Source: https://www.fdalawblog.net/2016/02/eisai-says-that-the-recently-enacted-irtnmta-should-result-in-a-longer-pte-for-fycompa-patent/
Timestamp: 2019-04-21 14:52:09+00:00

Document:
The ink from President Obama’s signature on Public Law No. 114-89, the “Improving Regulatory Transparency for New Medical Therapies Act” (or “IRTNMTA”), was hardly dry when the company that led the charge to change the law, Eisai Inc. (“Eisai”), asked the Patent and Trademark Office (“PTO”) in a submission made last month (Docket No. FDA-2014-E-0072) to consider how the new law applies and might affect Eisai’s request for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,949,571 (“the ‘571 patent”) covering Eisai’s FYCOMPA (perampanel) Tablets (NDA 202834). Under one PTE calculation, the term of the ‘571 patent would extend until September 4, 2025. But with the IRTNMTA, argues Eisai, the term of the ‘571 patent should extend until October 12, 2026.
The new statute is currently effective, and, as applied to the ’571 patent, would be prospective: the application for a PTE for the ’571 patent is currently pending, and neither the PTE nor the regulatory review period for Fycompa® has yet been determined; moreover, its effect as to Fycompa® and the ’571 patent would not occur until September 2025- nearly 10 years in the future. Therefore, FDCA § 505(x), 21 U.S.C. § 355(x) and the amendments to 35 U.S.C. § 156, apply to the pending applications for a PTE for the ’571 patent; and FDA and the PTO should apply those new provisions to determine Fycompa®’s “date of approval, ” FDCA § 505(x)(2), 21 U.S.C. § 355(x)(2), and its “covered date”, 35 U.S.C. § 156(i)(2). As relevant here, new FDCA 505(x), 21 U.S.C. § 355(x), and new 35 U.S.C. § 156(i) are essentially interchangeable. In view of the manifest purpose of the new statute, Fycompa®’s date of approval is the “date of issuance,” FDCA § 505(x)(2)(B), 21 U.S.C. § 355(x)(2)(B), 35 U.S.C. § 156(i)(2)(D), of the DEA’s regulation scheduling Fycompa®, i.e., the effective date of that regulation. Fycompa®’s date of approval is to be used in determining whether the Applicant’s second pending application (submitted on January 29, 2014) was submitted within the time period specified in Section 156(d)(1) as amended, and in determining the regulatory review period under Section 156(g)(1)(B) and (i) and, consequently, the length ofthe PTE under Section 156(c) and (g)(6).
Treating DEA’s regulation scheduling Fycompa® as the functional equivalent of an interim final rule under FDCA § 505(x), 21 U. S.C. § 355(x), would serve the manifest purpose of that statutory provision. That use of the DEA regulation is necessary and appropriate for applying the new statute to the pending applications.
The remainder of Eisai’s 51-page submission is spent providing legal justification for the company’s position on obtaining a longer PTE than compared to the PTE that would be due without application of the IRTNMTA. It may be some time before the PTO digests Eisai’s submission and makes a determination; however, if the PTO rules against Eisai, then we may see a new line of legal challenge for this drug.

References: § 505
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 § 156
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