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HK...
Yes...The lipid world was not so clear and unified as to the effects of EPA vs DHA as Judge Du fantasizes..There were a number of studies and a number of differing opinions. These situations are ripe for "Cherry Picking"...The old Meta Analysis problem..
Du's judgement is based on nothing more than her pre determined opinion and is flawed...The fact Vascepa (EPA) not only worked to lower CVD event risk, but worked so well was a total shock to the lipidologists, and cardiologists is by far and away the most important thing..Du and her opinion are twisted...She should have been present at the 2018 AHA meeting where the R-I results were presented. The presentation by Bhatt got a standing ovation...And the cardiologists were polled electronically on their cell phones as how they thought the R-I trial would effect their practices. Before the presentation less than ten percent of the Cards said they would treat their patients at risk with EPA and statins,,After the presentation the doctors who planned to use Vascepa was over 90%...
":>) JL
raf..how do you get to the presentation?
":>) JL
Anfla
This post is a far cry from your earlier one..Which I quote verbatim
Quote "FDA have no jurisdiction at all over physicians"...Now you temper this down to "They don't regulate physician "off label" prescribing..
The FDA also does not facilitate patent infringement...
":>) JL
Quote: "FDA have no jurisdiction at all over physicians"
Not true...
FDA deals mainly with marketing of the drugs and as such does usually get involved with individual physicians..but that does not mean they can't or haven't in the past..
In the second half of the 20th century the FDA went after individual physicians in private practice who were injecting patients with liquid silicone...They sent Consent Decrees to a number of plastic surgeons and threatened criminal prosecution. They actually charged Norman Orintreich a Manhattan dermatologist who had performed the first hair transplant..
If you keep posting long enough you might get something right
":>) JL
John King...
Quote ACC CVOT results...Evolacumab (PCSK9 inhibitor)
Interpretation:
Among patients with elevated cardiovascular risk on statin therapy, evolocumab versus placebo was effective at reducing adverse cardiovascular events. Evolocumab was associated with marked reductions in LDL-C levels. Serious adverse events were similar between treatment groups. Efficacy for evolocumab was similar among those with very low baseline LDL-C levels. There was a greater absolute reduction in major adverse events for evolocumab versus placebo among those with the highest baseline inflammatory risk and genetically determined high-risk status. PCSK9 inhibition represents a novel approach to lower LDL-C levels and improves cardiovascular outcomes. However, for the duration of follow-up, there was no benefit on cardiovascular or all-cause mortality, and cost remains an issue.
The treatment of heart disease is like "affirmation" you repeat a 1000 times "I believe I can do it"..Then on 1001 you say "no". The treatment of atherosclerosis has been under the guidance of cardiologists and lipidolgist for the past century and they have focused lipid levels and it is becoming more and more obvious they should be focusing on Systemic Inflammation (SI)..Blood markers such as trigs, sugar, and likely LDL-C reflect the SI and the R-I trial even though the cardiolgist (including Bhatt) have refused to consider the Inflammatory levels related to changes in the EPA/AA ratios (something we have not heard about) R-I's legacy will be its confirmation that elevated SI is the root cause of cardiovascular disease and is the "puppet master" and the blood markers are only the puppets..
Right now I would much rather be holding the deed to Vascepa rather than any drug that merely lowers blood lipids unless it is doing it by lowering SI...
":>) JL
G.
I see your point here...
As Toddrobertking explained in post# 283161...
A settlement without a reversal of Du's opinion of obviousness..Would not require the DC to vacate Du's opinion..The DC would not be compelled to change her opinion on the obviousness of the patents..And therefore Amarin would not have patent protection from others who wish to sell Vascepa for the MARINE label...
So Regardless of my thinking a settlement would be a good thing..Legally Amarin needs to win the appeal which will restore its patents.. And if Amarin wins the appeal...Then it is not clear that Amarin should settle.
Thanks for the explanation
":>) JL
zip...
The decision to try the case on appeal vs settling with H&R would try the wisdom of Solomon...
