Patentability of genes: a European Union perspective.

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.