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Copyright (c) 2003 Janet Hope, Research School of Social Sciences, Australian National University, Canberra, ACT 0200. Verbatim copying and distribution of this site is permitted in any medium, provided this notice is preserved.

Intellectual Property and Industry Structure

Inefficiencies associated with restricted access to intellectual property in biomedicine

Initiatives to improve access to proprietary biomedical research tools

Inefficiencies associated with restricted access to intellectual property in agricultural biotechnology

Initiatives to improve access to proprietary research tools in agricultural biotechnology

Why agbiotech?

Introduction

Following World War II, academic science had enjoyed relative independence from external influences as the result of large government grants which were distributed by scientists themselves through funding agencies such as the United States' National Research Council. [10] Given this background, it is not surprising that the emergence during the 1970s and early 1980s of closer relationships between universities and industry -- particularly those in which individual scientists or their institutions expected to profit directly from the commercialisation of research -- [11] generated lively discussion among academic scientists about the possible impact of commercialisation on the integrity of the research process. [12] Concerns expressed by scientists and observers at the beginning of the 1980s related to the prospect of corporate interests dictating the direction of research, deterioration in the quality of research due to the undermining of traditional peer review mechanisms, exploitation of graduate students and postdoctoral researchers, divided loyalties and financial conflicts of interest, and the danger that academic scientists would lose their credibility as impartial experts on matters of science policy. [13]

Many of these fundamental concerns are still relevant, though surrounding circumstances have changed. For example, in the early days of recombinant DNA technology, when questions of safety were still being openly debated within the scientific community, the appearance of impartiality was necessary if scientists as a group were to succeed in resisting the imposition of legislative controls on research. [14] Now that potential risks associated with the technology are again the subject of active debate, this time on a much broader scale, the need for impartial scientific advisers to inform the wider community is being keenly felt. [15] Similarly, it is arguable that our current lack of detailed empirical information about risks [16] bears out early concerns that commercialisation would influence the research agenda towards short-term product development and away from more complex and longer-term problems (such as determining the ecological impact of genetically engineered crops).

Of course questions of risk were, and are, highly contentious. But in their most general form, early concerns about the impact of commercialisation did not depend on any particular point of view about risks or about the relative merits of different lines of research. The most general concern expressed by scientists and others in the early 1980s was that by disrupting relationships among scientists and interfering with the flow of scientific communication, commercialisation would hinder the overall progress of science. [17]

Earlier sections of this website have outlined the theoretical basis for this concern and traced developments in the sociological, economic and legal literature that support the view that one aspect of commercialisation in particular, the strengthening of intellectual property rights in biotechnology's information products, may lead to a stifling of research and development. This section focuses on empirical evidence for and against such a stifling effect and notes existing efforts to overcome problems of access to biotechnology tools in two key industry sectors, biomedicine and agricultural biotechnology.

To provide a structure for this discussion, we return to the notion of the "tragedy of the anticommons". According to Heller and Eisenberg, the first precondition for anticommons tragedy is the proliferation of property rights. There is no doubt that in both biomedical and agricultural biotechnology, this condition is fulfilled: since the early 1980s, patenting of biotechnology inventions has increased literally exponentially, with many if not most fundamental tools of biotechnology research becoming subject to private ownership.

If all the different owners of biotechnology patents are able to negotiate with one another so that they can put together a useful-sized bundle of rights to serve as a basis for further development, this is not necessarily a problem. But as we have seen in previous sections, negotiations can be costly and difficult, and if transaction costs get too high there is the possibility that research and development will grind to a halt. High transaction costs are the second preconditon for anticommons tragedy.

In practice, it is difficult to tell to what extent, if at all, the proliferation of intellectual property rights has generated real obstacles in biotechnology research and development. What is apparent is that anticommons tragedy can manifest itself in qualitatively different ways in different sectors. In the legal literature, negotiation breakdown is the expected manifestation, but it appears that industry consolidation aimed at sidestepping the costs of negotiation may also lead to "tragedy".

Notes

[6][[Thackray, 1998 #167], Part I: From Brewing to Biotech ([Bud, 1998 #184],[Kay, 1998 #185],[Creager, 1998 #186]).]

[7][[Thackray, 1998 #167], Introduction, page ix; [Etzkowitz, 1989 #200], page 15-16; [Owen-Smith, 2001 #196], page 2]

[8][[Etzkowitz, 1989 #200], page 15]

[9][Blumenthal, 1986 #102; Blumenthal, 1992 #132; Blumenthal, 1996 #145; Blumenthal, 1996 #144; Blumenthal, 1997 #143; Campbell, 2000 #134]

[10][[Etzkowitz, 1989 #200], page 15]

[11][[Kevles, 1998 #187], page 66-67]

[12][For example, see [Fox, 1981 #358]. In 1981, Congress held a series of hearings on the impact of commercialisation of academic biomedical research; see [Eisenberg, 1987 #93], page 178, footnote 3.]

[13][ [Fox, 1981 #358],[Eisenberg, 1987 #93], page 178, footnote 3]

[14][In 1977 members of Congress introduced more than a dozen bills and resolutions aimed at regulating genetic engineering research: [Wright, 1998 #188], page 87]]

[15][For example, see the Report of the New Zealand Royal Commission on Genetic Modification (27 July 2001, downloaded from the Royal Commission's website at http://www.gmcommission.govt.nz/RCGM/rcgm_report.html on 1 August 2001), page 64, paragraphs 77 to 80). For one example of scientists' attempts to respond to this need, see the website of Physicians and Scientists for the Responsible Application of Science and Technology (PSRAST), which aims to provide and impartial scientific evaluation of the risks associated with genetically engineered food: http://www.psrast.org/aboutus.htm, last visited 4 March 2002.]

[16][Report of the New Zealand Royal Commission on Genetic Modification (27 July 2001, downloaded from the Royal Commission's website at http://www.gmcommission.govt.nz/RCGM/rcgm_report.html on 1 August 2001), page 68, paragraph 96 and Chapter 4 generally; see also PSRAST, "Is our knowledge sufficient for safe use of biotechnology?" http://www.psrast.org/defknintro.htm, last visited 4 March 2002.]

[17][For example, see [Fox, 1981 #358], page 41]

Biomedical biotechnology

At first glance, empirical studies in the field of biomedical biotechnology seem to suggest that despite proliferation of intellectual property rights, the tragedy of the anticommons has not eventuated. This is not because transaction costs are low; as we have seen in an earlier section, there is considerable evidence, at least of an anecdotal nature, that transaction costs associated with the exchange of biotechnology research tools are substantial. Instead, it appears that the value of many transactions is high enough that they are not abandoned despite high costs.

However, even if many industry participants still consider that deals with other owners of intellectual property rights are worth doing despite high transaction costs, from a broader perspective there are social costs associated with many of the working solutions that have been adopted within the biotechnology community to "keep the wheels turning". Moreover, many of these solutions -- such as building up a defensive patent portfolio so as to improve one's bargaining position -- are simply unavailable to the smallest and poorest participants (or would-be participants). In the light of this observation, it is arguable that at the very least, open source licensing for biotechnology tool might represent a less costly or more accessible instrument for negotiating the patent thicket than some others that are available.

Inefficiencies associated with restricted access to intellectual property in biomedicine

[The following is a summary, in note form only as at January 2003 and complete with voice software "typos", of Walsh, John P., Ashish Arora, and Wesley M. Cohen. 2002. The Patenting and Licensing of Research Tools and Biomedical Innovation: United States National Academies' Science, Technology and Economic Policy Board. See also Campbell et al. and Straus, Joseph, Henrik Holzapfel, and Matthias Lindenmeir. 2002. Empirical Survey on "Genetic Inventions and Patent Law". Munich.

(Walsh, Arora, and Cohen 2002):

In this paper, we have considered to possible impacts of the patenting of research tools on biomedical research. First, we consider whether the existence of multiple research tool patents associated with a new product or process poses particular challenges for either research on or commercialisation of biomedical innovation. Second, we examine whether restricted access to some of stream discovery -- perhaps protected by only one patents -- has significantly impeded subsequent innovation in the field. In brief, we find that the former issue -- the "anticommons" has not been especially problematic. The latter issue of access, at least two foundational upstream discoveries, has not yet impeded biomedical innovation significantly, but our interviews and prior cases suggest that the prospect exists and ongoing scrutiny is warranted.

1. Anticommons:

The patenting of research tools has made the patent landscape more complex. Interviews confirmed that there are on average more patents and more patent holders and before involved in a given commercialise the ball innovation in biomedicine, and many of these patents are on research tools. Despite this increased complexity, we do not find that socially worthwhile projects are either stopped or not undertaken at all (though our evidence on the latter is indirect). Why? Firms have been able to develop "working solutions" that allow their research to proceed. These working solutions combined taking licences (i.e., successful contracting), inventing around patents, going offshore, infringement (sometimes under an informal and typically self-proclaimed research exemption), the development and use of public databases and research tools, and court challenges. In addition, the members of a research community (which includes both academic and commercial researchers) are somewhat reluctant to assert their IP against one another if that means they will sacrifice the goodwill and information sharing that comes with it. Changes in the institutional environment, particularly new PTO guidelines and some shift in the courts' views toward a research tool patents, as well as pressure from powerful actors such as NIH (stimulated perhaps by the early concerns articulating the anticommons problem) also appear to have further reduced the threat of breakdown. Finally, the very high technological opportunity in this industry means that firms can shift their research to various less incumbent by intellectual property claims, and therefore the walling off of particular areas of research may not, under some circumstances, exact a high toll on social welfare. Those stopped and stillborn projects are not evident, many of the working solutions to the IP complexity can impose social costs. Firms' circumvention of patents, the use of substitute research tools, inventing around all going offshore -- while all privately rational strategies -- constitute a social waste. Court challenges and even the contract negotiations themselves can also impose significant social costs. Litigation can be expensive and Norma out-of-pocket costs, represented by the effort is devoted to the matter by researchers and management, can be substantial. Even when there is no court challenge, the negotiations can be long and complex and may impose costly delays. Disagreements can and have led to litigation, which is especially costly for small firms and universities. It is difficult to know, however, how much contracting costs in biomedicine reflect an enduring feature of IP in biomedicine, and how much is transitional. As new institutions and firms become owners of intellectual property, there is a costly period of adjustment as these new actors learn how to manage their IP effectively. The development of standard contracts and 10 plates may be helpful in diminishing these adjustment costs, and funding agencies such as NIH can play an important role in developing and encouraging the use of such standards.

