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Irish...
I am not following your logic..
(my fault).
A fair and equitable solution in the case of the Judges opinion.
The MARINE patents are invalid..but the R-I patents are valid and prescribing (not marketing) for the R-I indication (see her comments regarding indirect infringement by inducement) and (not marketing)...That she does not agree the generics have the right to prescribe for the R-I label indication.
So since allowing the generics to sell Vascepa does not and can not stop the generics from infringing on Amarin's patents. The best solution for all is to allow generics to receive payments in proportion to revenues from the MARINE indication.. From Amarin factoring in cost of production and sales etc. Amarin keeps the R-I indication which protected by valid patents..The generics get the revenues from the MARINE indication which is in accord of the Judges decision..
This may not be a perfect solution..but I would appreciate someone coming up with a better one other than throwing a lot of BS at my idea..
":>) JL
SB....
"Why would generics settle for a sliver of the pie (1/100), when they are staring down at the whole damn thing with a big toothy grin?"
The court might decide for them...
The current decision is not fair and equitable and will infringe on Amarin's patents.
":>) JL
Quote....
-- I just searched the ruling and could not find where Judge Du states that generics cannot sell the drug for the R-I indication because it infringes on Amarin's patents. What they cannot do, by law, is market the drug for that indication...
Did you not read the part where the judge stated prescribing the the drug for more than 12 days is ipso facto proof they are (selling) prescribing for the R-I indication and are inducing infringement on Amarin's patents..Do you think doctors are going to know they should not write the scripts for over two weeks because they are infringing on Amarin's legitimate patents..
Apparently you can not understand that the judge intended only to allow the MARINE indication...not just restrict them from marketing it..That is please point me to the place where the judge says the generics just can not market it..The generics don't do any marketing...
":>) JL
For those of you that are mentally challenged..
The judges decision has created a dilemma...On one hand she has decided that the patents for the MARINE indication are invalid and therefore the Generics will be allowed to sell/market Vascepa for the Marine indication.
But she has not invalidated the patents for the Vascepa Cardio-Vascular (R-I) indication and has stated for the record that generics can not sell the drug for the R-I indication because it infringes on Amarin's patents..
The dilemma exists because in the real world...Scripts are not confined to a single indication and physicians are free to prescribe a drug for any indication they wish (off label). They simply do it at their own risk..Even though the judge thinks she has a reasonable solution...Let the generics have the Marine indication...There is no way the generics can stop physicians from prescribing the drug for the R-I indication using generic Vascepa and there by, according to the judge, infringe on Amarin's patents..
What I am trying to do is offer a plausible solution to this dilemma..That is how the generics can reap the benefits of the Marine indication, but not end up with the R-I indication and I would appreciate not hearing a lot of nonsense..IMO The judges decision should not stand, not because she made procedural errors or factual errors..but because her decision has consequences she did not consider..The most important is she is giving away Amarin's property for no legal justification.. Because she is not familiar the FDA policy of allowing off label prescriptions..And this FDA policy renders her decision a defacto gift of Amarin's R-I indication..
The best solution I could imagine is to prevent the generics from prescribing Vascepa. Because the Marine indication.is a conduit to the R-I indication. Reward the Generics for what Judge Du thought she was giving them (The Marine indication)...by having Amarin give the generics a receipt which is a proportion of the entire USA sale of Vascepa commensurate with the percent of Vascepa sold for the Marine high trig label..This would be profit after M&S...and could be worked out..That would be I believe what the Judge intended..She just did realise her solution was not fair because of the off labelling issue...
I'm sure TET won't understand this but hopefully the company and some of you on board will..
":>) JL
zip...
Quote: This situation reeks of unfairness. Yes it does..Du even if she is right about the obviousness of the Marine patents...She is defacto giving away the R-I patents which she did not say were invalid..
She has not considered the realities of the situation regarding the ability of clinicians and drug plans to prescribe off label...and that includes the R-I indications which Judge Du has Already stated would be be infringing on Amarin's patent..So how can this be a fair judgement...
":>) JL
Why are we not emphasizing the fact that Du's verdict only granted the Marine Indication and left Amarin's patents intact on the R-I CVD reduction and her opinion stated the generics would be infringing on Amarin's patents if the generic's scripts are for the R-I indication...
This is not a "fair" decision.
It is "obvious" the generics have no intention of sticking to that restriction as the Marine indication is worth much less and the R-I indication .
