Summary – emotive, unbalanced, shallow and ultimately disappointing platform for the anti-gene-patent campaign.
However, Andrew Fowler's story "Body Corporate", billed as "the high stakes battle over who owns your genes", was not one of those occasions.
Patentology does not purport to be unbiased on this subject. We do not believe that the patent system is perfect, but we believe that, on balance, it works and provides a net benefit to society. We believe that many of the modern benefits that we take for granted, including well-established non-genetic diagnostic tests and medications, would have been less likely to be developed in the absence of the incentives provided by patent monopolies.
We take with a grain of salt claims by the pharmaceutical industry that a new drug costs over US$700 million to bring to market, but even if the true figure is just 10% of this it is clear that there is no government in the world that would fund drug development without substantial private sector investment. And no private company would spend that kind of money without protection for the returns on that investment.
And we are unaware of any technical reason why tests and treatments based on genetic technologies are significantly different in this regard. This is not to say that there are no reasons – this is not our area of expertise. But anyone hoping to learn those reasons by watching "Body Corporate" would have been sorely disappointed.
WHAT "BODY CORPORATE" DID NOT TELL US
It is more enlightening to list the issues that "Body Corporate" did not cover, rather than the ones that it did. Here are just a few of the things we did not learn from the program.
What exactly is a "gene patent"?
In fact, Fowler did not even attempt to explain to his audience what a patent, of any kind, actually is, or the precise nature of the monopoly it confers. The closest we got to a definition was the information that that drug and biotech companies "own" about 4000 (or 20%) of the genes that make up the human genome, "[b]ecause that's the law. For the past 20 years it has been perfectly legal to patent, to own the genes that occur naturally in your body." So a gene patent, according to Fowler, is something that gives someone else ownership of something that is "naturally yours."
Fowler also failed to mention at any point in "Body Corporate" that a patent generally expires 20 years after its original filing date. Accordingly, one benefit of the rapid pace of gene patenting is that in 20 years time every one of these 4000-odd genes will be out of patent, and never again subject to a patent monopoly in such a broad form.
What does it mean to say that someone "owns" a gene?
We doubt that it really means anything, but certainly this question was not addressed by the program. As we understand it, a claim directed to an isolated gene confers a monopoly only on use of the isolated gene for a variety of purposes. Thus, until a sample is taken (eg your blood is drawn), and the extracted genetic material processed to separate the gene in question into an isolated form different from that in which it existed within your DNA, nothing within the scope of the patent claim actually exists. If we have this wrong, our understanding was not enhanced in any way by "Body Corporate".
Myriad Genetics, Inc does not own the genes in your body any more than Sony, Philips, Toshiba and others who have patents covering DVD technology, own any of your DVD's, your DVD player, or your computer's DVD-ROM drive. Myriad does not have the right to show up at your door and repossess any of your genes! Or (fortunately) to prevent you from replicating them by natural processes.
What justification might there be for gene patents?
Why have governments, patent offices and courts in major developed economies thus far allowed such things to exist? It surely cannot be caprice! The transcript of the program comprises approximately 6500 words, of which about 250 are spoken by US patent attorney Kevin Noonan and Garvan Institute Executive Director Professor John Shine, the only two voices in the entire program speaking in favour of patents.
Even so, there is little substantive content in these contributions beyond the generic assertion, already outlined above, that research, development and commercialisation are expensive, and without patents they would not happen. We believe this to be true, but surely the public has a right to more detail? Surely we could be told what is involved in developing a commercially viable genetic diagnostic test, or a gene therapy, and where the costs lie? Surely someone can explain why it is not possible to go straight from (publicly-funded) laboratory research to a commercial scale of operation without private sector investment?
We learn absolutely nothing from this program about what is actually involved in bringing genetic technology to market. We are therefore given no basis to assess the potential positive influence of gene patents.
Indeed, the greatest failure of "Body Corporate" as a piece of journalism is its complete failure to present anything vaguely resembling a balanced view.
What are the alternatives to "outlawing" gene patents?
Most of the objections voiced in the program are quite specific in nature, and have nothing to do with the broader issue of patentability of genetic technologies per se. The assertion that research and development in this field is expensive, and that there needs to be some guarantee of a return on investment, was not seriously challenged. Rather, the main objections seem to be:
- that allowing patents on genes is somehow "morally wrong" which, as a practical matter, does not advance the debate much, because it might equally be said that removing an incentive to invest in potentially life-improving medical research is also "morally wrong";
- that there should be freedom to conduct further research for the public benefit without the need to acquire a patent licence, which is perhaps a fair argument that might be better addressed by an appropriate research or "public benefit" defence to infringement rather than by abolishing gene patents, which would also allow research outcomes to be exploited by purely commercial interests and potentially to the detriment of the public; and
- that the patented tests and therapies are too expensive, which fails to address whether they would exist at all in commercial form without the patent incentive, and in any event is better addressed through the management and funding of the public health system.
