Diagnostic Kits/Analysing DNA patents in relation with diagnostic genetic testing
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Verbeure, B., Matthijs, G. & Van Overwalle, G., 2005. Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet, 14(1), 26-33. Available at: http://www.nature.com/ejhg/journal/v14/n1/full/5201503a.html [Accessed August 11, 2009].
- Verbeure, et al., 2005 - This pilot study provides empirical data about DNA patents by analyzing 11 selected hereditary disorders. The possible influence of patents and licensing strategies on the provision of clinical genetic testing services is explored and extends beyond many current reports which “to a large exten[t] focus on ownership and licensing practices and not necessarily on the patents and the scope of patent protection” (Verbeure, et al., 2005).
- The study develops two tools important to the further development of empirical data: search strategy and claim classification. Narrowing patent searches to patents involving diagnostic genetic testing is difficult. Because of the difficulty of searching, several initiatives created ‘subset patent databases’ such as the DNA Patent Database and the BiOS patent database. The search strategy used made use of multiple patent databases. The search strategy employed here involved a two step approach. First, a general search algorithm aimed to find all DNA-patents relating to genetic diagnostic testing. Second, a search for diagnostic DNA patents on a specific gene or hereditary disorder was carried out. The claim classification grouped claim types into three main groups. The classification scheme used could be a template for further research or discussion about the scope of genetic patents.
- The report concludes “continuous care should be taken to confer a justifiable scope of protection to gene patents” (Verbeure, et al., 2005). The report does not go as far as to conclude that patent and licensing strategies are interfering with clinical genetic testing services but that “due to the recent events, there is a strong feeling of breach of the implicit social contract comprised in the patenting system that needs to be addressed” (Verbeure, et al., 2005).