This article is written by Arya Senapati. This article intends to explore the relationship between Intellectual Property Rights and Biodiversity Conservation by explaining their conjunctions like biopiracy, bioprospecting and provisions like Access and Benefit Sharing, Prior Informed Consent and Mutually Agreed Terms. 

This article has been published by Shashwat Kaushik.

Introduction

Intellectual property rights (IPR) seek to protect any creation, invention or existing traditional knowledge through the protection accorded by law. Biodiversity, on the other hand, refers to the coverage of flora and fauna in a specific region. In the globalised world, the relationship between biodiversity and IPR is of significant importance. Talks of climate change and global warming have led to crucial considerations for the preservation of biodiversity through regulations. The intellectual property regime is intricately linked to biodiversity as it seeks to protect, preserve and prevent its misutilisation while exploring its many benefits. In a capitalist world, corporations and individuals seek to derive monetary benefits from various sources. Biological and natural resources are regularly capitalized by sectors like pharmaceuticals, cosmetics, agriculture and even academics for research and knowledge transfer. In this process, many rights associated with biodiversity are prone to violation, and therefore, the international frameworks on Intellectual Property Law and Biodiversity need to complement each other to devise a balance and solution to the threats. 

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Relationship between Intellectual Property Rights (IPR) and biodiversity

Biodiversity conservation and Intellectual Property Rights, share an intricate relationship due to the effect they have on each other. Researchers utilise bio-resources and natural resources to derive their benefits and create products for pharma, cosmetics, agriculture and other industries that may require patenting or any other form of legal protection or sharing the knowledge through technology transfer, which are all facets of Intellectual Property Law. Still, over-exploitation of these resources and utilising resources that have community rights attached to them or are prevented from being used for human exploitation pose a threat to local and global biodiversity coverage. This must be tackled by both biodiversity conservation law and intellectual property law. Both of these legal disciplines need to incorporate commonalities of effect and cause to prevent each from overlapping with the other to a significant extent, with a detrimental effect.  There are many ways in which these effects can be felt. Some of them are:

Biopiracy

Biopiracy is one of the most inevitable concerns in the spheres of IPR and Biodiversity. It refers to the utilisation or exploitation of bio and natural resources for capital gains without providing any credit to the local community that preserves the biodiversity resources or has preserved the traditional knowledge attached to them. They are not compensated adequately or at all for their contribution, and neither is their consent obtained before venturing into the territory and researching their local biodiversity. This leads to conflict between industry and indigenous people, who have been protecting the resources for many generations. Due to the overarching effects that biopiracy has on local communities, many international frameworks, like the Nagoya Protocol, have attempted to deal effectively with the problem by trying to establish an equitable access and benefit sharing mechanism that intends to create a positive involvement of local communities in the process of utilizing the biodiversity that they are associated with. This will create a balance between protecting indigenous knowledge and innovation in the field of research while ensuring that local communities are fairly compensated and their consent remains vital. 

Bioprospecting

Unlike biopiracy, bioprospecting implies a more positive approach. It is the process of incentivising academia and research institutions to conduct more research on biological and natural resources to create innovative solutions for human problems. This helps in understanding or analysing ways of utilising certain bioresources for the benefit of mankind. It also promotes conducting research towards the discovery of new and unknown species, which can help in the creation of innovation. These innovations can have many tangible benefits for pharma companies and the agricultural sector. Further, they contribute largely to the growth of the economy. While innovation is beneficial, some entities would seek to over-exploit the resources, leading to their exhaustion or extinction, which needs to be prevented by intellectual property law as most of these innovations are patented for commercial use and monopolized under the particular legal system. There need to be limitations in place to conserve the resources from over-exploitation. There also needs to be provision for the promotion of the growth of such resources due to their demonstrated economic value and contribution to society. 

