Issues – Biopiracy, IPR issues, Ethical Dimensions – UPSC Science & Technology Notes

Biopiracy refers to the illegal or unauthorized acquisition of biological resources and traditional knowledge of indigenous communities by individuals or organizations, often for commercial purposes. It is a serious issue in India, where the country’s rich biodiversity and traditional knowledge systems are at risk of being exploited without adequate compensation or recognition of the rights of local communities. 

• Origin of the Term: Coined in the early 1990s by Pat Mooney of the ETC Group, biopiracy highlights the appropriation of genetic resources and traditional knowledge through intellectual property mechanisms. 
• Scope Beyond Drug Development: Biopiracy extends beyond pharmaceuticals to encompass agriculture and industry. Examples include the patenting of Indian products like neem, tamarind, turmeric, and Darjeeling tea by foreign entities. 
• Bioprospecting as an Alternative Term: Bioprospecting, a less contentious term, refers to the legal and respectful search for biological resources. However, positive examples of bioprospecting remain scarce. 
• Ethical Considerations: Ideally, bioprospecting involves prior informed consent, access and benefit sharing agreements, and material transfer agreements to ensure fair compensation and support local conservation efforts. 
• Historical Context: Scientific Colonialism: Biopiracy has historical ties to colonialism, where Western trading companies exploited local resources like sugar, pepper, quinine, and coffee from colonized regions for profit. 
• Ownership and Intellectual Property: The concept of ownership is contentious, particularly regarding patents and trademarks, which often prioritize individual rights over community interests, leading to conflicts with traditional farmers and indigenous groups. 
• International Legal Frameworks: The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1994 mandates WTO member countries to develop legal frameworks for protecting plant and animal resources, but some nations find this counterproductive. 
• Policy Changes: Since the early 2000s, many countries have revised their laws to safeguard their biological resources in alignment with the 1992 Convention on Biological Diversity, aiming to address the challenges posed by biopiracy and ensure equitable treatment of genetic resources and traditional knowledge. 

Case Studies: 

1. Basmati Rice: 

• In the late 1990s, a US company secured a patent on a strain of Basmati rice, falsely claiming it as their invention. 
• This incident led to the appropriation of the traditional knowledge of Indian farmers who had cultivated the strain over generations. 
• Ultimately, the patent was revoked, prompting the establishment of a legal framework in India to safeguard traditional knowledge. 

2. Turmeric: 

• In 1995, a US patent was granted to a researcher for the utilization of turmeric in wound healing, deeming it a novel invention. 
• However, turmeric has been an integral part of traditional Indian medicine for centuries. 
• Following a legal challenge, the patent was revoked, highlighting concerns about exploiting traditional knowledge without compensation. 

3. Neem: 

• During the 1990s, a European company acquired a patent for a fungicidal product derived from neem trees. 
• Despite neem being utilized for medicinal and agricultural purposes in India for centuries, the patent was granted. 
• Subsequently, the patent was revoked, but this incident spurred the introduction of a legal framework in India to safeguard traditional knowledge. 

4. Hoodia: 

• In 2005, a US-based company obtained a patent for the use of Hoodia, a plant found in South Africa, as an appetite suppressant. 
• However, Hoodia had been traditionally utilized by the San people of South Africa for medicinal and cultural practices. 
• This case underscored the global nature of biopiracy and its adverse effects on indigenous communities. 

Legal Framework: 

1. Biological Diversity Act, 2002: 

• The Biological Diversity Act, 2002, is designed to preserve India’s biological diversity and ensure fair sharing of benefits arising from the utilization of biological resources. 
• It mandates access and benefit-sharing agreements, necessitating individuals or organizations to seek consent from local communities before accessing biological resources or traditional knowledge. 
• The act establishes the National Biodiversity Authority, tasked with regulating access to biological resources and ensuring equitable benefit-sharing. 

2. Protection of Plant Varieties and Farmers’ Rights Act, 2001: 

• This act acknowledges the pivotal role of farmers and local communities in conserving and enhancing plant genetic resources. 
• It facilitates the registration of plant varieties and grants farmers’ rights over their traditional knowledge and resources. 
• Provisions are included for compensating farmers and local communities for the utilization of their resources. 

