Pharmaceutical Innovation, Competition and Patent Law
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Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.
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Chapter 1: The patentability of genetic diagnostics in US law and policy

A Trilateral Perspective

Rochelle C. Dreyfuss


In the US, a confluence of developments has drawn attention to the issue of patents on diagnostics, particularly to patents involving genetic information used in the diagnosis of familial conditions. Foremost is the movement of patents into ‘upstream’ research. Arguably fuelled, in part, by universities’ attempts to derive economic value from their faculty’s research efforts, the notion of patenting fundamental technologies initially enjoyed a warm reception in (not surprisingly) the court that was established specifically to hear patent appeals and stabilize patent law – the United States Court of Appeals for the Federal Circuit. As a result of Federal Circuit decisions – in particular its decision in State Street Bank & Trust Co. v. Signature Financial Group, In – patenting proliferated, including in the medical field. Thus, there are now patent rights covering around 20 percent of the genes said to comprise the human genome. There is, of course, ample precedent for using patents as a mechanism for spurring research and commercialization. However, because rights in this sphere can cover advances fundamental to the biological sciences, they could very well frustrate society’s ability to fully benefit from genomics’ considerable promise to revolutionize healthcare and transform pharmaceutical research. Patents on genes and on associations between genes and hereditary conditions can raise the cost of, and interpose other obstacles to, accessing diagnostic services. These patents also create an ‘anticommons’ that could undermine the development and implementation of more efficient diagnostic and research technologies.

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