Posted: 08 Feb 2016 11:52 AM PST
By Kurt R. Karst –
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.
As we previously reported, the cumbersome (both in acronym and in substance) IRTNMTA amended the FDC Act, the PHS Act, the PTE statute, and the Controlled Substances Act (“CSA”) to provide, among other things, that the “date of approval” of an NDA, NADA, or Section 351(a) BLA for a controlled substance awaiting a scheduling determination by the DEA (or the “covered date” for PTE submission purposes) is the later of the date of NDA, NADA, or Section 351(a) BLA approval, or “the date of issuance of the interim final rule controlling the drug.”
Why were these changes necessary? As we previously explained, the IRTNMTA remedies an unfairness created by bureaucratic red tape. Until the enactment of the IRTNMTA, drug products containing controlled substances could be approved by FDA, but could not be marketed until the DEA issued a final determination scheduling the controlled substance under the CSA (and appropriate labeling changes were made reflecting the scheduling determination). In some cases that meant that a company was unable to market its drug product after FDA approval – sometimes for more than a year – while the 5-year period of New Chemical Entity (“NCE”) exclusivity has ticked away. By resetting the date of approval of a drug product containing a controlled substance requiring scheduling to be the later of the date of application approval or the date of issuance of the interim final rule scheduling drug, a company will not be punished by a scheduling delay. (Eisai sued FDA over the issue of the start date of NCE exclusivity, but lost – see our previous post here.)
The question presented by Eisai is one of applicability of the IRTNMTA: does the new law have prospective application for pending (and timely submitted) PTE applications for patents covering a drug that is a controlled substance? The answer to that question is “yes” says Eisai, based on a January 29, 2014 PTE application for the ‘571 patent that was submitted to the PTO within 60 days of the effective date of the DEA’s scheduling of FYCOMPA under the CSA:
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).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