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Bouf,
Z Silbersher will say what he always says: (1) that Amarin should have thought about it earlier and had their chance to raise it(2) that Generics will claim that they don't need Mori and Kurabaysahi to prove obviousness etc,..
That still leaves mistake and fraud uncorrected by any party to this litigation...unless we believe that mistake (as in fatal errors in evidence adjudication), deliberate evidence tampering and systematic misrepresntation fraud no longer count for anything in the American judicial system.
HK
Alm
I am not a lawyer but lets look at Rule 24:
Permissive Intervention.
(1) In General. On timely motion, the court may permit anyone to intervene who: WE ARE TIMELY
(A) is given a conditional right to intervene by a federal statute; or
(B) has a claim or defense that shares with the main action a common question of law or fact.
WE HAVE A CLAIM FOR SURE AS STAKEHOLDERS AND DEMONSTARTED LOST SHARE VALUE
(2) By a Government Officer or Agency. On timely motion, the court may permit a federal or state governmental officer or agency to intervene if a party's claim or defense is based on:
(A) a statute or executive order administered by the officer or agency; or
THIS IS INTERESTING SINCE THE PATENT OFFICE GRANTED THE ORIGINAL PATENT BASED ON APOB AND THE MISTAKE/FRAUD ENACTED ON KURABAYSHI INVOLVES THEIR ORIGINAL ASSESSMENT WHICH WAS NOT ONLY SET ASIDE BUT DECRIED BY JUDGE DU 9BASED ON HEINECKE) AS NEING FACTUALLY INCORRECT (WHO IS CULPA HERE?)
(B) any regulation, order, requirement, or agreement issued or made under the statute or executive order.
(3) Delay or Prejudice. In exercising its discretion, the court must consider whether the intervention will unduly delay or prejudice the adjudication of the original parties’ rights. WE DO NOT DELAY OR PREJUDICE ANYONE'S RIGHTS SINCE THIS IS MISTAKE AND FRAUD DISCOVERED AFTER THE ADJUDICATION
(c) Notice and Pleading Required. A motion to intervene must be served on the parties as provided in Rule 5. The motion must state the grounds for intervention and be accompanied by a pleading that sets out the claim or defense for which intervention is sought.
WE HAVE SUPPLIED THE RULE 60 BRIEF PLEADING MISTAKE AND FRAUD
IT IS SURELY KEY THAT MULTIPLE OBVIOUS STATISTICAL MISTAKES AND FRAUD WERE ENACTED AND FOR A JUDGE OR COURT TO LOOK THE OTHER WAY WHEN YOU HAVE A CHANCE TO CORRECT IT (AT LEAST FACTUALLY AS EVIDENCE CONSIDERED IN ADJUDICATING THE PATENT VALIDITY) IS NOTHING SHORT OF DERELICTIONOF DUTY!
hk
Alm
I am not a lawyer but lets look at Rule 24:
Permissive Intervention.
(1) In General. On timely motion, the court may permit anyone to intervene who:
(A) is given a conditional right to intervene by a federal statute; or
(B) has a claim or defense that shares with the main action a common question of law or fact.
(2) By a Government Officer or Agency. On timely motion, the court may permit a federal or state governmental officer or agency to intervene if a party's claim or defense is based on:
(A) a statute or executive order administered by the officer or agency; or
(B) any regulation, order, requirement, or agreement issued or made under the statute or executive order.
(3) Delay or Prejudice. In exercising its discretion, the court must consider whether the intervention will unduly delay or prejudice the adjudication of the original parties’ rights.
(c) Notice and Pleading Required. A motion to intervene must be served on the parties as provided in Rule 5. The motion must state the grounds for intervention and be accompanied by a pleading that sets out the claim or defense for which intervention is sought.
North
Am I right in reasoning that Delaware hinges on GSK vs Teva decision and that the swiftest path to a Writ of Certiorari would be for either party (depending on which way the decision swings) to file to SCOTUS following the Appeals court's ultimate decision?
HK
Great idea Ratna please organize it--many will join the effort
Thank you Alm,
The path is clear. Every man, woman and Court has a moral choice..,
HK
Marjac
You are much too kind. I soldiered a while, little else.