While I do think the current situation is an asymmetrical bet...Because if we lose trial..We are in the same boat we are right now..The generics have won the right to sell Vascepa for the MARINE indication..Same situation existed before the appeals decision..(so the price might drop briefly..but should return at least to these levels..I am not hedging this)
I was until recently 100% against settling..But I have had an epiphany..I believe the generics now understand why winning the the MARINE label is a Pyrrhic victory..And why TEVA settled in the first place..and the recent settlement..There is a chance we could lose the appeals..and even if the generics' win is not super profitable . It will be a stone in Amarin's shoe..
I think the generics will settle for next to nothing. The MARINE label is a non starter..Give them some money and they will disappear. If they are not willing to settle for next to nothing..Then fine: "see you in court"..
Face the facts..nobody including me thought the generics had a ghost of a chance in the DC trial..And look what happened..IMO if you re looking for a B/out then settle up,,That's what you do if you are selling your house and someone has a lean on it.
Zip with real regards.and deep respect...JMO..":>) JL
Sorry I don't agree...
I have heard this argument that TG behaves differenly at different concentrations..And as far as I know disregarding the fact there there is a higher concentration of VLDL particles (the Lipo protein fraction that carries) trigs..I am not aware of a paper that says the concentration of VLDL effects the physiological activity of VLDL until you get into very low concentrations...When the particles begin to convert to LDL-C..I am not aware of a similar effect when the level increases over 500mg/DL.
I think it is very significant the president of the Association of Lipidologists at that time 2011 would favor DHA over EPA..And that should end all argument that a POSA (the president) would favor DHA over EPA..if he thought EPA was the logical choice.(ie obvious)
":>) JL
Kiwi...
Yes...But even in 2010 the most important consideration was that Systemic Inflammation (SI) might be the real culprit..For years cardiologists and lipidologists had viewed atherosclerosis as an accumulative process..Very similar to pipes that carried waste or sewage get clogged over time..
Evidence of the eicosanoid system..Was well known to medical scientist..but not widely known to MD clinicians..So there was (and still is) a wide separation between what PHD physiologist knew and what clinicians who treated the patients knew..
The key factor was the control of SI by cellular membrane receptors. Receptors which were present on every cell in the body except Red Blood cells.These receptors were effected only by active chemicals that presented the correct three dimensional structure..There active agents were "eicosanoids" arachidonic acid..Aspirin, NSAIDs and Cortical-steroids..EPA has the correct 3-D structure to interact with the membrane receptors DHA does not.
The early thinking that heart attacks and strokes were caused by sludge plugging up the arteries was caused by evidence the Aortas of 18 year olds killed in the Korean war showed cholesterol streaks..In clinical lipidology the sewer pipe clogging from accumulating cholesterol was pretty much the Gospel.."To the man who owns a hammer"..the world looks like a nail..Most of the lipidologists favored DHA overt EPA simply because DHA more effective than EPA at lowering Trigs..Which if you believed the orthodox theory would have made EPA less likely to lower CVD event risk..
Another fly in the ointment was although elevated trigs are most definitely a risk factor for CVD.. By a wicked twist of fate..Trig lowering does not always result in lowering CD event risk..Because elevated trigs are usually the result of elevated SI..And it is the elevated SI that is increasing the CVD event risk.
This is fairly convoluted and does not suggest anything at the time these patents were filed that anything was obvious or widely understood..
":>) JL
TTE...
Beg pardon..But IMO this is one of the most important references I have ever seen which blows Du's contention that POSAs would have found the patents obvious..
":>) JL
rdhitchcock...
Hitchie...I'm with you on this one..Apparently Judge Du did not have this resource on her bedtime reading list..
And this from the President of the National Lipid Association...This should be enough to convince the learned Judge that she did not know squat about what was obvious back in 2011..
This material completely debunks Du's notion that a POSA during the time the patents were applied for would have found them obvious..I am surprised Amarin and all its well paid lawyers did not come up with this...
