Intellectual property rights in Agriculture

(An Issues & Dialog note)

John Dodds

Dodds & Associates

1707 N St. NW

WashingtonDC20036

Table of Contents

  • 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

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.

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.

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 20th century 370 kg of cereals per person were harvested versus to only 275 kg in the mid-20th 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 21st 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.
  • Better management of seed storage facilities, so-called gene banks, and greater knowledge of biodiversity can be achieved with the aid of molecular-aided 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 CornellUniversity 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.

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 ‘bio-informatics’.

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

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

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 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.

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.