TRIPS Agreement

The TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement, established during the Uruguay Round negotiations, introduced intellectual property (IP) regulations into the global trading system, setting minimum standards for IP protection among WTO member countries. It aims to foster innovation, technology transfer, and fair trade relations while balancing the interests of rights holders and public health concerns. The agreement covers various forms of IP, including patents, trademarks, copyrights, and trade secrets, and mandates effective enforcement mechanisms. The Doha Declaration reaffirmed the importance of public health in IP regulation, allowing for flexibility in granting compulsory licenses for essential medicines. However, TRIPS has faced criticism for potentially limiting access to medicines and hindering technology transfer in developing countries. The recent failure to extend a waiver for Covid-19 therapeutics production highlights ongoing debates over TRIPS-related issues. Additionally, the concept of TRIPS Plus denotes stricter IP protection standards sought by developed countries, raising concerns about potential negative impacts on competition and healthcare access in developing nations. Despite challenges, ongoing dialogue and adaptation of IP policies are crucial for addressing the evolving needs of the global community.

Intellectual Property (IP) constitutes property derived from intellectual efforts and activities. It encompasses creations such as inventions, industrial designs, literary and artistic works, as well as symbols, originating from the human intellect and intended for commercial application. IP rights grant creators or proprietors the privilege to benefit commercially from their creations. These rights, regulated by statutory laws, ensure that creators have legal protections in accordance with relevant legislation. By incentivizing creativity and innovation, IP rights play a vital role in advancing human progress.

The World Trade Organisation’s TRIPS Agreement, formed during the Uruguay Round negotiations, marked the integration of intellectual property regulations into the multilateral trading system for the first time. While acknowledging that intellectual property rights (IPRs) are private rights, the Agreement sets minimum standards for IP protection that each WTO member country must adhere to. However, countries have the liberty to offer higher levels of IP rights protection if they choose to do so. Built upon principles like non-discrimination and intended to foster technological innovation and the transfer of technology, TRIPS has been in effect since 1995 and is instrumental in aligning IP regulations across WTO member nations.

The primary objectives of the TRIPS Agreement revolve around striking a balance between promoting innovation and ensuring access to essential goods and services. Key objectives include:

1. Establishing minimum standards of IP protection and enforcement to safeguard creators' rights.
2. Encouraging technological innovation and the transfer of technology for economic development.
3. Facilitating fair and equitable trade relations among WTO member states by preventing unfair competition through IP violations.
4. Balancing the interests of rights holders, consumers, and public health concerns, particularly in the context of pharmaceutical patents and access to medicines.

The TRIPS Agreement encompasses various provisions addressing different forms of intellectual property, including patents, trademarks, copyrights, industrial designs, and trade secrets. Key provisions include:

1. TRIPS officially came into effect in 1995, coinciding with the establishment of the World Trade Organisation (WTO).
2. Negotiations for TRIPS took place during the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) from 1986 to 1994.
3. Referred to as a "Berne and Paris-plus" Agreement, TRIPS builds upon the principles established in the Berne Convention (copyright) and the Paris Convention (industrial property).
4. The TRIPS Council is tasked with administering and monitoring the implementation of the TRIPS Agreement.
5. It applies universally to all members of the WTO
6. TRIPS aligns with fundamental international trade principles, applying them specifically to intellectual property matters among member states.
7. The agreement sets out minimum standards for the availability, scope, and utilization of seven types of intellectual property: trademarks, copyrights, geographical indications, patents, industrial designs, layout designs for integrated circuits, and undisclosed information or trade secrets.
8. Patent Protection: TRIPS mandates the availability of patents for inventions in all fields of technology, provided they meet the criteria of novelty, inventive step, and industrial applicability. It sets a minimum patent term of 20 years and requires members to offer patent protection without discrimination.
9. Copyright and Related Rights: TRIPS obliges member states to provide copyright protection for authors of literary, artistic, and scientific works, including computer programs and databases. It outlines minimum standards for the duration of copyright protection and the rights conferred upon copyright holders.
10. Trademarks: The agreement requires member states to provide trademark protection for distinctive signs, including words, logos, and symbols, used to distinguish goods and services in commerce. It sets out principles for trademark registration and enforcement to prevent confusion and deception in the marketplace.
11. Enforcement: TRIPS mandates effective enforcement mechanisms to combat IP infringement, including civil and criminal remedies, border measures, and procedures for the enforcement of IP rights. It encourages cooperation among authorities and rights holders to combat piracy and counterfeiting.

