Replies to post #344396 on Amarin Corp Plc (AMRN)

[postes]

Besides AMRN who has said >500tg is only 10% of scripts?
If it’s Symphony, how do they know?

[johngnatt]

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?