Separating Sheep from Goats: A European View on the Patent Eligibility of Biomedical Diagnostic Methods
Journal of Law and the Biosciences, Vol. 3, No. 2, pp. 365-372 (2016)
9 Pages Posted: 27 Jun 2019
Date Written: May 5, 2016
The Supreme Court’s decisions in Mayo, Myriad and Alice, as well as the CAFC’s in Roslin focused widespread attention on the formulation of patent-eligibility exclusions for specific biological material and diagnostic methods.
The debate recently intensified with the CAFC’s Sequenom decision and denial of a rehearing en banc. The claims at issue in U.S. Patent No. 6,258,540 (“US ’540 patent”) are directed to methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste.
A reluctant CAFC formulaically interpreted the Supreme Court-devised bifurcated test to identify patent ineligible subject matter and invalidated the patent for this ground-breaking method. Notably, Judge Linn wrote that this innovation deserves patent protection, but that the “sweeping language of the test” established in Mayo requires a determination that the claims are patent ineligible. On March 21, 2016 Sequenom Inc. filed for certiorari and the issue may once again find itself at the Supreme Court. As framed by Sequenom, the question presented is:
Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery?
Interestingly, in Europe the EPO upheld essentially the same claims. European equivalents of the patents considered in Myriad, Mayo, Alice and Roslin were also treated differently than in the US. Hence, these cases undermine the global integration of patent standards and provide fodder for discussing patentability requirements at an international level.
Referring to these developments, our paper discusses these issues from a comparative European perspective. Section 1 provides a very brief summary of the European patent framework and case law regarding medical diagnostic methods. Leaving aside national peculiarities that would exceed the limitations of this study we focus on the EPO’s patent eligibility approach vis-à-vis medical diagnostic methods similar to those in Sequenom v. Ariosa. Section 2 discusses our findings and the differences between the US and European approaches from a broader innovation and patent policy perspective providing the basis for concluding remarks in section 3.
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