Grant of Interim Extension: Term of U.S. Patent No. 9,724,499; V-WAVE Ventura Interatrial Shunt System

Grant of Interim Extension of the Term of U.S. Patent No. 9,724,499; V-WAVE® Ventura® Interatrial Shunt System

SUPPLEMENTARY INFORMATION:

35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent.

On December 10, 2025, V-Wave Ltd., the owner of record of the '499 patent, timely filed an application under 35 U.S.C. 156(d)(5) for a first interim extension of the term of the '499 patent. The '499 patent claims the medical device known by the tradename V-WAVE® Ventura® Interatrial Shunt System. The application indicates that a RRP as described in 35 U.S.C. 156(g)(3)(B)(ii) for the V-WAVE® Ventura® Interatrial Shunt System medical device is ongoing before the Food and Drug Administration for permission to market and use the device commercially.

Review of the application indicates that, except for permission to market or use the device commercially, the '499 patent would be eligible for an extension of its term under 35 U.S.C. 156. Because it appears reasonable to expect that the RRP will continue beyond the original expiration date of the '499 patent, i.e., March 11, 2026, interim extension of the patent's term under 35 U.S.C. 156(d)(5) is appropriate.

A first interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 9,724,499 is granted for a period of one year from the original expiration date of the patent.