What is the regulatory review period in patent term extension?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. 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 Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Length of Patent Term Extension Determined by Regulatory Review Period MPEP 2758 Notice of Final Determination for Patent Term Extension MPEP 2758 Permitted Notice of Final Determination for Patent Term Extension Calculations MPEP 2758 Procedure for Calculating Patent Term Extension Periods MPEP 2758 Office Calculates Patent Term Extension Length MPEP 2758 Notice of Final Determination for No Extension MPEP 2758 Office Relies on Secretary’s Determination for PTE Calculation MPEP 2758 Extension of Patent Term Including Adjustments and Disclaimers MPEP 2758 Permitted Patent Term Extension Only Dependent on Regulatory Review Period and Fourteen-Year Limit MPEP 2758 Permitted Regulatory Review Period for PTE Before 1984 MPEP 2758 Other Related FAQs 5 FAQs Collapse How does the 14-year rule affect patent term extension? What is the maximum period of patent term extension? What is the Notice of Final Determination in patent term ...