The Judge's decision needs to be vacated not based on legal mumbo -jumbo..but to use the judge's own thinking regarding Generics infringing on Amarin's R-I patent rights by writing scripts not for Marine but for the CVD indication.. Her decision as it stands, provides no remedy or theory on how to stop the generics from selling the drug for the R-I indication..So how can this be a fair or reasonable judgement if it allows the generics to infringe on Amarin's legitimate patents..The court needs to produce a viable (real world) way Amarin can protect its legal patents...And that is more than telling the generics not to do it...Because the truth is the generics can not prevent doctors from prescribing the drug off label... That is why Du's decision here is a Fool's decision because she has given the generics Amarin's IP property on no legal basis. The down the road consequences were never really looked at..
IMO given the judge's reasoning ( The generics are entitled to the Marine indication because the patents are obvious) a reasonable solution would be to give the generics a fraction of the Vascepa receipts.in the USA market..commensurate with the percentage of Vascepa scripts written for the Marine indication...That would be a fair decision...I hope the company reads this message and considers making this suggestion to the courts or approaching the generics..I believe this is fair and equitable. And saves face all around...
":>) JL
anfla...
Quote: . "Experienced judges in that space learn over time to try to assume every perspective is shaded by hindsight. Part of this comes from just seeing enough cases to see how every single patent seems obvious 10 years later. If it’s your first one, you wouldn’t recognize that."
This is a very important observation and much to the point...Jerry Jeff Walker begins his classic "London Homesick Blues" with the statement "Let me take you back to that place." She, (Du), has no idea how many ideas in the history of medicine were OBVIOUS at one time for a hundred years and were gone for good a month later...Or how many many treatments were replaced by obscure new therapies...which were suddenly OBVIOUS..This judge may know the law...but she is ignorant of medical history..
Let me take you back to that place...in 2010... Statins were the only recognised therapy for CVD event risk..By the FDA...Statins were viewed by orthodox medicine for cleaning out the arteries the same way "Draino " cleaned out the sink pipes..LDl-C was the gunk that stopped up the sink..
Omega threes.. were not any part of orthodox medicine..Even though the Nobel Prize in medicine and physiology had been awarded in the mid to late 1900s for explanation of the mechanism of Aspirin by John Vane in 1982. Indeed the Eicosanoid System which spirin, EPA and Corticosteroids all of which act on the Eicosanoid system. Is not really mainstream medicine even now as the doctors viewing the surprising REDUCE-IT trial results show even the cardiologists for the most part don't understand it is EPA's effects on the Eicosanoid system and Systemic Inflammation (SI) by which Vascepa makes its magic...
Taking you back to that place in 2010..I was actually working as a clinical consultant to a group at Harvard that was exploring novel ways to control inflammation..These were PHD medical scientists at Harvard..When I ask them how Omega-3 EPA could lower SI...They did not know the mechanism...And these were top grade medical scientist in the field..So at that time the mechanism of how EPA worked was understood by very few in medicine...and there was no Obvious...
Du's opinion on obviousness reminds me of a verse from an old MIT undergrad song...the words..
"Godiva was a lady who through Coventry did ride.
To show the noble villagers her pure and lillywhite hide.
The most observant man of all an engineer of course.
Was the only one that noticed that Godiva rode a horse."
And that is Du's observation of obviousness..Her observations may be correct..but they are only on trivial aspects and missed the main important idea...She may be a lawyer...but she is not a scientist..a scientist would never make such a colossal mistake...
It's ten years and a REDUCE-IT trial later and I would estimate less than 5% of all MDs could give a lecture on how EPA works to lower CVD event risk..And that includes cardiologists and lipidologists...
":>) JL
bouf...
Quote: "I think we need to see follow through in terms of who is new appeal lead counsel and where is the motion to expedite the appeal. Last time I checked (today) the appeal was not yet docketed with the Court of Appeals. The May timeline for filing the appeal brief seems aggressive if they don’t get an order the expedite the appeal.
I support the plan but don’t see the action yet."
Gotcha...We've heard the words...now we must see the deeds...
":>) JL
Jas...
Have you been sniffing the gas again?..You know that can kill you...
The idea is not to use Vascepa to treat Cytokine storm...The idea would be to prevent the storm..Once this hyper inflammatory condition reaches storm statis the condition becomes self sustaining...Putting patients on Vascepa before they go into the condition might prevent CS...Also since mortality and morbidity are higher in patients who have t2DM or other CVD risk factors..Vascepa is no brainer and everyone with these risk factors should be put on Vascepa as early as the Dx is made...JMO..
":>) JL
lb....
Yes only generics get Tier 1...but will be huge even if Vascepa gets Tier2 or 3....
:>) JL
Kuduos for JT
JT marshalling his inner Winston Churchill.
