I agree. Teva GSK ruling will have a lot to bring to the table.
I am guessing courts will put heat on FDA to clarify therapeutic equivalency rating in context of indication approved and patents.
Another thing that the courts need to take up with regards to patent infringement is on prescription writing.
When a doctor's writes a prescription for a off-label indication , it is in their right to do so for an indication that has not been clinically approved or validated. Eg- corticosteroids in covid, colchicine (gout drug) for pericarditis, viagara for female sexual enhancement , etc. This is true OFF-LABEL use.
Doctor can prescribe generic Vascepa for CVD. The question to ask is if EPA for CVD is a off label use?
IT IS NOT! It is a clinically PATENTED use by Vascepa.
The doctor does not know need to know that patents. They can prescribe it. The pharmacist does not need to know, they can dispense it.
The payer NEED to know that they can not cover it . The manufacturer needs to know that they can not supply it for this use.
So by paying for it and by supplying the demand , both the payer and manufacturer are infringing on the patent!!
The argument is not induction of patent infringement but contributing directly to patent infringement !
The analogy here could be to selling guns. A person is on a national no gun sale list and does not clear background check. Can the gun seller claim that selling guns to this person is legitimate because he asked for a gun ?
If the doctor writes a prescription , a pharmacist dispenses it (they do not need to know patents) , can the payer and manufacturer claim innocence and just say that they asked for the drug and we gave it to them clearly knowing that the drug was dispensed for CVD? Did the intentionally violate the rights of the patent holder?
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