Tag Archives: Patents

The plan for innovation, IPR and public health is adopted at the WHO. How can this be reconciled with the IPR Act?

It is not unusual in national policy for the right hand not to know what the left hand is doing. There is now a looming clash of priorities for the new Cabinet that goes to the very heart of the ‘better life for all’ mandate on which President Zuma’s government came to power. This  could cause embarrassment to a number of new ministers, in the DST, Higher Education, the DTI and Health. What is at stake is the way the South African government secures benefits from its investment in public research and how the country and its universities make research work for national development and the betterment of people’s lives.

What has happened is the IPR  Act, with its Draft regulations (due for final comment tomorrow) is on a collision course with a landmark resolution passed after years of debate at the  61st World Health Assembly at the World Health Authority. The South African delegation at the Assembly was headed by the Deputy Minister, Dr M. Sefularo and was attended by a delegation of 16 delegates and alternates from the Department of Health. The problem is a radical difference of views on how best to achieve benefit through innovation and intellectual property management.  The IPR Act requires universities and other publicly funded research organisations to secure intellectual property rights and patent as much research as possible, frowning upon open innovation and open source. The WHO, on the other hand promotes the idea of a collaborative world public health regime that uses patenting, but in a responsible way, and combines this with support for a number of open approaches to the shared dissemination of public health research.

The WHO resolution, passed on 22 May, finally agreed the way forward on the recommendations made to the Assembly by the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property. The purpose of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property that has now been voted through, aims to  ‘secure.. an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development.’ While many people glaze over as soon as intellectual property is mentioned, it is clear that this is a vitally important issue for South Africa, quite literally a matter of life and death.
The recommendations of the Global Strategy contain a vision of the scientific endeavour that stresses global collaboration and the sharing of research information and data. This is also the way forward that President Barack Obama proposed in his speech to the National Academy of Sciences in the US a few months ago. The way forward that he sees for US  science is a vision of collaborative science for the public good:

In biomedicine… we can harness the historic convergence between life sciences and physical sciences that’s underway today; undertaking public projects — in the spirit of the Human Genome Project — to create data and capabilities that fuel discoveries in tens of thousands of laboratories; and identifying and overcoming scientific and bureaucratic barriers to rapidly translating scientific breakthroughs into diagnostics and therapeutics that serve patients.

The WHO plan of action, which the South African government is now called upon to implement, contains a number of provisions that provide for the use of open source development, open access to research publications and data, voluntary provision of access to drug leads, open licensing, and voluntary patent pools. This runs alongside a more traditional approach to the patenting of drug discoveries and vaccines, but with the proviso that there must be measures in place to ensure that patents are managed in such a way as to be appropriate to public health goals. This includes delinking the costs of research from the price of health products, so that they can be affordable in developing countries.

The burning question now is how this can be implemented – presumably by the Department of Health – when the IPR Act and its Regulations will effectively block the WHO provisions for sharing research results and using open licensing and open access for the benefit of public health delivery.

It would perhaps be appropriate for public health departments in our universities and their researchers to submit a request to the DST for the withdrawal of the Regulations for further consideration of the issues at stake by all the government departments that might be involved in this potentially embarrassing clash.

Innovation policy

The Australian federal government has just completed a review of its National Innovation system. Australian research and innovation policy-making tends to be broadly consultative, wide-ranging  and forward-looking, so I was interested to compare this with what the South African government is doing. Our IPR Act of 2008 is Bayh-Dole on steroids, insisting on commercialisation and patenting wherever possible, and apparently treating open innovation as the exception, not the rule. And speaking of rules, the Regulations impose layers of bureaucratic filters between the researcher and the innovation outcome.

I am still working through the Australian document to absorb its detail but it has some valuable insights and the overall thrust is clear: there needs to be a balanced system, in which commercialisation is but one strand of the innovation role that universities can play. Far from taking Bayh-Dole as gospel, there is a critical evaluation of such strategies and a re-evaluation of  what innovation policy should look like in the 21st century.

Moreover, the Australian government and the participants in the policy process are aware of the pitfalls in excessive patenting. They review the past record, warn against the damage that can be done by patent law that is not rigourous enough and advise against policies that could create patent thickets. Most interesting, there is a strong argument for this arena to be opened up, so that the participants in the innovation system have a strong say, rather than this being the exclusive domain of lawyers. This is a lesson that I think South African universities might need to learn – it appears that our academics are not engaging with the South African legislation, thinking that this is the domain of professionals.