2. Cumulative research -- access to foundational tools:

The second issue we examined is the impact on biomedical innovation of restricted access to research tools. In thinking about the issue of access, it is helpful to distinguish research tools along two dimensions. First, it is obviously of interest how essential or "foundational" a research tool is for subsequent innovation both in the sense of whether the tool is key to subsequent research, and in the sense of the breadth of innovation that might depend on its use. [Charles Lawson's argument: cannot substitute for many of these biological molecules -- they are already perfectly adapted. Therefore lack of access does genuinely block off a lot of research.] second, to what degree is a research tool rival-in-use, ie primarily used to develop innovations that will compete with one another in the marketplace. The defining feature of research tools that are not rivalling use is that the use of the research tool by one firm will not typically reduce others' profits from using it. Such tools include PCR and combinatorial libraries. From a social welfare perspective, a research tool that is not rivalling use is like a public could in that it has a high fixed cost of development and zero or very low marginal cost in serving an additional user. Thus, maximisation of social welfare requires that the tool be made available to as larger set of users as possible. Empirical observation is that holders of IP on not rival research tools often charge prices that commit broad access, at least among firms. In some of these cases, IP holders have charged high prices to commercial clients and lower prices to university and other researchers who intend to use the tool largely for non-commercial purposes. From a social welfare perspective, such prices relation expands the use of the tool and is indeed welfare enhancing. However, there are cases where the IP holder cannot or does not developed pricing strategy that allows low value and academic projects access to the tool. Perhaps the greatest concern with regard to IP access tends to emerge when a research tool is both rivalling use and is potentially key to progress in one or more broad therapeutic area is. When a foundational research or is rivalling use, the IP holders often either tends to develop the technology themselves or grant exclusive licences. As suggested earlier, exclusive exploitation of a foundational discovery is unlikely to realise the full potential for building on my discovery because know one firm will be either capable of or able to conceive the different ways the discovery might be exploited. [Many eyes... open source] The social welfare analysis of this situation is not straightforward, however. Even though knowledge, once developed, can be shared a little additional cost and may be best exploited through broad access, it does not follow the social welfare is maximised by mandating low-cost access is such access dampens the incentive to develop for a social to begin with. Many of the same kind of working solutions that mitigate the prospect of an anticommons also apply to the issue of access for research. Our interviews suggest that the most common working solutions however is infringement under the guise of a "research exemption" that is broader than the existing legal exemption and is supported by norms of trust and exchange in the research community. One can rationalise the failure of the IP holder to aggressively monetary infringement as a form of price discrimination that can improve social welfare.

There are two central questions to ask when considering the effects of a given research tool patents on the progress of biomedical research. The first has to do with the specifics of the biology in question -- does current scientific knowledge provide us with many or only a few opportunities for modifying the biological system in question? Where there are many opportunities, the likelihood of a research tool patents impeding research is smaller. [Charles Lawson; but the human genome, for example, is is effectively a standard.] The second question has to do with the specifics of the legal rights in question -- does the scope of claims in this patents for cover few or many of the research activities using that technology? (P 55, Rochester versus Searle-Pharmacia COX-2) through a combination of like an appropriate institutional response, we appear to have avoided situations in which is a single firm organisation users is patents to impede research in one or more broad therapeutic area is. However, we must remain watchful of the danger that a broad area of research could be blocked off by patents holder trying to reserve the area exclusively for itself. The question is whether something systematic needs to be done. One possibility is a revision of the law providing for research exemption is to better reflect the current norms and practices of the biomedical research community. However, is not easy to tell when researchers commercial or non-commercial irrespective of the type of institution doing a research. So it isn't apparent that society would benefit from a policy response as opposed to continuous reliance on current ad hoc practices of infringement under the informal rubric of "research exemption". [Except that firms are obliged to keep aside a large amount of money as insurance against patent infringement suits and this is a social waste.]

Although there is some cause for optimism, we cannot rule out future problems resulting from patents currently under review, new shifts in technology, court decisions or even assertion of patents on foundational discovery is. We expect that from time to time new technologies and new entrants, or those shifting from a repeated play to an endgame strategy, will create problems. Yet the system empirically observed has appeared to develop a robust combination of working solutions for dealing with these problems. The issues that these solutions can take time and expense to workout and the results may not be optimal from either a private or social welfare perspective even if research generally moves forward. The assumption of the patent system is that the benefits to biomedical innovation through provision of incentives to invest in R&D our ways this cost. [Peter Drahos asserts the patent system is not for incentives to invest in R&D in a risky environment but for guaranteed public returns on private investment.] Therefore, the conclusion of this paper is that the industry seems to be succeeding, albeit not without some difficulty, in developing and accommodation that incorporates though the need to provide strong incentives to conduct research and the need to maintain free space for discovery. These issues may need to be revisited in future. [Interpretation of results is that in biomedicine, the conditions for anticommons tragedy and/or blocking of access in the cumulative innovation model have empirically been observed to exist, but that in practice research is generally not impeded. Bearing in mind these results related biomedicine rather than agricultural biotechnology, we may also observed that research goes ahead at potentially significant social cost and the question is whether this social cost is justified by the incentive effect of allowing patents on research tools -- a difficult question to answer. Moreover, some of these workarounds may be inaccessible to low income public research organisations in the developing world, and also some of them rely on the development of public research tools and information databases, which is what open source aims to encourage. So it is possible to see open source as one of a range of workarounds, and one that may be more accessible to poorer organisations. It also doesn't make sense to say (necessarily at any rate) that the law is fine because people are able to avoid its consequences by infringing legal rights. The cost of revision of laws that only work when they are ignored may be high and not worth paying, but that is a separate question which is not been answered by empirical studies.]

References:

Walsh, John P., Ashish Arora, and Wesley M. Cohen. 2002. The Patenting and Licensing of Research Tools and Biomedical Innovation: United States National Academies' Science, Technology and Economic Policy Board.

Straus, Joseph, Henrik Holzapfel, and Matthias Lindenmeir. 2002. Empirical Survey on "Genetic Inventions and Patent Law". Munich.

Campbell, Eric G., Brian R. Clarridge, Manjusha Gokhale, Lauren Birenbaum, Stephen Hilgartner, Neil A. Holtzman, and David Blumenthal. 2002. Data Withholding in Academic Genetics: Evidence from a National Survey. Journal of the American Medical Association 287 (4):473 - 479.

Lawson, Charles. 2002. Patenting genes and gene sequences and competition: patenting at the expense of competition. Federal Law Review 30:97-133.

{Barton, 1999 #384}

Initiatives to improve access to biomedical research tools

[Note and apology: this page is very much still under construction! It will be revised as soon as possible. - January 2003.]

D. regulation - during 1990s hte NIH was drawn into a series of high profile controversies involving sponsored research contracts, research tool and data horading - sponsored research: Scripp/Sandoz affair triggered NIH issuing a detailed setof consdieration that universities should observe when negotiating future sponsored reserach transactions - "NIH Sponsored Research Considerations" 1994; data sharing: Bermuda Protocol 1996; NIH has never officially adopted, but did require grantees to reslease as raplicly as possible and hortatry statements uring grantees not to patent data; in 200o NIH announced it would invoke the Bayh Dole exceptional circumstances clause to prevent mouse genome researchers from filing patents and a similar declaration has been issued in relation to national Cancer Institute. The biologists have been reluctant to extend the protocol beyond DNA sequence information; in 2001, the Wellcome Trust convened a meeting aimed at extending the protocol is to protest sequences, but this failed. Research tools: comprised roughly a quarter of all university technologies and historically were freely transferred to any competent scientists, but in the late Seventies some universities began requiring recipients to sign form contracts that contained a range of problematic causes and NIH reacted by encouraging participants to develop a new form for use between non-profit institutions: the uniform biological materials agreement (1995. I new set of guidelines was issued in 1999: NIH principles and guidelines for research tools 1999. (See pages 63-64). Mouse wars illustrates pressure is sometimes effective but benefits of pressure from NIH are limited to academic scientists and DuPont's ability to exploit exclusive rights with respect to commercial customers remains unaffected. Open source: three commercial software developers have circulated a petition that asks NIH and NSF to require grant recipients to make or bioinformatics software available under the open source and free software license terms, but NIH has expressed concern that this would violate Bayh Dole by depriving universities of the right to grant exclusive licences that; yet NSF panels trade open source licences as a positive factor in reviewing grant proposals

References:

Maurer, Stephen M. 2002. Promoting and disseminating knowledge: the public/private interface. Washington DC: National Research Council.

Alliance for Cellular Signaling 2002 [cited 3 January 2003]. Available from http://www.cellularsignaling.org/.

Carlson, Rob. 2000. Intentional Biology: Open Source Biology, v1.0. Available from http://www.intentionalbiology.org/osb.html.

