Gene Patenting In Australia Essay

1671 words - 7 pages

Gene patenting: recent debate
Much of the debate around gene patenting in Australia has been prompted by the case of the BRCA genes. BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumour suppressors. Mutation of these genes has been linked to hereditary breast and ovarian cancer. Patents for these genes are held by Myriad Genetics, an American company, which has granted Genetic Technologies exclusive rights to BRCA1 and BRCA2 testing in Australia.
In 2002-3, and again in 2008, Genetic Technologies sought to enforce its rights in relation to the BRCA genes in Australia, including through demands that public hospitals and other laboratories cease to offer the tests. ...view middle of the document...

Legal/definitional issues
Much of the debate regarding gene patents is based on questions of whether isolated gene sequences are ‘discoveries’ or ‘inventions’. Many argue that they are discoveries, which are not patentable; while others argue that the ‘application of human ingenuity’ to a discovery could result in an ‘invention’ for the purposes of Australia's patent law. The ruling in the Cancer Voices Australia v Myriad Genetics Inc case was that they are patentable.

Ethical questions
Ethical questions also prompt strong debate. Many of those providing input to the various Senate inquiries indicated their strong opposition to gene patenting, on the basis that genes, as naturally occurring parts of the human body, should not be patentable.
In relation to the ethical questions, the position of IP Australia, is as outlined in the report of the Senate Inquiry into Gene Patents:
“IP Australia stressed that, given the requirements of patentability, human genes and genetic materials occurring in their natural state—that is, in the body—are not patentable. It stated that '[a patent is not granted]…over a human gene. It is [granted] over the isolated human gene sequence for which a practical use has been identified'.”
Further, IP Australia noted that the grant of a patent does not confer any right of ownership or control of an individual's genes:
“A patent over a gene sequence does not equate to ownership of that sequence. A patent is a right to restrain others from using or exploiting the claimed invention without the patentee's permission; it does not confer ownership of the physical material as it exists in the body. A patent on an isolated gene sequence does not impinge on the freedom of the individual to use their own DNA.” [1]

Access to healthcare
It is clear that access to healthcare could be affected if companies holding patents seek to prevent others from making use of the patented material. This was the issue that could have arisen in the case of the BRCA patents, had the company holding the patent not withdrawn its demands.
The Senate Community Affairs Committee Inquiry report found, in relation to access to healthcare:
“While the Committee heard of a number of cases where the provision of healthcare or the conduct of medical research in Australia has been impeded, the evidence did not show that gene patents are systematically leading to adverse impacts in these areas.” [2]
There is an argument that preventing gene patents would actually reduce access to healthcare, with some stakeholders arguing that guaranteeing a period of market exclusivity through the patent system was necessary to mitigate the risks for companies in investing in research and development and bringing new therapies to market. It is not clear whether the role of these incentives is exaggerated and whether other models for promoting innovation would be sufficient.
Many stakeholders have expressed concerns in the past that gene patents prevent research...

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