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 July 31, 2023, Italfarmaco SPA, the owner of record of the '689 patent, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of the '689 patent. The '689 patent claims the drug product known by the tradename DUVYZAT^TM (Givinostat hydrochloride monohydrate). The application for interim patent term extension indicates that the approval phase of the RRP, as described in 35 U.S.C. 156(g)(1)(B)(ii), began on April 21, 2023, for DUVYZAT^TM (Givinostat hydrochloride monohydrate) and is ongoing before the Food and Drug Administration for permission to market and use the product commercially.

Review of the interim patent term extension application indicates that, except for permission to market or use the product commercially, the '689 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it appears reasonable to expect the approval phase of the RRP to continue beyond the expiration date of the patent, i.e., January 15, 2024, interim extension of the '689 patent's term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,329,689 is granted for a period of one year from the original expiration date of the '689 patent.

88 FR 81063