and it basically doesn't work with biologics since biosimilars are far more difficult to make.
It’s basically splitting the difference between two possible scenarios:
Scenario 1: patent is valid, generic drug doesn’t launch for 2 years
Scenario 2: patent is invalid and generic drug can launch immediately
The only reason you see pay for delay deals is when neither scenario is certain. Otherwise, why do a deal?
So they could only be called a “delay” if the patent is invalid. But if the patent was 100% invalid, the generic company wouldn’t negotiate a deal.
Most of the time, pay for “delay” deals get the generic drug on market sooner.
It’s basically splitting the difference between two possible scenarios:
Scenario 1: patent is valid, generic drug doesn’t launch for 2 years
Scenario 2: patent is invalid and generic drug can launch immediately
The only reason you see pay for delay deals is when neither scenario is certain. Otherwise, why do a deal?
So they could only be called a “delay” if the patent is invalid. But if the patent was 100% invalid, the generic company wouldn’t negotiate a deal.
Most of the time, pay for “delay” deals get the generic drug on market sooner.