whether more than 50% of the evidence supports the plaintiff's claim.

Clear and convincing evidence requires much more. I do not believe the courts have ever quantified what percent the evidence must be to be clear and convincing. In law school classes we debate whether it is 75% or more or whether it could be something less. What ever it equates to as a percentage, it is a very difficult burden to meet unless the evidence is there and the attorneys are good enough to make a stronger case than the opposing counsel.

I agree the judge doesn't make decisions solely on facts. Public policy also plays a role when policy is at issue. A weak patent system is contrary to public policy. To rule in favor of the defendants based on some small potential use for less than 12 weeks when the drug is intended to treat chronic conditions in my opinion, would be contrary to the intent of the law and violate public policy.