By Timo Minssen
With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods.
The claims at issue (see U.S. Patent No. 6,258,540 ) 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 much higher risk and maternal plasma was routinely discarded as waste.
In an earlier decision the district court ruled that the method claims were patent ineligible and an – apparently reluctant – Federal Circuit agreed in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015). Judge Linn, for example, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test” established in Mayo v. Prometheus requires a determination that the claims are patent ineligible.
Whereas it is clear that the patent eligibility thresholds have been heightened considerably since the U.S. Supreme Court decisions in Mayo, Myriad and Alice, I believe that a more holistic and balanced Diamond v. Diehr -like interpretation of these decisions should be possible and much welcomed. In my view, the mitigating effects of a systematically correct application of other patentability requirements, such as novelty, non-obviousness, utility and sufficient disclosure, would render overly restrictive patent eligibility approaches unnecessary and lead to more balanced results. Although there is little doubt that the US and European patent systems need to be re-calibrated and complementary incentives for innovation should be carefully considered in particular sectors, the patent system will presumably remain crucial for many areas of (biomedical) innovation. The very restrictive interpretation of patent eligibility in Ariosa swings the pendulum too far to the non-patent side. The current approach also contradicts longstanding decisions by the US Supreme Court and by lower federal courts. Moreover, it not only conflicts with current European approaches, but arguably also with international treaties. Although smart(er) claim drafting and am improved USPTO guidance might still help many inventors to avoid eligibility pitfalls even if Ariosa prevails, inventors would often have to rely on trade secrets, regulatory exclusivities, or other forms of protection and new business models. This would have a variety of consequences for technology transfer, open innovation and (public-private) collaborations . Hence, crucial issues are at stake, which may have a considerable impact on the development of – and access to – new therapies in increasingly important areas of medicine. From a European perspective, the dynamics and interplay of specialized jurisdiction with a generalist Supreme Court is also particularly interesting. Hence, this case provides a great forum for discussing challenges, alternatives and opportunities for both the U.S. and the global innovation system. In a rather recent paper we analyze the post-Myriad developments in the US and compare them to the situation in Europe and Australia. Please find further information below:
Title: Life after Myriad: The Uncertain Future of Patenting Biomedical Innovation & Personalized Medicine in an International Context.
Authors: Robert M. Schwartz & Timo Minssen, Universities of Lund and Copenhagen,
Journal: Intellectual Property Quarterly, Vol. 2015, Nr. 3, 08.2015, pp. 189-241.