Diagnostic Kits/Genes and ingenuity: gene patenting and human health report

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Australian Law Reform Commission. Genes and ingenuity: gene patenting and human health report. (2004) pp. 678. Available at http://www.austlii.edu.au/au/other/alrc/publications/reports/99/index.html. Accessed 2010-03-08.

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61 Concerns about Gene Patenting

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.

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.

175 Approach to Reform - Working with the patents system

3.68 An important feature of the patent system is its long-term perspective of the role of monopoly rights in fostering innovation and delivering public benefit. For example, some people think that exclusive rights to exploit a particular genetic invention are not in the public interest because they prevent open access to a specific medical genetic test for a period of 20 years. Yet this consideration must be weighed against the role of patent rights in promoting the innovation and investment that led to the availability of the test in the first place. Research and development are not only costly, but time-consuming. Many therapeutic benefits are still to be realised from the genetics revolution that began in the 1970s, whose landmarks have been described above.

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