Knight, Tom. Idempotent Vector Design for Standard Assembly of Biobricks. MIT Artificial Intelligence Laboratory, http://www.syntheticbiology.org/docs/sa3.pdf http://www.syntheticbiology.org/docs/sa3.pdf

Reichman, J. H., and Paul F. Uhlir. 2002. Promoting Public Good Uses of Scientific Data: A Contractually Reconstructed Commons for Science and Innovation.

Rai, Arti K., and Rebecca S. Eisenberg. 2001. The Public and the Private in Biopharmaceutical Research. Paper read at Conference on the Public Domain, at Duke University School of Law, Durham, North Carolina, November 9-11, 2001.

Marshall, Eliot. 2001. Bermuda Rules: Community Spirit, With Teeth. Science 291 (5507) (16 February 2001):1192.

Agricultural biotechnology

In agricultural biotechnology, a dramatic series of mergers and acquisitions have taken place over the past five or 10 years that have resulted in a large proportion of fundamental research tools ending up in the hands of a small number of big multinationals.

In one sense this does not fit Heller and Eisenberg's description of the tragedy of the anticommons , because merging with one another is one way that industry players can overcome the costs of negotiation and build up useful-sized bundles of rights: in other words, the merger is one type of Merges' "institution-forming success". But it would be surprising if such a high level of industry concentration had no adverse effects on further innovation. Moreover, although there are several possible explanations for the recent consolidation of agricultural biotechnology firms, some empirical evidence suggests that the changes have been driven largely by intellectual property management considerations.

Inefficiencies associated with restricted access to intellectual property in agricultural biotechnology

Among private corporations in agricultural biotechnology, an extreme form of transaction cost-lowering institution has emerged. Unable to afford the costs of obtaining and enforcing patents on their own, companies have resorted to mergers, described by Barton as "the ultimate cross-licence". [243] As a result, key intellectual property rights in agriculture are held by a small number of powerful firms, largely protected from the costs of litigation by the deterrent effect of mutually assured destruction.[244] While this outcome may constitute institution-forming success from the point of view of the major players, the effect of this market concentration has been to raise the barriers to market entry of others wishing to participate in research and development in agricultural biotechnology, because -- apart from anti-trust laws -- there is nothing to deter industry leaders from using their intellectual property portfolios against outsiders. [245] In other words, problems with maintaining a healthy competitive market, acknowledged by Merges as a possible downside to the formation of transaction-cost lowering institutions, are apparent in the context of agricultural biotechnology.

While the major private sector players have minimised the costs of bargaining over proprietary research tools through consolidation, there is evidence that other members of the agricultural biotechnology community are experiencing the effects of bargaining breakdown. As in the case of biomedical research, the problem affects different types of institutions differently. With respect to obtaining revenue by licensing out to other researchers, some institutions own very little intellectual property, while others (including many universities) may own substantial intellectual property portfolios, but face difficulties in relation to effective management and marketing. [246] With respect to gaining access to research tools (licensing in), the clearest distinction is between research institutions in developed and developing countries.

Researchers in developed countries are frequently under the misapprehension that they do not need to obtain permission to use other people's technology on the basis that they and their institutions are protected from any infringement action by a research exemption. [247] While sui generis regimes protecting plant breeders' rights do provide for a research exemption, many research tools in agricultural biotechnology are protected by patent rights, and as discussed in the previous chapter, patent law does not contain a significant research exemption. [248] In many cases in the actual risk of being sued for infringement may be quite low, and the penalty imposed even after a successful infringement action relatively light, especially where the research in question is clearly non-commercial. [249] However, as public and non-profit research institutions form closer relationships with industry and alter their activities to minimise the impact of declining external funding, the distinction between commercial and non-commercial research becomes increasingly blurred; thus, the risks associated with infringing uses of research tools in developed countries are likely to increase. [250]

By contrast, researchers in less developed countries are inclined to overestimate the risks associated with using other people's technology. [251] Nottenburg et al report a common misconception that a patent awarded in one country confers property rights in all countries.[252] In fact, the cost of obtaining protection in many different countries is such that most inventions are patented in just one or a few developed countries with large markets: in 1998, the number of patents granted in the US, Europe and Japan accounted for about 80 percent of the world's patents, and it is likely that most of the remainder were also granted in developed countries. [253] Although problems might theoretically arise with regard to technologies destined for crops grown in developing countries if those crops were subsequently exported to countries where the relevant intellectual property is protected, it has been shown empirically that exports from developing to developed countries are generally dwarfed by production and consumption in the developing world and that the value of these exports is concentrated in a few crops and a few exporting countries. [254] Thus, researchers in less developed countries are probably not seriously constrained by intellectual property considerations in the strict legal sense. (Depending on the manner in which developing countries choose to implement their obligations under TRIPs, this may soon change: in many developing countries, new patent laws are starting to come into effect such that technologies previously legally available to researchers in those jurisdictions will be protected.[255]) Rather, the chief current intellectual property-related problem for research institutions in developing countries is ignorance about intellectual property policy and an associated lack of capacity to manage intellectual property effectively; these deficiences prevent such institutions from taking advantage of their relative freedom from legal constraints.[256]

In this connection it must be acknowledged that restrictions (real or perceived) on access to proprietary research tools are not the only obstacle to further research and development in agricultural biotechnology -- just as successful research and development will not by itself solve the problem of food insecurity in developing countries. [258] Nottenburg et al point out that the real problems facing research institutions in many developing countries are a lack of local investment in science and limited experience and expertise in using and regulating, as well as accessing, modern biotechnologies.[259] C. S. Prakash also regards problems of access to proprietary technologies as just one of several factors standing in the way of applying biotechnologies in the agriculture of developing countries; in addition to those identified by Nottenburg et al, he refers to the spread of disinformation by major agricultural technology companies about matters relating to the most needy sectors of developing country agriculture, conduct which has led to a serious loss of trust.[260] In developed countries, the real hurdle for public and non-profit research institutions is the commercialisation of research results; [261] in many cases obtaining freedom to operate regarding intellectual property may be less of a barrier to commercialisation than other factors, such as a lack of acceptance of genetically modified products and uncertain government regulation. [262] Nevertheless, problems of ensuring ongoing access to proprietary research tools are acknowledged as important by members of the agricultural biotechnology community, including international aid agencies. [263] Even if intellectual property issues represent only one thread in a bigger tangle, extricating one thread can sometimes set the whole knot unravelling: easing problems of access to research tools could leave researchers free to work on the genuine scientific problems underlying consumer backlash and uncertain regulation, while developing country researchers have suggested that clearing the intellectual property logjam in developed countries would in itself go a long way to helping developing countries gain access to new technologies. [264]

[To be added: notes from Janet/Word version GBC #2.doc - industry effects subsection on market concentration in agbiotech]

Notes

[243] [Nottenburg, 2002 #373], page 25

[244] [Blakeney, 2001 #371], page137.

[245] [Blakeney, 2001 #371], page137; [Nottenburg, 2002 #373], page 21, citing Barton, J. H. (2000), "New International Arrangements in Intellectual Property and Competition Law", presented at the Swedish International Symposium on Economics, Law and Intellectual Property, Goteburg, Sweden, 26-30 June, page 8.

[246] [Graff, 2001 #376], pages 28-31.

[247] [Nottenburg, 2002 #373], page 7.

[248] [Blakeney, 2001 #353], page 129; [Nottenburg, 2002 #373], page 7; generally, [Eisenberg, 1989 #58]; [Division, 2001 #287] pages 15-16.

[249] [Nottenburg, 2002 #373], pages 9-10.

[250] [Nottenburg, 2002 #373], pages 11-14.

[251] [Graff, 2001 #376], page 18, summarising a presentation by John Barton.

[252] [Nottenburg, 2002 #373], page 5.

[253] [Nottenburg, 2002 #373], page 5.

[254] [Division, 2000 #289].

[255] [Nottenburg, 2002 #373], page 32; [Graff, 2001 #376], page 18, summarising a presentation by John Barton, and page 34. For a detailed discussion of TRIPS obligations relevant to agricultural biotechnology (including proposed changes to the TRIPs agreement), see [Barton, 1999 #379]... (note to myself: only partly read as at June 7 2002) and [Blakeney, 2001 #353], p129 and 139.

[256] [Graff, 2001 #376], page 29.

[257] Has been deleted.

[258] Other problems relate to markets and transport, incentives, agricultural inputs, and improving other technologies: [Graff, 2001 #376], pages 26-27, summarising a presentation by Robert Herdt.

[259] [Nottenburg, 2002 #373], page 32. See also [Graff, 2001 #376], page 20, summarising a presentation by Brian Wright.

[260] [Graff, 2001 #376], pages 18-19.

[261] [Nottenburg, 2002 #373], page 11; [Graff, 2001 #376], page 29.

[262] [Graff, 2001 #376], page 15.

[263] See generally [Graff, 2001 #376].

[264] [Graff, 2001 #376], page 31.

References:

King, John L. 2001. Concentration and Technology in Agricultural Input Industries: United States Department of Agriculture Economic Research Service.

Graff, Gregory D, Gordon C. Rausser, and Arthur A. Small. 2001. Agricultural Biotechnology's Complementary Intellectual Assets. In Social Science Research Network Electronic Library.

Fulton, Murray, and Konstantinos Giannakas. 2001. Agricultural Biotechnology and Industry Structure. AgBioForum 4 (2):137-151.

Rural Advancement Foundation International 2002. Ag Biotech Countdown: Vital Statistics and GM Crops, Update June, 2002.

Drahos, P., and J. Braithwaite. 2002. Information Feudalism: Who Owns the Knowledge Economy? London: Earthscan.

