THE PATENTABILITY OF LIVING ORGANISMS DEBATED AT UNESCO SYMPOSIUM

Paris, February 2 (No.2001-17) - More than 200 researchers, legal experts and representatives of national and international organizations took stock and exchanged points of view on the patentability of living organisms during the International Symposium Ethics, Intellectual Property and Genomics which took place at UNESCO Headquarters from January 30 to February 1.

This subject of growing importance because of its philosophical implications, its impact on the evolution of humanity and the economic stakes involved - was discussed by heads of patent offices, specialised lawyers, international law experts, as well as geneticists, members of UNESCO’s International Bioethics Committee (IBC), representatives of the World Intellectual Property Organization (WIPO) and of the Organisation for Economic Cooperation and Development (OECD).

While nobody questions the great interest of genetic research and the fact that it paves the way for medical progress, the patenting of gene or genetic sequences, particularly of the human genome, as well as the patenting of genetically modified animals and vegetable crops, raises ethical questions. As Bernard Edelman, Doctor at Law of the University of Paris I (France), argues, the debate reflects two opposing views of man and law: “Either we consider that some things are not tradable, animal species and human genes for example, for reasons connected to ethics or to [the sharing of] knowledge. Or, according to the opposite view, it can be considered that the living is a matter like any other and that it suffices for it to have been treated by human intervention, i.e. removed from its actual state, to be appropriated.”

The many presentations made during the Symposium demonstrated an increase in the private ownership of genes and of the genetic resources of populations, despite the reiteration of certain principles such as those of the Universal Declaration on the Human Genome and Human Rights of UNESCO which notably stipulates that the human genome is, in a symbolic sense, the “heritage of humanity”. Several speakers quoted Willy Rothley’s report which shows that already in 1997, there were more than 1,175 patents on the sequencing of human DNA. Elizabeth Longworth, a consultant from New Zealand, recalled: “Human Genome Organisation (HUGO) statistics have stated that there are at least three million patent applications pending. No doubt this statistic is already outdated.”

There is opposition to the economic speculation that largely characterizes the present situation. “Patenting is increasingly being seen as promoting gambling rather than enterprise”, in the words of Sandy Thomas, Director of the Nuffield Council on Bioethics (United Kingdom). This reaction - described by one participant as “humanist resistance” - upholds several principles: notably that of the non-commercialization of the human body, of free access to genetic data and knowledge-sharing, particularly between the countries of the North and South, and the principle of mandatory free and informed consent.

These contradictions are sometimes even reflected within legal texts. Thus, European Directive 98/44, which is expected to be incorporated into the national legislation of all European Union states but is now criticized by some EU members, stipulates: “The human body […] and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.” (Article 5 Paragraph 1). Yet the next paragraph states: “An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention even if the structure of that element is identical to that of a natural element.” As observed by the French patent lawyer, Jacques Warcoin, “genes don’t just turn up on every street corner”, the fact that they are not discovered by chance invalidates the impact of the first paragraph. It also opens the door to a new contradiction, since patent law in Europe does not consider natural elements to be patentable.

The debate at times became highly technical. Other criteria for patentability, such as usefulness and industrial application, were discussed as well as the distinction between a discovery and an invention, which is fundamental to European law but is non-existent in the United States where the concept of “manufacture” applies. There was ample discussion of the issue concerning the dependence between patents, namely the fact that the holder of a patent issued for the identification of a gene function becomes the “owner” of the gene, whose rights can impinge on those of a researcher who discovers another function for the same gene.

Several speakers expressed concern about the inequality regarding genetic knowledge, an inequality that is likely to increase because of the existence of numerous patents most of which are the property of laboratories and institutions in rich countries. The looting of genetic material, notably in Asia and Africa, was decried, as some rural populations provide, without really consenting to this, genetic resources from which others profit. The issue of access to health products was also raised and some pointed to the emergence of real monopolies (on tests indicating risk of breast cancer, for example).

Against the backdrop of privatisation through the extension of intellectual property rights - both geographically and to new objects - there are initiatives to produce public goods based on the genome and to limit the private appropriation of genes. In his summary of the debates, Maurice Cassier, sociology researcher at France’s National Centre for Scientific Research, CNRS, named several such undertakings by pharmaceutical companies, scientific organizations, (HUGO, the Bermuda Agreement) and regional organisations (model law of the Organization for African Unity on community rights and the control of access to biological resources) and stressed the appearance of “a process of regulation which allows for possible adjustments, adaptation and innovation”.

As IBC Chairperson Ryuichi Ida declared at the close of the Symposium, the event was bound to be simply one stage, destined not to legislate but to help bring divergent points of view closer together. “This stage was valuable and successful,” he said. Promising ideas to be explored were discussed, including reach through licenses and the creation of a fund - to be financed by part of the profits of the private and public sectors from human genome data - to pay for research and dissemination of knowledge around the world. The IBC intends to pursue these ideas further.

 

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