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Personally, I have several that are approved for "generic Vascepa Icosapent Ethyl" all with a CV indication clearly written on them-I maybe have one for TG>500--which incidentally to qualify for you need to be age>45!
If these HMO's are to be believed, you would have to be a one-legged monkey that can turn tricks and simultaneously read Shakespeare, before you would qualify for any medicine worth having...
HK
PS Envolve uses Cover my Meds software to pre-auth everything
YES
they didn't give it a second thought--infringe away who cares? right?
HK
Happy to help --PDude has a lot of it done.
HK
Lest anyone doubt the veracity of Amarin's claims regarding Healthnet and Envolve infringement: Here is an anonymised but otherwise true reproduction of prior authorization from Calviva (Healthnet subsidiary company) demonstrating exactly what the Delaware suit claims: Authorization of the generic IPE (HIKMA) product for CV risk reduction. It even says generic will be substituted for Vascepa. The CV indication that my office put in for the patients is also clear to see.
Sleven,
You are right styles
This is an epic battle of wills all-round...maybe a seminal case for the books.
HK
Sleven,
I have never heard of this scenario before--lawyers will be able to search for precedent more comprehensively than I. However, I see no case precedent quoted in Amarin's brief in this regard. This seems therefore at face value an unique approach.
GSK's case was in comparison an afterthought litigation that succeeded on a technicality of labelling requirements. Here great trouble has been taken to show (1) motivation of both parties (HIKMA press release and investor statements and Healthnet drug policy statements re TIER substitutions), means (the Healthnet TIER system alterations to allow/encourage CV indication use, the inaccurate labelling from HIKMA ) and opportunity (Trojan horse MARINE indication as a back door opportunity to infringe R-IT and a willing partner in Healthnet)
HK
Thinking about it LB:
Rose,
I think Amrin is good because as far as I can see Healthnet neither ceased nor desisted.
HK
Kiwi,
I think we mean the same. Tier 1 greatest preference and decreasing preference as the Tier number goes up. My words lower-tier meant lower in preference, not numerical value...
HK
Figures Ralphey--kudos for trying for your patients!
Shado,
IMHO, the Nevada case was heralded as a "slam dunk" and then evolved into botched Amrn pitch and a misled Umpire. Wrong argument and wrong judge who wanted to believe the prior art concoction BS fed her by the generics, who not only fooled her but embarrassingly fooled the Plaintiff's attorneys as well who wee busy barking up the wrong (LDL-TG) tree. The Appeal to the Federal circuit was a political shut down with no reasons given, and quite obviously a closing of ranks amongst the Appeals court panel and the Chief Judge who probably enabled it.
The Delaware case, on the other hand, is a struggle of issues from the git-go since it asks a thorny question that the courts have thus far dodged: Are you willing to stand by established rulings on who owns what indications for any given drug? Does patent law have any teeth or is Hatch Waxman just a carte blanche to ignore the law and allow generics to violate intellectual property at will? The GSK vs Teva case set the stage but I feel was sufficiently different in the way that infringement was alleged that Amarin's is actually chartering new territory.
HK
There is an old English phrase for this:
Hoist by your own petard!
Fidelis--please enlighten us?
Yes exactly LB
But here's the thing GSK was a much murkier issue than Amarin's: there was a great overlap and grey zone in the overlapping HTN and CF indications for Carvedilol. Here, Amrn has 93% market for CV and 7% for HyperTG (vast and clear divide). With GSK, TEVA claimed the "encouraging" citation of CHF indications was forced on them by the FDA. With Amrn ALL HIKMA had to do was clearly put in "not indicated for CV risk reduction"--they deliberately didn't and the connection to Healthnet proves exactly why. You cannot say that you didn't promote or encourage infringement directly when you actually DID via the label!
HK
Para 159--the Prior Auth documents the reasons for prescribing and if CV risk prevention was checked off--how do you say that you didn't know there was infringement deliberately or that you didn't incentivize patients via the Tier system to deliberately infringe?...
HK
One good example should serve as a deterrent. adding others will need the same quality of evidence as they have against Healthnet--Healthnet is so widespread in California that with CVS policies and Healthnet requirement for PA's even for the gen IPE (with BOTH indications listed) there should be ample volume of incriminating data for infringement and knowledge thereof--just add motivation and stir before tasting...
