What information does the regulatory agency’s letter to the USPTO not take into account?

The letter sent by the regulatory agency to the USPTO regarding the regulatory review period determination does not take into account two important factors:

1. The issue date of the patent
2. The exclusion of one-half of the testing phase

MPEP 2757 specifies: “The letter to the Office makes clear that the determination does not take into account the issue date of the patent nor does it exclude one-half of the testing phase.” This information is crucial for patent attorneys and examiners to understand, as these factors will need to be considered separately when calculating the actual patent term extension.

To learn more:

• regulatory agency letter
• USPTO
• patent issue date
• testing phase
• regulatory review period