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首页> 外文期刊>Expert Review of Molecular Diagnostics >Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?
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Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?

机译：还有更多必要：基因和基因诊断测试是否是美国专利的法定主题？

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摘要

In a recent decision (AMP v. USPTO) from the US District Court, patent claims directed at DNA sequences corresponding to human genes and to diagnostic tests based on such genes have been found to be invalid, primarily on the basis that the DNA molecules claimed, which included cDNA, primers and probes, are 'products of nature' and are thus unpatentable. If upheld, this decision will have considerable impact on the ability of biotechnical companies and universities to patent the results of their research. In this article, we will explain the basis for this decision and discuss the appropriateness of patenting discoveries and their (obvious) uses in the light of this fascinating case. While our focus will primarily be on the product claims, diagnostic method claims were also revoked in AMP v. USPTO on the basis that they were for mental acts or did not involve any 'transformation of matter'. This will be discussed in the light of the recent US Supreme Court decision in Bilski v. Kappos, which focused on the patent-eligibility of process claims.
机译：在美国地方法院最近的一项判决（AMP诉USPTO）中，发现针对与人类基因相对应的DNA序列以及基于此类基因的诊断测试的专利主张无效，主要是基于要求保护的DNA分子包括cDNA，引物和探针的，是“自然产物”，因此不具有专利权。如果坚持下去，这一决定将对生物技术公司和大学对其研究结果申请专利的能力产生重大影响。在本文中，我们将根据这一引人入胜的案例，说明做出这一决定的基础，并讨论对发现专利及其（明显）用途进行专利申请的适当性。虽然我们的重点将主要放在产品声明上，但AMP诉USPTO也撤销了诊断方法声明，理由是它们是出于精神行为或不涉及任何“物质转换”。将根据美国最高法院最近在Bilski诉Kappos案中的裁决进行讨论，该裁决侧重于过程索赔的专利资格。

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