Graff, Gregory D. 2002. The Sources of Biological Innovation in Agriculture: Comparative Advantages of Public, Entrepreneurial, and Corporate R&D. ?

{Barton, 1999 #384}

Blakeney, Michael. 2001. Intellectual Property Rights and Global Food Security. Bio-science Law Review 4 (4):127-140.

Initiatives to improve access to proprietary research tools in agricultural biotechnology

The previous section highlighted the existence of problems with negotiating access to research tools in agricultural biotechnology. The next section makes the point that it is precisely those institutions which are currently excluded from the oligopoly established by major private sector firms -- public and non-profit institutions in both developed and developing countries -- which are most likely to contribute to social welfare by conducting research and development that might help solve the problem of food insecurity in developing countries and allow proper risk assessment of future generations of biotechnology products.

Given a need to improve access to proprietary research tools for public and non-profit institutions in agricultural biotechnology, what are the options? Adopting the non-profit perspective (with some emphasis on agencies operating in less developed countries), Nottenburg et al have evaluated a number of options for obtaining access to other people's technology, among them several which would fall into Merges' category of transaction cost-lowering institutions. [265]

The first option is crosslicensing. Observing that this is a popular solution for deals among agricultural biotechnology oligopolists, Nottenburg et al consider the possibilities for out-licensing by public and non-profit institutions in exchange for access to privately owned technology. They conclude that, as indicated earlier, for these institutions crosslicensing tends to be more part of the problem than a solution. [266] One reason is that the number and value of intellectual property bargaining chips held by most public agencies operating in or for less developed countries is tiny compared to those available to large private sector firms. This is partly due to the way public agencies have been constituted -- for example, of the approximately 670,000 accessions of germplasm held by the International Agricultural Research Centres (IARCs) of the Consultative Group on International Agricultural Research (CGIAR), approximately 520,000 cannot be used in bargaining with the private sector because they are held in trust under a 1994 agreement with the United Nations Food and Agriculture Organisation (the FAO Trust Agreement) to be made freely available to public and private sector researchers alike. [267] It is also partly due to the sheer difference in resources available to the public and private sectors. Nottenburg et al illustrate the point by comparing the collective expenditure on biotechnology research of the CGIAR centres in 1998 -- US$25 million -- with the expenditure of Monsanto (now Pharmacia) in the same year -- US$1,263 million. [268]

The second option for non-profit and public research agencies is to obtain low-cost, research-only licenses from owners of research tools. Nottenburg et al note that while this option does have some advantages for the licensee, they are often outweighed by the difficulties encountered if the research project succeeds and the researcher wishes to commercialise or otherwise disseminate the results: at this stage the researcher is at a disadvantage in bargaining for a broader licence, as the costs of the research have already been incurred. [269] The third option is to employ market segmentation strategies based on geography, field of use, length of licence, or other criteria, the idea being that the owner of a research tool will be more willing to grant access to the tool if the owner's profits are not likely to be threatened by its use. [270] A related option is to negotiate licence fees which are scaled according to the licensee's ability to pay or the amount of profit the licensee expects to gain from the use of the research tool. (Nottenburg et al outline an initiative for market segmentation of pharmaceuticals with large potential markets in both developed and less developed countries which would effectively require patent applicants to choose between enforcing their patents in developed countries or developing countries, but not both; they suggest that plant biotechnology patents could be included in this scheme. [271]) The difficulty for public and non-profit research institutions in relying on market segmentation strategies and scaled fees is that successfully negotiating agreements that embody these strategies requires substantial expertise and other resources. [272]

The fourth option listed by Nottenburg et al is to forge links with owners of research tools through mergers or joint ventures. [273] Noting that for many public research institutions privatisation through merging with a private company is neither feasible nor desirable, they suggest that joint ventures between public research institutions and industry can deliver significant benefits. However, such relationships can be controversial, for example because of concerns about conflicts of interest and undue influence on the part of the industry partner on the conduct of research or dissemination of results. [274] Similar concerns arise in relation to a further option identified by Nottenburg et al, that of obtaining direct programmatic research support from the private sector. [275] From the private firm's viewpoint, the provision of such support may be motivated by the prospect of close contact with the innovative activities and expertise of the public sector institution; for example, a firm might sponsor a research program in a university laboratory in order to be able to recruit graduate students trained in skills that are highly valuable to the firm. Another motivation for a company to provide such support might be the chance of obtaining tax deductions in exchange for unused, perhaps useless, technology. [276] Some private firms appear to have taken this approach to the extreme by making well-publicised free donations to public research institutions of technology to which the private firm does not in fact have an exclusive right, for example because the relevant patents have expired or are otherwise invalid. [277] Genuine cost-free licences may sometimes be available for technologies relating to crops which are not of any commercial interest in developed countries, but Nottenburg et al warn that in such cases the private firm will want to be protected from blame, loss of reputation or liability for misuse of the technology in countries that lack effective regulatory oversight. [278] (They do not mention liability for harm caused by proper use of the technology, perhaps because even though current biotechnology regulation even in developed countries does not in fact exclude the risk of such harm, it would be almost impossible for victims of harm to prove liability.[279])

Other options canvassed by Nottenburg et al involve forging alliances with other institutions outside the private sector. One such option is for public or non-profit institutions to ally with independent developers of research tools who may sponsor the creation of substitutes for existing proprietary tools -- that is, "inventing around" intellectual property rights, a strategy which is beyond the resources of many non-profit institutions acting on their own. [280] One such independent institution is the Centre for Applications of Molecular Biology in Agriculture (CAMBIA), which develops agricultural biotechnology research tools unencumbered by restrictive proprietary claims; these tools are made available to other research institutions on an ability-to-pay basis. [281] Another option which relies on taking advantage of common interests within the public sector is for non-profit and research institutions to get together with powerful allies such as the NIH (which has made a commitment to encouraging the free dissemination of research tools in biotechnology generally: see footnote [162] above) and apply political pressure for owners of intellectual property rights to make concessions in favour of international agricultural non-profit research and its dissemination to non-commercial markets.[282]

The two remaining options listed by Nottenburg et al are closely related and have been left until last because they one of them is discussed in greater detail in the next section. The first of these options is for prospective users of research tools to obtain a joint grant of freedom to operate in certain markets from all holders of relevant intellectual property rights, through the owners' membership of a patent pool which bundles members' intellectual property rights and licences the bundles to third parties. [283] This option may not be feasible as a long term solution to the access problems experienced by public and non-profit institutions because the operation of the patent pool, and thus the availability of particular bundles of licences, would be beyond their control. A more promising option is for members of the agricultural biotechnology community generally (or a subset of that community, including public and non-profit institutions) to establish some kind of collective rights organisation which could perform a range of functions, including that of assembling useful bundles of intellectual property rights belonging to members and possibly also to non-members. [284]

A number of voices have advocated the formation of such an institution in the field of agricultural biotechnology. Peter Drahos proposes a global bio-collecting society (GBS) to help overcome problems of uncertainty and enforcement that confront life sciences companies and indigenous groups contracting over the use of knowledge relating to plant material. [285] The proposed GBS would be analogous to collecting societies which already exist in the copyright area, but would differ in two important respects. First, it would be a single international organisation, because this would promote greater transparency and would serve the interests of indigenous groups better than having many national societies.[286] Second, protecting the interests of the indigenous intellectual property owners would be a primary but not an absolute duty of the proposed GBS: it would be chartered to serve the broader purposes specified in the Convention on Biological Diversity and perhaps also the International Undertaking on Plant Genetic Resources.[287] Drahos suggests that a GBS could be set up as a private organisation outside the context of any treaty negotiation, that it could be funded by the World Bank, and that membership should be open to companies as well as indigenous groups.[288] Membership would be optional: if the GBS proved helpful to contracting parties, it would automatically attract and keep enough members to continue functioning.[289] Drahos analyses the advantages of a GBS for indigenous groups and members of the life sciences industry and concludes that both groups would have sufficient incentive to participate. [290]

Drahos proposes five functions for a GBS. First, it could be a repository for confidential community registers of indigenous knowledge. Companies could access the register to the extent of identifying which group had made an entry and could then approach that group directly.[291] Second, it could facilitate negotiations between indigenous groups and third parties, including by keeping a register of independent legal experts willing to assist indigenous groups in such negotiations. [292] Third, it could monitor the global use of indigenous knowledge by conducting regular checks of patent applications or by keeping information about the use of licensed knowledge. [293] Fourth, it could help to resolve disputes. Drahos suggests a standing committee which would publicly examine the conduct of parties to dispute and make recommendations. These recommendations would not be legally binding, but any party who ignored the committee's recommendations could be excluded from the GBS and would be publicly shamed. Drahos emphasises that for this approach to be effective, the members of such a committee would need to be, and be seen to be, independent and impartial. [294] Finally, a GBS could have some kind of standard setting function. For example, it could bring representatives from industry, national governments and indigenous groups together to develop an authoritative code of conduct for the negotiation of a biodiversity prospecting contract. [295] This function would be similar to that performed by national funding agencies such as the NIH in promoting sharing of research tools through guidelines and the development of model contracts like the Uniform Biological Materials Transfer Agreement (referred to in footnotes 93 and 162 above).

Other, similar, proposals relate to the establishment of a collective rights organisation for international agricultural research generally. [296] The most highly developed of these proposals envisages membership being limited to public and non-profit institutions, but some discussions have also canvassed the participation of industry. [297] One group of scholars working towards a detailed model of an intellectual property clearinghouse for international agricultural research is located at the UC Berkeley Center for Sustainable Resource Development. [298] The following subtopic highlights some of the features of this group's current model.

Notes

[265] [Nottenburg, 2002 #373], pages 19-32.

