TABLE OF CONTENTS
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Summary

Foreword

Biotechnology and its Special Impact

Existing IPR regimes: What Issues do they Raise in a Global Agricultural Context

Agriculture, Biotechnology, Poverty Alleviation and International Public Goods

Intellectual Property Rights in Research and Agriculture

Intellectual Property Rights and Trade

The Public Sector and International Public Goods

Public Sector - Private Sector Interactions

Conclusions and Potential Mechanisms to Address Identified Constraints

Selected Bibliography
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SUMMARY
There has been a revolution in science in agriculture over the last ten years, primarily in the area of biotechnology. At the same time there have been substantial changes in the application of Intellectual Property Rights (IPR) to scientific discovery in the life sciences. In addition to the technical and legal shifts, there has also been a move towards greater globalization of trade. This issues and dialog note is structured in a way as to point to the key issues that are arising because of the use of IP on agricultural inventions.
There are concerns in regards to access to technology by developing countries, there are concerns regarding the rights to use of germplasm, the basic building blocks for genetic improvement, and there are concerns that technology is perceived to be controlled by a limited number of large corporate entities.
The issues and dialog note describes some of the key technology tools that are used in animal or plant improvement; it also describes the basic IPR tools that are used to protect ownership rights. It is noted that the IPR tools vary from jurisdiction to jurisdiction, but there are common platforms such as the Paris Convention that govern the international implementation of these rules.
There are many fundamental beliefs that underpin this dialog. The subject matter is complex and involves analysis that incorporates science, law and ethics. There is no right answer on many of these issues, only the possibility of compromise and consensus, such that fairness and equity are seen as a part of the outcomes.
The issues and dialog note ends with conclusions and some initial ideas as to how to address some of the constraints. These views are personal views of the author and in no way are intended to preempt discussion and dialog. In fact the author holds an open mind on these matters and may choose to modify these positions depending on the dialog. The article closes with some selected bibliography that readers may wish to follow up on.
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FOREWORD
The world economy has experienced significant growth and transformation over the last twenty years. There have at the global level been significant increases in productivity, product quality, and export base diversification. These advances were in part driven by growth in the industrial sectors, and in agriculture, including the natural resource-based sectors. However, despite these achievements, some characteristics of the global economic and industrial structure cast long shadows on the world’s long-term socioeconomic development perspectives, in particular the ability of the world to meet the growing food needs over the next fifty years, given current population growth trends.
If we fail to address these matters in an appropriate and timely fashion current poverty levels in the world will further deteriorate. This paper outlines the impact of Intellectual
Property Rights (IPR) in determining transfer of biotechnology tools and products to developing countries.
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BIOTECHNOLOGY AND ITS SPECIAL IMPACT
Background and Prior Debate
Scientific advances in plant breeding led to the “Green Revolution”, regarded as one of the most important achievements to feed the world during the last century. Mostly staple cereal crops, particularly wheat, rice and maize, were targeted by the “Green
Revolution”. Towards the end of the 20 th
century 370 kg of cereals per person were harvested versus to only 275 kg in the mid-20 th
century (i.e., in excess of 33% per capita gain). In other crops the gains since the early 1960s were about 20%. In simple language, this has helped alleviate starvation and malnutrition in almost 1 billion people. However, the “Green Revolution” approach appears to have been exploited close to its limits, and other alternative approaches are required to continue improving plants and livestock for the agriculture of the 21 st century. This will be very important considering that about 12% of the world’s land surface grows crops and that the per capita area to support food production will decline from 0.44 ha in 1961 to 0.15 in 2050.
Biotechnology offers today new and better means to complement classical breeding tools for the genetic improvement of both crops and livestock. Biotechnology offers new means for achieving a higher intensity of selection, e.g. through in vitro techniques, or for a more objective selection of individuals through genetic markers. Likewise, genetically engineered (so-called transgenic or GMO) plants offer new methods for inserting new genes to the breeding pool, thus enhancing the quality of the new variety. Let us go on to discuss some examples of the new biotechnology and indicate some of the value these new products may have for the developing world.
Key Applications
The most common and successful applications of biotechnology for crop and livestock improvements include:

Cell and Tissue Culture. This is the growing of plant cells as a way of producing uniform individuals or for shortening the number of years needed to produce and release new varieties. Tissue culture techniques have led to dramatic production increases in cassava, yams, bananas and plantains, palms, and potato to mention only a few.

Genetic Engineering for pest and disease resistance. There are now hundreds of millions of acres of genetically engineered crops grown in North America and
Argentina and increasing interest is being shown in these in some developing countries, particularly China.

DNA fingerprinting, the same as used in forensic science, is used to gain better insight into pathogen diversity that may allow pre-empting breakdowns of host plant resistance to pests and diseases.
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Better management of seed storage facilities, so-called gene banks, and greater knowledge of biodiversity can be achieved with the aid of molecular-aided
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analyses. The more we know about this genetic diversity, the more we can apply it to produce higher yielding, more resistant materials.

