Forthcoming US publication on the patent eligibility of biotechnological processes, methods and products – Københavns Universitet

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25. september 2010

Forthcoming US publication on the patent eligibility of biotechnological processes, methods and products

The article "US Patent Eligibility in the wake of Bilski v. Kappos: Business as Usual in an Age of new Technologies?" (71 p.) by Ass. Prof. Timo Minssen (CIIR) & Robert M. Schwartz (US) will be published in Vol. 29, issue 6 (part I) and Vol. 30, issue 1 (part II) of the US journal "Biotechnology Law Report" (see: http://www.liebertonline.com/blr).

Abstract
The article discusses the recent U.S. Supreme Court decision in Bilski v. Kappos. While specifically applicable to the patentability of business methods, this seminal decision has consequences for determining patentable subject matter in various technologies. Focusing ultimately on Bilski's implications for the patentability of biopharmaceutical inventions, the paper first provides a chronological overview of the complex historical debate over patent eligibility under U.S. law. It is followed by a discussion of the outcome and impact of the rather restrictive CAFC decision in In re Bilski, now abrogated by the Supreme Court. Here a majority of the CAFC judges misinterpreted Supreme Court precedent to hold that the so-called "machine or transformation" test (MOT) is the universal and exclusive test for deciding patent eligibility for all process claims, implicitly including claims on biotechnological processes. Next, we analyze the Supreme Court decision rejecting this rigid application of the MOT test and permitting more flexibility in eligibility assessments. The analysis includes general considerations, as well as a discussion of the decision's specific implications for biotechnology. In that context we refer to most recent developments at the PTO and in the U.S. courts, including the pending CAFC decisions in Prometheus v. Mayo, Classen v. Biogen and AMP v. USPTO (concerning Myriad's BRCA claims). Acknowledging the criticism concerning overly broad patent claims and referring briefly to parallel developments in Europe, the paper finally highlights the effects of heightened thresholds for other patentability requirements. Considering those developments and realizing that it appears impossible to achieve static legal certainty in high-tech patenting without risking technological progress, we generally welcome the outcome in Bilski v. Kappos. Yet, it is also recognized that crucial questions remain unresolved and that lower courts are now tasked with articulating a coherent eligibility doctrine with plausible principles.

An unedited version of the entire article is also available on SSRN, see: http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=735221