Daily Rules, Proposed Rules, and Notices of the Federal Government
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 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 human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, 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 human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA approved for marketing the human drug product TORISEL (temsirolimus). TORISEL is indicated for the treatment of advanced renal cell carcinoma. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for TORISEL (U.S. Patent No. 5,362,718) from Wyeth, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration and that FDA determine the product's regulatory review period. In a letter dated August 7, 2012, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of TORISEL represented the first permitted commercial marketing or use of the product.
FDA has determined that the applicable regulatory review period for TORISEL is 3,290 days. Of this time, 3,052 days occurred during the testing phase of the regulatory review period, while 238 days occurred during the approval phase. These periods of time were derived from the following dates:
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,764 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see
Interested persons may submit to the Division of Dockets Management (see
Comments and petitions that have not been made publicly available on