The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the

World Trade Organization The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and e ...

(WTO). It establishes minimum standards for the regulation by national governments of different forms of

intellectual property Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, cop ...

(IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the

Uruguay Round The Uruguay Round was the 8th round of multilateral trade negotiations (MTN) conducted within the framework of the General Agreement on Tariffs and Trade (GATT), spanning from 1986 to 1993 and embracing 123 countries as "contracting parties". The R ...

of the

General Agreement on Tariffs and Trade The General Agreement on Tariffs and Trade (GATT) is a legal agreement between many countries, whose overall purpose was to promote international trade by reducing or eliminating trade barriers such as tariffs or quotas. According to its pre ...

(GATT) between 1989 and 1990 and is administered by the WTO. The TRIPS agreement introduced intellectual property law into the multilateral trading system for the first time and remains the most comprehensive multilateral agreement on intellectual property to date. In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the

Doha Declaration The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001. It reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to ...

. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal "to promote access to medicines for all." Specifically, TRIPS requires WTO members to provide

copyright A copyright is a type of intellectual property that gives its owner the exclusive right to copy, distribute, adapt, display, and perform a creative work, usually for a limited time. The creative work may be in a literary, artistic, education ...

rights, covering authors and other copyright holders, as well as holders of related rights, namely performers, sound recording producers and broadcasting organisations;

geographical indication A geographical indication (GI) is a name or sign used on products which corresponds to a specific geographical location or origin (e.g., a town, region, or country). The use of a geographical indication, as an indication of the product's source, ...

industrial designs Industrial design is a process of design applied to physical products that are to be manufactured by mass production. It is the creative act of determining and defining a product's form and features, which takes place in advance of the manufactu ...

; integrated circuit layout-designs;

patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...

s; new plant varieties;

trademark A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from others ...

trade name A trade name, trading name, or business name, is a pseudonym used by companies that do not operate under their registered company name. The term for this type of alternative name is a "fictitious" business name. Registering the fictitious name w ...

s and undisclosed or

confidential information Confidentiality involves a set of rules or a promise usually executed through confidentiality agreements that limits the access or places restrictions on certain types of information. Legal confidentiality By law, lawyers are often required ...

. TRIPS also specifies

enforcement Enforcement is the proper execution of the process of ensuring compliance with laws, regulations, rules, standards, and social norms. Governments attempt to effectuate successful implementation of policies by enforcing laws and regulations. Ena ...

procedures, remedies, and dispute resolution procedures. Protection and enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Background and history

TRIPS was negotiated during the

of the

(GATT) in 1986–1994. Its inclusion was the culmination of a program of intense

lobbying In politics, lobbying, persuasion or interest representation is the act of lawfully attempting to influence the actions, policies, or decisions of government officials, most often legislators or members of regulatory agency, regulatory agencie ...

by the

United States The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territorie ...

by the

International Intellectual Property Alliance The International Intellectual Property Alliance (IIPA), formed in 1984, is a private sector coalition of seven trade associations representing U.S. companies that produce copyright-protected material, including computer software, films, televisio ...

, supported by the

European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...

Japan Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north ...

and other

developed nations A developed country (or industrialized country, high-income country, more economically developed country (MEDC), advanced country) is a sovereign state that has a high quality of life, developed economy and advanced technological infrastruct ...

. Campaigns of unilateral economic encouragement under the

Generalized System of Preferences The Generalized System of Preferences, or GSP, is a preferential tariff system which provides tariff reduction on various products. The concept of GSP is very different from the concept of " most favored nation" (MFN). MFN status provides equal tre ...

and

coercion Coercion () is compelling a party to act in an involuntary manner by the use of threats, including threats to use force against a party. It involves a set of forceful actions which violate the free will of an individual in order to induce a desi ...

under

Section 301 Section 301 of the U.S. Trade Act of 1974 (19U.S.C.br>§ 2411 last amended March 23, 2018) authorizes the President to take all appropriate action, including tariff-based and non-tariff-based retaliation, to obtain the removal of any act, poli ...

of the Trade Act played an important role in defeating competing policy positions that were favored by developing countries like Brazil, but also including Thailand, India and Caribbean Basin states. In turn, the US strategy of linking trade policy to intellectual property standards can be traced back to the entrepreneurship of senior management at

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...

in the early 1980s, who mobilized corporations in the United States and made maximizing intellectual property privileges the number one priority of trade policy in the United States (Braithwaite and Drahos, 2000, Chapter 7). Unlike other agreements on intellectual property, TRIPS has a powerful enforcement mechanism. States can be disciplined through the WTO's dispute settlement mechanism.

