ABSTRACT
The development of new pharmaceutical- or biotechnology-derived products undergoes a lengthy and expensive cycle. A patent is a grant of exclusive rights given by the government for a limited time with respect to a new and useful invention—rights to prevent others from making or selling the invention in a limited territory, as defined by the patent-issuing authority. The patenting of inventions is a complex process that has historically been confusing, particularly to the inventors who may not be practitioners of patent law. Of great importance to the pharmaceutical industry is the Drug Price Competition and Patent Restoration Act of 1984, commonly known as the Hatch-Waxman Act, which provided for extensions of patent terms for human drugs, food additives, and medical devices. There are certain specific exceptions to patentability, which apply whether or not the invention is capable of industrial application.