This Australian policy document reminds me of a recommendation from Arie Rip at an  early stage of the South African higher education policy process (2000):

The common mimetic route is to define the nature of capacity-building in terms of what is now seen as important. This may well be a recipe to become obsolete before one’s time … [T]he world (of science and more generally) may well evolve in such a way that present-day exemplars will be left behind. So developing countries should set their sights on what is important in 2010, rather than what appears to be important now – however difficult this will be politically. 1

The IPR Act of 2008 is unfortunately trapped in the ‘mimetic route’ that Rip warns about here. But what about Australian thinking in 2009? Here are some extracts that give some insight into the thinking that will inform policy review down south:

On the commercialisation of research:

Research commercialisation is not a core role for universities. Nevertheless, universities can play a vital role in the commercial process. In cases where the benefits of research are best achieved through commercial engagement, universities should, where possible, attempt to partner with appropriate stakeholders to achieve these goals. Such instances are in the minority and universities more commonly play a role of commercial significance through provision of vital research advancement, workforce training and substantial international links.

On the protection of intellectual property rights:

[T]here is a caveat which is increasingly important: The development of intellectual property is cumulative. In the words of Sir Isaac Newton, we stand on the shoulders of giants. Because new knowledge always builds on old knowledge, the property rights we have erected to encourage innovation can actually obstruct it.

On the need to open up the question of patenting and IP beyond the legal profession and the IP industries:

Nevertheless the consideration of policy … is dominated by IP practitioners and by the beneficiaries of the IP system. We need the expertise of lawyers in this as in many other areas of policy but it is imperative that IP policy make the transition that competition policy made over a decade ago now, from a specialist policy area dominated by lawyers, to an important front of micro-economic reform.

On access and dissemination for social and economic benefit

Along with the rise in support for access to information has come a growing recognition of the need for users to be able to search and interact with data and content. Legal frameworks must also be developed to facilitate access and reuse. This points to the need for an Australian National Information Policy (or Strategy) that optimizes the generation and flow of ideas and information in the Australian economy. As the National Competition Policy (NCP) involved systematically scanning Australian institutions to optimize the operation of competition to enhance outcomes so National Information Policy would scan Australian institutions to optimize the generation and dissemination of information for social and economic benefit.

Thus for instance, unless it seriously undermines its commercial objectives of sale of product, the ABC should err on the side of making its content available over theinternet unless this has large opportunity costs. The presumption against free availability might be overcome where it would involve the foregoing of substantial commercial revenue from the sale of the content or there are large costs of hosting the necessary internet bandwidth (although in this latter case, peer to peer means of distribution should also be explored as should the diversion of funding from other activities and/or additional funding).

The advantages of  open science

To drive cumulative knowledge creation researchers and others must have access to high quality data and information on developments not just in their field but beyond. For instance, Jeff Furman and Scott Stern have calculated that Biological Resource Centres that are repositories of biological materials (including cell lines, microorganisms and DNA material) have boosted cumulative scientific knowledge by three times more than alternative institutional structures 2.Australian physicist Michael Nielsen has stressed the importance of unlocking scientific information in scientific journals to make it more easily discoverable, searchable and useable to enable the cross-disciplinary search for knowledge:

We should aim to create an open scientific culture where as much information as possible is moved out of people’s heads and labs, onto the network, and into tools which can help us structure and filter the information. This means everything – data, scientific opinions, questions, ideas, folk knowledge, workflows, and everything else – the works. Information not on the network can’t do any good.3

There is a lot more in this report – I recommend that South African researchers read it as they engage with our legislative process with an eye to preserving their expertise and independence in the process of ensuring that their research has maximum national impact.

1. Rip, A. (2000) Fashions, Lock-ins and the Heterogeneity of Knowledge Production. In Kraak, A. (ed.) Changing Modes: New knowledge production and its implications for Higher Education in South Africa. Pretoria: Human Sciences Research Council.

2. Furman, J. and Stern, S., Standing Atop the Shoulders of Giants: The Impact of Institutions on Cumulative Research, National Bureau Economic Research Working Paper. 2004.

3. http://michaelnielsen.org/blog/?p=448

Patents and open science – and that Bill again!

Today is the last day for submissions on the Draft Bill for IPR for Publicly Funded Research. So it was good to see a very balanced and insightful article, Sharing the fruits of science by Glerry Toomey in University Affairs on the question of patents and the value of open science. In contrast to the obsessive insistence of the South African Draft Bill on patenting everything that can be patented and on commercialisation as the only way of getting benefit from research, Toomey makes it clear that international science is now taking other directions:

We … know that the social behaviour of modern science, and of the broader domain of innovation, is marked by a continual tug-of-war. At one end of the rope we find the forces of collaboration and sharing. At the other end are the instincts to compete and to protect one’s hard-earned intellectual property. While both kinds of behaviour lubricate scientific discovery and technological innovation, IP protection via patenting, with a view to future profits, has become a dominant trend in recent decades, particularly in the life sciences.

