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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

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

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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