What is the regulatory agency’s role in determining the length of the regulatory review period?

The regulatory agency is responsible for determining the length of the regulatory review period for the approved product on which a patent term extension application is based. This determination is made based on the application and official regulatory agency records for the approved product.

According to MPEP 2757, “Under 35 U.S.C. 156, the regulatory agency is responsible for the determination of the length of the regulatory review period for the approved product on which the application for patent term extension is based.” This determination is crucial for calculating the potential patent term extension.

To learn more:

• regulatory review period
• patent term extension
• regulatory agency
• FDA
• USPTO