But now an international scientific counterculture is emerging. Often referred to as “open science,” this growing movement proposes that we err on the side of collaboration and sharing. That’s especially true when it comes to creating and using the basic scientific tools needed both for downstream innovation and for solving broader human problems.

Patenting has a role to play, the article argues, but the mistake that has been made in recent years is a failure to ‘distinguish between the research tools and basic knowledge’ of science and the inventions with industrial application that the patent system was designed for.

The article tracks a number of open science projects and links these to the recognition of scientific discovery as the generator of public good. He quotes at length Dr Richard Jefferson, a biotechnologist now living in Australia, the founder of an international research unit in Canberra called CAMBIA, which promotes open science.

Dr. Jefferson distinguishes between the development of basic scientific tools and the application of those tools, between “discovery and invention.” He sees scientific discovery as a social enterprise – not only serving as midwife to marketable inventions, but also delivering publicly valuable products for which markets or profit margins may be small. That includes alleviating poverty and hunger, especially in the developing countries, preventing or curing the diseases of the disadvantaged, and improving human stewardship of natural resources. So, while open science is described as a pragmatic way of doing research, it also has a social and ethical backbone. Terms like global public goods, common heritage of humankind and human rights recur in the literature on open science.

This would seem to be very much in line with the policy of the Department of Science and Technology, which argues for the need for research to contribute to national upliftment. On the other hand, Toomey claims, the commercialisation of public research, driven by the Bayh-Dole Act in the US some 27 years ago led to a ‘filing frenzy’ resulting in a tendency to privatise the tools and platforms of science.

This has not povided beneficial to the universities:

For universities in the technologically advanced countries, says Dr. Jefferson, the promise of getting fat cheques in the mail from patenting the fruits of their biosciences research projects has simply not materialized. He maintains that offices of technology transfer are “generally losing money” and that there’s ample evidence that private biotechnology enterprises, as a commercial industry, have fallen flat as well.

The article ends by suggesting that there needs to be a total rethink of the role of intellectual property, as a powerful tool for creating social value, through providing the platforms and sharing the improvements that result.

I would suggest that the South African Department of Science and technology needs to consider these arguments before enacting any legislation on IPR rights in university research. In promoting a Bill that looks backwards to 25-year-old US legislation, proven to have had many negative consequences; in insisting on a very wide-ranging definition of what research needs to be protected for patenting purposes, the Department would be locking the country into a backward-looking paradigm, just when exciting new prospects are available for delivering real development impact from public research.

Thanks to Peter Suber’s Open Access News for drawing my attention to this article

IP in Publicly Funded Research Bill – does the cure match the disease?

The first question that arises in relation to this piece of legislation is why it has been drafted – what perceived need does it fill? And why the need to draft so widely – and even inventions that might conceivably become patents some day?

As far as I can establish, there are two separate areas that the government feels needs addressing. One is the perception that the universities are not performing well enough in delivering value for the money that is being invested in public research in the country. The other is that South African knowledge resources and intellectual property – as is common across the developing world – risk being pillaged by patent-seekers from the global North, particularly from the USA. In the later view, unless we protect ourselves with a strong IP regime, we will risk losing the exploitation of our intellectual capital to more powerful
Northern pirates and raiders.

As South Africa’s National Research and Development Strategy (2002) said: ‘These are valid concerns. More South African research needs to be more effectively disseminated and exploited for the national benefit. And the risk of predatory raids by US bounty hunters is real enough – the Rooibos case is the most high-profile recent case in this regard and there are genuine concerns about how best to protect traditional knowledge from appropriation. The problem is in the solution being proposed, which, I would suggest, is in fact contrary to some of the DST’s most enlightened – and most central – policy-making and
might well be the wrong cure for the disease.

I was concerned to see in an ITWeb article that Matlu Mabokano, manager of hydrogen and energy at the Department of Science and Technology (DST), is quoted as saying that the Bill is heading for Parliament this week even as comment is being sought. He is quoted as being dismissive of the fact that there have not been many comments submitted yet, accusing South Africans of being chronic last-minuter responders. This seems an opinion based on a blithe assumption that the issues in the Bill are not problematic and are simple and straightforward to respond to. This is not the case -the issues at stake are very complex and it has taken the Australian government, for example 800 pages to summarise the outcome of its consultation on the same issues in the Productivity Commission Report published two months ago. Moreover, as the DST itself wrote in the National Strategy for Science and Technology: ‘International thinking on legislation is as fluid and fast-moving as the new technologies themselves’. Yet Mabokano’s apparent assumption of simplicity and obviousness is not an uncommon view among those who propound proprietary models of IP protection. The Copy/South Dossier, which reviews the global IP regime from the perspective of developing countries, argues that the ‘dominant discourse around intellectual property – whether legal or sociological – starts from some largely unexamined assumptions’.

