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If generics launch then
1) sue generics and obtain injunction so they cannot sell
2) tie generics in court for 4 or 5 years while selling Vascepa.
3) if generics win, pay them damages proportional to marine population
Yup
The only way i would know if a patient gets generic substitution is if patient brings me the medication bottle. We have no clue when they substitute.
All scripts are electronic but yes i can print them as well for my file
If gV cones out, I will start using a statement : “take 2 grams bid for cardiovascular risk prevention based on a reduce it study” and if they issue a generic, i can report to amarin and see if they can do anything with that info.
The substitution for generic is not driven by pharmacies but by the payers (insurance companies).
Physicians can write off label legally. No risk.
Whoever has leverage with pharmacies by selling them 100s of other drugs has the advantage. Amarin has no leverage.
Unfortunately i am only a doctor, not a patent lawyer. No clue.
Sorry doctors have no power. Insurance companies do. We can write vascepa daw, brand only for CV indication all day long and insurances will approve generic version
First, send carefully drafted letters to all generic manufacturers who are in line to market generic IPE demanding that they not facilitate infringement of Amarin's CVD risk reduction patents and that prudence and ordinary care require that they take various (specified), affirmative steps to avoid doing so. Those steps would include that all product literature, and their label, advise that generic IPE has been approved only for severe hypertriglyceridemia, and not for CVD risk reduction, and that under no circumstances should generic IPE be prescribed for CVD risk reduction, which indication is protected by a federally issued patent, with the consequences for doing so including potential liability for infringement damages (and enhancement, in the event of a willfulness finding).
No you want generics to promote as much as possible so Amarin can get the evidence.
So amarin needs to delist marine patents in OB. That should be their next step.
60,000 is what lovaza has currently. But many of those on Lovaza have triglycerides less than 500
1 percent of population have triglycerides more than 500
However only 1.5 percent use omegas
So whether generics get a lot of off label scripts can be easily calculated
In the United States, the National Health and Nutrition Examination Surveys from 2007 to 2014 found that the percentages of non-statin-treated adults with triglyceride levels >150 mg/dL (1.7 mmol/L), >200 mg/dL (2.3 mmol/L), >500 mg/dL (5.7 mmol/L), and >1000 mg/dL (11.3 mmol/L) were 25, 11, 1, and <1 percent, respectively [2]. There were also racial and ethnic differences, with non-Hispanic African Americans having lower fasting TG levels than in non-Hispanic Caucasians and Mexican Americans [3].
Serum TG values >1000 mg/dL (11.3 mmol/L) occur in fewer than 1 in 5000 individuals [4
Approximately
Triglycerides more than 500 is 3.8 millions in the US
Most patients treated with statins, then fibrates then niacin
Only 1.5 percent is treated by omegas.
https://www.ajconline.org/article/S0002-9149(10)02418-5/pdf
Not in a developed market
3.8 million and only 1.5 percent use omegas to treat it
The main question for the lawyers
Can generics borrow portions of reduce-it label that they don’t own?
Generics hope to copy the exact marine label and that would proof their case against amarin
However, it is not possible to do so since reduce it reveals 2 new findings:
Afib and bleeding.
Amarin owns all rights to reduce it study.
They invested 500 million
Because gsk removed some patents from OB
It is not only the afib but also increased risk of bleeding that was discovered in reduce-it.
Generics don’t do promotions to physicians
This is the key article to use
Only 1.5 percent of patients with triglycerides above 500 use omega 3
This represents 50 to 60 k patients out of 3.4 millions.
So it will be easy to determine that they will be infringing
Here is the article
https://www.ajconline.org/article/S0002-9149(10)02418-5/pdf
https://www.ajconline.org/article/S0002-9149(10)02418-5/pdf
So 3.4 million with TG above 500 in US
14 percent treated with statins
Omegas used in only 1.5 percent of these patients
So 1.5 percent of 3.4 million is 51,000 patients
So Hikmas statement that their drug will be distributed to millions of Americans is a proof of their intentions.
“Today’s decision demonstrates Hikma’s ability to successfully challenge patents on important
medicines and to provide value to our customers and millions of patients across the United States “
I doubt there are millions of patients with trig above 500. The condition is rare.
Here is the latest
HTn is listed
They removed some patents from OB?
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Coreg_CR/pdf/COREG-CR-PI-PIL.PDF
I have the old label from 2005
Can someone find current coreg label?
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020297s013lbl.pdf
Gsk did it. So fda forced teva to copy gsk’s label
Amarin’s next step. Delist Marine label as GSK did for Coreg.
Yes they put him on aspirin for covid. Confirmed yesterday.
Looks like amarin needs to pull out marine label and ambush generics like gsk did
Exactly. Imagine you develop afib and have a huge stroke due to atrial fibrillation
how will they make a label without mentioning the risk of atrial fibrillation? We learned about atrial fibrillation risk in reduce-it trial. That risk is not included on marine label. It is still the same medication.
Whoever said you can’t sue generics for infringement due to skinny label is wrong.
I think Markman said it officially in their blog.
Based on Teva’s loss yesterday
It makes sense Amarin sues generics for infringement.
Hopefully this deters generic from selling it.
If generics win in few years, amarin pays generics loss for only marine patients which is minimal. Amarin keeps Reduce it sales.
Even if doctors write “DAW” insurance still approves the generic. I tried it many time. DAW does not work.
The best part
Teva argued it wasn’t responsible for the actions of doctors who prescribed the generic for congestive heart failure, because the doctors were acting based on their knowledge of Coreg’s uses that they learned from Glaxo.
So why is amarin up then?
Again generics don’t promote. They claimed their drugs is identical to the brand. They used it as a carve out for hypertension while coreg is also patented for congestive heart failure.
“It was ultimately more costly to sell an unpatented drug for unpatented uses than it would have been to stay out of the market altogether,” Circuit Judge Sharon Prost said in dissent
Generics don’t do promotions