How is the regulatory review period determination communicated and published?

Once the regulatory agency determines the length of the regulatory review period, it publishes the information in the Federal Register and sends a letter to the USPTO with the same information. Both the Federal Register Notice and the letter to the USPTO include:

• The total length of the regulatory review period
• The relevant dates on which the determination is based
• A breakdown of the total regulatory period into the initial (testing) phase and the final approval phase

MPEP 2757 states: “Included in both the Federal Register Notice and the letter to the Office are the total length of the regulatory review period and the relevant dates on which the determination is based. Both the letter to the Office and the Federal Register Notice separate the total regulatory period into the initial or testing phase and the final approval phase.“

To learn more:

• regulatory review period
• Federal Register
• USPTO
• patent term extension