Gene sequences are considered patentable, in principle, in proceedings before the European Patent Office (EPO), even if occurring in nature and/or are isolated from “nature.”  For example, isolated DNA coding for a BRCA1 polypeptide, found as not patent eligible by the US Supreme Court in its 2013 Molecular Pathology v. Myriad Genetics decision, based on the assumption that the isolated DNA sequence is a "product of nature," is patent eligible in Europe, in principle.         <br/>The principles for "gene sequence patenting" as currently applicable to proceedings before the EPO can be summarized as follows: The human body as such, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene as such, cannot constitute patentable inventions. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, as long as its industrial applicability i.e. functionality, is disclosed may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The rationale for allowing such patents, in principle, is that the element (e.g. a gene sequence) is the result of technical processes used to identify, purify and classify the element and to produce it outside the human body, i.e. "processes which human beings alone are capable of putting into practice and which nature is incapable of accomplishing itself" (EU Dir. 98/44/EC, recital 21). Ironically, this eloquent reasoning of the EU Directive echoes the "product of human ingenuity" language of Chief Justice Warren Burger in the 1980 US Supreme Court decision Diamond v. Chakrabarty, which was overturned by the Molecular Pathology v. Myriad Genetics decision.<br/>

"Human ingenuity" vs. "application of laws of nature": Patenting gene sequences in Europe

251st National Meeting (2016)

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