Message: "We will fight them on the land and fight them on the sea and we will never quit...Never..."
Bravo speech pretty much covering A-Z...I especially like most of what he said..But highlight that it is not clear that Generics can beat the brand prices here and that is basically the generics only viable strategy...
Why?? well for one thing Ararin has many markets where the generics can not sell and Amarin can use those sources of revenue to subsidise the USA market..
Sure Generics also have other drug and other markets,,,But is it going make it worthwhile particularly if the generics have to risk selling for the ilegal CVD/R-I label where they are not allowed by the patent decision..I don't know about the wisdom of settling because I am not sure other generics might get the smell of warm meat. But maybe they can and will..It has been my opinion for ten years now, that Vascepa is not an Ideal target for generics,,,But we will see..
JT noted the appeal will not be based on the many disturbing statements and mistakes that Judge DU made...but on legal mumbo jumbo such as how many i's were not dotted and ts not crossed,,,You know the important stuff. But some credit will be given to the fact the judge did not fully understand clinical trials...And it is not altogether obvious Du..knows more about patents than the USPTO..
Meanwhile we do have the European theatre...Where there are an estimated 80 million CVD patients including (I think) T2Dabetics, Plus Canada and possibly China (whatever that means)...
Anyway JT was very convincing and I am pretty sure he was reading off a prompter as he did not have a single Ah...very impressive..Especially nice to hear Vascepa has been up graded to Preferred Brand most likely that is Tier 2 or three...Will wait to see if the price is down at CVS..This might actually help the generics because it would remove gen Lovaza as a generic blocker...but nothing is perfect...
I am pretty tired but think I will sleep well tonight...Best of luck to all you longs..and long term posters...
":<) JL
G...
Very nice synopsis..Did not know you were such a patent expert...
Agree...
":>) JL
TTE...
Good post...your point on the obvious issue is right on...Add to it she is formulating her opinion on the trivial matter, The high trigs. and then miraculously she transforms her descents into the important point which is the R-I indication. Which is a separate issue and unrelated to the trig situation...
Its like arguing that since Michael Phelps can beat Usain Bolt in the hundred meter freestyle..That Phelps must be able to beat bolt in the hundred meter sprint.
Du is a lay person as far as medicine and physiology...I have yet to see evidence that she has doctorate or any other special knowledge in the medical field..Yet she freely opines on subjects that the worlds greatest authorities don't always agree on...Complex subjects which are still fought over..And suddenly she is the authority...Something about "that" is so wrong..'
I have seen this behavior from a judge I worked with on the Malpractice Tribunal in Mass..A judge who knew it all..And yet knews nothing..to begin with did not know how stupid he or she really are..These people are "bullies"..
There is
no other word for it..And like this ignorant Judge they do great harm..
The biggest outrage here is this stupid woman judge puts herself above the patent office and the medical community..And she is not even smart enough to read a Nutritional Journal article (Mori) and get her facts straight...If this be the law then our country is in woeful shape.
I call Du out as an arrogant fool...Steeped in the arrogance of these judges in their robes...These are not wise men they are fools behind their robes...Arrogant fools...And they are the worst...
By the way...I am an American citizen both of whose parents died in service of the USA in foreign lands during WW11...Orphaning me and my brother when I was five years old...And even though I graduated from Harvard Med School during the Vietnam war..and could have gotten out it like virtually all the rest of my class did..I like Chris in Platoon was stupid enough to volunteer for Vietnam where I was a combat surgeon and was awarded the bronze Star....
I have lived long enough to see this court action..And see them do this to me and other Americans...I spit on you judges in your phony robes..
":>) JL anyone who wishes to forward this please feel free.
Lem...
You must be a millennial...I can not understand a word in this song and I listened to it twice..The music is IMO awful...No lyrics no music..doesn't cut it...One step ahead of YoKo Ono....
Guess you don't listen to a lot of music...
try this ..
The Du decision and why it sucks...
Quote..
" I asked a thief to steal me a peach.
And upward he turned his eyes.
I asked a lithe lady to lay her down.
And holy and meek she cries..
A good judgement...Ends the issue...Perhaps only to the delight of only one of the parties, but a good judgement ends things.. at least until the appeal..
Judge Du's judgement ends nothing..Du completely ignores the nature of generics..They are not in the business of furthering medical knowledge. They are in the business stealing property..Albeit with the help of the legal system. Du makes a very foolish assumption that Generics are going to follow the rules. Generics don't care about the Marine indication because it is not worth a wheelbarrow of cow pies. The Generics are after the R-I label indication and Judge Du has provided a situation where there is little or nothing standing between the Generics and the R-I indication..
