Patenting and licensing in genetic testingRecommendations of the European Society of Human Genetics

The members of the Public and Professional Policy Committee (PPPC) and the Patenting and Licensing Committee (PLC) of ESHG who were involved in setting up these recommendations were Ségolène Aymé (Paris, France), Gert Matthijs (Leuven, Belgium), Violetta Anastasiadou (Nicosia, Cyprus), Fatmahan Atalar (Istanbul, Turkey), Suzanne Braga (Berne, Switzerland), John Burn (Newcastle upon Tyne, UK), Jean-Jacques Cassiman (Leuven, Belgium), Martina Cornel (Amsterdam, The Netherlands), Domenico Coviello (Milano, Italy), Gerry Evers-Kiebooms (Leuven, Belgium), Philippe Gorry (Bordeaux, France), Shirley Hodgson (London, UK), Helena Kääriäinen (Turku, Finland), György Kosztolányi (Pécs, Hungary), Ulf Kristoffersson (Lund, Sweden), Milan Macek Jr (Prague, Czech Republic), Christine Patch (London, UK), Jörg Schmidtke (Hannover, Germany), Jorge Sequeiros (Porto, Portugal), Dominique Stoppa-Lyonnet (Paris, France), Lisbeth Tranebjærg (Copenhagen, Denmark), Veronica van Heyningen (Edinburgh, UK) and Gert-Jan van Ommen (Leiden, The Netherlands). Patents for inventions can be beneficial for society, if they drive innovation and promote progress. In most areas, the patenting system works satisfactorily. However, it must be recognized that in some instances it can also be problematic; this is the case in the field of genetics, and particularly in the area of genetic testing. As patents should serve their original purpose (promoting innovation through a fair reward system for the inventors), the European Society of Human Genetics (ESHG) suggests ways to improve the mechanisms that already form part of the patents system as a whole. In brief, the ESHG recommends limiting the breadth of the claims in genetic patents and, more practically, to reduce the number of patents by limiting the patentable subject matter, thereby improving the quality of the patents that will eventually be granted. There is also a suggestion to redefine the concept of utility in patent law, by taking account of downstream clinical experience. The ESHG sees no harm in the patenting of novel technical tools for genetic testing (eg PCR or chip technologies), as they can promote investment and still allow for invention around them. Many disputes between supporters of the patenting system and the public revolve around ethical issues. The European Patent Office should consider the benefit of having an ethics committee to consider issues of major interest, such as patents applied to genes. The problem of licensing should also be addressed. Practically, this means supporting the Organisation for Economic Co-operation and Development guidelines, which prescribe that licences should be non-exclusive and easily obtainable, both in practical and in financial terms. To promote this, the practical exploration of alternative models for licensing, like patent pools and clearinghouses, is a prerequisite. To better track developments in this field, the establishment of a voluntary reporting system, whereby geneticists could report on any issues related to new and/or old patents or licences in the light of service provision to patients, would be worthwhile. Finally, the ESHG is calling upon all stakeholders to start the process of developing a code of conduct for partners with patents, covering ethical aspects as well as smooth licensing arrangements.