Traditional knowledge

Traditional knowledge refers to knowledge about the correct ways of using certain biological resources like plants, forest produce, herbs, and shrubs for deriving medicinal properties or other beneficial uses. This traditional knowledge is preserved by local indigenous communities and passed down through generations to keep it alive. Appropriating this traditional knowledge can have an adverse effect on the local communities, as they are largely dependent on it. Therefore, while appropriation of this knowledge is done for the greater good of mankind and economic valuation, the local communities that pass on this traditional knowledge through their generations must be fairly compensated and must receive credit or benefits arising out of it. One such example of traditional knowledge is using haldi/ turmeric for its antiseptic and anti-bacterial properties for healing wounds. This was also appropriated by a big pharma and we shall discuss the case in detail later. India has a repository of its traditional knowledge in the form of TKDL, i.e., the Traditional Knowledge Digital Library, which enlists the traditional knowledge, its usage and the communities associated with it so as to prevent misappropriation of the same by global industries. 

International frameworks – TRIPS and CBD

The Agreement on Trade Related Aspects of Intellectual Property Rights, or TRIPS, is a central part of the WTO (World Trade Organisation) regime and is one of the primary pieces of legislation and the international framework on IPR on a global level. It primarily deals with the commercial nature of intellectual property. Considering how commerce can adversely affect biodiversity, it also has provisions that deal with the interplay of biodiversity conservation and intellectual property rights. 

The TRIPS agreement describes the minimum standard of protection that every member nation that is a part of the WTO needs to abide by for parents, especially those dealing with genetic resources. They have to follow certain guidelines when an entity tries to get patent protection for an invention that utilises genetic resources from plants, animals and microbes. In terms of provisions, Article 27.3(b) of TRIPS allows for the registration of patents that involve plants and animals but specifically excludes microorganisms. It also allows for the registration of patents involving “essential biological processes” for the production of plants and animals, but it also enables member nations to restrict the usage of certain microorganisms in terms of inventions and their patenting. One of the criticisms that TRIPS faces is that it does not directly mention anything regarding “access and benefit sharing” mechanisms, which has left a huge loophole for entities to exploit biological resources without bearing any compensation to the nations of origin or the local communities dealing with those resources. 

TRIPS acknowledges the significance that traditional knowledge holds and recognises the role that indigenous communities play in protecting and preserving it. Yet, at the same time, it does not create any strict protection norm for traditional knowledge except for Article 8(j). The provision simply calls for “mutually supportive” actions for the cross sections of IPR and Traditional knowledge. This lacuna or ambiguity needs to be addressed to effectively deal with concerns regarding the misappropriation of traditional knowledge without equitable monetary benefits for the local communities. 

TRIPS vitally deals with patent protection and rights, but it also sheds light on the protection of plant varieties and, by doing so, tries to acknowledge the role that plant variety protection could have on biodiversity conservation. Article 27.3(b) of the TRIPS enables its member nations to create a “sui generis” (nation’s own domestic system of laws) system for the protection of plant variety with the goal of securing various approaches towards the promotion of biodiversity conservation and the ethical use of genetic materials extracted from plant species. 

The public health enabling provision of the TRIPS agreement has raised the most crucial contentions about the conservation of biodiversity. This provision, which is essentially a part of the Doha Declaration, allows member nations to take actions suitable for the protection of public health and to increase accessibility to crucial medicines. This is contentious, as this provision is often used by pharmaceutical companies to get unfair access to bio-resources and allows them to exploit biodiversity under the guise of public necessity. There needs to be a balance between public necessity and biological conservation in the sense that both are achieved without hampering the other. 

The Convention on Biological Diversity, 2003 or the CBD, is an international framework of legislation that was adopted by nations on the occasion of the Earth Summit of Rio 2000 with the objective of protecting biological and natural resources for future generations. It rests on three main pillars: protection of biological diversity, sustainable use of biological resources, and equitable benefit sharing models. Having recognised the interplay between IPR and biological diversity, CBD enlists certain provisions to manifest this relationship positively. 

It enlists the concept of “prior informed consent” in terms of accessibility towards the biological resources of a particular nation. It mandates corporations to acquire prior informed consent from the member nations and the local indigenous communities before granting access to any traditional knowledge or biological material associated with the country or originating from the country. This provision tries to ensure that every nation has the utmost sovereignty over its natural resources and can enact provisions to prevent registration of any form of IPR that could potentially have an adverse effect on the biological diversity and the local communities of the nation. This has caused many nations to modify their patent laws in such a way that they incorporate provisions highlighting the requirements and the process to gain prior informed consent from the local communities and biodiversity boards for gaining access to research and inventing innovations using the genetic resources of plants and animal species. 

