4 ms·
How is the FDA responsible for patent issuance? Isn't that the remit of the US Patent Office?
by rocqua 3y ago
How is the FDA responsible for patent issuance? Isn't that the remit of the US Patent Office?
- akira2501 3y agoYou are correct, but in a process that requires submission of the patent to the FDA, you can also request an FDA "new drug product exclusivity."
- refurb 3y agoNo, the patent has nothing to do with it. "New drug exclusivity" is an FDA regulation separate from patents. Basically you get a minimum of 5 year exclusivity for new molecular entities, and you can add on another couple years if it's a rare disease. Even generic drugs get 6 months exclusivity.