• TRIPS provides a framework for enforcing IP standards among member countries.
• It addresses issues such as pharmaceutical patents, access to essential medicines, and technology transfer.
• TRIPS includes flexibilities like compulsory licensing and parallel importation to ensure access to vital goods, especially medicines, during public health emergencies.
• It holds particular relevance in discussions regarding innovation, knowledge accessibility, and the public interest.

The Doha Declaration, adopted at the World Trade Organization's Ministerial Conference in 2001, stands as a significant milestone in the intersection of intellectual property rights and global public health. Here's a breakdown of its key points:

• Protection of Public Health: The Doha Declaration emphasizes that the TRIPS Agreement should not hinder WTO member governments from taking measures to safeguard public health. It reaffirms the rights of member states to utilize the provisions within the TRIPS Agreement, which offer flexibility for this purpose. This means ensuring access to essential medicines and healthcare services for all citizens.
• Interpretation and Implementation of TRIPS: The declaration underscores the need to interpret and implement the TRIPS Agreement in a manner that supports the protection of public health by WTO member states. It stresses the importance of promoting access to medicines as a fundamental aspect of public health policy.
• Compulsory Licensing: The Doha Declaration clarifies that each WTO member has the freedom to determine the grounds upon which compulsory licenses for patented medicines are granted. Compulsory licensing allows governments to authorize the production or importation of generic versions of patented medicines to address public health needs, particularly in cases where access to affordable treatment is essential.

Despite its aims to harmonize global IP standards, the TRIPS Agreement has faced criticism and challenges, particularly regarding its impact on access to essential medicines, technology transfer, and the balance between IP protection and public interest. Criticisms include:

1. Access to Medicines: TRIPS has been criticized for potentially restricting access to affordable medicines, particularly in developing countries, by granting pharmaceutical companies lengthy patent monopolies. This issue gained prominence during the HIV/AIDS crisis in the late 1990s and early 2000s.
2. Technology Transfer: Critics argue that TRIPS may hinder technology transfer to developing countries by imposing stringent IP protection requirements, thus impeding their ability to access and utilize technological advancements for economic development.
3. Flexibilities and Public Health: While TRIPS includes flexibilities such as compulsory licensing and parallel importing to address public health concerns, their utilization and effectiveness vary among member states. Some argue for further flexibility to ensure access to essential medicines, especially during health emergencies.

In October 2020, India and South Africa made a joint proposal to waive certain provisions of the TRIPS Agreement concerning COVID-19-related medical products, including drugs, vaccines, diagnostics kits, and personal protective equipment (PPE), among others. Essentially, they advocated for developed countries to share patents and technology with developing nations without facing any complaints or penalties at WIPO/WTO. Initially, the USA opposed this proposal in 2020. At the 12th Ministerial Conference of the World Trade Organisation (WTO) in Geneva, the text that was finally adopted, however, it is limited to vaccines and excludes therapeutics and diagnostics.

• The 13th Ministerial Conference of the WTO in Abu Dhabi in 2024 failed to extend the temporary waiver of specific TRIPS for Covid-19 therapeutics and diagnostics production.
• India, Bangladesh, Colombia, and Egypt jointly called for a review of the TRIPS Agreement at the WTO.The focus of the review includes the development dimension, technology transfer, and other concerns of developing countries, drawing from lessons learned during the pandemic.
• India specifically urged the TRIPS Council to examine the TRIPS Agreement, the Doha Declaration on the TRIPS Agreement and Public Health of 2001, and the Ministerial Decision on the TRIPS Agreement of 2022.

