(The term of a patent may be extended for a period of time that is the sum of one-half of the time in the “testing phase,” plus all the time in the “review phase,” and minus any of the “regulatory review period” that occurs prior to the patent grant or where the sponsor did not act with due diligence.) FDA’s regulations implementing the statute’s PTE provisions state that “[t]he approval phase begins on the date a marketing application under section 351 of the Public Health Service Act or section 505(b) of the Act is initially submitted to FDA . . . and ends on the date the application is approved” (21 C.F.R. § 60.22(a)(2) (emphasis added)), and that “[f]or purposes of determining the regulatory review period for any product, a marketing application . . . is initially submitted on the date it contains sufficient information to allow FDA to commence review of the application” (21 C.F.R. § 60.22(f) (emphasis added)).Over the years, questions have cropped up as to when the review phase begins – that is, when is an application considered initially submitted to FDA – in the context of “rolling” or modular submissions.

The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. § 60.22(f) clarify that a marketing application “is initially submitted on the date it contains sufficient information to allow FDA to commence review of the application.” In September 2006, FDA issued a Federal Registernotice stating the Agency’s determination that the date NADA No. 141-099 was initially submitted to FDA was on January 13, 1998, when the final NADA component was submitted to the Agency.

The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. § 60.22(f) clarify that a marketing application “is initially submitted on the date it contains sufficient information to allow FDA to commence review of the application.” The CYDECTIN PTE case concerns when the NADA was “initially submitted” to FDA. FDA first approved CYDECTIN on January 28, 1998 under NADA #141-099.

The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R. § 60.22(f) clarify that a marketing application “is initially submitted on the date it contains sufficient information to allow FDA to commence review of the application.” A patent term may be extended for a period of time that is the sum of one-half of the time in the “testing phase,” plus all the time in the “review phase” (minus any of the “regulatory review period” that occurs prior to the patent issuance or during which the applicant did not act with due diligence to obtain approval).

terminationto Angiotech stating that the PTE date would be calculated based on the March 21, 2002 IDE date and the March 4, 2004 approval date. Angiotech was given the option of filing a request for reconsideration of PTO’s determination.On May 3, 2007, Angiotech filed a request for reconsiderationchallenging the PTE determination.Angiotech argued that the testing phase should have begun on October 12, 2000 when the first clinical trial was initiated in Germany, and not on the March 21, 2002 IDE date.In referring to FDA’s decision that the testing phase began on March 21, 2002 instead of October 12, 2000, Angiotech’s request for reconsideration states that “[t]he apparent basis for this determination is [FDA’s] regulation governing calculation of the regulatory review period.Although the statue mandates that the regulatory review period be deemed to commence ‘on the date a clinical investigation on humans involving the device was begun,’ 35 U.S.C. 156(g)(3)(B)(i), FDA’s regulation [at 21 C.F.R. § 60.22(c)(1)] imposes additional criteria.”Specifically, FDA’s regulatory review period determinations regulation at 21 C.F.R. § 60.22(c)(1) states:[A] clinical investigation is considered to begin on whichever of the following dates applies:(i) If an [IDE] is required, the effective date of the exemption.

See 35 U.S.C. § 156(a)(5)(A) and 37 C.F.R. § 1.720(e)(1).See 35 U.S.C. § 156(c)(4) and 37 C.F.R. § 1.720(h).See 35 U.S.C. § 156(d)(1) and 37 C.F.R. § 1.720(f). The PTE application should include all the information required by 37 C.F.R. §§ 1.710 through 1.785.See Memorandum of Understanding between the Patent and Trademark Office and the Food and Drug Administration, 52 FR 17830 (May 12, 1987).See 37 C.F.R. § 1.750.See 21 C.F.R. § 60.10 and MPEP Section 2756.See 35 U.S.C. § 156(d)(2)(A)(ii) and 21 C.F.R. § 60.20.See 21 C.F.R. § 60.24.See 35 U.S.C. § 156(d)(2).See 21 C.F.R. § 60.30.See 21 C.F.R. Part 60, Subparts D and E. Any person may file a request for informal hearing, within the prescribed period, on the due diligence determination published by the FDA.See 21 C.F.R. § 60.26. 37 C.F.R. § 1.775 and 35 U.S.C. § 156(c)See 21 C.F.R. § 60.22(a).See 37 C.F.R. § 1.775 and 35 U.S.C. § 156(c).

See, e.g., FDA, Determination of Regulatory Review Period for Purposes of Patent Extension, MIFEPREX; Amendment, 67 Fed. Reg. 65358, 65358-59 (Oct. 24, 2002), available athttps://www.gpo.gov/fdsys/pkg/FR-2002-10-24/pdf/02-27096.pdf(concluding that the testing phase for Mifeprex began with the first IND filed in 1983 for mifepristone alone and not the second IND filed in 1994 for mifepristone followed administration of misoprostol, which was ultimately the subject of the approved NDA).6 35 U.S.C. § 156(g)(3)(B); 37 C.F.R. § 1.740(a)(10)(v)(A).7 35 U.S.C. § 156(g)(1)(B) (emphasis added).8 21 C.F.R. § 60.22. See also Letter from FDA to Arnold & Porter LLP denying its request for revision of the regulatory review period for Kepivance (March 2002); Letter from FDA to Covington & Burling LLP denying its request for revision of the regulatory review period for Zolinza, at 8 (Apr. 17, 2012).

Therefore, it is proper not to consider any such deficient application to have been “initially submitted.” [(Emphasis in original)]Boehringer also argued that FDA’s action was inconsistent with the Agency’s regulations, and specifically with 21 C.F.R. § 60.22, which provides that the approval phase of the PTE regulatory review period begins “on the date [the application] contains sufficient information to allow FDA to commence review of the application.” But like Boehringer’s statutory argument, Judge Kollar-Kotelly deferred to FDA’s interpretation of the PTE regulation, concluding that “it was reasonable for [FDA] to determine that the materials provided to the agency as of December 15, 2009, did not ‘contain[] sufficient information to allow FDA to commence review of the application’ because they were fatally deficient and would not allow a full substantive review of the proposed product.”

An application is “initially submitted” when it “contains sufficient information to allow FDA to commence review.” 21 C.F.R. § 60.22(f). The PRADAXA® application was “initially submitted” to FDA no later than December 15, 2009, when BIPI submitted the final elements of the application.