Author: Sandeep Bhunia, Techno India University, Saltlake

Recent innovation in the biotechnology field has reshaped the agricultural sector. This puts India in a unique position where traditional farming remains essential for livelihoods. This paper examines the intersection between innovation, intellectual property and farmers rights in accordance with the Indian legal framework. Under Section 3(j) of the Patents Act, 1970 plants, seeds, and essentially biological processes are barred from being patented. This provision is implemented to safeguard traditional agricultural practices. Protection of Plant Varieties and Farmers’ Rights Act, 2001 provides a sui generis approach that ensures farmers' right to save, use and exchange seed. Judicial interpretations in the cases of Monsanto Technology LLC v. Nuziveedu Seeds Ltd. and Sakata Seed Corporation vs The Controller of Patents and Designs perfectly demonstrate the ongoing tussle between the innovation and patent regime. This paper also examines the international guidelines like UPOV, the Cartagena protocol and WIPO’s treaty on agricultural biotechnology. It concludes by advocating for clearer statutory guidelines for more incentive for innovations.  

KEYWORDS

Agricultural Biotechnology, genetically modified crop, TRIPS agreement, Patentibility, Cartagena Protocol, Biological process

The agricultural landscape globally has gone through unprecedented transformation by the virtue of rapid biotechnological innovations. Genetically modified crops, gene edited seed varieties and synthetic biology are reshaping the global food production system worldwide. As global food security challenges intensifies and innovative technologies grow rapidly, India finds itself in a crucial junction due to its traditional agricultural practices. It is one of the largest agricultural economies in the world. According to government reports, the agricultural sector contributes nearly 16% of the country's GDP for the financial year 2024 and it is the primary source of livelihood for nearly 46% of the population. To feed its population it has gone through some profound transformation in recent decades. It started with the Green revolution which introduced high yielding varieties and modern agricultural practices which has substantially increased the production of wheat. The contemporary biotechnology revolution promises genetically modified crops, gene editing technologies, and precision agriculture. 

The significance of this legal research extends to legal, ethical and practical dimensions of agricultural biotechnology and seed patents. It particularly focuses on the Indian context while paralleling international guidelines. Through the discussion of statutory provisions, judicial precedents and comparative analysis this research paper tries to highlight the balance pathway for biotechnology governance framework.

There exists a number of research papers, articles, blogs written on the intricate interplay of biotechnology, intellectual property and plant variety protection in India. Most of them discuss Section 3(j) which excludes plants and animals from patentability while others compare Protection of Plant Varieties and Farmers Rights Act, 2001 as India’s sui generis system with international frameworks, throwing light on India’s emphasis on traditional farming practices by the farmers. Overall, this is an evolving topic as there exists a narrow focus and relatively fewer reported or decided cases in recent years. 

This article relies on a doctrinal and analytical analysis of qualitative data, drawing on a range of existing sources including research papers, articles and other pertinent documents related to the topic. Primary sources such as Statues, government reports, regulations, judicial decisions and empirical data and secondary sources like journal articles, case commentaries form the basis of this paper. The collected data was thoroughly analysed to examine legal principles, judicial interpretations ensuring a multidimensional approach for understanding of the topic.  

The Patents Act, 1970 and Section 3(j) Exclusions

India's approach to biotechnology patentability resides in Section 3(j) of the Patents Act, 1970, which categorically excludes from patentability of "plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals."  This provision was introduced in 2002 to ensure compliance with the TRIPS agreement. It was aimed to preserve farmers rights and traditional agricultural methods though it has emerged as the focal point of extensive legal debate and judicial interpretation.

The legislative intent behind Section 3(j) reflects India's deliberate policy choice to protect traditional agricultural practices while permitting biotechnological innovation within controlled parameters. Despite the basic clarity the provision's language has generated interpretive ambiguity regarding the scope of the phrase "any part thereof" and its application to genetic constructs, plant cells and biotechnological processes.

The Patent Office currently excludes plant cells as a patentable matter rendering g transgenic plant cells non-patentable. But on the other hand, it also holds recombinant DNA sequences which is categorised as a synthetic product patentable subject matter. This distinction has created confusion among biotechnology companies seeking to protect their innovations while complying with India's legal framework.

