Determination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair System

SUPPLEMENTARY INFORMATION:

I. Background

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM. PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR>=3+) due to primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. Subsequent to this approval, the USPTO received a patent term restoration application for PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM (U.S. Patent No. 10,507,102) from Edwards Lifesciences Corp., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 18, 2024, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM is 1,879 days. Of this time, 1,698 days occurred during the testing phase of the regulatory review period, while 181 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: July 25, 2017. FDA has verified the applicant's claim that the date the investigational device exemption for human tests to begin, as required under section 520(g) of the FD&C Act, became effective July 25, 2017.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): March 18, 2022. The applicant claims March 16, 2022, as the date the premarket approval application (PMA) for PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM (PMA P220003) was initially submitted. However, FDA records indicate that PMA P220003 was submitted on March 18, 2022.

3. The date the application was approved: September 14, 2022. FDA has verified the applicant's claim that PMA P220003 was approved on September 14, 2022.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 592 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[FR Doc. 2024-24244 Filed 10-18-24; 8:45 am]

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