Requirements

TRIPS requires member states to provide strong protection for intellectual property rights. For example, under TRIPS: * Copyright terms must extend at least 50 years, unless based on the life of the

author An author is the writer of a book, article, play, mostly written work. A broader definition of the word "author" states: "''An author is "the person who originated or gave existence to anything" and whose authorship determines responsibility f ...

. (Art. 12 and 14) * Copyright must be granted automatically, and not based upon any "

formality A formality is an established procedure or set of specific behaviors and utterances, conceptually similar to a ritual although typically secular and less involved. A formality may be as simple as a handshake upon making new acquaintances in Weste ...

", such as registrations, as specified in the

Berne Convention The Berne Convention for the Protection of Literary and Artistic Works, usually known as the Berne Convention, was an international assembly held in 1886 in the Swiss city of Bern by ten European countries with the goal to agree on a set of leg ...

. (Art. 9) * Computer programs must be regarded as "literary works" under copyright law and receive the same terms of protection. * National exceptions to copyright (such as "

fair use Fair use is a doctrine in United States law that permits limited use of copyrighted material without having to first acquire permission from the copyright holder. Fair use is one of the limitations to copyright intended to balance the interests ...

" in the United States) are constrained by the

Berne three-step test The Berne three-step test is a clause that is included in several international treaties on intellectual property. Signatories of those treaties agree to standardize possible limitations and exceptions to exclusive rights under their respective na ...

. * Patents must be granted for "inventions" in all "fields of technology" provided they meet all other patentability requirements (although exceptions for certain public interests are allowed (Art. 27.2 and 27.3) and must be enforceable for at least 20 years (Art 33). * Exceptions to exclusive rights must be limited, provided that a normal exploitation of the work (Art. 13) and normal exploitation of the patent (Art 30) is not in conflict. * No unreasonable prejudice to the legitimate interests of the right holders of computer programs and patents is allowed. * Legitimate interests of third parties have to be taken into account by patent rights (Art 30). * In each state, intellectual property laws may not offer any benefits to local citizens which are not available to citizens of other TRIPS signatories under the principle of

national treatment National treatment is a principle in international law. Utilized in many treaty regimes involving trade and intellectual property, it requires equal treatment of foreigners and locals. Under national treatment, a state that grants particular right ...

(with certain limited exceptions, Art. 3 and 5). TRIPS also has a most favored nation clause. The TRIPS Agreement incorporates by reference the provisions on copyright from the Berne Convention for the Protection of Literary and Artistic Works (Art 9), with the exception of moral rights. It also incorporated by reference the substantive provisions of the

Paris Convention for the Protection of Industrial Property The Paris Convention for the Protection of Industrial Property, signed in Paris, France, on 20 March 1883, was one of the first intellectual property treaties. It established a Union for the protection of industrial property. The convention is c ...

(Art 2.1). The TRIPS Agreement specifically mentions that software and databases are protected by copyright, subject to originality requirement (Art 10). Article 10 of the Agreement stipulates:

Implementation in developing countries

The obligations under TRIPS apply equally to all member states; however,

developing countries A developing country is a sovereign state with a lesser developed industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreem ...

were allowed extra time to implement the applicable changes to their national laws, in two tiers of transition according to their level of development. The transition period for developing countries expired in 2005. The transition period for least developed countries to implement TRIPS was extended to 2013, and until 1 January 2016 for pharmaceutical patents, with the possibility of further extension. It has therefore been argued that the TRIPS standard of requiring all countries to create strict intellectual property systems will be detrimental to poorer countries' development. It has been argued that it is, ''prima facie'', in the strategic interest of most if not all underdeveloped nations to use the flexibility available in TRIPS to legislate the weakest IP laws possible. This has not happened in most cases. A 2005 report by the

WHO Who or WHO may refer to: * Who (pronoun), an interrogative or relative pronoun * Who?, one of the Five Ws in journalism * World Health Organization Arts and entertainment Fictional characters * Who, a creature in the Dr. Seuss book '' Horton He ...

found that many developing countries have not incorporated TRIPS flexibilities (compulsory licensing, parallel importation, limits on data protection, use of broad research and other exceptions to patentability, etc.) into their legislation to the extent authorized under Doha. This is likely caused by the lack of legal and technical expertise needed to draft legislation that implements flexibilities, which has often led to developing countries directly copying developed country IP legislation, or relying on technical assistance from the

World Intellectual Property Organization The World Intellectual Property Organization (WIPO; french: link=no, Organisation mondiale de la propriété intellectuelle (OMPI)) is one of the list of specialized agencies of the United Nations, 15 specialized agencies of the United Nation ...

