Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I agree as to the point you make relative to the 6 months generic benefit of filing ANDA ...and thus the race between generics to do so - but there is a huge difference between the taking of that Administrative step and the investment involved in getting the product to launch point - it’s a commercial decision -does a generic spend all those bucks on taking those further steps -only to find that within a few months they lose appeal and can not launch and thus have wasted all the money involved - or are stopped by injunction - or do so but lose appeal and have to pay significant damages
I suspect Amarin consider it most unlikely indeed any launch by generic before appeal
Alm
At the moment the generics are not selling the drug ... they might never do so - (although the expectation is they will - the injunction is presently not necessary - when it becomes necessary to protect through injunctive relief Amarin can apply - so no time limit operates per se
If they launched (or were obviously about to )amarin can seek injunction
Alm
Biobill-how many months are we talking about until appeal outcome known ? And we are still in a covid world- how many months before “business”returns to normal?
Is it wise to spend big bucks pre appeal outcome- as to cost-? as to covid effect?as to spending big for generics If appeal loss?-is it a good commercial decision in these few months -
and part of the emotional argument in appeal is that DU’s stops the promotion of the drug in the USA - so why act contrary to that possibly highly persuasive element ( I appreciate it will not be a legal argument in appeal but the FC must be aware of this impact )
If amarin loose are they not better having healthy cash at bank to develop (by whatever route) the next direction for the company- ? In Europe- ROW and retrieving whatever they can in USA
It’s not a long time to wait - doing nothing as to big buck promotion until appeal outcome is intelligent
After Amarin win (they will) - go for it !!
Alm
Yes -they can apply for an injunction after generics launch
Alm
Risks re injunction -
Costs of doing so - minor
Not getting one - generics don’t know / nor amarin know whether they will get injunction-but for generics to incur all costs incurred for launch to then get an injunction slapped on them and then losing appeal means they have spent a bucket of money for no gain - remember generics don’t have a patent life to try and profit over - they will be selling the product forever - so their intelligent move is to wait -the right commercial decision
Amarin not applying for an injunction now is intelligent .. applying now and losing the application is not - if generics do launch it may be a question of timing - for example if they launched a week before appeal hearing why bother ? - the appeal will resolve the issue (maybe it might just be a negative for generics in the appeal -they launched as though they were cock sure of winning )
And if generics launch and lose appeal - damages to boot to pay
Amarin applying and not getting injunction would send out another bad (wrongly perceived )signal to the market - (which would be over reaction share price drop)because the appeal is the crux decision that Amarin faces as to USA
Sometimes doing nothing is intelligent
Alm
Injunction
Until amarin has evidence that H is about to launch there is no point obtaining -injunctions are very quickly obtained-H has to balance the commercial risk - all the costs of getting this into the market being incurred for what profit prior to appeal result - peanuts
And they risk damages if they did launch and appeal won and they risk an injunction in any event stopping them selling the stuff
Good commercial decision to launch prior to appeal result ? I don’t think so !!
They may get ducks in a row ready if possible to launch as soon as they win (which they will not)- but they will wait the few months for appeal outcome
If they win they will be selling forever so a few months makes no difference and makes no commercial sense in to actually do so prior to appeal outcome
The whole crux of the amarin situation as to USA market rests on the appeal outcome for the generics and for amarin and shareholders
Alm
Zip
We complete agree ...
