Cole Paul
Bournemouth University, Bournemouth, Dorset BH12 5BB, United Kingdom; and Lucas & Co, Warlingham, Surrey CR6 9HJ, United Kingdom.
Cold Spring Harb Perspect Med. 2014 Oct 16;5(5):a020891. doi: 10.1101/cshperspect.a020891.
Unlike the position in the United States following the recent Supreme Court decision in Myriad, in the European Union naturally occurring genetic sequences, whether of human or other origin, remain patent-eligible. Here the basis for such eligibility in legislation and in case law is explained. The utility of a sequence must be disclosed as a condition of eligibility, and requirements outlined in European Patent Office (EPO) and U.K. case law are discussed. A claimed sequence must also satisfy requirements of novelty and inventive step, the latter being considered primarily using the tests of "obvious to try" and reasonable expectation of success. From both positive and negative examples the significance of an identifiable difficulty supported by documentary and/or experimental evidence is apparent. Issues of priority and subject matter added by amendment during prosecution of an application can create unexpected problems given the narrow interpretation within the EPO of the identity of a disclosed sequence, and these problems are explored using as an example an opposition to a European patent covering BRCA1 gene sequences. Practical steps for the drafting of patent specifications to be filed in Europe are outlined.
与美国最高法院最近在“麦利亚德案”（Myriad）后所处的立场不同，在欧盟，天然存在的基因序列，无论其来源是人类还是其他，仍然具备专利资格。本文将解释立法和判例法中此类资格的依据。作为资格条件，序列的实用性必须予以披露，并讨论欧洲专利局（EPO）和英国判例法中概述的要求。要求保护的序列还必须满足新颖性和创造性步骤的要求，后者主要通过“易于尝试”测试和成功的合理预期来考量。从正反两方面的例子来看，有文献和/或实验证据支持的可识别困难的重要性显而易见。鉴于欧洲专利局对所披露序列同一性的狭义解释，申请审查期间的优先权问题和修正后增加的主题可能会产生意想不到的问题，本文将以一项针对涵盖BRCA1基因序列的欧洲专利的异议为例探讨这些问题。概述了在欧洲提交专利说明书的实际步骤。
