Acknowledgements

The following contributions were first presented at a symposium - Seeds of Change Intellectual Property Protection for Agricultural Biotechnology - held at the University of Illinois at Urbana-Champaign. I would like to gratefully acknowledge the following sponsors for supporting both the symposium and the creation of this volume College of Agricultural, Consumer and Environmental Sciences College of Law European Union Center Institute of Government and Public Affairs and National Soybean...

References

ABSPa (Agricultural Biotechnology Support Available at http www.iia.msu.edu absp Project) Egypt and the potato tuber moth. egypt-ptm.html ABSPb (Agricultural Biotechnology Support Project) Development and management of resistance to the potato tuber moth. Available at http www.iia.msu.edu absp egypt-ptm.html Alston, J.M. and Venner, R.J. (2002) The effects of the US plant variety protection act on wheat genetic improvement. Research Policy 31(4), 527-542. Babcock, B.A. and Foster, W.E. (1991)...

Note

1 Without any statement about its relation to other international treaties, and in accordance with the Vienna Convention on the Law of Treaties, the CPB as the more recent and more specific agreement would prevail over the WTO. As a compromise, the CPB preamble reads that the parties 'recognis(e) that trade and environment agreements should be mutually supportive with a view to achieve sustainable development, emphasiz(e) that this Protocol shall not be interpreted as implying a change in the...

Conclusion

The investment made by USAID-funded ABSP-I has, to date, not led to any commercial output in Egypt. Hence, assessing the economic impacts of such investments and efforts in building IPR infrastructure (to facilitate product commercialization) is difficult at this stage. There are, however, many lessons to be learned from the Egyptian case study in terms of biotechnology research and the impacts of building an IPR infrastructure in a developing country setting. First, investment in IPR and...

The Current Situation and Prognostications

ASBP's long-term goal is to commercialize the GM potato and put this technology into the hands of both resource-poor and commercial farmers in developing countries. As a step towards the goal, ASBP and USAID, the main financial sponsor of the project, have begun licensing discussions with the Syngenta Company that owns the CRYlIal gene property rights. The company is willing to grant a semi-commercial licence to developing countries, but wants liability release and assurance that regulatory...

The road to commerce

The commercialization of the GM potatoes required full transfer of the rights to use the technology to AGERI and or Egyptian seed potato distributors. Safety issues moved from biosafety to food safety, bringing yet another complex set of international regulations in the mix (Codex Alimentarius is the internationally recognized body for setting food standards). The IPR issues moved from research MTAs to technology transfer and commercialization agreements. The ABSP supported the renewed interest...

Agricultural Economics Mail

Banik, Department of Management and Technology, Universit du Qu bec a Montr al, Montreal, Canada. E-mail banik.marc uqam.ca S. Buccola, Department of Agricultural and Resource Economics, Oregon State University, Corvallis, Oregon, USA. E-mail sbuccola oregonstate.edu D.L. Burk, Law School, University of Minnesota, Minneapolis, Minnesota, USA. E-mail burkxGG6 umn.edu J. Chen, University of Minnesota Law School, Minneapolis, Minnesota, USA. E-mail chenxG64 umn.edu T. Dhar, Sauder School of...

Impact of Regulation on Innovation Indicators in the EU

The impact of the regulatory framework relevant for agro-food biotechnology and genetic engineering in the different regions can be analysed on various levels. In the following, respective data are presented for the areas of scientific research, field trials with GMOs, approval and cultivation of GMOs in the different regions. In the EU there is still a broad pipeline of R& D activities related to agricultural and food GMOs, which is fuelled by differing organizations like large...

Intellectual Property Rights for Plants

Till the end of the 20th century, US utility patent statutes excluded patents on living organisms. The IP needs or demands of the plant and seed propagation industry led to a number of IP rules to allow IP on plants despite this exclusion. After a series of complaints by nursery owners, the US Congress created the PPA in 1930 to permit intellectual property protection (IPP) of asexually propagated plants, which propagate by cuttings rather than seeds. Over the years the court traditions...

Genetic use restriction technology

Another method used to protect IP is the development of genetic use restriction technologies (GURTs) such as the 'Terminator' gene. The technology has significant application in agriculture and provides self-executing IPRs (Peng and Goldsmith, 2005). GURTs allow the seed company to exclude the use of the seed beyond its contracted use. This technology would transform self-pollinating seeds like soybeans to being 'hybrid-like' requiring users to purchase new seed each year. One direct advantage...