Finding the location of genes on a chromosome with DNA markers will allow scientists to custom make plants and animals with specific disease and pest tolerance.

New tools to test for pests, diseases and to detect dangerous food contaminants.
These techniques will help us produce not only more food, [but food that is nutritious and safe to eat since it may contain lower levels of toxins and/or pesticides]
Major Constraints and Opportunities
Biotechnology may provide new methods to add value to raw agricultural products. For example growing edible portions of food crops in vitro or converting plants into producers of high value chemicals. “Pharming” (derived from Pharmaceutical) is the term that has been coined to refer to a new system in which medicine production capabilities are incorporated into the plant. A research group at The Boyce Thomson Institute at
Cornell University has already engineered banana plants for production of vaccines. The plant serves as a medicine factory.
The identification, isolation and cloning of new genes controlling specific characteristics will also facilitate the development of a more stable, diversified germplasm with improved resistance to diseases and pests, stress tolerance, better food quality, and higher productivity. For example genes allowing a reduced crop cycle or modified plant structure will provide pathways for new cropping systems.
Nonetheless, conventional crossbreeding will be still required for an appropriate testing and further transfer of these genes to the advanced breeding pools of the crop.
Furthermore, seed delivery systems of improved genotypes should be in place to promote the utilization of new cultivars, which will enhance and stabilize the agricultural production, farm income, and farm-family welfare. In brief, the new tools of biotechnology alone cannot provide the answer to genetic improvement, but they are facilitating and accelerating the pace in the development of new cultivars.
Some of the current achievements of biotechnology applications for improving agriculture are surpassing the original expectations and the outlook appears to be even more promising. However, the fulfillment and impact of biotechnology does not depend only in the demonstrated research advances and technology ensuing from their applications but on both favorable regulatory frameworks by national governments (or through regional agreements) and positive public acceptance.
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The new era of “genomics” and “bioinformatics”
‘Genomics’ refers to the systematic use of genome information, in conjunction with new experimental data, to answer biological questions. Genomic databases are the public window on which high-throughput genomics facilities will depend on. In a sense, the success or failure of genomic projects now depends on the availability and utility to the scientific community the data that they produce. This interface of biology and computing
/ information science is often referred to as bioinformatics.
A number of technical innovations aided the success of the Human Genome project. The sequencing and mapping components of the project relied heavily on the advances made in the automation and robotics of the sequencer, which led to the production of sequence data at an extraordinary rate. This would have led to ‘drowning in data syndrome’ but for the advances made in the information technology that led to the genesis of ‘bioinformatics’.
Currently bioinformatics is largely handled by protecting, then sharing information. For continued advances access to sequenced data is critical. In the mid 1990s, the interactive communication technology, i.e., the ‘Internet technology’ became widely available for public use. This has been a major stimulus to in modern day genomics. The World Wide
Web provided the means to share and integrate databases, distribute software, and perform sophisticated analyses. Currently, there are at least 400 internet-accessible databases of biological data and about 20 applications software to analyze sequence data.
The human genome project relied heavily on sharing of information and knowledge including the information held by private sector. This knowledge-based revolution can drive agricultural research for the benefit of all.
International efforts to have a plant-crop genome project similar to the Human Genome project is already a reality with the initiative started in rice known as International Rice
Genome Sequencing Project (IRGP), which is led by Japan. Recently, Monsanto
Company has agreed to make its rice genome data available to be shared with worldwide researchers. A few developing countries are aware of this new potential area and have already invested in plant genomics.
Key Issues
The need for international co-operation to share information is more relevant in genomics today than in any other field. This area largely depends on information held by others.
These databases are huge both in size and depth. New information and databases will be constantly built and old ones expanded. Initially the job would be data mining and determining patterns, which later could lead to diagnostic and remedy. This then will lead to key issues