The most significant effect of CBD has been the creation of a robust “Access and Benefit Sharing Model,” which mandates entities to share equitably any benefit arising from an invention or innovation utilising natural resources of a particular community with the particular indigenous or local community of a member nation. It recognises the interdependence that local communities and biological resources have with each other and therefore requires the entities to fairly and equitably compensate the communities for gaining access to and commercialising the flora and fauna or the traditional knowledge of the community. It mandates disclosure of the origin of the natural resources so as to ensure that the patent applicants have an access and benefit sharing agreement with the local community and are abiding by the provisions secured by CBD. 

In terms of provisions, Article 8(j) of the CBD recognises the significance of traditional knowledge and requires member nations to create a repository for the same so as to ensure strict protection of the same and consequently achieve implementation of the ABS (Access and Benefit Sharing Model) for the local communities. Article 15(7) lays out the ABS model in intricate detail as a mandate for member nations to include in their domestic legislation. 

The Nagoya Protocol also complements CBD by dealing with prior informed consent and the Access and Benefit Sharing Model. Except for those, it also talks about “mutually agreed terms,” which is a concept that requires thorough negotiation between the inventor and the community that provides the biological material, consequently leading up to an agreement that highlights all the conditions regarding the extent of access, the amount of compensation, etc. This helps empower local communities by giving them the authority to set the terms for the commercialization of their resources. It also requires the creation of an Access and Benefit Sharing Clearing House (ABSCH), which would be a digital documentation of all sorts of information relating to the ABS mechanism and enable access to information on biological material, associated traditional knowledge and IPR norms for researchers and innovators interested in the same. 

Indian legislations surrounding IPR and biodiversity

India as a nation is known for its rich biological diversity and natural resources in terms of distinct flora and fauna unique to its soil. It is also home to many indigenous communities and tribes who have preserved their traditional knowledge for generations and are deeply associated with the local natural coverage for their livelihood, medicinal uses and religious beliefs. At the same time, India is also a fast-growing economy with a focus on industry-academia collaboration for research on these natural resources with the intention of gaining commercial value for the same. Therefore, it becomes highly essential for a country like India to have a strict and comprehensive legal regime protecting biological diversity by incorporating provisions in IPR laws, amongst many other laws, that achieve a balance between monopolistic interests and natural conservation.  

The Biological Diversity Act of 2002 is one of the prime pieces of legislation in India that deals with the interplay between IPR and Biological Conservation by regulating access to bio-resources and traditional knowledge. 

Its Section 3, creates a provision for controlling access to bio-resources by mandating entities to secure prior approval from the National Biodiversity Authority (NBA) or the State Biodiversity Board so as to ensure legal and ethical access to natural resources. 

Section 4 also requires the entities to comply with the requirement of getting the approval of the National Biodiversity Authority for implementing any Access and Benefit Sharing Model related to access towards any natural and biological resources arising from India. 

Section 6 of the Act states that any individual or entity obtaining IPR protection for any research or invention arising out of access to any biological resources in India must share the benefits with local communities and the NBA. 

Section 7 mandates the approval of the NBA for sharing the results or knowledge obtained from any research on natural and biological resources with any foreign body so as to prevent biopiracy and any unintended use, exploitation or misappropriation of any bio-resources and traditional knowledge coming from India. 

It also establishes the National Biodiversity Board and State Biodiversity Board, tasked with the responsibility of providing equitable access and benefit sharing mechanisms to local communities and authorities for utilisation of any bio-resource in India. 

The Plant Varieties and Farmers Rights Act, 2001 envisions creating a balance between IPR protection and the rights of farmers. Chapter IV talks about the rights and duties of plant breeders while providing the right to protect any new plant variety through IPR registration. It also acknowledges the right of a farmer to sow, resow, utilise, save, share, exchange and sell their farm produce, which can also be seeds and plant material, with the goal of promoting biodiversity and agriculture. 

