New publication in Queen Mary Journal of Intellectual Property – Københavns Universitet

20. februar 2012

New publication in Queen Mary Journal of Intellectual Property

Ass. Prof. Timo Minssen (CIIR) and LL.M. David Nilsson have written a four-partite article entitled "Standing on shaky ground- US patent-eligibility of isolated DNA and genetic diagnostics after AMP v. USPTO", which has been accepted for publication by the peer-reviewed Queen Mary Journal of Intellectual Property ( ). This study broadly analyzes the context, outcome and implications of the recent U.S. Federal Circuit decision in AMP v. USPTO, which was announced on July 29, 2011. The decision, which is also referred to as the ACLU/Myriad "gene patenting" case, partially overturned a much debated summary judgment by the District Court for the Southern District of New York, which had held unpatentable claims to isolated DNA per se, as well as claims directed to diagnostic methods relying on the claimed DNA, and processes for cell-based drug screening. 

Part I, which was published in Vol. 1, Issue 3, pp. 223-247 (October 2011), commenced with a description of the legal framework and an explanation of how the decision relates to the recently invigorated U.S. debate on patent eligibility, referring inter alia to the 2010 U.S. Supreme Court decision in Bilski v. Kappos and the pending certiorari in Prometheus v. Mayo (1). Before this background, Part I recited the complex procedural history of AMP v. USPTO (2) and summarized the underpinnings of the outcome, i.e. the three different opinions of the Federal Circuit judges Lourie, Moore & Bryson(3).

Part II, which will be published in Vol. 2, Issue 2 (April 2012), continues the tale with a detailed analysis of the decision's practical implications (4), which is followed by a closer look on the chances for an ultimate Supreme Court review (5).

Why a potential Supreme Court review of AMP v. USPTO would indeed be a much welcomed and necessary development is analyzed in Part III, which will be published in Vol. 2, Issue 3 (July 2012). This part elaborates on the myriad of unsolved questions raised by both AMP v. USPTO and a bulk of subsequent case law addressing the patent-eligibility of biological correlations and software-related "inventions" (6). A combined study of these subsequent decisions indicates a serious split at the Federal Circuit with potentially broad implications not only for the patent eligibility of software-related patent applications and so-called "Beauregard"- claims, but also for biotech-claims directed to personalized medicine, biological correlations and compounds containing biological information. This part also incorporates new developments to be expected in the coming months, such as the pending certiorari decision in AMP v. USPTO and the pending Supreme Court decision in Prometheus v. Mayo.

Part IV, which is to be published in Vol. 2, Issue 4 (October 2012), finally offers a broader discussion of the recent US patent-eligibility developments from an innovation policy perspective including brief references to recent European developments (7). This provides the basis for summarizing conclusions (8).