The issue of ‘gene patents’ has been a hot topic of late, and has recently resurfaced in the news as a result of Angelina Jolie having a double mastectomy. However, having been a scientific researcher working on technologies which predominantly benefit children in underdeveloped countries, and now being a patent attorney in private practice, I genuinely believe that much of the angst directed at patents and the legal profession is misdirected.
It appears Ms Jolie used the genetic test patented by Myriad Genetics before opting for surgery. For some, the financial cost of having the patented test performed is out of reach, so it is understandable why the public see ‘gene patents’ as an obstacle to providing cheap and accessible healthcare. But are ‘gene patents’ really an obstacle? Lost in the discussions (and court cases) is the importance of patents in the process of bringing life-saving technologies from the lab bench to the market.
Would there be test for breast and ovarian cancers without gene patents?
The driver for writing this article actually began late one evening when I was driving and listening to late night talkback on the radio. The topic of discussion was ‘gene patenting’. A panel was discussing the recent decision of the Federal Court in Cancer Voices Australia v Myriad Genetics Inc confirming the patentability of gene sequences in Australia. The discussion then turned to the merits of having ‘gene patents’. At some point, Rebecca Gilsenan, a panellist and principal lawyer representing Cancer Voices Australia stated that, in her opinion, biological matter should not be patentable. Ms Gilsenan also stated that public funding should not be used to support privatisation of healthcare. The remaining panellists seemed agreeable to these points.
To me, Ms Gilsenan’s comments were alarming and unrealistic. Having been an academic researcher with a background in molecular biology and vaccine development, but now being a patent attorney, I am one of few who have a unique perspective on the issue. During my time as post doctoral researcher in the US working at the University of Maryland, I helped develop vaccines (comprising gene sequences) targeting diseases prominent in underdeveloped countries, particularly in children. Patenting was given equal if not greater importance to publishing in scientific journals at the University. Quite simply, it was understood that there was a risk that the vaccines would not be manufactured, let alone reach the intended patients, if not protected by patents.
The pool of public funding for Australian universities and institutes is constantly decreasing. Combined with a growing emphasis on producing commercially relevant research outcomes, Australian universities and institutes are increasingly relying on the patent system to provide alternate revenue streams. However, most Australian universities and institutes are not geared to undertake the entire commercialisation process in bringing new life-saving technologies to market. The only ‘way out’ is then to seek partnerships with industry, or to license or sell intellectual property. One could therefore argue that the ‘privatisation’ of research outcomes from publicly funded healthcare is inevitable. In any case, public healthcare costs and accessibility are secondary and subsequent issues to the commercialisation process which, in the health and life sciences sectors, is highly reliant on patents.
In the Myriad case, it is sometimes forgotten that Myriad’s patented test is a result of years of research and expenditure of more than US $500 million (see here and here). It is doubtful that the test would exist had the company not made these investments. Patenting the test provided Myriad with some guarantee that there would be a return on its investments. Surely, for Australian businesses or Universities investing into research on life saving medicines and therapies, guaranteeing a return on investment is a good thing.
Ms Jolie’s op-ed article in the New York Times has garnered much attention, and has emphasised the significant cost (~US$ 3,000) to US citizens for having Myriad’s patented test performed. In the US, under a privatised healthcare system, the cost is largely covered insurance provided that you can afford the insurance premiums. In Australia, under a government subsidised healthcare system, the test costs taxpayers up to about A$1,800 for those in families with a history of breast cancer. Patients not having this history can pay for their own testing at a cost of approximately A$2,200, a portion of which may be recoverable with private health insurance.
A recent report by the Grattan Institute highlights the point that drug pricing remains a contentious issue in Australia, and that Australians are currently paying too much for prescription drugs. However, the cost of drugs and, for that matter, the cost of Myriad’s test for breast and ovarian cancers, are completely separate issues to whether drugs, diagnostic tests and gene sequences are eligible for patent protection.
Why is gene patenting in the headlines?
While the eligibility of gene sequences as patentable subject matter will shortly be addressed by the US Supreme Court, the Australian Federal Court has determined isolated gene sequences to be patentable. Interestingly, claims of the patent directed to the method of screening for breast and ovarian cancers were not challenged in Australia. So, even if the genes responsible for breast and ovarian cancers where not patent eligible, Myriad could still enforce its rights to the patented screening test in Australia.
The reality is that, as eloquently expressed by my colleague, Dr Mark Summerfield, it is the moral, ethical and social concerns about gene patenting which are the drivers for litigation. The courts have avoided dealing with these issues and have focussed on the technical aspects of the law surrounding the validity of Myriad’s patent.
Patents for Genes per se Are Getting Harder To Obtain
Recent amendments to Australia’s patent laws will increase the hurdle for obtaining patents for isolated gene sequences. Amongst other things, the amendments increase:
- the threshold test for inventive step, and
- the level of disclosure required in a patent specification to support the full scope of a claim.
In reality, the question of whether isolated genes per se are patentable under these new laws will be addressed on a case by case basis, as it was before. For an unmodified, isolated human gene for which its sequence has been previously published, the ‘invention’ will reside in the use of the gene in a method or process rather than the actual sequence itself. For novel, synthetic genes having a sequence not normally found in nature, one would expect the sequence itself to be considered inventive and therefore patentable.
Clearly, further amending the laws to exclude genes per se from patentability will have a significant impact on the patentability of ‘man-made’ genes.
What will happen if isolated genes are excluded from patent protection?
Given the complexities of patents and the intense emotions behind the gene patenting debate, it is unlikely that amending Australia’s patent laws to exclude genes per se from being patent eligible will address moral, ethical and social concerns without detriment to academia and industry and, consequently, the public.
I am probably not alone in thinking that the current gene patenting debate should be taken out of the courts. If anything, the Myriad court cases perhaps reflect the failure of Government authorities and the global patent profession in effectively communicating to the public the benefits of protecting and leveraging intellectual property to bring life-saving technologies to market.
Given that the gene patenting debate really centres on the exploitation of monopoly rights to genes, rather than the eligibility of genes per se as patentable subject matter, there needs to be a seismic shift in discussions. In my personal view, greater emphasis needs to be placed on alternative mechanisms for providing accessible healthcare which don’t involve ‘fixing’ an allegedly ‘broken’ patent system. In my experience, the ‘fixes’ proposed for the patent system by those opposed to the patenting of genes will only result in more misery, less accessibility to drugs and fewer healthcare solutions for those who really need them.