Patents for Human Genes and Methods of Analysis and Comparison

Law Quarterly Review, Vol. 126, 2010

Oxford Legal Studies Research Paper No. 41/2010

Posted: 10 May 2011 Last revised: 13 Jul 2013

See all articles by Justine Pila

Justine Pila

Professor of Law - University of Oxford

Date Written: May 1, 2010

Abstract

In AMP v USPTO, a US District Court held that isolated human cancer genes are “products of nature”, and methods of analysis and comparison abstract mental processes, for which a US patent cannot validly be granted. Its decision undermined US patent granting practices, and widens the gap between US and European law on what constitutes inherently patentable subject matter (inventions), as well as proportionate patent grants. It did so at a time when the scope of protection for DNA sequences is the focus of European attention, along with inherent patentability itself, following the decisions in Monsanto (ECJ) and G_3/08 (EBA). Here I consider AMP from the perspective of European law, which has long supported patents for isolated genes, and methods of comparison and analysis, consistent with an expansive understanding of the invention. A central issue in this regard is how isolated genes are properly conceived as inventions. According to Sweet DJ in AMP, a DNA sequence is a physical embodiment of information, fundamentally different from other chemical products. However, while this may be a scientifically accurate conception, it is not necessarily appropriate for patent law. In my suggestion there is a more appropriate conception informed by a different understanding of the invention itself. Nonetheless, it is argued that Sweet DJ’s analysis is preferable to that of the EPO, and that the central significance of AMP for European law lies in the encouragement it offers to the EPO (in combination with Monsanto) to formulate a more meaningful definition of the invention than currently exists. A copy of this case note is available from my institutional website.

Keywords: Patents, inventions, genes, biotechnology, Biotech Directive, AMP v. USPTO, EPC

Suggested Citation

Pila, Justine, Patents for Human Genes and Methods of Analysis and Comparison (May 1, 2010). Law Quarterly Review, Vol. 126, 2010 , Oxford Legal Studies Research Paper No. 41/2010, Available at SSRN: https://ssrn.com/abstract=1599366

Justine Pila (Contact Author)

Professor of Law - University of Oxford ( email )

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