Congratulations you have always been my favorite nutritionist along with Dr..Bernie Sears...
":>) JL
Crikker...
The state laws only mandate cheaper drugs get lower tiers..Less out of pocket payments...These can be substantial and if the physician insists on the more costly drug then generally he must have some rationale. I know because I am both a patient and a doctor. My PCP did file an appeal to Silver Scripts..MY Medicare Drug plan..But the drug plan denied the appeal.
The basis of their denial was that the R-I FDA Label was not approved and finalized until very late December.2019..And by that time the medicare formularies were closed until Nov 2020..These are insurance companies and they don't give Ice in the winter..The only label they were recognizing was the MARINE high trig label..
Right now Vascepa is patent protected for the R-I CVD event label..And no one..generics, drug plans, or states other than Amarin can sell the drug for the R-I indication without Amarin's consent..Infringing on Amarin's valid patents is a federal offence...
":>) JL
HK...
I am also a clinician...I hope you do not think I am in disagreement..I was in private practice for forty plus years..The biggest issue that comes up is that if there are alternative drugs with the same label "Indications and
usage..That would be the case of Marine vascepa AND gen lovaza. State laws can mandate the cheaper brand is preferred and is lower tiered And the Tiering out of pocket expense can be very dramatic..Eg, Brand is tier 4 and the generic (or cheaper alternative is tier 1 or tier 2..The supplier can fill your request..but it can cost your patient a couple of hundred dollars a month..
Vascepa currently is a Unicorn..Because it is still under H-W exclusion period for the R-I indication...But at least for the present is not still under H-W for the Marine indication..Ie generics and others must respect Amarin's still valid patents covering the R-I indication..And even judge Du ruled that Amarin's F-I patents are still valid and even "encouraging" by the generics to use the drug for the R-I indication would be considered Infringement..Indirectly inducing doctors to use Gen Vascepa for the R-I label indications..
":>) JL
JF...
Thanx for posting...You sound very knowledgeable about 5G and Inseego..
How likely in your opinion is INSG going to be involved in autonomous cars and the TAAS (Transportation as a Service)..Eliminating expensive and error prone human drivers in cars, trucks, ships planes and trains..could revolutionize The entire transportation system as we now know it and what is needed is super fast transmission of information..
":>) JL
Tal10...
Sorry you don't understand it either...
Please read North40000's post immediately below yours..He is a Patent attorney....If you don't believe me then maybe you will the Patent Lawyer..
":>) JL
north40000..
Thanks for your learned opinion.. As a distinguished and long practicing Patent lawyer with years of specializing in Patent law maybe this guy will listen to you...
":>) JL
jas...
Wonderful song... wonderful singer..
Thanks..:L<( JL
HK...
The pharmacists will be educated by their corporations..It is Amarin's job to remind Medicare and the drug plans that the generics have not (at this date) been granted the rights under the H-W federal laws to prescribe Vascepa for the R-I indication..and if generics fill the script it can only be substituted for using a drug which is FDA approved for the MARINE indication..
HK...Generic Lovaza scripts are in fact FDA approved for the MARINE indication..and (look it up) Marine and Generic Lovaza have the same "word for word" FDA label for "Indications and Usage"..FDA considers them interchangeable...And the substitution of Gen Lovaza for Gen Vascepa perfectly legal...
":>) JL
anfla...
Sorry but you don't get it..You want to argue off label..but in this case Off label is against the law. The only legal off labeling is for the MARINE label...Off labeling for the R-I indication will be considered Indirect infringement by inducing doctors to prescribe MARINE Generic Vascepa for the R-I (patent protected) indication...
This was spelled out in great detail in the transcripts of DC trial..You need to go back and read them..Medicare will not sanction illegal activity or violating federal law..Actual pharmacists these days mainly work for large corporations and these corporations will definitely tell their pharmacists what the law is...
I don't want to discuss this with you any more..You need to read the trial transcripts.. this infringement issue has been discussed extensively on this board..