The PPV&FR Act, 2001: Sui Generis Protection Framework

According to the Article 27.3(b) of the TRIPS Agreement the member states had to provide protection for plant varieties either through patent systems or through effective sui generis mechanisms. India opted for the latter option by implementing Protection of Plant Varieties and Farmers' Rights Act, 2001. This sui generis system provides protection for plant varieties while explicitly preserving farmers' rights to "save, use, sow, re-sow, exchange, share or sell their farm produce including seed of a variety protected under the PPV&FR Act,".

This act functions differently from the International Union for the Protection of New Varieties of Plants (UPOV) Convention approach. Plant breeders enjoy various commercial rights under this act provided the harvested material is unbranded and they are not selling it commercially.

UPOV Convention and Plant Breeders' Rights

The International Union for the Protection of New Varieties of Plants (UPOV) Convention, established in 1961 is the primary body regarding the framework for plant variety protection. It lays down standardized criteria and procedures in order to protect plant breeders' rights. UPOV establishes a distinctive method called sui generis system to specifically protect plant varieties. Under the guidelines the UPOV member countries must grant its plant breeders some exclusive rights over new, distinct and uniform varieties for a period of 20-25 years.

These rights include production, reproduction, conditioning for propagation, offering for sale, selling, exporting, importing, and stocking for these purposes. It also establishes a "breeder's exemption" in order to allow protected varieties of plants for further breeding without authorization.

The rights given to farmers by UPOV have evolved with the different acts of the convention. In 1978 it allowed farmers to save, use and exchange seed of protected varieties saved from previous years of farming but in 1991 with the new guideline it restricts these practices. Though these restrictions had specific exceptions that member countries may choose to implement.

This evolution of the rights of the breeders has created significant tension between traditional farming practices and food sovereignty concerns. Many developing countries have argued that the restrictions that were brought upon by the 1991 guidelines undermine agricultural biodiversity and are detrimental to small scale farming. India instead of joining UPOV developed its own sui generis system by PPVFR Act 2001.

Cartagena Protocol on Biosafety

The Cartagena Protocol on Biosafety was adopted in 2000 as an alternative to agreement to the Convention on Biological Diversity. Its primary function is to establish rules for the transport, safe handling and use of living modified organisms (LMOs). This protocol supervises the impact of LMOs on biodiversity conservation and sustainability in the context of cross boundary movements. The protocol establishes a necessary procedure named Advance Informed Agreement (AIA). The procedure requires the exporters to obtain consent from the authorities of the importing countries before shipping LMOA intended for environmental release. This procedure consists of multiple checks like notification requirements, acknowledgment of receipt, decision-making processes and review mechanisms to ensure that importing countries have sufficient information to make decisions about LMO imports. 

The protocol’s most significant provisions are designed for LMOs involving food, feed, or processing (FFP). These commodities don't require individual AIA clearance but must carry documentation indicating that shipments "may contain" LMOs and are "not intended for intentional introduction into the environment." The protocol also mandates a Biosafety clearing house for information exchange at the transition to developing nations in implementing frameworks. To implement Cartagena Protocol through domestic biosafety regulations India is facing additional challenges. It has added an additional complex layer for biotechnology patents. Patent holders now have to navigate both intellectual property protection and biosafety approval processes which creates additional hassle for them. The Protocol's precautionary nature and emphasis on risk assessment may also delay patent examination procedures for biotechnology inventions.

India's implementation of the Cartagena Protocol through domestic biosafety regulations has created additional complexity for biotechnology patents. Patent holders must navigate both intellectual property protection and biosafety approval processes, which may operate on different timelines and criteria. The Protocol's emphasis on risk assessment and precautionary approaches may also influence patent examination procedures for biotechnology inventions.

WIPO Negotiations on Traditional Knowledge

The World Intellectual Property Organization (WIPO) is trying to mitigate the ongoing interface between intellectual property systems and traditional knowledge holders. These 25 yearlong negotiations between the member states were successful as they adopted the Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge in May 2024.