Judge Du should have thought about that before she ripped off Amarin and its shareholders and gave their money to the generics..The least she could have done was to offer a strategy that would block the generics clear path to the R-I label which she agreed they have no right to. Our great hope at this time is that we win the appeal and that appears to be a coin flip...
Maybe the appeals court can come up with a solution that would prevent the generics from selling off label..
Right now preventing the Generics from infringing on Amarin's patents seems a daunting proposition..The only solution seems to be that Generic Vascepa can only be prescribed for patients with documented (by lab test)
Trigs in the 500mg/dl range...That is the very least the Federal Courts owe Amarin...
If Amarin is wise they should cut their profit margins on individual scripts to the lowest level they can and still make money..
Our only hope now is the Appeals court understands this additional secondary condition...That is the generics will try to game the system...
Without the R-I indication the High trig indication. Is virtually worthless.
":>) JL
north....
Brilliant north...
See if I have it right...Amarin owns the now defrocked Marine patients (The "Marine 6")...Which are now deemed "Obvious" by the all knowing Du...
Being the author of the patents Amarin has the right to disclaim the patent claims, and after fees etc. Amarin Is free to give the patents to the public so they are not owned by any entity...This is no big deal for Amarin because the Marine label sucks..Very few customers and a label that reads..."The benefits of this drug have yet to be determined."
I'm not sure how this prevents the tricky Generics from selling off label G-Vascepa under the guise they are treating very high trigs...I think Amarin still needs a sure fire method of proving the Generics are indirectly infringing on the R-I patents..Seems Amarin needs to make sure pharmacists and the drug plans understand filling Vascepa scripts with Generic V for the R-I indication is an infringement of Amarin's patents and violates Federal Law...Amarin somehow needs to get the script fillers to document Very High trigs (with a blood test).. if a generic script is filled..
What am I missing???
":>) JL
ilove...
Quote: Null shows, and "Mori states in his own words" that the effects on LDL-C by DHA against control compared to EPA effects on LDL-C against control, Null Hypothesis shows NS between the two agent's effects on LDL-C.
Yes this pretty much blows the conclusion; that Mori is obvious. right out of the water...Mori also claimed DHA increased LDL-C and EPA did not so much..But DHA increased LDL particle size and EPA did not...It is well known presently that increasing LDL particle size decreases CVD event risk..At least to the extent it would/could outway the effects of increasing the LDL-C. Current research indicates small LDL particle size increases atherogenicity. This would argue that EPA and DHA would have roughly the same effect on CVD event risk..
If I was challenging Du's verdict I would attack her on the basis that she is neither educated or knowledgable on the complicated pathophysiology of Lipids, and how lipids and other molecular and non molecular mechanisms and nothing in this field (of which she is not an expert) could be considered Obvious because there is no universally accepted theory of exactly how Omega-3s work to reduce CVD event risk...As far as LDL-C which Mori mentions..There is no absolute or anything even close to proof that elevated LDL-C causes heart attacks or other CVD events..If Du was a true expert she would have known over 50% of patients having their first heart attack have LDL-Cs in the normal range..
EPA's ability to lower Systemic Inflammation by way of increasing the EPA/AA ratios is much more important in lowering CVD event risk than any effect on blood lipids seen in Mori or the Japanese study..
Du is not medical scientist or even an MD and her views on how Omega-3s effect heart disease are simplistic...She may be a Judge, but from a medical standpoint she is a "layman". She would no more be allowed to treat patients anymore than I would be allowed to be try a case in Federal Court. because I am an MD.. And in this case..And her conclusions are only tangentially based on fact and some are erroneous.
She should not be allowed devastated and destroy a company who has developed an FDA approved drug...That has been proven to cut the risk of stroke and heart attack down an amazing 25 %...And is going be proven to treat many other serious medical conditions ..Not because it lowers trigs or effect LDL levels...These are merely side issues..If this drug was obvious why did it take 20 years (after Mori) to convince the FDA that the drug would work...
":>) JL MD
NickHouse..Its always been the lawyers and the judges that are the biggest Cheats and thieves...
Read the novel "The Son". It is the story of America and the expansion West..It was never the brave pioneers..That is just a crock.. It was the lawyers and judges who got paid off to invalidate deeds and land claims. Long after the land had been settled...And the real pioneers were forced off their land to move ever westward farther away from civilization..But long before that the Comanches established an empire which was similar to the mongols in every way...And they did not employ judges and lawyers..They drove the surrounding tribes off the land and killed many who resisted..They kept the Spaniards out of the western territories for 250 years and still sold slaves in the markets of Mexico until halfway through the 19th century..
