Patenting Of Plants: A Boon Or A Bane?

If a plant or seed is defined by a single DNA sequence developed by research, it has chances of being patented in many countries. Whereas India has granted numerous process patents on plants that have undergone genetic modification. But patents for plants per say is not possible in India. Similarly, asexually grown plants along with plants found in an uncultivated state are likewise ineligible for patent protection. Newly discovered plants or seeds that are improved via natural selection are not patentable which allows farmers to save seeds and plants to assure the highest possible yields in the future.

Although, plant patents are not allowed in India directly, through patenting the process for genetic modification of the plant, patent holder can indirectly claim patent rights on the GM plant. This can be understood clearly from the following scenario.

Ideally anyone other than the plant's patent holder will be barred in future to create, use, offer for sale, sell, or import the pesticide-resistant plant. At the same time any individual other than the modified gene's patent holder would be prohibited from creating, using, offering for sale, selling, or importing any organisms having the gene. Therefore, the gene patent-the invention relating to the process of genetic modification, actually has a wider scope than the plant patent as the process can be used to seek protection for a microbe, plant etc.

However, India never allowed patenting plants as such because patents on innovations relating to plants, such as genetic sequence, are just as detrimental to farmers as patents on the actual plants. A new variety created by a seed company with a changed genetic sequence protected by a biotech firm's patent will have both the seed company's and the biotech company's IP rights. In this case the modified genome is protected under the Patents Act of 1970, and the new variety is protected under the Protection of Plant Varieties & Farmer's Rights Authorities Act, 2001. As a result, both the seed producer and company will own intellectual property (IP) for the transgenic strain.

HISTORICAL PERSPECTIVE

TRIPS Agreement went into effect on January 1, 1995, raising the global protection of intellectual property rights to an extraordinary level. One of the major concerns was the TRIPS recognition that living things may be patented; there is no general exclusion for micro-organisms, and even developers of plant varieties must receive some sort of IPR for their "inventions."

If Article 27.3 and Article 27.1 of TRIPS are interpreted together, biotechnological inventions in agriculture would be patentable and not excluded subject matter, assuming they meet other criteria. In India the Patents Act, 1970 was based on the Ayyangar Committee Report of 1959, which expressly stated that the prohibition under Section 3(h) of the Patents Act, which exempts "methods of agriculture or horticulture" from patentability, was intended to apply to "inventions in the field of plant propagation by asexual methods. But at the same time plants, including Genetically Modified plants, are, however, claimed to be excluded under Section 3 of the Patents Act and hence non-patentable subject matter.

To solve this problem The Protection of Plant Varieties and Farmers Rights Act, 2001 (PPV&FRA) was enacted. The major goal of this Act is to provide an effective framework for protecting plant variations and breeders' rights, as well as to promote the production of new plant kinds.

The choice before India was to either enact a law that protected the interests of farming communities or to accept the framework of plant breeders' rights given by the International Union for Protection of New Plant Varieties (UPOV Convention). The latter option was rejected primarily because the current version of UPOV, which was adopted in 1991, denies the farmers the freedom to reuse farm-saved seeds and to exchange them with their neighbours.

UPOV does not fulfil Indian demands, and its methods are completely unfamiliar with the agricultural conditions. One of the major reasons to reject a strict adherence of the UPOV Convention, and formulate a sui generis system was its severe criticism with regard to the monopolies it grants to breeders and that it turns a blind eye to farmers contributions and rights and also endangers biodiversity. The UPOV system is unsuitable for poor countries such as India since it is designed to preserve the interests of powerful seed companies, which are the breeders. In UPOV, all rights are guaranteed to breeders, but not to farmers, and the Indian situation is not conducive to this. Corporate plant breeders are not existent in India. Farmers and farmer cooperatives are the primary seed producers. Logic dictates that our law focus on preserving the interests of the farmer as both a producer and a consumer of seed.

However, in a country like India, where farmers have traditionally practiced free exchange of seeds for greater agricultural produce, monopolisation would have thwarted the anticipated benefit. Thus, the PPV&FR Act was enacted with the objective to provide an effective system of protection of plant varieties, as well as rights of farmers and plant breeders. Development of new varieties for accelerated agricultural development of the country was encouraged.

