Abstract
In the ongoing debate concerning DNA patents, there is a need for empirical data. We aim at creating this data set for DNA patents related to diagnostic genetic testing. To this end we developed two tools to facilitate this process. First, we set up a search strategy to find the relevant patents. Second, we provide a claim classification template to assist the user in the assessment of the subject matter covered by the patent claims and in creating a comprehensive overview of the patent situation within this field. These tools have been used in a pilot study on 11 selected hereditary disorders. In addition, a detailed analysis of the familial breast and ovarian cancer genes patents retrieved by the developed search strategy and their claim classification, after meticulous reading of the documents, allowed us to better describe the problems which medical geneticists and researchers might face when dealing with the patented technology.
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References
Collins FS, Green ED, Guttmacher AE, Guyer MS : A vision for the future of genomics research. Nature 2003; 422: 835–847.
Eisenberg RS : Why gene patenting controversy persists. Acad Med 2002; 77 (12): 1381–1387.
Rimmer M : Myriad Genetics: Patent Law and Genetic Testing. EIPR 2003; 25: 20–33.
Williams-Jones B : History of a Gene Patent: Tracing the Development and Application of Commercial BRCA-Testing. Health Law J 2002; 10: 123–146.
Walpole IR, Dawkins HJS, Sinden PD, O'Leary PC : Human gene patents: the possible impacts on genetic services healthcare. Med J Aus 2003; 179: 203–205.
Merz JF, Kriss AG, Leonard DGB, Cho MK : Diagnostic testing fails the test. Nature 2002; 415: 577–579.
Organisation for Economic Co-operation and Development (OECD): Genetic inventions, intellectual property rights and licensing practices: evidence and policies, 2002, http://www.oecd.org/dataoecd/42/21/2491084.pdf.
Nuffield council on Bioethics: The ethics of patenting DNA. A discussion Paper, 2002, www.nuffieldbioethics.com.
Nicol D : Gene Patents and access to genetic tests. Aus Health Law Bull 2003; 11: 73–77.
Straus J, Holzapfel H, Lindenmeir M : Empirical survey on ‘Genetic Inventions and Patent Law’; Munich. 2002 commissioned by the Federal Ministry of Education and Research, Germany.
Matthijs G, Halley D : European-wide opposition against the breast cancer gene patents. Eur J Hum Gen 2002; 10: 783–784.
Cho MK, Illangasekare S, Weaver MA, Leonard DGB, Merz JF : Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagnostics 2003; 5: 3–8.
Sevilla C, Moatti JP, Julian-Reynier C, Eisinger F, Stoppa-Lyonnet D, Bressac-de Paillerets SH : Testing for BRCA1 mutations: a cost-effectiveness analysis. Eur J Hum Gen 2002; 10: 599–606.
Paradise J, Andrews L, Holbrook T : Patents on human genes: an analysis of scope and claims. Science 2005; 307: 1566–1567.
Abbott A : Pressured staff ‘lose faith’ in patent quality. Nature 2004; 429: 493.
Abbott A : Clinicians win fight to overturn patent for breast-cancer gene. Nature 2004; 429: 329.
Abbott A : Europe pares down double patents on breast-cancer gene. Nature 2005; 433: 344.
Abbott A : Genetic patent singles out Jewish women. Nature 2005; 436: 12.
Dalpé R, Bouchard L, Houle AJ, Bédard L : Watching the race to find the breast cancer genes. Sci Technol Human Values 2003; 28: 187–216.
Acknowledgements
This research was supported by grant number G.0120.04 of the Fund for Scientific Research (FWO, Flanders, Belgium) and the Vancraesbeeck Fund (KULeuven, Belgium). Special thanks goes to Paul Vancraesbeeck (Senior advisor CIR) and William Bird (qualified British, German and European Patent and Trademark Attorney) for helpful discussions. We also thank Sjoerd Hoekstra and Olivier Lonnoy (European Patent Office, The Hague), and Nico Deconinck (Belgian Patent Office, Brussels).
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Verbeure, B., Matthijs, G. & Van Overwalle, G. Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet 14, 26–33 (2006). https://doi.org/10.1038/sj.ejhg.5201503
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DOI: https://doi.org/10.1038/sj.ejhg.5201503
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