So those of us who have had our property stolen we should not expert these thieves to graciously give our money back..History says the only thing these people respect is retribution...Do not expect the state to protect you...
":>) JL
The rationale for these media announcements is not to effect patient behavior...Patients do not knowingly subvert the law..or know they are sub verting the law..The idea here is to wake up the doctors, but even more so target pharmacies and pharmacists...And educate them to the knowledge that only Amarin has a legal right to sell Vascepa for the R-I indication and those who prescribe Generic Vascepa to reduced CVD event risk are breaking the law as was established in the Federal Court.
Ignorance of the law is no excuse...but Amarin has to understand educating the pharmacists is very important...
":>) JL
raf...
Quote: "I have no clue what that number is". (profit margin)...
"and then Amarin would have to cut their profit margin by 90% to match Generics' price."
Yes if that was indeed the profit margin..IMO (just an opinion) I do not think its going to be impossible by any measure for Amarin to meet and beat the generic price...Ie out generic the generic...and still make mega bucks..
Also why are so many of us ignoring Europe and other locales...and the fact the generics can only "legally" sell for the Marine indication...Remember hardly any other drug on the market is prohibited by law to sell a drug for a specific off label indication..
Everyone on this board thinks the generics are going to be able to flaunt that law with impunity...But that may not turn out to be the case..If the practice (generics selling for the R-I off label indication)..is wide spread and I believe it will be..I think Amarin will sue the generics for indirectly inducing infringement on their patents and that will be an easy victory for Amarin and the generics will not be allowed to sell Vascepa..
Why will it be easy...Big data will reveal number of scripts will exceed the number of cases of very high trigs by a factor..In patient pools there is a significant number of patients who for whatever reason are unhappy with their medical care or their doctors or both..If I was Amarin I would do a DTC ad soliciting patients who have had generic Vascepa prescribed for CVD and do not have Very high trigs. Explain the federal court has prohibited generic companies to sell Vascepa for anything but Very high trigs. And And offer a reward..Six months free Vascepa for information identifying fraudulent prescriptions...made for indications such as for Heart disease or diabetes..
":>) JL
Hondo...
I agree...Most PCP's (Primary physicians) here in Florida are not seeing their patient..Telephone and the message says your appointment is delayed a couple of months and if you feel sick then go to the hospital...
PCPs are not setup to treat the Virus in their offices and are affraid they will contaminate their locales...
The scripts are awesome considering these facts...
":>) JL
Bolio98...
Thanks for posting..
Quote: "They did lower their price to the generic level and effectively locked out the generic. Obviously revenue suffered, but the generic got no foothold."
So many on this board have claimed this can not be done..Matching or beating the generic price..Or they claim the generic is always preferred..Which is just not true.. Cheapest is always preferred if the drugs or their effects are the same.
Amarin has a good chance here to beat the generics price because they are not a price play..They are volume play..."Fast nickels beat slow dimes.' Vascepa was never cut out to be a good generic. Good generics are those that go up against marked up brands...Generic strategy is just " beat the price of the brand"..
amarin has the suppliers as well as the patents "yet unseen" that deal with drug production and synthesis..
Leonard Cohen laid out our strategy...
The Du decision...A Tale of Two Indications..
The Amarin patent trial is really about two separate and unequal indications..
The first is the indication for reducing high trigs.
The second indication is for lowering Cardiovascular event risk...
The second indication is orders of magnitude more valuable from both a therapeutic and a financial standpoint...
Although there might be some suggestion of obviousness in the patents for the trig lowering indication...There is virtually none for the CVD indications and there is no "cross over" between these two indications. No one has argued that MARINE was a CVD event trial...and FDA label stipulated there was no proof Vascepa was effective
Quote FDA Marine Label...
"VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an
adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
•The effect of VASCEPA on cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been determined. (1)"
So regardless of anyone's personal belief even if she is a judge. She can not carry over an opinion that Mori says anything about the R-I results which were far from obvious..(and she didn't)
The problem with Du's decision (even if she is correct in her opinion on Mori and the other trial)...She has ignored a very huge secondary consideration...And that consideration is her judgement is not going to prevent Generics from pilfering the The reducing indication. She is using the patent results affecting the Marine indication to allow generics the CVD event R-I indication.
Because there is no obvious way to prevent the generics from selling Generic Vascepa for the CVD event indication...And that is an enormous secondary consideration which needs to be addressed..Given that drugs can be prescribed "off label"...Obviously the Generics are going to write scripts and most will be for the R-I indication even though it infringes on Amarin's patents and steals Amarin's property...And currently there is no good way to prove the generics are breaking the law..Secondary consideration. She is not protecting Amarins hard earned property..