3. Traditional Knowledge Digital Library: 

• The Traditional Knowledge Digital Library serves as a repository of traditional knowledge and resources. 
• It is designed to prevent the misappropriation of traditional knowledge by patent offices worldwide and encompasses information on traditional knowledge associated with medicinal plants, yoga, Ayurveda, and more. 

4. National Biodiversity Authority’s Guidelines for Access and Benefit Sharing: 

• The National Biodiversity Authority has formulated guidelines for access and benefit-sharing agreements. 
• These guidelines establish a framework for safeguarding traditional knowledge and ensuring equitable benefit distribution. 
• They outline procedures for identifying local communities and their traditional knowledge, negotiating benefit-sharing agreements, and overseeing enforcement measures. 

Impact of Biopiracy: 

• Cultural Heritage Erosion 
  • Indigenous communities hold invaluable traditional knowledge about their environment, including plants, animals, and ecosystems. 
  • Biopiracy disrupts the transmission of this knowledge, leading to the erosion of cultural heritage and identity. 
  • Disconnecting generations from ancestral practices accelerates the loss of cultural identity. 

• Economic Exploitation 
  • Biopiracy entails the extraction and commercialization of resources from indigenous territories without fair compensation. 
  • Corporations and individuals profit from nature’s treasures while indigenous communities, the guardians of these resources, face impoverishment. 
  • Economic disparities perpetuate cycles of poverty and marginalization within affected communities. 

• Environmental Degradation 
  • Unregulated exploitation of biological resources poses severe environmental risks. 
  • Overharvesting of medicinal plants and other resources can deplete ecosystems and threaten biodiversity. 
  • Bioprospecting practices lacking sustainability measures disrupt natural balances and cause irreversible harm to the environment and its inhabitants. 

• Healthcare Inequity 
  • Indigenous communities possess deep knowledge of medicinal plants and their healing properties. 
  • Biopiracy often leads to the monopolization of these resources, making healthcare solutions derived from traditional knowledge inaccessible and unaffordable. 
  • This exacerbates the healthcare gap between different socio-economic groups, leaving marginalized communities without essential healthcare resources. 

Way Forward: 

• Enhancing Intellectual Property Rights 
  • Governments can introduce legislation to bolster the protection of intellectual property rights for indigenous communities and traditional knowledge holders. 
  • These legal frameworks should ensure equitable benefit-sharing mechanisms for the commercial utilization of genetic resources. 

• Prior Informed Consent and Benefit Sharing 
  • Implementing prior informed consent (PIC) and mutually agreed terms for benefit-sharing (MAT) are vital strategies in combatting biopiracy. 
  • Involving indigenous communities in decision-making processes and ensuring fair compensation for their contributions can mitigate the exploitation of their resources. 

• Ethical Research and Collaboration 
  • Researchers and corporations should uphold ethical standards when interacting with indigenous communities. 
  • This includes obtaining informed consent, respecting cultural protocols, and fairly distributing benefits from research or the commercialization of traditional knowledge. 

• Awareness and Advocacy 
  • Raising awareness about biopiracy among the public, policymakers, and international entities is essential. 
  • Advocacy campaigns can highlight the injustices faced by indigenous communities and mobilize support for robust legal frameworks and ethical conduct in bioprospecting activities. 

Intellectual Property Rights (IPR) 

Intellectual property rights (IPR) constitute legal protections granted to inventors or creators to safeguard their intellectual creations across various domains such as arts, sciences, literature, and technology. These legal privileges afford the inventor, creator, or their assignee exclusive rights to utilize and exploit their creation for a defined duration.  

The Universal Declaration of Human Rights, particularly Article 27, underscores the entitlement to seek protection for one’s material and moral interests arising from the authorship of scientific, literary, or artistic works. 

The World Intellectual Property Organization (WIPO) serves as the principal body overseeing the global preservation of IPRs. It administers key international treaties that recognize the significance of intellectual property, including the Paris Convention for the Protection of Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886). 

