Traditional Knowledge and Patent Issues in India: Biopiracy, TKDL, and Case Studies

Introduction

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Throughout history, a wide array of ideas and innovations spanning music, dance, science, and technology have been passed down from one generation to the next within diverse communities. Today, this collective knowledge represents the culmination of inventions and discoveries transferred across time, evolving into what we recognize as traditional knowledge. Embedded within communities across generations, these concepts and creations have developed deep cultural significance, fostering a sense of ownership within the community over this specific body of knowledge. A recent trend indicates that many of these traditional practices and ideas serve as the foundation for new inventions. While traditional knowledge emphasizes communal interests, patent law promotes private monopoly and profit. Nevertheless, in today’s commercial landscape, there is a growing acknowledgment of the convergence between traditional knowledge and patent laws.

India stands among the world’s twelve megadiverse nations, celebrated for its abundant and varied biological wealth. With a remarkable ten bio-geographic regions, India boasts a recorded tally of over 91,200 animal species and 45,500 plant species. Notably, it serves as a focal point for crop diversity, hosting numerous wild variants of cultivated crops and ranking among the primary centers of plant production globally. This wealth of biodiversity contributes significantly to India’s wealth of traditional knowledge, forming the bedrock of its cultural heritage. Indigenous and local communities, predominantly situated in the most biodiverse regions, draw upon this natural environment as an integral part of their cultural identity and way of life. These communities serve as custodians of traditional wisdom regarding conservation and sustainable resource utilization. However, this invaluable traditional knowledge, readily accessible and long cherished, remains susceptible to exploitation and misappropriation.

Traditional knowledge forms an integral component of the cultural identities of many indigenous peoples. Vital for achieving sustainable development, traditional knowledge encompasses intricate information structures. Equally important is the safeguarding of the social and physical environments intertwined with traditional knowledge. Any endeavors to exploit this expertise for industrial or commercial gains risk depriving rightful custodians of their heritage. Hence, it is imperative to devise strategies for preserving and safeguarding traditional knowledge, ensuring alignment with the interests inherent in sustainable development.

Meaning Of Traditional Knowledge

An African proverb states,
“when a wise elder passes away, an entire library vanishes with them”

This proverb underscores the profound value of traditional knowledge, which is deeply ingrained in communities worldwide. Traditional knowledge, rooted in the accumulated wisdom of generations, has long served as a cornerstone for sustainable development and livelihoods.

There is no agreed definition for “traditional knowledge”. The word Traditional Knowledge is itself a suggestive word. “Traditional” means hereditary or which is given by generation to generation. “Knowledge” means useful information.

In simple terms, traditional knowledge (TK) comprises insights honed over time within specific communities. These insights are tested and refined, reflecting a deep understanding of local environments and cultures. Unlike profit-driven motives, TK prioritizes risk reduction and adaptation to local conditions. It’s crucial to recognize that TK is communal, belonging to entire communities rather than individuals.

According to a report by the World Health Organization, approximately 80 percent of the global population relies on traditional knowledge, especially in ancient medical practices, for disease treatment.

Traditional knowledge (TK) is knowledge, know-how, skills and practices that are developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity.

While there is not yet an accepted definition of TK at the international level, it can be said that:

• TK in a general sense embraces the content of knowledge itself as well as traditional cultural expressions, including distinctive signs and symbols associated with TK.
• TK in the narrow sense refers to knowledge as such, in particular the knowledge resulting from intellectual activity in a traditional context, and includes know-how, practices, skills, and innovations.

Traditional knowledge can be found in a wide variety of contexts, including: agricultural, scientific, technical, ecological and medicinal knowledge as well as biodiversity-related knowledge.

Traditional knowledge refers to the long-standing tradition and the practices of certain indigenous or local communities. A fundamentally important aspect of traditional knowledge is that it is “traditional” only to the extent that its creation and use are the part of the cultural traditions of communities.

Characteristics Of Traditional Knowledge

Oral Transmission

Traditionally, much of TK has been passed down orally from one generation to another. Elders, healers, and community members impart knowledge through storytelling, rituals, ceremonies, and informal apprenticeships. This oral tradition fosters a deep sense of cultural identity and community cohesion.

Community-Based Knowledge

TK is rooted in specific communities and cultures, shaped by their values, beliefs, and experiences. It is often collective knowledge, shared and preserved within the community rather than belonging to individuals. This communal ownership reinforces social cohesion and mutual support networks.

