Department of Plant Sciences, Director of Development, University Libraries, The University of Tennessee, 612 John C. Hodges Library, Knoxville, TN 37996, USA.
Expert Opin Ther Pat. 2010 May;20(5):603-8. doi: 10.1517/13543771003709775.
The current patent landscape in the US has not undergone major legislative reform since 1952. The US Senate version of the most recently proposed patent reform legislation puts forward a number of rule changes that could impact the pharmaceutical industry. Among the bill's major provisions are moving to a first-to-file system, changes to post-grant review and reexamination procedures, and damages reform. Various industries with a stake in patent reform have responded to the proposed changes. The need for balanced reform makes the stakes particularly high for the pharmaceutical industry which must invest a significant amount of time and money in the research and development process in exchange for already abbreviated patent lifetimes due to the lengthy clinical trial process.
自 1952 年以来,美国的专利格局尚未进行重大立法改革。美国参议院版本的最新提议专利改革立法提出了一些可能影响制药行业的规则变更。该法案的主要条款包括转向先申请制、修改授权后审查和重新审查程序,以及损害赔偿改革。对专利改革有既得利益的各个行业对拟议的变更做出了回应。由于临床试验过程漫长,制药行业的研发过程需要投入大量的时间和资金,而专利寿命已经缩短,因此平衡改革的必要性使得制药行业的利益尤为重要。