Gene Patenting, Biotechnology Patents and Green Patents

Written by Anubhav Seth

INTRODUCTION

‘Everyone has the right to protection of moral and material interests resulting from any scientific, literary or artistic production of which he is the author.’[1]

Intellectual Property is an invention, idea, product, or technique that has been registered with the government and provides the inventor or applicant exclusive rights to use the invention for a set period of time. It encompasses all intellectual property rights arising from industrial, scientific, literary, or artistic endeavours. Copyrights, trademarks, trade dress, and, in some jurisdictions, trade secrets, patents, industrial designs, and geographical indications are all examples of intellectual property rights.

The most significant feature of the property is that the owner or proprietor is free to use his property as he pleases and no one else can lawfully use his property. It grants the right to prevent others from creating, using, or selling the invention within the nation’s territory. The primary objective underlying this is to encourage innovation, research, and development. In the absence of IPR protection, other companies would be able to profit from the inventor’s research and development.

IP protection provides incentives for innovation and technological dissemination. However, because of his monopolistic control over his invention, he may be able to manipulate the market equilibrium by fixing prices, controlling and exploiting market understanding etc. This may provide Intellectual Property owners with an unfair edge. Furthermore, these rights are only applicable in nations where a patent application has been granted. The lack of an international intellectual property rights system may have a tremendous impact on the amount of innovative activity.

The government protects intellectual property in a variety of ways. For example, Copyrights protect original works of authorship, such as literary, artistic, and musical works, whereas trademarks provide a manufacturer exclusive rights to a well-known name, symbol, or mark. Some of the different forms of Intellectual Property Rights abuse are:

• Patent infringement: The unauthorized use of acquired patent rights is known as patent infringement. Patent infringement can include things like illegally linking products and services to a patented idea, price fixing, and forcing customers to pay royalties on items whose patents have expired.
• Trademark infringement: Trademark infringement happens when a third party uses a mark that is identical to a registered trademark in the course of business, usually for similar or competing goods (or so similar to the registered trademark that consumers are likely to be confused or deceived as to the origin of the goods).
• Copyright infringement: When a firm or an individual makes unjustified use of a copyright that is beyond its legal capacity and in contravention of the Copyright Act of the concerned country, it is known as copyright misuse. A copyright owner could commit misuse by violating any public policy choices embodied in the Copyright Act. Copyright misuse can also occur when the assertion of copyright is aimed at suppressing speech.
• Trade secret violation: Non-disclosure agreements (NDAs) are commonly used to protect trade secrets when they are shared between two parties. As a result, if a party that has seen another party’s trade secrets decides to publicize them in violation of an agreement or use the knowledge commercially without the approval of the information holder, they have breached their NDA.

GENE PATENTING

Gene patenting is the process of patenting a technique of manipulating DNA and chemical substances associated with it, as well as gene sequences and fragments that are not found in nature in their natural state.

Section 3(c) of the Patent Act, 1970, does not allow the “discovery of any living thing or non-living substance occurring in nature” as patentable subject matter. Further, section 3 (j) of the Indian Patent Act, 1970 includes objection to plants and animals, in whole or any part thereof, other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals to be patentable.

To cater to the global developments in biotechnology and its corresponding growth in the Indian economy, the India patent Office released the Indian Biotechnology Guidelines, 2013[2] and Manual of Patent Office Practice and Procedure[3]that includes the following conditions to be satisfied for granting a patent for any gene:

• The genetically modified gene sequence/amino acid sequence must be novel, involve inventive step and also have industrial applicability;
• The method of expressing the genetically modified gene sequence/amino acid sequence is novel;
• an antibody against that protein/sequence that is genetically modified can be claimed to be protected; or
• A kit made from the antibody/sequence can be claimed to be protected.

The “novelty owing to substantial human intervention” requirement must be met in order to patent recombinant DNA.

