2757 Regulatory Agency Determination of the Length of the Regulatory Review Period [R-11.2013]
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) (regarding U.S. Patent No. 4,215,113). To determine the regulatory review period for an animal drug where the New Animal Drug Application (NADA) components were submitted to FDA in a phased review, the approval phase, as defined by 35 U.S.C. 156(g)(4)(B)(ii) , begins on the date of the submission of the administrative NADA. See Wyeth Holdings Corp. v. Sebelius, 603 F.3d 1291, 1299-1300, 95 USPQ2d 1233,1240 (Fed. Cir. 2010).
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) .
2757.01 Due Diligence Determination [R-11.2013]
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 will proceed with the final eligibility determination. See 21 CFR Ch. 1, Subparts D and E.