Objectives of Intellectual Property Rights: 

The term “intellectual property” encompasses any original creation of the human intellect, spanning arts, sciences, literature, technology, and other domains. Intellectual property rights are established with the following objectives in mind: 

1. Facilitating individuals to derive financial benefits or attain recognition from their innovations and creations. 
2. Fostering an environment conducive to creativity and innovation by striking a harmonious balance between the interests of innovators and the broader public interest. 
3. Safeguarding traditional knowledge and cultural heritage from exploitation and misappropriation. 

Types of Intellectual Property Rights 

Intellectual property rights encompass two primary categories: copyright and industrial property rights. Industrial property rights include trademarks, geographical indications, industrial designs, and trade secrets. 

Patents in Intellectual Property Rights 

A patent is granted when an invention meets the criteria of novelty, non-obviousness, and industrial or commercial applicability. Both products and processes are eligible for patent protection. Patents confer the owner with the authority to control the use of an invention by others. In return, patent holders must disclose technical details about the invention in the patent document for public access. 

Copyrights 

Copyright refers to the ownership rights of authors and artists over their creative works. Protected works range from computer programs, databases, and advertisements to maps, technical drawings, books, music, paintings, sculptures, and films. Copyright protection extends for at least 50 years after the owner’s death. Performers, phonogram producers, and broadcasting organizations also enjoy copyright and related rights protection. 

Trademarks 

A trademark is a symbol used to distinguish the products or services of one company from those of another. Trademarks date back to early artisanal practices where creators would mark their creations. 

Industrial Designs 

Industrial design pertains to the decorative or aesthetic aspect of an object, encompassing both two-dimensional elements like patterns, lines, and colors, and three-dimensional elements like shape and surface. 

Geographical Indications 

Geographical indications and appellations of origin are labels affixed to products with specific geographical origins, possessing qualities or characteristics linked to that location. 

The geographical location where the goods are produced is typically included in a geographical indication. 

Trade Secrets 

Trade secrets entail intellectual property rights over confidential information (e.g., the formula for Pepsi) that can be licensed or sold. Obtaining, using, or disclosing such confidential information without authorization is deemed an unfair practice and a violation of trade secret protection. 

International Bodies/Conventions on Intellectual Property Rights 

World Intellectual Property Organisation (WIPO) 

WIPO is responsible for promoting the global protection of intellectual property rights and overseeing the following treaties and conventions: 

• Paris Convention for the Protection of Industrial Property (1883): This convention encompasses all aspects of industrial property, including patents, trademarks, industrial designs, utility models, and more. It was the first major initiative to ensure creators’ intellectual property rights were protected internationally, establishing principles such as national treatment. Berne  
• Convention for the Protection of Literary and Artistic Works (1886): This convention governs international copyright law, covering authors’ rights and works’ protection. Budapest Treaty: This treaty concerns the international recognition of the deposit of microorganisms for patent procedures.  
• Marrakesh Treaty: Overseen by WIPO, this treaty facilitates the creation and transfer of adapted books for the visually impaired, providing exceptions and limitations to traditional copyright laws. 
• Patent Cooperation Treaty (1970): This treaty offers a standardized process for filing patent applications to protect inventions across its signatory states, streamlining international patent protection procedures and reducing associated costs. 

TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), 1994 

The TRIPS Agreement, a crucial WTO agreement, covers various intellectual property domains, including copyright, trademarks, geographical indications, patents, and more. Key features of the agreement include: 

• Standards: TRIPS establishes minimum standards of protection for intellectual property rights, defining subject matter, rights granted, permissible variations, and minimum duration of protection.  
• Enforcement: It addresses domestic enforcement of intellectual property rights, outlining procedures and remedies for enforcement, including criminal procedures, border measures, interim measures, and civil and administrative procedures.  
• Dispute Settlement: TRIPS resolves disputes among WTO members regarding compliance with TRIPS obligations through the WTO’s dispute resolution processes, emphasizing concepts like national treatment and most-favored-nation treatment. 

Intellectual Property Rights in India 

India has demonstrated a steadfast commitment to safeguarding intellectual property rights both domestically and internationally. 

