TRIPS flexibility for patents and food security: options for developing countries
Achieving food security is a major objective of the international community. The effort to reduce the number of people suffering from food insecurity faces many obstacles, including underinvestment in agriculture and rural development, substantial increases in food prices, poverty and the impact of Intellectual Property Rights (IPRs).
The development and production of commercial seeds is highly concentrated. There is a growing orientation of research and development (R&D) towards commercially attractive crops and varieties, while traditional seed supply systems are eroded. The spread of commercial plant varieties has significantly reduced the genetic variability and increased the vulnerability of agricultural production. In addition, some forms of IPRs can create barriers to the free flow of information and materials which is essential to sustained levels of food production as well as development of new plant varieties.
IPRs were originally conceived for innovations in manufacturing and artistic creations. However the recent expansion of IPRs to plant materials and food has given rise to concerns about the possible implications for food security. IPRs generally grant exclusive rights. This means that the right holder can exclude, for a period of time, anyone from using the protected subject matter, unless the national law provides for specific exceptions or limitations.
Thus, IPRs remove competition and enable the right holder to charge the price that the market will bear. Hence, the granting of IPRs affects access to protected products and their affordability. Higher prices for seeds and other agricultural inputs may be detrimental to small farmers and increase the concentration of agricultural production for food.
The growing use of patents to protect innovations in plants, as a result of the obligations arising from the TRIPS Agreement and from bilateral and regional free-trade agreements (FTAs) entered into by a number of developed and developing countries, may drastically transform the paradigm related to the free flow of knowledge and materials under which agriculture developed over the past centuries.
Although the TRIPS Agreement provides WTO Members with flexibilities for implementing its provisions in ways that are consistent with their agriculture and food policy objectives, such flexibilities have received little attention so far. In fact, many WTO Members have not used them or have done so only to a limited extent. This contrasts with the situation in the area of public health, where a large range of measures have been debated and adopted nationally and internationally to ensure access to medicines.
Exclusions from patentability
Food security may be negatively affected by the appropriation of plant genetic resources, as it may prevent further research and breeding or limit the possible sources of supply of seeds. TRIPS article 27.3(b) allows WTO Members considerable policy space to define national laws in this area.
Article 27.3(b) allows (but does not oblige) WTO Members to exclude plants from patent protection. It is important to note that, in the absence of any definition in TRIPS itself, the exclusion for plants can be interpreted in broad terms, inclusive of plants as well as plant varieties and species. In addition, countries that opt to implement this exception may exclude plants, whether obtained through conventional breeding processes or through the use of genetic engineering.
An important question is whether the possibility of prohibiting patents on plants may be understood, under the TRIPS Agreement, as applicable also to plant cells, genes and other sub-cellular components. It could be argued that none of those components are "plants" and, therefore, that they are not covered by the exclusion provided for in Article 27.3(b). But patenting of such components (even if modified) may be equivalent to patenting the plant as such, since the patent owner may prevent commercial acts relating to any plant that contains the patented subject matter and thereby nullify, in practice, the exclusion relating to patents for plants.
Essentially biological processes
TRIPS Article 27.3(b) allows the exclusion from patentability of "essentially biological processes" for the production of plants. The meaning of "essentially biological processes" - a concept drawn from the European Patent Convention (EPC) - has been examined in many European Patent Office (EPO) decisions and given a rather narrow interpretation. For instance, in Decision T320/87, Lubrizol (1990), the EPO held that "a novel combination of traditional plant breeding techniques that results in plants and seeds" is patentable.
A growing number of patent applications claim IP protection over conventional breeding methods. In 2010, about 200 patents on seeds with and without the use of genetic engineering were granted by the EPO, and 100 applications were received on plants bred without using genetic engineering.
National laws should not allow for the patentability of conventional methods for plant breeding, even where selection is assisted by genetic markers. The use of such markers should not be deemed either a sufficient ground to grant patents on the products obtained with those methods.
The TRIPS Agreement mandates the protection of plant varieties, allowing several options: "patents, an effective sui generis regime or a combination of both." This was one of the most controversial provisions in the TRIPS negotiating process. The initial proposals by the US, Japan, the Nordic countries and Switzerland aimed at broad patent coverage for plants and living organisms. In contrast, most developing countries rejected such an approach. Meanwhile, EU countries wanted to preserve the freedom to exclude plant varieties (and animal races) from patentability, as provided for in the European Patent Convention.