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To promote awareness among users the need to share information
Access to information especially those who do not have access
Investments into information and communication technologies to promote sharing and access to information
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Major Constraints and Opportunities
The major constraints would be the lack of accessibility to share this technology and the lack of trained people who could use the information. Currently, the Information
Technology industry is investing into bio-informatics as a business venture; both IBM and Compaq have recently invested hundreds of millions in bioinformatics ventures. The future would be on the know how to use the information for practical application, e.g. transform data obtained from genomics and bioinformatics into diagnostics or for therapy. Again this will require multidisciplinary teams of trained personnel capable of interlinking bioinformatics with knowledge of modern biotechnology, disease- host relationships and farming practices.
Should Animals & Plants be treated differently?
In biochemistry scientists will often be heard to say: “DNA is DNA” meaning that they don’t care whether it came from a plant, an animal or a microbe. While that principle is similar in terms of IPR applications, there are a few examples where differences occur particularly in relation to ethical concerns.
Animal biotechnology research has the benefit of gaining substantial knowledge from overspill in the human genomics and health area. However it has the disadvantage of competing for research talent and investments in that area.
The human genome project has led to the production of a wealth of information that clearly will have added value in areas of animal science. Likewise development of vaccines and other treatments for diseases will benefit animal science researchers.
Animal science has also had its difficult times in regards to public relations and perceptions in recent years. The so-called “mad cow disease” and the recent outbreaks of foot and mouth disease have swayed public perception in animal science away from high technology and in particular the application of biotechnology towards more so called organic production systems. Ironically the “mad cow” outbreak was spread by recycling of animal wastes.
Key Issues in Relation to Animal Science.
The critical issues and some examples of how to address them are:
(a) How to build on the human genome project for animal science? This is perhaps in the short terms where the most rapid advances in genomics research may be made. The International Livestock Research Institute (ILRI) of the CGIAR is already working with the Institute of Genomic Research (a not for profit entity related to Celera Genomics) to sequence animal parasite genomes. This will lead to the production of new vaccines to address tropical animal diseases.
(b) What about the ethical issues related to animal cloning? This is worthy of an entire treatise in its own rights. If pork genes are put into chicken can Muslims eat it? If animal genes are put into plants can vegetarians eat them? If a
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chromosome is made synthetically and inserted in an animal is this ethical?
There are no simple answers to these questions. Answers to these religious and ethical dilemmas must come from those skilled in that area.
(c) What about the biosafety aspects of animal science? Clearly there are animal diseases that can be passed to humans. Again, the concerns on mad cow disease underline this matter. The biosafety issues in relation to research studies and the use of research containment for animal science again are highly complex. More research is needed in this area, especially where there is any perception that the disease can be transmitted to humans.
(d) Which animals and diseases should take priority? This is a national priority setting exercise. It should balance the technical capabilities against the needs and economics. There is some rational to study those pests and diseases that clearly cross-national barriers and cause regional health problems.
Major Constraints and Opportunities
Constraints:
The ethical issues associated with animal science are more complex and more culturally linked than is the case with plant technologies.
The economic impact of diseases is important in a global sense. The costs of vaccine production and distribution can be recuperated for high value farming systems, but how can these techniques be economically applied to resource poor small farmers. The arguments here are very similar to those for human tropical diseases. We have not solved this for malaria, so when will it be tackled for animal disease? There is light at the end of this tunnel. The Institute of Genomics Research (TIGR) is discussing a malaria vaccine trial for 2002.
Opportunities:
The revolution in human genomics can and is revolutionizing animal science. The synergy between the human research and animal science offers unique opportunities for common platforms and reduced cost. Once we identify genes in the human genome with specific characteristics, we can almost certainly apply the same knowledge in animal science.
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EXISTING IPR REGIMES: WHAT ISSUES DO THEY RAISE IN A GLOBAL
AGRICULTURAL CONTEXT?
This section of the discussion paper describes the different forms of intellectual property protection that exist, and indicates in broad terms some of the issues that arise from the application of these IPR tools in agriculture.
WHAT IS INTELLECTUAL PROPERTY?
Intellectual property is in many ways similar to a parcel of real estate. As with any piece of property it can be bought, sold and rented (i.e. licensed). However, unlike real estate, intellectual property is intangible, you cannot touch it, since it is an idea or invention. The legal mechanisms of patents, copyrights, trade secrets and trademarks are used to protect such intangible property. Keep in mind that some contract mechanisms, such as licenses or material contract agreements (MTA’s), have the effect of conveying ownership rights over materials. A basic understanding of these mechanisms is essential for anyone whose research may lead to an invention, and for research administrators who must deal with intellectual property issues, both for acquisition and deployment.
Patents
A patent is an agreement between the Government and the inventor. The Government sets statutory standards as to what types of materials may be patented. In some jurisdictions this may include living organisms, in some they may be exempted, and in many the law is silent on the matter.
The Paris Convention that underpins the Patent Cooperation Treaty (PCT) lays the basis for multi-jurisdictional filing of patent applications.
In exchange for a limited-term right (20 years) to exclude others from making, using or selling the potential invention, the inventor must provide a complete and accurate public description of the invention and the best mode of "practicing" it. The public policy basis for this approach is that this provides other members of the public with the ability to use that information to invent further, thus pushing technology forward for the benefit of society. That is, the information is available to all; however, it cannot be used for profit without a license agreement.
This right to exclude means that a patent is a "negative right" since a patent holder may only exclude others from the using, manufacturing, copying or selling his or her invention.
A very important concept in terms of international agriculture is that patents are territorial. A patent in one country generally has no force in other countries. However, products sold in a country, even if they are made outside the patent domain of that country, may infringe a. patent if the product is re-imported into the country where protection is effective. Patent terms vary considerably from country to country, although the PCT provides a mechanism for some harmonization.
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There are three basic statutory types of patents: utility, design, and plant:
A utility patent is the type with which most people are familiar, and it is granted for any new and useful process, machine, manufacture or composition of matter or any new or useful improvement thereof. In simple terms, it has to be USEFUL.
A design patent protects a new, original and ornamental design for an article of manufacture
A plant patent protects a new and distinct, asexually reproduced variety of plant.
Maintenance fees on utility patents must be paid at 4, 7 and 11 years after the date of issue or the patent will expire. Once a patent expires, the invention is in the public domain and anyone may use it without authorization from the patent holder.
What then are the key issues that arise in discussions on patenting in agriculture, that impact globally, but perhaps have even greater impact in the developing world?

