This month the Federal Court decided that private companies have the right to control human genes in an important test case. A sensible win for private investment in research or a scary corporatisation of our shared genes? Jane Lyons sequences the debate.
Q. What was the "breast-cancer gene" court case about?
A. Social justice law firm Maurice Blackburn, which launched the court case in 2010, has gone two rounds with US biotech behemoth Myriad Genetics to invalidate its Australian patent for a mutation of the BRCA1 gene. This gives the patent holder a monopoly over the breast and ovarian cancer gene itself as well as its diagnostic test.
It lost the first Federal Court round last year and copped another beating in the appeal this month. But while this case was ostensibly about one patent, both sides have had their eyes firmly on the bigger prize.
For Maurice Blackburn, the BRCA1 case tests the controversial practice of gene patenting, which has been happening in Australia since the 1990s and has never been legally challenged here.
The lawyers argue the practice is based on an invalid premise: that isolating a gene from the body makes it an "artificial state of affairs" and therefore an invention (which can be protected by a patent), rather than a discovery (which cannot).
Their problem with these patents? Monopolies, higher test costs for patients, the stifling of genetic research and the questionable ethics of a company owning the rights to our genes.
Over in the other corner, Myriad has been fighting not only for its future but also for the biotech industry, which has anxiously watched the outcome. Myriad's 20-year BRCA1 patent expires next August, but it has more gene-patent irons in the fire. It argues that the isolation and chemical modification of BRCA1 needed to analyse it in the laboratory makes it an innovation worthy of patent protection.
Interestingly, the company and its supporters share a key argument with their adversaries - the future of research. They argue that patents risk stifling genetic research – if they are overturned. Patents are the pied piper call for investors who are critical for taking research from lab to patient, they say.
Q. What did the full bench of the Federal Court decide?
A. The court decided the BRCA1 patent was A-OK under Australian patent law. It ruled that the structure and function of the gene made it different from the naturally occurring gene in the human body. It had therefore resulted in an "artificially created state of affairs for economic benefit", which met the patentability criteria of the Patents Act 1990.
Q. What will happen to costs and access to test for people with breast cancer?
Australian patients can now access the government-subsidised BRCA1 test through public laboratories here. In 2002 and 2008, Genetic Technologies tried to enforce its exclusive Australian licence for testing the BRCA1 gene – to the tune of $2100 a test - but backed down after a public furore.
Some question whether the ruling provides the incentive for the company to try again, while others raise the likelihood of Myriad suing for patent infringement back to 1995.
Q. What will happen to investment in genetic research and in medical patents?
A. For the pro-gene patent posse, the ruling goes to the heart of their rationale: it's a win for investment in genetic research.
Given a separate recent US decision against gene patents, some pundits suggest the Australian decision may sweeten the deal for US companies looking to commercialise their genetic research elsewhere and for investors looking for the next big breakthrough.
Whether the floodgates will open on gene patents is debatable: IP Australia, which oversees the regime, has previously reported gene patent applications in Australia peaked around the completion of the Human Genome Project in 2003. This reflects the global arena, where an estimated 16,000 gene patents now exist, although thousands more isolated genes remain unpatented.
However, there is concern over the broader patenting of other parts of human DNA, proteins and microbial genes. Some fear the decision could mean a renewed drive to patent more genes and biological products.
Q. Are there other areas of biomedicine and biotechnology that will change as a result of this decision?
A. Yes, cries the pro-posse, there will be more critical investment that will enable these important industries to grow, Australian biotechs to survive and research breakthroughs to reach the public.
A complete furphy, the anti-posse cries. They say patents will restrict biomedical research and the shiny promise of medicine "personalised" medicine. Much of this research focuses on the interplay of multiple genes. Negotiating access to single gene patents can often be a convoluted, unclear and expensive process for researchers. Dealing with multiple patents and multiple patent holders is likely to make this process even more of a research hindrance.
Q. How does the Australian court decision compare with other jurisdictions?
A. The Australian court decision has been particularly controversial given a US Supreme Court decision last year against Myriad and its BRCA1 and BRCA2 patents. The US court ruled genes extracted from the human body were not patentable, invalidating Myriad's two breast cancer gene patents and therefore all gene patents.
Q. Where to from here for the law in Australia?
A. Maurice Blackburn has come out swinging by lodging an appeal application with the High Court of Australia this week.
Meanwhile, political ire is stirring once again. Labor Federal Member for Fremantle, Melissa Parke, is stepping back into the ring after pushing for a private member's bill to disallow gene patents in 2012. She's looking to gather the troops again in both her party and across the floor. Liberal Senator Bill Heffernan, a past advocate for changing the law, says he would back any renewed effort to amend the Patents Act. The Cancer Council, a stalwart of the anti-gene patent campaign, will also continue to push for the change.
But other anti-gene patent campaigners are less hopeful, saying the Parliament is incapable of dealing with the matter. Two previous attempts at amendment bills have failed and two inquiries have maintained the status quo.