Holistic Perspective

Traditional knowledge tends to view the world holistically, recognizing interconnectedness between humans, nature, and the spiritual realm. It encompasses diverse domains such as healthcare, agriculture, ecology, spirituality, and social organization. This holistic perspective emphasizes balance, harmony, and sustainability.

Adaptability and Flexibility

Traditional knowledge is adaptive and responsive to local contexts, environmental changes, and socio-cultural shifts. It evolves over time through experimentation, observation, and innovation, incorporating new insights while retaining core principles. This flexibility enables communities to address emerging challenges and maintain resilience.

Empirical Basis

Traditional knowledge is often based on empirical observations and practical experience accumulated over generations. It relies on trial and error, experimentation, and direct interaction with the environment. This empirical approach fosters a deep understanding of natural phenomena and effective problem-solving strategies.

Embedded in Cultural Practices

TK is closely intertwined with cultural practices, rituals, ceremonies, and indigenous languages. It reflects a community’s worldview, values, social norms, and spiritual beliefs. Cultural expressions such as folklore, music, dance, and art serve as vehicles for transmitting and preserving traditional knowledge.

Place-Based and Context-Specific

Traditional knowledge is deeply rooted in specific geographical locations and ecosystems. It is shaped by local environmental conditions, biodiversity, and socio-economic factors. This place-based knowledge is tailored to meet the needs of specific communities and is closely tied to the land, water, and natural resources.

Dynamic and Living Nature

Traditional knowledge is not static but dynamic, continuously evolving in response to changing circumstances and interactions with external influences. It accommodates new knowledge, technologies, and cultural exchanges while retaining its core principles and values. This dynamic nature ensures its relevance and resilience across generations.

Respect for Ancestral Wisdom

Traditional knowledge honours the wisdom of ancestors and past generations, recognizing their contributions to shaping cultural identity and survival strategies. It fosters intergenerational learning and transmission, preserving ancestral teachings for future generations.

Resilience and Sustainability

Traditional knowledge embodies principles of resilience, sustainability, and harmony with nature. It promotes practices that maintain ecological balance, conserve biodiversity, and ensure the well-being of present and future generations. By integrating traditional ecological knowledge with modern approaches, communities strive for sustainable development and environmental stewardship.

Why Traditional Knowledge Must Be Protected

The rationale for safeguarding traditional knowledge (TK) within intellectual property rights (IPR) frameworks is multifaceted and extends to both indigenous and non-indigenous communities. Indigenous peoples assert their rights to uphold and regulate their cultural heritage, seeking fair recognition and compensation for their contributions. Additionally, non-indigenous communities recognize the valuable contributions of TK to modern society, spanning various domains such as decision-making in food diversity, health, commerce, and economic growth. There are five key reasons underpinning the need for TK protection:

Equity and Fair Benefit-Sharing

TK often generates valuable insights and innovations that are not adequately acknowledged or compensated. For instance, traditional farmers play a crucial role in nurturing and enhancing plant genetic resources, yet seed companies may exploit these varieties without fair compensation. This disparity underscores the need for equity within the existing intellectual property rights system.

Biodiversity Conservation

Indigenous knowledge and traditions serve as repositories of cultural heritage and are intertwined with the conservation of biodiversity. Protecting TK can promote environmental conservation, sustainable agriculture, and food security by preserving the link between communities and their natural surroundings.

Preservation of Traditional Practices

Securing TK provides a foundation for preserving traditional lifestyle practices and knowledge, thereby safeguarding cultural identity and ensuring the continuity of indigenous and traditional communities. Effective TK protection extends beyond existing intellectual property rights frameworks, elevating the status of traditional knowledge and fostering its preservation.

Prevention of Biopiracy

Instances of biopiracy, where patents are granted for genetic resources and knowledge obtained from developing countries without proper consent or acknowledgment, highlight the urgent need to prevent misappropriation of TK. Measures such as TK documentation, proof of origin requirements for patenting, and prior informed consent mechanisms are crucial in curbing biopiracy and safeguarding indigenous knowledge.

Utilization and Importance in Development

Protecting TK from loss and misappropriation can incentivize local communities to share their knowledge and genetic resources. Fair compensation encourages information owners to facilitate access to TK, maintain its integrity, and ensure future utilization. However, it is essential to balance TK protection with promoting access to products and services vital for communities, particularly in the realm of traditional medicine.

Challenges in Protecting Traditional Knowledge

Challenges for the protection of Traditional Knowledge are as follows:

Traditional knowledge, in most cases, is passed down orally from one generation to the next. Without written material, it becomes difficult to trace the origin of the knowledge system. In India, the problem is complicated by the fact that traditional knowledge exists in many different languages and dialects. For example, in the absence of written evidence, the origin of Yoga is not known. While some texts suggest that the practice was present during pre-Vedic era, many have argued that Yoga was first mentioned in the Vedas. Without a credible source, it becomes difficult to protect traditional knowledge of a community, as other communities may claim rights to the same.

