Nearly 20% of all human genes are already patented in the US, but is this grab for intellectual property slowing down vital, potentially lifesaving medical research? Does the patenting of genes reduce public access to predictive, diagnostic and potentially lifesaving genetic technology and increase the costs of diagnosis and treatment? Or are patents necessary to ensure a return on investment and secure future research?
Thu 30 July at 10am AEST online
TRANSCRIPTS NOW AVAILABLE
BRIEFING DETAILS:
DATE: Thursday 30 July 2009
START TIME: 10am AEST
DURATION: 45 mins
VENUE: Online
The Senate Standing Committee on Community Affairs next week begins the main public hearings into whether genes should be patented..
This briefing will bring together three key experts to outline why gene patenting could threaten Australian medical research, diagnosis and treatment.
See a recording of the full presentation by clicking here (WebEx)
SPEAKERS:
Dr Luigi Palombi is a patent lawyer and author of Gene Cartels: Biotech Patents in the Age of Free Trade. He is also an academic at the Centre for the Governance of Knowledge and Development at The Australian National University.
Listen (mp3) | Luigi’s presentation (pdf) | Extended version of Luigi’s presentation (pdf - 12Mb) | Transcript
Professor Ian Olver is CEO of the Cancer Council Australia. He is a medical oncologist with a quarter of a century of experience and expertise.
Listen (mp3) | Ian’s presentation (pdf) | Transcript
Dr Graeme Suthers is Chair of the Genetics Advisory Committee of the College of Pathologists and Head of the South Australian Familial Cancer Unit. Listen (mp3) | Graeme’s presentation (pdf) | Transcript
Listen to the Q & A session (mp3) | Transcript
Video of Prof Ian Frazer, President of Cancer Council Australia speaking on the issue (vnr - 3:19 min (24Mb .wmv file) (high res available on request)
Video of Prof Ian Frazer, President of Cancer Council Australia speaking on the issue (vnr - 3:19 min (24Mb .wmv file) (high res available on request)
RAPID ROUNDUP: Who owns DNA - should genes be patented?
See Also “Gene patents: we need them” (external link) by Dr Julian Clark, Walter and Eliza Hall Institute of Medical Research (WEHI). 
Associate Professor Judy Kirk is Director of the Familial Cancer Service at the Westmead Millenium Institute for Medical Research in Sydney.
“This inquiry’s terms of reference provide an opportunity to emphasise the significant potential risk to patient outcomes associated with commercial monopolisation of genes and genetic technology.
Under current arrangements, genetic tests for familial cancers such as breast and ovarian cancer are freely available through a number of public hospital laboratories in Australia. Patenting genetic material could lead to commercial monopolies of cancer tests and increased costs.
This has occurred overseas, when gene patents have been enforced.
In my opinion, on the basis of my lay understanding of patent law and its evolution, human biological material should not be considered patentable subject matter. Its identification is a discovery, rather than an invention.
I hope this inquiry results in a more comprehensive /government/ review of the problems of gene patenting, on a multidisciplinary level involving economists, scientists, health professionals and consumers, as well as the patent lawyers. The Australian Competition and Consumer Commission needs the resources to challenge any claims regarding gene patents and we need to consider an amendment of the /Patents Act 1990/, to ensure genes that have already been patented are exempt from excessive licensing fees or monopolisation.”
Dr Charles Lawson is a Senior Lecturer in the Griffith Law School at Griffith University.
“The gene patent debate has moved on, and whether genes are patented or not is probably a moot question in the same way debates about patents on sewing machines, aeroplane parts, telecommunications devices, and so on were contentious and moved on. The challenge for the Senate inquiry is to detail the kinds of lessons we should have learned from the gene patenting experience:
(a) The extraordinary amounts of money spent on drafting and lodging gene patents with no real or prospective commercial value that might have been invested in actual research and development.
(b) The failure of apparently substantive threshold standard such as ‘inventive step’ to distinguish between real and worthy contribution to invention and those inventions that block and clog invention and innovation.
