| Patents > Search Collections > MPEP > 2757 Regulatory Agency Determination of the Length of the Regulatory Review Period - 2700 Patent Terms and Extensions |
|
|
|
Go to MPEP - Table of Contents
2757 Regulatory Agency Determination of the Length of the Regulatory Review Period - 2700 Patent Terms and Extensions
2757 Regulatory Agency Determination of the Length of the Regulatory Review Period
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. The determination by the regulatory agency is made based on the application as well as the official regulatory agency records for the approved product. See, e.g., 21 CFR Ch. 1, Subpart C. The determination of the length of the regulatory review period is solely the responsibility of the regulatory agency. Aktiebolaget Astra v. Lehman, 71 F.3d 1578, 1580-81, 37 USPQ2d 1212, 1214-15 (Fed. Cir. 1995); U.S. Patent No. 4,215,113.
Once the determination has been made, the regulatory agency publishes the information in the Federal Register and forwards a letter to the Office with the same information. 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. This provides the Office with the information necessary to determine the actual length of extension for which the patent may be eligible. The Federal Register Notice also sets a date, 180 days after publication of the notice, as a deadline for filing written comments concerning any of the information set forth in the notice or a petition for a determination regarding whether the marketing applicant has acted with due diligence during the regulatory review period. 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.
The regulatory review period determination is not final until due diligence petitions and informal hearings, if any, have been resolved. A certificate for extension of the term of a patent may not issue from the Office until the regulatory review period determination is final unless an interim extension appears warranted under 35 U.S.C. 156(d)(5) and (e)(2).
The Inventors Assistance Center is available to help you on patent matters.Send questions about USPTO programs and services to the USPTO Contact Center (UCC). You can suggest USPTO webpages or material you would like featured on this section by E-mail to the webmaster@uspto.gov. While we cannot promise to accommodate all requests, your suggestions will be considered and may lead to other improvements on the website. |
|
|
Go to MPEP - Table of Contents
=online
business system 
=fees 
=forms
=help 
=laws/regulations 
=definition
(glossary)