Mar. 17 at 2:43 PM
$ZVRA
Miplyffa patent term extension:
"Following the 9/25 notice, a 180-day period ending 3/30/26 is allowed for any person to file a "due diligence petition" challenging the FDA's determination of the review period."
"If no challenges are filed, the USPTO generally issues the formal Notice of Final Determination shortly (1 month - May?) after this 180-day window expires."
"Once a determination is made pursuant to 37 CFR 1.750 that a patent is eligible for extension of its term, a certificate of extension, under seal, will be issued to the patent owner. Following the one-month period provided in the Notice of Final Determination, the certificate of extension is prepared and signed by the Director. Upon issuance of the certificate of extension, the file wrapper available in the USPTO patent electronic filing system will include an image of the certificate of extension. A courtesy copy of the certificate is sent to the regulatory agency." (FDA)