One of the things we found most perplexing in "Body Corporate" was the repeated assertion that because of gene patents it is cheaper, and potentially faster, to have tests conducted overseas.
According to Professor John Christodoulou, of Westmead hospital, it is cheaper ($700.00, as opposed to $2000.00) to have a genetic test for Dravet's Syndrome carried out in the UK, rather than by Genetic Technologies in Melbourne. Furthermore, some sort of impasse with Genetic Technologies resulted in an additional three month delay before samples were sent overseas. Now, we would be very surprised if the patent in question was not also granted in Europe, so it seems unlikely that the problem here is purely, or even primarily, due to the existence of an Australian patent. In any event, no plausible explanation was offered.
Similarly, Dr Chris Semsarian of the Royal Prince Alfred Hospital explained that having a test for Long QT Syndrome costs half the price in overseas laboratories compared with using an Australian laboratory in Melbourne, and is completed in a few weeks, rather than about six months in the Australian lab. Again, it makes no sense to us that there would be no patent protection in the overseas countries in question, or that the Australian provider would price itself out of the market so dramatically. While there must be some explanation, the best that Dr Semsarian was able to offer was this:
Ah, my understanding is probably twofold. Ah, the first um, um, explanation is ah, that there is a higher throughput of samples in the overseas laboratory. So the higher throughput in the overseas laboratory no doubt brings down the costs. Ah, I also understand that there is a patent on these Long QT genes, and so there is a royalty that needs to be paid with each test for that particular test to be conducted.This hardly constitutes convincing evidence that gene patents are to blame.
What is the marginal cost to society of gene patents?
Since Fowler failed to investigate the real costs of research and development of genetic technologies, "Body Corporate" provides no insight into the relative cost of providing private incentives through patent monopolies, as compared with the alternative, which we presume would be greater reliance on public funding of the research.
There is a case to be made for this. The argument goes that no matter how the technology is developed, ultimately society pays. At one extreme, we can pay up-front for the research and development, and then enjoy the benefits of the outcomes at little or no additional cost. At the other, we defer to private investment and pay at the output end through the price of the resulting tests and therapies. The public-funding model has the benefit of sharing the cost more fairly across all of society, rather than burdening only those that directly benefit from the outcomes, although this can obviously be addressed, if necessary, through provision of public healthcare subsidies. Many economists would argue that a competitive market, even distorted by the grant of patent monopolies, will always result in greater efficiencies, and lower overall cost to society, than a public model.
In practice, the system already operates somewhere between these two extremes. There is both public and private research conducted, with technology transfer often running in both directions. The costs of the resulting diagnostic tests and therapies are generally shared between individual patients, private health insurers, and government subsidies and rebates. The real situation is complex, and not as black-and-white as presented in "Body Corporate".
There is no evidence of which we are aware, and certainly none presented in "Body Corporate", demonstrating that the system we have is ineffective or inefficient, or that a patent-free alternative would result in lower social and individual costs and/or greater benefits.
After the lack of balance in the opinions presented, this lack of any depth is the second major weakness of "Body Corporate".
CONCLUSION AND VERDICT
"Body Corporate" is strong on emotive polemic, and faithfully trots out the usual selection of heartbreaking examples of individuals and families – particularly women and children – whose lives have been disrupted by diseases and conditions that may be diagnosed and/or ameliorated using patented genetic therapies. We are not unsympathetic to their plight – indeed many of their stories are undeniably tragic and distressing.
But surely that is the point. It is difficult to argue that the system should not be kinder to such people. The problem is that no evidence has been presented to show that an alternative approach would result in any real improvement in circumstances or outcomes. In many cases, there may have been no diagnostic test or therapy available as little as ten years ago, and ten years from now the relevant patents will have mostly expired. Of course, new ones will take their place, as medical knowledge and technology continue to advance.
We would ask: which is worse – to have an expensive treatment available, which cost tens or hundreds of millions of dollars to develop (and which will one day be a cheap treatment), or to have no treatment at all?
Or is it really possible that an alternative model would avoid the need to make this choice?
These are the hard, but important, questions to which Fowler should have been seeking answers in "Body Corporate". Instead, we got a shallow report, littered with hyperbole and largely providing a soapbox for a few anti-gene-patent campaigners. We would expect this from 60 Minutes, but we set higher standards for Four Corners.
Final verdict – disappointing.