All of us, and by which I mean everyone who believes in Vascepa (and by extension Amrn) want our equity to be restored. However, I would like to think that all of us believe in a greater principle that benefits everyone in our society. We speak often in platitudes about Truth, Justice, Equality, but little ponder how those things are to be achieved. They are in fact achieved by Honesty. The fundamental thing that went wrong in this litigation was that evidence was tainted by scientific and personal dishonesty. You see all through my modest scientific and medical career, I was taught that whatever the outcome, scrupulous data collection and analysis and ethical practice were the sine qua non of being called a physician-scientist.To see these principles savaged so wantonly by the expert witness for the generics, made every hair on my body stand on end. If, we succeed it will be because we spoke the truth. If we fail, we will have at once and forever set the record straight, so that honest free-thinking ethical people will see that for reasons of ego politics and personal gain, the Truth was so recklessly set aside by the legal system in the United States.
Sunlight remains the best disinfectant.
Still,
Man can propose but it is God that disposes.
HK
HDG Iryo
These are useless tail spinning semantic games:
A "substantial non-infringing use" (e.g. to lower Hyper TG>500 mg/dl) is simply the skinny label market label after you have carved out the protected market (the R-IT) CV indication. Substantial is defined here as "meaningful" and definable and not by volume. The volume of use comes up in establishing infringement because it has bearing on how many scripts for the skinny label one could possibly observe in reality, IF there was no infringement.
However, it becomes difficult for the SK label manufacturer to maintain that they are pursuing a skinny label indication when the majority of the scripts are being filled for the carve-out indications and the skinny label owner has not bothered to point out amongst all the carve-out label copied warnings on the SK drug label, that the drug is not for the carve-out indication or worse still the generic is in deals through PBM's to supply a volume consistent with the much larger carve-out (R-IT) indication. It becomes even more untenable if it is established that scripts filled for the skinny label product are documented by review of prior authorizations from the third party payor mandating the skinny label drug, are shown by documentation to be for the carve-out use.
Of course the generic will claim no ACTIVE participation just passive enablement...but this is a feeble excuse though it may just hold up legally if enough slavish H-W enthusiasts are on the judicial bench.
HK
Zip,
Nothing could be more vital to the preservation of drug development and innovation in this country. To ignore (1) The deficiencies of Federal Appeals court constructions of Graham vs Deere and the consequent battles of prima facie vs. secondary objective indicia employment in obviousness adjudication and (2) The reckless politicized use of Hatch-Waxman again by the Federal Appeals court to justify skinny label abuse is to risk throwing out everything good about drug development at a fair price in this country.
If POTUS opts for laissez-faire when they can judiciously guide the Appeals courts is to invite a much larger legal mess to clear up down the road. The public will undoubtedly pay the price of inaction with their wallets and their lives.
HK
Yes Kiwi
these insurers would deny mother's milk if it put more money in their coffers...
HK
jasbg
I am married twice so evidently I don't take too much convincing.
I speak of the doubting Thomases who question Vascepa's benefit--they will need more trials to confirm their belief--that's what I was saying. I am a firm believer in the benefits of Vascepa -believe me.
HK
Amazing--I am speechless.
Yes indeed pretty easy once you meet the diabetes and category:
as per R-IT these were:
CV Risk Category 2: defined as patients with:
1. Diabetes mellitus (Type 1 or Type 2) requiring treatment with medication AND
2. Men and women ≥50 years of age AND
3. One of the following (additional risk factor for CVD):
• Men ≥55 years of age and Women ≥65 years of age;
• Cigarette smoker or stopped smoking within 3 months before Visit 1;
• Hypertension (blood pressure ≥140 mmHg systolic OR ≥90 mmHg diastolic)
or on antihypertensive medication;
• HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women;
• hs-CRP >3.0 mg/L;
• Renal dysfunction: Creatinine clearance (CrCL) >30 and <60 mL/min;
Amarin Pharma Inc. Protocol AMR-01-01-0019
• Retinopathy, defined as any of the following: non-proliferative retinopathy,
pre proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation;
• Micro- or macroalbuminuria. Microalbuminuria is defined as either a positive micral or other strip test, an albumin /creatinine ratio ≥2.5 mg/mmol or an albumin excretion rate on timed collection ≥20 mg/min all on at least two successive occasions; macroalbuminuria, defined as albustix or other dipstick evidence of gross proteinuria, an album in/creatinine ratio ≥25 mg/mmol or an albumin excretion rate on timed collection ≥200 mg/min all on at least two successive occasions;
• ABI <0.9 without symptoms of intermittent claudication (patients with ABI <0.9 with symptoms of intermittent claudication are counted under CV Risk Category 1).
