Analysis of the impact of the Uruguay Round Agreements Act on pharmaceutical patents.

The Uruguay Round Agreements Act (URAA) was enacted by the United States Congress in 1994. The URAA provided substantial modifications to the framework for U.S. patent law that came into effect January 1, 1953. Changes in patent regulation are especially important in the pharmaceutical sector because the patent system determines, in large part, the reward that an inventor can derive from discovery of a new drug. Most pharmaceutical patents are classified as utility patents. Pharmaceutical patents may include claims for the active ingredient per se, for the formulation of the active ingredient for use as a pharmaceutical, for therapeutic indications and uses, and for methods of manufacturing the drug. The U.S. has a First-to-Invent system to establishing the right of priority of an invention, but most countries have a First-to-File priority system. The First-to-Invent system allows for public disclosure of inventions prior to patent filing. In contrast, the First-to-File system encourages early filing of patent applications. In both systems, filing an application for a patent as soon as the drug is discovered allows inventors to obtain an earlier date of invention relative to potential competitors and establish the right of priority over the invention.