The Federal Court has ruled it is legal for anyone to patent genes, provided they are “isolated”. There’s worrying consequences for healthcare, diagnostic practice and the the future of research, writes Anna George
A recent Federal Court case has determined it is legal for anyone — companies, hedge funds, individuals or institutions — to patent isolated gene sequences. The case specifically focused on the BRCA1 breast and ovarian cancer gene sequence. But the decision has implications for the patentability of all genetic resources in Australia.
It is legal in Australia to patent even unmodified, naturally occurring gene sequences that have been “isolated” — and as any gene scientist will tell you, the “isolation” technique is neither new nor inventive.
Does that mean the human genome can be patented? Figures from 2005 estimated that 20% of the human genome had already been patented — including genes associated with Alzheimer’s, epilepsy and hepatitis — and we are only at the beginning of this genetic revolution.
Health professionals and advocacy groups have been active in criticising this practice for several years, including through Senate inquiries, and are rightly alarmed with the outcome. How can the national interest and the public interest be served if this legal decision is allowed to define and influence healthcare, diagnostic practice, health costs and the future of research and innovation?
The challenge to the BRCA breast and ovarian gene patent is a path-breaking case. These deliberations deserve to be considered from the basis of first principles — a “discovery” is not patentable subject matter in Australia, and a “product of nature” is not considered patentable because humans did not invent it. Instead, this case was assessed against a 50-year-old National Resources Defence Council legal interpretation devised when the revolution in genetic technologies was unknown.
The magic words to look out for that legally transforms the “isolated” copy of the naturally occurring human DNA gene into “an invention” are justified by the argument that the “isolated” form involved “the creation of an artificial state of affairs”. Did you all get that?
Following a Senate inquiry into the patenting of gene sequences, eight MPs — including Greens, Liberals and independents — pushed for an amendment of the Patents Act 1990 to ensure that patents cannot be granted over biological materials that are identical or substantially identical to what exists in nature.
The bill failed to get the support of the Senate Legal and Constitutional Committee. The patent, biotech and pharma industries strongly argued against the bill. Curiously, universities and other scientific organisations also played a large part in blocking adoption. This article by Professor Peter Drahos of the Australian National University provides a very interesting and thought-provoking analysis of the role of some from the scientific community and universities in preserving patents over genetic resources that have not been modified.
The main argument put by the patent and biotech industries throughout these long, drawn-out inquiries is that there is no evidence of patents causing harm or blocking innovation. They also state innovation won’t happen without patents. But contradictory evidence is now trickling out.
Although a little late for our Senate inquiry, this new research reinforces the evidence given by the Federal Department of Health policy experts who directly challenged the view and policy rationale of IP Australia’s bureaucrats — a rare scene to behold.
All sides of Parliament need to examine and question the rationale that underpins the awarding of patents. They should also try to understand the policy co-ordination and governance failures within the bureaucracy and government advisory bodies that have allowed this to occur in the first instance. Politicians will recall the strong public support for Australia’s Pharmaceutical Benefits Scheme as being one of the few areas of public policy that transcend party politics — unimpeded access to unique genetic resources is an integral part of our health system.
*Anna George is a former Australian diplomat and multilateral negotiator with extensive experience in intellectual property cases