• TRIPs Plus refers to stricter intellectual property protection standards requested by developed countries, which surpass the requirements outlined in the WTO's TRIPs agreement.
• This term signifies that these demands exceed the basic standards mandated by TRIPs.
• Many developing nations face pressure to adopt these more stringent conditions into their patent laws.
• Developing countries express apprehensions about the increased protection levels demanded by developed nations. They worry that if such standards are universally adopted, it could diminish competition and potentially raise drug prices, affecting healthcare access in poorer countries.
• India consistently opposes the imposition of higher protection levels (TRIPs Plus) beyond what is stipulated in TRIPs.

In India, Intellectual Property Rights (IPRs) fall under the jurisdiction of the Department of Industrial Policy and Promotion (DIPP) within the Ministry of Commerce & Industry. India amended its intellectual property rights (IPR) laws, including the Patent Act of 1970, in 2005 to align with the provisions of the TRIPS agreement. Additionally, various international treaties and conventions address different aspects of intellectual property and industrial property, underscoring the global importance of protecting and regulating intellectual creations and innovations. This includes

• Paris Convention for the Protection of Industrial Property (1883), amended in 1979.
• Patent Cooperation Treaty (1970), modified in 2001.
• Berne Convention for the Protection of Literary and Artistic Works (1886), amended in 1979.
• Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, 1994.
• Convention on Biological Diversity (CBD), 1992.

The Berne Convention, formally titled the Berne Convention for the Protection of Literary and Artistic Works, is an international treaty focusing on copyright protection. Adopted in Berne, Switzerland, in 1886, it aims to ensure uniform copyright standards among its signatories. Alongside establishing a framework for equal treatment, the convention mandates member states to uphold robust minimum copyright regulations. It empowers creators—including authors, musicians, poets, and painters—to dictate the usage, distribution, and terms of their works.

• WIPO, the World Intellectual Property Organization, stands as a specialized agency within the United Nations, established by the WIPO Convention in 1967.
• Headquartered in Geneva, Switzerland, WIPO is committed to fostering a balanced and accessible international intellectual property system. This system aims to reward creativity, spur innovation, and facilitate economic development while upholding public interest.
• WIPO is renowned for its Global Innovation Index (GII), developed in collaboration with Cornell University (USA) and INSEAD Business School (Paris). India's remarkable ascent in the GII rankings is notable, rising consistently from 81st place in 2015 to 40th place in 2023.
  • The GII evaluates countries based on their performance across seven pillars, which include
  • 1) knowledge and technology outputs, 2) market sophistication, 3) human capital and research, 4) institutions, 5) business sophistication, 6) infrastructure, 7) creative outputs.
• Apart from this , it is also renowned for Marrakesh Treaty ( Explained below)

NITI Aayog, the policy think tank of the Government of India, introduced the India Innovation Index, with support from the Institute for Competitiveness, a private organization acting as a knowledge partner. This index serves to monitor the innovation performance of Indian states and union territories (UTs) across two key dimensions:

1. Enablers: This dimension encompasses five pillars that serve as foundational factors facilitating innovation. These pillars include:
   • Human Capital
   • Investment
   • Knowledge Workers
   • Business Environment
   • Safety and Legal Environment
2. Performance: This dimension evaluates the actual innovation performance of states and UTs based on two pillars:
   • Knowledge Output
   • Knowledge Diffusion

NITI Aayog’s India Innovation Index 2021 (published in 2022 July)- Karnataka has topped again in the ‘Major States’ category, Manipur is leading the ‘North East and Hill States’ category and Chandigarh is the top performer in the ‘Union Territories and City States’ category.