The Future of Agriculture and Patents Together A Good Marriage or a Shotgun Wedding

As one who believes in the patent system, I believe it is a good marriage even though forced by the decisions of the US Supreme Court. As said in Chakrabarty and as reaffirmed in J.E.M. AgSupply, the limits of patentability are up to Congress. The Supreme Court's job is to interpret laws, not expand them. Thus, the ultimate destiny of application of the patent laws to any industry is completely dependent upon Congress. It is possible and likely that changes will occur in the future. For...

Implications of IPR for Application of Biotechnology for Other Crops in Leader Countries Especially the USA

The leading agricultural biotechnology firms at present see insufficient prospective returns in most agricultural or horticultural crops except soybean, cotton, maize and canola, whether in developed countries where such crops have been called 'orphans' (analogous to 'orphan drugs', pharmaceuticals with prospective markets of relatively 'small' value) or in developing countries.11 The public and non-profit sectors will have to continue to shoulder the bulk of the burden for these crops. Indeed...

Case Studies in Biopiracy Pharms and Farmers

Advocates for the global South have been clamouring for proprietary treatment of TK, and that demand shows no sign of abating (Heald, 2003, p. 536). For the time being, potential property interests abound whenever biodiversity is exploited for commercial gain. In order to resolve the conflicting claims of the North and the South, let us return to the annals of the biodiversity battles. One set of conflicts may be considered 'pharmaceutical' in flavour the other, 'agricultural'. Let us first...

Eligibility for protection

UPOV vests breeders' rights on new, distinct, uniform and stable varieties. Article 6 of UPOV deems a variety as 'new', provided that, 'at the date of filing of the application for a breeder's right, propagating or harvested material of the variety has not been sold or otherwise disposed of to others, by or with the consent of the breeder, for purposes of exploitation of the variety' (UPOV, 1991). Thus, novelty is determined solely by prior sale or disposal of the application material. Public...

Notes

1 By 'inadvertent use' we mean unintended use through natural phenomena such as pollen drift or other forms of contamination through, for example, mixing of seeds in handling and conditioning facilities. Knowingly replanting a seed or a plant produced from inadvertent use (as in the case of Schmeiser) is regarded as infringement. 2 In this chapter we refer to farmers as individuals who can create new varieties but who do not necessarily patent them. Licensees or 'growers' are users of the...

Case studies of public or nonprofit agricultural innovation blocked by domestic IPRs

For the public and non-profit agricultural research sector, any direct effects of IPRs on the overall research are difficult to measure objectively. Indirect indicators such as citations number in the thousands, but there is, in the end, only a handful of commercialized products (several of which, of course, are highly valuable). Thus a direct statistical analysis of effects of IPRs on public sector agricultural biotechnology innovation through to adoption on farmers' fields is impossible at...

Introduction

Conducting an economic impact assessment of intellectual property rights (IPRs) legislation that does not directly lead to an economic output is, in some ways, a peculiar task. The peculiarities lie in determining how to attribute quantifiable economic values to IPR legislation (which will be addressed momentarily), not in the importance of the impact assessment. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO) requires all...

Model of Firm Intellectual Property Strategy

This section examines a firm's ex ante decision problem to apply for any form of IPRs through patents or to keep a trade secret. For the purposes of this exercise, we abstract from the differences between PVPA and utility patent property rights, but it is the differences in rules that will drive the value of IPRs with respect to trade secrets. Let there be two firms (i and j) competing in a market to produce a seed to sell to a set of farmers. The firms can choose between keeping a trade secret...

Corporate concentration

Second, and this follows on from the first issue, GURTs exemplify the way that agricultural research is more and more expensive, commercially oriented and technologically advanced. The consequence of this is that the sector is becoming one in which an ever smaller number of companies are able to enter, while those that are already in it and can compete come to dominate it. In fact, terminator may accelerate this process of corporate concentration, which is already quite noticeable,7 while...

Plant Breeders Rights Patents and the Research Exemption

PBRs in the USA are defined by the 1970 PVPA, whereby the US Department of Agriculture (USDA) can issue Plant Variety Protection Certificates (PVPCs). Varieties claiming a PVPC must be new and must satisfy requirements of distinctiveness, uniformity and stability. The protection offered by PVPCs is similar to that provided by patents, including the standard 20-year term, with two major qualifications there is an RE, which means that protected varieties may be used by others for research...

