Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation

Timo Minssen Biotechnology, Intellectual Property, Pharmaceuticals, Timo Minssen

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.

ABSTRACT:  

In a unanimous judgment the US Supreme Court held in the 2013 Myriad gene patent case that patent claims directed to isolated genomic DNA are identical to the naturally occurring sequence and thus not patent eligible “products of nature”. It appears therefore that for a new biological composition of matter to be patent eligible, it must not be identical to the naturally occurring biological composition. This decision affects all isolated “products of nature”, including genes, gene fragments, and other naturally occurring nucleotide sequences, as well as naturally occurring amino acid sequences, including peptides, ligands, and proteins. Consequently, Myriad has a severe impact on many patent portfolios. Although Myriad does not directly affect the patentability of cDNA or sufficiently modified compounds, and the most recent USPTO guidance provides some hints on how the new eligibility standard can be met, it is still not entirely clear how much modification is required to render a molecule sufficiently distinct from naturally occurring counterparts. Moreover, when combined with the US Supreme Court decisions in Prometheus and Alice , Myriad may affect method claims which depend upon unmodified biological materials. The USPTO guidance, however, still leaves much uncertainty over the patentability of such methods and diagnostics. The substantial impact of these decisions on the biomedical sector and personalized medicine, as recently demonstrated by the 2015 CAFC decision in Ariosa v. Sequenom, as well the methodology used by the generalist Supreme Court in reversing a specialized CAFC judgment is particularly interesting from a comparative perspective. This paper analyses and discusses these U.S. developments, and compares them with the situation in Australia and in the EU.

Timo Minssen

Timo Minssen is Professor of Law at the University of Copenhagen (UCPH) and the Founder and Managing Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL). He is also affiliated with Lund University as a researcher in Quantum Law. His research concentrates on Intellectual Property, Competition & Regulatory Law with a special focus on new technologies in the pharma, life science & biotech sectors including biologics and biosimilars. His studies comprise a plethora of legal issues emerging in the lifecycle of biotechnological and medical products and processes - from the regulation of research and incentives for innovation to technology transfer and commercialization.

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