Academies voice concerns about gene patents legislation
The Australian Academy of Science (AAS) and the Australian Academy of Technological Sciences (ATSE) and Engineering have both expressed concerns that proposed changes to the gene patents legislation could stifle research and limit availability of effective new drugs for the treatment of diseases such as cancer.
In its submission to the Senate Inquiry into the Patent Amendment (Human Genes and Biological Materials) Bill, ATSE said the proposed amendment would not rectify the concerns of Senators expressed in the proposed Bill and would be likely to have the opposite effect.
ATSE contends that there would likely be several serious negative consequences if the Bill were passed, including:
- contravention of international agreements;
- inhibition of scientific research;
- loss of Australian competitive advantage;
- loss of investment;
- reduction in the quality of medical products and medical care available to the Australian community; and
- longer patent examination times and increased litigation.
ATSE recommended that the Senate reject the Bill and replace it with modifications to existing patent legislation that:
- establish the research use exemption for non-commercial research;
- tighten terminology so that Australian patent laws and examination practices are consistent with and as rigorous as those of our trading partners; and
- do not define additional categories for exclusion, since these would lead to legal arguments over terminology, delays and increased patenting costs.
ATSE also recommended that measures be initiated at IP Australia to ensure rigorous patent examination practices that limit claims to those which are truly inventive, novel and useful.
The President of the AAS, Professor Suzanne Cory, said that the proposed changes could stifle research and development for new diagnostic tests, therapies and vaccines, and therefore impact heavily on Australian people's access to new world-class treatments and tests.
'It would also prevent the patenting – and therefore the availability – of many of the new biological drugs that are already proving so successful in treating cancer and other diseases.'
The AAS believes the proposed amendments go too far. The definition of 'biological materials' in the Bill would prevent patenting any biological entity found in nature in any form. It would cover DNA, RNA, proteins such as insulin, cells, antibodies and vaccines, and fluids from any source, including plants, fungi, bacteria or viruses.
The Australian Academy of Science has urged Parliament to ensure that Australia's patent legislation does not lag behind that of other nations.
'This amendment would leave Australia with a very different set of criteria for patentability from most other countries,' Professor Cory said.