The assumption that a strong IP regime on its own fosters development and economic growth is one that is being increasingly challenged worldwide. Policy-making needs to be forward-thinking. As NEPAD argues in its discussion document on science and technology indicators, policy-makers need to be able ‘to discern, based on their expert knowledge, the future trajectories of the subject and the interventions which might improve its development’. The future does not look as if it will be one of proprietary IP systems only.

The DST’s policy on Science and Technology puts the role of technology and the changes being wrought by ICT at the heart of its proposals for development. As the White Paper on Science and Technology says:

The world is in the throes of a revolution that will change forever the way we live, work, play, organise our societies and ultimately define ourselves … The ability to maximise the use of information is now considered to be the single most important factor in defining the competitiveness of countries as well as their ability to empower their citizens through enhanced access to information.

This perspective seems to be missing from the Draft Bill. Worse, in fact the White Paper’s policy perspective, which stresses access and the maximisation of the use of information, risks being marginalised in a vision in this Bill which seeks to subordinate a very wide range of information management to the proprietorial and necessarily secretive
world of patents. South Africa’s Science and Technology Policy is also firmly founded on the need for research to make a public
development contribution: ‘A South African vision of the information society should seek to ensure that the advantages offered by the information revolution reach down to every level of society and achieve as best a balance between individuals and social groups, communities and societies as is practically possible.’ Science and Technology, it argues, must address the real needs of South Africa as for social and economic development. Patents on their own do not achieve this. In fact it is widely recognised that commercialising the research system by focusing on patents alone will advantage inventions that appeal to the wealthy, rather than those that serve the needs of the poor. A patent-driven system of research evaluation, on its own, would tend
to marginalise poorer communities and their needs.

At the very least, a forward-looking Bill would need to address and incorporate the need for non-proprietary methods of production, as this is now mainstream in world thinking and policy-making.

Governments across the world, including the UK, the USA, the EU, and Australia, have convened commissions to discuss and explore this issue. Ironically, South Africa is part of this movement and is a signatory of the OECD Declaration on Access to Research Data from Public Funding , something that would be rendered problematic by this Bill.

Something that the non-proprietary, commons approach is doing in the international arena is re-positioning the developing countries. A symptom is that the Development Agenda being driven by Brazil and Argentina has very recently been accepted on the WIPO Agenda. As Yochai Benkler charted in a complex and tightly-argued paper at the iCommons Summit in Dubrovnik last month, this but one symptom of the fact that we are at one of those turning points where a dominant system – the ‘strong’
IP regime – is being challenged across the globe by a radical re-thinking of how best to achieve the very goals that this Bill
seeks to promote. And, as he argued, this is now a social movement, in the beginning stages, which is moving developing nations from the periphery to the centre of international affairs, a world in which human development and justice are the core drivers, not the specifics of IP law and copyright.

One strong thread in the critiques of the global IP system is that patents in particular are damaging to developing and transitional economies. As Benkler puts it: ‘The above-marginal-cost prices paid in …. poorer countries [as a result of patents] are purely regressive redistribution. The morality of this redistribution from the world’s poor to the world’s rich has never been confronted or defended in the European or American public spheres. It simply goes unnoticed.’ And yes, there is value in effective patents and yes, developing countries have managed to patent successfully themselves. And so my argument is not, in addressing this Bill, that it needs to be thrown out in favour of non-proprietary and open methods of dissemination. It is that, in formulating the Bill as widely as they have, the drafters have sidelined a number of important questions that are being debated around the world as we speak. As the Australian government put it in the Productivity Commission Report:

Universities’ core role remains the provision of teaching and the generation of high quality, openly disseminated, basic research. Even where universities undertake research that has practical applications, it is the transfer, diffusion and utilisation of such knowledge and technology that matters in terms of community well-being. Commercialisation is just one way of achieving this. Productivity Commission
2007: xiii – my emphasis)

In other words, there needs to be more flexibility in the provisions of this Bill for the commercialisation of research results and space for non-proprietary collaborative approaches that could advantage the poorest sections of our community at the same time as we grow our competitiveness in global business.