[266] [Nottenburg, 2002 #373], pages 19-21.

[267] [Nottenburg, 2002 #373], page 20.

[268] [Nottenburg, 2002 #373], page 21.

[269] [Nottenburg, 2002 #373], pages 21-22.

[270] [Nottenburg, 2002 #373], pages 22-25.

[271] [Nottenburg, 2002 #373], page 25.

[272] [Nottenburg, 2002 #373], page 22.

[273] [Nottenburg, 2002 #373], pages 25-26.

[274] [Nottenburg, 2002 #373], page 26.

[275] [Nottenburg, 2002 #373], pages 27-29.

[276] [Nottenburg, 2002 #373], page 28.

[277] [Nottenburg, 2002 #373], page 27.

[278] [Nottenburg, 2002 #373], page 27.

[279] See, for example, Report of the Royal Commission on Genetic Modification, Wellington, New Zealand, July 2001, chapter 12: "Liability Issues".

[280] [Nottenburg, 2002 #373], pages 30-31.

[281] [Nottenburg, 2002 #373], pages 30-31. Richard Jefferson, founder of CAMBIA, sees the future of genetic engineering in agriculture as a tool for developing new crop varieties which can then be bred using conventional techniques. If successful, this approach would satisfy those who object to genetic engineering on the ground that genetically engineered plants contain combinations of genes that could never have come together through evolutionary processes. See, for example, Wills, P. R., "Disrupting Evolution: Biotechnology's Real Result", in [Hindmarsh, 1998 #2], pages 66-80.

[282] [Nottenburg, 2002 #373], pages 31-32.

[283] [Nottenburg, 2002 #373], pages 29-30.

[284] [Nottenburg, 2002 #373], page 30.

[285] [Drahos, 2000 #372]. The process of obtaining new plant genetic material from geographic areas with high biodiversity levels, as it happens located exclusively in developing countries, is known as "bioprospecting".

[286] [Drahos, 2000 #372], page 248.

[287] [Drahos, 2000 #372], page 248. Both the Convention on Biodiversity and the International Undertaking on Plant Genetic Resources are also discussed by Blakeney: [Blakeney, 2001 #353].

[288] [Drahos, 2000 #372], page 248.

[289] [Drahos, 2000 #372], page 248.

[290] [Drahos, 2000 #372], page 249-250.

[291] [Drahos, 2000 #372], page 248.

[292] [Drahos, 2000 #372], page 248.

[293] [Drahos, 2000 #372], page 248.

[294] [Drahos, 2000 #372], page 248.

[295] [Drahos, 2000 #372], page 249.

[296] See Prakash, C.S., Ives, C. and Comstock, G., Minutes form the Technology Transfer Meeting, World Food Prize Symposium, October 12 and 13, 2000 cited in [Graff, 2001 #377] at page 10; [Graff, 2001 #376], pages 26 to 27, summarising a talk by Robert Herdt of the Rockefeller Foundation; Rockefeller Foundation, McKnight Foundation, and Meridian Institute, "IP Sharing for Public-Sector Agricultural Research adn Development", Discussion Paper, New York, February 2002, cited in [Bennett, 2002 #378]; [Nottenburg, 2002 #373], page 30.

[297] [Bennett, 2002 #378].

[298] Initiative on Intellectual Property Clearinghouse Mechanisms for Agricultural Research, http://www.CNR.Berkeley.EDU/csrd/technology/ipcmech/, last visited 4 June 2002.

References:

Reichman, J. H., and Paul F. Uhlir. 2002. Promoting Public Good Uses of Scientific Data: A Contractually Reconstructed Commons for Science and Innovation.

Carlson, Rob. 2000. Intentional Biology: Open Source Biology, v1.0. Available from http://www.intentionalbiology.org/osb.html.

Knight, Tom. Idempotent Vector Design for Standard Assembly of Biobricks. MIT Artificial Intelligence Laboratory, http://www.syntheticbiology.org/docs/sa3.pdf http://www.syntheticbiology.org/docs/sa3.pdf

Michaels, Tom. 1999. General Public Release for Plant Germplasm: A proposal by Tom Michaels, Professor of Plant Agriculture, University of Guelph, v1.1, 26, February 1999. Available from http://www.oac.uoguelph.ca/www/CRSC/pltag/1998-99/gnucrop2.htm

Centre for the Application of Molecular Biology to International Agriculture: Intellectual Property Strategy and Management, http://www.cambia.org/main/a_ipsm2.htm

An Intellectual Property Clearinghouse for international agricultural research

(a) need for a collective solution

In a 2001 article in Nature Biotechnology, Graff and Zilberman outline the need for a collective solution to the tragedy of the anticommons in agricultural biotechnology and introduce the concept of an intellectual property clearinghouse.[299] Their arguments follow the same lines sketched in this literature review, but are set out here in order to refresh the reader's memory.

Graff and Zilberman begin by noting that the effectiveness of patent system turns on two factors: the definition of what is patentable, which demarcates private property from the public domain, and the efficiency of mechanisms available for trading in patent rights. Therefore, any critique of the patent system can focus on the scope or definition of what is patentable or on issues surrounding the exchange of patent rights (or both). Graff and Zilberman argue that by focusing on the exchange of patent rights, significant improvements in freedom to operate can be achieved no matter what shape patent policies end up taking. [300]

Graff and Zilberman point to the existence of a tragedy of the anticommons in agricultural biotechnology, asserting that the current fray of agricultural biotechnology patenting has two effects: first, the interdependent or complementary nature of intellectual property rights in this area is being lost in the subdivision among multiple private property claims, and second, difficulties in negotiating and managing access to needed intellectual property saps the power of private incentives to innovate. The cumulative result, they say, is a dampening of research and innovation productivity -- a "tragedy of the anticommons". [301]

Graff and Zilberman go on to consider the options both for individual companies pursuing freedom to operate within a congested intellectual property landscape and for government intervention to solve the problems just mentioned. [303] Both may involve the formation of collective rights organisations, a subset of Merges' "transaction cost-lowering institutions". Graff and Zilberman argue that private collective rights organisations have historically been more economically efficient than government-invoked organisations, sometimes providing substantial savings for whole industries. [304] Further, they argue that advances in information technology have created new tools for intellectual property information management and marketing that open up new organisational possibilities for collective intellectual property rights organisations, suggesting that problems that have plagued past attempts to lower transaction costs in this area (such as online intellectual property informatics and patent exchange services) can now be overcome. [305]

Like that of Drahos' global bio-collecting society, the goal of the intellectual property clearinghouse proposed by Graff and Zilberman would be broader than merely to serve the interests of intellectual property owners. They believe that a clearinghouse could serve as a focal point for the management of public sector intellectual property related to the agricultural life sciences, to enable the widest possible commercial adoption of relevant technologies and to promote access for research and humanitarian use.[306] Its purpose would be to reduce transaction costs and other market failures that hinder the exchange of intellectual property, creating pathways through the patent thicket and giving access for researchers to, and commercial freedom to operate with, proprietary biotechnologies. [307]

Such an intellectual property clearinghouse would, it is argued, have a range of beneficial effects. It could serve to level the playing field and free up agricultural research. It could reduce the drive for firms to consolidate in order to obtain complete in-house control of complementary technologies and enable them to improve their product design as innovation would be less constrained by current intellectual property holdings. It could help to move appropriate technologies out into regional and applied agricultural research systems around the world and provide incentives and means for current outside players to strengthen their agricultural research capacities. Finally, it could help agricultural research define and maintain a healthy balance between public and private forces and grow along a more efficient, safe and beneficial trajectory.[308]

(b) Essential functions of an IP clearinghouse

(i) Information

(ii) Negotiation

The second function of an intellectual property clearinghouse, like the first, would start by improving on services which already exist but are not entirely satisfactory. Some recently founded online patent and technology licensing services have pioneered information technology tools designed to assist negotiations by matching prospective parties to a transaction and providing pricing information. [321] Though promising, these services are limited in their capacity to manage multi-party, multi-patent transactions and, like most existing IP informatics data sources, they have not yet achieved critical mass with respect to the specific intellectual property relevant to agricultural biotechnology research. [322] Besides matching parties and establishing prices or pricing indicators, the staff of an intellectual property clearinghouse could negotiate with technology providers to allow multiple complementary patents to be bundled into "micropools" and sublicensed to users under single contracts; [323] such multi-patent licences could be constructed to provide access to "research tool boxes" containing all the platform technology required for a particular agronomic or plant system. [324] Staff of a clearinghouse would also actively pursue flexible licensing strategies, including customised packages for particular licensees. [325] By acting as an honest and reliable broker, an intellectual property clearinghouse could facilitate negotiations between parties who might have problems of trust or confidence due to cultural barriers or negative past experience.[326] It would emphasise fair trading, avoiding reach-through agreements and other restrictive licensing provisions, offering scaled fees determined by ability to pay and renegotiating licences with each change of intellectual property ownership.[327] Because biosafety considerations strongly affect the value of a technology, keeping track of which components of a technology system have been approved for which uses in which countries is an important part of conducting biotechnology negotiations; an intellectual property clearinghouse could could help by maintaining data about the current regulatory approval and biosafety status of new technologies in different countries.[328]

(iii) Monitoring and enforcement

The third essential function of an intellectual property clearinghouse would be to help reduce enforcement costs by offering mechanisms for monitoring compliance with negotiated agreements.[329] It could also perform a dispute resolution function at any stage from negotiation onwards, possibly modelled after Drahos' suggestion in relation to the GBS of an independent standing committee.[330] Depending on the nature of the dispute management system adopted, there might be a capacity for providing external review of licence agreements. [331] The intellectual property clearinghouse could also offer practical services such as making arrangements for the shipment of necessary materials between parties or electronically distributing research data. [332]

