What happens if FDA approval is received during an interim extension?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-29 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. If FDA approval is received during an interim extension period, the patent holder must notify the USPTO promptly. According to MPEP 2755.01 : “ The patent owner must immediately notify the Office of any determination by the regulatory agency regarding the application for regulatory approval. After receiving permission for commercial marketing or use, the patent holder must file a written notice thereof within 5 working days with the Office. ” This notification triggers the start of the 60-day period after which the interim extension will terminate, as per 35 U.S.C. 156(e)(2) . Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Interim Extension of Patent Term Is Discretionary Up to One Year MPEP 2755.01 Notification of Patent Term Extension Eligibility MPEP 2755 Interim Extension Cannot Extend Patent Term Beyond Eligible Period MPEP 2755.01 Notification of Patent Extension Determination MPEP 2755 Interim Extension After Commercial Approval MPEP 2755.02 Permitted Copies of Interim Extension Applications Maintained Like Term Extensions MPEP 2755.02 Interim Extension Terminates After 60 Days Unless Additional Information Submitted MPEP 2755.02 Permitted Patent Owner Notified of Interim Extensions MPEP 2755.01 No Interim Extension for Non-Eligible PTE Patent MPEP 2755.01 Fee for Interim Patent Term Extension MPEP 2755.02 Other Related FAQs 5 FAQs Collapse How long can an interim extension last? What is the deadline for filing an application for interim extension? How long does an interim extension last? Can multiple interim extensions be granted for a single patent? Can multiple patents receive interim extensions based on a single regulatory review period?