Seoane-Vazquez Enrique, Rodriguez-Monguio Rosa, Szeinbach Sheryl L, Beyer Andrew, Visaria Jay
Ohio State University Colleges of Pharmacy and Public Health, Columbus, Ohio, USA.
Food Drug Law J. 2009;64(1):171-81.
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.
《乌拉圭回合协议法》（URAA）于1994年由美国国会颁布。该法案对1953年1月1日生效的美国专利法框架进行了重大修改。专利法规的变化在制药行业尤为重要，因为专利制度在很大程度上决定了发明者从新药发现中所能获得的回报。大多数制药专利被归类为实用专利。制药专利可能包括对活性成分本身、用作药物的活性成分制剂、治疗适应症和用途以及药物制造方法的权利要求。美国有一个先发明制度来确定发明的优先权，但大多数国家采用先申请优先权制度。先发明制度允许在专利申请之前对发明进行公开披露。相比之下，先申请制度鼓励尽早提交专利申请。在这两种制度下，一旦发现药物就尽快提交专利申请，可使发明者相对于潜在竞争对手获得更早的发明日期，并确立对该发明的优先权。