Du's judgement will rob Amarin and needs to be reversed...
":>) JL
TTE...
Generics can not legally sell the drug for the R-I indication...as they are infringing on Amarin's "good " patents and Amarin can sue them for that (in federal court) and Amarin will win...
Consider the possibility Amarin can produce the drug for less than the generics can and sell it for less. Its not all about being a generic..Its about the lowest retail price..The potential market for this drug is so astronomical that Amarin can make a fortune even selling it using razor thin margins,,,Also Amarin does have Europe and IMO they will seek a partner for Europe ..a BP, but not sell..
Consider the real possibility the Du determination gets reversed on appeal..Why wouldn't it be...She did not follow procedure..The Patent circuit has repeatedly stated it wants the districts all on the same page regarding patent issues..Not a bunch of wild ass ideas or creative thinking...Judge Du's opinion is rife with wild ass ideas and furthermore she included some facts that were incorrect..Medical experts could educate the court to the fact Omega-3s are a very controversial subject in medicine and if you Cherry pick the literature you can pretty much come up with any notion you wish..For example the Cochrane Meta analysis
https://www.cochrane.org/news/new-cochrane-health-evidence-challenges-belief-omega-3-supplements-reduce-risk-heart-disease
This article which was reviewed in JAMA questions (rebukes) the very notion Omega-3s have therapeutic benefit in CVD...And this article was published 18 years after Mori...and was not published in Journal of Nutrition...But was published in the most widely read journal in the world and was peer reviewed...How can anyone judge or not claim tht Mori rendered Obvious that Vascepa would lower the risk of CVD to the extent it did.
I understand the judges verdict only applies to the MARINE indication..But I see three secondary considerations the judge failed to consider..First is a treatment is only a treatment if it has proven therapeutic benefit..It is possible for an agent or device to change blood levels or effect some other bodily function and not have any therapeutic benefit..Such was the case in 1993 when FDA took the silicone gel breast implants off the market..They were remove not because there was clear proof they were a health hazard..They were removed because FDA director Kessler assigned them no clinical benefit and therefore any possible risk factor known or unknown would create an unfavorable risk/benefit ratio....
At present time the FDA label for the MARINE indication is quite clear Vascepa does not have proven therapeutic benefit for either treating or preventing Acute pancreatitis or at the time of the label...Any proven therapeutic benefit for treating Cardiovascular disease...The simple fact the FDA issued that information on the label..Is absolute proof that there was no accepted or obvious proof that EPA would lower CVD event risk to the extent the REDUCE-IT trial proved it would...All studies done prior to R-I on EPA or any of the omega-3, including Mori and Kay,...are totally irrelevant..
Judge Du seemingly just copied the defendants' arguments even to the point of copying their mistakes...She did not copy any of the Plaintiff's arguments...The first responsibility for a judge is to be impartial. Adopting one side's pleas and copying them to you decision does not argue for impartiality...
Judge Du was required to include secondary considerations which would have included the fact it was Amarin who spent hundreds of billions of dollars and years to get this through the FDA marketing process and the FDA was not assuming anything was obvious...Without Amarin's commitment, determination and willingness to carry on when almost everyone in the medical community considered this to be a fool's errand and predicted Vascepa would end up in the wastebasket that holds so many other Omega three trials...There would be no Vascepa...A drug that will in all likelihood save millions of lives including possibly a few judges..
Another secondary consideration was Judge Du's decision would have far reaching consequences which she did IMO not consider. And that is her decision is a clear cut invitation for the generics to induce on Amarin's valid patents by poaching the CVD indication..She can not be possibly be naive enough to think the generics are not going to be headed straight for the CVD (R-I) label and she has placed Amarin in a position where they are powerless to defend their franchise...and all this from some woebegotten obscure nutritional..article that says nothing..
Du's decision is a travesty and must be overturned on appeal..Otherwise there is no justice..
":>) JL
Bb...hostile takeover...Irish Company with English Charter,,,
No way....
":>) JL
TTE....
The circutt judges are not morons...and there are issues other than Kurabayasi or Sacashaytisi...or any other of the asi family...If this is what the law is all bout..legalised theft and cheating honest people out of their hard earned accomplishments..by legal trickery and technicalities then these judges should be hanged because they are worse than the criminals.
This is all a farce and because somebody is a judge does not mean anything if he or she is really a cheat, a thief and a scoundrel And they belong in the same prisons the hard core criminals are in...
