Implications Of Biotechnology On Patents And Food Security

IMPLICATIONS OF BIOTECHNOLOGY ON PATENTS AND FOOD SECURITY Submitted by: Uttam Maheshwari (4th year, National Law School of India University). Submitted on: August 2002. Key words: biotech, biotechnology, Cartagena Protocol, food security, Convention on Biological Diversity, patenting biotechnology.

INTRODUCTION “Biotech cases are filling the patent offices in the US and Europe, and the administrative burden is proving excessive. How will developing countries cope with such a situation? And in any case the patents have not yet been contested? What judgments are likely in the future, when the definition of novelty and utility are so difficult to assess? The relationship between gene and product is not straightforward; it is the whole interaction of genome and proteome that is key, and this would have the impact on the patenting regime as well.”

For technologies with potential such as biotechnology, governance to ensure desired social outcomes is the pressing need of the hour. There are two main mechanisms in order to control the way this can be governed one being Intellectual Property Rights (IPR regime can address the issues like that of ownership and control, and also the availability of the developed products to the developing countries) and secondly Bio-safety regime (It has to answer is the host of the issues varying from hybridisation, gene flow from one crop to another, super weeds, adaptation to the socio-economic tenure of the land, mixing of traditional and advanced seeds, and safe use of the biotechnology resulted seeds ). In this project an attempt would be made to understand the relation between the biotechnology and IPR regime. It has been heralded that the biotechnology would be able to solve the problems that the humanity is facing due to the shortage of food. At the outset, the researcher would like to submit that the food security is not ensured by the mere fact of higher production, but by host of other factors as well, including economy or otherwise. There are host of issues that are raised with regard to the patenting of bio-technology, and the paper would be in regard to address few of them. This paper starts with a general overview of the working of the bio-technology, and then progresses into the patent regime for a protection to the bio-technology, and what are the various factors that lead in to this debate. Hence, the chapterisation is as follows: 1. Section One: Concept of Bio-technology: This section deals with the relationship of biotechnology and plants; advantages and possible harms of biotechnology, and finally the testing requirements. 2. Section Two: Protection under the Patents: In this section an attempt has been made to understand as to the patentability debate, Indian scenario; and ginally contention and objections to granting of patent. 3. Section Three: Would biotech ensure food Security: This section first deals with the fact that the results of the tests are still not conclusive; then the section moves into the understanding the traditional knowledge, Plant Varieties Act and the same.

RESEARCH METHODOLOGY Aims and objectives: The main aim of this project is to look at the role that biotechnology plays in agriculture and the requirement and appropriateness of giving the Patent protection to it. The project also aims to probe the reasoning of the proponents and opponents of biotechnology.

Sources of information: All the sources of data have been secondary in nature. This includes books, journals, and internet, and unpublished research documents.

Mode of citation: A uniform mode of citation has been used adopted all throughout the project.

Scope and limitation: The main emphasis of this project would be to find out the rationale for Patent protection to biotechnology, and the impact that it might have on the agriculture production, farmers and food security. This project does not cover all the aspects that are related to biotechnology and law, i.e., with respect to testing and labelling in detail. The paper has also not looked into the empirical data that is supposedly provided to prove that either biotechnology has succeeded or failed as in either case the data was not conclusive enough. The researcher was unable to find any Indian case law, and the main emphasis has been on the rationale behind such a debate. Research Questions: Following have been the main research questions: 1. What is the purpose and mechanism of patenting of Biotechnology? 2. What are the implications on the patenting of biotechnology on food security, rights of the farmers, and sustainable development? 3. Is the decision regarding patenting of biotechnology wholly legal? 4. What is the legal regime governing patenting of biotechnology in India?

SECTION ONE: CONCEPT OF BIO-TECHNOLOGY “Any technique that uses living organisms, or parts of such organisms, to make or modify products, to improve plants or animals for human needs, or to develop micro-organisms for specific use”.

