Concerns about gene patenting

3.23 During the course of the Inquiry, the ALRC received 119 submissions in relation to gene patenting and conducted 73 targeted consultations with stakeholders, involving many hundreds of individuals. The submissions came from individuals, organisations and government departments spanning a wide range of interests.

3.24 A number of submissions expressed the view that the patent system works reasonably well across all fields of technology, including human genetics. On this view, if there are real or perceived problems with gene patents, these are no more than the expected consequence of applying an established and generalised patent system to a new field of human endeavour. From this standpoint, the problems of today will be viewed by the next generation in the same way we now view the problems produced by technologies of the previous generation. The broad conclusion of these submissions is that the patent system is robust and adaptable, and should be left alone—or, at most, adapted at the margins to address the limited problems that have been shown to exist.

3.25 At the other end of the spectrum were those who considered the patent system to be fundamentally flawed in its application to all technologies, with a consequent degradation in the quality and economic value of patents throughout the industrialised world. These concerns extended well beyond the Terms of Reference. Their principal criticism was the ‘functional redundancy’ of patents, which was said to arise because many granted patents plagiarise earlier ones, or because the only innovation is the use of alternative linguistic expressions to describe a previously patented invention.^[31] The problem was said to stem from the inadequacies in the examination process, combined with the incentive for patent offices to be overly generous in their grant of patents because their revenues depend on receipt of patent fees.

3.26 Between these extremes were the far more numerous submissions and consultations in which concerns were expressed about the patenting of genetic materials and technologies—ranging from mild dissatisfaction with particular arrangements, to strenuous objection to the way in which the patent system deals with genetic materials and technologies. These concerns are described and analysed in detail in later chapters of this Report. For present purposes it is sufficient to distinguish between two classes of criticism: those relating to the law or practice of patenting genetic materials and technologies; and those relating to the manner in which gene patents are exploited in the marketplace.

3.27 Submissions that criticised the patenting of genetic materials and technologies identified a broad range of concerns, including the following:

• Patent legislation fails to take sufficient account of ethical considerations, such as whether human genetic sequences are a proper subject matter for a statutory monopoly.

• Human genetic sequences should not be patentable because they are discoveries, not inventions. Alternatively, the level of inventiveness required to isolate and purify human genetic material is insufficient to justify the grant of a patent.

• Patents granted over genetic materials and technologies are often too broad, and are granted without proper evidence that the invention is useful.

• Patents over genetic materials and technologies are too easily granted in Australia, in comparison with overseas patent offices; and patent examiners should be more highly skilled in assessing applications in this field of biotechnology.

3.28 Many submissions directed their attention not to the patentability of genetic materials and technologies but to the manner in which a patent holder or its licensee exploits gene patents in the marketplace. Again, many different views were expressed, including the following:

• Restrictive licensing practices limit access to medical genetic testing, and compromise the quality of such testing, to the detriment of public health.

• Exploitation of the monopoly rights conferred by gene patents drives up the cost of medical genetic testing beyond a fair and equitable level, to the detriment of public health.

• Licensing practices restrict access to genetic materials and technologies for research purposes. Negotiating licences for a large number of related or overlapping gene patents is problematic due to the high transaction costs and the lack of expertise of many researchers.

• The use of gene patents for experimentation or research should be exempt from claims of patent infringement, so as to facilitate research, not hinder it.