The Indian Patents Act, 1970, through its provision in Section 3(j), directly restricts the registration or grant of any patent that includes inventions contrary to natural laws and involving plant material, animals and traditional knowledge. This is aimed at preventing the loss of biodiversity. Section 25(1), deals with compulsory licensing, which states that every patented invention, in times of necessity and in specific situations, must be made available to the general public at reasonable rates. This is also known as the public necessity doctrine and can be used to counter misuse of any IPR or to counter gaining monopoly over IPR involving beneficial natural resources and traditional knowledge. 

Case studies on biopiracy

India has been a victim of multiple cases of biopiracy and has tried to resolve the same on a global level. Some of them are: 

Neem (2000) and Turmeric (1993) Patents case

The neem and turmeric patents case is a highly known matter of biopiracy in an Indian context. In this case, the United States Patents and Trademark Office (USPTO) registered a patent with an American company for a product involving the medicinal use of neem and turmeric. This led to conflict as many Indian organisations protested against the misappropriation of this traditional knowledge associated with local communities in India, as haldi and neem have been used since time immemorial in India for their antiseptic and healing properties. The Indian government opposed the grant of this patent, and after an array of legal battles, the USPTO revoked all the patents involving Haldi and Neem for medicinal usage in the year 2000. This was the first case that highlighted the necessity for India to protect its biological resources and traditional knowledge. 

Basmati Rice case (2000)

This particular case talks about the granting of a patent for Basmati rice to a US company by the USPTO. Basmati rice is a fragrant variety of rice known for its distinct taste and smell and is largely grown in India and Pakistan. The applicants had falsely claimed that they invented the new variety of basmati rice, which led to conflict between Indian organisations focused on agriculture and American institutions. After multiple arguments, the claims of the patent were narrowed down as the applicants agreed that they didn’t invent basmati rice. 

Wheat Varieties case (2003)

It is a case involving the biopiracy of Indian wheat harvests referred to as Nap Hal and Nap Hal-49 which were granted as patented products to a European company as they claimed to be inventors of these wheat varieties. This led to an intervention by the Indian authorities, which provided enough evidence to substantially claim that the wheat varieties originally belonged to India, were its own natural resources and crop varieties, and therefore were not novel inventions. The patents were therefore revoked. 

Aloe Vera case

This conflict arose when a South Korean entity was granted a patent for a “method of producing aloe vera extract,” which was originally a traditional knowledge associated with India as aloe vera has been used since time immemorial as a medicinal plant in India. After the intervention of authorities, the patent application was withdrawn, and the importance of supervising patent applications involving traditional knowledge was recognised. 

Case studies on access and benefit sharing

While the access and benefit sharing model came after a long time, it has many success stories in terms of helping local communities get the credit that they deserve. Some instances are noted below:

Kani Tribe case (1987)

In this case, we focus on the Kani Tribe, which is an indigenous community local to the Nilgiri Biosphere Reserve. In one instance of bioprospecting, foreign researchers found that that tribe uses a medicinal plant’s leaves to stay high on energy and extend vital functions. The researchers then sought to commercialise the medicinal properties of the plant by trying to patent it and sell it as a product marked as an energy booster. Neither did they obtain prior informed consent from the local communities, nor did they share any compensation or benefit with the local tribe. This led to a conflict, and the Supreme Court of India held that the Kani tribe has a right to utilise their traditional knowledge and must be fairly compensated for the same. 

Tea Board of India v. ITC Ltd. (2011)

In this matter, the Tea Board of India highlighted the importance of regulating access to products, which are considered geographical indications in India, as they are rooted in the efforts of the local communities to make them unique to a place and preserve their authenticity. In this case, the Geographical Indication (GI) concerned was Darjeeling tea and the Court ruled in favour of the tea board and stated that there needs to be proper regulation regarding access to products marked as Geographical Indications so as to guarantee that the interests of the local communities associated with the product are not compromised in any way.