The Marrakesh Treaty, signed in Marrakesh, Morocco, on June 27, 2013, and enforced from September 30, 2016, is a significant international agreement designed to improve access to published works for individuals who are blind, visually impaired, or otherwise print disabled. Here are the key points regarding the treaty:

• Access to Published Works: The treaty aims to facilitate access to published works for individuals with disabilities by providing an exception to domestic copyright law. This exception allows for the creation and distribution of accessible format copies of copyrighted works without the need to seek permission from the copyright holder.
• Membership and Ratification: All member states of the World Intellectual Property Organization (WIPO) are eligible to become parties to the Marrakesh Treaty. Countries that ratify the treaty commit to ensuring that their laws permit the creation and distribution of accessible format books for individuals with disabilities.
• India's Role: India played a pioneering role by being the first country to ratify the Marrakesh Treaty. The Indian Copyright (Amendment) Act of 2012 aligns with the provisions of the treaty, ensuring compliance and facilitating the import and translation of accessible format copies.
• Accessible Books Consortium (ABC): The treaty led to the establishment of the Accessible Books Consortium (ABC), which aims to increase the availability of books in accessible formats such as braille, audio, and large print. The ABC works to make these books accessible to individuals who are blind, visually impaired, or otherwise print disabled on a global scale.

Patent

• A patent is a government-granted statutory right given to an inventor for a limited duration in exchange for disclosing the invention. This right excludes others from making, using, selling, or importing the patented product or process without the inventor's permission.
• It offers exclusive rights to a new product or process, typically providing a novel solution to a problem or a new way of doing something.
• To be patentable, an invention must meet certain criteria: novelty, inventive step (non-obviousness), capability of industrial application, and compliance with the provisions of the Patents Act 1970, which lists non-patentable subjects.
• Patent protection is territorial, meaning it is only effective within the territory of the country where it is granted. Thus, inventors must obtain separate patents in each country where they seek protection.
• Patents are not valid worldwide; they are granted for a limited period, currently set at 20 years.
• In India, patent rights are protected under the Patents Act of 1970, which has been amended multiple times (in 1995, 1999, 2002, and 2005) to meet the country's obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

What cannot be patented:

• Inventions that pose serious harm to public order, morality, humans, animals, plants, or the environment
• Inventions related to atomic energy.
• Traditional knowledge, such as Ayurvedic information.
• Mere discoveries of scientific principles, abstract theories, living organisms, or naturally occurring substances.
• Animal breeding and medical treatments for humans and animals.
• Discoveries of new forms of known substances lacking enhanced efficiency.
• Simple rearrangements or duplications of existing devices.
• Plant seed varieties and biological processes for creating them.
• Literary, dramatic, musical, or artistic works, including cinema and TV shows
• Mathematical formulas, business methods, or game-playing methods
• Computer programs or the presentation of information.
• Integrated circuits (though their intellectual property rights can be registered separately under the Semiconductor Integrated Circuits Layout-Design Act).

Evergreening of Patents:

• A patent grants a statutory right for an invention for a limited period, typically 20 years, and it provides exclusive rights within the territory of the country where it is granted.
• However, when a patent is nearing expiration, some companies engage in unethical practices known as "evergreening." This involves making slight modifications to the original drug formula to create a new drug and then seeking a patent for the modified version.
• Evergreening effectively extends the monopoly of the company over the drug, preventing others from manufacturing generic versions and keeping prices high.
• The Indian Patent Act addresses evergreening under Section 3(d), prohibiting the grant of patents for minor modifications or incremental innovations of existing drugs.

Trade Marks

• A trademark serves as a distinctive symbol that sets apart goods in the market, distinguishing them from those of other traders.
• It can take various forms, including a device, brand, label, word, sign, number, drawing, color, shape of goods, or combination thereof.
• In India, trademarks are regulated by the Trade Marks Act of 1999, which underwent an amendment in 2010.
• The objective of the Trade Marks Act is to facilitate the registration of trademarks within the country, enhance protection for goods and services, and prevent fraudulent use of marks.
• The Trade Marks Registry, established in India in 1940, administers the Trade Marks Act of 1999 and the associated rules.
• The primary function of the Registry is to register trademarks that meet the criteria outlined in the Act and its Rules and to maintain the Register of trademarks.
• The Controller General of Patents, Designs, and Trademarks oversees the Trade Marks Registry offices and serves as the Registrar of Trademarks.
• Currently, all functions of the Trade Marks Registry are carried out through an automated Trade Marks System, streamlining processes and enhancing efficiency.

