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Saturday, May 09, 2020 7:54:43 AM
Nice synopsis...but you can take all this legal mumbo -jumbo and stick it, because if this Du determination stands then you can say good-bye to the entire FDA marketing process.
Who in their right mind is going to put up the money, millions and millions of dollars and all that time and risk...If some DC judge; who, can not even get her facts correct; can counterfeit the PTO opinion as to patent validity and make an end run around the the Hatch-Waxman legislation.
I am not a lawyer, but if this simple fact does not scream "Unintended
Consequences"; Those consequences being a chilling effect on future medical research. ...AND don't think the FDA, the USPTO, BP, the AHA, the ADA and the AMA are not going to be weighing in with Amicus Curiae(S).
Another thing I may be overlooking in your post is the fact the obligation to prove with clear and overwhelming evidence the patents were obvious is the responsibility of the defendents..But the judge instead charged Amarin with proving the patents were valid and this is clearly a procedural error which can be introduced in the appeal.
IMHO...Focusing on the line items which you have done a great job. Is a situation in which the sum of the total does not reflect the magnitude of the harm that this decision will do..And that is what the AC judges will consider if they are indeed wise..What will be the consequences if Du's opinion is upheld..And of course it is the job of Amarin's legal team to point this out..And Amarin will in all likelihood receive help from the drug and medical community..
The whole episode reminds me of Cyril and Hypatia. And the burning of the great library of Alexandria...
":>) JL
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