The Hatch Waxman Act 35 U.S.C. 156 enables the owners of patents on human drug products, medical devices, food additives, or color additives, and animal drug products to obtain patent term extension for delays at the regulatory agency, i.e., the United States Food & Drug Administration or FDA. In the case of drugs an extension is available where the holder of the patent (the patent owner or its agen) can show:
- the patent claims a drug, a method of using the drug, or a method of manufacturing the drug;
- The patent has not yet expired; and
- it has not previously been extended;
- The product was subject to a regulatory review period (licensing) prior to its permitted commercial marketing or use;
- The product has received FDA permission for commercial marketing or use, and the permission for the commercial marketing or use of the product is the first it has received.
The extension is limited to 5 additional years which cannot amount to more than 14 years of patent protection total.