A LITTLE HISTORY
After Dr Akira Endo in 1973 discovered compactin (mevastatin), an HMG-CoA reductase inhibitor, of the fungus Penicillium citrinum, Merck discovered a potent inhibitor of HMG-CoA reductase of Aspergillus terreus and named it mevinolin (later lovastatin). Lovastatin gained FDA approval in August 1987. In July 1982, Merck made lovastatin available, under an arrangement approved by the FDA to amongst others Scott Grundy who successfully treated familial hypercholesterolemic patients with it for over a decade. In 1982, the climate for lipid-altering drug development was not particularly good. Treatment for elevated LDL was based, he said, on "a conjecture known as the lipid hypothesis." namely, that pharmacologic or dietary reduction of the "harmful" cholesterol would benefit the patient by arresting atherosclerosis. In 1984 this changed, Lipid Research Clinic Coronary Primary Prevention Trial (LRCCPPT), a multi-centre, randomized double-blind study that tested the efficacy of cholesterol-lowering in reducing the risk of coronary heart disease in 3,806 asymptomatic middle-aged men with high cholesterol. The trial did not use lovastatin; rather it relied on dietary changes and cholestyramine and the results were modest, but they did demonstrate that lowering cholesterol levels for 7.4 years, on average, did support a 19 per cent reduction in the endpoints of heart disease, death or heart attack.
Simultaneously, Brown and Goldstein discovered the cell-surface LDL receptor and demonstrated that inhibition of HMG-CoA reductase stimulates the upregulation of hepatic LDL receptors thereby lowering the concentration of plasma LDL cholesterol(awarded the Nobel Prize in Medicine 1985). The stage was now set for statin outcome trials...
4S TRIAL WITH SIMVASTATIN FOLLOWED 1994: In this landmark double-blinded, randomized, multi-centre study, 4,444 patients with coronary heart disease were randomized to receive either simvastatin or placebo and followed for five years-an astonishing 30% reduction in all-cause mortality with simvastatin treatment....this got the party underway
WOSCOPS trial 1995 and AFCAPS/TexCAPS (1998) EXTENDED statin Rx to moderate levels of hypercholesterolemia.
Lipitor or atorvastatin was born in 1985 (warner -Lambert) and approved as Lipitor in 1997 and then Pfizer marketed the hell out of Lipitor riding the coattails of these seminal statin CV outcome trials (until they finally produced a decade later CV outcomes data for atorvastatin), largely capitalizing on the promise of being the most powerful statin compared with its contemporaries lovastatin and simvastatin, until rosuvastatin arrived in 2003.
ASCOT-LLA in 2005 and CARDS (2004) were these seminal outcome trials validating Lipitor. The rest of the next two decades to date have been spent proving their use in secondary prevention use in PAD CKD CVD and all the pleitropic non-lipid actions of statins including improvements in endothelial function, antithrombotic actions, plaque stabilization, reduction of the vascular inflammatory process and anti-oxidation.
How fitting then (or ironic) that the omega-three struggles since their earliest investigation in the 1970s to JELIS in 2007 now have to come to fruition in REDUCE-IT 2019 as an outcome trial and now we debate if pure EPA is beneficial as opposed to mixed omega 3 Rx. I think it will take an additional corroborative CV outcomes study done independently of Bhatt et al to launch this field into acceptance as we have seen in the JAMA editorials recently including honest doubters like Curfman, Blumenthal, etc...