Alm
Tasty- not a patent lawyer or a USA lawyer
The patents were granted -and were thus valid patents
The obligation in the litigation fell on H and R to show that the patents were obvious
That obligation did not fall on Judge Du to do it for them
They - H and R had to demonstrate by the relevant test as to evidence and as to the “evidence”before the court in the litigation
That was not in my view to be found in a re examination of how the patent was granted - that was no evidence - because they were granted and presumed valid
Singer is right - Du was wrong to undertake this re examination in effect introducing such process into her own judicial mind and thus influencing the decision she made - and also in effect doing such on behalf of the defendants -
Alm
If they have very good intelligence on generics activity and thus when they are about to launch - that would be the ideal time to obtain injunction - an immediate threat to their Amarins commercial rights - and hell let the generics waste some more money on all that goes with getting ready to launch- but if you were Hikma what would you say the commercial gain would be to them actually launching pre appeal decision ? And what are the commercial risks in so doing ? They are a business wishing to make a profit so they will balance these commercial risks and rewards - I am not privy to their financial analysis - but my view is they are most unlikely to try to launch pre appeal outcome
This whole story now turns on appeal outcome as far as USA market concerned -
Alm
Send to Singer - great work
Alm
Gozips - thank you for helping to get this vital work to Singer
Alm
I don’t but others on the board do - can those who can make sure HK’s brilliant work is sent to amarin / Singer
Alm
HK
You must send on to amarin / Singer
Alm
Tasty- absolutely right - it was inevitable so why everyone jumping up and down beyond me !what else was Hikma going to do - they will get their ducks in a row to launch as soon as they can - after the appeal if they win
If they loose - they ain’t launching nothing but a few turd millions that they spend in this game whenever they challenge a patent
This is their game
We always new the crunch as to USA is now appeal outcome
Alm
Injunction - there was no point applying for an injunction until Hikma took this step -this is all a sequence of events that is known - but will Amarin get injunction is the next question-given that the appeal is expedited the injunction will more likely than not be granted - the injunction need only run over a relatively short time frame - once injunction granted all this then simply rests on the appeal outcome - generics once injunction obtained won’t be doing anything in terms of launching -so we sit and await appeal outcome
Surely we all know that this is the big deal - if amarin wins appeal we are back to where we were save some months lost - and in reality those months are lost with covid anyway
Alm
It’s not per se bad news - the bad news was loosing before Du-it is news that was only to be expected -they would inevitably obtain such following their dc win - there are far more exacting issues for the generics to address in actually reaching the market place - prior to appeal outcome if and when amarin believes generics are about to launch Amarin will presumably apply/obtain injunction ... and /or if generics launch pre appeal outcome once appeal over/ and if successful generics face punitive damages
Given the short time frame to appeal it is hard to imagine generics will attempt launch prior to appeal outcome
So it’s just a step in the direction Hikma would have to travel
It’s nothing news
Alm
Brilliant work - send to amarin / Singer
Alm
From one lawyer to another..you absolutely did the right thing-
Du absolutely did the wrong thing-as to her conduct in a press interview during the course of proceedings -and as to the decision she reached in those proceedings which has caused catastrophic damage.
She needs learn that Judges can be judged too.
I stand in awe
Alm
JMFR and JL
Both in the wars ... but hope both of you recover quickly and stay well - we need you guys on point !!
Alm
Brilliant reply ... Amarin is immortal !!
The company will live forever....although many will hope only until a BO!!
Alm
Marjac may wish to enlist HK help or another as to the chemical definitions here of Vascepa as opposed to fish oil and how Vascepa is actually made - these are matters Du should have through the trial “schooling” clearly known so that she should not equate - as a Judge-Vascepa in any way as fishy or fish oil !
Alm
DM - strangely the idea of shareholders in a company having rights through the company is a concept that is usually afforded protection in law
Shareholders are perfectly entitled /as is the company to expect that a Judge adjudicating on litigation actually applies the protections of the law correctly
Does your business /you not expect that your rights as a business owner would be dealt with fairly and according to the law - ? or do just not care and would simply meekly accept any injustice
I rather suspect DM that you would be the first to jump up and down !!!
Alm
DMiller - hate to disagree - the shareholders comprise many citizens of the USA - they have have been hugely adversely affected by the conduct of a Judge who has utilised a denigratory and derogatory description of a prescription medicine approved by a government agency the FDA for medical use in CV treatment which kills and renders seriously ill thousands of USA citizens and thus she undermines both the drugs value and usage
Judges need be very aware of what they say in a public forum - they should be pillars of society and lead by their example
The complaint will be carefully considered and action will be required of her to correct her foolish error
Just as the FC will correct her foolish errors in the Appeal hearing
Alm
Great work !!!
It will stir a very messy shit storm !!
Alm
A not very well thought through piece as to how the appeal process operates -in particular completely ignoring the issue of serious error as to fact ..Alm
Marjac -that is a well conceived and brilliantly expounded basis of complaint as to Judge DU’s conduct- why don’t YOU submit it as a formal complaint -??- irrespective of how Amarin/Singer may wish to consider this - it does no harm (on the contrary) to Amarins case - indeed every Amarin shareholder should consider laying this complaint .... a wall of formal complaint about this Judge will serve well - and formal complaints have to be investigated ... especially as to a Judge
It may be that Amarin/Singer will use this directly in the Appeal in any event - although quite how such will be worked in is in my view unclear - but the formal complaint you can lay will play its part in other ways
Alm
Jeffries has not received a “new report” from their expert - what you refer to was issued immediately after the decision - not as a response to a consideration of singers brief on appeal
Alm
We don’t need three ... just two !! Alm
Du - let us all remember how colossal was the damage that she has caused - billions of value has been lost to the shareholders of Amarin -no doubt countless thousands of shareholders and pension holders were relying on the value of their shares in this company - value destroyed at the stroke of her pen when she signed off her order- she has put in jeopardy the distribution of a vital drug that will save the lives of many thousands of people each year
Judge Du had a duty and an obligation to diligently and impartially try this case applying appropriately legal precedents and arriving at an accurate and balanced assessment of the facts.
