The next Australian government can show global leadership and build on a US legal precedent by amending the Patents Act to exclude human genetic material from patentable subject matter, thus protecting the public interest from commercial monopolisation that occurs because of an outdated system.
The Australian Senate has twice extended the reporting deadline for its inquiry into gene patents, reflecting the perceived complexities of the issue. But the principle for reform – and the recommended process – is straightforward: human genetic material is not an invention and should not be patented. And a simple amendment to the Patents Act 1990 would protect the public interest from commercial gene monopolies.
Cancer Council Australia and the Clinical Oncological Society of Australia uphold the principle that the patent system should reward innovation in medical science. But applying 17th century patent laws to the discovery of human genetic material that requires no inventive step is a serious threat to competitive cancer research and the future of genetic testing, particularly as the technology evolves.
A commercial demand in 2008 for public laboratories to cease testing for familial risk of breast and ovarian cancers because the human BRCA1 and BRCA2 gene mutations were patented was just the tip of the iceberg. While the company’s subsequent withdrawal of its demand saw the issue abate in the public arena, corporate monopolisation of human genetic material is set to become a continuing legal quagmire, restricting research and access to diagnostic services – unless patent law is changed now, before the use of genetics for predicting and treating cancer becomes commonplace.
As the technology rapidly progresses, the need for law reform becomes increasingly urgent. The application of outdated patent law has already hindered healthcare and medical research in Australia, with examples (as well as BRCA1 and BRCA2) including:
- monopolisation of erythropoietin medicines and related biological materials, which increased healthcare costs in Australia and could have impeded competitive research into new medicines;
- a patent monopoly over purified hepatitis C polynucleotide and polypeptides, preventing anyone but the patent holder (a US company) from developing or supplying these materials between 1988 and 2008. This resulted in laboratories, including blood banks, relying on an inferior test during the period; and
- corporate ownership of the human genetic materials that encode proteins linked to a severe form of epilepsy, resulting in restrictions to diagnostic testing. The patent remains in force until 2024.(1)
Nothing in the current legal framework could prevent these and other abuses of the patents system – just as the demand for public laboratories to cease testing for breast and ovarian cancers in 2008 was withdrawn voluntarily after widespread negative media rather than through any legal mechanism to protect the public interest.
Problems with current patent law were identified in 2004 by the Australian Law Commission,(2) yet governments have declined to act despite subsequent recommendations from the non-commercial clinical community and the threats to public testing laboratories in 2008.
A ruling in March 2010 by the US district court of Southern New York (3) provides an international precedent that should guide legal reform in Australia, particularly because the decision was based on the principle that biological materials in purified form are discoveries, not inventions.
The evidence overwhelmingly supports the need for legal reform.(1)
Commercial opponents of legislative change claim that investment in medical research is dependent on gene patents. However, as the vast majority of independent cancer clinicians and researchers have advised the Senate, patenting genes in effect restricts innovation by locking up the building blocks for competitive research.(1)
The next Australian government can show global leadership by committing to a much-needed review of gene patent law to protect the public interest from exploitation of an outdated system.
References
1. Evidence tendered to the current Senate inquiry into gene patents.
2. Australian Law Reform Commission, Genes and ingenuity, report of a review of gene patenting law, 2004.
3. American Civil Liberties Union versus Myriad Genetics, US District Court for the Southern District of New York, March 2010.