Analysing DNA patents in relation with diagnostic genetic testing.

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.