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Dancing in the dark

09/06/20 7:39 PM

#297015 RE: Dancing in the dark #297007

based upon this historical revenue ramp up and when marketing materials beyond the MARINE result indication (i.e., management of very high triglyceride levels (≥500 mg/dL) were introduced, i believe a strong case could be made that generic icosapent ethyl will be infringing upon branded vascepa once generic icosapent ethyl sales exceed $200-250M / year.

my question is, what would happen if amarin successfully sued the generic manufacturers for infringement at that point? would the generic manufacturers pull their product from the market to cease infringing? what would this mean to the patients using generic icosapent ethyl? are those patients suddenly forced to use branded vascepa instead?



so ... sign a distribution agreement with teva/apotex for branded generic, expect the existing branded vascepa Rx's to quickly convert to branded generic. once the branded generic sales reach $200-250M in revenues, indicate the entire skinny label has been converted to branded generic and terminate the branded generic distribution agreement with teva/apotex. branded generic suddenly becomes difficult to obtain and branded vascepa sales fill the void.

alm2

09/07/20 2:31 AM

#297059 RE: Dancing in the dark #297007

Excellent analysis- from earlier posts - see Fish and Richardson article-there appears opportunity to seek injunction to prevent infringement of the reduce it label patents which are not affected by the D.C./FC decision
If granted the generics would have to cease selling

Amarin would lose nothing in attempting to obtain such an injunction save the legal fees involved - the gain would be immense - such goes without saying

Evidence could be carefully collected from various sources as to how generic sales infringe on the reduce it patents
The generics will of course be aware of this risk to them and it may colour their enthusiasm
Alm

circuitcity

09/07/20 9:08 AM

#297093 RE: Dancing in the dark #297007

Excellent analysis and summary. Thank you, let us continue to debate about this. I will read the article again.

Using the statically percentage of folks above trig 500 to set a theoretical thread hold. This amrn historical rev provide real data point.

Remember H presentation couple times this year? Targeting 700m and 1b rev respectively.

This is the best solution on legal front. If used properly as you said in your follow up post can convert to a business solution.

Well done!!

dmiller

09/07/20 10:12 AM

#297104 RE: Dancing in the dark #297007

I don't understand why the backseat lawyering continues from non-attorney's. Most here felt pretty good about Amarin's chances in winning the appeal and after all the back and forth with why the decision should be reversed, they lost the appeal before it actually begun. Same thing will happen here. After all this back and forth with what Amarin should do or could potentially do, Amarin will continue with their already announced GIA strategy in the EU.