Should living organisms be patented at all?
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What is the role of other legal mechanisms, such as plant variety protection?

How far does the research exemption flow?

What is commercial sale?
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What about the ability to reproduce for own use, ie farmer seed?
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Is the cost prohibitive for small companies, developing countries, and public sector?
Trade Secrets
A trade secret is any formula, pattern, device, process, tool, mechanism, compound, etc., of value to its owner, which is not protected by a patent and is not known or accessible to others. As long as it is kept secret, the owner may obtain a great deal of commercial benefit.
This form of protection is a weak mechanism, in as far as once the secret is out it’s too late!
There are several issues that arise from the application of trade secrets, including:

Is it appropriate for public organizations to keep information secret?

What are the costs associated with maintaining secrecy?
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How to deal with movement of staff who are aware of the secrets?
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Interaction of trade secrecy with other legal instruments, such as freedom of information acts, or disclosures for regulatory matters, such as field-test permits.
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Copyrights
In contrast to a patent, which protects an idea and its implementation, copyright protects the expression of an idea, not the idea itself. Such expression must be in some retrievable form such as handwriting, set in type, recorded on magnetic tape or other storage medium. Copyright covers the expression in literary or musical works, computer programs, video or motion pictures, sound recording, photographs, and sculpture. Unlike patents, copyrights automatically come into being when the idea is fixed in a tangible medium of expression.
While no longer required by law, it is still useful to apply a copyright notice to the work.
The notice should include the familiar ©symbol or the word "copyright," the year of first publication and the name of the owner of the copyright.
The owner of the copyrighted work has the exclusive right to control copying, adaptations, and distribution of copies, public performances and public displays. In the
"fair use doctrine," others may use a copyrighted work in limited ways for criticism, comment, news reporting, teaching, scholarship or research without infringing”.
The area of copyright law is one that has been very active over the last decade. There is apparent strengthening of the copyright enforcements by the courts, such as the Napster music case, where there was an apparent narrowing of the fair use doctrine. Given the application of copyrights to protect other data important to agriculture such as genome databases, meteorological data, GIS images, etc. there are many issues arising from this area of IPR protection.
The major issues that will need further dialog include:

Copyright on databases, implications for genomics.
 Clear position on “fair use”, how does this impact on research?

Global agreements on copyright enforcement

How much modification is required to indicate that information is novel?

Impact of the internet on copyright, and fair use
Trademarks
A trademark is a word, name, symbol or device used by a person or legal entity to identify their goods and distinguish them from others. Commercial logos are common examples of trademarks. Trademark rights can be asserted by using the familiar trademark indicator TM in association with particular goods or services. Trademarks play a critical role in the development of an “image” for a product or service. This leads to the
IP concept of “branding”. Branding has been used in the agricultural sector extensively over the years, from seed companies, food and drink manufacturers, and even developing
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country commodity associations, such as the Colombian coffee growers effective use of the brand name “Juan Valdez”.
Branding, or trademark protection again raises issues for the global agricultural sector, the se include:

