Re-Examining the Role of Patents in Appropriating the Value of DNA Sequences

As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence and function, with due regard to the interests of the scientific community and the broader public

DNA Sequences as Unpatentable Subject Matter

Man has played no part in creating DNA. It is nature which created and perfected DNA over thousands of years of evolution. What required man’s ingenuity was isolating, purifying, and sequencing the DNA. These inventions deserve patent protection. After uncovering nature’s handiwork, man then used his ingenuity and nature’s DNA sequences to develop new inventions such as genetically modified micro-organisms. These inventions also deserve patent protection. What is not worthy of patent protection is the DNA sequence itself. These were created by nature and merely uncovered by man. DNA sequences should not be patented because in the words of Funk Brothers they are “free to all men and reserved exclusively to noneâ€

Why It Is Time to Eliminate Genomic Patents, Together with Natural Extracts Doctrine That Have Supported Such Patents

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as drugs, represent codification of old, outdated science, by allowing genes to be patented. While this paper does not give a whole scale solution regarding the policies that best incentivize biotechnological innovations, it does show how the natural extracts doctrine and the genetic patents it has spawned can impede innovations in the biotechnological context. It ends by offering a glimpse of how eliminating the natural extracts doctrine can remove not only some of unnecessary wrinkles in current patent law but more importantly the many current and future patent shackles to biotechnological innovations

Genomic stuff: Governing the (im)matter of life

Emphasizing the context of what has often been referred to as “scarce natural resources”, in particular forests, meadows, and fishing stocks, Elinor Ostrom’s important work Governing the commons (1990) presents an institutional framework for discussing the development and use of collective action with respect to environmental problems. In this article we discuss extensions of Ostrom’s approach to genes and genomes and explore its limits and usefulness. With the new genetics, we suggest, the biological gaze has not only been turned inward to the management and mining of the human body, also the very notion of the “biological” has been destabilized. This shift and destabilization, we argue, which is the result of human refashioning and appropriation of “life itself”, raises important questions about the relevance and applicability of Ostrom’s institutional framework in the context of what we call “genomic stuff”, genomic material, data, and information

How Did the Gene Become a Chemical Compound? The Ontology of the Gene and the Patenting of DNA

International audienceThe ability to patent is bounded by a set of conditions that define what is patentable and what is not. In the 1980s, the problem of the patentability of genes was solved by the use of an analogy between genes and chemical compounds. In this article we analyze the process of the reduction of the gene to a chemical compound, and show how this analogy made the practice of gene patenting routine long before it came to public attention. When we did eventually see public controversies surrounding gene patenting in the 1990s, the chemical analogy allowed patent offices in the US and Europe to 'close down' these debates by presenting the issues as merely technical

From Protecting Texts to Protecting Objects in Biotechnology and Software:A Tale of Changes of Ontological Assumptions in Intellectual Property Protection

International audienceBoth software and agricultural inventions have recently become patentable. Previously, software was protected by copyright, while agricultural inventions were protected by plant breeders' rights. Here we argue that legislation on intellectual property is shaped by ontological considerations (i.e. ideas about the object to be protected), and we propose that the introduction of patenting in software and biotechnology marks a change from protecting a text to protecting an object. However, this change rests on outdated assumptions about the relationship between structures and functions in both fields. Such an ontological perspective gives us a deeper understanding of recent transformations in intellectual property regimes

Innovation, technical change and patents in the development process: A long term view

An essential aspect of catching up by developing countries is the emulation of technological leaders and the rapid accumulation by individuals and organizations of the knowledge and capabilities needed in order to sustain processes of technical learning. The rates and patterns of development of such capabilities are fundamentally shaped by the opportunities that indigenous organizations have to enter and operate in particular markets and technology areas. However, knowledge accumulation is also influenced by the governance of intellectual property rights (IPRs). The purpose of this work - prepared for a volume of the Initiative for Policy Dialogue, Columbia University, Intellectual and Property Rights Taskforce - is to offer an assessment of such influences in the long term, beginning with the early episodes of industrialization all the way to the present regime. The historical record is indeed quite diverse and variegated. However if there is a robust historical fact, it is the laxity or sheer absence of intellectual property rights in nearly all instances of successful catching up. We begin by reviewing a few theoretical arguments that economists have formulated on the effects of a system of patent protection. We will then review the historical evidence on the roles of patents in economic development. Next we discuss the changes in the IPR regime that have taken place roughly over the last third of a century in the United States. The reason for focusing on the United States is that doing so will outline the broad template of patent policy reform that has been adopted by policy makers in many other countries as a result of a varying mix of external pressures, myopia, corruption and ideological blindness. The final part of this essay, explores the likely impact of harmonization of international patent laws - including TRIPS - on developing countries

Defensive Publishing An Empirical Study

Defensive Publishing denotes publication of an invention with the purpose of creating prior art, and thus preventing patents being granted on this invention. Although widely employed, it has hardly been investigated empirically. Our study is based on 56 in-depth interviews, among others with most industrial firms in the German DAX 30 stock index. We find that 70 percent of the companies in our sample use defensive publications, for up to one third of their inventions. Interestingly, we find that the patent system itself is frequently used for defensive publishing. Our findings also challenge contributions connecting defensive publishing to patent races.Defensive publication, Intellectual property, Freedom to operate, Patens

The role of the research sector in ABS governance

The aims of this paper are to examine the renewed role of the academic sector in the innovation chain, starting from traditional knowledge and wild genetic resources and ending with a final product marketed by bio-industries; to identify changes in the institutional framework in which scientists carry out their task; and to reorganize their interactions with the holders of traditional knowledge (TK) and genetic resources (GR). In the first part, we describe the role of scientists and the changing institutional environment in which they work. In the second part, we examine examples of institutional solutions set up by scientists to cope with this new institutional environment and to come to terms with their responsibility as an interface between different actors with different norms of behavior. (Résumé d'auteur