Modelling Cumulative and Sequential Innovations

The recognition that inventions are typically the springboard for further innovations has long been noted in the analysis of the economics of IPRs (Scotchmer, 1991). When innovation is cumulative, the first inventor will not necessarily be compensated for his or her contribution to the social value created by the subsequent inventions, which adds another dimension to the task of designing an efficient IPR regime. Scotchmer (2oo4) distinguishes between three main types of cumulativeness of the...

Comparative Studies

Kesan and Gallo provide insights into the effect of property rights on biotechnology research through their survey of Argentinian soybean and corn farmers, who have made Argentina the world's leading producer and exporter of both crops. Their results claim that the definition and enforcement of property rights have important effects on the incentives that private firms face in the market and on the productivity of the agricultural sector, including the local incentives in Argentina for plant...

Intellectual property rights and biosafety guidelines

In 1993, the ABSP's initial attempts to raise awareness of IPR and biosafety issues in Egypt were met with interest, because everyone was excited about biotechnology at that time. The initial ABSP programme was designed to promote awareness of IPR and biosafety issues, including the general concepts of patent law and PVP as they affect biotechnology-based plant breeders. MSU and Stanford University pioneered an Intellectual Property Patent Internship Program in April 1993 in California and...

Dynamic Moral Hazards Model

The model is a dynamic game with complete but imperfect information, where the players' pay-off functions are common knowledge (complete information), whereas the player with the move does not know the whole history of the game at some points in the game (imperfect information), referring to the farmer-saved seed. The game involves two participants in the contract the risk-neutral seed company (principal) and the risk-averse farmer (agent), and also represents a long-term business relationship...

Have Intellectual Property Problems Been a Major Hindrance to Diffusion of Agricultural Biotechnology in Other

In the international agricultural research community, the belief has been widespread that patents have been hindering access to important plant biotechnologies for developing countries. Talk by economists of international 'violation' of US patents indicates that their reach in the non-profit sector can extend well beyond the geographic bounds of their legal, if not their political, reality, and certainly beyond the scope of protection recognized by well-informed private firms. Such confusion is...

Exceptions to patentability for agricultural biotechnology

Although the default standard under TRIPS requires all inventions to be patented, there are several notable exceptions that are relevant to plant products. The general rule is that patent protection must be provided for all inventions that satisfy the patentability criteria of being useful, new and non-obvious (TRIPS, 1994, art. 27(1)). However, because TRIPS defines neither 'invention' nor 'new and non-obvious', countries have some discretion with regard to what qualifies as patentable,...

Limiting Patent Exhaustion and Seed Saving through Licence Agreements

Both the research exemption and farmer's ability to save seed limit the IPP provided by the PVPA. Although utility patents do provide broader IPP than PVPCs do, stand-alone utility patents do not prevent seed saving because the patentee's rights are 'exhausted' after the initial sale to the farmer. The exhaustion doctrine only applies to an unconditional sale or licence of a patented article (B. Braun Medical, Inc. v Abbott Laboratories, 1997). In a conditional transaction, the court will infer...

Motivations for Globalization of Stronger IPR Regimes

Pressures for strengthening US patent law and expanding its scope began in the 1970s and originated outside of agriculture. They arose from the concern of business interests with capturing rents on existing technology, as distinct from creation of new incentives for innovation. They reflected the pessimistic perception that the USA had lost its technological edge in the 19 70s to other countries such as Japan, and that these countries were insufficiently compensating the USA for past...

Specialty Crops Regulatory Initiative

The Specialty Crops Regulatory Initiative, launched in November 2004, is a collaborative effort to establish an organization to facilitate, and reduce the cost of, the regulatory approval of biotechnology-derived specialty crops.18 This initiative seeks to play a role in this area similar to that of the IR-4 Project of the USDA to facilitate approval of pesticides for small crops, and the Orphan Drug Act to encourage the development of new drugs for diseases with small markets. Economists have...

Introduction Contesting Knowledge Resources

Has the emergence of a knowledge economy - a knowledge-based (UNDP, 1999) or knowledge-driven economy (DTI, 1998) - fundamentally redefined a nations' trade interests Or are such terms, with 'new economy', a fading imprint of the dot-com era, a high-water mark of a tide, now receding, of technological optimism and exceptionalism It may, in any event, be impossible to intelligibly isolate a knowledge economy as such. The enticing idea that a fresh set of economic rules now governs...