(c) The failure of balances in the patent system, such as ‘compulsory licensing’, to balance the needs of inventors (and their investors) against a broader public interested in new inventions.
(d) The focus on patents as an end in themselves rather than part of a broader (and more efficient and effective) economic policy directed to promoting invention, innovation, and more products to market at a lower price.
While the gene patent debate has passed, and it’s a shame the Senate has only got around to dedicate its time to these important patent questions in 2009, the lessons learned have direct application to current controversies - access to vaccines for influenza pandemics, dealing with the high costs of the new generation ‘biologics’ for our aging population, the design of carrot and stick incentives for patents as part of a broader economic innovation policy, patents as non-tariff barriers to free trade, and so on. Let’s hope for some inspired thinking from our Senators … “
Professor Dianne Nicol and Dr Jane Nielsen both lecture in the Centre for Law and Genetics in the School of Law at the University of Tasmania.
“Biotechnology is one of the largest areas of growth in patent activity. Most if not all biotechnology companies have patenting as a major plank of their business strategy. Public research organisations are also some of the most active patenters in this area. Patents clearly play some role in facilitating innovation in biotechnology, as they do in other areas of technology, for why else would the industry so wholeheartedly adopt patenting as its primary business strategy?
The extent of the positive role that patents actually play in promoting innovation is exceedingly difficult to measure. Concerns have been raised for a number of years around the world that gene patents and various other types of patents in biotechnology have the potential to have negative impacts, particularly in biomedical research, biomedical innovation and delivery of the products of biomedical innovations into healthcare, particularly genetic testing.
Aside from philosophical objections to patenting in biomedicine, the key question that must be addressed from the policy perspective is whether the negative impacts of these patents outweigh their positive impact. Extensive research has been undertaken in a number of jurisdictions in an attempt to elucidate whether or not negative impacts are eventuating, including analysis of patent claims, infringement actions, publication rates, access to healthcare and surveys and interviews with participants in the industry.
To date, that research has produced equivocal results. There is no definitive evidence that the negative impacts of gene and related patents outweigh the positive, nor is there convincing evidence to the contrary. Clearly there is scope for much further research to be undertaken.
Despite the lack of concrete evidence, it is generally accepted that the potential exists for patents to impact negatively on biomedical research, innovation and healthcare, but research suggests that practical solutions are being found - licensing and other collaborative arrangements, ignoring patents, working around them, challenging validity. There are many reasons for this, including difficulty for patent holders in pursuing infringers, practical benefits in cooperative strategies, uncertain validity and so on. However, this is not to deny that there are examples of more aggressive patent practices which cannot be worked around - the breast cancer gene patent enforcement practices being perhaps the most notorious example - and the potential exists for greater negative consequences to emerge in future.
A holistic approach is necessary in deciding the way forward; it is not desirable to focus exclusively on the question of whether or not gene sequences should be excluded from patenting because this would not address all of the perceived negative impacts of patents on biomedical research, innovation and healthcare. Indeed, the actual practical consequences of such an exclusion may be quite minor, because patent claims covering methods of using gene sequences and patents claiming other genetic products and processes are likely to create much the same difficulties as claims to gene sequences. Patent attorneys are highly skilled at drafting around impediments to patenting.
It is necessary to look more generally at the application of the general patent criteria of invention, novelty, inventive step and utility to patent claims in biotechnology and whether there should be limitations on the scope of claims. The ways in which patents are examined and awarded also warrant some scrutiny. It may be appropriate for an independent agency to set policy directions in areas such as this. It is also important to consider how patent use may be better regulated, including use by or on behalf of the government without having to get permission from the patent holder, as well as the role of competition law. Mechanisms that facilitate cooperative innovation strategies also need to be examined.
Ultimately, it may be the case that excluding gene sequences from patenting is an important symbolic first step in readjusting the balance in this area. Public opinion certainly would support taking this step. However, it may be a hollow step that would achieve little unless it is backed up by more detailed policy analysis and law reform, where appropriate.”