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

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.

To learn more:

• USPTO
• regulatory agencies
• patent term extension
• eligibility information