Reform proposals in other jurisdictions

21.27 In those jurisdictions that exclude methods of medical treatment from patentability based on the interpretation of patentability criteria, the rationale for the exclusion is that the success of such treatments depends largely on the skill of the physician administering them.^[24] In patent law terms, this has been taken to mean that methods of medical treatment fail to meet the utility and related criteria for patentability of some jurisdictions.^[25]

21.28 The United States medical treatment defence also recognises the role of physicians in medical treatment. The intention of the provision has been said to be to ensure that physicians ‘performing life saving or health enhancing medical or surgical procedures are not inhibited by fear of lawsuits for patent infringement’.^[26]

21.29 The introduction of a medical treatment defence to address concerns about the impact of gene patents specifically has been considered in some jurisdictions. The focus has been on options for ensuring access by patients to patented genetic technologies and involves a broader conception of medical treatment, which includes in vitro diagnosis.

21.30 In Canada, the 2002 Ontario Government report, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare (Ontario Report), recommended that the current Canadian medical treatment exclusion be replaced with a medical treatment defence. The Ontario Report stated that adopting the United States approach, with an extension to cover diagnostic procedures, could address concerns about access to patented genetic technologies. It recommended an amendment to prevent patent holders from bringing an action for infringement against a medical practitioner for providing medical services (including treatment and diagnosis) to patients.^[27]

21.31 In 2002, a report by the Organisation for Economic Co-operation and Development noted suggestions that ‘clinical use’ exceptions should be enacted into national laws. The report observed that a difficulty with such an approach would be to ‘distinguish clinical use from commercial use’.^[28]

21.32 A 2003 report for the United Kingdom Department of Health referred to a ‘groundswell of opinion’ in countries that exclude methods of medical treatment from patentability that the exemption should be removed.^[29] It concluded that, if this were done in the United Kingdom, clinicians would require the benefit of a defence against infringement.^[30]