Red Sanders Auction case study (2015)

In this matter, the State Government of Andhra Pradesh held a global auction to sell its procure of “Red Sanders,” which is known for its exquisite value and rare and unique charm. The monetary value that accrued from this deal was shared on a 5:95 basis between the NBA and the Regional Management Community for the betterment of the local communities invested in the harvest, growth and conservation of Red Sanders. They involved the indigenous communities in the conservation process. 

Novozymes Biologicals case 2004

In this study, a company called “Novozymes” from the USA formed a contract with the NBA to utilise the “Bacillus and Pseudomonas microorganisms” in a commercial way as these enzymes were found in the local forests of Kerala. The NBA was guaranteed a 5% royalty on all the income generated from selling products made from these microorganisms. 

Role of the National Biodiversity Authority

  • Policy measures: The NBA is tasked with the duty of creating policies and guidelines for maintaining the proper implementation of access and benefit sharing models when it comes to natural and biological resources. They also adjudicate the implementation process from a central level. 
  • Granting access: The NBA has the right and power to grant accessibility to certain biological resources and traditional knowledge when requested by entities, both national and global, for research purposes to create innovations through bioprospecting and gaining commercial utilisation. 
  • Sharing of benefits: The NBA has the duty to ensure that any commercial benefits arising from the usage of any natural and biological resources must be shared equitably with the communities attached to those resources and associated knowledge so as to counter any form of bio-piracy.
  • Maintaining register: The NBA has the duty to maintain and make entries into the National Register for Access and Benefit Sharing to ensure smooth documentation of all ABS agreements and adherence to norms. 
  • International representation: The NBA is also responsible for representing India and its interests in conserving biodiversity at a global level on global platforms such as CBD and Nagoya Protocol. 

Role of State Biodiversity Authority

  • Policy implementation: The SBA is tasked with the duty of ensuring that all national policies related to the conservation of biodiversity are thoroughly implemented at a local level within their jurisdiction. They can also create state-level policies and strategies to advance national goals. 
  • Access granting: They have the power to grant access to biological resources within their own state and jurisdiction for purposes of bioprospecting and creating innovation for commercial uses through research. 
  • Documenting resources: SBAs are required to maintain a thorough and formal record of all the bio-resources and natural resources found within the limits of their jurisdiction for the purposes of promoting research on those resources and for their subsequent conservation. 
  • Local actions: They have the duty to coordinate with local bodies, communities and NGOs acting in the field of biodiversity conservation to ensure coordinated action and the incentivisation of stakeholders through recognition of their efforts. 
  • Awareness raising: They work with local communities to organise educational camps and workshops for promoting methods and techniques of biodiversity conservation and make the local community aware of their rights towards any benefits arising from access to the resources or traditional knowledge. 

Conclusion 

In conclusion, we can say that IPR and biodiversity are inextricably linked in this capitalist and globalised world. We must affirm that there needs to be a stricter regime or ensure that the ABS models are implemented meticulously and the International Legal Frameworks create stronger obligations for nations to have their domestic laws meet the minimum standard of protection for biodiversity. While human gains and wants are unlimited, natural and biological resources are scarcely limited and can go extinct through overexploitation; therefore, with proper reinforcements in place in terms of legal protection, the global community can successfully conserve biodiversity and achieve sustainable development goals. The National Biodiversity Authority and State Biodiversity Authority must be more active in supervising the implementation of the Access and Benefit Sharing and Prior Informed Consent measures and must ensure strict adherence to the same.

Frequently Asked Questions

How do patents contribute towards the conservation of biodiversity?

Patenting can have a positive impact on the protection of biodiversity as it leads to multiple research projects on biodiversity and innovations that consequently protect biodiversity.

How can traditional knowledge be protected?

Traditional knowledge can be protected through a sui generis system, which can be developed by nations on their own or through geographical indications. 

How can IPR impact access to genetic resources?

Strict IPR legislations can limit the access of researchers and institutions to the bioresources of a nation, thereby restricting innovation efforts. 

Can legislations be made to regulate biopiracy and bioprospecting?

Yes, through both domestic and international legislations, biopiracy can be curbed and bioprospecting can be regulated. 

References

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