1. 1 How is Bio-technology related to plants Using biotechnology it is possible that there transmission of genes takes place from one specie to another, scientifically proven to be useful in nature, where the same has not happened naturally. The most common purposes of genetic engineering are herbicide resistance , pesticide resistance and forcing expression or suppression of different traits, which includes anything from using genetic engineering to attempt to change the nutritional qualities or reproductive cycle of a crop, or a plant's ability to grow at different temperatures. Progress in plant biotechnology revolves around recombinant microorganisms such as soybean nodule bacteria, nitrogen-fixing bacteria for rice and corn, and phytase from recombinant yeasts for feed additives. Genetic traits viewed as priorities may be transferred into target crops. Priority traits include those related to insect and disease resistance, stress tolerance, and quality improvement. Quality improvement traits have been included as priority traits in response to increased market demand for quality foods particularly for rice and wheat. In addition, stress tolerance traits, particularly resistance to drought are gaining attention, particularly with the growing concern over water shortages. The first step in the process of creation of genetically modified crop is isolation of the genetic material that would produce the desired result in the new plant. There are various plant traits that are influenced by the protein with which the plant is made, and these include colour, size, life, time taken for ripening and the same. The genes in the plants determine production of these genes, and this is the focus of genetic engineers. At the same time, there are other factors that also influence the appearance and functioning of the plant, like the soil quality , air temperature, toxicity, and amount of water available. And the second step is that the scientist must get the material integrated into the cells of the host plants. Scientists are still experimenting with several different ways to do this including using recombinant DNA , microinjection , electro-and chemical poration , and bio-ballistics . Following are the main implications that have to be addressed in the regulations with respect to any management of the biotechnology : ➢ Equal attention to bio-safety and development; ➢ Prevention of negative health, ecological and other risks; ➢ This should be based on scientific methods; ➢ Labelling to educate the consumers and also to differentiate as between the traditional and modified crops.
2. 2 Advantages of Bio-technology There are major proponents of the GM technology, and USA has hailed as one of the major supporters of the same. Following are the main advantages that have been purported by the proponents of the technology : ➢ Pest resistance: This would control done to the crops due to the pests without any usage of chemicals ; ➢ Herbicide tolerance: This would facilitate removal of other weeds without any damage to the plants; ➢ Disease resistance: This may be prevented with the use of technology; ➢ Cold tolerance: This would protect the plants from the unexpected frost, and any other natural bearings; ➢ Drought/Salinity tolerance: This would facilitate production in hitherto unsuitable plots for cultivation; ➢ Nutrition: Keeping in mind the fact that poor people rely mostly on single staple food, that variety may be developed to take care of malnutrition.
3. 3 Possible harms of bio-technology’ “Genetic engineers are still experimenting with the best ways to get plants to take up foreign DNA. It is a complex challenge, requiring genetic engineers to isolate the genetic and chemical basis of the quality they want the new plant to have, find a way to get the foreign genetic material into the new plant at the appropriate spot, functioning at the right time in the appropriate sequence of development, and at the appropriate level of expression - all without affecting any of the other processes of the living plant. With so many variables, it is understandable that the technology is still experimental.” Although cross breeding has been the effective means to improve the crops on a large scale, it can be time-consuming and imprecise. There is no guarantee that there would be control over the individual traits without covering all other traits . At the same time, there is no protection during cross-pollination , and this sometimes resulted in super weeds, impact on small farmers , standard of testing , terminator technology, impact on the environment, and the same. All living things contain the molecule deoxyribonucleic acid -- DNA. Each strand of DNA is comprised of thousands of genes, each of which, in turn, controls the existence or expression of a specific function or trait. It is the different combinations of genes within the strands of DNA that make different organisms, even organisms of the same species, unique.
4. 4 Testing requirements There are series of requirements that have to be fulfilled by the companies before they would be allowed commercial production. This indicates the fact that there are risks involved in the process, and the science of biotechnology. Department of Biotechnology (DBT) and the Genetic Engineering Approval Committee (GEAC) , which is the apex body under the Ministry of Environment and Forests is authorized to approve the commercial release of GM crops. GEAC has the authority to both approve the technology, as well take action against those who have not taken the prior permission before the distribution of the GMS to the market. The product before being marketed has to be approved by GEAC, under which it has to first be field-tested and on it being successful, the commercial viability would be tested. The government has reserved the power to allow such commercial production in only those areas where there is an acute requirement of the same. It is submitted that since the implications of this new technology are not known , the application should be in a restricted manner. This would facilitate implementation of the new technology where the same is required the most, and would have a major impact on the productivity as then it would cause a change in the productivity from low to high productivity.

