MPEP Section 2757.01, Due Diligence Determination

Executive summary:

This document contains Section 2757.01 ("Due Diligence Determination") of the Manual of Patent Examining Procedure (the "M.P.E.P."), Eighth Edition, Eighth Revision (July 2010). This page was last updated in January 2011. You may return to the section index to find a particular section. Alternatively, you may search the MPEP using the search box that appears on the left side of every page of BitLaw--you may restrict your search to the MPEP on the search results page.

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2757.01 Due Diligence Determination

If a due diligence petition is filed during the 180-day period following publication of the regulatory agency determination of the regulatory review period, the regulatory agency (e.g., FDA) makes the determination under 35 U.S.C. 156(d)(2)(B) whether the applicant for patent term extension acted with due diligence during the regulatory review proceedings. The term "due diligence" is defined in 35 U.S.C. 156(d)(3) as "that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period." After affirming or revising the determination of the regulatory review period, the regulatory agency notifies the Office and publishes the results in the Federal Register. If no comment or petition is filed in the time period provided, the regulatory agency notifies the Office that the period for filing a due diligence petition pursuant to the notice has expired and that the regulatory agency therefore considers its determination of the regulatory review period for the product to be final. Following notification from the regulatory agency, the Office proceeds with the final eligibility determination. See 21 CFR Ch. 1, Subparts D and E.