What is the role of the FDA in the patent term extension process?

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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. The Food and Drug Administration (FDA) plays a crucial role in the patent term extension process for certain products. Specifically: The FDA assists the USPTO in determining the eligibility of patents for term extension for products requiring regulatory review (excluding veterinary biological products). It is responsible for determining the regulatory review period for these products. According to the MPEP: “The Secretary of Health and Human Services of the Food and Drug Administration is responsible for assisting the Office in determining the eligibility of patents for patent term extension which claims any other product for which regulatory review is required and for determining the regulatory review period for such products.” This collaboration is formalized through a Memorandum of Understanding between the USPTO and the FDA, which establishes procedures for information exchange and cooperation in the patent term extension process. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Secretary of Health and Human Services Determines PTE Eligibility MPEP 2756 Required Regulatory Agency Assistance for Patent Term Extension Determinations MPEP 2756 Cooperation Agreement for Patent Term Extension Determinations MPEP 2756 Preliminary Eligibility for Patent Term Extension Determined After Agency Reply MPEP 2756 Patent Term Extension Applicant Receives Office-Regulatory Agency Correspondence MPEP 2756 Request for Regulatory Review Period After Eligibility Determination MPEP 2756 Regulatory Review Period Determination for Veterinary Biological Products MPEP 2756 USDA Service Reviews Veterinary Biological Products and Patent Extensions MPEP 2756 Request for Regulatory Revi...