The patent system has been seen as a critical factor driving innovation in clinical medicine, particularly in medical devices and diagnostic assays.
The licence terms and business model proposed by Myriad Genetics Inc. for testing the hereditary breast cancer susceptibility genes BRCA1 and BRCA2 could stifle innovation (particularly if other companies adopt similar business models), and are likely to limit the ability to provide high quality public genetic testing services in Australia.
Under the Myriad model, testing for the BRCA1 gene would be undertaken by an organisation removed from the integrated public healthcare system. Based on overseas experience, Australia can expect a 2–3-fold increase in the cost of this testing, which will provide only partial information on the hereditary breast cancer status of the patient.
Commercial exploitation of gene patents needs to be regulated to balance the patent holders’ right to profit from their inventions (necessary to drive further innovation) and the public policy objective of high quality, equitable healthcare.
- 1. Patenting life. The primary patents. Guardian (UK) 2000; 15 Nov. Available at: www.guardian.co.uk/genes/article/0,2763,397403,00.html (accessed Jun 2003).
- 2. Andrews L. Genes and patent policy: rethinking intellectual property rights. Nat Rev Genet 2002; 3: 803-808.
- 3. Merz J. Disease gene patents: overcoming unethical constraints on clinical laboratory medicine. Clin Chem 1999; 45: 324-330.
- 4. Miller F, Hurley J, Morgan S, et al. Predictive genetic tests and healthcare costs: final report prepared for the Ontario Ministry of Health and Long Term Care. Ontario: The Ministry, 2002. Available at: www.health.gov.on.ca/english/public/pub/ministry_reports/geneticsrep02/chepa.html (accessed Jun 2003).
- 5. Benowitz S. French challenge to BRCA1 patent underlies European discontent. J Natl Cancer Inst 2002; 94: 80-81.
- 6. Heller M, Eisenberg R. Can patents deter innovation? The anticommons in biomedical research. Science 1998; 280: 698-701.
- 7. Rimmer M. Myriad Genetics: patent law and genetic testing. Eur Intellect Prop Rev 2003; 25: 20-33.
- 8. Borger J. Rush to patent genes stalls cures for disease. Guardian (UK) 1999; 15 Dec. Available at: www.guardian.co.uk/genes/article/0,2763,191864,00.html (accessed Jun 2003).
- 9. Patenting genes — stifling research and jeopardising healthcare. Econexus and GeneWatch UK, 2001. Available at: www.genewatch.org/Patenting/briefs.htm (accessed Jun 2003).
- 10. Reynolds R, Stoianoff N. Intellectual property text and essential cases. Sydney: Federation Press, 2003: 5-6.
- 11. Dierker DA, Phillips PWB. The search for the holy grail? Maximizing social welfare under Canadian biotechnology patent policy. IP Strategy Today 2003; (6): 45-62. Available at: biodevelopments.org/ip/index.htm (accessed Jun 2003).
- 12. Bounpheng M, McGrath S, Macias D, et al. Rapid inexpensive scanning for all possible BRCA1 and BRCA2 gene sequence variants in a single assay: implications for genetic testing. J Med Genet 2003; 40: e33. Available at: jmg.bmjjournals.com/cgi/content/full/40/4/e33 (accessed Jun 2003).
Publication of your online response is subject to the Medical Journal of Australia's editorial discretion. You will be notified by email within five working days should your response be accepted.