Do patents impede the provision of genetic tests in Australia?Dianne Nicol A B and John Liddicoat A
A Law Faculty, University of Tasmania, Private Bag 89, Hobart, Tas. 7001, Australia.
B Corresponding author. Email: firstname.lastname@example.org
Australian Health Review 37(3) 281-285 http://dx.doi.org/10.1071/AH13029
Submitted: 8 February 2013 Accepted: 22 March 2013 Published: 24 May 2013
Objective. Health policy and law reform agencies lack a sound evidence base of the impacts of patents on innovation and access to healthcare to assist them in their deliberations. This paper reports the results of a survey of managers of Australian genetic testing laboratories that asked a series of questions relating to the tests they perform, whether they pay to access patented inventions and whether they have received notifications from patent holders about patents associated with particular tests.
Results. Some diagnostics facilities are exposed to patent costs, but they are all located in the private sector. No public hospitals reported paying licence fees or royalties beyond those included in the price of commercial test kits. Some respondents reported having received enforcement notices from patent holders, but almost all related to the widely known breast cancer-associated patents. Respondents were also asked for their views on the most effective mechanisms to protect their ability to provide genetic tests now and in the future. Going to the media, paying licence fees, ignoring patent rights and relying on the government to take action were widely seen as most effective. Litigation and applications for compulsory licences were seen as some of the least effective mechanisms.
Conclusion. These results provide an evidence base for development of health policy and law reform.
What is known about the topic? The impact of patents on the delivery of genetic testing services remains unclear in Australia.
What does this paper add? The survey reported in this paper suggests that, aside from well-known enforcement actions relating to the breast cancer associated patents, there is little evidence that providers of genetic testing services are being exposed to aggressive patent-enforcement practices.
What are the implications for practitioners? Although patent-enforcement actions may increase in the future, a range of strategies are available to providers of testing services to protect them against adverse consequences of such actions. There are ongoing law reform activities aimed at improving these strategies.
References Jensen K, Murray F. Intellectual property landscape of the human genome. Science 2005; 310 239–40.
| Intellectual property landscape of the human genome.CrossRef | 1:CAS:528:DC%2BD2MXhtFWksr7O&md5=49739200a0a92559f78b220efcbc5194CAS | 16224006PubMed |
 Holman CM. Will gene patents impede whole genome sequencing? Deconstructing the myth that 20% of the human genome is patented. IP Theory 2011; 2(1): Article 1.
 Huys I, Berthels N, Matthijs G, Van Overwalle G. Legal uncertainty in the area of genetic diagnostic testing. Nat Biotechnol 2009; 27 903–9.
| Legal uncertainty in the area of genetic diagnostic testing.CrossRef | 1:CAS:528:DC%2BD1MXht1CisLfJ&md5=601c08bd31e79e86f3de2719fa56ffdfCAS | 19816443PubMed |
 Gold ER, Carbone J. Myriad Genetics: in the eye of the policy storm. Genet Med 2010; 12 S39–70.
| Myriad Genetics: in the eye of the policy storm.CrossRef | 1:CAS:528:DC%2BC3cXkvVOnsLY%3D&md5=f4afa6dfad7856679b707f6f22594a83CAS | 20393310PubMed |
 Cho MK, Illangasekare S, Weaver MA, Leonard DGB, Merz JF. Effect of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn 2003; 5 3–8.
| Effect of patents and licenses on the provision of clinical genetic testing services.CrossRef | 12552073PubMed |
 Merz JF, Kriss DG, Leonard DGB, Cho MK. Diagnostic testing fails the test. Nature 2002; 415 577–9.
| Diagnostic testing fails the test.CrossRef | 1:CAS:528:DC%2BD38XhsVequrg%3D&md5=4780fb4384f000f01e7f3cbd28c742daCAS | 11832913PubMed |
 US Secretary’s Advisory Committee on Genetics. Health and society (SACGHS), gene patents and licensing practices and their impact on patient access to genetic tests. Washington DC: 2010. Available at http://oba.od.nih.gov/SACGHS/sacghs_documents.html#GHSDOC_011 [verified 15 April 2013]
 Cook-Deegan R, Conley JM, Evans JP, Vorhaus D. The next controversy in genetic testing: clinical data as trade secrets? Eur J Hum Genet 2012;
| The next controversy in genetic testing: clinical data as trade secrets?CrossRef | 23150081PubMed |
 Nicol D. Balancing innovation and access to healthcare through the patent system - an Australian perspective. Community Genet 2005; 8 228–34.