Most IPs, including patents and copyrights, are granted for a period of time, say 10 years or 20 years. In case of traditional knowledge, the period of protection is a bone of contention. How long can traditional knowledge systems be protected, especially since the knowledge systems are themselves evolving, is a question.

There are no specific laws to protect traditional knowledge systems. Some parts and sections of existing laws can be used to protect the rights of the communities.

Methods of Protecting Traditional Knowledge

In general sense, there are two methods through which traditional knowledge can be protected. They are as follows:

• Positive Method
• Defensive Method

Positive Protection

Positive protection of TK through IP rights involves two main aspects:

1. Preventing unauthorized utilization.
2. Actively promoting the exploitation of TK by the originating community itself.

Positive protection is the act of providing traditional knowledge holders with the rights to take necessary action and seek remedies against the misuse of the knowledge base. It involves the enactment of specific rules and regulations and laws, as well as access to benefit-sharing provisions, royalty payments, etc.

Defensive Protection

Defensive protection encompasses strategies aimed at preventing third parties from obtaining unjust or unwarranted IP rights over TK. These measures include modifications to WIPO-administered patent systems, such as the International Patent Classification system and the Patent Cooperation Treaty Minimum Documentation. Some countries and communities are also developing TK databases to serve as evidence of prior art, countering claims to patents on such TK. WIPO has devised a toolkit to offer practical guidance to TK holders in documenting their knowledge.

Traditional knowledge protection encompasses measures undertaken by traditional knowledge owners to safeguard their intellectual property rights. This method aids traditional knowledge holders in preventing the unauthorized acquisition of their intellectual property rights by third parties.

Defensive protection entails providing legal remedies to communities to deter the exploitation of their knowledge systems. This approach involves the development of strategies and legal mechanisms aimed at preventing third parties from exploiting community knowledge networks. A practical approach to defensive protection involves compiling lists or ready reckoners of existing traditional knowledge systems accessible to patenting authorities. These resources serve as reference materials for patenting authorities during the patent granting process, helping to prevent illegitimate patent acquisitions.

Whether Exploitation of Traditional Knowledge Amounts to a Legal Violation

International Perspective

Traditional knowledge does not have a criterion which allow it to get protection in the international Arena. Every country has certain restriction. Eg India, under Article 253 of the Constitution of India, whenever there is an international Treaty and if India is a party to the international Treaty, it has to accept the Treaty and under article 253 of the Constitution of India which authorizes the Parliament to bring a legislation in that behalf and thereby allow the protective mechanism in support of whatever agreement it has done through International Treaty and convention. Hence, every country thinks that it is our mandate not to allow somebody to raise objection unless such country makes some sort of agreement with it so this is what the reciprocal will help us to protect the traditional knowledge, hence we find it very difficult to protect traditional knowledge in the international perspective.

Technically we do not have any protection mechanism for the protection of the interest of the indigenous committee having traditional knowledge in the international arena. Hence in technical sense, the exploitation of the traditional knowledge is not a legal violation at the international level.

However, India has played a pivotal role in the decade old efforts of developing countries on the global platform for bringing the protection of traditional knowledge at the centre stage of the International Intellectual Property System. These efforts have resulted inter alia in setting up of an Inter-Governmental Committee (IGC) on Intellectual Property, Traditional Knowledge, Genetic Resources and Folklore by WIPO and the Doha Ministerial Declaration of the year 2001 wherein it was decided to establish a relationship between the TRIPS Agreement and the UN Convention on Biological Diversity (CBD) on the issue of Access to Genetic Resources and the fair and equitable sharing of the benefits arising from their utilization. Further, India has been able to conclude TKDL Access (Non-Disclosure) Agreements with several international patent offices including USPTO, EPO, JPO etc. Consequently, many patent applications concerning India’s traditional knowledge have either been cancelled or withdrawn or claims have been amended in several international patent offices. Negotiations are also under way for establishing an international legally binding instrument on protection of TK.

Convention on Biodiversity

Article 8(j):
Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.

Article 15:
Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.

Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention.

Each Contracting Party shall endeavour to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and where possible in, such Contracting Parties.

Each Contracting Party shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms.

