2024-22480. Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162-GRAFAPEXTM (Treosulfan)

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Department of Commerce

Patent and Trademark Office

1. [Docket No. PTO-P-2024-0047]

AGENCY:

United States Patent and Trademark Office, Commerce.

ACTION:

Notice of interim patent term extension.

SUMMARY:

The United States Patent and Trademark Office has issued a certificate for a one-year interim extension of the term of U.S. Patent No. 7,199,162.

FOR FURTHER INFORMATION CONTACT:

Kathleen Kahler Fonda, Senior Legal Advisor (telephone [phone]; email [e-mail]). Alternatively, mail may be addressed to Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450, and marked to the attention of Ms. Fonda.

SUPPLEMENTARY INFORMATION:

Section 156 of title 35, United States Code, 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, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On August 20, 2024, Medac Gesellschaft für Klinische Spezialpräparate mbH, the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for a fourth interim extension of the term of U.S. Patent No. 7,199,162. The patent claims a method of using the human drug product GRAFAPEX^TM (treosulfan). The application for patent term extension indicates that New Drug Application 214759 was submitted to the Food and Drug Administration on August 11, 2020, and its review in order for the patent owner to obtain permission to market and use the product commercially is ongoing.

Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the thrice-extended expiration date of the patent, October 12, 2024, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,199,162 is granted for a period of one year from the thrice-extended expiration date of the patent.

Charles Kim,

Deputy Commissioner for Patents, United States Patent and Trademark Office.