SECTION TWO: PROTECTION UNDER PATENTS “A live, human-made micro-organism is patentable subject matter under § 101. Respondent's micro-organism constitutes a “manufacture” or “composition of matter” within that statute.” The decision by the USA Supreme Court had raised the issue as to the patentability of the microorganism and held that it was allowed as it formed the part of manufacture, or composition of matter. The claim was “not a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter a product of human ingenuity having a distinctive name, character and use.” The development of the patent regime is not independent legal development, but is closely associated to the economy and the requirements of industry. There have been protests as against the inclusion of biotechnology in agriculture facilitating the understanding of Public policy considerations as debated. There are two considerations : ➢ Understanding of the limits and potential of legal instruments as tools of development . ➢ Organisation and practice of biotech science is largely undertaken in the private sector, this means in particular that we need to understand better, how businesses respond to regulation. Though it has been the business that has dominated the scene , it is equally important to understand the relevance of public considerations in determining the patenting policy. Patents protect technical inventions , for example, a product, a product use, an apparatus or a process, and containing some new functional or technical aspect, these conditions shall be specified in the next part of this section. The patent is an exclusive right enabling its owner to prevent others from using his invention.

1. 1 Requirements under Intellectual Property Rights regime There are various considerations that go into the decision before patents are granted, as to what matters could be patented, for how long?, and can there be monopoly? There are other considerations as to the fact that there are political/cultural/economic implications. The main conditions for patent are as follows: ➢ Novelty (or not anticipated); ➢ An inventive step (non-obviousness); ➢ Capable of industrial application; ➢ Does not fall into any of the specific categories that are provided for being excluded. It is accepted that patents may be granted for any invention as to the new use of the already existing technology.

Article 27 (3) (b) of the TRIPs Agreement provides for protection of plant biotechnology inventions states as follows : “Members may also exclude from patentability: (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes...The provisions of this sub-paragraph shall be reviewed four years after the entry into force of the agreement establishing the WTO.”

1. 2 Present Indian legal position Before moving onto the legal position in India, it would be helpful if the biotechnology is compared with that of green revolution technology, and then consider the IPR regime protection to the agribiotechnology. The comparison stands as follows : Biotechnology Green Revolution Methods Data mining (genomic/ bioinformatics), lab and greenhouse trial end error (transgenic). Classical experimental work Time Lines From initiation to product takes 6-8 years Short span of time Hardware Requires expensive technology, and other laboratory requirement Minimal requirement, though there was extensive field testing Personnel/ Skills Molecular biology, biophysics, bio-computer modelling, etc. The technicians did day-to-day work. R&D Mostly in the public sector, but growing in the private sector through the MNC’s. Mostly in the public sector . Intellectual property Patents (for genes/sequences and processes); plant variety protection (for background material). This was not an issue with regard to them, as the government funding developed them. Whether the Indian Patents Act, 1970 provides protection for other plant biotechnology inventions is a controversial issue. The Patents Act explicitly excludes some areas of technology, at the same time absence of biotechnology inventions in the exclusions has given rise to arguments that they can be patented. Initially there was reluctance in granting patents to the microorganisms as they were neither expressly stated nor excluded from the definition. But lately, the microorganisms have been granted patent , as in the case of cotton. WIPO (1988c) gives a list of countries where certain technologies are explicitly excluded from patent protection. These technologies basically refer to plant varieties, biotechnological processes for producing animals or plant varieties , microorganisms, and substances obtained by microbiological processes. India is not listed in any of these technological areas as explicitly excluding patents. It also identifies India as the lone country excluding methods of agriculture and horticulture. Thus, presently, inventions leading to the process of biotechnology would be patentable, but the final product will not be patented as microorganisms cannot be patented. As far as procedure is concerned, the first step as to the exclusion from patentability, novelty or usefulness (industrial applicability) is done by the examiner. Once the examiner accepts it the controller can object only on the grounds of prior art. Once the complete specification is accepted and if there is no opposition then it has to be sealed and the only ground can be not being new, obviousness and non-patentability after such sealing. This can be used by the farmers and the government for the patents already granted and not fulfilling the technical requirements . As once a patent is granted, it can be revoked only by two methods: ➢ Initiated by private parties as under s.64; ➢ Initiated by government as under s.66 in the matters related to public interest. 2.3 Contentions for granting the patents Technology can be considered as enabling management, control and hence commodification of seeds, and also for continued invention .

Substantialist theorist: It is argued that there should be protection under IPR regime as one who takes the pain shall be allowed to keep the benefits as well. This would even stand in cases where the inventions are argued as discoveries with respect to biotechnology as there would be human knowledge that would be required to reach that stage as well. Functionalist theories: Patent law provides for commodification of biotechnology. The main objections are raised from the perspective of functional theorists point of view. This can be contended as : ➢ Regulations would take care of any copying; ➢ In absence of not granting of patents, there would be further complications.