HK
Here is the modified HIKMA site details now--all sorts of things have been REMOVED/ALTERED/ADDED compared with their first SHADY release:
https://investorshub.advfn.com/uimage/uploads/2021/1/26/mezpgnew_HIKMA_site_IPE.png
The Delaware case is a masterpiece of legal encirclement of both HIKMA and Healthnet. Singer's team have excelled. Thanks to some on this board (and others no doubt) who investigated the press releases and the HIKMA web site, Amrn attorneys were able to connect their Nov 20 press release statements to their actual label and their promises to investors. They have also beautifully linked Healthnet in the conspiracy to infringe with financial motivation and full knowledge of BOTH Hikma and Healthnet that they were infringing and promoting infringement defacto to consumers via price incentives of copay and to physicians by cropping out the indication limitation for CV. HIKMA are a clever bunch of croppers as we know from the Nevada trial--but the stime they went too far in cropping out the section viii limitation they disclosed pre-ANDA approval to the FDA. The best part is Healthnet issued a prior auth for their generic which if subpoenaed will show the numbers of pts PA'd for a CV indication because that box was ticked prior to submission by the prescriber's office!! (see para 159)Let's keep our fingers crossed!
Here are the relevant sections of my notes:
https://investorshub.advfn.com/uimage/uploads/2021/1/26/ougufhow_healthnet_is_encircled.png
Go figure Ralphey ...the Law allows it and our crazy society
Consumers are lab rats in this game of pills. The third-party payors and the PBM's are stacking the deck any way that suits them while all the time playing the cost-saving generic martyr scenario. Our "managed" free-market pharmaceutical drug sales regulations and consumer protections are messed up badly. In Europe where the prices are negotiated periodically and agreed, and huge bulk sales result at more reasonable prices, things work better. Here we have a busted free market, where the third party payors and PBM's have a free hand to rape the consumer. The flip side of the coin is that the brand name companies also resort to dirty tricks and no one is happy while all the time the politicos make capital from human misery.
Here is an example from Rose's article that Amarin should take a long look at:
Amrn is actually attempting to define the boundaries of what is and isn't infringement--a great service to the entire pharmaceutical and generic industry alike. We can't play football until we know where all the yard lines stand. If the Appeals court doesn't have the hutzpah to take this thorny subject on, it should turn it over to the big boys and girls newly enthroned at the SC. Clearly, the wise ones presiding over the GSKvs.Teva affair didn't want to stick their necks out or get too far above their pay grade.
HK
This will be the toughest decision of her life: Her political aspirations, ego, and her ethics will all be in juxtapose. What Judge Du does next will be a defining moment not only for us investors and stakeholders but for her as a person and as a judge.
HK
Could not agree more.
It is the court's fault--as I have said before on this board, this is the most relevant Supreme Court issue in Amrn's case. The primary-secondary indicia thing maybe for another day BUT you cannot set a legal boundary for infringement in terms of patent indications as a court and then have the congress and the courts (at the SC and Appeals court levels) abrogate their responsibilities to define the limits of infringement better and police and protect these boundaries so all parties play by the rules. Unfortunately, the generics have politically biased judges in their pockets and feel free to do whatever.
HK
This is interesting...because unlike the GSK drug carvedilol which has extensive overlap in hypertension and heart failure indications, the Vascepa/generic overlap is minimal and has very clearly defined boundaries. Any mandated coverage for anything other than TG>500 would have to be justified. In the absence of specific pre-authorization for every one of these scripts (and there will a v large number) could not tenably be written off as "prescriber directed". Since this could not be true based on volumes, it leaves Healthnet with some explaining to do based on its known knowledge of the generic indications:
Some context: Healthnet Calviva is the main subcontractor /contractor for Medicaid (MediCal) insurance in the state of California. One of the two major players Anthem BC pulled out. Amrn has gone for the jugular. Let's see how this plays out.
HK
Interesting that Amrn has chosen to go after Healthnet for allowing the infringement--even though the PBM servicing Healthnet Envolve was most likely the negotiator of the genetic pricing with HIKMA. Likely the same PBM would go for any drug brand or generic IPE, that gave them the largest retained commission for brokering the deal. Amrn now has the undivided attention of all these HMO's and their PBM peddlers, like Express-scripts CAREMARK etc... all these guys have now woken up. Amrn obviously decided to attack the top of this illicit indication generic drug food chain rather than going after the bottom feeder pharmacies. Healthnet has handed off its legal responsibilities contractually, to the PBM, who while working its exclusivity angle for-profit has actually been the perpetrator/facilitator of the infringement.
HK
Unfortunately quite a few patients I have cannot make head or tail of anything like this--they get their pills on trust and take it similarly...
HK
Cardiovascularly speaking we who are of faith believe, DHA sucks, EPA rules, and levels REALLY matter. having recited this catechism, What next?