Taking property by legal leger de main is theft pure and simple..The judges that do this should be in jail
The truth is Amarin and its share holders who are ordinary citizens. Spent millions of dollars and ten years of our lives nursing Vascepa through The expensive and lengthy FDA drug marketing process..and that is all the courts need to consider if they want to decide obviousness..It is obvious FDA did not think Vascepa would reduce CVD event risk...Nor was it obvious to the rest of the Medical community..The positive results of the REDUCE-IT trial lifted the price per share from a low of 80 cents a share to over twenty dollars..Virtually every doctor in cardiology was amazed Vascepa had such therapeutic effects on cardio-vascular events..I was in Chicago at the meeting and there was a standing ovation from cardiologists (something I have never seen following a clinical presentation and I have been going to meetings for fifty years)...And no body ever heard about Mori or Kurabayasi..and certainly their pityful little trials had no effect on clinicians. And if they had presented evidence that EPA would lower CVD event risk to the extent Vascepa did they would be world famous...
I don't expect that any of the learned judges is an expert in cardiac Pathophysiology...And they know just as much about medical science as I do about Patent law...I know you won't be reading my post..You judges..but I curse you as liars and thieves and hidden behind your robes are not truth and justice,,Just lies and thievery...You are nothing but common criminals...
":>) JL
Jas...
We don't want her getting a chance to weasel out of her errors and omissions..We have her on a video proving she should be judging livestock at the county fair and not presiding over legal matters...Let Covington rip her a new one...But don't let her change her story or make excuses..We don't want any noise out of her..We need to go straight to Appeal...
":>) JL
Gusman....
Quote."Trump hates Obama appointments as much as we do. How do we get Trump involved in righting this wrong??"
Trump has never been adverse to campaign contributions..Last time I looked Amarin still had a couple of dollars in the till..Also its high time Amarin started playing the bigboy game...Amarin needs a serious lobbiest and I am sure Covington can point them in the right direction..
Time to take off the pillows and don the Brass Knuckles....
":>) JL
Keyser....
Good post...Quote.."Her errors (Du's) are in stone--Covington gets to address them, without her trying to re-characterize them as something they are not."
Amen...":>) JL
Lots...
Lovaza only is substitute for Generic or Brand vascpa in the Marine indication,,,not in the expanded label indication..There is no alternative to Brand Vascepa in the expanded label indication (to lower CVD event risk)...
Generic V can not be substituted for brand V in the expanded label for CVD event risk indication because that would infringe on Amarin's patents..
":>) JL
rydad...
Yes..Its very weird because its such a rare situation where a drug vendor is prohibited from treating an indication because in doing so they would infringe on the brands patents...
You are correct..This is the case..
":>) JL
Please read my ten posts on the subject....
The Tier level determines the out of pocket costs for people in drug plans which is just about everybody medicare age..Tier one..No charge..Tier 2 maybe twenty dollars..Tier 4 read Vascepa before the CVD label indication and still on Tier four because FDA pushed the label back to late december after the close of the open enrollment Medicare period ..And we are likely stuck till this coming November..
So Vascepa at tier four can cost $350/month..out of pocket and because of that people buy alternatives in the hope they work...
":>) JL
Card...
I know no doctor writes indications on the script I have been a clinician for forty years...
You don;t understand what I am saying ,,the indication does not mean anything..The only thing that counts is whether its the brand drug or the generic because in this scenario the Brand can use both the Marine indication and the R-I label indication...And doctors will for the most part be writing it for CVD event risk...The generic can not by law write for any other indications than trig lowering (the MARINE label) and there are drugs in that space that are cheaper..There is no cheaper drug in the R=I indication.
Just because a doctor writes a script using the generic for the CVD label indication does not mean the Drug plans are going to be treating it like a CVD drug. They will treat it like a MARINE Drug as that is the only condition the generic is legally indicated for...This was the same thing last year for Amarin...Doctors wrote the V script off label for its cardiac benefits...But the Drug plans treated it as a high trig drug because that was the only indication on the label. The company did not get the expanded label until the end of December,.Since there were other trig lowering drugs that were cheaper than Vascepa. Drugs like Lovaza.. is why Vascepa was Tier four on most drug plans..And the company could do very little to correct that...
":>) JL
Card...
You are wrong..Generic Vascepa is the same molecule as Brand Vascepa..but the reason brand Vascepa was set at Tier four for the Marine indication is specifically because it was not the cheapest molecule for the high trig indication and that Lovaza was placed at a lower tier..because it was cheaper..
