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

The Association for Molecular Pathology v United States Patent and Trademark Office (AMP v USPTO), United States Court of Appeals, Federal Circuit (NY), 29 July 20111

Timo Minssen and David Nilsson

In AMP v USPTO the US Federal Circuit partially reversed a controversial district court decision on Myriad's BRCA patents, in holding that (1) product claims on ‘isolated DNA’ are patent-eligible under 35 USC § 101. The Federal Circuit also found that (2) the court erred in invalidating Myriad's method claims directed to ‘screening’ potential cancer drugs. At the same time, however, the Federal Circuit affirmed that (3) the court did have jurisdiction over the case and that (4) Myriad's method claims directed to ‘comparing or analyzing’ BRCA genes are invalid. With a 105-page-long split decision featuring contentious opinions by each member of the panel, further analysis is necessary to grasp the full impact of this judgment. At first glance the decision appears to be rather favorable to the bio-technological and pharmaceutical industry, but the judgment also contains elusive statements which could represent a serious threat to current patent practice. Consequently both parties filed (unsuccessful) petitions for a rehearing by the Federal Circuit panel. Requests for a rehearing en banc and/or petitions for certiorari to the Supreme Court will most likely follow. As long as the requirement for legal standing is met, the Supreme Court will probably grant certiorari.

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Timo Minssen and David Nilsson

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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Timo Minssen and David Nilsson

At first reading, the Federal Circuit's decision in AMP v USPTO, summarized in Part I of this four-partite 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 a 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.1 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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The US Supreme Court in Mayo v Prometheus – taking the fire from or to biotechnology and personalized medicine?

Supreme Court of the United States, Mayo Collaborative Services, dba Mayo Medical Laboratories, et al., Petitioners v Prometheus Laboratories, Inc., 132 S.Ct. 1289

Timo Minssen and David Nilsson

On 20 March 2012, the US Supreme Court handed down its much awaited patent-eligibility ruling in the dispute between Prometheus Laboratories Inc (‘Prometheus’), acting as plaintiffs, and Mayo Medical Laboratories (‘Mayo’), as alleged infringers of Prometheus' licensed patents.1 The decision addresses primarily the US patent-eligibility of diagnostic methods and dosage regimes, but it could ultimately also affect the patent-eligibility of isolated or purified biological and chemical compounds. This case review will first briefly describe the background to the case and the patents at issue (section 1), the procedural history (section 2), and the judgment of the Supreme Court (section 3). This is followed by a brief discussion of the decision's actual and potential implications for the patentability of biomedical methods and products including some comparative European views (section 4). The paper concludes with general remarks (section 5).

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Timo Minssen and Robert M Schwartz

In March 2011 the Supreme Court issued its Prometheus opinion and granted certiorari, and reversed and remanded Myriad I for consideration in light of Prometheus. In August 2012 the Myriad II decision was issued. The panel in Myriad II repeated most of their separate Myriad I opinions. Myriad déjà vu looked much like Myriad I with panel members agreeing that Prometheus did not control the composition of matter claims. The opinions differed on whether composition claims were to be analysed from a chemical, structural or carrier of information standpoint with respect to laws of nature. The rationales used such rhetorical metaphors as cleaving, baseball bats, magic microscopes, extracted kidneys, slabs of marble or marble statues, the Sistine Chapel, and whether cells were ‘transformed’ molecules or ‘carriers of information’. The differing evaluations of patent-eligibility and the cursory manner in which they addressed the Supreme Court's GVR mandate may well guarantee a return appearance before the Supreme Court or, at a minimum, en banc review by the Circuit.

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Timo Minssen and Robert M Schwartz

As discussed in the previous issues of QMJIP, the Federal Circuit's decisions in Myriad I 2 and II 3 appear to provide considerable prospects for patentees, as clever claim drafting may still help to avoid most patent-eligibility traps set by the much debated US Supreme Court decision in Prometheus.4 Yet, the split opinions also contain elusive reasoning by each of the three judges. The questions left open by Prometheus and the remaining split at the Federal Circuit with regard to inter alia DNA-related product claims provide excellent fodder for another US Supreme Court review with potentially broad implications for biotech patents. Acknowledging the criticism of excessively broad upstream patent claims and referring briefly to corresponding European debates, Part IV of this series finally discusses the recent developments from a broader innovation-policy perspective. Highlighting the mitigating effects of additional factors, such as higher thresholds for other patentability criteria, scientific advances, post-grant mechanisms 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 further clarifies its principles, the authors urge it not to categorically close the ‘patent-eligibility door’ to important emerging technologies.

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Olga Kokoulina and Timo Minssen

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Timo Minssen and Jakob B. Wested