This groundbreaking treaty mandates the patent applicants to disclose the genetic resources or associated traditional knowledge. The primary goal of the treaty is to prevent erroneous patent grants based on traditional knowledge.But the scope of this treaty is limited as it only addresses traditional knowledge associated with genetic resources. It excludes broader categories like agricultural practices, cultural expressions or ecological management systems. This treaty also leaves the benefit sharing requirements in the hands of national legislations. WIPO treaty may be fruitful to agricultural biotechnology as it involves genetic resources of the plants and traditional agricultural knowledge. According to the treaty biotechnology companies who are seeking patent protection for innovations based on traditional crop varieties may need to provide comprehensive disclosure of their knowledge sources and share benefits among relevant communities.

Monsanto Technology LLC v. Nuziveedu Seeds Ltd. is one of the most significant disputes related to agricultural biotechnology in India with implications far beyond the involved parties. In this case Monsanto Technology LLC (plaintiff) developed “BOLGARD” and “BOLGARD   II” cotton technology. The plaintiff had a registered patent no. 214436 for Nucleotide Acid Sequence (NAS) containing the gene Bacillus thuringiensis (Bt gene). It had granted a sublicence to Nuziveedu Seeds Ltd (defendant) to develop and commercialise Bt hybrid cotton seeds for a fixed licence fee. But due to state level price control measures, the market was affected and the plaintiff decided to terminate the licence following a dispute over payments. Hereafter the plaintiff sued the Nuziveedu Seeds Ltd for injunctions restraining use of the patented technology and for relief on account of alleged infringement. The defendant counter-claimed for revocation of the patent. At first the trial court held that the patent is valid, ordered in favour of Monsanto Technology LLC restraining Nuziveedu seeds from using the technology. Afterwards the division bench of the Delhi HC revoked the patent mentioning the subject matter is not patentable under Section 3(j) of the Patents Act. The reason mentioned was that transgenic plants with integrated Bt traits produced through hybridization constituted "essentially biological processes".  But it observed that the patent is more suitably protected under the Protection of Plant Variety and Farmers’ Rights Act, 2001 (PPV). Upon an appeal to the Supreme court it has put aside the division bench order and remanded the matter back for trial observing that “The Division Bench ought not to have examined the counter-claim itself usurping the jurisdiction of the Single Judge to decide unpatentability of the process claims also in the summary manner done.”

The key legal issue before the court was whether the patent claims were excluded from patentability under Section 3(j) of the Patents Act and how the patent act interacts with the Protection of Plant Varieties & Farmers’ Rights Act (PPVFR Act). The Court emphasized that the validity of a patent in a biotechnology case involves technical and factual questions. It ordinarily requires full trial with expert evidence and cannot be conclusively decided in summary proceedings. Many commentators welcomed the Court’s decisions on the evidentiary process while others regret that the Supreme Court did not use the opportunity to clarify the ambiguity related to sec 3(j) of the Patent Act. The order could have provided long term clarity for the innovators.

In the case of Sakata Seed Corporation vs The Controller of Patents And Designs The plaintiff filed a patent application regarding cytoplasmic male sterile (CMS) Eustoma plant and a method for producing it. The controller of patent rejected the application on the grounds that it is an essential biological process hence excluded by Section 3(j) of the Patent Act. The Japanese entity argued before the Madras high court that the Controller had failed to see that the claim was clearly not a biological process and it involves human interventions at critical times which produce variable results. The plaintiff also highlighted the definition of “essentially biological process” by the European Patent Conventions, Rule 26(5) which clarifies that as an instance where the process is for the production of plants and animals and it consists of entirely a natural phenomenon. The key issues  before the Madras High Court was whether the claimed method is an “essentially biological process” for the production or propagation of plants and whether the Controller has correctly interpreted the claims and the role of “human intervention”. The court ruled in favour of the Sakata Seed Corporation and set aside the Controller’s refusal. It stated that “The Controller has erred in holding that the amended claims 1 to 4 were hit by Section 3(j) of the Patents Act and without noticing that the surprise element was the human intervention and therefore, it cannot be termed as a biological process.”