What drug tier is Vascepa typically on? Medicare plans typically list Vascepa in Tier 4 of their formulary. Tier 4 drugs are usually non-preferred brand-name drugs. Tier 4 drugs cost more than Tier 1, 2 and 3 drugs.
":>) JL
Cardio...
Quote: "The pharmacists and the insurance do not have to waste their time to separate indication..."
The only distinction they need to make is whether the drug is the generic or the brand...And the brand in this case will be cheaper because it is indicated for the CVD indication and has no cheaper molecule for that indication and therefore will have a low tier price..
The courts have declared generics can not claim the R-I indication because the infringes on Amarin' patents..So the only indication the Generics can claim is the Marine high trigs..(regardless if they really intend to use it for the CVD indication)...That puts them in exactly the same position Amarin's Vascepa faced the past two years..That is with only the Marine label they faced competition from drugs like Lovaza which are cheaper molecules Which also lower trigs... Last year all our complaints about the out of pocket costs for Vascepa was due to the fact the only FDA label we had was for the Marine high trigs...and since Lovaza was a cheaper molecule the Insurance companies put Vascepa at a high tier...This time Amarin has no legal cheaper competition for the R-I label...and that means lower Tier levels..There is no violation of insurance dictum of supporting the cheapest molecule..
":>) JL
In this case the lowest priced equivalent molecule for the Marine indication will not be Gen Vascepa..It will be Lovaza or gen Lovaza...And that means Tier four for Gen Vascepa..
There is no cheaper equivalent molecule for the REDUCE-IT label than Brand Vascepa because Generic Vascepa can not be used because it infringes on Amarin's patents.and can only claim Marine indication..And Brand Vascepa does not have any other drug which is cheaper alternative...
Amazing but true...Try understanding what I am saying...
":>) JL
john....
I do not see that happening..but as i have posted...Brand Vascpa in this case will have lower Tier than Generic Vascepa because G. Vascepa will only be approved for high trigs...and even if the the plan is to off label gen Vascepa...The court decision is that gen V can not be prescribed for CVD events...So it can only be sold for the Marine indication regardless if it is used off label...
That means Gen Vascepa must face competition with drugs like Lovaza, G, Lovaza, Niacin, fibrates and all of these are cheaper than G.Vascep..So the generic company has the same problem Vascepa had last year which is a high Tier meaning the scripts will have to compete with cheaper alternatives..Which means Gen Vascepa will be Tier 4...
The paradox here is the brand will be cheaper than the Generic because there are no cheper alternatives for the CVD event label..
":>) JL
goamrn....
So these are not really questions just your way of educating me...
If you think Pharmadude and the others are are right..you need to read my post...It's pretty cut and dry...The pharmacist can not overule the court..The court says Generic Vascepa can not be prescribed for the R-I label...
The druggist can fill the script with a generic or a brand.
Normally the answer would be obvious and the pharmacist would fill the scrip for the generic..But in this strange case if the Pharmacist decides to use the generic (regardless of whether or not the patient uses the drug for high trigs or the R-I) The generic, by law. can only be used for the Marine indication and therefore must confront the fact that other drugs (lovaza, G.Lovaza..fibrates and niacin)..all of these drugs are trig lowerers, essentially have same label and are cheaper than Generic Vascepa...And that means G. Vascepa will be Tier four...
So in this unusual case the Brand (Amarin's Vascepa) will be the cheapest alternative. This is because Amarin's brand has no cheaper alternative for CVD event risk and will will have a lower Tier designation. I understand this is counter intuitive (not obvious if you will). The generics would had a much bigger win if the could have ghotten the CVD event (R-I ) label...but too bad they didn't.
":>) JL
.
Please forgive all my typo errors...My keyboard is essentially non functional and I look up and see letters are missing amd spaces created where they do not belong...I go back line by line but I still miss some errors..
goamrn...I do not understand your first sentence...The NDA holders do not win the price war because they need to recoup their costs in developing the drug. Ie. that means going through the FDA's "Marketing" process" ..That is the reasoning behind Hatch-Waxman...And the costs of "marketing drugs" have gone way up since the advent of H-W..,It aint getting cheaper and these opportunistic generics don't become less greedy...And then we have a moron Federal judge. complete with an agenda...
What ever happened to "Impartial".
":>) JL
Zip....
LOL...I believe FDR said "We have nothing to fear but fear" when he was talking about the "Great Depression"...
FDR said Dec 7th will live on as "day of Infamy"...When the Empire of Japan conducted a sneak attack on Pearl Harbor.
I appreciate your John Belushi imitation. We can use the humor on this board right now...
":>) JL