• KAPILA Initiative: The Kalam Programme for IP Literacy and Awareness (KAPILA) represents a systematic and comprehensive effort aimed at addressing barriers within the innovation ecosystem, particularly in Higher Education Institutions (HEIs). This program aims to enhance awareness among students and faculty about the importance of filing IP, the associated processes, and the relevant laws governing IP filing in India and globally. 
• International Memberships: As a member of the World Trade Organization (WTO), India is bound by the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement). Additionally, India holds membership in the World Intellectual Property Organization (WIPO). 

Legal Framework: 

• Indian Patents Act: The Patents Act of 1970 governs patents in India and is overseen by the Office of the Controller General of Patents, Designs, and Trade Marks (CGPDTM). A significant amendment to this act was made in 2005.  
• Design Act of 2000: This act supports innovation by safeguarding the interests of manufacturers and consumers.  
• Trademarks Act of 1999: The Trademarks Act, along with its 2010 amendment, features unique provisions for international trademark registration. It allows for the filing of an international application in India within eighteen months to extend protection to specified nations.  
• Geographical Indications of Goods (Registration and Protection) Act, 1999: This legislation aims to enhance the protection and registration of geographical indications associated with products.  
• Cell for IPR Promotion and Management (CIPAM): Established to promote the implementation of the National Intellectual Property Rights (IPR) Policy 2016, CIPAM operates under the Department for Promotion of Industry and Internal Trade (DPIIT). It focuses on addressing IPR-related issues and advancing the policy’s objectives through targeted actions. CIPAM also works to simplify and streamline IP processes, in addition to promoting awareness, commercialization, and enforcement of IPRs. 
• National IPR Policy 2016:The policy serves as a unified platform for all Intellectual Property Rights (IPRs) and establishes a formal system for implementation, oversight, and evaluation. It seeks to integrate global best practices into the Indian context and empower communities to protect and profit from their traditional knowledge. In essence, the National IPR Policy 2016 aims to strengthen India’s intellectual property landscape while ensuring equitable benefits for all stakeholders, including traditional knowledge holders. 

Benefits of Intellectual Property Rights 

Intellectual property rights (IPRs) offer numerous advantages aimed at encouraging innovation, protecting creators, and fostering economic growth through the development and utilization of inventions, trademarks, designs, creative works, and other intangible assets. 

1. Economic Growth: By providing legal recognition to creators’ economic rights and promoting fair trade, intellectual property rights contribute to economic growth and development. They create avenues for income generation through direct marketing and licensing arrangements with third parties. 
2. Cultural Enrichment: Copyright protection allows authors, performers, producers, and creators to receive economic rewards for their contributions to cultural heritage. This enriches cultural diversity, promotes creativity, and benefits society at large, particularly in industries such as publishing, music, and film. 
3. Dissemination of Technical Information: Patent information is made available to the public, including researchers, enabling the utilization of patented inventions for further innovation and development, even by entities unrelated to the original patent holder. 
4. Promotion of Fair Competition: Intellectual property rights, including distinctive signs like trademarks, empower consumers to make informed choices and encourage fair competition among producers and service providers, ultimately safeguarding consumer interests. 
5. Stimulus for Research and Development (R&D): IPRs serve as incentives for R&D activities by providing creators with financial rewards and recognition for their innovations. This fosters the development of new technologies and solutions, including advancements in critical areas such as healthcare. 
6. Facilitation of “Open Source” Mechanisms: Industries like software benefit from open-source mechanisms, such as General Public Licences (GPLs), which promote collaboration, flexibility, and community-driven innovation. These mechanisms leverage intellectual property rights, particularly copyright, to ensure compliance with licensing terms and conditions. 
7. Collateral for Securing Financing: Intangible assets, including intellectual property rights, serve as collateral for securing financing, especially for small and medium enterprises (SMEs) and startups. Knowledge-intensive SMEs rely on the valuation of intangible assets, such as patents, to attract investments and obtain loans from financial institutions. 

