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

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.

To learn more:

• FDA
• patent term extension
• regulatory review
• eligibility determination