Revisiting Basmati and the Nature of Biopiracy

Individual cases of disputed biopiracy have helped structure and define this debate, and give impetus to broader claims of misappropriation they may also provide insights on possible policy responses. A prominent case is the development of cross-bred rice suitable for production in the western hemisphere and design to imitate the organoleptic and cooking characteristics of traditional basmati rice, which was the subject of a controversial patent.4 Apart from its potent actual influence in the...

Trade in Wine Bilateral Bartering between Tradition and Innovation

The debate over the protection of GIs accordingly spans the same conceptual gap between fair appropriation or emulation and misappropriation or usurpation, and is also influenced by a mix of cultural and value differences, and divergent trade interests. GIs are defined in TRIPS as a form of IP, but are not defined and need not be protected as distinct property rights. Therefore, the array of laws used to protect them ranges from specific laws on appellations or designations, over trademark law...

Other international forums

Another possibility is to utilize forums outside the WTO either alone, or in conjunction with continued discussion under the WTO. The need to protect CBD goals, as well as the right to food, has already been discussed in a number of forums outside of the WTO. In addition, a few authors have specifically discussed the present or potential utility of raising these issues in multiple forums to take advantage of different political constituencies and processes for negotiation (Cullet, 2004, pp. 2...

Potential benefits of plant breeders rights

The introduction of PBRs was meant to reduce one of the barriers to international trade in agriculture by opening up developing country markets to hybrids. PBRs, by increasing agricultural investments, can result in high-yielding, newer hybrid varieties or genetically modified plant varieties, otherwise generally unavailable in developing nations. Hybrid varieties have the capacity to eliminate traditional deficiencies in agriculture that induce an element of unpredictability in farming by...

Concerns of developing nations

Developing nations underscored several factors necessitating a national regime for PVP rather than adopting a system similar to the protection prevalent in developed nations. First, in developing nations agriculture has a close nexus with the national economy. Compared with developed nations, the agricultural population is higher in developing nations. For example, the Food and Agriculture Organization (FAO) estimates the agricultural population for 2000 in developed nations at 99,752,000...

Trade gets ugly

In the middle of IPR negotiations, due to a fear and concern of a possible trade blockade with EU, Egypt decided not to pursue the commercialization of Bt potatoes. The issue is partly based on a concern that even if Egypt tried to keep export shipments free from GM potatoes, some would slip through part of the issue also appears to be a general stance by EU against agricultural biotechnology. The EU has brought considerable pressure to bear on developing countries, particularly African...

Moving Beyond TRIPS

The balance of IP rights against other norms under TRIPS-plus agreements is of potentially much greater concern than present conflicts between TRIPS and other international agreements. These agreements tend to be bilateral or regional, negotiated by an industrialized country, such as the USA or EU and require more protection than TRIPS, or adherence to TRIPS under a faster timeline. The increased rights generally coincide with a reduced opportunity to accommodate other social policy norms, such...

International Regulation

Dutfield suggests that not all transgenic technologies will help farmers in developing countries. He examines the implications of GURTs for developing countries, particularly 'terminator technology', a patented and highly controversial method of controlling gene expression in plants that render harvested crop seeds sterile, and discusses its advantages and disadvantages. He argues that an expensive terminator-protected seed might make farming even riskier for the poor by preventing local...

Model of Cumulative Innovation for Plant Breeding

The model of REs that we want to construct is related to the second strand in the literature previously discussed. In particular, we want to construct a simple model of innovation that captures some salient features of plant breeding. Plant breeding is a lengthy and risky endeavour that consists of 'developing new varieties through the creation of new genetic diversity by the reassembling of existing diversity' (International Seed Federation, 2003). Thus, the process is both sequential and...

Is UPOV an Effective Sui Generis System

Developed nations acknowledge that art. 27.3 of TRIPS provides a choice between patenting and a sui generis system for protecting plants. Developed nations, however, construe UPOV as a minimum standard for establishing a sui generis system (Grain, 1999 UPOV Position, 2000). The following two sections discuss whether the reference to an effective sui generis system in art. 27.3 of TRIPS is a reference to UPOV. The first section argues that historically UPOV was never construed as the minimum...

Introducing Plant Breeders Rights Will Not Reduce Trade Barriers in Agriculture

This section argues that even if PBRs fulfil promised expectations, they can neither benefit the developing nations nor reduce distortions in international trade in goods as long as agricultural subsidies foreclose the markets for the developing country produce. Instead, the prevalence of subsidies will result in subjecting farmers to additional costs without any benefits. The reduction of subsidies, which create the maximum international trade barriers in agriculture, should precede the...

