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No. Physicians work in the interest of the patient. It is not their job to know if a drug meets the patent threshold UNLESS THEY HAVE A ECONOMIC INTEREST, which they don’t. Getting paid to prescribe is a kickback and a legal offense in its own right.
A company may find that some how the doctor can be sued. How many doctors are you going to sue? More importantly, when you sue a doctor for prescribing a generic, the company is TOAST. Which doctor will prescribe the company’s drug ever?
The doctor just can not and should not prescribe a expensive drug to their patients unless the patient insists and willing to spend more.
If the doctor has concern with the quality of the generic , either it is unsubstantiated or the FDA is not doing its job. The latter is more likely.
Occasionally, generics may have issues but if they are following the regulations, they should be at par with any branded drug.
Branded drug are NOT kosher. They are just chemical entities and nothing more.
@marjac Where can I find your original case, Du denial on flimsy ground and your request for appeal.
I am in the folder but can not find the document. Can you let me know the file names to look at?
1.Teva settled with Amrn. They will not make distribute the generic
2. 2019 CRL what are you looking for? It has to do
With the original Anchor patent . That is for all practical purposes invalid. Once the court ruled in favor of Hikma , FDA granted the approval
3. Hikma updated its label over time. The latest one was updated in Dec 2020 when they launched. It is on their website
Doctors can never be liable (and should never be) unless they openly declare that they are getting a kickback for writing a specific drug. I am guessing all docs openly declare this COI if they have one, which unfortunately is illegal.
Doctors do and should work in the patients best interest. The hurdle the law has creates is providing evidence of inducement.
Amarin need to do the following
1. Somehow showing that supplying drug BEYOND what has been identified as a acceptable market for severe Trig is equivalent to inducing infringement.
2. Continue to supply drug after being aware that it is being used for patented use is induction.
3. Insurance approving drug use for patented use is induction.
4. Relying on third party (FDA and AB rating) to “support” off label use is induction.
This is the only solution around skinny label provision.
My previous comment was sarcasm.
FDA has become a puppet to lobbying. They approved a $5-10 billion drug to be sold at $56k/ year without any evidence of efficacy .
The biomarker reduction showed that there is no impact of dementia in two trials.
FDA says , even though there is no benefit , WE BELIEVE there will be benefit because when we farted the it sounded like approve. So we are approving it.
I look forward to reading your prose. Just one humble request (I don't understand legal stuff ) - keep the language simple. It makes a big difference.
I am involved in a lot of scientific literature. Whenever I see simplicity around complex topics , I pay special attention. When I see endless tech jargon, I am tuned out by page 1
This is correct. No issues there. Knowledge of infringement was always understood.
The question was always around inducement. The generics always won on this front.
Generic Company-We kept the cookie jar open. We did not ask the child to come and get the cookie. Go argue with the child
Insurance - the child said I am eating the cookie. The insurance said you know better. Who.am I to stop?
Doctor/child - I ate the cookie . How am I supposed to know that I should not eat this cookie or I should only eat 10% of the cookie. For me the 10% and 100% is the same cookie.
You are wrong. FDA just said that if clinical efficacy fails but biomarker reduction happens, the drug clinical effectiveness is irrelevant . The useless biomarker wins.
Welcome to the world of #Aducanumab
Yes. You ought to remember that the 10% market ballons to 100% market at the generic price.
Doctors will prescribe generic Amarin/ other drug for CVD and everyone pays the generic price .
AMARIN can not go and say for this you charge cents for this you charge $$$
Marjac, I am curious how you plan on refuting the arrogant claims made by Du to deny your case
1. Timely filing ( despite doing it within the stipulated period prescribed by law)
2. Not a party to.patent defense
3. shareholderS have no stake in the lawsuit.
4. And a few more things she noted
Does any one have the PDF of Hikma press releases from March 2020 and Sept 2020 that was noted in the law suit?
The bigger question. Why will doctors prescribe 500 mg?
These are gelatin capsules and their very nature makes swallowing the easiest thing.
If doctors go only with 500 mg , compliance will be a HUGE issue. People will stop taking the drug.
Also, Hikma has 500 mg dose that is approved as well.
Knowing the patent will infringe will not be sufficient. Hikma knows that. The issue is what are they doing to induce the infringement. I am having issue how Teva-GSK will make a difference in the long term. The max it can do is eliminate Hikma from the play for others to fill the void.
I am having hard time with that for the long-term.
Hikma says sorry and will fix "things" . Pays a token fine which at this time is tiny unless the trial is going to take a long time.
There are new entrants and insurance companies who now have a list of things that they should not do.
Most important being
1. Keep generic and Vascepa on same tier.
2. Generics sell at the lowest possible cost. For them other than material cost, there is no other cost
3. Vascepa can not compete because if they do , there is no premium for being a inventor and make substantially more.
4. Doctors will always ask for substitution if there is a pricing differential.
The only path forward is FDA revoke the AB status of generic. If they do not everyone is following the law.
Generic just supply for cheap (no inducement).
Doctors write generic ( free will).
Insurance approves (diagnosis irrelevant).
Pharmacy dispenses as indicated
Patients use.