Challenges Concerning Intellectual Property Rights in India 

• Transition from Process to Product Patents: India’s adherence to the TRIPS agreement necessitated a shift from process patents to product patents. While process patents safeguard manufacturing procedures, product patents protect the final product. This transition aims to foster competition in India’s IP landscape, promoting market diversity and reducing monopolistic practices. 
• Section 3(d) of the Indian Patent Act: This provision addresses perpetual patents and poses challenges by limiting patent renewal for minor modifications. Courts require substantial evidence of therapeutic efficacy for multinational corporations (MNCs) to extend patent protection for previously granted patents, ensuring rigorous scrutiny of patent claims. 
• Section 84 of the Indian Patent Act: A significant IPR issue in India, this section governs Compulsory Licensing, which empowers license holders to efficiently produce certain medications. However, concerns arise regarding potential exploitation by some companies, leading to inflated product costs, while others may struggle to meet demand adequately. 
• Subsidy Reduction or Elimination: India provides various subsidies to individuals and entities, but compliance with TRIPS agreement requirements necessitates the reduction or elimination of these subsidies. Balancing subsidies with intellectual property rights enforcement can help address IPR issues in India effectively. 
• Inclusion in USTR’s Priority Watch List: India’s IPR challenges have garnered attention from the United States Trade Representatives (USTR), resulting in its inclusion in the “Priority Watch List.” This list highlights concerns over IP enforcement and protection, impacting business operations and innovation initiatives in India. 
• Opacity in State-Issued Pharmaceutical Manufacturing Licenses: Transparency issues surround state-issued pharmaceutical manufacturing licenses, hindering clarity and accountability in the industry. Additionally, certain agricultural chemical products lack protection from unfair commercial use or disclosure, exacerbating IP-related concerns. 
• Evergreening Prohibitions: The Indian Patent Act prohibits the granting of patents for inventions involving new forms of known substances unless significant differences in efficacy properties are demonstrated. This prohibition aims to prevent evergreening practices, posing challenges for pharmaceutical companies seeking patent extensions. 
• Compulsory Licensing (CL): CL provisions under the Indian Patents Act authorize organizations to utilize patented inventions without the patent owner’s consent. While intended to promote access to essential technologies, CL presents uncertainties for foreign investors concerned about potential misuse and unauthorized replication of their products. 

FAQs

1. What is biopiracy, and why is it a concern?

• Biopiracy refers to the unauthorized appropriation of biological resources or traditional knowledge, often from indigenous communities, by individuals or organizations seeking to profit from them without fair compensation or recognition. It’s a concern because it exploits vulnerable communities, undermines biodiversity conservation efforts, and perpetuates inequities in the distribution of benefits derived from natural resources.

2. What are the main intellectual property rights (IPR) issues related to biopiracy?

• One major IPR issue is the lack of effective mechanisms to protect traditional knowledge associated with biological resources. Existing intellectual property frameworks often favor Western-centric notions of innovation, making it difficult for indigenous communities to assert ownership over their traditional knowledge. Additionally, patent systems may grant monopolies over genetic resources or biological processes without considering the rights or contributions of the communities that have stewarded these resources for generations.

3. How do ethical dimensions intersect with biopiracy and IPR issues?

• Ethical considerations are paramount in addressing biopiracy and IPR issues. It involves recognizing and respecting the rights and sovereignty of indigenous peoples and local communities over their traditional knowledge and biological resources. Ethical frameworks must prioritize principles such as justice, equity, and respect for cultural diversity. Furthermore, ethical guidelines should promote fair and equitable benefit-sharing mechanisms, ensuring that communities receive just compensation for their contributions to scientific and commercial endeavors.

4. What steps can be taken to address biopiracy and IPR issues ethically?

• One crucial step is to involve indigenous communities and other stakeholders in decision-making processes related to the use and commercialization of their traditional knowledge and biological resources. This may involve the development of mutually beneficial agreements, such as benefit-sharing arrangements or codes of conduct, that uphold ethical principles and ensure fair compensation. Additionally, strengthening legal frameworks at both national and international levels to protect traditional knowledge and prevent biopiracy is essential.

5. How can collaboration between different stakeholders mitigate biopiracy and IPR issues?

• Collaboration is key to addressing biopiracy and IPR issues effectively. Governments, indigenous communities, researchers, corporations, and civil society organizations can work together to develop inclusive policies, promote responsible research practices, and establish transparent mechanisms for benefit-sharing. By fostering dialogue, building trust, and recognizing the diverse perspectives and interests of all stakeholders, collaborative efforts can lead to more equitable and sustainable outcomes in the management and utilization of biological resources.

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