Waiting game with human gene patent law
By Jason Major
TechNyou
The Australian Senate’s, Community Affairs References Committee last week released its long-awaited report into gene patents, with a specific focus on the patenting of human genes.
The brief version
I have yet to read it in full (it’s 190 pages), but based on the executive summary it seems the committee has formed strong opinions, but stopped short of making explicit recommendations about whether the patenting of human genes should be allowed, or not.
Although the report states that it heard a number of cases where the provision of healthcare or the conduct of medical research in Australia has been impeded because of human gene patents, at this stage they claim the evidence did not show that gene patents are systematically leading to adverse effects in these areas.
They also state there is sufficient uncertainty remaining about the effect of human gene patents and so have recommended mechanisms such as monitoring and auditing functions be installed to improve the quality of the data and provide greater clarity on the issues. That is, they want more and better quality info before committing to any sort of firm recommendation.
Opinion versus recommendation
Although the committee didn’t get carried away with recommendations they occasionally got opinionated, and this is possibly more indicative of how the committee feels on a more personal level. One of their more strongly worded opinions relates to the concept of a human gene as an invention. A quote from the report: “The Committee strongly rejects the reasoning which says that, for the purposes of the Patents Act 1990 (the Act), genetic information that is ‘isolated’ from its naturally occurring state in the human body may be classed as an invention, and therefore properly be the subject of a patent (where the other requirements of patentability are satisfied).”
But they then go onto to say, “However, a number of considerations persuaded the Committee that it would not, at this point in time, recommend that the Act be amended to expressly prohibit the patenting of genes.”
Some of the committee’s reluctance to make specific recommendations for or against gene patenting comes from legal developments happening here and in the US.
In the USA, a legal challenge to the validity of two human breast cancer gene patents was recently decided in a US District Court and found that isolated genetic materials are not patentable. Should this decision be confirmed by a higher court on appeal, the finding will become binding on the practices of the United States Patent and Trademark Office (USPTO), and is expected to have implications for IP Australia.
Australia also has a similar challenge to the breast cancer (BRCA) gene patents happening in the Federal Court. If the court finds that isolated genetic materials are not
patentable, IP Australia will need to adjust its approach to gene patenting.
On top of this there is expected to be a Private Member’s bill introduced into Australian Federal Parliament that will attempt to amend the Human Genes and Biological Materials Bill 2010 and ultimately prevent the patenting of human genes and biological materials existing in nature.
So if there is a gene for patience, it would be worth gold at the moment, but possibly not for long. And the period of uncertainty will continue for those anxious Biotech CEOs
More info
Image: dna-structure.com