| Balancing innovation and access to healthcare through the patent system - an Australian perspective.CrossRef | 16244477PubMed |
 Gaisser S, Hopkins MM, Liddell K, Zika E, Ibarreta D. The phantom menace of gene patents. Nature 2009; 458 407–8.
| The phantom menace of gene patents.CrossRef | 1:CAS:528:DC%2BD1MXjs1Klsbs%3D&md5=d553291bb5c78fc13e134f59d333bc5aCAS | 19325609PubMed | 19325609PubMed |
 Hawkins N. The impact of human gene patents on genetic testing in the United Kingdom. Genet Med 2011; 13 320–4.
| The impact of human gene patents on genetic testing in the United Kingdom.CrossRef | 21150786PubMed | 21150786PubMed |
 Australian Senate Community Affairs Committee. Report on gene patents. Canberra: Parliament of Australia; 2010. Available at http://www.aph.gov.au/Parliamentary_Business/Committees/Senate_Committees?url=clac_ctte/completed_inquiries/2010-13/gene_patents_43/index.htm [Verified 15 April 2013]
 Berg JS, Khoury MJ, Evans JP. Deploying whole genome sequencing in clinical practice and public health: meeting the challenge one bin at a time. Genet Med 2011; 13 499–504.
| Deploying whole genome sequencing in clinical practice and public health: meeting the challenge one bin at a time.CrossRef | 21558861PubMed | 21558861PubMed |
 Price WN. Unblocked future: why gene patents won’t hinder whole genome sequencing and personalized medicine. Cardozo Law Rev 2012; 33 1601–31.
 Holman CM. Debunking the myth that whole-genome sequencing infringes thousands of gene patents. Nat Biotechnol 2012; 30 240–4.
| Debunking the myth that whole-genome sequencing infringes thousands of gene patents.CrossRef | 1:CAS:528:DC%2BC38XjtlOksrk%3D&md5=17ef511e03768b7c5fff884457100196CAS | 1:CAS:528:DC%2BC38XjtlOksrk%3D&md5=17ef511e03768b7c5fff884457100196CAS | 22398617PubMed | 22398617PubMed |
 Ridley A, Nicol D. Is there still a place for gene patents in Australia? Implications of recent US and European case law. J Law Med 2011; 19 282–99.
| 22320004PubMed |
| 22320004PubMed |
 Patent Amendment (Human Genes and Biological Materials) Bill 2010. Available at http://www.comlaw.gov.au/Details/C2011B00012 [Verified 18 April 2013]
 Australian Senate Legal and Constitutional Affairs Legislation Committee. Patent Amendment (Human Genes and Biological Materials) Bill 2010. Canberra; Parliament of Australia; 2011.
 Nicol D, Liddicoat J. Legislating to exclude gene patents: difficult and unhelpful or useful and feasible. J Law Inf Sci 2012; 22 32–54.
 Van Overwalle G, van Zimmeren E, Verbeure B, Matthijs G. Models for facilitating access to patents on genetic inventions. Nat Rev Genet 2006; 7 143–54.
| Models for facilitating access to patents on genetic inventions.CrossRef | 1:CAS:528:DC%2BD28XkvFOjtQ%3D%3D&md5=c1bdad8f545e63c6a7f7b35258f07679CAS | 16385347PubMed | 16385347PubMed |
 Productivity Commission. Compulsory licensing of patents, draft report. Canberra: Australian Government; 2012.
 Nicol D, Nielsen J. Patents and medical biotechnology: an empirical analysis of issues facing the Australian industry. Occasional Paper No. 6. Hobart: Centre for Law and Genetics; 2003.
 Nicol D, Nielsen J. Australian medical biotechnology: navigating a complex patent landscape. Eur Intellect Prop Rev 2005; 27 313–8.
 Australian Law Reform Commission. Genes and ingenuity: gene patenting and human health. Report 99. Canberra: Commonwealth of Australia; 2004. Available at http://www.austlii.edu.au/au/other/alrc/publications/reports/99/ [Verified 18 April 2013]
 Australian Government. Response to Senate Community Affairs References Committee gene patents report. Available at http://www.ipaustralia.gov.au/pdfs/Australian-Government-response-senate-committee-gene-patents-report.doc [Verified 18 April 2013]
 Smith S. Push for ban on gene patents. Lateline, 14 May 2012. Available at http://www.abc.net.au/lateline/content/2012/s3502732.htm [Verified 18 April 2013]
 Nielsen J, Nicol D. Whither patent use without authorisation in Australia. Fed Law Rev 2008; 36 333–64.