Fax +41 61 306 12 34 E-Mail karger@karger.ch www.karger.com Community Genet 2005;8:228–234 DOI: 10.1159/000087960 Balancing Innovation and Access to Healthcare through the Patent System – An Australian Perspective Dianne Nicol Centre for Law and Genetics, Law Faculty, University of Tasmania, Hobart, Australia Introduction The patent system is justified on the basis that it en- courages innovation, which is in the public interest. There is also public interest in consumer access to new developments in healthcare. These public interests will often be in harmony, because innovation ultimately leads to improved access. However, they may conflict if innovators are granted broad patents and choose to en- force them in ways that delay consumer access or exces- sively increase the cost of access. Gene patents may be particularly problematic both because they tend to in- clude broad claims and because they have a range of uses [1] . This article considers these issues from the Austra- lian perspective, with particular focus on the provision of clinical genetic testing services and diagnostics re- search. Australia has a strong biomedical research base, well-developed legal and healthcare systems and govern- ment support for the expansion of the medical biotech- nology industry, which is in common with the countries of North America, Europe and Japan. However, the in- dustry itself is less well developed than in most of those other countries, and hence, the focus of inquiry is some- what different. Key Words Patenting practices  Junk DNA  Diagnostic testing Abstract This article examines the enforcement of gene and other research tool patents in Australia. An empirical analysis of patenting practices in the Australian medical biotech- nology industry showed heightened concern about the impact of patents on research and diagnostic testing, but provided little evidence to support these concerns at that time. Since then, the Australian company Genetic Tech- nologies Ltd. has been enforcing its patents for non-cod- ing DNA sequences. The governments of Australia are encouraging the biotechnology industry to better protect and enforce intellectual property rights, but recognize these needs to be balanced against access to healthcare. The article discusses proposals made by the Australian Law Reform Commission to adjust the balance, both by tightening the requirements for obtaining patents and by introducing various options to assist providers of diag- nostic services and others in using patented inventions, but at the same time maintaining the incentive to inno- vate. Copyright © 2005 S. Karger AG, Basel Dianne Nicol Centre for Law and Genetics, Law Faculty, University of Tasmania Private Bag 89 Hobart, Tas. 7001 (Australia) Tel. +61 3 6226 7553, Fax +61 3 6226 7623, E-Mail Dianne.Nicol@utas.edu.au © 2005 S. Karger AG, Basel 1422–2795/05/0084–0228$22.00/0 Accessible online at: www.karger.com/cmg