Once the clearinghouse became effective at performing its basic functions, it could extend its operations in whatever direction its members saw fit, such as IP policy development. There would, of course, be some fundamental constraints. For example, at a recent industry, academia and international development round table to discuss the possibility of an intellectual property clearinghouse, the possibility of working out general deployment agreements with companies and universities for the application of agricultural technologies in all developing countries was raised, but dismissed because it was thought that such agreements would be too inflexible to deal appropriately with heterogeneities within and among developing countries, differences among technologies and the varied interests of technology providers. [333] Similarly, participants in the round table discussion considered that an intellectual property clearinghouse would be better at providing access to research tools -- "enabling" or "process" technologies -- than to specific trait or product technologies, because process technologies raise fewer ongoing regulatory, liability or other product stewardship issues.[334]

(iv) Summary of essential functions

In a recent study directed specifically at the possibilities for corporation among public and non-profit research institutions in agricultural biotechnology, Bennett et al summarise the services which could be performed by a public sector intellectual property clearinghouse by dividing these services into two tiers. [335] The first tier, designed to reduce the cost and uncertainties of intellectual property information, corresponds to the first essential function described above, while the second tier, designed to reduce the transaction costs and uncertainties of intellectual property licensing and to create new commercial opportunities, corresponds to the second and third functions and involves operations similar to those of a patent management company or patent licensing organisation such as a patent pool. [336] Bennett et al propose a series of steps for establishing the services to be provided by an intellectual property clearinghouse to ensure that each new service builds on the infrastructure created by already established services. [337] The advantage of this approach is not only that it helps to focus efforts to set up a clearinghouse in a logical sequence, but that if any of the more elaborate propose services proves unworkable or unnecessary, the more basic services can still be made available. [338]

The steps are as follows: [339]

First tier:

1. Licensing status information collection

2. Regulatory information collection

3. Compilation and analysis of the available public sector intellectual asset base

4. Dissemination of licensing information

5. Dissemination of licensing standards and best practices

6. Advisory consulting and professional training

Second tier:

7. Patent sublicensing through an incorporated legal entity that could take on options, licences or assignments of IP from member and nonmember IP providers and sublicence to users

8. Patent pooling -- rights obtained from multiple IP providers that are identified to cover complex technology systems could be prepackaged into patent pools to be sublicensed in single transactions

9. Proactive IP management.

This final step would involve the identification of new opportunities arising out of established services. Bennett et al give examples: shopping lists of needed technologies to be fulfilled by the clearinghouse approaching rights holders and seeking sublicences; updating and optimising of pools on an ongoing basis; adding new and phasing out pools; obtaining key technologies from private sector sources to round out and assemble better sublicensing opportunities; and active licence marketing of unlicensed technologies of participating IP providers so as to increase the attractiveness of those technologies. [340] Eventually, it is suggested, the intellectual property clearinghouse could become proactive in research and development by interfacing with grant agencies to help identify areas where technology bottlenecks block freedom to operate.[341]

(c) Potential users of an IP clearinghouse

The advantage of developing a model which does not rely on the participation of large commercial firms is that it allows those organisations whose activities are most hindered by the current "tragedy of the anticommons" in agricultural biotechnology, and who share similar missions, to reconcile their differences and improve their situation before tackling the more difficult problem of negotiating with organisations whose mission is fundamentally different. However, there is no reason in principle to exclude any particular sector of the agricultural biotechnology research and development community from a collective rights organisation. As was established at the round table discussion mentioned earlier, the success of such an institution must be measured in terms of the system as a whole, not by reference to the interests of any particular participants.[344]

In fact, more general discussions regarding the establishment of an intellectual property clearinghouse have revealed incentives to participate for all members of the agricultural biotechnology community. Graff and Zilberman suggest that those already actively patenting in agricultural biotechnology are the most likely initial participants both as the main suppliers and the most active users of proprietary technologies. [345] In this category would be leading multinationals, some universities and smaller laboratories and biotechnology firms. From the industry leaders' perspective, licensing, even outside the oligopoly, may sometimes be more profitable than exclusive use, provided the firms involved can protect themselves from liability, negative publicity and use of the technology in competition with the firm's paying customers.[346] Universities would benefit from any system which allowed them to licence currently unlicensed and unused technologies, or to grant non-exclusive licences where they currently have no alternative but to licence exclusively.[347] Like universities, smaller laboratories and biotechnology firms are often in possession of individual technologies which would be more valuable as part of a package; a clearinghouse would benefit them by providing a secure outlet for their technology or a source of the complementary pieces they need to commercialise their discoveries themselves.[348]

In addition to these players, Graff and Zilberman point to the existence of many others who are not currently patenting but would benefit from a better functioning intellectual property market. [349] Included in this category would be farmers, agricultural cooperatives and growers' associations; medium and small-scale seed enterprises and nurseries in developed countries and national seed companies of developing countries; many universities, including many land grant and public universities in the US and elsewhere; the CGIAR's International Agricultural Research Centres; National Agricultural Research Services (NARS) of developing countries; and non-government agricultural development organisations.[350] These players would benefit from an international intellectual property clearinghouse for agricultural biotechnology by being enabled to licence in currently unavailable technologies at affordable prices and on reasonable terms, that they would be encouraged to develop and licence out their own inventions on reasonable terms, and that over time this would encourage the development of agricultural research capacity within those organisations. [351] The possibility of achieving this latter result through the operation of an intellectual property clearinghouse could also attract non-profit funding agencies as participants (Catherine Ives gives the Rockefeller Institute and USAID as examples).[352]

(d) structure and governance

Discussions about the prospect of an IP clearinghouse have left other issues of structure and governance open, but have specified key design criteria. Specifically, participants have emphasised that confidence and trust are crucial to the success of any attempt to promote cooperation between individual technology stakeholders, both in developed and developing countries. [357] To win and retain the confidence of members and potential members, the clearinghouse must have clear and decisive governance (one participant suggested this meant non-consensus governance mechanisms). [358] To maintain trust, the organisation should be independent of each of its members. One way to achieve this independence might be for the clearinghouse to be governed by a Board of Directors drawn from member organisations, and/or external directors of sufficient number to assure the neutrality and objectivity of the Board. [359] There are many possibilities: what matters is that the final shape of the institution reflects the needs and desires of all its members or prospective members and that financial and governance structures are both appropriately distributed among members and transparent, to avoid any problems arising out of conflicts of interest or the formation of destructive coalitions. The clearinghouse must not be perceived as a technology users' club or a technology sellers' marketing tool: this is important both to attract and keep members and to avoid falling foul of competition (anti-trust) laws.[360]

In this context it is worth repeating an important point made by Richard Jefferson of CAMBIA about the design of any collective rights organisation for agricultural biotechnology research: that terms such as "biotechnology", "developing country", "public sector" and "patent" are all generalisations whose detailed meanings will need to be broken down and clarified as the terms of a clearinghouse are spelt out. [361]

(e) next steps

The first recommendation was to define individual intellectual property-related problems clearly and succinctly and set parameters for solving these problems. The second was to seek input from the potential clients of an intellectual property clearing house in agricultural biotechnology in order to assess what elements they would like to see in its design and how they would expect to benefit by participating. It was envisaged that this input would be sought through interviews, focus groups and case studies among agricultural researchers in order to identify actual needs for intellectual property capacity building, information services, patent bundling and pooling, patent exchange and other (not yet specified) mechanisms. In this regard, the round table acknowledged that special care should be taken to assess the needs of the national agricultural research systems of developing countries, which were largely unrepresented at the discussion.

The third recommendation was to focus on access to information, asking what information would be most useful to whom, what interpretation and analysis should offered with it and what opportunities might exist for partnering publicly available information resources with private information tool providers. The fourth recommendation was to develop partnership arrangements within particular sectors of the research and development community: for example, public institutions and universities could pool or combine intellectual property portfolios based on the identification of mutually complementary technology components.

The fifth recommendation was to explore potential strategies for meeting the intellectual property needs of different sectors with common mechanisms. In particular, the round table considered that research and development relating to specialty crops and subsistence crops for developing countries encounter similar problems, so that needs in these areas should be explored simultaneously in case the same solutions were appropriate to both. On the other hand, participants in the round table acknowledged that there is a variety of needs which may require a variety of different solutions: the sixth recommendation was that those involved in developing an intellectual property clearinghouse should expect to take separate steps to reflect different parties' interests.

The seventh recommendation was that potential clearinghouse mechanisms should be pre-tested with empirical studies or simulations. The eighth was to identify in what specific technologies, particularly what research tools, an intellectual property clearinghouse should deal, and to determine what conditions the owners of those technologies would wish to stipulate. The round table noted that, depending on the immediate goal of the clearing house, it will be necessary to identify specific technologies in which freedom to operate is required, to determine the combinations of patents under which they are practicable, and to approach the owners of the rights represented in those patents to negotiate terms of use.

The ninth recommendation from the floor of the round table discussion was to focus on organisational questions of how an intellectual property clearinghouse organisations could be structured and funded. Questions raised included exactly what form a clearing house institution or network of institutions should take; whether the institution should be a single organisation with a commercial arm and a non-profit arm; whether separate services should be established by concerned parties in their own sectors which could then represent them and negotiate on their behalf with others; and whether a central hub to such a network of sector-specific clearinghouses could provide generalised services such as intellectual property information listings and flows of royalty payments. In terms of funding, the round table considered whether private investors would be interested in backing such a venture, and if they were, whether the public sector would view such backing as legitimate.

The tenth and final recommendation was to get beyond the generalities and designate a smaller subset of people to start work on specifics.

