Bobrow Martin, Thomas Sandy
Department of Medical Genetics, Cambridge Institute for Medical Research, Wellcome/MRC Building, Addenbrooke's Hospital, Cambridge, CB2 2XY, UK.
Curr Opin Mol Ther. 2002 Dec;4(6):542-7.
The protection of inventions based on human DNA sequences has been achieved mainly through application of the patent system. Over the past decade, there has been continuing debate about whether this use of intellectual property rights is acceptable. Companies and universities have been active during this period in filing thousands of patent applications. Although many have argued that to claim a DNA sequence in a patent is to claim a discovery, patent law allows discoveries that are useful to be claimed as part of an invention. As the technology to isolate DNA sequences has advanced, the criterion for inventiveness, necessary for any invention to be eligible for filing, has become more difficult to justify in the case of claims to DNA sequences. Moreover, the discovery that a gene is associated with a particular disease is, it is argued, to discover a fact about the world and undeserving of the status of an invention. Careful examination of the grounds for allowing the patenting of DNA sequences as research tools suggests such rewards will rarely be justified. The patenting of DNA sequences as chemical intermediates necessary for the manufacture of therapeutic proteins is, however, reasonable given that the information within the sequence is applied to produce a tangible substance which has application as a medicine. Despite the legal, technical and political complexities of applying the flexibilities with the current law, it is argued that much could be achieved in the area of patenting DNA by raising the thresholds for patentability.
基于人类DNA序列的发明的保护主要通过专利制度的应用来实现。在过去十年中，关于这种知识产权的使用是否可接受一直存在持续的争论。在此期间，公司和大学积极提交了数千份专利申请。尽管许多人认为在专利中主张DNA序列就是主张一项发现，但专利法允许将有用的发现作为发明的一部分进行主张。随着分离DNA序列技术的进步，对于任何有资格提交申请的发明所必需的创造性标准，在涉及DNA序列主张的情况下变得越来越难以证明其合理性。此外，有人认为，发现一个基因与一种特定疾病相关是发现关于世界的一个事实，不应享有发明的地位。仔细审查允许将DNA序列作为研究工具授予专利的理由表明，这样的奖励很少有正当理由。然而，鉴于序列中的信息被用于生产一种具有药物用途的有形物质，将DNA序列作为制造治疗性蛋白质所需的化学中间体授予专利是合理的。尽管在应用现行法律的灵活性方面存在法律、技术和政治复杂性，但有人认为，通过提高可专利性的门槛，在DNA专利领域可以取得很大成就。