Article 16:
(1) Each Contracting Party, recognizing that technology includes biotechnology, and that both access to and transfer of technology among Contracting Parties are essential elements for the attainment of the objectives of this Convention, undertakes subject to the provisions of this Article to provide and/or facilitate access for and transfer to other Contracting Parties of technologies that are relevant to the conservation and sustainable use of biological diversity or make use of genetic resources and do not cause significant damage to the environment.⁸

WHO

The World Health Organization (WHO) was established on April 7th, 1948, as a specialized agency of the United Nations focusing on health. WHO’s involvement with Traditional Knowledge primarily pertains to its work in traditional medicine. The WHO’s constitution outlines its objective to attain the highest standard of health for all individuals. The economic and commercial value of traditional knowledge, particularly in traditional medicine and medicinal plants, has gained increasing recognition. Consequently, more WHO member states are expressing concern about the necessity to safeguard this knowledge and ensure equitable distribution of benefits derived from its utilization.

The WHO Traditional Medicine Strategy for the years 2002 to 2005 comprises four main components:

• Policy: Integration of traditional and corresponding or alternative medicines into national health systems.
• Safety, Competence, and Excellence: Providing assessment, oversight, and support for effective regulation.
• Access: Ensuring the availability and affordability of Traditional Medicine (TM) and Complementary and Alternative Medicine (CAM), including essential herbal remedies.
• Rational Use: Encouraging the therapeutically-sound application of TM/CAM by both providers and consumers.

WIPO

WIPO initiated its work on Traditional Knowledge (TK) and folklore in 1978, when it collaborated with UNESCO to develop the Sui generis model for national folklore protection. In 1998, WIPO embarked on a new initiative, conducting a fact-finding mission to 28 countries on the intersection of intellectual property (IP) and TK. This mission contributed to a global study on the requirements of IP and the objectives of TK holders. At its 26th meeting, the WIPO General Assembly established the IGC. Additionally, WIPO has made commendable efforts in producing a diverse range of documents, including model clauses for contracts on genetic resources, the Conventional Information Security documentation toolkit, and initiatives towards establishing a sui generis framework for the protection of traditional knowledge.

Nagoya Protocol

In 2001, at the Doha conference, that it was agreed under para 19 of the Doha Declaration that pursuant on Article 71.1 of TRIPs, the TRIPs council should examine the relationship between TRIPS and CBD. After several years of debates various fora, the parties to the CBD meet at Nagoya, Japan in 2010 and finalized the draft protocol which defines the terms for access to Genetic Resources (GR), their utilization and fair and equitable sharing of benefits from such utilization. In fact, the Nagoya Protocol broadens the CBD provisions relating to access and benefit-sharing.

Indian Perspective

In India we do not have any statute which provides for the protection of the traditional knowledge. hence it can be said that we do not have any substantive law for the protection of the traditional knowledge. However, India being the hotspot of the traditional knowledge should need laws for the protection of the traditional knowledge. Hence, India being such rich in traditional knowledge has found out certain indirect ways for the protection of the traditional knowledge as it exist in the international Arena by way of Patent Act. the protective measures present in India exist in the form of defensive method and not as a positive method. Hence it can be said that there is that there is no direct or main provision in any statute however there are certain indirect ways that are provided by the existing statutes.

Under the Indian Patent Act of 1970,

Section 2 (1) (j):
Traditional knowledge, by its very definition, is in the public domain and hence, any application for patent relating to TK does not qualify as an invention under section 2 (1) (j) of the Patents Act, 1970, which defines that “invention means a new product or process involving an inventive step and capable of industrial application”.

Section 3(e):
Further, under section 3(e) of the Patents Act “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or process for producing such substances” is not an invention and hence, not patentable.

Section 3 (p):
The Indian Patents Act also has a unique provision under Section 3 (p), wherein “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” is not an invention and hence, not patentable, within the meaning of the Patents Act.

Sections 3 (b), (c), (d), (f), (h), (i) and (j):
Additionally, sections 3 (b), (c), (d), (f), (h), (i) and (j) are of relevance with respect to the patent applications related to TK and/or biological material.

Section 10(4)(ii)(D):
Provisions within the Patent Act of 1970 mandate the disclosure of traditional knowledge (TK) as the origin of the invention under consideration. Section 10(4)(ii)(D) of the Act specifically stipulates the requirement for disclosure in the specification of the source and geographical origin of all biological material utilized in the invention.

Sections 25 (1) and 25 (2):
Applications for patents based on TK and/or biological material contravening the provisions of law can be refused under section 15 or in pre-grant opposition under clauses (d), (f) and (k) of Section 25 (1) and granted patents can be revoked in post-grant opposition under clauses (d), (f) and (k) of Section 25 (2) of the Patents Act, 1970. Nondisclosure or wrong mention of the source or geographical origin of biological material used for an invention in the complete specification also forms a ground for pre- and post- grant opposition under clause (j) of Sections 25 (1) and 25 (2) respectively of the Patents Act, 1970.

