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2014 ; 5
(5
): a020891
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Patentability of genes: a European Union perspective
#MMPMID25324232
Cole P
Cold Spring Harb Perspect Med
2014[Oct]; 5
(5
): a020891
PMID25324232
show ga
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.
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