SARS genome patent: symptom or disease?

In addition to straining public-health administrations, severe acute respiratory syndrome (SARS) is testing out the patent system. Recent news1Brickley P Preemptive SARS patents: U.S. and Canadian agencies say patents will preserve access. The Scientist, May 9, 2003.http://www.biomedcentral.com/news/20030509/02Google Scholar that researchers in the USA, Canada, and Hong Kong have applied for patents covering the SARS genome illustrates how the patent system is still not yet ready for the breakout of genomic patent claims. In particular, the news demonstrates that the patent system needs to be adjusted—not discarded—by governments to better reach the goal of that system: the attainment of the public good. It may seem odd that two non-profit organisations, the US Centers for Disease Control and Prevention (CDC) and the British Columbia Cancer Agency (BCCA), would bother patenting the SARS genome, because both want the genome to remain in the public domain, free to all researchers. As an alternative, these agencies could have published the genome, thus preventing others from being able to patent it. Instead they will eventually spend about US$10 000 per country to not only prevent others from patenting the genome but also to obtain the exclusive right to use and sell molecular forms of the genome. It is this fact, that publishing the genome is not sufficient, that points to the need to adjust the patent system. For there are good reasons why the CDC and the BCCA actually prefer the patent option. First, this option provides them with more leverage in dealing with the University of Hong Kong's Versitech Ltd, which has also applied for a patent. Second, and more importantly, publishing is not enough for the two agencies to prevent others from patenting the SARS genome given their goal of preserving the public domain. Even if nobody else could patent the genome, others could patent various uses of and products that interact with the SARS genome, thus removing these uses and products from the public domain. With a patent, the CDC and BCCA can indirectly control this activity, because they will be able to impose conditions—such as making these uses and products easily available—on anyone needing access to the genome in the course of their work. They thus can use the patent system to serve the public good.2Gold ER Merging business and ethics: new models for using biotechnological intellectual property in genetically modified foods.in: Castle D Ruse M Debating biotechnology. Prometheus Press, New York2002: 163-181Google Scholar One could argue that the CDC's and BCCA's use of the patents actually demonstrates that the patent system is working well. What this argument ignores is that, as genomic patents increase in number, it will become prohibitively expensive for public organisations to afford not only the expense of patenting genomes and DNA sequences, but also the significant costs of entering into licences and administering those licences. Expecting nonprofit organisations to obtain patents on all their genomic inventions is not a sustainable solution to maintaining an open and free public domain. The goal of the patent system is to serve the public good, here by not only encouraging biomedical research but also providing access to the results of that research.3Gold ER Making room: reintegrating basic research, health policy, and ethics into patent law.in: Caulfield TA Williams-Jones B The commercialization of genetic research: ethical, legal, and policy issues. Kluwer Academic/Plenum Publishers, New York1999: 63-78Crossref Google Scholar Giving exclusive rights to inventors is simply the means through which the system reaches this goal but is not the goal itself. Thus, if we keep our eye on the target of our efforts, we soon realise that the system as currently constructed fails to meet its own objectives. As the CDC's and BCCA's efforts illustrate, researchers are concerned that patents held in private hands will decrease research, particularly for the development of clinical applications such as genetic tests. Whilst empirical data are not yet conclusive,4Cho MK Illangaskekare S Weaver MA Leonard DGB Merz JF Effects of patents and licenses on the provision of clinical genetic testing services.JMolec Diagn. 2003; 5: 3-8Summary Full Text Full Text PDF PubMed Scopus (151) Google Scholar, 5Merz JF Kriss AG Leonard DGB Cho MK Diagnostic testing fails the test: the pitfalls of patents are illustrated by the case of haemochromatosis.Nature. 2002; 415: 577-579Crossref PubMed Scopus (110) Google Scholar, researchers are feeling threatened by the current system. Health-care administrators have also voiced concern that the patent system limits access to biomedical advances.6Ministry of Health and Long-term CareGovernment of OntarioCanada. Genetics, testing & gene patenting: charting new territory in healthcare. January, 2002.http://www.health.gov.on.ca/english/public/pub/ministry_reports/geneticsrep02/genetics.htmlGoogle Scholar, 7Gold ER Caulfield T Ray P Gene patents and the standard of care.CMAJ. 2002; 167: 256-257PubMed Google Scholar Whatever the empirical data eventually demonstrate, there is an emerging crisis of confidence in the patent system that is in itself serious. Several proposals have been made to adjust the patent system to better serve the public good. These proposals include the drafting of licensing guidelines to ensure access to genomic developments,8Organisation for Economic Co-operation and DevelopmentGenetic inventions, intellectual property rights and licensing practices: evidence and policies. OECD, Paris2002Google Scholar introducing compulsory licensing provisions,9Gold ER Biotechnology patents: strategies for meeting economic and ethical concerns.Nat Genet. 2002; 30: 359Crossref PubMed Scopus (8) Google Scholar better defining the experimental-use exception in countries without a clear exception (eg, the USA and Canada),9Gold ER Biotechnology patents: strategies for meeting economic and ethical concerns.Nat Genet. 2002; 30: 359Crossref PubMed Scopus (8) Google Scholar and introducing a morality clause linked to the manner in which genomic and genetic innovations are commercialised.10Gold ER, Caulfield TA. The moral tollbooth: a method that makes use of the patent system to address ethical concerns in biotechnology.Google Scholar It is unlikely that any one option will work alone. For example, industry will probably only follow licensing guidelines if governments make it clear that they are prepared to grant compulsory licences if these guidelines are not implemented. Fundamentally we must remember that the people who need to make these decisions are not the patent experts but the legislatures. Defining the public good is no more the role of patent agents or the courts than it is the role of air-traffic controllers to tell us where to go on holiday. In each case, the experts can tell us where it is safe to land, but cannot tell us where we want to land. Determining our goals and ensuring that they are met is why developed countries have opted for democratic governments. Let us use them.

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