The patentability requirements (particularly the inventive step) seem not only unsuited to plant varieties, but also, given the scope of rights generally granted under patents, these may deter further research and breeding on protected materials and erode the rights of farmers to save and reuse seeds.
Ordre public and morality
Article 27.2 of the TRIPS Agreement provides for the possibility of refusing patents for inventions the commercial exploitation of which is "necessary to protect public order or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law."
Although Article 27.2 is likely to be relevant in only a limited number of circumstances, it may be applied, for instance, when the diffusion of a certain plant technologies, such as the sterilisation of seeds, may have negative effects on agricultural production or the environment.
Proliferation of patents on plant materials
Although the patenting of plant materials raises a number of concerns from the perspective of food security, many countries do allow such patenting. Patents are routinely granted in many developed and developing countries (such as China, Chile, India and South Africa) on genetically modified plants, plant cells, genes and other sub-cellular components as well as on enabling plant biotechnologies. In order to address the proliferation of patents in this field, the following policies may be adopted:
- National laws should establish a clear-cut distinction between "invention" and "discovery" and consider that an "invention" does not exist where a natural substance, such as a gene, has been isolated or the properties or a function thereof identified. Allowing appropriation of plant materials found in nature through IPRs creates barriers that may negatively affect agricultural research. The TRIPS Agreement does not oblige WTO Members to confer patents on natural biological materials.
- National laws should apply an absolute concept of novelty and consider that a substance found in nature is not "novel" even if its composition, properties or characteristics have not been previously described. Maintaining access to genetic resources for use and improvement is crucial for agricultural development and food security.
- A low standard of inventive step may reduce the sources of supply and limit research and breeding. Patent offices should apply rigorous criteria to establish inventive step in plant-related innovations, so as to grant patents only when the invention is not obvious for a person, or a team of persons, with high technical qualification and experience in the field.
The range of exclusive rights
In the case of patents covering genes, an important issue is whether the exclusive rights extend to any possible utilisation of the gene. If this were the case, nobody could use the patented gene even for functions not discovered or disclosed by the patent owner. An absolute protection of this kind is likely to discourage further research on and prevent other possible uses of a patented gene until the patent expires. Even if research is allowed under a "research exception" - as permitted under many national laws - a product that contains the patented gene could not be commercialised without the patent owner's authorisation until the expiration of the patent.
In the same line of thought, and in accordance with TRIPS article 44.1, national laws should exempt from liability unintentional infringement caused by the dissemination of patented genetic materials.
Importantly, farmers should be free to save and re-use seeds as allowed under the ‘farmers' privilege' generally recognized under plant variety protection laws. Few patent laws clarify the rights conferred with regard to reproductive materials, such as seeds. French law, for instance, makes it clear that plant material can be multiplied or reproduced where it has been legally put on the market by the patent holder or with his or her consent, where this was the purpose for which the material has been marketed; the obtained material, however, cannot be subsequently used for further reproduction or multiplication.
The continuous improvement of plant varieties requires freedom to undertake research and breeding where patented materials are involved. Exceptions to this effect should be adopted even where a country opts not to grant patents on plants (or plant varieties). If a country opts to grant such patents, national laws may permit the commercialisation of the newly obtained varieties, on the basis of non-remunerative exceptions. However, the compatibility of an exception of this kind with the TRIPS Agreement has not been tested.
National patent laws should provide for compulsory licenses in cases where the exploitation of a protected plant variety would infringe a patent. A cross-license may be granted to the patent owner with regard to the concerned variety.
When designing and applying IPRs, it is necessary to make decisions concerning the the type and the scope of rights conferred regarding plants and food. Advances in the improvement of food crops are the fruit of centuries of free circulation of products and knowledge, through exchange of seeds and information empirically generated by farmers. Countries could do much more in the way of developing IPRs protection systems which, while complying with the TRIPS Agreement, are adapted to local conditions, promote genuine innovation and its diffusion and enhance food security.
Author: Carlos Correa is the Director of the Center for Interdisciplinary Studies for Industrial and Economic Law (CEIDIE) of the University of Buenos Aires and a Special Advisor on Intellectual Property and Trade at South Centre.
This article is based on a policy guide : TRIPS-Related Patent Flexibilities and Food Security: Options for Developing Countries, ICTSD, Correa, Carlos (2012), http://www.ictsd.org/themes/agriculture/trips-related-patent-flexibilities-and-food-security-options-for-developing