Abstract

THIS ARTICLE DISCUSSES the recent US Supreme Court decision in Bilski v Kappos. Although 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, this paper first provides a broad chronological overview of the complex history of the judicial debate over patent eligibility under US law. It is followed by a brief discussion of the outcome and impact of the more restrictive Federal Circuit decision in In re Bilski, now abrogated by the Supreme Court. Here, a majority of the Federal Circuit judges misinterpreted Supreme Court precedent to hold that the machine-or-transformation (MOT) test was the universal and exclusive means for deciding patent eligibility for all process claims, implicitly including claims on biotechnological processes. Next, we carefully describe and analyze the Supreme Court decision rejecting this rigid application of the MOT test and allowing more flexibility in the eligibility assessment. The analysis includes general considerations, as well as a detailed discussion of the decision's potential implications for biotechnology inventions. In that context, we also refer to the most recent post-Bilski developments at the US Patent and Trademark Office (PTO) and in the US courts. Acknowledging the criticism concerning overly broad patent claims and referring briefly to parallel developments in Europe, this 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-technology patenting without risking technological progress, the authors generally welcome the Supreme Court decision. Yet it is also recognized that crucial questions remain unresolved and that lower courts are now tasked with articulating a reasonably coherent eligibility doctrine with identifiable and plausible principles.

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