INCENTIVES OF PLANT VARIETY PROTECTION

Plant variety protection (PVP) grants breeders some degree of exclusive rights over the vegetative and reproductive materials of plant varieties they have invented or discovered. Along with these few other benefits arise out of the act such as:

1. Promotion and development of new plant varieties,
2. Protection of farmers' and breeders' rights
3. Registration of existing and new plant varieties
4. Development of characterisation and documentation of varieties
5. Compulsory licencing of protected varieties if the right holder fails to arrange for the production and sale of seeds (to ensure that protected seeds are available to farmers)
6. Collection of statistics on plant varieties and germplasm for compilation and publication.

Plants of all types are included by the Act, but microbes are not. A variety in order to qualify for protection must be Distinct, Uniform and Stable.

Trees and vines are protected for 18 years, while other plants are protected for 15 years. The breeders right stipulates that the producing or propagating material of a protected variety must be produced and commercially sold with the breeder's permission.

The PPVFR Act requires all farmers' varieties to be registered. The codification of farmers' rights is the Act's most remarkable aspect. These rights include the ability to conserve, use, sow, resow, exchange, share, and sell produce, including seed from a protected variety. In addition, Section 39(2) states that if the propagating material fails to perform as promised, the breeder must compensate the farmer. Section 41 enumerates the rights of communities. It permits any individual or group of individuals, including non-governmental organisations (NGOs), to ask for a portion of the benefits if the community has contributed to the evolution of a particular variety. The breeder must give adequate compensation to local communities or farmers who have assisted in the preservation or evolution of such types, and this money must be put in the National Gene Fund established for this purpose, from which it will be allocated to the appropriate community.

Although both systems provide breeders identical exclusionary rights (exclusive rights to produce, sell, and market), most PVP systems have crucial exceptions and constraints, such as the farmers' privilege and breeders' exemption. The breadth of exclusive rights afforded by patent protection is more absolute than that provided by PVP systems since TRIPS-compliant patent systems do not allow for such exceptions and limits.

As mentioned, patent protection is more absolute, but sometimes the inventors are blockaded from enjoying the benefits of a patent due to other external factors. Bt cotton was a successful GM crop, but crops those came later could not be efficiently monetized and this in turn prevents future R&D investment in India.

GENETICALLY MODIFIED CROPS AND THE PUBLIC OUTCRY

Bt crops have generally more yield so theoretically is more beneficial for consumers. Technically competition concerns should be addressed but the past history of Monsanto¹ case shows otherwise. After Bt Cotton, farmers had to take out loans for the seeds, causing rural indebtedness. Time and evolution also saw new resistant pests introduced into the environment.

It took India several years to give regulatory approval for the marketing of Bt cotton. While Bt cotton has been produced successfully in India since then, new changes have harmed this success, creating difficulties to the future of such crops/plants in the country.

In India, no genetically modified food crops have been approved for usage. The Indian regulatory body, the Genetic Engineering Approval Committee (GEAC), has declared Bt brinjal (eggplant) to be biosafe; nevertheless, the Ministry of Environment, Forest and Climate Change did not allow its commercialization, citing the precautionary principle. The Genetic Engineering Appraisal Committee (GEAC) approved commercial cultivation of Bt Cotton in India in 2002². Followed by BT Cotton, Bt Brinjal and HT Mustard were also approved by the GEAC in 2007 and 2017 respectively. However, Bt Brinjal was blocked in 2010 and the Supreme Court stayed release of HT Mustard in 2017, asking for a public opinion³.

PITFALLS IN INDIAN SCENARIO

Currently, the Indian Patent Office considers any traditional agricultural technique carried out in an open field to be a method of agriculture. As a result, any claim in a patent application that relates to concepts/inventions like germinate, seeds, hybrid, variety, and so on is objected to by the Indian Patent Office under Section 3(h) and ruled unpatentable. Comparing Art 27.3(b) and Section 3(j), India has made two additions - the first is to add further limitation by stating "plants and animals in whole or any part thereof" and the second is to specifically include seeds in the category to be excluded.

The patentability of genes and genomic sequences is not covered by the Patent Act. The prohibition in section 3(j), on the other hand, applies to any portion without limitation. Natural genes, cells, tissues, and nucleic acids will continue to be prohibited.