HK
Kiwi
(1) Prescribers need a lipid panel that's recent-most third-party payors insist on <3 months, and a patient on maximally tolerated" statin dose with a residual elevated TG>150
(2) The TG >500 mg/dl cohort gets automatically prior authorized for Vascepa, though some HMO's insist on substituting generic omega 3 ethyl esters eg Lovaza since we claim that we are treating hypertriglyceridemia and not preventing CAD/CVD.
(3) The TG<500 and >150 mg/dl pprimary/secondary prevention cohort are then eligible for Vascepa IF they have diabetes on a maximally tolerated statin and TG>150 mg/dl OR any evidence of established CAD CVD PAD demonstrated either by direct imaging eg vascular ultrasound or coronary artery CT angiography or conventional direct contrast injection angiography, non-invasive testing e.g. abnormal Ankle Brachial Index, abnormal stress imaging OR clinical events eg MI STENT CVA PAD with gangrene or needing vascular intervention etc...
(4) Far far more of these prescriptions will emerge from the outpatient screening arena than ever from the ER or post-hospital admission because the focus there is not on prevention but immediate medical therapy and discharge...
HK
CVS does this all the time in California
thanks sts
Sleven,
I see the logic. But what happens when the customer goes through the savings card system? Is a switch possible at this point to achieve the savings?
HK
When it comes to the people writing these formularies..money talks and little else.
Apparently, it's not just okay to blissfully ignore the therapeutically life-saving treatments available and approved by the FDA, but also to poison their beneficiaries with Lovaza, presumably, the actuarial logic behind this is to diminish the number of liabilities they have to pay out for.
HK
I agree, HDG- better to fight as T2 than T3
but the role of generic coupons is a bit murkier.
Great post and long-needed reform focus: when it comes to the scandal of drug pricing to the public the much-publicized generic vs. BP interests are nowhere as determinant as the for-profit price-fixing done by the PBM and third-party payor sharks!
Hk
Go Braun!
We can expect some big money thrown by the interested parties at quelling this.
This is about the broadest label anyone could ever hope to get short of putting it in the drinking water.
PDude
This one is worth adding:
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.052209
Effects of n-3 Fatty Acid Supplements in Elderly Patients After Myocardial Infarction
A Randomized, Controlled Trial
Are Annesønn Kalstad, Peder Langeland Myhre, Kristian Laake, Sjur Hansen Tveit, Erik Berg Schmidt, Paal Smith, Dennis Winston Trygve Nilsen, Arnljot Tveit, Morten Wang Fagerland, Svein Solheim, Ingebjørg Seljeflot, Harald Arnesen, and On behalf of the OMEMI Investigators
Originally published15 Nov 2020
https://doi.org/10.1161/CIRCULATIONAHA.120.052209Circulation. 2020;143:528–539
Thank you ggwpq
All valid points indeed
HK
Ralphey
It is true that one can make biochemical conjectures as to why DHA may be "bad" and EPA "good" but the proof of this construct is a clinical one..Hence the need for outcomes analysis based on analyzing EPA /DHA levels and changes.
HK
See Iryo's post--it is to be given by Nissen
North
This is always a concern. However, he is limited by the findings of the main trial which I illustrate pictographically from the JAMA strength publication and compare with JELIS and R-IT.
https://jamanetwork.com/journals/jama/fullarticle/2773120
Nissen has three issues to address:
(1) STRENGTH could not show a difference in outcomes based on tertiles of either EPA or DHA across a median 42 months of study in which pts were treated with EPANOVA (EPA and DHA carboxylic acids) for a median 38 months-contrast median REDUCE-IT follow up of 59 months)
(2) The plasma EPA levels rose from a baseline of 21 ug/ml(12.7-33.9) to 89.6 ug/ml (46.7-131.5) a 268.8% change (85.7-549.1). Similar degrees of EPA increases were seen in the RBC EPA levels. Compare to R-IT where the median EPA level was 26.1 ug/ml at baseline and 144 ugs/ml at year 1 --fair disclosure we do not know the correlation between the Omega 3 Quant test (promoted commercially by Willam Harris)in STRENGTH and the Omega 3 assays used in R-IT or indeed exactly how many patients underwent the plasma level testing in R-IT or for that matter in STRENGTH).
