What information does the USPTO request from regulatory agencies to determine patent term extension eligibility?

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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 USPTO requests specific information from regulatory agencies to help determine patent term extension eligibility. According to the MPEP, this information typically includes: Verification of whether the product underwent a regulatory review period within the meaning of 35 U.S.C. 156(g) prior to commercial marketing or use Confirmation that the marketing permission was for the first permitted commercial marketing or use of the product Information on whether the patent term extension application was submitted within 60 days after product approval Any other relevant information for determining patent eligibility for term extension The MPEP states: “The regulatory agency reply is usually in the form of a written response” addressing these points. This information is crucial for the USPTO to make an informed decision on patent term extension eligibility. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Preliminary Eligibility for Patent Term Extension Determined After Agency Reply MPEP 2756 Director Decides Patent Term Extension Eligibility MPEP 2756 Regulatory Agency Reply for PTE Calculation MPEP 2756 Permitted Regulatory Agency Reply Determines PTE Eligibility MPEP 2756 Patent Term Extension Applicant Receives Office-Regulatory Agency Correspondence MPEP 2756 Request for Regulatory Review Period After Eligibility Determination MPEP 2756 Regulatory Agency Assistance for Patent Term Extension Determinations MPEP 2756 Request for Regulatory Review Period Determination After Eligibility MPEP 2756 Provide Relevant Information for PTE Eligibility MPEP 2756 Permitted Cooperation Agreement for Patent Term Extension Determinations MPEP 2756 Other Related FAQs 5 FAQs Coll...