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…
Read MoreWhat 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 MoreWhat 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: The issue date of the patent 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…
Read MoreWhen is a regulatory review period determination considered final?
A regulatory review period determination is not considered final until all due diligence petitions and informal hearings, if any, have been resolved. This is important because the USPTO cannot issue a certificate for extension of the term of a patent until the regulatory review period determination is final, unless an interim extension is warranted under…
Read MoreWhat deadlines are set in the Federal Register Notice regarding regulatory review period determinations?
The Federal Register Notice sets two important deadlines: A deadline 180 days after publication for filing written comments or petitions regarding the marketing applicant’s due diligence during the regulatory review period. A deadline 60 days after publication for requesting redetermination if anyone believes the published dates are incorrect. MPEP 2757 states: “The Federal Register Notice…
Read MoreHow is the regulatory review period for an animal drug determined?
For animal drugs where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase begins on the date of the submission of the administrative NADA. As stated in MPEP 2757: “To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA)…
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