A Critical Analysis On Consideration Of Plant Patents In India
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Category: Intellectual Property
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A CRITICAL ANALYSIS ON CONSIDERATION OF PLANT
PATENTS IN INDIA
Mahaashri J, SASTRA Deemed University Raja Vyshanavi R, SASTRA Deemed University
ABSTRACT
Patent is a right given to any creator who has invented a new article or an improvement of an existing article or a new process of making an article. It gives exclusive rights to the new creation for a limited period. It is given for an invention if it meets the prescribed conditions. Plant patents can be used to incentivize research and development in plant varieties. Naturally available plants or a plant developed through traditional breeding methods cannot be patented. Plant patents protects the inventor of a new and distinct asexually reproduced plant varieties granting them an exclusive right to reproduce, use and sell the plant. Plants that have undergone genetic modification or have been developed by using a technical process can also be patented. This makes any person liable for their unauthorised use.
In most of the countries they have implemented a sui generis system to give protection to new plant varieties. Whereas some countries provide patent protection for new plant varieties. In India there is no specific provision for granting patents for plants. However, protections were given under the Protection of Plant Varieties and Farmers Right Act, 2001. An attempt is made in this research article to critically analyse the consideration of plant patents in India while balancing patents for new plant varieties and traditional practices of farmers. Keywords: Patent, Asexual reproduced plants, Genetically Modified plants, new plant varieties, Farmer's right.
Introduction:
A patent is a right given to an inventor for their invention to a specific time period. This right
prevents any other person from making, using or selling the invention without the permission of an inventor. This encourages invention and dissemination of knowledge about new technologies. The Patent rights in India are governed by the Indian Patent Act, 1970. But there is no provision for granting patents to plant varieties in India. Moreover, patenting of plants was specifically excluded under the Section 3 of the Indian Patent Act, 1970. This paper focuses on the patentability of asexually reproduced plants and genetically modified plants along with looking at the different countries perspective. Asexually reproduced Plants: The Asexually reproduced plants are those plants that grow and produce new plants from a single parent without involvement of any gametes, fertilization or pollination.
This process was also known as vegetative propagation which occurs through the structures like runners, bulbs or tubers or through the human-induced methods such as cuttings and graftings. Genetically Modified Plants: Any organisms whose genetic material has been altered using genetic engineering techniques are called genetically modified plants. In contrast to conventional breeding, genetically modified technology require intentional molecular human intervention. The two notable examples of Genetically Modified Plants were Golden Rice worldwide and Bt cotton. In the year of 1960 when India was facing a food crisis, the High Yielding Variety Programme was adopted to overcome this critical situation and also provide a benefit in the Indian economy. Dr. M. S.
Swaminathan, also known as the “Father of India's Green Revolution, developed and popularized the high-yielding crop varieties, specifically wheat and rice. The crop’s early successes were in Mexico and India. When India was facing a food crisis which led to the death of approximately 4 million people, the Green Revolution came as a period of reform in Indian Agricultural practices. This process uses modern methods and techniques focussing on high yield. The production of crops increased by three times. These crops were the new varieties that revolutionized agriculture and also helped in reducing poverty and hunger in
many countries. Thus these measures increased the food grain production helping India to reduce food shortages and to attain self-sufficiency in food. Dr. M. S. Swaminathan’s Green Revolution included the development and use of asexually reproduced plants. His work extended to potato genetics including the development of frostresistant varieties. Potatoes are one of the examples of a crop propagated asexually through vegetative methods, such as cuttings or tubers. Then, the new major technological involvement in agriculture is genetic engineering or genetically modified technology called the Gene Revolution. Thus, the advancement in technology could have a significant role in agriculture and also in reducing poverty and hunger.
In most of the countries, plants and inventions related to plants or plant products are not eligible for patent, but in some countries plant patent is available for both the asexually reproduced plants and genetically modified plants provided certain legal criteria for patentability are met. The main object of this research paper is to focus mainly on the consideration of plant patents in India for Genetically Modified plants and asexually reproduced plants as well as looking at the existing legislation available for protecting plant varieties. It also aims to make a comparable approach in global practices with respect to plant patents and how they are applicable to the Indian circumstances. Plant Patent in India: The Indian Patent Act, 1970: The Indian Patent Act, 1970 grants patents to inventions provided the criteria of novel, nonobvious and industrial applicability were met.