Given India’s thriving agricultural sector and the fact that agriculture employs the great majority of the country’s people, strong legal protection for genetic engineering in plants may have adverse implications for the country. Through their traditional practices, Indian farmers and local communities have made significant contributions to the development, conservation, exchange, and use of genetic variation.

Nevertheless, because gene patenting is permissible in other countries, this legal framework may benefit agro-biotech enterprises outside of India that have acquired many patents on plant-related genetic inventions. The developed countries have unrestricted access to the biological resources and accompanying knowledge of the developing countries which results in “bio-piracy” and “cultural piracy”.

India has implemented a number of measures under the Indian Patent Act, 1970, the Protection of Plant Variety and Farmers Right (PPVFR) Act, 2001, and the Biological Diversity Act, 2002, to fight “bio-piracy” and “culture piracy,” which include:

• Disclosure Requirement that requires the applicant to reveal all details about the parent variety of the gene, as well as a declaration that the genetic material has been obtained legally.
• Benefit Sharing, wherein the Indian citizens or groups of Indian citizens may be entitled to a share of the advantages based on the extent and nature of genetic material used in creating the variety, commercial utility of the variety, and market demand for the variety.
• Critical examination of the benefit-sharing provisions to ensure that the PPFVR Act’s goal reaches local people and peasants in a vast country like India via traditional societies in different states.

Many people are against Gene Patenting because it is part of the “commercialization of life.” It is argued that using it for therapeutic or diagnostic purposes is unethical because it modifies the course of nature by altering the natural being itself. It’s one thing to cure sickness with external operations or drugs; it’s quite another to alter the genetic make-up using engineered products.

Human genes are all one-of-a-kind. The ones that are naturally found must be left undisturbed; it is unethical to profit financially from them, regardless of the purpose for which they are used. The information about a person’s DNA is personal in nature. It should not be made available to the public for the purpose of filing a patent application.

Further, implications of gene patenting include: Limitation on research for many other organisations and people without infringing on patents, the development of new inventions severely hampered, non-access to healthcare facilities, for example, many hospitals find it difficult to conduct cancer tests that are essential for identification or therapy.

BIO-TECHNOLOGY PATENTS

Biotechnology may be defined as the application of science and engineering in the direct use of living organisms or parts or products of living organisms in their natural or modified forms.[4] Biotechnology encompasses the application of all biological systems, which include whole cells, tissues, organelles or enzymes derived from animal and plant cells, as well as microorganisms.[5]

Biotechnology further deals with recombinant DNA technology, which can be used to modify the genetic material of living cells to produce new substances or perform new functions. Biotechnology inventions are important for human development. It is a vast area of biology that involves the use of living systems and organisms to produce or manufacture products, or any technological application that employs biological systems, living organisms, or derivatives thereof to create or alter products or processes for specific purposes.

According to Section 2(1) (j) of the Indian Patent Act, 1970, to be patentable, an invention must be novel, innovative (non-obvious), and of industrial utility. It is also necessary for the innovation to be reproducible. The above-mentioned criteria will be used to decide if substances found in nature, such as microalgae or other organic materials, can be regarded as new.

The Act also states that no process is authorized to be patented for the treatment of human beings or any process for medical, surgical, curative, prophylactic or diagnostic treatment of animals that would free them from any disease, boost their economic value or increase their value or that of their product[6]. Despite these limitations on patentable inventions, biotechnology inventions are on the rise, notably from traditional biotechnology sources such as fermentation, east, and other sources.

The key problem in terms of novelty is establishing that the patented biotechnology product or method is new rather than natural. Another element of intricacy in biotechnological inventions stems from the ability of biological material to reproduce itself. In essence, a biological material may be patented in its current form one moment, but may mutate or transform the next. This raises the question of whether the patent protects the change or whether it is limited to the original state. The International Patent System should be harmonized in order to secure resource sovereignty while also pursuing international cooperation in biotechnological science.

GREEN INTELLECTUAL PROPERTY

The term ‘Green Intellectual Property’ refers to the safeguarding of innovation in the field of green technology. The term green technology encompasses any kind of environmentally friendly or clean technology, which includes a growing number of methods and materials ranging from energy generation techniques to non-toxic cleaning products and services.