The Court focused on the degree and nature of human intervention where the steps claimed by the plaintiff require directed human technical activity to produce results that would not occur by mere natural propagation. This ruling of the Madras High Court is significant for the fields of agriculture and genetic engineering. By this order the court clarifies its position regarding “human intervention" under sec 3(j).

Farmers' Rights, Traditional Knowledge, and Biodiversity Implications

Historically agricultural communities have maintained their native sophisticated seed systems based on selection saving sharing and other aspects. These ancient community-controlled practices had been crucial for conserving agricultural biodiversity. Recently the expansion of intellectual property rights over seeds has created barriers in traditional practices. It is also responsible for altering farmers relationship with genetic resources. Corporatization in the global seed industry has further challenged traditional farming systems. The farmer’s right to save and exchange seeds are compromised due to dealing with patented biotechnologically modified seeds. The landmark Monsanto case has illustrated how licensing agreements can restrict farmers' traditional practices despite presence of variety protection laws.

The appropriation of traditional knowledge associated with genetic resources is called biopiracy. It is one of the most contentious aspects of agricultural biotechnology patents. Biopiracy occurs when big corporations and research institutes attempt to patent products or methods that are developed and used by indigenous communities for ages without their consent.

Large scale adoption of genetically modified crops affects soils, biodiversity and ecosystem. These genetically modified crops are causing habitat complexity reduction and resource reduction for nontarget species. This is contributing to declines in birds, pollinators and beneficial insects. The Food and Agriculture Organization estimates that 75% of plant genetic diversity has been lost. The farmers worldwide are using genetically uniform high-yielding crops instead of diverse local varieties. This genetic erosion is reducing the adaptive capabilities of the environment.

India’s patent framework requires comprehensive reforms to address emerging challenges in the sector of agricultural biotechnology. The primary step involves clarification of the interpretation of Section 3(j) of the Patents Act. This can be done by legislative amendment or by providing detailed guidelines for patent applicants and examiners. It should also establish a clear distinction between patentable biotechnological processes and excluded biological processes after considering factors like degree of human intervention and technical complexity. Coordination between patent examination and biosafety regulation should be enhanced. It would prevent situations where patented technologies fail to receive regulatory approval for commercial purposes.

The legal landscape of agricultural biotechnology and seed patents revolves around innovation, traditional agricultural policy and international obligations. The current framework is based on Section 3(j) of the Patent Act, 1970 and the Protection of Plant Varieties and Farmers' Rights Act. This unique framework attempts to strike a balance between technological innovation and traditional agricultural practices. Recent developments specially in the case of Sakata seed case the decision is indicating a more lenient approach towards recognition of biotechnological patents. This evolution creates new opportunities for biotechnological patent companies. The emergence of new gene editing technologies and the patent options associated with it will require significant policy changes in future. The international body governing biotechnological patents must come up with more prudent guidelines to combat fast developing technologies. India can lead the path by setting judicial precedents regarding this issue. The unique approach of India could be a lesson for other developing countries with the same grappling problem.

1. Economic Survey 2024-25: Agriculture and Allied Activities Sector Contribute Approximately 16% of the Country’s GDP for FY24 and Supports About 46.1% of the Population, India Brand Equity Foundation (Jan. 31, 2025), https://ibef.org/economy/economic-survey-2024-25.

2. The Patents (Amendment) Act, No. 38 of 2002, § 4, inserting § 3(j) into The Patents Act, No. 39 of 1970 (India).

3. Remfry & Sagar, IP Report April 2020, Remfry & Sagar (Apr. 2020), https://www.remfry.com/wp-content/uploads/2020/05/030_031-IPM_April_2020-FO2.pdf.

4. Office of the Controller General of Patents, Designs & Trade Marks, India, Guidelines for Examination of Biotechnological Inventions, https://www.ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf.

5. Sui-Generis Protection to the Plant Varieties: Farmers’ Rights v. Breeders’ Rights, Corpbiz (June 21, 2023), https://corpbiz.io/learning/sui-generis-protection-to-the-plant-varieties-farmers-rights-v-breeders-rights/.