However, Section 3(j) of the patent Act specifically excludes plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties, and species and essentially biological processes for the production or propagation of plants and animals from being patentable. 1 The Protection of Plant Varieties and Farmers’ Rights Act, 2001: India having ratified the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement makes the provision for giving effect to sub-paragraph (b) of paragraph 3 of Article
1 Section 3(j) the Indian Patent Act, 1970.
27 in Part II of the said Agreement relating to the protection of plant varieties. Sub-paragraph
(b) of paragraph 3 of Article 27 of the TRIPS Agreement states that the members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by combination thereof. India has a sui generis system to provide protection for plant varieties under the Protection of Plant Varieties and Farmers' Rights Act 2001. 2 The Protection of Plant Varieties and Farmers' Rights Act 2001 aims to provide for an establishment of an effective system for the protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. Under this Act new plant inventions are granted exclusive commercial rights by allowing the breeder to prevent others from producing, selling or distributing the variety without the permission for a specific period.
It also provides protection for traditional rights allowing them to save, use, and share seeds of protected varieties. For registering a plant variety, certain scientific and legal requirements need to be met before it can be protected such as novelty, distinctiveness, uniformity and stability. Thus, this Act provides certain protections to the plant varieties and also protects the traditional rights of farmers for a certain period of time depending on their type. It gives protection of 18 years for trees and vines and 15 years for extant varieties and other crops. Judicial Approaches in Plant Patents: Monsanto Canada Inc. Vs. Schmeiser3 In this case, it was alleged that Schmeiser infringed on Monsanto's patent for genetically modified canola which made the plants resistant to herbicides by planting it without the license.
Monsanto brought an action against Schmeiser for patent infringement. The Supreme Court of Canada held that saving and planting seed and then harvesting and selling plants which contain patented cells and genes appears to constitute “utilization’ of the patented material. By cultivating a plant containing a patented gene and composed of a patented cell without license deprived the owner’s full enjoyment of the monopoly. It was also held that Schmeiser was not liable for damages because the inventor is only entitled to the portion of infringer’s profit. Here,
2 The Protection of Plant Varieties and Farmers' Rights Act, 2001.
3 [2004] 1 S.C.R.902
Schmeiser earned no profit from the invention and hence the inventor is entitled to nothing on their claim of account. Bowman Vs. Monsanto Co. 4 Monsanto developed and obtained a patent for a genetically modified Roundup Ready soybean seed that can survive the application of the herbicide glyphosate. The Monsanto Company sold those seeds under a licensing agreement that allows the farmers to plant the purchased seed only for one growing season and prohibits them from saving any harvested soybeans for replanting. Bowman bought the Roundup Ready soybean seeds and complied with the terms of the agreement by not saving any of his seed. Subsequently, Bowman bought secondgeneration seed at a grain elevator for his second planting and saved seeds from the ones he bought for the later reuse. Monsanto filed a suit against Bowman for patent infringement.
Bowman raised the defence of patent exhaustion which is the right to use or sell the patented article given to the purchaser. The United States Court of Appeals decided that patent exhaustion does not allow a farmer to reproduce patented seeds by planting and harvesting without the authorization of the patent holder. Diamond Vs. Chakrabarty5 Dr. Ananda Chakrabarty invented a genetically engineered bacterium and sought a patent for it. He made the Pseudomonas bacterium capable of breaking down crude oil by introducing genetic material that enables the bacterial cells to metabolize the constituent parts. In fact, he envisioned that it could be used to lessen the impact of oil spills. The claim over the bacteria itself was disallowed. After an appeal by Chakrabarty, the examiner overturned the prior decisions and accepted Chakrabarty’s claims.