Different aspects of traditional knowledge (TK) can be safeguarded through the patent system. Novel and innovative technical advancements found in prior art worldwide can be protected through patent applications. For example, trademarks featuring contemporary subject matter may fall within the scope of patent protection. Patents have the capacity to safeguard processes involved in the preparation of products derived from biological resources like microorganisms, plants, and animals.

However, under the patent system, codified traditional medicine (TM) may not meet the novelty requirements necessary for patent coverage. Despite this, utilization of codified knowledge regarding TM as prior art can prevent others from obtaining patents in this domain.¹⁰

The Patents (Amendment) Act of 2005

The Patents (Amendment) Act of 2005, aimed at safeguarding the rights of indigenous communities, imposes an obligation on patent applicants to disclose the origin of the biological resources utilized in their inventions. If this information pertains to traditional knowledge (TK), the patent office retains the discretion to deny patent grant.

Furthermore, according to the 2005 Amendment, the following circumstances may lead to the refusal of a patent application or the revocation of an existing patent:

• The patent may be revoked if it is revealed that it was secured by providing false or misleading information regarding the geographical origin of the biological resources involved in the patent.
• If the patent represents merely a collection of properties inherent in traditional knowledge, it would not meet the criteria for patentability.
• If the patent, based on the existing knowledge within indigenous communities, is deemed anticipated, it may be subject to refusal or revocation.

Case Studies

1. The Neem Patent Dispute

Background of the Neem Patent Case

Initially filed by W.R. Grace and the Department of Agriculture, USA, the patent for Neem in the European Patent Office claimed a method for controlling fungi on plants using a Neem oil formulation. India, represented by the Research Foundation for Science, Technology and Ecology (RFSTE), together with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former MEP, opposed the patent.

The Neem tree, deeply rooted in Indian tradition, harbors numerous potent compounds, notably azadirachtin found in its seeds. It has been utilized for various medicinal and agricultural purposes for centuries. Opponents presented evidence of its traditional uses from ancient Indian texts to challenge the patent’s novelty. Eventually, the European Patent Office revoked the patent, recognizing the lack of novelty and inventive step.

Grace Patent under US Laws

Under US patent laws, the Grace patent met criteria, as it involved the modification of a naturally occurring compound, satisfying sections 101, 102, and 103 of the US Code. Despite being known to Indian farmers, foreign knowledge couldn’t invalidate the patent’s novelty claim unless published before the US application.

Analysis of the Decision

Activists, including Dr. Shiva and international organizations, vehemently opposed the patent, leading to its revocation in 2000 by the European Patent Office. However, an appeal ensued, during which evidence of prior knowledge and research on Neem was presented, eventually leading to the dismissal of the appeal in 2005.

Post-Dispute

The controversy prompted India to safeguard its traditional knowledge through initiatives like the TKDL, aiding patent examiners in identifying prior art and preventing unjust patents.

Conclusion

The Neem patent controversy highlighted distrust towards multinational corporations in India and underscored the skewed distribution of economic benefits from traditional knowledge. Developing countries perceive intellectual property regimes as favoring developed nations, fueling resistance. Addressing philosophical differences over patenting life and sharing benefits from biodiversity is crucial to fostering equitable partnerships and resolving future disputes.

2. The Turmeric Patent Controversy

Background of the Case

In the mid-1990s, a significant patent dispute emerged surrounding a particular plant. In 1995, the University of Mississippi Medical Center was granted a US patent (number 5,401,504) for the wound healing properties of turmeric. This patent specifically focused on the utilization of turmeric powder for both oral and topical applications in wound healing. Dr. Suman K Das and Harihar Kohli, Indian American scientists at the University of Mississippi, were named as inventors on the patent, which included six claims covering the use of turmeric powder for healing surgical wounds and ulcers. The patent application was filed on December 28, 1993, with the University of Mississippi Medical Center listed as the assignee.

Issue

In October 1996, the Indian Council for Scientific and Industrial Research (CSIR) filed a re-examination claim with the USPTO, seeking to invalidate patent application no. 5401540. CSIR argued that the patent lacked novelty as turmeric powder’s healing properties were well-established in traditional Indian knowledge and practice.