Agricultural product branding and the effect on markets

Globalization of marketing

Quality control and brand image

Use of indigenous terms in a brand, ie Jasmine or Basmati

Costs associated with branding
Having covered the basis elements of the current IP regimes and the issues that they raise for those with an interest in agricultural research and development, let us now go on and look at some of the crucial interfaces of IPR mechanisms in biotechnology, and the interplay between IPR and other structural economic matters such as trade.
Opportunities and Constraints of the IP mechanisms on Agricultural Biotechnology in Developing Countries
There is no doubt that IPR is having a substantial impact on investment in biotechnology in the industrial world. This raises questions of technology access and product pricing.
The development of this new proprietary science raises both opportunities and problems for those in the developing world. These include:
Opportunities:
A number of potentially valuable opportunities derive from the growth of proprietary science, these include:
(a) Access to new science.
(b) Development of commercial type relationships.
(c) Development of new partnerships.
(d) Novel delivery mechanisms for new products.
(e) Increased value / income for re-investment in science.
Problems / Constraints:
There are of course potential negatives to the development of proprietary science, these include:
(a) Access problems.
(b) Dealing with exclusive licenses.
(c) Liability Issues.
(d) Terms and Conditions of Access.
(e) Cost of access.
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(f) Failure to establish humanitarian license terms.
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AGRICULTURE, BIOTECHNOLOGY, POVERTY ALLEVIATION AND
INTERNATIONAL PUBLIC GOODS
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Despite massive efforts by national and international organizations, today, a fifth of the world’s population still lives in absolute poverty (i.e., < US $ 1 daily), and almost 50% of the total world’s population lives with less than US $ 2 per day. Extreme poverty and financial insolvency translate into despair and economic isolation. Public health and food production are distinctive crisis features of Highly Indebted Poor Countries (HIPC). Poor people spend up to 80% of their very low income on food.
The diets of the poorest are often deficient in vitamins, leading not only to malnutrition but also diseases, and in severe cases, blindness. In the 21 st
century these poor people and all children should have a right to enjoy human betterment.
Poverty reduction and economic development need a stable base of agricultural production. Particularly since a high percentage of people in the developing world depend on agriculture for their livelihoods. In this regard, science-based agricultural improvements play an important role. Hence, it has become critical that development investors, such as the FAO, review the advances of applied biotechnology for improving agriculture and how these will benefit the poor. The focus of applying biotechnology for crop improvement should also consider the benefits to people working and living in the agro-ecosystem rather than only the plant species per se .
Any strategy to be supported by development investors for deployment of biotechnology to improve agriculture in the developing world needs to determine how it will address poverty issues, keeping in mind that poverty alleviation needs an integrated solution owing to its multi-facet nature. Agricultural biotechnology should not be perceived as the panacea but as one of the available options to enhance sustainable productivity and ensure food security, thereby reducing poverty, especially in rural areas, whose fragile environments need to be protected by introducing new eco-friendly technology.
A more proactive approach appears to be needed for ensuring equitable access to private sector proprietary agricultural biotechnology tools so that the benefits of the so called
‘gene revolution’ reach the poor, particularly in rural areas of the developing world. Of course, agricultural biotechnology products developed by the private sector must be deployed in a way that considers both environmental issues and human health safety.
Discussions need to be broadened so as to bring the public into the debate of the risks and benefits of bringing agricultural biotechnology to improve food crops, while this is an issue that remains sensitive, especially for some of the inhabitants of the industrialized world, it is a debate in which the developing world must have its own voice, and must set its own standards. It must be remembered that developing counties have far different economies, ecologies and climates. They must ensure that the new science serves their needs and aspirations. Innovative license provisions based on income, farm size, commodity price structures and nature of the technology must be developed that can form a template agreement without the overhead costs of negotiating each and every deal.
By incorporating resistance to pests into crops, crop yields and/or quality improve, thereby enhancing the profits of poor farmers and eco-friendly, sustainable food security, especially in HIPC. In short, the higher and more stable yield potential and profitability
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permit poor farmers to invest in inputs for producing more food and income; likewise high yield may lead to reducing food prices for the urban and rural poor.
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IPR IN RESEARCH AND AGRICULTURE
Background and Prior Debate
It is a broadly held hypothesis that a framework of intellectual property (IP) protection and its rights of limited exclusivity has served to foster research and development.
Biotechnology is often used as an example of the stimulatory power of IP to promote research investment. The landmark case of Diamond v Chakrabharty in which the United
States Supreme Court held that it was allowable to issue utility patents on living organisms arguably then allowed investment to take place in biotechnology with a realistic possibility of recuperating that investment.
This boom in investment in biotechnology in industrialized countries has continued throughout the 1990’s and into this new millennium. Despite the sharp downturn in investment in information technology since 2000, the investment in biotechnology research continues to grow. The US Patent & Trademark Office now has more patents pending than it has issued in its entire 200+year history, most of these in the biotechnology and information technology fields of art. This arguably serves as an indirect indicator of the stimulus this has provided to research investment.
To those persons actively involved in international agricultural research and development another fundamental component to IP and research is the application of the so called
“research exemption”. This provision provides for a person to use a patented invention where the intention is to use the patented technology for further research. The true challenge here is to adequately define what is “research”. The usual interpretation of this language is narrowly read, research by a university scientist that leads to the development of new varieties is not covered under the research exemption per se.
In part as a result of public pressure for publicly funded science to be seen as useful to society there is a need for public organizations to get their research outputs “in the field”.
One of the challenges that therefore faces public research organizations worldwide is to what extent should they seek proprietary protection of their research in order to obtain funds or recoup costs, or to ensure uptake and deployment of their technology. In order to try and foster closer cooperation between the public and private sectors in the United
States the government enacted the Bayh / Dole Act (1980). This act allows public research organizations to hold title to their inventions if invented on Federal research dollars. While this potentially can serve as a source of funding to public institutions it has also blurred the lines of comparative advantage between the public and private sectors.
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Key Issues
One of the first key issues is whether agricultural research is in some way “special” as it relates to IP and research. The fact that human well being depends on food, the timeframes involved with the research process and the underpinning of free global access to genetic resources all feed into this special status concept. On the other hand there are those that argue that there is no substantial difference between food and telephones, therefore the invention is concept neutral and no special advantages should be given.