":>) JL
raf...
Thanks for posting...Better than we could have expected..This sound very optimistic...
":>) JL
anfla...
Quote:"Yea but is it feasible to sue 10s of thousands of pharmacists for skinny label infringement.".
This isn't America 2014...You might have thousands of Pharmacits..but a relative small number of drug plans and Pharmaceutical Corporations..And only one Medicare..
You definitely can sue the generics for infringement..Did you follow the Du trial..More specifically for indirectly inducing infringement by doctors..
":>) JL
anfla...
1) no one has a legal right to infringe on a valid US patent.That include generics, drug plans..you name it..The drug dealers can only substitute for the MARINE label...And the substitution will be gen Lovaza because it is cheaper and has the same label indications and usage as the MARINE Vascepa label..ie The generics Vascepa...The generics right now have only won the right to sell Vascepa for the MARINE high trig indication,,
If the drug plans or pharmacies substitute Gen Lovaza for Amarin's R-I Vascepa.. They will be infringing on Amarin's valid patents. The generics Vascepa is by definition only legal for the MARINE indication. The generics know this and can not market this for the ANCHOR Dec/2019 label expansion,
The drug sellers can not substitute gen Lovaza for R-I Vascepa because Gen Lovaza does not have the same FDA Label indications and usage..Right now only Amarin has the right in the USA to market and sell R-I Vascepa for the R-I indication..Drug plans and pharmacies can not substitute Gen V or Gen L for Amarin's Vascepa if it is prescribed for CVD event risk..To do so they would be inducing infringement.
":>) JL
Kiwi...
I have my appointment with the "Shockwave" cardiologist ..on July 7th...
Thanks a lot for turning me on to this...I will keep you posted...
":>) JL
Prediction...
I'm going out on a limb and saying 60-80% chance Settlement..All parties understand the Marine indication is not worth squat...TEVA "got it" right away...Gen L is going to be the preferred (The low Tier alternative). Amarin's most important job is to protect the R-I indication. By this time the generics have woken up to the fact as far as the MARINE indication..Gen L holds the trump cards..
I expect Amarin is spending most of its time figuring out how to prevent..Off labeling the MARINE label..And this is going to be a legal issue..Don't be surprised if a substantial percent of Amarin's total revenues is tied to patent infringement lawsuits..
JMO..":>) JL
Slim...
Insee ...gooooo!!!!! Nice action today..Right up to 15 and then off to the races..Now my biggest position...Though I believe Amarin ends up coming out of this a big winner..
":>) JL
Capt...
Watch what you are saying..You are in great danger of offending the du istas..Judge Du is a kind hearted soul who made a couple of minor errors and who among us hasn't made some mistakes..That's why they put erasers on H-Bombs..
I would not in the least bit be surprised if both Hikma and Reddi both settled..The way it looks to me right now is the only winner (let me check the ticket)... is Teva...Gen Lovaza looking strong...
":>) JL
marjac...
Thanks for your professional advice..We need more expert opinion and less bomb throwing..
No guarantee that there will be a settlement..But it sounds like a very reasonable solution which can benefit all parties..I agree with you'
"In sum, the road to settlement is not an easy one, but with skilled lawyers and business people making reasonably prudent business decisions in an effort to structure a win-win for both sides, it is definitely possible, and in my view, the best course of action given the risks both sides face continuing upon the adversarial track."
":>) JL
MS83....
Do realize most of the time this TTE has been playing the roll of class clown on this board..Changing his identity monthly..And now you think he is the "Sage of Omaha."
None of us including "TTE", "The Bus", TasGreWaf (stands for "Tasty green Wafers")...Know how this trial is going to play out.
Settlement is an option..Right now the whole situation is very convoluted because the court at best has the Generics in a position where the temptation to shoe horn into the R-I indication is overwhelming..But from a legal standpoint it would be breaking the law..If they are caught (and right now nobody can put odds on that)...It could be very expensive.
