Addressing the Effects of Genetic Material Patents on Diagnostic Testing in the Health Sector
Methods of Medical Treatment Exclusion
38. An exclusion from patentability for "diagnostic, therapeutic and surgical methods for the treatment of humans" has been agreed to by Cabinet (CAB Min (03) 25/4 refers). Internationally, courts and patent examiners apply a narrow, technical interpretation of this formula because it constitutes an exception. Thus diagnosis that takes place outside the body is treated as patentable (for example, a blood or genetic test). The Ontario report cites the fact that methods of medical treatment are not patentable in Canada and suggests that this exclusion be extended to the use of genetic materials in diagnosis. Under this approach, different diagnostic technologies themselves would still be patentable, but the simple use of patented genetic materials in diagnosis per se would not expose a clinician to liability for infringement of a patent.
39. However, the Nuffield Bioethics Council suggested that patents on diagnostic tests are unlikely to now occur and therefore should be the exception rather than the norm, providing that the criteria already in place within the patent system (such as inventiveness) are stringently applied.
Comment
40. Consideration could be given to expanding the methods of medical treatment exclusion in the Patents Act to exclude from patentability methods of diagnostic testing that are carried out outside the body. However, we tend to agree with the Nuffield Council that such patents should now be the exception rather than the norm and therefore we reiterate that the focus of further work should be on stringent application of the criteria rather than amending the methods of medical treatment exclusion in the Patents Act.
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