CSIR’s legal challenge presented evidence of turmeric powder’s historical use in India for wound healing, among other applications, asserting it as prior art. Despite the widespread recognition of turmeric’s medicinal benefits, sourcing published evidence supporting its specific use in wound healing proved challenging. Nevertheless, after extensive research, 32 references were found in various languages, along with a 1953 paper by the Indian Medical Association.

The inventors countered by highlighting distinctions between turmeric powder and paste forms in terms of bioavailability and absorbability. They also argued that the powder’s efficacy, especially when consumed with honey, was not obvious to those skilled in the art.

Ultimately, the USPTO revoked the patent in 1997, deeming its claims obvious and anticipated, and recognizing turmeric’s long-standing use in healing wounds. All six claims were rejected, rendering the patent invalid.

Analysis of Decision

The Indian government successfully pressured the USPTO to revoke a patent granted to two researchers in the United States for the use of turmeric powder in wound healing. After a year-long legal battle with CSIR, the patent was withdrawn by the USPTO on August 13th. CSIR argued that turmeric, being a native Indian plant used for centuries for wound healing, lacked novelty, a key criterion for patenting.

Hiring a US patent lawyer and spending considerable resources, CSIR supported its case with scientific publications, home remedy books, and ancient Ayurvedic texts. This marked the first instance of a developing country overturning a US patent on its traditional remedy.

The patent was invalidated on grounds of prior art, with the USPTO confirming that both powdered and paste forms of turmeric served the same purpose. Claims were rejected again in 1997, and in 1998, a re-examination certificate signaled the conclusion of the case.

This victory safeguarded India’s traditional knowledge regarding turmeric, setting a precedent in the fight against biopiracy.

3. The Basmati Rice Patent Battle

Background of the Case

In the late 1997, the United States Patent and Trademark Office awarded a patent to Ricetec Inc., a multinational company based in the United States with its headquarters in Alvin, Texas, for a new type of grain commonly referred to as ‘basmati’. This company sought protection for improved varieties of basmati crops, claiming they possessed superior qualities compared to the original crop. Ricetec marketed these varieties under names such as ‘Jasmati’ or ‘Kasmati’ in the global rice market. Additionally, they purportedly created a novel strain of aromatic rice through crossbreeding basmati with another crop known as American basmati or ‘Texmati’. The USPTO granted the patent for these basmati rice grains and varieties.

However, opposition to the patent arose from Indian NGOs like the Research Foundation for Science, the Centre for Food Safety, and eventually the Centre for Scientific and Industrial Research. These groups aimed to protect India’s traditional basmati crop. Simultaneously, Thailand contested to safeguard its claim for jasmine rice. In 2000, after reviewing evidence, the Indian Government challenged Ricetec’s patent claims.

Issues Raised

The controversy surrounding this situation brought forth several issues, primarily revolving around emerging patents, bio-piracy concerns, and geographical indication laws. The key questions raised included:

• Whether the term ‘basmati’ is a generic term or specifically denotes the aromatic rice cultivated in India and various South Asian nations.
• Whether the grain developed by Ricetec Inc. constitutes a genuinely novel variety and strain.
• Whether Ricetec Inc. is culpable of bio-piracy and infringing upon the traditional knowledge of indigenous communities in South Asian countries.
• Whether the patent granted to Ricetec should be revoked in response to protests from numerous NGOs and indigenous communities.
• Whether the decision by the USPTO to grant a patent to Basmati Rice violates the TRIPs Agreement.

Analysis of Decision

Initially, Ricetec secured a patent for cultivating rice crops, developing identical characteristics in these crops, and identifying rice based on Starch Index testing. The company argued that its patent covered an enhanced form of basmati, surpassing its previous varieties. Regarding the use of the geographical indication ‘Basmati’, it contended that the term wasn’t inherently linked to the Indian subcontinent and had become generic through usage in phrases like American Basmati and Thai Basmati. Ricetec claimed that ‘Basmati’ didn’t denote a specific geographical area and fell under the public domain.

India countered by highlighting that over 75 percent of U.S. rice imports come from countries like Thailand, Pakistan, and India, which couldn’t be cultivated in the U.S. It argued that the patent lacked novelty and was obvious, rendering it invalid. After a three-year legal battle, India gathered sufficient data and evidence to challenge the patent’s validity. Ultimately, the USPTO granted the patent for three hybrid basmati strains out of approximately 20 claims. The remaining three strains received protection due to noticeable differences from the original crop strain.

Regarding the use of the geographical indication and trademark ‘Basmati’ by Ricetec, the USPTO stated that since it didn’t denote a specific region like Champagne or Porto, it could be utilized as a trademark and geographical indication in India. As the crop was grown across South Asia rather than just India, it wasn’t considered a geographical indicator. Following protests from India and Pakistan, the USPTO eventually disallowed the patent holder from using the name ‘basmati’.

