What is the regulatory review period in patent term extension?
The regulatory review period is a crucial component in calculating patent term extension. According to 35 U.S.C. 156(g), the regulatory review period has specific meanings for different types of products. MPEP 2758 states:
“The Office will rely on the Secretary’s determination of the length of the regulatory review period when calculating the length of the extension period under 37 CFR 1.775 – 1.779.”
Key points about the regulatory review period:
- It’s determined by the relevant regulatory agency (e.g., FDA)
- Only the portion occurring after the patent was granted is considered for extension
- Periods of lack of due diligence by the applicant are subtracted
- Half days are ignored in the calculation
To learn more:
Topics:
Adjustments,
And Extensions,
MPEP 2700 - Patent Terms,
MPEP 2758 - Notice Of Final Determination - Calculation Of Patent Term Extension,
Patent Law,
Patent Procedure