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Standing on shaky ground: US patent-eligibility of isolated DNA and genetic diagnostics after AMP v USPTO – Part II1

Timo Minssen and David Nilsson

Keywords: biotechnology; US; DNA; Myriad; patent-eligibility; personalized medicine; genetic diagnostics

At first reading, the Federal Circuit's decision in AMP v USPTO, summarized in Part I of this four-part paper, appears to favor the biotechnological and pharmaceutical industry. Its practical impact seems moderate because clever claim drafting helps to avoid most patent eligibility traps. Yet, the split decision also contains elusive reasoning by each of the three judges that provides excellent fodder for potential US Supreme Court review. Although legal standing requirements may block the road to ‘the nine’, a potential review and the pending certiorari in Prometheus could have broad implications for the future of individualized medicine and tailored drug-research. Acknowledging the criticism of excessively broad upstream patent claims, and referring briefly to similar European debates, this paper discusses the recent developments from a broader innovation-policy perspective. This includes consideration of additional factors, such as higher thresholds for patentability criteria, scientific advances and post-grant mechanisms. Highlighting the mitigating effects of such factors and the dynamic qualities of biomedical innovation, the authors note that overly static eligibility doctrines entail considerable risks for technological progress. While it is essential that the Supreme Court clarifies its principles, the authors urge it not to categorically close the ‘patent eligibility door’ to important emerging technologies.

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