The Australian Senate Legal and Constitutional Affairs Legislation Committee recommended against the Patent Amendment (Human Genes and Biological Materials) which would have banned DNA patents in Australia. The push by members of the Australian Senate seemed to mirror efforts in the United States surrounding the Myriad case.
The Committee found that:
“While previous inquiries and public discussions have focused on the patenting of human genes, the Bill goes further and proposes a specific exclusion for biological materials which are identical or substantially identical to such materials ‘as they exist in nature’. The evidence received during the inquiry indicates that this exclusion is likely to have significant implications for a broad range of sectors and industries in Australia, including healthcare, pharmaceuticals, agriculture, food manufacturing and biotechnology. Extensive inquiries by the ALRC, the Senate Community Affairs Committee and ACIP have not revealed any persuasive evidence that would justify this type of broad exclusion from patentability for all biological materials.”
“There was no evidence received by the committee that patents on human genes or biological materials are systematically leading to adverse impacts in the provision of healthcare in Australia. Further, as a number of submissions and witnesses highlighted, the enactment of the Bill would not resolve the issue which focused public attention on the patenting of human genes in Australia in the first place: the claims of Genetic Technologies over BRCA1 and BRCA2 genetic testing.”
“The evidence the committee received suggests that the key measure proposed by the Bill, the exclusion from patentability of biological materials which exist in nature, would also have significant adverse consequences for healthcare in Australia. This could potentially include:
- long delays for Australian patients to access new diagnostic tests, medicines and treatments;
- reduced access for Australian patients to clinical trials; and
- a reduction in investment for medical research and development in Australia. “
“The evidence the committee received indicates that patents over human genes and biological materials have not hindered research, particularly medical research, in Australia. In contrast, there was clear evidence from submitters and witnesses that these patents have encouraged and contributed to research and development activities. Patents allow researchers to attract investment to pursue the development of new inventions and allow companies to mitigate the risks associated with developing costly new products, such as medicines.”
“In the view of the committee there is a clear risk that, without certainty in relation patent protection for biological materials, companies will have less incentive to develop and commercialise new products for the Australian market. This could negatively impact these companies, and their employees and shareholders, but also Australian industries and consumers who would lose access to these new products. Additionally, there is a risk that without clear patent protection for inventions related to biological materials, there will be less incentive for researchers to publicly disclose recently developed knowledge and inventions in this area. Other researchers would then be unable to utilise and build on this new knowledge in their own endeavours.”
“ In the view of the committee, the enactment of the Bill could breach Australia’s international obligations under the TRIPS Agreement and the AUSFTA to allow for the patenting of inventions in ‘all fields of technology’ without discrimination. While there is explicit scope in these international agreements for other relevant exceptions, such as to protect ordre public or morality and for human healthcare, the provisions of the Bill are not framed in these terms.”
A dissenting report was also filed.
BIO engaged on this issue by providing a submission to the Senate to review.