Source: https://www.pepperlaw.com/publications/not-so-simple-math-calculating-the-regulatory-review-period-for-patent-term-extension-2017-05-18/
Timestamp: 2019-04-22 18:54:36+00:00

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This is the third article in our five-part series on PTE.
Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is “straightforward and largely ministerial in nature.” But recent court decisions coupled with prior FDA determinations demonstrate that the calculation is not so easy. Identifying the testing phase — from the effective date of the investigational new drug (IND) exemption to the filing date of the new drug application (NDA) — and the approval phase — from the filing date of the NDA to its approval date — can be tricky in certain circumstances.
If multiple INDs have been filed for a product, the first IND for the product should be used.
If no investigational device exemption (IDE) was submitted for a device, the testing phase begins on the date on which the applicant began the first clinical investigation for the device.
The filing date of the NDA is the date when the NDA is initially submitted.
The approval phase may not begin until the user fees have been paid.
The FDA has jurisdiction over the calculation of the RRP.
It is important for applicants to work with both patent and regulatory counsel to ensure that the RRP is calculated correctly and that the application for PTE is timely submitted. Applicants should not embark on such an analysis once their product is approved. Rather, the analysis should be started as soon as the application for approval is submitted to the FDA, if not sooner.
1 35 U.S.C. § 156(g).
2 35 U.S.C. § 156(c).
3 PGRRP = pre-patent grant regulatory review period; DD = time period during which applicant did not act with due diligence; TP = regulatory review period, which is the testing phase; PGTP = pre-patent grant testing phase.
5 Brian Malkin, FDA’s Role in Administering the Hatch-Waxman Act, 54 Food & Drug L.J. 211, 213 (1999). 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 at https://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).
9 See Boehringer Ingelheim Pharma GmbH & Co. KG v. FDA, 195 F. Supp. 3d 366 (D.D.C. 2016).
10 Id. at 380 (“The agency determined that the mere assessment of the application for completeness is not tantamount to the agency’s substantive review of the application, and the Court concludes that this determination is reasonable.”).
11 See, e.g., 61 Fed. Reg. 24316 (May 14, 1996) (finding that the “initial submission” date for Epivir’s NDA was the date the user fees, not the NDA, were received because “[r]eview of a NDA does not begin until the correct amount of User Fee money has been received by the agency from the sponsor of the NDA”).
12 35 U.S.C. § 156(d)(1).
13 See 21 U.S.C. §§ 505(x), 512 (q); 42 U.S.C. § 351(n); see also 35 U.S.C. § 156(d)(1). The Improving Regulatory Transparency for New Medical Therapies Act addressed the unfairness that previously resulted in cases like Unimed, Inc. v. Quigg, 888 F.2d 826, 828-29 (Fed. Cir. 1989) (“[T]he Patent Term Restoration Act takes into account only the regulatory review carried out by the FDA and no other government obstacles to marketing new drugs.”).
Nicole Stakleff is a partner in Pepper Hamilton’s Health Sciences Department, a team of 110 attorneys who collaborate across disciplines to solve complex legal challenges confronting clients throughout the health sciences spectrum. Kyle Dolinsky is an associate in the Health Sciences Department.
Part Five: We Received a Patent Term Extension - Now What?

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