Copyright

• Copyright is a legal right granted to creators of literary, dramatic, musical, and artistic works, as well as producers of cinematograph films and sound recordings.
• It encompasses a range of rights, including reproduction, communication to the public, adaptation, and translation of the work, tailored to the specific type of creation.
• Copyright protects the originality of creators' works, rewarding and safeguarding their creativity.
• However, copyright does not extend to ideas, procedures, methods of operation, or mathematical concepts.
• In India, copyright law is governed by the Copyright Act of 1957, which has undergone several amendments, including one in 2012.
• The Copyright Act protects various forms of original works, such as literary, dramatic, musical, and artistic creations, as well as cinematograph films and sound recordings.
• By safeguarding the efforts of writers, artists, musicians, and others, copyright fosters an environment conducive to creativity and encourages further innovation.
• Unlike patents, copyright protects expressions rather than ideas.
• Two important internet treaties negotiated in 1996 under WIPO are the WIPO Copyright Treaty (WCT) and the WIPO Performances and Phonograms Treaty (WPPT).
• These treaties aim to protect the rights of copyright holders, performers, and producers of phonograms in the digital and internet era.
• India ratified the WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty in 2018, endorsing international efforts to protect intellectual property rights in the digital age.

Industrial Designs

• Industrial design involves the original design of a product intended for industrial or commercial use.
• Design refers specifically to the shape, configuration, pattern, ornament, composition of lines, or color, or a combination thereof, applied to any article, whether two-dimensional or three-dimensional.
• These design features must be visually appealing and judged solely by the eye.
• However, industrial design does not include any mechanical device, mode, or principle of construction. Nor does it encompass trademarks, property marks, or artistic works as defined in the Copyright Act of 1957.
• Registration of a design grants the registered proprietor copyright in the design for the duration of registration.
• Copyright in this context means the exclusive right to apply the design to articles within the class for which it is registered.
• In India, the Designs Act of 2000 aligns with the requirements of TRIPS, making it directly relevant for international trade.
• The Act serves to protect the rights of the original owner of the product's design.

Geographical Indication

• Geographical Indication (GI) is a sign used on products with a specific geographical origin and unique qualities attributable to that origin. For example, Darjeeling tea from West Bengal was the first product in India to obtain a GI tag.
• The benefits of obtaining a GI tag are significant. It adds a sense of premiumness to the product, which in turn helps in fetching higher prices in the international market. This increase in revenue directly benefits farmers and artisans involved in the production process.
• Registration of a geographical indication is initially valid for 10 years and can be renewed for further periods of 10 years each.
• At the international level, the World Intellectual Property Organization (WIPO), serves as a nodal organization for GI-related matters. WIPO is headquartered in Geneva, Switzerland.
• In India, the nodal authority for Geographical Indications is the Ministry of Commerce, specifically the Controller General of Patents, Designs, and Trademarks. The Geographical Indications Registry, responsible for registering GIs in India, is located in Chennai.

• A trade secret refers to any confidential information, such as a formula, pattern, compilation, program, device, method, technique, or process.
• To qualify as a trade secret, the information must have independent economic value, whether actual or potential, due to not being generally known to others or readily ascertainable by proper means.
• Additionally, the information must be the subject of reasonable efforts to maintain its secrecy under the circumstances.
• For instance, a business may possess internal processes or strategies that provide it with a competitive advantage over others in the industry.

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes three fundamental conditions that must be met by any information to qualify as undisclosed information (trade secret):

1. Secrecy: The information must be kept secret and not generally known or readily accessible to individuals within the relevant industry circles.
2. Commercial Value: The information must possess commercial value because of its secrecy.
3. Reasonable Steps: The owners of the information must take reasonable measures to maintain its secrecy.