Subsequently the commissioner of the Patent Office, Sidney A. Diamond appealed to the Supreme Court. The petitioners argued that the Plant Patent Act 1930 and the Plant Variety Protection Act 1970 indicate that living things were not included within the terms ‘manufacture’ or ‘composition of matters' and therefore bacteria was not included, so Chakrabarty's invention is not patentable. It was decided that the purpose of these two acts were not to distinguish between the living and inanimate, but between products of nature and human-made inventions. Here it was ruled that the microorganism of Chakrabarty is the is a result of human ingenuity. Therefore it does not result in a patent being
4 569 U.S. 278.
5 447 U.S.303 (1980).
rejected. Hence, the companies could patent genetically modified organisms which can lead to innovations in medicine, agriculture and more, etc. Monsanto Technology LLC Vs. Nuziveedu Seeds Ltd6 Monsanto has given licenses for its BT Cotton technology related to several Indian companies for seeds of cotton to be developed. These seeds which are patented are resistant to the bollworm and so helps in producing higher yields. The license was given for a life usage for 50 Lakhs and they have to give the trait value as a token of remuneration. Indian companies also made use of this BT Cotton to produce cotton seeds. After that, the government imposed new regulations to have control over the trait value fees. Therefore, the companies asked Monsanto for the reduction of their trait fees but the reply was in the negative.
Then the eight Indian companies including Nuziveedu decided to stop paying royalties to Monsanto. Monsanto ended the license agreement and filed a patent infringement suit against Naziveedu. The court asked Monsanto to keep on providing Genetically Modified hybrid seed as per the already issued license and allowed Nuziveedu and other companies to use the technology until the suit was finally disposed of, provided that the trait value was paid. The court gave months to take protection under the Protection of Plant Varieties and Farmers' Rights Act, 2001. These case studies help to understand the international practices for patentability and protection of new plant varieties. Thus tries to make a comparative analysis in judicial perspectives in different countries. Even though there is no interdependence on these decisions, there is a substantial amount of influence on policy making.
Patent Protection for plants in other countries: Plant Patents in the United States: In the United States, plant patents can be provided for both an asexually reproduced plant and the genetically modified plants. There are three main ways by which an inventor or breeder may able to obtain a formal intellectual property rights on plants:
1. Patent rights under the Plant Patent Act
6 AIR 2019 Supreme Court 559.
2. Plant Breeders’ Rights through the Plant Variety Protection Act and
3. Patent rights (for inventions) as a utility patent, under 35 USC Section 101.7
In the above mentioned Acts, the Plant Patent Act is applied to asexually reproduced plants but it does not include tuber propagated plants or plants found in uncultivated states. The Plant Variety Protection Act gives protection of some sexually reproduced plants. The Utility patents safeguards the functional aspects of an invention and it also applies to genetically modified plants. A utility patent provides for a legal right to a new and useful machine, process, an article of manufacture or composition of matter. The Plant patent Act covers new and distinct asexually reproduced plant varieties whereas the utility patents under 35 U. S. C. protects the novel, useful and non-obvious inventions which includes technological processes, machines and the articles of manufacture. It was held by the Supreme Court that plant varieties can be protected under three different U. S.
statutes: the Plant Variety Protection Act protects varieties that are reproduced by seed, whereas the Plant Patent Law protects varieties reproduced asexually, Varieties irrespective of how they are reproduced, could be protected under the General Patent Statute. 8 Genetically modified plants can also be patented in the United States. It was held in the U. S. that companies could patent genetically modified organisms which can help in innovations on medicine, agriculture and so on. Bt Cotton is an example of Genetically modified plants. Monsanto, a company based in the US designed Bt Cotton, a genetically engineered variety of cotton, in order to reduce the need to spray for bollworms. And the patent was also approved for commercial use in the United States.