Plant Breeding Intellectual Property and Technological Protection

Immediately after the 1900 rediscovery of Mendel's insights into the rules of heredity, scientists sought to apply them to crop improvement. One early breakthrough was the development of 'pure lines' of self-pollinating crops. Pure lines breed true to type and contain consistent and identifiable traits that can be transferred to other plants. According to Pistorius and van Wijk (1999, p. 36) 'while Mendelian breeding allowed for a controlled mixing of genetic characteristics, pure line breeding...

Implications of UPOV 1991

This agreement enhances the problem inherent in simultaneously respecting TRIPS, as well as rights recognized under the UNDHR and CBD. For example, farmers have traditionally saved harvested seed to use in subsequent crops, as well as to engage in experimental breeding - both of which foster the right to food. However, under UPOV 1991, the farmer's rights to save seed and experimentally breed plants are both restricted. Although there is a possibility for farmers to save seed, it is limited by...

Recalibrating Trade Interests for a New Economy

Since it has substance and influence, the conception of a 'new economy' or a 'knowledge economy' brings a fresh array of redefined interests to bear on the positions taken in trade negotiations, and induces a demand for new legal and ethical standards, most strikingly in revisiting the conventional notion of the public domain or the common heritage. Alongside, and influenced by, traditional factor endowments, economic interests are increasingly structured, construed and calculated in terms of...

Effects on Biotechnological Innovation

The innovation effects of changes in IP market strength and structure are best examined through the impacts of these changes on IP owners' net revenues and IP users' net costs. Owners' net revenues are their nominal contract revenues minus contract enforcement costs. Users' net costs are their nominal contract costs plus the product of their conditional contract compliance costs (i.e. assuming technology use is detected) and the probability that the use will be detected. Nominal contract...

Negotiating Equity over Genetic Resources and Traditional Knowledge

Trade negotiations over knowledge resource issues are marked by diversity and divergence in principles and values in cultural and ethical perspectives, in policy objectives and in trade and property interests, as well as negotiating asymmetries and the impact of technological development. These factors help shape the contested interaction between the regimes that govern custodianship and sovereignty over GR and the regulation of the access to, use of, and sharing of, benefits from GR and...

Implementation of Regulation in the EU

GMOs have been regulated by the EU since the beginning of the 1990s. The EU directive on the contained use of GMOs (Directive 9 0 219 EEC) and on their deliberate release (Directive 90 220 EEC) were the first regulations which tried to establish a system for controlling research and development (R& D) and commercialization of GMOs in the EU. These regulations were designed to protect citizens' health and the environment, and addressed authorization, labelling and trace-ability issues...

The Agricultural Biotechnology Intellectual Property Database Linking Technologies Ownership and Intellectual Property

The ABIP database was developed jointly by researchers at the USDA ERS and the Rutgers University Department of Agricultural, Food and Resource Economics. It assembles data on several different types of IPRs US utility patents, plant patents, PVPCs and results of field trials for deregulatory release of genetically engineered varieties. There are several reasons to bring together these different types of intangible assets. First, the different types of IPRs reflect success at different stages...

The Limits of Seedwrap Licensing

The question of overlapping patent and PVPA protection in turn implicates the licensing of patented plant varieties. The jurisprudence of utility patent licensing for plants could closely parallel the employment of GURTs and GURTs-enabled licences for plants, either because the technological protection confers exclusivity analogous to patent protection, or because the GURT itself is patented, and tampering with it may trigger patent liability. Patent rights are extensive, but they are not...

Enablement of Transgenic Plant Inventions

A US patent document must provide a description of the patented invention that is adequate to enable a person of ordinary skill in the art to make and use the claimed invention 35 U.S.C. 112, 1st . The enablement requirement seeks to ensure that patentees provide high-quality teachings that correlate in scope with the scope of the potentially valuable patent rights that they receive as such, enablement is an essential part of the quid pro quo of the patent system in re Wright, Enzo Biochem,...

The conflict between TRIPS and other international agreements

In addition to the tension under TRIPS itself, it has been criticized for conflicting with the ability of member states to fulfil other international agreements. The United Nations UN has taken an active role not only in advocating a conflict between the realization of human rights and TRIPS requirements, but also suggesting that human rights should be given primacy in any conflict UN SubCommission, 2000 UN Draft Resolution, 2001 UN High Commissioner's Expert Group, 2002 . Similarly, the CBD...