Several laws have been enacted to protect Intellectual Property Rights (IPR) in various sectors:

1. Protection of Plant Varieties and Farmers’ Rights Act, 2001:
   • This law safeguards the rights of plant breeders engaged in research.
   • It encourages the development of new plant varieties by farmers and breeders.
   • The act acknowledges the significant impact of plant breeding on sustainable agriculture.
2. Semiconductor Integrated Circuits Layout Design Act, 2000:
   • This law protects the rights of creators of semiconductor integrated circuit designs and layouts.
   • It addresses the advancements in electronics, computers, and telecommunications, particularly in the field of microelectronics.
3. Biological Diversity Act, 2002:
   • This act focuses on the conservation of biological resources and associated knowledge.
   • It aims to facilitate access to these resources in a sustainable and equitable manner.
   • The National Biodiversity Authority (NBA) oversees the implementation of the law and approves applications for IPR related to biological resources.

The National Intellectual Property Rights (IPR) Policy was approved by the Union Cabinet on May 12, 2016, to chart the future course for IPRs in India. This policy sets out a comprehensive roadmap to enhance the protection and utilization of intellectual property rights across the country.

Goal: The overarching goal of the National IPR Policy is to foster a "Creative India; Innovative India" (रचनात्मक भारत; अभिनव भारत), promoting a culture of creativity, innovation, and entrepreneurship across the nation.

Key Highlights:

1. Recognition of Existing Framework: The policy acknowledges India's well-established TRIPS-compliant legislative, administrative, and judicial framework for safeguarding IPRs. It emphasizes the utilization of international flexibilities to address developmental concerns while fulfilling international obligations.
2. Commitment to International Agreements: The policy reaffirms India's commitment to the Doha Development Agenda and the TRIPS agreement, ensuring alignment with global standards while pursuing national interests.

Objectives: The National IPR Policy outlines seven key objectives:

1. IPR Awareness and Promotion: To raise public awareness about the economic, social, and cultural benefits of IPRs across all segments of society.
2. Generation of IPRs: To foster an environment conducive to the creation and generation of intellectual property rights.
3. Legal and Legislative Framework: To establish robust and effective IPR laws that strike a balance between the rights of owners and the broader public interest.
4. Administration and Management: To modernize and strengthen service-oriented IPR administration for efficient management.
5. Commercialization of IPRs: To extract value from intellectual property rights through effective commercialization strategies.
6. Enforcement and Adjudication: To enhance enforcement and adjudication mechanisms to combat infringements of IPRs effectively.
7. Human Capital Development: To enhance and expand human resources, institutions, and capacities for education, training, research, and skill development in the field of IPRs.

Implementation: The Department of Industrial Policy and Promotion (DIPP) serves as the nodal department responsible for coordinating, guiding, and overseeing the implementation and future development of IPRs in India.

AIM (2015):

• The Atal Innovation Mission (AIM) was established within NITI Aayog in 2015 with the aim of fostering innovation and entrepreneurship across India
• Key Initiatives:
  1. ARISE-ANIC Initiative: Launched in September 2020, the ARISE-ANIC initiative focuses on promoting applied research and innovation among Indian MSMEs (Micro, Small & Medium Enterprises) and startups
  2. AIM-Sirius Innovation Programme 3.0: Introduced in November 2020, the AIM-Sirius Innovation Programme 3.0 is a collaborative effort between AIM and Sirius, a leading research institute in Russia. This program targets schoolchildren in India and Russia, aiming to foster innovation and creativity among the youth.

The TRIPS Agreement stands as a pivotal international treaty shaping the landscape of intellectual property rights and global trade. While it has spurred innovation, facilitated trade relations, and provided a framework for IP protection and enforcement, challenges remain in balancing IP rights with public health concerns, ensuring access to essential medicines, and promoting technology transfer for sustainable development. Addressing these challenges requires ongoing dialogue, cooperation, and adaptation of IP policies to meet the evolving needs of the global community.