What 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…

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Are 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…

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