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Introduction
Patent is a type of intellectual property that protects an invention or a process that is new, results from an inventive activity, is capable of industrial application (useful) or constitutes an improvement upon an existing patented invention.
The World Intellectual Property Organisation (WIPO) defines a patent as an exclusive right granted in respect of an invention, which may be a product or a process that provides a new and inventive technical solution to a problem. Thus, a patent is granted in respect of an invention where such an invention complies with the conditions stipulated under the relevant law.
Before the Plant Variety Protection Act (PVP Act) in 2021, the protection of plant varieties that resulted from microbiological processes was provided under the Patent and Designs Act (PDA). However, the provisions of the PDA on this subject could be misunderstood as excluding all plant varieties from protection due to the use of some scientific terms without definition. This article provides clarity around these terms and further provides a justification for the new PVP Act.
Patentable Inventions and Exclusions
The conditions for patentability stipulated under the PDA are that the invention must be new, result from inventive activity, and be capable of industrial application. An improvement upon a patented invention is also patentable if it is new, results from inventive activity, and is capable of industrial activity.
With respect to the excluded subject matter, the PDA provides that a patent cannot be validly obtained with respect to plant or animal varieties or essentially biological processes for the production of plants or animals, but not microbiological processes and their products. What could this mean? Is the legal implication of this exclusion clear in light of the Plant Variety Protection Act 2021? The PVP Act, among other things, grants exclusive intellectual property rights to plant breeders over new plant varieties. The Act aims to promote innovation and development in the plant breeding sector and ensures that breeders are adequately protected from creating new plant species.
This article will clarify the terms ‘biological processes,’ ‘microbiological processes’, and ‘non-biological processes’ under the PDA in relation to plant varieties and establish the basis for the PVP Act. Although the PDA is clear on the items excluded from protection, failure to understand the concepts could imply the exclusion of all plant varieties from production under the PDA and create uncertainty as to why the PVP Act even exists.
Conceptual Clarification and Justification for Plant Variety Protection
The PDA provides that “plant or animal varieties, or essentially, biological processes for the production of plants and animals (other than microbiological processes and their products)” are excluded from patent protection. The confusion in this section stems from the fact that the Act failed to interpret or explain some of the scientific terms that form the basis for the distinction between patentable plant varieties and non-patentable plant and animal varieties.
The enactment of Nigeria’s PVP Act 2021 was in response to Article 27.3(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which provides for the protection by member states of plant varieties through a patent, sui generis, or combination of both. The provision also gave member states the liberty to exclude biological processes for the production of plants and animals other than non-biological and microbiological processes from patentability. As seen from the provisions of the Nigerian PDA, varieties produced from biological processes are excluded from patentability, not non-biological and microbiological processes such as plants modified through genetic engineering.
From the above, it is clear that a plant or animal variety without more, or, essentially, a biological process that results in the production of a plant or animal variety, is not patentable. A biological process is a naturally occurring process vital for an organism to live, shaping its capacity for interacting with its environment. These are activities carried out by living organisms. Examples of naturally occurring biological processes include metabolism, respiration, reproduction, digestion, growth etc. Simply put, it is a process or activity requiring minimal or no human interference. According to the Technical Board of the European Patent Office (TBEPC), what does not constitute an essentially biological process refers to the process for the production of plants comprising at least one essential technical act that cannot be carried out without human intervention and which has a decisive impact on the final result. In this sense, an essentially biological process is understood as one that is performed by humans without the application of any external technical skills by humans. A biological process excludes manipulation. When human technology interferes with an independent natural process such as reproduction or germination, it eliminates its biological nature and becomes artificial or inventive. Thus, the term essentially biological used in Section 1(4)(a) of the PDA is clearer and explains why such a process is excluded from patent protection. If otherwise, agricultural activities would be significantly impeded, hindering scientific research and innovation. In addition, one of the fundamental principles of patent law is that natural phenomena, laws of nature, and abstract ideas cannot be patented. This doctrine is based on the idea that these are the basic tools of scientific and technological work that should be freely available to everyone. Since many biological processes occur naturally, they are considered part of natural phenomena and thus not subject to patent protection.
Microbiological and non-biological processes often involve sophisticated technical methods that are human-engineered rather than naturally occurring, although non-biological processes are more technical in nature. This distinction underlines the argument that such processes are eligible for patent protection due to their human-designed nature. Any method of genetic engineering could be a microbiological process involving the manipulation of microorganisms such as bacteria, viruses, or yeast to produce a specific or desired result. Genetic engineering is also referred to as genetic modification or genetic manipulation. It is the direct manipulation of an organism's genes through biotechnology, i.e., the application of biology to solve problems and create useful products. Such a process carried out with human intervention is not considered an essentially biological process, and the product or process could be patented. This justifies its protection under the PDA and the PVP Act. It is not produced naturally (biological process) but involves using specialised technical tools and skills to produce a new plant variety. It is not a product of conventional breeding methods but was created by human manipulation.
Justification for Plant Variety Protection
According to the International Union for the Protection of New Varieties of Plants (UPOV), plant variety protection, also called a ‘plant breeder’s right’ is a form of intellectual property right granted to the breeder of a new plant variety in relation to certain acts concerning the exploitation of the protected variety that require the prior authorisation of the breeder.
The Nigeria PVP Act 2021 protects plant varieties and encourages investment in plant breeding and crop variety development. This protection is justified on several grounds.
Breeding new plant varieties requires time, skill, labour, and resources and takes years (about 15-20 years in the case of many plant species) to develop. However, when a new variety is released, it is capable of multiple reproductions by others, depriving the breeder of any possible return on their investment. It is important to provide an effective plant variety protection system to produce more plant varieties for society's benefit. Research has shown that new plant varieties are more productive, more resistant to pests and diseases, and yield more than normal. It is, therefore, only right to protect these plants through intellectual property and encourage breeders to produce high-performing plants for the benefit of society. The PVP Act established the Nigerian Plant Variety Protection Office (NPVPO) as an agency under the National Agricultural Seeds Council (NASC) to promote and protect breeders' rights in Nigeria. It also creates a registration portal for breeders to easily apply to register their plant varieties. The NPVPO regulates and controls the registration of new plant varieties.
Since agriculture contributes greatly to the economy's growth through plant breeding and food security, it is important to adequately protect this process and ensure continued plant variety development. Intellectual property protection is necessary to serve as an incentive to plant breeders for the development of new varieties that contribute to sustainable progress in agriculture.
Conclusion
The Nigerian PDA failed to conceptualise the terms ‘biological process’ and ‘microbiological process’, which led to confusion as to which category of plant variety is patentable. It is clear from this analysis that plant and animal varieties, or more specifically, the biological processes that produce plant and animal varieties, are exempt from patent protection because they result from a natural biological process and remain in the public domain. There is minimal human intervention or manipulation in this process, and as intellectual property concerns itself with creativity and innovation, it is only right that such natural processes be exempted from protection. Everyone should be allowed to freely benefit from nature. However, plant varieties produced through microbiological processes such as genetic engineering and the use of specialised equipment to manipulate plant development and growth are protected by law because they result from the skills and efforts of a person (the breeder), which is why the law considers it necessary and fair to protect the plant variety and also give the breeder exclusive rights to the exploitation of their investment. These broader rights are now protected under a specific law in Nigeria, the PVP Act. Breeders are free to apply for the registration of their rights through the NPVPO website.
