Meridia Newsroom

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 Commissioner 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 recently approved for marketing the human drug product Meridia (sibutramine hydrochloride monohydrate).
Meridia is indicated for management of obesity, including weight loss and maintenance of weight loss. Subsequent to this
approval, the Patent and Trademark Office received a patent term restoration application for Meridia (U.S. Patent No.
4,746,680) from Knoll Aktiengesellschaft, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated November 19,1998, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval
of Meridia represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory review period.