The International Patent Classification Committee developed an “IPC Green Inventory”[7] which alleviates searches for patent information relating to Environmentally Sound Technologies as mentioned by the United Nations Framework Convention on Climate Change. It includes the following categories of technology:

1. Alternative Energy Production;
2. Energy Conservation;
3. Nuclear power generation;
4. Transportation;
5. Waste management;
6. Agriculture forestry;
7. Administrative, regulatory, and design aspects.

The objective of developing green technologies is to combat global warming caused by greenhouse gas emissions, conserve exhaustible energy, use all resources more sustainably, reuse and recycle waste and products, and dispose of residual waste in a more environmentally responsible way than previous technologies.

WHAT IS GREEN PATENT?

Green patents refer to the patenting of green technology. This means patents are granted for environmentally friendly technology. A green patent is one that is obtained for a technology that is either environmentally friendly or effectively prevents environmental degradation. When it concerns fostering sustainable human development, the term “green patent” refers to the promotion of green technologies that mitigate climate change and promote development on economic, social, and environmental lines.

The law in India regulating the status of green patents in relation to sustainable human development needs to be clarified. There is currently no provision specifically for green patents. The problem with the current patent system is that it is skewed toward Intellectual Property Rights-based firms that are lobbying for more robust patent protection, resulting in a bias against sustainable development and a rush for using patents to develop cutting-edge solely for financial gain. The impact of technology on the environment is being completely ignored.

In the contemporaneous world, most developing countries have been unable to reap the benefits of green technology owing to the high cost of innovation and lack of accessibility. The focus of developing countries should be on economic development. They may not have the privilege of diverting their resources to social events at the cost of economic development. Developed countries, on the other hand, can focus their efforts on the development of ecologically sustainable technology.

This is due to the fact that they have reached a certain level of economic development. It’s critical to establish a balance between green technology’s economic and financial aspects and its environmental aspect. Green technology must be employed globally if it is to be a viable answer to global issues such as climate change. We can’t have developed countries utilizing ecologically sustainable technology while underdeveloped countries deprived of access to it. This would be counterproductive to the whole idea of green technology.

CONCLUSION

Gene patenting offers its own set of benefits and drawbacks. Genetic modifications benefit medical development and help India meet its food security needs. The law governing plant biotechnology, on the other hand, is expected to protect the interests of India’s local farmers, who make up a large bulk of the country’s population.

The benefit claimants (mostly peasants and farmers with traditional seed expertise) have no say in determining and negotiating benefit sharing. A significant number of legislative reforms are needed to enhance the norms and regulations that govern gene patenting in India, while still offering reasonable benefits to the owners of traditional knowledge that has been passed down for thousands of years.

As far as Green Patents are concerned, technical innovation is critical in today’s society. What’s even more important is technological progress, along with environmental sustainability. The curious yet viable compromise between economic growth and environmental security can be reached through patents. Patenting of green technology can help save the environment and ensure that the goal of sustainable development is achieved in its entirety.

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[1] Universal Declaration of Human Rights (UDHR), art. 27, § 2

[2] Guidelines for Examination of Biotechnology Applications for Patent, 2013. These guidelines were issued by the Indian Office of the Controller General of Patents, Designs and Trade Marks, http://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech-guidelines.pdf

[3]Manual may be considered as a practical guide for effective prosecution of patent applications in India. However, it does not constitute rulemaking and hence, does not have the force and effect of law. https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Procedure_.pdf

[4] Canadian Environmental Protection Act, § 3, No. 33, 1999

[5] Malathi Lakshmikumaran, Patenting of Genetic Inventions, 12 Journal of Intellectual Property Rights 45, 45-45 (2007)

[6] Indian Patent Act,§3(i), No. 39, 1970

[7] WIPO IP Portal, https://www.wipo.int/classifications/ipc/green-inventory/home, (last visited Aug.4, 2021).

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