“Honeycrisp” apple variety: In the United States a patent was given to the Honeycrisp apple variety which is an asexually reproduced plant. This Honeycrisp apple contains an exceptionally crisp and juicy texture as mentioned in the text of its patent. If an apple seed from a parent plant is grown into trees then it might be genetically distinct from the parent as a result the taste may differ from that of a parent whereas an asexually reproduced plant which is produced using a method of propagation of a parent plant will be identical to its parent plant. An exclusive right to asexual reproduction of an apple tree can guarantee that an apple tree will produce the same exact fruit as that of its parent. Therefore patent protection was given to the
7 Elizabeth Verkey, Law of Patents, 2011, p.206
8 Diamond Vs. Chakrabarty, 447 U.S.303 (1980).
Honeycrisp apple variety. Thus, asexually reproduced plants are given patents in certain countries other than India. Plant patents in Australia: In Australia the protection for plant varieties was provided both under the Australian Plant Breeder's Rights Act 1994 and the Australian Patents Act 1990 provided the criteria of novelty, inventive step or an innovative step were met. A patent helps to protect the components and processes of a variety such as gene technology. Plant breeders Rights Act 1994 gives protection to the new plant varieties. This protection is similar to patent protection and focussed on encouraging innovation in plant breeding. Plant Breeders' rights allows an exemption for the use of a protected variety if it is used for research or further breeding purposes. This is an automatic right and prior permission is not required.
On the other hand, if a patent is given then a license from the patent owner must be required to use those protected materials. While patents for plants themselves are generally not possible, specific inventions like novel methods of asexually reproducing a plant can be patentable. Furthermore the Genetically Modified plants and their components were also patentable under the Patents Act. Patents offer broader protection for plants than the Plant Breeder's Rights. In the case of Western Australia Vs. Commonwealth of Australia (2000), the Australian Court confirmed that there is no intrinsic restriction to the patentability of plant varieties9. Plant patents in European Union: Plant varieties selected from a species having a series of common characteristics are not patentable under Article 53(b).
European Convention states that the patents could not be granted for the plant and animal varieties or essentially biological processes for the production of any plants or animals. The new plant varieties can be protected in the European Union by means of specific intellectual property rights under the Community Protection of plant varieties (CPVR). The CPVR confers protection to the new botanical genera and species including their hybrids, provided that the varieties had met the requirements of UPOV Convention. This CPVR is issued by the Community Plant Variety Office. However, EU Directive 98/44/EC Recital 29 clarifies that microbiological and certain biotechnological inventions remain patentable. Rule 27(b) of EPC explains inventions that concern a product, a process or a use that is not confined
9 (2000) 202 CLR 479.
to natural phenomena. The Recital balances exclusion of conventional breeding with protection for genuine biotechnological interventions. Community Plant Variety Rights (CPVR) and the EU Biotech Directive address different needs such as CPVR protects new plant varieties as under a sui generis “breeders’ rights” system, while Directive 98/44/EC including the Recital
29 and the EPC’s biotech rules define what biotechnological inventions can be patented
excluding “essentially biological processes”. Major concern about the patenting of Plants: Monopolisation and over reliance: Monopolisation is one of the major concerns about the patenting of plants as there might be potential for patents to restrict the farmers ability to save and replant seeds for agriculture. There may be over reliance of farmers on large agro-biotech firms for patented seeds and agricultural chemicals. This may create concentration of power in a few hands that can control large portions of the seed market and the entire food chain thereby leading to higher costs, reduced seed diversity and increased corporate control over agriculture. Effects on the Human health: There are three common concerns associated with the Genetically Modified food consumption such as toxicity, allergenicity and unintended genetic effects.
‘Starlink’ corn was a genetically modified product linked to several allergenicity reports. It contained Cry9C Bt protein designed to resist insect pests. Due to the concern about the allergenic potential of Cry9C protein in humans, the U. S. Environmental Protection Agency (EPA) approved only for animal feed. Whereas in 2000, traces of Starlink corn were found in human food products which led to recall of several food products containing Starlink corn. However the subsequent investigation by the Centers for Disease Control and Prevention concluded that there was no evidence to show that the allergenic reactions were associated with hypersensitivity to the Cry9C protein. Effects on Genetic Diversity: The patenting of asexually reproduced or Genetically Modified plants can reduce the natural genetic diversity and promote monocultures of patented, uniform crop varieties.
