When 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 MoreAre there any exceptions to the prohibition on third-party participation in patent term extension proceedings?
While MPEP 2763 generally prohibits third-party participation in patent term extension proceedings, there is one potential exception mentioned: “Absent an invitation from the Director, any such submission would be inappropriate.“ This suggests that the Director of the USPTO has the discretion to invite third-party submissions in exceptional circumstances. However, such invitations are likely to be…
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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