1. 4 Contentions against granting the patents “Access to modern biotechnology is the most controversial phase in the evolution of biotechnology. Although genetically modified organisms or plants could result in increased productivity or more diverse and better quality products, serious concerns have been raised over their R and D policy process. These concerns include issues such as health and environmental safety, intellectual property rights, supplantation of traditional knowledge and production systems, and the influence of the multinationals.” The main opposition to the patenting of the agricultural and plant varieties is due to the fact that it would lead to the control over the food chain. There has been an argument that corporations first alter these discoveries with science, patent them, and then resell the derived products or processes at exorbitant rates to the very people from whom they took this knowledge. Farmers have traditionally saved seeds and reused them , they have also traded and sold seeds to each other, and have created and experimented with new hybrids thus contributing to biological diversity. Those against the patents to GMS state that patenting might result in the monopolisation of the market. At the same time the argument to the contrary states that existence of substitute products often inhibits the would-be monopolist from charging monopolistic prices. It is also argued that there is no deprivation of public by the monopolised use of discovery/invention by the person as that did not exist for the public anyways. In the words of Vandana Shiva, “Patents are then intrinsically conflict laden. They embody conflicts between individual rights and public interest. Patent systems are sites of a basic conflict between private ownership, creation of monopolies and private benefits against public interest and the social benefits of science and technology.” It would be fallacious to argue that absence of patenting would lead to fall in the inventions or development of sciences as this assumes the fact that development of science is detached from the society, and the development so far has been in the absence of such a regime. It has to be accepted that the main purpose of patents has been to generate revenue , and not mere propagation of knowledge, transfer of technology, and [for that matter food security].

SECTION THREE: WOULD BIOTECHNOLOGY ENSURE FOOD SECURITY? The main reason for food scarcity is not the mere fact of production, but that of distribution. The argument that the biotechnology as developed by the MNC’s would facilitate the farmers in dealing with the peculiar circumstances in the region, is negated by scholars as to why such a responsibility be given to the profit-minded corporations, when there are many educational and government departments already doing the same. 3.1 Are the results conclusive? There have been no conclusive proof that the GM seeds would be a success in all the circumstances. Though the main focus of GM has been development of new hybrids, genes for abiotic and antibiotic resistance, and development of planting material. There has been a fall in the growth rate of the coupled with the increase in population, and bio-technology can be utilised to achieve the same end. Following data reflect the impact of trade liberalization on food security: Criterion 1989-90 1993-94 Rise in price - 63%(since 1989-90) Per capita food consumption 510 grams 466 grams

It is submitted that the main cause of hunger is not less production, but that of distribution, and with the MNC’s in the same arena, there would be more inequality. It has been contended that presently, though there is enough food for everybody, there is poverty due to inequality in distribution. In such a scenario, how valid would be the ground that is taken by the MNC’s that biotechnology would solve the food problem? It is submitted that, this argument does not stand, and merely biotechnology would be of no avail.