Crops, both natural and genetically modified, are not protected by patents. As a result, GM crops are not patentable. Since the process is patentable there is a whole set of legislations to be followed. GM Crops are governed under several existing legislations, such as the Environment Protection Act, 1986 and the Rules for the Manufacture, Use, Import, Export, and Storage of Hazardous Micro-Organisms/ Genetically Engineered Micro-Organisms or Cells, 1989 ("the Rules, 1989") notified under the Act. These legislations cover the large-scale applications of GM Crops. The Environment Protection Act further lays down the competent authorities and their compositions for handling different aspects of the Rules.

The Competent Authorities under the Act include:

"The Recombinant DNA Advisory Committee (RDAC): Advisory limb of the Department of Biotechnology, Ministry of Science and Technology. The RDAC is tasked with policy review of biotechnology at national and international levels.

"Review Committee on Genetic Manipulation (RCGM): Executive limb of Department of Biotechnology, Ministry of Science and Technology. The RCGM monitors the safety and protocol. It also provides the guidelines for GMOs. The implementation of these guidelines is further done by bodies like Institutional Biosafety Committees (IBSC).

"Genetic Engineering Appraisal Committee (GEAC): Constituted under the Environment Ministry, this is the statutory body that regulates and approves large scale use of GMOs for research and commercial purpose, particularly from the environmental safety perspective.

"In addition to the Environment Protection Act, 1986, India is also signatory to the Convention on Biological Diversity. The Parties to this Convention adopted a supplementary agreement to the Convention in 2003, known as the Cartagena Protocol on Biosafety, which sought to protect the biological diversity from potential risks through use of genetically modified organisms. To comply with this requirement, India enacted the National Biological Diversity Act, 2002. This Act constitutes a separate body called National Biodiversity Authority (NBA). The NBA performs both advisory and regulatory functions.

CONCLUSION

Traditional plants are particularly adapted to local conditions, and even though they may have a lower output, they need not rely on as intensive an application of pesticides and fertilizers as Bt crops. Further, despite the low produce, there are less chances that the farmers will take on debts because locally available crops they use are nearly free. It was noticed that, whereas erstwhile produce was low, there was however, no reason for debts because of the availability of seeds.

Finally, when it comes to the regulation and determination of IP rights for GM plants, India has a well-balanced system. When it comes to protecting intellectual property, India has adopted measures that are stricter than those found in the TRIPS Agreement, and it also has a strong regulatory system in place. However, the reluctance protecting plant variety because it was developed by a patented gene has yet to be thoroughly addressed. As a result, it is evident how this expansion of patent rights affects other stakeholders such as farmers, local businesses, and so on. In the meantime, the PPVFR Act properly addresses the loophole until such a stance is determined.

It can be stated at this point that India has once again demonstrated via several examples that Indian patent law cannot be utilised to abuse the general public. The existing embargo on genetically modified Brinjal, as well as other examples, reflects the fact that it is difficult to sell and produce GMOs with exclusive rights in India until and unless it is proven that they have no negative effects. If it cannot be proven that genetically modified crops do not harm people's health, their utility will be questioned.

Patenting the process of development of GM crop is one aspect, getting protection for plant variety is another and getting regulatory approval to market it is altogether a different hurdle. Patent protection provides quid pro quo for big companies to innovate while PPVFRA ensures the rights of poor farmers and breeders are not curtailed. Regulatory hurdles act as check points to ensure that the interests of public are safeguarded. Through its legislative framework India is striving to attain a balance between private and public interests.

Footnotes

1 Monsanto Holdings (P) Ltd. v. CCI, 2020 SCC OnLine Del 598

2 Sebastian, John, and Apoorva Sharma. 213AD. "BT BRINJAL DEBATE-A FEW COMMENTS ON GM CROPS AND FARMERS' RIGHTS." NSLR 8(140):141-59.

3 National Academies Of Sciences, Engineering; Studies, Division on Earth Life; Resources, Board on Agriculture Natural; Prospects, Committee on Genetically Engineered Crops: Past Experience Future (2016-12-28). Genetically Engineered Crops. doi:10.17226/23395

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