In this context, the rise in EPA levels in STRENGTH at 269% sound very impressive but it is sobering to realize that this is still below R-IT at peak exposure and well below JELIS. Indeed the peak median STRENGTH trial levels were at best approaching the BASELINE levels in JELIS. Witness Itakura et al and the clear demonstration in 16000 pt analysis that the benefit of hazard ratio reduction in JELIS was seen at levels>150 ugs/ml.
https://www.jstage.jst.go.jp/article/jat/18/2/18_5876/_pdf/-char/en
So, while STRENGTH could not show a difference in MACE outcomes based on increasing tertiles of EPA acquisition, there remains the possibility that they never achieved a threshold >100-150ug/ml level to gain effect.
(3) The EPA levels in STRENGTH showed no relationship to improved or detrimental outcomes across all tertiles of DHA elevation from baseline. This along with the EPA lack of correlation with MACE improvement is used by Nissen to impute, that neither benefits and Afib goes up( presumably also an EPA effect since seen in R-IT), it must follow that ALL omega 3 are non-beneficial and even deleterious, and should be thrown out therapeutically as a choice.
This ignores the very REAL possibility increasingly being demonstrated at ACC May and in future publications that DHA incrementally abrogates the biological benefit of EPA, and that it may independently exert a non-beneficial (or harmful) effect on CV outcomes. Thi sis being demonstrated in basic work by Preston Mason and in clinical studies (watch Viet Le at ACC) and Budoff EVAPORATE EPA level analyses.
I think that Nissen will show that even in HIGH-risk CV pts in STRENGTH (recollect that 50% were secondary prevention ~6500pts), there will be no improvement in MACE with increasing tertiles of EPA (or DHA also). This will be used to argue therapeutic futility.
There is one other intriguing possibility: IF you observe carefully the table I illustrate below taken from STRENGTH, you see that amongst the secondary endpoints all-cause death amongst those with pre-established CVD at baseline was trending as increased with a p=0.09 in eh EPA treated group. Itis possible that the STRENGTH investigators will illustrate a significant adverse signal for increased all-cause death in the highest tertile of the highest CV risk subset of the STRENGTH group. This will reinforce the Nissen narrative of NO benefit and POSITIVE harm for all Omega 3 and requests to throw out the (VASC)EPA baby with the EPANOVA bathwater.
https://investorshub.advfn.com/uimage/uploads/2021/3/11/lwhlfnissen.png
It's all in Congress' hands. They must step up and curtail these abuses but you and I both know who has bought off all the politicians before they can think about their duty...
HK
You are painfully right zip-we have had to take it up the rear from these third-party payors cooking up the rules and then switching the goalposts at will and no one gets to sue them or saying anything. Oh, and BTW if you kick up a stink as a provider they will simply remove you from their panel. The patients don't know half of their blackmail strategies...and what we as physicians have to do to get them drug...
HK
swg_tdr,
It is such a disgrace that you had to go to these lengths to get the real thing...
HK
sts
Glad to hear there are still a few of us that won't be steamrollered into degrading spinal acquiescence of these unscientific and immoral third party payor edicts, not to mention everything else BS they cook up daily at UHC and the like.
HK
Ralphey,
In Freud's version of psychoanalytic theory, there is the Id, Ego, and superego. in Nissen's case, the Id (the set of uncoordinated instinctual desires) has rapidly degraded into the super-ego (the critical and moralizing role).
Iryo,
Nissen will be crass, and Bhatt will take him apart with a few well-placed cuts of the intellectual scalpel.
HK
Iryo
Should be very interesting, Bhatt is a panellist also
HK
Which conference and is there an abstract?
Where did you see this Iryo?
Doctor: Joe your blood pressure looks great
Joe: Can I get off my meds now Doc?
Kiwi
I agree with your assessment
Primary care is being shackled here
The strategy is to prevent the Vascepa Rxs getting out of hand quickly by restricting who can request it by Rx and then by imposing absurd renewal requirements to put up a bureaucratic wall.
The strategy also works for them as it necessitates a PI for the Vascepa.
The CV indication is possible with a PI for Vascepa - no guarantee though that the pharmacy won’t substitute it
HK