There are already exceptions in the pharmaceutical area that relate to the time frames of getting products to market, and the high cost of research development. A good argument exists that in the biotechnology field, as it relates to agriculture, the same arguments hold.
Some of the critical questions in this area that must be addressed by policy makers at the international, national and institutional levels are given below. While the author has a personal viewpoint on these matters, it is inappropriate to present that at this time. It is hoped that as a result of the debate and dialog that a consensus position may be developed on some of these key issues.
(a) Does IP protection truly stimulate research investment in agriculture?
(b) Can proprietary research help fund developing country research?
(c) Should governments or institutions see this as a revenue source or only cost recovery?
(d)
Is there a role for truly “public” goods, both nationally and internationally?
(e) Does publishing play a key role in the public domain?
(f)
What is the scope of the “research exemption”?
Major Constraints and Opportunities
Constraints:
There exists a distinct possibility of a backlash in relation to IP protection in the area of living organisms and in food production; this if it happens will be driven by negative public perceptions. This may in part be driven by fundamental ethical or religious beliefs, or on the basis of lack of complete understanding of the facts involved.
There is also a risk that the drive to produce global technologies for a global market, with all the associated regulatory frameworks may push small companies, if not countries, out of the market. The IP portfolio of the small will be eaten by the big. There are even doubts in some minds that current anti-trust laws are able to adequately deal with these problems. The issues of anti trust actions at a global level are also worthy of much further attention.
Opportunities:
The time is right for action to harmonize and simplify the current IP system in order to even the playing field for the smaller entities, and countries, that wish to seek global
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protection. There are opportunities to amend IP statutes in a way that will more equitably reward invention, including those who work through non-conventional channels.
When good quality science is performed in the public sector and adequate and effective protection is established it may be possible to use the tools of IPR to expand the total budget allocations for public research. More creativity and efficiencies are already beginning to show in this area. The public sector can use the tools of IP to generate new revenue for increased investment in additional research.
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IPR AND TRADE
Background and Prior Debate
Heated debates, occasionally literally in flames, have fueled the development of the regional and international trade pacts. We have seen the growth of trade related legislation and organizing bodies such as APEC (Asia Pacific Economic Community) and NAFTA (North America Free Trade Association). We also witnessed the formation of the World Trade Organization (WTO) as a forum for these matters.
Globalization of the world economy, and the massive increase in global trade has led to the application of rules and regulations relating to intellectual property also at a global level. The so-called TRIPS [Trade-Related Aspects of Intellectual Property Rights
(General Agreement on Tariff and Trade -(GATT/WTO)] provisions have brought the concept of IP protection front and center in trade matters.
Trade related IP matters involving agricultural products are increasingly common, and in some cases the arguments are between nations who hardly even produce the materials, i.e., the banana wars between the USA and Europe.
There is an increasing focus on the use of non-tariff barriers to trade. This may take a variety of forms, from plant quarantine issues, to biosafety concerns, to genetic resource flow concerns. If we see the current impasse on GMO foods between Europe and the
USA, this has already flowed to a series of discussions with governments in Africa and
Asia, where clearly links are drawn between the ability to export GMO foods and the IP that controls the ownership and expression of those genes.
Through a variety of international conventions IP has become a global, trade related practice. The barriers that once clearly made patents a national (territorial) matter have been substantially blurred in recent years.
Key Issues
This area of interface is still in turmoil and the upcoming rounds of debate at WTO on
Agriculture will clearly keep this matter in the policy spotlight. It is crucial that a detailed dialog is aired in relation to these matters. Failure to reach a compromise situation could drastically impact food production and distribution mechanisms both at regional and global levels.
A number of critical issues face policy makers in coming years, these include:
(a) WTO Agriculture Round Negotiations.
(b) Continued Globalization of Agricultural Trade.
(c) The issue of non-tariff IP matters, e.g., release of genetically modified foods or organisms (GMOs).
(d) Globalization of IP protection and concurrent transactional costs.
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Major Constraints and Opportunities
Constraints:
There is a continuing constraint of information to both policy makers and the general public as to the advantages and disadvantages of IPR regimes and trade matters. This is in part due to the polarity of the issues, and the vested interests of the various groups that are putting forward their positions. This lack of information, in a useable format, allows various interest groups to take the limelight and spread their own message, irrespective of the facts. We need a balanced debate. It is hoped that the current document will serve to assist that dialog, and lead to the production of some form of consensus document that indicates areas where there is general acceptance of a position. It should also show which areas are still in dispute.
There is a need to work during a time of unprecedented rate of change. Current regulatory structures and existing national legislation are often unable to deal with the speed and nature of the trade related changes that are ongoing. Despite the lead times to enact legislation for WTO compliance many countries find themselves passing hasty legislation simply to avoid punishments for non-compliance.
Global litigation of trade matters, although necessary in the current framework, is slow and costly and as such again favors the large entity over the small entity. More efficient mechanisms must be devised for dispute resolution.
Opportunities:
New technologies and new trading relationships offer tremendous opportunities for new growth, including the rapid expansion of new markets being available to developing countries. There is still a need for greater access to markets. Creativity should also be encouraged to develop new mechanisms to allow for economic growth, particularly associated with the more poor sectors of society.
New markets provide the opportunity for greater diversification, greater output and as such more and better employment opportunities. Clearly greater access to markets creates internal competitive pressures that in a positive environment can be translated into increased efficiency and higher productivity. The initial impetus must be focused on the developing world gaining greater access to industrial markets. This will in turn lead to greater general market access, benefiting all parties concerned. Again the use of innovative partnerships, particularly in the private sector, will be crucial to the success of this transformation process.
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The PUBLIC SECTOR AND INTERNATIONAL PUBLIC GOODS
Background and Prior Debate
The overwhelming majority of scientific knowledge is in the public domain. It forms a body of international public goods. Remember that so called proprietary technologies, with the exception of trade secrets are by the very nature of the statutes of IP are made public as a part of the exclusive right to use. A patent is the right to prevent others from using, making or selling your invention, however, the exact nature of the patentable material must be fully disclosed to the public as a quid pro quo .
