This article is written by Chandana Pradeep, from the School of Law, University of Petroleum and Energy Studies, Dehradun. This article analyses how biodiversity and patents go hand in hand with each other and also examines the issues which are faced while granting a patent for biological resources.
Biodiversity signifies every living thing which includes various types of plants, animals, etc. cohabiting in this ecosystem. It consists of millions of different types of species of plants and animals. Due to human behaviour and climatic conditions, there has been a dire need to protect and conserve biodiversity as the biological resources are depleting according to various statistics and it is the need of the hour to protect and conserve them.
The industrial revolution has been happening by different factors such as cross-breeding or using the resources for research etc. Intellectual Property Rights (IPR) is one of the mechanisms which was developed by the West for rewarding the innovators and facilitating the steady pace of the industrial revolution. This also assures a place in the commercial market. The aim of intellectual property rights is to promote this. Patents are issued to parties for twenty years for their innovative idea so as a means of encouraging this.
The starting step that was taken to include biodiversity as a product was in the United Kingdom, where seeds of high quality were used for agriculture, and once this started, companies started to register their seeds and slowly, the government started to give rewards to anyone who had innovated this product and this initiated breeders rights which started commercialising.
The International Union for the Protection of New Varieties of New Varieties of Plants (UPOV) was set up with its headquarters in Geneva, for coordinating the Plant Breeders Rights internationally, this Convention had been signed in 1961 in Paris but finally, came into effect in 1981. The Convention had listed out the eligibility criteria to protect their plants as following:
- Had to be distinct than the existing variety of plants;
- Must not have been commercialised before filing for the patent;
- Had to be stable;
There were countries which started to give patents for Genetically Modified Organisms(GMO). The first country to start doing this was the United States where a microbiologist patented a bacterial strain which he had modified.
India became part of the Convention on Biological Diversity (CBD) in the year 1992, to promote biodiversity and its conservation as well sharing of benefits by the use of genetic resources. To comply with the decisions that were made by the Convention, India passed a law called the Biodiversity Act, 2002.
The Biodiversity Act, 2002
This Act is a very important part of the Indian legislation and aims to protect the biological diversity which exists in India, ensuring the sustainable utilisation of the resources. The Act came into being in 2002 but was enacted in 2004 when the rules had been notified.
The Act covers in broad perspective how the resources found in India are to be used in India or abroad as the case may be, be it for commercial use or research purpose. The Act focuses on sharing the benefit-sharing of resources which have been agreed upon.
Protection of Plant Varieties and Farmers Rights Act, 2001
India is home to millions of plants and plant varieties that have been cultivated here and ones introduced from abroad, just as scientists get patents for their invention, farmers should get rights to as they are the ones who are cultivating these crops. The farmers are not just cultivating them but they also have a vast knowledge regarding the plants. This Act focuses on the rights of the farmers as well as the rights of the plant breeder.
The Patent (Amendment) Act, 2005
After the TRIPS agreement was adopted by India in 1995, India had to change all its patent laws. India enacted the Patent (Amendment) Act, 2005. Amendment was also necessary to improve the shortcoming that arose in traditional knowledge. In this Act, Section 2(1)(m) clearly defines patent, other amendments include provisions related to opposition grounds for patenting under Section 25(1) among many others.
How intellectual property rights play a role in biodiversity cannot be estimated. Crops and plants are all vulnerable to pests and any sort of disease that can affect them, to survive they have to evolve; in this case, they have to be genetically diverse to survive. How these are conserved and modified is of concern worldwide.
Farmers modify their plants and adapt to plants that are commercially viable seeds, sometimes government initiatives also cause the farmers to adapt to various types of seeds which are uniform. Commercial farming leads to situations such as soil erosion, the intellectual property laws in a way promote this and encourages commercial farming regardless of situations that arise.
The development of biological diversity depends on the formal and community systems and to achieve this the policymakers should concentrate on transfer of technology so that biodiversity can be protected and not destroyed, so there should be more stringent rules related to research and commercial purposes, as the main aim of protecting biodiversity is for the benefit of humans and should not be in the negative.
- There is an interplay regarding intellectual property rights and biodiversity. In the Biodiversity Act, there are many sections which relate to patents. Section 6(1) of the Act states, No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application: Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned: Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.
- Section 10(4)(d)(ii) of the Patents Act, 1970, that the person applying for the patent has to reveal or disclose the information as to the origin of the location from where the source is found for the biological source used for the invention, it should be disclosed at the beginning of filing for the patents. It has to be compulsorily approved by the National Biodiversity Authority (NBA), it is even allowed for the controller to object to the process of patenting to move any further if the permission has not been obtained.
- The approval from the NBA is not required if the biological source for the invention is obtained from a foreign land, and has to submit a declaration stating the same so as to avoid any further questioning at any later stage.
- There are penalties imposed too in case the provisions relating to biodiversity in the Patents Act, 2002, then the patent can also be refused according to Section 15 of the Act. This applies to situations of pre-grant and post grant as well under Section 25(1) and Section 25(2) respectively.
There are specific inventions that are not included in the ambit of “biological resources” and biowastes, as follows:
Products which are value added
Section 2(p) of the Biological Diversity Act,2002 defines the value added products as products which contain extracts of plants and animals in an inseparable form.