Notes

[265] [Nottenburg, 2002 #373], pages 19-32.

[266] [Nottenburg, 2002 #373], pages 19-21.

[267] [Nottenburg, 2002 #373], page 20.

[268] [Nottenburg, 2002 #373], page 21.

[269] [Nottenburg, 2002 #373], pages 21-22.

[270] [Nottenburg, 2002 #373], pages 22-25.

[271] [Nottenburg, 2002 #373], page 25.

[272] [Nottenburg, 2002 #373], page 22.

[273] [Nottenburg, 2002 #373], pages 25-26.

[274] [Nottenburg, 2002 #373], page 26.

[275] [Nottenburg, 2002 #373], pages 27-29.

[276] [Nottenburg, 2002 #373], page 28.

[277] [Nottenburg, 2002 #373], page 27.

[278] [Nottenburg, 2002 #373], page 27.

[279] See, for example, Report of the Royal Commission on Genetic Modification, Wellington, New Zealand, July 2001, chapter 12: "Liability Issues".

[280] [Nottenburg, 2002 #373], pages 30-31.

[281] [Nottenburg, 2002 #373], pages 30-31. Richard Jefferson, founder of CAMBIA, sees the future of genetic engineering in agriculture as a tool for developing new crop varieties which can then be bred using conventional techniques. If successful, this approach would satisfy those who object to genetic engineering on the ground that genetically engineered plants contain combinations of genes that could never have come together through evolutionary processes. See, for example, Wills, P. R., "Disrupting Evolution: Biotechnology's Real Result", in [Hindmarsh, 1998 #2], pages 66-80.

[282] [Nottenburg, 2002 #373], pages 31-32.

[283] [Nottenburg, 2002 #373], pages 29-30.

[284] [Nottenburg, 2002 #373], page 30.

[285] [Drahos, 2000 #372]. The process of obtaining new plant genetic material from geographic areas with high biodiversity levels, as it happens located exclusively in developing countries, is known as "bioprospecting".

[286] [Drahos, 2000 #372], page 248.

[287] [Drahos, 2000 #372], page 248. Both the Convention on Biodiversity and the International Undertaking on Plant Genetic Resources are also discussed by Blakeney: [Blakeney, 2001 #353].

[288] [Drahos, 2000 #372], page 248.

[289] [Drahos, 2000 #372], page 248.

[290] [Drahos, 2000 #372], page 249-250.

[291] [Drahos, 2000 #372], page 248.

[292] [Drahos, 2000 #372], page 248.

[293] [Drahos, 2000 #372], page 248.

[294] [Drahos, 2000 #372], page 248.

[295] [Drahos, 2000 #372], page 249.

[296] See Prakash, C.S., Ives, C. and Comstock, G., Minutes form the Technology Transfer Meeting, World Food Prize Symposium, October 12 and 13, 2000 cited in [Graff, 2001 #377] at page 10; [Graff, 2001 #376], pages 26 to 27, summarising a talk by Robert Herdt of the Rockefeller Foundation; Rockefeller Foundation, McKnight Foundation, and Meridian Institute, "IP Sharing for Public-Sector Agricultural Research adn Development", Discussion Paper, New York, February 2002, cited in [Bennett, 2002 #378]; [Nottenburg, 2002 #373], page 30.

[297] [Bennett, 2002 #378].

[298] Initiative on Intellectual Property Clearinghouse Mechanisms for Agricultural Research, http://www.CNR.Berkeley.EDU/csrd/technology/ipcmech/, last visited 4 June 2002.

Why agbiotech?

A point of comparison with other incipient "tragedies of the anticommons"

Research and development in agricultural biotechnology relies heavily on access to multiple research tools. [210] One reason is that most agricultural biotechnologies are actually packages comprising multiple components. Transformation technology -- the means by which foreign genes coding for desired traits are integrated into a plant genome, allowing the regeneration of whole genetically engineered plants from the transformed tissue -- is a case in point. [211] An essential tool in both commercial crop development and experimental plant biology, transformation requires access to specific gene sequences and functional information, to a range of enabling technologies (including gene introduction methods, promoters and selectable markers), and to germplasm or cultivars into which the novel genes can be integrated. [212] Another reason why scientific exchange is especially important to the progress of research and development in this field is that agricultural biotechnology is not a single discipline: it combines resources from many areas of biology, including crop genetics, breeding, agronomy, pest control and agroecology. [213] For these reasons, innovation in agricultural biotechnology is both cumulative, in the sense that each invention builds on previous inventions, and complementary, in the sense that each invention contains elements derived from more than one source. [214]

Not only does research and development in agricultural biotechnology rely on access to multiple research tools, but these tools are increasingly subject to proprietary controls. Changes in intellectual property laws outlined in the previous chapter have strengthened protection for inventions in agricultural as well as biomedical biotechnology; stronger protection has made molecular biological techniques more profitable and therefore more widely used, which in turn has increased the demand for protection. [215] Legal means of protecting intellectual property in agricultural biotechnology include patents, plant breeders' rights (in the US, Plant Variety Protection Certificates), trademarks, geographical indications, trade secrets and contracts, the first two categories being the most important. [217] (The use of intellectual property in agricultural biotechnology can also be controlled by technical means, such as hybridisation and genetic use restriction technologies -- GURTs -- which render seed unsuitable for replanting or suppress the expression of introduced traits in saved seed.[218]) While legal rights are established by national legislation and court decisions, in practice their content is determined by international agreements, which in recent years have further encouraged the proliferation of strong intellectual property rights by requiring national governments to meet certain minimum standards of protection. [219] As a result of these trends, research tools in agricultural biotechnology are subject to numerous overlapping proprietary claims. [220] Depending on the complexity of a product, its development may involve the use of dozens of proprietary research tools; an often cited example is that of GoldenRiceTM, a genetically engineered rice variety developed using approximately 70 different patented technologies.[221]

So researchers in agricultural biotechnology must coordinate numerous disparate property rights in order to obtain an effective privilege of use; this means the first condition stipulated by Heller and Eisenberg as necessary to the creation of a tragedy of the anticommons is fulfilled. [222] There is also evidence that transaction costs associated with obtaining freedom to research and to commercialise the results of research in this field are mounting. [223] Indeed, streamlining access to patented technologies appears to have been a key motivation behind consolidation of a number of private agricultural biotechnology firms in the 1990s. [224] High transaction costs associated with licensing intellectual property rights in agricultural biotechnology have been reported to result from uncertainty of patent validity, excessive breadth of patents, conflicting claims of patents, difficulty of identifying valid licensors, the costs and slow pace of litigation and concern over liability, brand image and externalities control; in some cases, owners have been simply unwilling to negotiate with potential users. [225] In addition to the costs of licence negotiation, the costs of determining whether it is even necessary to obtain permission are significant. [226] Barton suggests that as a result, individuals and organisations may be too conservative in their use of proprietary technologies, thereby placing unnecessary restrictions on research and development. [227] (As observed earlier in relation to the costs of negotiation, the parties' perceptions, in this case regarding the likelihood that a particular technology is owned by someone else who would object to its use, are as important as the legal reality.) Evidence of high transaction costs means that Heller and Eisenberg's second condition is also fulfilled.

Thus, it is apparent that an investigation of bargaining behaviour in the field of agricultural biotechnology could generate useful data for comparison with existing studies of the emergence -- or failure to emerge -- of Merges "transaction cost-lowering institutions" in the face of a potential tragedy of the anticommons. Agricultural biotechnology is particularly useful as a point of comparison with biomedical biotechnology, the field cited by Heller and Eisenberg as exemplifying anticommons tragedy. [228] This is because these fields are closely related in terms of both technology and the types of institutions participating in research and development -- in fact, there is significant overlap in relation to particular institutions such as universities which are active in both fields -- and yet they are distinct in that they are funded differently, commercial products are aimed at different end consumers, and their research communities constitute distinct markets or audiences for research tools. It should therefore be possible, by studying bargaining over proprietary research tools in agricultural biotechnology, to observe some of the issues which have become familiar to biomedical researchers playing themselves out in a different context. Moreover, any solutions to bargaining breakdown which may emerge from a study of agricultural biotechnology might turn out to be applicable (with appropriate modifications) in the biomedical field as well.

A stark illustration of the effects of commercialising "public good" research

Besides providing a comparison with other areas of research and development, agricultural biotechnology is of interest in its own right in relation to issues arising out of the commercialisation of scientific research. There are several aspects to this reason for studying agricultural biotechnology. The first is that in agriculture, as in medicine, the stakes are high: any hindrance to the progress of research and development is likely to have serious consequences for social welfare. In this regard it is necessary to acknowledge that the application of biotechnology in agriculture is highly controversial. Nevertheless, at least to the extent that the biotechnology debate turns on scientific questions, people on both sides have reason to care about the progress of agricultural research and to be concerned about the possibility that difficulties of access to proprietary research tools could stifle that research.

