How does the USPTO process a patent term extension application?

The USPTO follows a specific process for handling patent term extension applications under 35 U.S.C. 156. According to the MPEP, the process includes the following steps: The USPTO initially determines whether the application is formally complete and whether the patent is eligible for extension. The Director of the USPTO notifies the Secretary of Agriculture or…

Read More

What is the regulatory review period in patent term extension?

The regulatory review period is a crucial component in calculating patent term extension. According to 35 U.S.C. 156(g), the regulatory review period has specific meanings for different types of products. MPEP 2758 states: “The Office will rely on the Secretary’s determination of the length of the regulatory review period when calculating the length of the…

Read More

What information about the regulatory review period must be included in a patent term extension application?

A patent term extension application must include specific information about the regulatory review period as outlined in 37 CFR 1.740(a)(10). The required information varies depending on the type of product: For human drugs, antibiotics, and biological products: Effective date and number of the investigational new drug (IND) application Date and number of the new drug…

Read More

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…

Read More

Can multiple patents receive interim extensions based on a single regulatory review period?

Yes, multiple patents can receive interim extensions based on a single regulatory review period under certain circumstances. According to MPEP 2755.01: “In circumstances where extensions of multiple patents have been sought based on a single regulatory review period as per 37 CFR 1.785, where those patents expire on the same day, multiple interim extensions under…

Read More

What is the maximum period of patent term extension?

The maximum period of patent term extension depends on several factors, including the date of patent issuance and the regulatory review period. According to MPEP 2758: For patents issued after September 24, 1984, the extension cannot exceed five years. For patents issued before September 24, 1984, with regulatory review starting after this date, the extension…

Read More