The whole field of omega 3 FA therapy is evolving to the next stage--Novel synthetic n-3 second-generation FA's. Chemical modifications to form unique patented/patentable structures will avoid some of the Nevada court assertions of obviousness in the art. Further, these structural modifications have had one key benefit: they are able to alter glucose metabolism and lower HBA1C We see this then extends the field from just CV prevention to all dysmetabolic disorders e.g. NASH. There are many candidates: Epeleuton which is 15-hydroxy eicosapentaenoic acid ethyl ester(whose trials Bhatt heads up), Icosbutate which is the joint development project of Pronova (makers of Omacor EPA/DHA used in VITAL)and Northsea therapeutics. It doesn't surprise me that Sofinnova as an incubator would hedge all its bets and invest in Amarin (EPA/IPE bet) and NOrtseatherapeutics (Icosabutate bet). The icosabutate bet with Kastelein is interesting because he knows that STRENGTH failed because of insufficient EPA dosing and not because R-IT failed due to a mineral oil comparator. The next big CV and NASH/metabolic outcomes trials will be led by (1) Bhatt in America using either Epeleuton (Afimmune) which also has great NASH HbA1C results and shows and exquisite therapeutic dependence on Epaleuton plasma levels) and (2) Kastelein and the STRENGTH investigators with Icosbutate. That is my prediction. Kastelein et al will support the Amrn Vascepa cause ostensibly at the EMA level because to kill it would be counterproductive. An approval for Vascepa now clears the way for Icosabutate later.
There is a third choice which is also an EPA derivative Astaxanthin . The results for this compound have not advanced as far clinically as the other two (Cardax-Paresh Soni of Amrn fame is their chief scientific officer).
The alternative approach, playing with high dose EPA/DPA (no DHA) combinations for better absorption/efficacy eg MATINAS or binding the EPA to phospholipids (ACASTI) is still in its infancy and while lipid effects may be dramatically shown, demonstration of therapeutic benefit 9an altogether different animal) is still awaited...Icosabutate (ICONA trial) is well advanced in the NASH field.
https://apnews.com/press-release/business-wire/business-europe-corporate-news-netherlands-drug-trials-d89feb37b12448ae87acbf554d389350
Here is my pictorial guide showing the chemical modifications and how these new synthetic omega 3's act:
Gbert
I have found that the snake in the grass is the refill moment--then the pharmacy silently substitutes and treats it like you never wrote DAW1 in the first place. The unsuspecting patient thinks he got the real deal and instead the generic is in the container. My staff, PA's all watch for this and now the pharmacies (and my patients) never try this switch.
HK
Exactly. Let's hope the good hope, that despite the odds, once again the underdog can win.
Speaking of underdogs and perceived hail Mary's, I agree with you also on Rule 60:
jasbg,
Can someone explain to me ?
TRIUMPH OF DOUBT OVER EXPERIENCE
DK,
If the aim were to settle it would be a done deal by now. I personally feel there is nothing to be gained for Amrn by settling with HIKMA/DRL or anyone else. If the generic strategy succeeds de facto thanks to thrid-party payor/state/PBM policies then Amrn will eventually have to launch an authorized generic as a trump card at the right price by negotiating with the PBM's involved. JT should never negotiate from weakness. the only reason the gen V scripts have plateaued is supply strangulation from API manufacture sourcing..this continues to drift upwards. Bear in mind that the Chinese API supplier currently supplying HIKMA, would equally well like a bigger potential contract to supply mainland China via EddingPharma/Amrn than chase the coat tails of a HIKMA or DRL in N America. JMHO
HK
Absolutely correct.
[quote]Fraud in patent cases is a matter of public concern extending beyond the parties to the litigation. Fraige v. American-National Watermatress Corp., 996 F.2d 295, 298 (Fed. Cir. 1993)(citing Hazel-Atlas Glass Co. v. Hartford Empire Co., 322 U.S. 238, 246, 64 S.Ct. 997, 1001, 88 L.Ed. 1250 (1944)). Indeed, fraud upon the court is especially troubling in patent cases as “patent law is a field where so much depends upon familiarity with specific problems and principles not usually contained in the general storehouse of knowledge and experience.” Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 328, 135 S.Ct. 831, 838, 190 L.Ed.2d 719 (2015).
Public policy demands that eminent institutions of public justice such as the Court “be not so impotent that they must always be mute and helpless victims of deception and fraud.” Hazel-Atlas, supra. This is so even if Amarin did not exercise the highest degree of diligence in uncovering the fraud. [/quote]
Pterion,
Semaglutide which is the GLP1 agonist in combinations with cilofexor and/or firsocostat in non-alcoholic steatohepatitis (NASH)NASH trials is independently exploding in the CV diabetic prevention space. As BB says due the multiplicity of mechanisms in initiation and progression of NASH, there are a lot of moving parts with some reducing hepatic steatosis and improving metabolic profiles, but yet others being needed to reduce fibrosis/cirrhosis. Separately GLP-1 agonists and SGLT2 inhibitors are our hope for CV prevention in diabetics thus far.
HK