On one hand, proponents of the development and application of genetically modified crop varieties argue that agricultural biotechnology has the potential to solve the problem of world hunger. [229] Hunger leads to intense suffering and currently affects an unacceptably large proportion of the world's population. Its causes are complex, but they include poverty and lack of access to affordable staple foods. Proponents of genetic engineering point to the success of the "Green Revolution" of the 1950s and 1960s in increasing food production, but acknowledge that the technology behind the Green Revolution -- especially its heavy reliance on chemical fertilisers and pesticides -- is environmentally unsustainable. They conclude there is a need for a second Green Revolution in which existing crop varieties are replaced by high yielding, nutritionally enhanced, pest- and disease-resistant genetically engineered plant varieties. From this perspective, any hindrance to the progress of research and development in agricultural biotechnology prolongs the suffering of hungry people, especially in less developed countries. [230] It is even arguable that a full-blown tragedy of the anticommons in agricultural biotechnology would be more disastrous than in biomedical research, on the basis that the alleviation of hunger could by itself be expected to lead to greater improvements in public health than any medical advance. [230a]

Opponents of genetically modified crops, on the other hand, are sceptical about the role of biotechnology in increasing food security. Instead of seeing genetic engineering as an environmentally sound alternative to existing Green Revolution crops, they view the release of genetically modified plants as a potential environmental and public health disaster. [231] Despite some attempts by proponents of biotechnology to cast those who object to its use in agriculture as irrational Luddites, opponents stand on sound scientific ground when they argue that substantial further research is needed in order to identify and assess possible risks associated with the release of genetically modified organisms into the environment. [232] So from this perspective too, free access to research tools by scientists studying the effects of genetic engineering in agricultural systems is essential.

Whichever position one takes with respect to the promises and risks of agricultural biotechnology, it matters who has access to research tools: private firms are less likely than public or non-profit organisations to be interested either in developing the kinds of crops which might be suitable for addressing food insecurity in the developing world, or in research which might expose serious risks associated with genetic engineering. [233] Historically, agricultural research, including research leading to the development of Green Revolution crops varieties, has largely been conducted in the public and non-profit sector, [234] but organisations operating in this sector have generally failed to keep up with the changes imposed by developments in intellectual property law and other aspects of commercialisation [235], and recent declines in research funding in agricultural science have impacted disproportionately on public sector institutions.[236] In terms of social welfare, it is important to avoid a tragedy of the anticommons in agricultural biotechnology because if bargaining over proprietary research tools in agricultural biotechnology breaks down, it is the non-profit sector which will be left without the capacity to continue research and development. (In fact, concern that this is already happening underlies much of the current opposition to applications of genetic engineering in agriculture. As Blakeney has observed, objections relate not just to the technology itself (either because of environmental or health risks or on moral or spiritual grounds) but also to risks arising from the particular social settings (which include intellectual property laws) in which the technology might be deployed. [237] The possibility that non-profit research and therefore its intended beneficiaries, the poor and hungry, could be shut out of the biotechnology revolution, is an example of the latter class of objections. [238]) Thus, a tragedy of the anticommons occurring in agricultural biotechnology would be a particularly stark illustration of the adverse effects of commercialising "public good" scientific research.

In this context it is worth noting that there are two aspects to a potential tragedy of the anticommons in agricultural biotechnology. The first relates to the problem of accessing information and biological materials necessary to the conduct of research. The second relates to the problem of ensuring freedom to commercialise the results of research conducted using proprietary research tools.[239] The term "freedom to operate" is sometimes used loosely to cover both research and commercialisation, but more often it refers to commercial freedom to operate, and that is the sense in which it will be used here. (Freedom to conduct research is sometimes referred to as "freedom to innovate", but this is confusing because it conflicts with the usual use of the word "innovation" to refer to bringing a new product to market.) Despite the conceptual distinction, both types of freedom are important to public and non-profit research institutions in agricultural biotechnology because in an environment where funding is difficult to obtain, many institutions rely on the ability to commercialise some of their research results in order to support their other activities. [240] In addition, owning intellectual property rights even in inventions which are not intended to be sold for profit gives these institutions a useful bargaining chip in their negotiations for access to research tools owned by others. [241]

Notes

[210] [Nottenburg, 2002 #373], page 17.

[211] The process is explained in detail at the website of the UC Davis Center for Engineering Plants for Resistance Against Pathogens, http://ceprap.ucdavis.edu/Transformation/tranform1.htm, last visited 6 June 2002.

[212] [Bennett, 2002 #378], page 5.

[213] [Graff, 2001 #377], page 2.

[214] [Nelson, 1997 #48], page 7.

[215] [Graff, 2001 #376], pages19-20, summarising a presentation by Brian Wright. The magnitude of this trend is indicated by the dramatic increase in US patent applications for gene sequences from 4000 in 1991 to 500,000 in 1996, a result of US and European court decisions allowing the patenting of DNA sequences of unknown function: [Blakeney, 2001 #353], page 120. Since pulled back: utitlity requirement...

[216] Has been deleted...

[217] See generally [Blakeney, 2001 #353]

[218] [Nottenburg, 2002 #373], pages 3-4.

[219] [Blakeney, 2001 #353], p127-129, discussing in particular: modifications to plant breeders' rights under the latest (1991) amendment to the Convention for the Protection of New Varieties of Plants ("UPOV Convention") which limit farmer's privilege, i.e. the right of a farmer to save seed from a first crop grown from purchased seed of the protected variety for use in sowing subsequent crops; and Article 27.3(b) of the World Trade Organisation (WTO) Agreement on Intellectual Property rights ("TRIPs Agreement") of 1994, which requires that WTO "Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof". The effect of TRIPs is that developing countries are no longer free to ignore the UPOV Convention limitation on farmer's privilege. See also [Graff, 2001 #376], pages 19-20, summarising a presentation by Brian Wright.

[220] [Nottenburg, 2002 #373], page 4.

[221] [Nottenburg, 2002 #373], page 17.

[222] [Graff, 2001 #376], page 18, summarising a presentation by John Barton.

[223] [Graff, 2001 #377], page 2.

[224] [Graff, 2001 #377], page 2, citing Graff, G., Rausser, G., and Small, A., 2001, "Agricultural Biotechnology's Complementary Intellectual Assets", SSRN Working Paper Series, August 2001, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=280107.

[225] Recent examples of hold-ups relate to the University of California's long shelf life tomato, Michigan State University's herbicide resistant turfgrass and CLIMA (Australia)'s (...?) herbicide tolerant lupin: [Graff, 2001 #376], pages 19-20, summarising a presentation by Brian Wright.

[226] Determining freedom to operate can be costly if analysis is referred to a lawyer and daunting for non-legal professionals due to the dynamic nature of patents, difficulties in claim interpretation, the cumulative nature of biotechnologies, the difficulty of searching patent literature, and frequently a lack of in-house infrastructure: [Nottenburg, 2002 #373], page 14.

[227] [Graff, 2001 #376], page 18, summarising a presentation by John Barton.

[228] [Heller, 1998 #56].

[229] See [Blakeney, 2001 #353], especially pages 127 and 129.

[230] For example, see [Graff, 2001 #376], page 18-19 summarising a presentation by C S Prakash, and page 25, summarising a presentation by Catherine Ives.

[230a] Lewontin questions whether modern improvements in public health can be attributed to scientific medicine at all, observing that in developing countries rises and falls in infant mortality are intimately correlated with fluctuations in the minimum wage (and hence presumably nutrition and basic living conditions): [Lewontin, 1993 #3], page...

[231] [Blakeney, 2001 #353], page 130.

[232] See Regal, P. J., "Scientific principles for ecologically based risk assessment of transgenic organisms" (1994) Molecular Ecology 3:5-13; Regal, P.J. "The geography of risk: special concerns for insular ecosystems and for centres of crop origins and genetic diversity", in Mulongoy, Kalemani J. (ed.), Transboundary Movement of Living Modified Organisms Resulting from Modern Biotechnology: Issues and Opportunities for Policy-makers, International Academy of the Environment, Geneva, Switzerland, 1997, pages 159 to169; and generally, the "Biosafety Page" maintained by the same author (a Professor of Ecology at the University of Minnesota), at http://www.cbs.umn.edu/~pregal/biosafety.html (last visited 7 June 2002). The recent New Zealand Royal Commission on Genetic Modification heard evidence that genetic modification could not be subjected to the usual methods of scientific risk analysis, both because of the inherent instability of the process of genetic modification, and because there was, as yet, an inadequate body of knowledge on which to either base an assessment of the risks or establish risk management mechanisms (Report of the Royal Commission on Genetic Modification, Wellington, July 2001, pages 68 to 69; a copy of the report is available at http://www.gmcommission.govt.nz/RCGM/rcgm_report.html, last visited June 7 2002). Scientific witnesses included Dr Mark Lonsdale, an ecologist with the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia, Dr Peter Wills, theoretical biologist at the University of Auckland, and Professor Terje Traavik, a virologist from the Department of Medicine at the University of Tromso, Norway. Dr Lonsdale is co-ordinator of a three year, A$3 million research project being conducted by CSIRO on the ecological implications of genetically modified organisms due for completion in 2003 (http://www.biodiversity.csiro.au/2nd_level/3rd_level/plan_gmos.htm, last visited June 11 2002). See also Wills, P. R., "Disrupting Evolution: Biotechnology's Real Result", in [Hindmarsh, 1998 #2], pages 66-80.

[233] [Graff, 2001 #376], page 16; [Nottenburg, 2002 #373], page 32; [Blakeney, 2001 #370], page 131.

[234] [Graff, 2001 #376], pages 24-25, summarising a presentation by Alan Bennett.

[235] [Graff, 2001 #376], pages 26-27, summarising a presentation by Robert Herdt.

[236] [Blakeney, 2001 #353], pages 136-7.

[237] [Blakeney, 2001 #353], page 130.

[238] [Graff, 2001 #377], pages 2-3; [Blakeney, 2001 #353], page 130.

[239] [Graff, 2001 #375], p1179.

[240] [Nottenburg, 2002 #373], pages 1-2; see also generally [EPTD, 2001 #270].

[241] [Nottenburg, 2002 #373], pages 19-21.

Other references

CGIAR, and National Academy of Sciences. 1999. Agricultural Biotechnology and the Poor. Paper read at Agricultural Biotechnology and the Poor, October 21-22, at Washington, D. C.

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