1. 2 Sustainable development and food security It is submitted though there is no direct evidence as to the fact that GM seeds are able to have a better yield, and there has been no evidence as to the contrary as well to the knowledge of the researcher, it submitted that the likely harm is more due to the mechanism that has been followed by the companies, like, if foreign researchers and TNCs can patent indigenous crop plants without making recompense to the communities who provided them, requiring farmers not to save the seeds, and the same. Genetically Modified Organisms have an impact on the food security, as few corporations are able to attain rights (legal or physical) over the food supply through the larger share over the seed market. With the same seeds being sold by the corporations, the farmers would be sowing the same seeds in the farm, leading to the loss of diversity that is required for the development of agriculture. Thus, if the new crop were susceptible to new virus, then the whole crop would be damaged. Hence the concern that the grant of patent to the seeds would have very wide ramifications over large sections of the society. Through the patents the corporations that develop the product are able to secure the profits till the time, the farmers purchase their seeds, and consumers their products. Through the process of patenting, the corporations are able to patent the seeds that have the foreign element introduced in it, and then dictate the terms of usage for the farmers. This might be used for selling other commodities that are also produced by the corporation. This is the position when the production in agriculture is largely manual, and as the society moves towards industrialisation, there would be centralised production, and that would facilitate increased production even without biotechnology . In other words, biotechnology may force us to accept the industrialization of agriculture. Recognition accorded to indigenous and local communities, and their entitlements to benefit sharing, is circumscribed because knowledge, innovations and practices must be ‘relevant for the conservation and sustainable use of biological diversity’. The main impacts of patenting of bio-technology with reference to plants may be summarised as follows : ➢ Free exchange of the seeds amongst the farmers has been disrupted; ➢ Creation of the threat to bio-diversity; ➢ Threat to the small farmers ; ➢ Implications on food security as the protected varieties need not be related to food production; ➢ There is termination of germination.
2. 3 Protection of the bio-diversity The Convention on Biological Diversity, 1992 recognizes the rights of indigenous cultures to preserve their knowledge and resources . Article 8(j) of CBD provides as follows: “Innovations . . . and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and to promote their wider application with the approval and involvement of the holders of such knowledge, innovations and utilization of such knowledge, innovations and practices.” The rigid structure of the enforcement of the patent rights, the benefits as to the patent of the plant varieties has been taken away by the MNC’s. It has been argued that this would facilitate to remove the inequality that has been faced by the developing nations and the farmers thereof. Various nations have been providing with a separate treatment for the agriculture biotechnology, and this includes USA, Germany and other civil law countries. There are many nations that provide for IPR protection to the patents for plant varieties that satisfy novelty and other requirements and thus are products of human intervention, rather than nature, and were not protected under a separate plant varieties legal regime . Patenting has been considered as a threat to biodiversity as these claims have been based on the development and inserting of microbes in another organism, and this is claimed as the exclusive right over the property. And for any further production/usage, royalty has to be paid to such an owner. Once patenting of diversity, genes, cells, processes and products become possible, the next step may be moving from patents of genetically engineered organisms and start patenting plants as well. This arises from the capitalist understanding of property, and it is contended to be bio-piracy, as the knowledge from the developing countries is taken away and sold back to them in a modified form. On the contrary it has been the common pool of knowledge that has resulted in the diversity that exists presently.

CONCLUSION Can IPR's be utilised for public policy considerations? This was the main question that revolves around the paper, and it is submitted that the ground may be taken and there may be restriction on the patents that are given to the companies with regard to biotechnology, keeping in tandem with the present law. It is submitted that there is a requirement of protecting the traditional knowledge so that there is sustainable development of agriculture, and food security in its real sense of the terms may be maintained. This also reflects on the point that IPR is never per se are not bad, but there has to be level playing field. There is a requirement of distinguishing as between biotechnology and other patentable products before deciding as to patenability of the biotechnology. Following are the essentials that can be stated for the regulatory regime for the biotechnology : ➢ Require manufacturers to inform the regulatory agency in advance of releasing a novel genetically engineered plant or microorganism into the environment; ➢ Data Collection, Data Evaluation, and Risk Assessment; ➢ When risk assessments suggest that particular agricultural biotechnologies pose unacceptable risks, an adequate regulatory regime must be capable of reducing or eliminating those risks; ➢ Public participation .

Another questions that comes before concluding a debate over patenting of biotechnology is whether Protection of Plant Varieties and Farmers’ Rights Act, 2001 provides for a solution? This Act provides for the following : ➢ It creates a system of Plant Breeders’ Rights that confers on the holder an exclusive right of ownership of a plant variety for a specified period of time. However the main tension in India has been the distinction between the breeder and grower, former claiming the rights as to recover his investments. It has to be understood that such rights shall be conferred on the community as trustees for present and future generations; ➢ It introduces the concept of Farmers’ Rights to counter-balance Breeders’ Rights and address the issue of farmers’ proprietary claims to plant varieties.

Thus, there is an attempt to provide a balance as between the companies that are developing seeds and the traditional farmers for maintaining food security.

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Unpublished documents 1. “Intellectual Property Rights, Trade and Bio-diversity”, at 40 [Taken from file of Field Vol. One at CIPRA in NLSIU, Bangalore]. 2. Dr. B. Dhar, “Regulating Bio-technology in India” [Taken from file of Field Vol. One at CIPRA in NLSIU, Bangalore]. 3. Dr. Gulshan Wadhwa, and Bindu Sarkesh, “Patenting in Biotechnology”, [Taken from file of Field Vol. One at CIPRA in NLSIU, Bangalore]. 4. Munyaradzi Saruchera, “Poor Resource Farmers Perspective on Agricultural Biotechnology: A Case Study of Hwedza communal area in Zimbabwe”, (presented at) Indian Biotechnology Workshop, held on 4th to 8th February 2002 [Taken from file of Field Vol. One at CIPRA in NLSIU, Bangalore]. 5. Peter Newell and Dominic Grover, “Globalisation Power” [Taken from file of Field Vol. One at CIPRA in NLSIU, Bangalore].

Websites

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