Elliott George C
United States Patent and Trademark Office, USA.
Acad Med. 2002 Dec;77(12 Pt 2):1309-14. doi: 10.1097/00001888-200212001-00002.
This author provides a brief overview to the U.S. patent system with respect to DNA-based or gene patents, examines the statutory requirements for the U.S. Patent and Trademark Office (USPTO) and its processes of review, and explains how this system is implemented in the issue or decline of a patent. The author describes the important role played by the courts in their continuing reinterpretation and application of the patent law. He notes that many issues raised in discussions about the perceived benefits to society or general concerns arising from the patenting of gene sequences actually pertain to matters of enforcement and licensing of patents. These aspects, the author notes, lie outside of the USPTO's purview. Social questions about access to patented subject matter-such as the practice of patented gene-based diagnostic tests-must be addressed in other forums.
本文作者简要概述了美国关于基于DNA或基因专利的专利制度，审视了美国专利商标局（USPTO）的法定要求及其审查程序，并解释了该制度在专利授予或驳回过程中是如何实施的。作者描述了法院在不断重新解释和适用专利法方面所发挥的重要作用。他指出，在关于基因序列专利给社会带来的预期益处的讨论中提出的许多问题，或由此引发的普遍担忧，实际上都与专利的实施和许可有关。作者指出，这些方面超出了USPTO的职权范围。关于获取专利主题的社会问题，如基于专利基因的诊断测试的实践，必须在其他论坛上加以解决。
