Nicol, Dianne --- "Editorial" [2012] JlLawInfoSci 16; (2012) 22(1) Journal of Law, Information and Science i

---

Editorial

I am delighted to be writing the editorial to this special edition of the Journal of Law, Information and Science on The Role of Law in DNA Patenting. I thank the general editor, Dr Brendan Gogarty for giving me the opportunity to invite leading academic scholars within Australia and internationally, as well as members of my own research team, to write on this important topic. This is the second special edition of the journal to be published in 2012. The first, Vehicles Unmanned, considered the legal implications of unmanned vehicles (or drones, in the vernacular). Both of these special editions are dedicated to informing public debate about the role of law in regulating and facilitating the development important scientific and technological innovations.

I would not have been able to put together this special edition without the willingness of my colleagues in Australia, Canada and the United States to participate. I am most grateful to them. I would also like to thank the reviewers for agreeing to peer review the manuscripts, and for the timely way they turned them around. Special thanks go to the publication team, especially the Managing Editor, Bruce Newey.

A précis article for this special edition was published in an earlier general edition of the journal: D Nicol, “Implications of DNA Patenting: Reviewing the Evidence” (2011) 21 Journal of Law, Information and Science 7-36. It was noted in that article that:

The patentability of DNA continues to capture the attention of lawyers, politicians, scientists, the popular press and the public alike. Many thousands of patents relating to DNA have been granted, and many tomes have been written on the desirability or otherwise of allowing this practice to continue. Yet here we are, apparently as far away from settling this issue as ever. In reflecting on the appropriateness of DNA patenting, it is necessary to consider whether the law is in need of reform. Is there a problem with DNA patenting and, if there is, can we leave it to the market to sort this problem out for itself? My argument in this article is that we must have some knowledge about how the market is dealing with DNA patenting: we need to explore the evidence. This article provides an historical account of the body of evidence that has emerged over the past decade or so on the consequences of allowing DNA patents, including recent work undertaken by myself and my research team focusing specifically on the Australian biotechnology industry. This article is intended to provide a reference point for a follow-on special issue of this journal: The Role of Law in DNA Patenting.

Each of the authors in this special edition was provided with a copy of that article and asked to provide an opinion piece, as an expert in the field, on issues associated with DNA patenting, with particular emphasis on the role of law. It was anticipated that each author would bring their own particular expertise and interest to their responses. Although they are all lawyers, each author has taken a very distinct disciplinary approach to the topic, with emphasis on: policy analysis, regulatory theory, statutory interpretation, best practice methodologies, black letter jurisprudential analysis, sociologic case study analysis and philosophy of science.

In the first article in this edition, Professor Rochelle Dreyfuss from New York University provides a compelling interpretation of the evidence presented in the précis article, and discusses further evidence, case law and policy developments relevant to the debates about the role of law in DNA patenting. While she has serious concerns about the deleterious impact of DNA patents in the research and clinical contexts in the US, she agrees that attention should move away from stripping genetic inventions of patent protection, shifting to alternative strategies for dealing with their adverse impact.

Chris Dent brings his interest in regulatory theory to bear in his article, which focuses on patent legislation as a regulatory instrument. He argues that there is incomplete understanding of the purposes and limitations of patent law. His central argument is that observing the patent system through a regulatory lens allows for the adoption of reforms that support an internally consistent view of the overall system, which will facilitate the better regulation of innovation. He concludes that the better regulation of inventors and commercialisers of inventions (including DNA) can only be achieved when the norms established by patent legislation are tied to the reasons for those norms.

Dianne Nicol and John Liddicoat use their training in science as well as law to analyse the feasibility of crafting an exclusion from patenting for DNA and other biological materials. They use a recent attempt in Australia to introduce such an exclusion as a case study to build their arguments around. Their central argument is that a more holistic approach is needed in relation to patent law reform, concluding that, at best, a statutory exclusion from patent eligibility will be a token improvement to the status quo and, at worst, it may actually cause greater detriment than benefit.

Ben Mee uses his experience as an associate to his Honour, Robert French, Chief Justice of the High Court of Australia, to analyse recent jurisprudence relevant to the patentability of DNA. He particularly focuses on the US Supreme Court decision in Mayo Collaborative Services v Prometheus Laboratories Inc on the patentability of methods of diagnosis. He is critical of the Supreme Court for introducing a threshold requirement that an invention “be disclosed” on the basis that it essentially introduces a preliminary inquiry into whether or not an inventive step exists. In his view this results in the replacement of an evidentiary and technical approach traditionally undertaken in a non-obviousness/inventive step analysis with a malleable, intuitive process. Mee queries the soundness of this approach based on precedent in the US context, and cautions against the adoption of such an approach in other jurisdictions.

Richard Gold and Andrew Baker change tack again, focusing on their particular interest in patent landscaping as a mechanism to provide evidence of the implications of patenting in biotechnology and other areas of technology. They recognise the crucial importance of an evidence base in resolving longstanding arguments over gene patents. They are critical of debates that have largely been conducted on the basis of assumption rather than on evidence, but emphasise that not just any evidence will do. Rather, they argue that evidence should be collected and analysed following standard practices in a transparent manner and with an acknowledgement of the limitations of the analysis. They conclude that while patent landscaping exercises conducted to date may not have met exacting standards, they provide the basis for harmonising methods in the future.

Tania Bubela writes with two scientists, a legal practitioner and an in-house counsel for the Jackson Laboratory, the leading supplier of biological materials for research use in North America. Their focus is on the development of new models for research and innovation in the life sciences, which emphasise collaboration and partnership between a variety of stakeholders, including academia, government, industry and non-governmental organisations. These new models are emerging despite (or perhaps because of) the increasing propertisation of basic science. They emphasise the centrality of the research commons in biomedical science. Their concern is that community norms, policies and guidelines must have adequate enforcement mechanisms to have the maximum desired effect.

Tim Caulfield argues for a change in focus of the debate away from patents and towards commercialisation of biomedical research. He presents a persuasive argument that many of the issues so often attributed to patents are just as likely the result of commercialisation pressure. He argues that we need more research on the impact of commercialisation on data sharing, collaborative activities and a range of other issues. Finally, he reminds that, as with patents, the impact of commercialisation on the research environment is likely complex and context dependent.

Finally, Matthew Rimmer uses a case study of the direct to consumer testing company 23andMe Inc to inform his analysis of DNA patenting. He argues that future reform of patent law, policy, and practice needs to take into account new developments in lifestyle genetics and personalised medicine — as exemplified by 23andMe. His main point is that there is a need for an integrated approach to lifestyle regulations and personalised medicine. While he endorses a holistic approach to patent law reform, he also emphasises the need to take into account bioethics and human rights, and health regulation.

I hope that you find this edition interesting and insightful and that it contributes to further academic and policy debate on the many thorny questions associated with DNA patenting.

Dianne Nicol