The Hikma case is solid to give a slap on the wrist. No issues there. The bigger question is what after that?
Permanent injunction is IMPOSSIBLE. Even if they are banned , they can just be a supplier to another company with a profit-sharing agreement.
Other generics and new entrants have to just follow the playbook.
How so do they show that Hikma induced infringement?
Have you looked at the pill burden? It is massive . You are asking senior population to take 8 pills instead if 4 .
Not gonna work.
Second, why would doctors prescribe 500 mg when 1 g is now approved. Even if Amarin dumps it's 1-g, the others can still make it.
The problem is FDA. As long as they say it is AB rated, nobody can do a damn thing about it.
FDA has the power of seizure but as long as they play along, no luck.
I agree. My concern is this may partially handicap Hikma ( if Amarin wins) but noting more. They can get their acts together and other generics have the field open to just make the drug available. The more use the drug gets the generic will be automatically written without any inducement. Unless the FDA orange book make an explicit statement that generic is not AB rated to Vascepa, the US market is gone.
On your end, I am hoping this is the best chance. Getting a hearing for your case is the most important thing.
A question for you.
When a judge makes a scientifically incorrect conclusion and it is presented by the judge in writing, why is it difficult to correct the course? When it can be easily proven that conclusion is fundamentally incorrect and FALSE and forms the primary basis of the final ruling, there have to be better option to bring the error to the courts notice.
there is a lot of circumstantial evidence that Amarin talked about in the lawsuit
1. Mention of $1 billion sales
2. telling the generic is equivalent to vascepa (based on FDA guidelines)
3. Removing press releases from website
However, none of these would classify as INDUCING a physician to prescribe generic V.
And even if they infringe, beyond a tiny slap and reminder to correct wrongdoing, an injunction is impossible.
Does anyone have the MSDS for Vascepa where the composition is listed?
I was not aware of the MSDS. Is it accurate? Something is not adding up.
So that what is the case Amarin is fighting?
Hikma has insulated them from any induced infringement claim. Does Hikma's reliance on FDA AB rating enough to convince the judge?
@marjac Regarding the generic, I posted under @captbeer 's post.
Since Hikma has posted the MSDS sheet on their website, we have to assume it is true.
They are selling a misbranded drug. No evidence need to be provided. There is no way that with 80% as the max (100% pure content of EPA), they can have a bioequivalent product.
I do not disagree.
All I am saying FDA is the joke here and a serious contender like Hikma will not play with fire with their generic.
Having said that HIKMA clearly has dug their own hole if MSDS sheet is correct. There is no way they are selling a drug that is bioequivalent.
@marjac @captbeer
I was not aware of the MSDS label that HIKMA has on its website.
https://www.west-ward.com/~/media/Files/wwsite/Products/SDS/Icosapent%20Ethyl%20Capsules%20-%20SDS.ashx
Capt, I read your write-up with great interest. This is what I have to offer. Based on what Hikma has posted publicly, the drug should be withdrawn for the market immediately. FDA need to take action RIGHT NOW.
Give the fact that Hikma claims that the maximum content
of EPA at 100% purity is 80% based on the mSDS , there is no way that this can meet the requirement for FDA bioeqivalence.
The 90% confidence interval for geometric mean bioequvalence states:
90% Confidence Interval (CI) acceptance criteria is
80.00-125.00% for the test/reference ratio for all
three parameters AUCt, AUCinf, and Cmax
If the max composition of API is 80%, there is NO WAY this can meet the 80-125% range. It is mathematical and statistically impossible
Every capsule should have exactly 1000 mg of content and API should be exactly 800 mg in each capsule.
For all practical purposes the HIKMA product is mislabeled and misbranded and need to be pulled off immediately.
Section 502 of the Federal Food, Drug and Cosmetic Act
(FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:
Its labeling is false or misleading in any particular;
It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
@marjac I can not emphasize enough that generic drugs have to meet the same standards as original patented drug. FDA routinely analyzes drug formulations to ensure they meet the standards. Generic companies do not mess around. The cost of non-compliance is quite severe. They can just shut down the plant and every product at the plant will be shut down. The time it takes to get into compliance again is very long.
Hikma will not dole out an inferior product that does not meet FDA standards. It is just not worth their time and money to cheat. This is a wrong focus.
However, I do have a question for you about the Reduce-It patent.
Based on what we know to date, what is the most compelling evidence to show induced infringement. Does the AstraZeneca v Apotex case shed some light?
Hikma has removed everything that is suggestive of induced infringement, including the AB rating from their promotion.
However, they are definitely relying on the FDA orange book for the doctors to prescribe the GV.
The insurance will also be approving the GV based on the FDA orange book.
The LEGAL question that I have for you is this:
Does Hikma's reliance on FDA orange book AB rating for the drug to be used as alternateive to Vascepa suggestive of induced infringement?
Retail speculators will still be bag holders
Nothing is going to severe TG Indication. The drug is being primarily prescribed for CVD.
The question is what will prove that Hikma is knowingly supporting the use of the drug for CVD use.
Based on everything that is known about patent infringement laws, Amarin needs to openly discuss exactly how the generic are infringing on the patent.