At the end of the statutory life of a patent, the exclusive right is gone and the material is public knowledge. This approach in the pharmaceutical area has led to the growth of the so-called “generics” market. Products whose patents have expired are then manufactured by a variety of companies for direct sale in the marketplace.
In the case of agriculture up until the last decade most information and materials were so called public domain material. The Green Revolution was based in large part on materials and knowledge flowing from Universities and governmental research and breeding programs. Before the 1980 Bayh/Dole act all such information was in the public domain.
Over the last decade however a substantial shift has taken place in the ability and encouragement of public organizations to seek proprietary protection. Most governmental research laboratories and large universities in the industrial world now have their own offices of IP and patent inventions from their research, including that sponsored by the governmental agencies.
This “privatization” of public sector research has blurred the line in terms of those international bodies that are accessing research materials. It is no different in essence to negotiate a license agreement with a major university than with a multinational company.
Key Issues
Of all the areas under consideration in this report none is so complex or sensitive as determining ownership over the ideas and materials. There are strong opposing schools of thought on these matters, both of which offer rational and convincing arguments. A number of questions need to be addressed:
(a)
Is the current “privatization” of public goods healthy?
(b) Are we looking at the availability of information, or its ownership?
(c) Is the privatization of these systems economic?
(d) How much is the trend driven by a desire to gain bargaining power?
(e) How much is public access rather than ownership the issue?
(f) Are international public goods something unique?
(g) Is agriculture a unique circumstance that can be afforded some exemption?
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Major Constraints and Opportunities
Constraints:
A major constraint for developing counties will be the computing and database skills and infrastructure to be able to access the huge amount of public data that will be available.
As more data becomes proprietary the skills needed to negotiate equitable license agreements, not only with the private sector, but also with the new public sector will be very important.
The costs associated with IPR are not insignificant. The funds used to provide for
International Public Goods are not usually earmarked for the costs of IPR, and it is unclear as to who should pay.
Public Goods research is funded out of tax revenue. The use of IP as a “bargaining chip” with the private sector is often viewed as double dipping, since the corporations have already paid taxes.
Opportunities:
New technology offers access by developing countries to information in a revolutionary way. The poorly stocked libraries of the developing world can be upgraded to the highest possible standards with minimal investments in databases and infrastructure. In short books are fast becoming an obsolete medium for technology dissemination and transfer all countries have equal access to data! What an opportunity for technology dissemination and innovative and creative research for a better world.
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PUBLIC SECTOR/ PRIVATE SECTOR INTERACTIONS: MORE, AND MORE
DIVERSE PARTNERSHIPS ARE NEEDED, AND ARE BEING TRIED.
Background and Prior Debate
Interesting models have been established to enhance and foster interaction and cooperation between the public and the private sectors. Each sector brings its unique set of comparative advantages to the relationship and a synergy is obtained through these interactions.
The basis for the success of these relationships is complex and involves trust, mutual understanding, respect for goals and aims, and a clear set of institutional objectives. The issues of trust and understanding cannot be underestimated.
Several programs have been enacted over the last decade in promoting public/private interactions, these include ABSP, a USAID funded program, ISAAA a not for profit program with its headquarters at Cornell University, and IBS (Intermediary
Biotechnology Service) managed at ISNAR (International Service for National
Agricultural Research), one of the CGIAR research centers.
Key Issues
As indicated above the fostering of productive relationships between these sectors is complex and takes time to build. There are additional complications to these arrangements at the international level given the sovereignty matters in IP law and regulatory affairs. Some progress has been made as indicated by the following examples:
(a) How to build trust and confidence, particularly as to confidential information
The ABSP project brokered a wide range of partnerships with small and large companies, universities and governmental research organizations in both the US and various developing countries. These partnerships among others included: i.
DNAP, a New Jersey small cap research company, and Private sector producers in Indonesia and Costa Rica. ii.
The Egyptian Agricultural Genetic Engineering Research Institute and
Pioneer Seeds. iii.
Monsanto Company and the Kenyan Agricultural Research Institute. iv.
Zeneca Seeds and the Indonesian Food Crops Research Institute.
(b) Product and Technology liability concerns. When a company “donates” its technology to a developing program it foregoes income but is not absolved of liability.
(c) The issue of confidentiality is critical to the building of the trust and confidence of these types of arrangements. This is true not only in the IP area but also in
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regulatory matters. There is a need for greater understanding of the importance of confidentiality to the private sector.
(d) More analysis is needed as to the elements that help build a successful partnership, ie trust, parties, ground rules, product focus etc.
(e) Are there differences between developing and industrial counties as to expectations form a partnership agreement?
Major Constraints and Opportunities
Constraints:
There exists the possibility of public backlash against privatization and the globalization of research, particularly in relation to health and safety concerns.
It is however fundamental those developing countries should be allowed to set their own risk and benefit parameters.
Opportunities:
The lifeblood of research, whether in the public or the private sector, is knowledge, linked to the ability to access and develop that knowledge into new products and technologies. There are potentially tremendous benefits to all sectors of society from greater knowledge sharing.
The opportunity clearly exists for substantial synergy from these partnerships. The may even be cases where impact of a private sector technology on a major commodity or disease can then be used by the public sector for orphan crops or for diseases where the private sector is unable to see equitable returns from a purely economic standpoint.
The public sector is still the primary producer of the raw material of innovation, skilled people! The role that education plays in terms of building scientific, legal and entrepreneurial skills cannot and should not be underestimated.
So called “orphan crops” may provide unique opportunities, such as organic teas, medicinal plants, spices etc. This requires the use of creative IP to develop marketing strategies, brand development etc.
There are also opportunities to develop global approaches for strategic research initiatives. The improvements in communications should facilitate improved growth of research infrastructure in the developing world, if IP can be protected. An example of this can be found in the information technology area where India now has more software developers that most other countries.
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CONCLUSIONS AND POTENTIAL MECHANISMS TO ADDRESS IDENTIFIED
CONSTRAINTS
Despite the complexity of these issues I will try to distill a list of key discussion points that are worthy of further dialog. There are often no concrete conclusions or resolutions that can be brought to bear on these matters. We should not search for black and white in an area that is perhaps gray by nature. But let us discuss and debate the following: While the author offers his own comments on these points, there will be a need to refine these positions based on the additional inputs to the debate.