In the meantime..Winning the MARINE indication..is back seat in the garbage wagon..The FDA label for Indications and Usage is the same for both The Marine Vascepa label and for Generic Lovaza..The exact word for word same..The fact V cures CVD does not come into play and if the generics try and promote this they will be indirectly inducing patent infringement..
The generics are dammed if they do..or dammed if they don't..Unless they can figure out a way to produce and sell Marine Gen Vascepa at a price lower than Teva can sell gen L then they are going to lose most of their market for Gen Vascepa..
So settlement might be the road to go..
JMO..":>) JL
urbandk24
GFY.....
":>) JL
Bouf...
Where did I say that "every person whom grew up in any of (those countries ???) is corrupt enough to accept a bribe to fix a US Federal Trial.)"
Once again all I ever said was she was "not impartial"..If you really want argument then all you have to say is.."I think she was Impartial" ..
I don't think you want to go there as that is way past your bed time. We can speculate on her motives..But there is a good chance she just didn't feel compelled to follow the rules..Just wanted her opinion to prevail.
":>) JL
Bouf...
Have you ever spent any time in Vietnam????
Quote: "because she is Vietnamese and because of that country’s tortured history she must have accepted a payoff to hand the case to the generics. What?"
Just where in any my posts did I make that accusation...All I said was she was clearly not impartial. You could use a little help in dealing with the truth..
":>) JL
john....
I guess what we can glean from this little vignette is the unfortunate young man (Du's stepson) did not learn obeying the rules was important. We can see from the "honorable" judge's comportment in the Vascepa trial where the stepson learned that he did not have worry about the rules...
The world can be a very stern teacher..
":>) JL
Bouf...
You seem to be an individual that is always looking for the most convoluted explanation..Rather than simplicity. (Hannibal Lector)
Its not who judge Du favored..Its the fact she did not remain impartial. A judge is not supposed to "pick sides"...The first rule of being a judge.
":>) JL
Bouf...
The drug choice is very simple and does not need a bunch of conditions..
It is based on the label..If two drugs have the same FDA "Indications and Usage" then the mandate is the cheaper alternative is preferred and will get the lower tier. In this case it will be gen L..
":>) JL
KIWI...
My vascular surgeon was not thrilled when I brought in the Shockwave info..He seemed to forget that he had pretty much told me the arterial procedure he was going to perform would cure the Intermittent Claudication..But it was a complete failure...
Although he did not have any personal experience with Shockwave he told me it would not work because my anterior popliteal artery was totally occluded..
He did at my insistence promise to get me a referral to a cardiologist who does do Shockwave..And as of yet I do not have the referral.. So I don't know whether the cardiologist would do the procedure..or would say I am not a candidate.
":>) JL
Gen L can not be substituted for the R-I indication because they do not the same indications and usage on the FDA label..There will be no alternative to Vascepa for the CVD event label..No competition..
Since Du did say if the generics market or sell gen V for the R-I indication they would be inducing infringement of Amarin's patents..
From a practical and legal standpoint standpoint Generics (H&R) would be breaking the law if they encourage off label prescriptions using the Marine label..I would say it's going to come down to the label and what the generics put on their label..It's going to be tricky...Its Scylla and Cerberus all over again..Teva will have them trumped for the Marine and Amarin for the R-I label..
I could see both R&H settling....
":>) JL
ilove...
The reality is that Gen L has the exact same label for indications and usage as the Marine label for V...So there will be no distinction of the type you are describing...
These are issues for the scientists..Not for the drug plans and state laws..Gen L will be a cheaper alternative..
If you don't like that ..Take it up with the FDA....
":>) JL
Slim...
Thanks...Appreciate the the opinions..Things looking very good on both issues..Still have my full position on INSG..
":>) JL
Kiwi...
The rates went up in Fl..because of the influx of tourists and events like the opening of the parks and the rocket launch..Just a much larger population..Also those infected are dropping in age..As these younger guys are the ones not observing the C-19 rules..
":>) JL
MS and HK....