4. The Ayahuasca Bio-Patent Case

Background of Case

In March 1999, CIEL initiated a legal challenge against a US patent pertaining to the “ayahuasca” vine, scientifically known as Banisteriopsis caapi, which is indigenous to the Amazon rainforest. Acting on behalf of the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Coalition for Amazonian Peoples and Their Environment (Amazon Alliance), CIEL submitted a request for reexamination of the patent to the US Patent and Trademark Office (PTO). COICA objected to the patent on the grounds that it sought to claim ownership of a plant sacred to many indigenous peoples of the Amazon, traditionally utilized by them in religious and healing rituals.

Analysis of the Decision

In November 1999, the PTO issued a decision denying the patent. The PTO agreed with the petitioners’ arguments that the claimed plant variety lacked distinctiveness or novelty. However, it did not acknowledge the argument advocating for an exception from patenting based on the plant’s religious significance.

The PTO finalized its decision in an office action dated April 14, 2000. At this stage, CIEL, COICA, and Amazon Alliance were legally barred from further participation in the reexamination process. The PTO strictly enforced this restriction. Simultaneously, the law allowed the patent holder, Loren Miller, to either appeal the decision to the Board of Patent Appeals and Interferences or attempt to amend the patent.

Despite this restriction, the PTO examiners repeatedly allowed Miller to present new “evidence” and arguments in attempts to sway their decision. Without considering opposing viewpoints, the PTO reversed its rejection in January 2001, concluding the reexamination process. It then issued a certificate in April, allowing the patent to remain valid for the remaining two years of its term. An examination of the PTO’s reversal indicates legal inaccuracies and raises concerns about the irregular manner in which the PTO disregarded its own procedures.

Under the law, a patent filed before 1995 expires 17 years from its original issuance date in 1986. The “ayahuasca patent” expired on June 17, 2003, and cannot be renewed.

Traditional Knowledge Digital Library (TKDL)

These cases were an eye opener and they triggered the Government of India to create traditional knowledge digital library and also to include traditional knowledge in the international permanent clarification system. TKDL is an initiative by the India to digitise and document knowledge available in the public domain to facilitate systematic arrangements, and retrieval of information. while granting patents, authorities check invention to prior art in public domain. documentation of knowledge will help them trace invention in public domain and health them to know whether it is eligible for patents, thus preventing miss appropriation of traditional knowledge¹⁵. Some detailed information on

Introduction

Traditional knowledge represents a vast repository of wisdom, susceptible to exploitation due to its immense potential. Particularly in the realm of disease treatment, traditional knowledge has often served as a catalyst for the development of biologically active compounds. However, the bio-piracy of codified Indian traditional knowledge persists, largely due to language barriers hindering patent offices’ ability to search this information as prior art before granting patents. Formulations derived from traditional knowledge for treating human ailments are deeply rooted in centuries-old practices, making them reliable. However, the absence of this information within patent offices provides opportunistic interlopers with an easy path to securing patents on therapeutic formulations derived from traditional medicine systems.

Misappropriation of Traditional Knowledge

The grant of patents on non-patentable knowledge, particularly related to traditional medicines, has raised significant concerns in the developing world. Instances of bio-piracy, as illustrated in Annex 1, have led countries to pursue the revocation of granted patents, a costly and time-consuming endeavor. However, revocation may not always be a viable option for all patents derived from traditional knowledge.

Protecting Codified Traditional Knowledge

In international patent offices, patent examiners rely on available resources to assess the patentability of claimed subject matter. While patent literature is readily accessible through distinct databases, non-patent literature sources, including traditional knowledge, are often challenging to locate. Hence, there’s a pressing need to establish easily accessible non-patent literature databases on traditional knowledge, particularly from India.

Traditional Knowledge Digital Library – A Tool for Prevention of Misappropriation

The Traditional Knowledge Digital Library (TKDL) houses information from Indian Systems of Medicine, including Ayurveda, Unani, Siddha, Sowa Rigpa, and Yoga, available in the public domain. TKDL converts traditional knowledge from local languages like Sanskrit, Urdu, Arabic, Persian, and Tamil into digitized format, accessible in five international languages. To facilitate systematic arrangement and retrieval, TKDL employs the Traditional Knowledge Resource Classification (TKRC), an innovative structured classification system tailored to medicinal plants. With approximately 4.24 lakh formulations/practices transcribed from ISM and Yoga texts, TKDL bridges the gap between formulations in local languages and global patent examiners.