Cultivation focussing only on a small number of crops may affect the genetic diversity which is significant
for the plant adaptation against climate change, virus and pest infestation. 10 Need for consideration of plant patent in India: The Asexually reproduced and genetically modified plants can help in the promotion of agricultural innovation and the development in the biotechnology sector and also provide the following benefits in the society: Incentivize innovation and investment: The provision for plant patents may encourage further research and investment in new plant varieties. The methods of asexually reproduced or genetic modification of plants can be used to reproduce or replicate the plant varieties. Lack of legal protection to innovation may deter the inventors from spending money on expensive or risky research. Therefore, providing patents for asexually reproduced or genetically modified plants can increase innovation and investment in the field of plant varieties.
Ensure Food Security and Sustainability: Food security can also be ensured by recognising patents for asexually reproduced and Genetically Modified plants. This method will be helpful in the development of crops that are resistant to environmental pressures, diseases, and pests. For example: Golden Rice was engineered to combat the widespread Vitamin A deficiency in countries where rice is a staple food. This helped in the serious issue that can lead to blindness and other serious ailments. This is viewed as an addition to the existing micronutrient therapies and exemplifies how biotechnology can directly address malnutrition. Similarly, Bt cotton in India has already demonstrated the potential of Genetically Modified crops to reduce pesticide usage and improve yields.
Therefore, allowing patents on such innovations could accelerate the development in ensuring food security for its growing population and the sustainability of agricultural systems. Farmers' Benefits: There are different approaches in order to address the situation and to reward the farmers for 10 Mohd Fadhli Hamdan & et. al, Green Revolution to Gene Revolution: Technological Advances in Agriculture to Feed the World,https://pmc. ncbi. nlm. nih. gov/articles/PMC9146367/
their contributions to the plant genetic diversity. The first approach precluded the breeders from demanding payment from the farmers who have engaged in farming activities like saving seeds and planting the saved seeds from prior purchases. The second approach suggests modification in existing IPR laws to permit farmers themselves to claim exclusive rights in the different plant varieties they cultivate informally. The third approach aims to recognise the farmer's rights not through the IPRs but through the benefit sharing mechanisms such as the financial payments or technology transfers which compensate farmers for their contributions to the new plant genetic diversity. This third approach was recognised in the Article 9 of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)11.
Article 9 of the said treaty recognises and protects the rights of farmers in relation to the plant genetic Resources. 12 Farmers should be able to participate equally in the sharing of benefits derived from the use of plant genetic resources. Thus through this approach farmers can also be benefited from the asexually reproduced or genetically modified plants. The Green Revolution helped the farmers in raising their income. Adverse Conditions: This asexually reproduced or genetically modified plants will be helpful in crop survival in challenging environments. These plants can also be used to tolerate adverse conditions like drought and also reduce the reliance on groundwater. The yield of plant products will also increase. The method of asexual reproduction ensures consistency in the plant varieties.
Genetic modification could help in enhancing the nutritional value and to resist pests and diseases leading to healthier crops and fewer losses. Thus, the patent to these plants gives these kinds of benefits to the farmers. Economic Growth: Providing patents for asexually reproduced and Genetically modified plants can have potential economic benefits by encouraging innovation in new plant varieties and investment in biotechnology and agricultural research which in turn contribute to national socio-economic development.
11 Legal and Policy Concepts relating to the protection of Plant Varieties and Breeders’ Rights,
https://www.fao.org/4/y5714e/y5714e02.htm
12 Article 9 of the International Treaty on Plant Genetic Resources For Food and Agriculture.
Thus, these Asexually reproduced and genetically modified plants can be useful in disease resistance, drought tolerance and nutrition enrichment and paves the way for plant breeders to develop high yielding varieties. Patents for plants may also have a benefit in supporting a limited plant patent, especially for genetically modified (GM) and asexually reproduced plants. The examination of these viewpoints on a balanced basis indicates that properly constructed plant patents can be instrumental in the transformation of Indian agriculture. Controlled Monopolies with effective safeguards: The major critics on plant patents are with respect to monopolies. But patents are neither permanent nor absolute. They are time-bound like 20 years under current law and also subject to mechanisms like compulsory licensing and price regulation.
