What is the deadline for filing a patent term extension application under 35 U.S.C. 156(d)(1)?

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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 deadline for filing a patent term extension application under 35 U.S.C. 156(d)(1) is within a 60-day period that begins on the date the product received permission for commercial marketing or use. According to the MPEP 2754.01 : “An application for patent term extension under 35 U.S.C. 156(d)(1) may only be filed within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use.” It’s important to note that this statutory time period is strict and cannot be extended, waived, or excused. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Deadline for Filing an Application Under 35 U.S.C. 156(d)(1) MPEP 2754.01 Application for Patent Term Extension Must Be Filed Within 60 Days of Regulatory Approval MPEP 2754.01 Permitted Patent Term Extension Filing Deadline Begins on FDA Approval MPEP 2754.01 Statutory Time Period Cannot Be Extended MPEP 2754.01 Prohibited Application for Patent Term Extension Must Be Filed Within 60 Days of Approval MPEP 2754.01 Required Deadline for Filing Patent Term Extension Application MPEP 2754.01 First Day of Patent Term Extension Period Is Marketing Approval Date MPEP 2754.01 Complete Application Requirement for Filing Date MPEP 2754 Covered Date for Drug Product Review Begins on Application Approval MPEP 2754.01 First Day of Extension Period Is Approval Date MPEP 2754.01 Other Related FAQs 5 FAQs Collapse Can the 60-day filing period for patent term extension applications be extended or waived? How is the approval date determined for drug products under the Controlled Substances Act? How is the approv...