Utilizing TKDL’s search interface, patent examiners can access traditional knowledge information in multiple languages and formats, enabling comprehensive searches based on International Patent Classification (IPC) codes and keywords. Through this interface, TKDL serves as a crucial link between traditional knowledge and patent examiners, aiding in the prevention of misappropriation by addressing the gap in access to prior art traditional knowledge.

Other Provisions for the Protection of Traditional Knowledge

Conclusion

In summary, the intersection of traditional knowledge and patent issues presents a complex and delicate balance between promoting innovation and preserving cultural heritage. Traditional knowledge, often held by indigenous communities, embodies centuries of wisdom and practices that contribute to various fields like medicine, agriculture, and biodiversity conservation. However, the commercialization of this knowledge through patents raises ethical, legal, and socio-economic concerns.

While patents incentivize innovation by granting exclusive rights to inventors, they can also lead to the misappropriation and exploitation of traditional knowledge. This exploitation can marginalize indigenous communities, depriving them of recognition, benefits, and control over their cultural heritage. Additionally, the criteria for patentability may not align with the communal and dynamic nature of traditional knowledge, leading to conflicts over intellectual property rights.

Efforts to address these challenges require a multi-faceted approach that respects the rights and interests of indigenous peoples while fostering innovation. Collaborative frameworks involving indigenous communities, governments, academia, and industry are essential for developing fair and equitable mechanisms for the protection and utilization of traditional knowledge. This may include establishing protocols for obtaining free, prior, and informed consent, ensuring benefit-sharing arrangements, and implementing safeguards against biopiracy and exploitation.

Ultimately, striking a balance between promoting innovation and protecting traditional knowledge requires a nuanced understanding of cultural values, legal frameworks, and ethical considerations. By fostering dialogue, respecting indigenous rights, and promoting responsible innovation, societies can navigate the complexities of traditional knowledge and patent issues to foster sustainable development and cultural diversity.

Suggestions

Improving the protection of traditional knowledge amidst patent issues requires a comprehensive approach that addresses legal, ethical, and practical considerations. Here are some suggestions for enhancement:

Legal Frameworks: Develop or strengthen legal frameworks at both national and international levels to recognize and protect traditional knowledge. This could involve creating specialized intellectual property laws or amending existing ones to incorporate provisions specific to traditional knowledge.

Informed Consent Mechanisms: Implement robust mechanisms to ensure free, prior, and informed consent (FPIC) from indigenous communities before engaging in research, development, or commercialization activities involving their traditional knowledge. This ensures that communities have agency over their cultural heritage.

Benefit-Sharing Arrangements: Establish transparent and equitable benefit-sharing mechanisms that guarantee fair compensation for indigenous communities when their traditional knowledge is used commercially. This could include royalties, revenue-sharing agreements, or other forms of compensation.

Documentation and Registration: Facilitate the documentation and registration of traditional knowledge to establish ownership rights and prevent misappropriation. This could involve establishing databases, registries, or certification systems managed in collaboration with indigenous communities.

Capacity Building: Invest in capacity-building initiatives to empower indigenous communities to assert their rights, engage in negotiations, and participate in decision-making processes related to traditional knowledge protection and management.

Public Awareness and Education: Raise public awareness about the importance of traditional knowledge, indigenous rights, and the ethical implications of patenting traditional knowledge. Education programs can promote cultural sensitivity and foster respect for diverse knowledge systems.

International Cooperation: Foster international cooperation and collaboration among governments, indigenous organizations, academia, and industry to develop harmonized approaches for protecting traditional knowledge and addressing patent issues across borders.

Ethical Guidelines: Develop ethical guidelines or codes of conduct for researchers, companies, and other stakeholders involved in the utilization of traditional knowledge. These guidelines should emphasize respect for indigenous rights, cultural integrity, and sustainable practices.

Enforcement Mechanisms: Strengthen enforcement mechanisms to prevent biopiracy, unauthorized exploitation, and infringement of traditional knowledge rights. This may involve enhanced monitoring, legal remedies, and penalties for violations.

Participatory Approaches: Embrace participatory approaches that involve meaningful engagement and collaboration with indigenous communities throughout the process of developing and implementing protection measures. This ensures that solutions are contextually appropriate and reflective of community needs and aspirations.

By implementing these suggestions, stakeholders can work towards a more inclusive, equitable, and sustainable approach to protecting traditional knowledge while addressing patent issues.

Also Read: Aventose Energy v. Patent Controller: Madras HC Sets Aside Rejection

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