What exactly is Hikma doing to make doctors prescribe GV?
All this has to meet the legal standard that we know to date
Generic synthroid has sub equivalency
For example Myland generic is equivalent to synthroid but not necessarily other "branded" drugs .
The point being this drug has a small window to be effective . After all it is a hormone and the dose is 15 micrograms
Nexium 40 mg is not going to be different form generic 40 mg .
I can not access it.
Bio equivalency and therapeutic equivalency are different things.
Low therapeutic index drugs (synthroid) need the therapeutic equivalency for obvious reasons. Furthermore, the issue is dose titration. Even the branded drug will need dose titration. When switched to generic, it will also need some tweaking before it can work
Bio equivalency for high therapeutic window drugs will translate to clincial equivalency. The reason 80-125% works has to do with the fact that humans come in difference size shape and ethnicity. Drug response is a range and not a specific number. Even for a branded drug two individuals with same dose will have different AUC.
Synthroid has very specific labeling requirements. They are bioequivalent but NOT therapeutically equivalent.
Synthroid and it's generic ARE NOT INTERCHANGABLE. They need specific designation since this is a low therapeutic window drug and needs a lot of titration before the dose is adjusted.
You must be dreaming here. Generics are NOT inferior to the branded drug. If they are different from the branded version, FDA is not doing its job.
I was again thinking about patent infringement.
Generics are aware that their drug under the skinny label will infringe the patent. But since the label does not indicate anything including disclaimers that the drug is not approved for CVD use, can they claim ignorance? They want to claim that they are not inducing infringement because their label does not say so.
FDA has the orange book that rates the generic to be equivalent to Vascepa as follows:
RX ICOSAPENT ETHYL A209499 CAPSULE ORAL 1GM AB DR REDDYS LABORATORIES INC
RX ICOSAPENT ETHYL A209457 CAPSULE ORAL 1GM AB HIKMA PHARMACEUTICALS USA INC
Are Hikma and Reddy along with the payers relying on the FDA orange book to decide what the generic is equivalent to?
Does the orange book SERVE AS A LABEL which the manufacturer relies on to seek payment from the payer.
Generics' reliance on an EXTERNAL LABEL should be adequate to show that they will be using it to seek reimbursement for the product they supplied to the patient.
Picking your brains. the big questions
ARE GENERICS RELYING ON EXTERNAL LABEL TO GET THEIR REIMBURSEMENT FOR AN INDICATION NOT COVERED BY THEIR LABEL. DOES THIS SHOW ACTIVE INFRINGEMENT?
https://www.ajconline.org/article/S0002-9149(10)02418-5/pdf
Based on prevelance. Probably 3 mil with severe Trig.
May be 1-2 % on meds.
Reduce-It Patent infringement
Playing devil's advocate .honest discussion.
1. What unequivocal evidence Amarin needs to convince the judge of infringement? Induction is a high bar.
2. The judge rules in favor . Slaps 3x penalty ( tiny ) tell Hikma not to do it. Hikma pays and gets it act together
3. Tells doc that Icsapent ethyl is not approved for Cvd but ICOSAPENT ETHLY is
4. What does doc do ? Prescribe ICOSAPENT ethly
5.what does pharmacy do ? Dispense icosapent ethyl.
How does the patent infringement help Amarin?
Why the hell these morons did not go with Waxmann when they went to Judge Du and during the oral arguments of the en banc appeal ?
When off-label use is 90% and on-label use is 10%, someone is doing something wrong, especially when the 90% is protected by a patent.
The party supplying the 90% which is beyond its authorized legal mandate?
The insurance approving the payment for the 90% off label, knowing that it can be a legal problem.
or PBM pushing for generics over branded for ALL indications?
The point I am making is when there is demand for off-label use for a patented indication, someone is fulfilling the demand in the supply chain and are there any "CONCRETE" legal precedent to object to this?
It looks like there are none.
Mfg- They asked for it, we gave it.
Doctor - They had it, so we gave it.
The way things are going in the US courts, it looks like the intent is to keep status co ongoing.
Rule 60 and Rule 24 are going to be equally challenging. A colleague is not going tell the other colleague, you don't know law. This is the primary problem with the appeal. All peas belong to the same pod
The most certain avenue is to figure out a way to fight the Reduce-It patent infringement beyond the inducibility clause.
Courts can wash off hands saying there is no ACTIVE inducement and nothing is being infringed. They have a good shot at winning but all Hikma has to do is sorry and pay a small penalty and continue selling the generic.
The solution is to find a way to hold someone accountable for allowing the drug to be used for CVD use.
Insurance? Yes, they are being sued by Amarin but under what clauses can they hide? How can their willful support of Hikma be objectively identified as infringement? Under which law will this be definitely illegal.
Doctors? They can not be held accountable. But what about the Healthcare systems where they work? Nobody will go after the doctors, since they will stop prescribing the drug altogether.
Pharmacy? Definitely. Pharmacies have an economic incentive to promote generics without regard for patents. They can not claim ignorance to infringement by arguing that current pharmacy state laws encourage patent infringement
Thank you.