By implementing a plant patent framework while mandating affordable seed pricing, preserving farmers’ rights and enforcing benefit-sharing with indigenous communities, India can prevent monopolistic abuse while still encouraging innovation in plant varieties. Conclusion and Suggestions: Patent is not available for plants in India and it is specifically excluded under the Indian Patent Act. But certain protections were given under the Protection of Plant Varieties and Farmers' Rights Act 2001 for protecting breeders and farmers right over plant varieties yet it is separate from the patent rights. Plant patents may grant exclusive rights preventing others from making, using or selling the product. This encourages investment in research and development to create new and improved products.
In India we have a process patent for genetically modified plants that protects only the specific method used to produce the product which makes the competitors use alternative processes to produce the same product. If a product patent is given to plants then it provides stronger protection for the product itself, which can motivate increased innovation. Using alternative production methods can legally bypass the patented process which may lead to inconsistent quality or techniques. Hence, patents can be granted for biotechnological plant-related inventions subject to certain conditions such as strong control mechanisms guaranteeing innovation and protecting farmers rights. Under Article 27. 3 of the TRIPS Agreement recommends plant protection by way of patent or sui generis system or combination of both. 13 Hence, if both the protection then it will be helpful in protecting both
13 Article 27.3 (b) of the TRIPS Agreement.
the farmers’ right and the new innovations on plants. Patents for biotechnological plant related inventions can become a strategic tool for India’s agricultural future rather than a threat to it. In India, there is no specific provision for granting patents to asexually reproduced plants or genetically modified plants. Most of the developing countries prefer sui generis in order to balance breeder innovation with the farmers’ rights and public interest. But under Article 27. 3 (b) of the TRIPS Agreement prescribes members to choose between patents, a sui generis system, or a combination of both for the plant variety protection. Using both the systems countries can offer broader protection for the agricultural sector. A sui generis system protects the farmer's rights and traditional knowledge and while patents can protect specific technological advancements.
Including plant patents for biotechnological plant related inventions with a sui generis system may give a flexible approach by allowing a country to choose the most appropriate form of protection for the different types of plant innovations according to their need in agricultural sectors. Under the European Union Convention and the European Union law, plants are patentable as long as the technical feasibility of the invention is not limited to a single plant variety. Effectiveness of this European approach could be high innovation with preserved conventional breeding space due to clear exclusions and breeder exemptions and also demonstrates that a patent and a Plant Variety Protection approach can balance breeding freedom with biotech incentives when legal demarcations are explicit.
Rule 27 of the Implementing Regulations to the Convention on the Grant of European Patents implements the EU Biotech Directive within EPO practice which provides that biotechnological inventions can be patented if they meet the standard patentability requirements of novelty, inventiveness and industrial applicability as well as subject to the exclusions like plant varieties and essentially biological processes under Article 53(b) of the European Patent Convention. This could provide examination of both product and process claims in biotechnology ensuring technical plant inventions can be patented. Whereas the Community Protection of Plant Varieties grants sui generis right over a specific plant variety that is distinct, uniform and stable and protects the commercial exploitation of the registered plant varieties.
Thus the patents can protect technical plant inventions as product or process above the single-variety level and CPVR an individual variety as such after the Distinct, Uniform and DUS testing and registration. Thus under the existing law both product and process patents are available in the European Union.
In India even there exists Plant variety rights Act (PPV&FR) along with using patents for enabling technologies with the detailed biotech examination guidance to clarify what are the patent eligible biotechnological inventions may be more helpful. This may enhance access, reduce duplicative approvals and support responsible biotechnology innovation without undermining the farmer's protections. Patents may be considered for Genetically Modified plants and asexually reproduced plants not to replace the sui generis system, but to complement it by protecting non‐varietal, technical inventions that drive modern plant innovation, while PVP remains the right instrument for variety outputs and preserving breeder and farmer spaces.
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