6. Regine Andersen, The Union for the Protection of New Varieties of Plants (UPOV), FarmersRights.org (Feb. 22, 2023; last updated Feb. 27, 2023), https://www.farmersrights.org/international-negotiations/other-international-processes/the-union-for-the-protection-of-new-varieties-of-plants-upov/.

7. 11 Key International Treaties for Plant Genetic Resources: Fact Sheet, PlantSuccess (Sept. 2022), https://www.plantsuccess.org/wp-content/uploads/2022/10/11-Key-International-Treaties-for-Plant-Genetic-Resources-Fact-Sheet.pdf.

8. Regine Andersen, The Union for the Protection of New Varieties of Plants (UPOV), FarmersRights.org (Feb. 22, 2023; last updated Feb. 27, 2023), https://www.farmersrights.org/international-negotiations/other-international-processes/the-union-for-the-protection-of-new-varieties-of-plants-upov/.

9. The Protection of Plant Varieties and Farmers’ Rights Act, No. 53 of 2001 (India).

10. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 2226 U.N.T.S. 208.

11. International Service for the Acquisition of Agri-biotech Applications (ISAAA), Pocket K No. 8: Cartagena Protocol on Biosafety (2004), https://www.isaaa.org/resources/publications/pocketk/8/default.asp.

12. Government of India, Ministry of Environment, Forest and Climate Change, Understanding Cartagena Protocol on Biosafety: A Guide (2014), https://geacindia.gov.in/resource-documents/14-Understanding_Cartagena_Protocol_on_Biosafety_A_Guide.pdf.

13. Peter K. Yu, WIPO Negotiations on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, 57 Akron L. Rev. 277 (2024), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4656267.

14. Ayla do Vale Alves, WIPO’s New Treaty on Intellectual Property, Genetic Resources and Traditional Knowledge – A Turning Point for Indigenous Heritage?, ESIL Reflections, Vol. 13, Issue 11 (2024), https://esil-sedi.eu/esil-reflection-wipos-new-treaty-on-intellectual-property-genetic-resources-and-traditional-knowledge-a-turning-point-for-indigenous-heritage/.

15. Monsanto Tech. LLC v. Nuziveedu Seeds Ltd., Civil Appeal Nos. 4616–4617 of 2018, (2019) 3 S.C.C. 381 (India).

16. The Protection of Plant Varieties and Farmers’ Rights Act, No. 53 of 2001 (India).

17. The Patents (Amendment) Act, No. 38 of 2002, § 4, inserting § 3(j) into The Patents Act, No. 39 of 1970 (India).

18. Nidhisha Garg, Monsanto v. Nuziveedu: A Missed Opportunity by the Supreme Court?, Kluwer Patent Blog (Jan. 27, 2020), https://legalblogs.wolterskluwer.com/patent-blog/monsanto-v-nuziveedu-a-missed-opportunity-by-the-supreme-court/.

19. Sakata Seed Corp. v. Controller of Patents & Designs, C.M.A. (P.T.) No. 30 of 2023, Madras H.C. (India, July 19, 2024).

20. Section 3(j), Essentially Biological Processes and Human Intervention, BANANAIP Intellipedia (Sept. 17, 2024), https://www.bananaip.com/intellepedia/section-3j-essentially-biological-processes-human-intervention-patent-law/.

21. Nuziveedu Seeds Ltd. v. Monsanto Technology LLC, 3 S.C.C. 381 (India 2019), MANUPATRA (July 16, 2021), https://articles.manupatra.com/article-details/Nuziveedu-Seeds-Ltd-vs-Monsanto-Technology-LLC-3SCC-381.

22. Meera Patel, Bio-piracy of Traditional Knowledge, iPleaders (Jan. 6, 2021), https://blog.ipleaders.in/bio-piracy-of-traditional-knowledge/.

23. Food & Agriculture Org. of the United Nations, What is Happening to Agrobiodiversity? (1999), https://www.fao.org/4/y5609e/y5609e02.htm.