Patent Term Extension Under 35 U.S.C. §156

In the United States, patent term extension is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act ("The Act")¹. The Act allows the extension of the term of a patent claiming a product that requires regulatory approval prior to being sold, or a method of using or manufacturing the product. Such products include human and veterinary pharmaceuticals, food additives, color additives and medical devices.² The determination as to whether a patent term extension should be granted is made by the U.S. Patent and Trademark Office ('USPTO"), in consultation with the regulatory agency responsible for approval of the product. The term extension aims to restore a portion of the patent term that is lost while the patent holder is awaiting regulatory approval of the safety and efficacy of the product.