She failed in her duty - there can be few judicial failures as gross as this one in the history of the USA district court
Alm
Tasty- whilst neither a patent lawyer,nor a lawyer from USA - I have read it - I conclude it as brilliant - all persuasive and incisive- it tears the courts decision apart on a multitude of significant and fundamental basis- I find it inconceivable that when orally argued before the appeal court that any other conclusion but reversal could be reached -Du didn’t just make one error- her justifications for reaching her decision were riddled with error as to fact and procedure as this brief so overwhelmingly demonstrates - Alm
HDG-Ah - sorry I understand now-!!what you are saying is until there is a grant of expedition the case remains on a usual non expedited timeframe for hearing
One would expect to hear in the not to distant future whether the application for an expedited hearing is granted or refused.
As to submission of the appeal brief by Fish/ Singer they will no doubt submit as soon as possible because to not do so as I understand matters would prejudice the possibility of granting expedited appeal ..
Alm
HDG - has there been a formal decision released that the appeal will not be expedited - if so can you post link
Alm
TTF - shall we say the briefing document should be a brilliant expression of the complete weakness of the generics case, of the overwhelming strength of Amarins case and of the destruction of DU’s decision pinpointing the errors of fact and procedure upon which the FC can overturn her decision
Possibly the share price will move upwards to reflect increasing confidence in the preservation of the patents through the appeal - we will soon enough see how good Singer and Fish are
Alm
HDG - well thank you for clearing that up -I was clearly mistaken - I thought you had previously posted on this very point and had it in my mind that this had been in response to some earlier action taken by the generics !!
If they had the choice where to file one would expect there was a perception that 9th circuit was thus most advantageous venue for such litigation? Clearly not the case !!
As a lawyer(UK) I would like to see the written advice they were given on that one! - hope all well - you and family and that Hungary not overrun with covid
Alm
HDG -can you repeat your prior post that the 9th circuit was not selected by Amarin (I recall your having resolved that this was not the case) folk are still under illusion it was a choice by amarin !!
Alm
The granting of the patent - are we barking up the wrong tree over the issue of precisely how the patent was first granted -? I am no patent expert but is this not a process which is viewed in the round ? - the patent was granted - most important point-and by the application of all the principles to be applied in considering whether or not to actually grant a patent .
The fact that prior art led the patent examiner in his unique consideration of the application to determine there was obviousness did not adversely affect the patent application - it was granted - in his unique consideration by virtue of the secondary tests- which it is to be stressed are not secondary in value as opposed to a consideration of obviousness -but are simply a second part of the process . On the contrary secondary considerations may well carry very significant weight - one secondary consideration alone may lead to patent grant.
It is a unique consideration by the patent examiner
The simply fact was that the patent was granted - how it came to be granted does not reveal an issue of weakness - it is a grant or a refusal- it was a grant
The application for a patent and how it is granted is a different concept and process from the matter in issue in patent litigation
Indeed the starting point of such litigation is that the patent - those the subject of litigation is/ are entirely valid
In litigation it falls on the party asserting invalidity to prove - in a clearly defined manner -based on the evidence that the patent is invalid
The genetics of course - via Du decision did just this - proved before the district court the patents were invalid
The real issue is that Du reached the wrong decision -by serious error of fact and serious error in procedure
The appeal will be the test of whether in law it is viewed that indeed she reached the wrong decision
Du was not the patent examiner. She was a judge obliged in her court and jurisdiction to correctly interpret the facts and apply the appropriate legal precedents as to patent litigation
She did not
Alm
FFS
Then are thoughts are with him and his family in their difficult time
And all those others who are sadly touched by this blight upon our world
Your response may I say is touching and to your immense credit - I hope you and your loved ones stay safe and well
Alm
FFS - my thoughts are with you and your family - let us all support your strength and focus and that of your family to see your son through to a full recovery
You rightly bring the reality of the terrible personal impact of this pandemic to the fore - no one should ignore its reach
Alm
Are you sending these on to Amarin / Covington - vital to reflect the state of knowledge as of 2008.... great work
Alm
Amarin wins appeal - not just saying it though - they will ....
Alm