An historical and contemporaneous analysis of patenting of methods of medical treatment of human beings in Australia and overseas

This thesis makes an historical and contemporaneous analysis of patenting of methods of medical treatment of human beings in Australia and other common law jurisdictions that derived their origin from the UK law. The issue of patenting of methods of medical treatment has never been an easy question to discuss for it raises public policy considerations surrounding this area. The main difficulty derives from the conflict between the intellectual property and practice of medicine. There is a public policy concern that in order to ensure the best possible health treatment, physicians must always be free in their choice of treatment. Since a patent may restrict this freedom, many countries around the globe prohibit methods of medical treatment from being granted patent protection. Yet, Australian courts decided to depart from those exclusions. This thesis examines how courts deal with express exclusions of patents for method of medical treatment and how such exclusions can be avoided by creative drafting of patent specifications. It will also examine the approach taken in Australia where there are no express exclusions. It first provides the descriptive background of the case law in UK, Member States of the European Patent Convention, Canada, Israel, New Zealand, US and Australia in order to make a comparative analysis of the approaches adopted in these countries in dealing with the issue, and in order to establish the framework around which the doctrinal issues can be analysed. Against this background an examination of the origins of the patent law is necessary in order to fully assess the interpretation of patent legislation by courts and consequences of such interpretation for medical profession. The thesis investigates the pre-enacting history of the 1624 Statute of Monopolies in order to analyse whether patenting of methods of medical treatment of human beings is 'generally inconvenient' within the meaning of the proviso to s 6 of the Statute of Monopolies, which in turn, form a part of s 18 (1) of the Patents Act 1990 (Cth). The analysis of early patent law cases at the time they were argued and decided will lead to the conclusion that the actual original meaning of the term 'generally inconvenient' has been wrongly interpreted and applied by modern courts. The thesis considers the role of the courts in deciding whether methods of medical treatment should be granted patent protection and whether judges should and/or have ability to make moral or public policy judgments in interpreting statutes. The thesis explore the consequences of interpretation of 'generally inconvenient' as a main public policy objection to granting patents for methods of medical treatment. It concludes that it is questionable whether the term 'generally inconvenient' includes public policy considerations in its scope, and though there may be some circumstances where a patent to method of medical treatment should be rejected on public policy grounds, 'generally inconvenient' does not provide a basis upon which patents to methods of medical treatment can be denied. The thesis is that such methods should not be expressly excluded from patenting. Each method must be treated equally with other inventions and examined on its merits, on case by case basis. The tensions associated with patents for methods of medical treatment can be resolved within patent legislation by making the public policy ground for objection a separate criterion for patentability, equally relevant for any invention. Accordingly, the author argues that legislative amendments are necessary to rectify the existing problem and makes a number of proposals to this effect. The author also suggests the involvement of an independent body to make public policy decisions.