What can be done to enhance the debate over the harmonization and costs of patenting?
A more proactive stance is required from the scientists and policy makers. There will be substantial support from the private sector to make these types of changes. More training and education is required for institutions to develop strategies that will keep down patent costs by selecting the focus countries of the technology. The use of innovative partnerships, where the partners share or bear all of the costs of filing is also important.

What can be done to evaluate the impact of private investment in agricultural research and product development?
Some work in this area has already been undertaken by a number of organizations, including the World Bank and IFPRI. More studies are required, and are needed across a range of models. The focus should not be per se on the major agricultural multinationals, but also on the small venture capital seed companies in the developing world.

What can be done to ensure equity to those who provide the raw materials so crucial to new product development in agriculture?
There is still an ongoing debate as to how to provide “benefit sharing” to those persons or communities that have served as “inventors” or “holders” of technology. The
Government of Thailand has recently passed legislation that tries to link benefit sharing to PVP. This mechanism, while containing some problems of international acceptability, has merit and is worthy of further study.
 How can IPR be balanced and integrated with other areas of product development such as regulatory review?
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More integrated training is required to deal with the whole issue of “product stewardship”, there are a wide range of different issues surrounding product deployment that need to be teased apart, then reintegrated to meet both local and global standards for food and health.
 How can greater understanding and human capital be developed in this area?
There is a massive need in this area. There should be more focused education at the
University level on IPR and the development of business activities. Scientists should also be made aware of the enabling environment that can be associated with effective IP management.

How can the ethical matters associated with these issues be debated and addressed?
More effort is needed to get these issues onto the agenda of those that deal with issues of ethics and science. The FAO has a key role to play in this area. Just because the science exists that something can be done, does not mean that it has to be done.

How can International and National Public Goods be developed and deployed most effectively?
There is a need for the broader dissemination of public science. That science may at times need to be packaged in a form that makes it attractive to a broader range of clients. There should also be creative use of licenses and partnerships to ensure update of public goods.

What role do International Organizations such as FAO, WIPO and WTO play in this debate?
Clearly a key role exists for these organizations. There is however a need to get beyond the “mere words” and develop innovative programs of education, partnership, and science development that can test the various models that may exist to use IP as a mechanism to enhance technology transfer to the developing world.
END
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