These are the waste that are created after using the biological resource, and there is no approval that is needed by the National Biodiversity Authority.
Biological material made synthetically
Approval is not needed from the National Biodiversity Authority(NBA) which are produced from biological resources.
Traditional knowledge refers to the knowledge, innovations and practices of indigenous and local communities around the world. Developed from experience gained over the centuries and adapted to the local culture and environment, traditional knowledge is transmitted orally from generation to generation.
Loss of biodiversity
India has significant biodiversity ranging from forests to agriculture, but with time it is all being affected with time due to deforestation,soil erosion etc. Traditional knowledge (TK) was an important aspect to protect the biodiversity that is prevalent in our country. Agriculture based on traditional knowledge has sufficiently decreased but when irrigation systems were all developed after a deep understanding of the ecosystem, and the crops could even sustain in extreme harsh climates.
The traditional knowledge has lost its importance somewhere, and now it is all about modernising agriculture which includes exporting seeds, and having a presence in the economy has increased. Hence it is very important to conserve the biological resources even more. The best method to conserve biological resources is to create a connecting factor between people and the biological resources.
It is first necessary to understand the definition of the word “Protection.” According to Section 8(j) of the Convention of Biodiversity, protection includes the wider ambit of traditional knowledge.
A main issue of traditional knowledge is how it is always misused. In India, there has never been a ownership privately in terms of knowledge relating to biodiversity and how biological resources can help for certain factors such as farming and agriculture among others. Even though the concept of private ownership existed it was not there for things such as agriculture etc, it used to be more of a traditional approach where the knowledge was shared from one person to another. This is against what is in the Trade Related Aspects of Intellectual Property Rights.
Hence most people are misusing this, and the most vulnerable are the developing countries as they are exploited for biological resources needed for various purposes with no benefit being shared to the people and hence traditional knowledge and Intellectual property rights began to have conflicts. IPR laws should give benefit to all and not just favour one particular organisation or company.
Patenting of Genetically Modified Organisms (GMO)
Despite not having enough support, India still allows genetic modification using the genes of plants or animals for different purposes.
An example is when the company called “Agracetus” had been granted a patent which covered transgenic soybeans, once patent has been granted claims can be stated as well as can prevent anyone else from researching with the patented object.
Protection of plant varieties
Till recent times, the patenting of plants and its varieties were not allowed but that has changed. India has passed a law called Plant Varieties and Farmers Rights Act,2001 which focuses on protecting the plant varieties. This is extremely important as there are a lot of new varieties of plants being created through methods such as cross breeding and due to this, there is a huge increase in various companies and organisations pushing through to patents their creations, but at the same time, the farmers who put in their hard work to develop these crops will have no rights compared to that of the companies who have the patent.
Disclosure of origin and prior concern which has been informed
Disclosure of origin has been a topic of discussion as to whether to make it mandatory or not whether the source of traditional knowledge and origin be revealed during the process of patenting. There were different proposals being made to the Trade Related Aspects of Intellectual Property Rights (TRIPS) to reveal the source of the invention as well as to maintain legal requirements. In 2000, India had realised the need for the protection of knowledge of tribal and indigenious people and for them to have rights over it as well as share benefits with them to protect the biodiversity and biological resources of the country. India has also introduced a provision for disclosing information of the source of biological resources in the Patents(Amendment) Act, 2005.
Access and benefit-sharing
Article 15 of the Convention of Biodiversity focuses on access and benefit-sharing, which states that the country has access and rights to all its natural resources and also has the right to decide how the resources get to be used. The access to these should be on the basis of Patent Information Center (PIC) and on mutually agreed terms and conditions which give equal benefit to all parties, this is also applicable in cases where the source of the biological resources is from traditional knowledge. Access of genetic resources should be at par with the protection of IPR.
The government should introduce different legislation and policies to help with this, as well as make sure that developing countries with ample amounts of natural resources are not overpowered by the developed countries and should not be in disagreement with Article 16 of the Convention of Biodiversity (objectives). Although the Convention is not bound legally to the members, it provides guidelines as to how benefit sharing and access of biological resources can be effective without discriminating against any party.
Though the National Biodiversity Board and Indian Patent Office is taking extra steps to ensure that all the processing of patenting of biological resources and other related processes are being done with any downfall, there are still some loopholes which exist.
Under Section 7 of the Biodiversity Development Act, it is important disclose the source of biological resource if the person is a foreigner, it requires other agreements to also be entered into by the party where the State authorizes it and pay money, one suggestion would be to make it a single agreement as it causes a lot of chaos and confusion.
Developments have to come about with time, as the saying goes “to improve is to change, to be perfect is to change often.” There has been a constant debate regarding the two statutes which are the Patents Act and the Biodiversity Act as both of them have conflicting provisions, but is also important to realise that both these statutes go hand in hand to ensure that the rights of the parties are protected while a patent is applied for and no party involved or otherwise is discriminated. India needs to protect its biodiversity and for that both the authorities (National Biodiversity Board and Indian Patent Office) have to develop with time regarding their procedures by getting regular feedback from its stakeholders.
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