(WIPO), which, according to critics such as

Cory Doctorow Cory Efram Doctorow (; born July 17, 1971) is a Canadian-British blogger, journalist, and science fiction author who served as co-editor of the blog ''Boing Boing''. He is an activist in favour of liberalising copyright laws and a proponent of ...

, encourages them to implement stronger intellectual property monopolies. Banerjee and Nayak shows that TRIPS has a positive effect on R&D expenditure of Indian pharmaceutical firms.

Post-TRIPS expansion

In addition to the baseline

standards created by the TRIPS agreement, many nations have engaged in bilateral agreements to adopt a higher standard of protection. These collection of standards, known as TRIPS+ or TRIPS-Plus, can take many forms. General objectives of these agreements include: * The creation of anti-circumvention laws to protect

Digital Rights Management Digital rights management (DRM) is the management of legal access to digital content. Various tools or technological protection measures (TPM) such as access control technologies can restrict the use of proprietary hardware and copyrighted works. ...

systems. This was achieved through the 1996

World Intellectual Property Organization Copyright Treaty The World Intellectual Property Organization Copyright Treaty (WIPO Copyright Treaty or WCT) is an international treaty on copyright law adopted by the member states of the World Intellectual Property Organization (WIPO) in 1996. It provides addi ...

(WIPO Treaty) and the

WIPO Performances and Phonograms Treaty The WIPO Performances and Phonograms Treaty (or WPPT) is an international treaty signed by the member states of the World Intellectual Property Organization and was adopted in Geneva on 20 December 1996. It came into effect on 20 May 2002. As of ...

. * More stringent restrictions on

compulsory license A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of adjudication or arbitration. In essence, under a compulsory license, an i ...

s for patents. * More aggressive patent enforcement. This effort has been observed more broadly in proposals for WIPO and

rules on intellectual property enforcement. The 2001

EU Copyright Directive The copyright law of the European Union is the copyright law applicable within the European Union. Copyright law is largely harmonized in the Union, although country to country differences exist. The body of law was implemented in the EU through ...

was to implement the 1996 WIPO Copyright Treaty. * The campaign for the creation of a WIPO Broadcasting Treaty that would give broadcasters (and possibly webcasters) exclusive rights over the copies of works they have distributed.

Panel reports

According to ''WTO 10th Anniversary, Highlights of the first decade, Annual Report 2005'' page 142, in the first ten years, 25 complaints have been lodged leading to the panel reports and appellate body reports on TRIPS listed below. * ''2005 Panel Report'': ** European Communities – Protection of

Trademark A trademark (also written trade mark or trade-mark) is a type of intellectual property consisting of a recognizable sign, design, or expression that identifies products or services from a particular source and distinguishes them from others ...

s and

Geographical Indication A geographical indication (GI) is a name or sign used on products which corresponds to a specific geographical location or origin (e.g., a town, region, or country). The use of a geographical indication, as an indication of the product's source, ...

s for Agricultural Products and Foodstuffs. * ''2000 Panel Report'': Part 2 and 2000 Appellate Body Report **

Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by tot ...

– Term of Patent Protection. * ''2000 Panel Report'', Part 1: and Part 2 **

– Section 110(5) of the US Copyright Act. * ''2000 Panel Report'': ** Canada – Patent Protection of Pharmaceutical Products. * ''2001 Panel Report'': and 2002 Appellate Body Report ** United States – Section 211 Omnibus Appropriations Act of 1998. * ''1998 Panel Report'': **

India India, officially the Republic of India (Hindi: ), is a country in South Asia. It is the seventh-largest country by area, the second-most populous country, and the most populous democracy in the world. Bounded by the Indian Ocean on the so ...

– Patent Protection for Pharmaceutical and Agricultural Chemical Products. * ''1998 Panel Report'': **

Indonesia Indonesia, officially the Republic of Indonesia, is a country in Southeast Asia and Oceania between the Indian and Pacific oceans. It consists of over 17,000 islands, including Sumatra, Java, Sulawesi, and parts of Borneo and New Guine ...

– Certain Measures Affecting the Automobile Industry.

Criticism

Since TRIPS came into force, it has been subject to criticism from

academic An academy (Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of secondary education, secondary or tertiary education, tertiary higher education, higher learning (and generally also research or honorary membershi ...

s, and

non-governmental organization A non-governmental organization (NGO) or non-governmental organisation (see spelling differences) is an organization that generally is formed independent from government. They are typically nonprofit entities, and many of them are active in h ...

s. Though some of this criticism is against the WTO generally, many advocates of trade liberalisation also regard TRIPS as poor policy. TRIPS's wealth concentration effects (moving money from people in developing countries to copyright and patent owners in developed countries), and its imposition of

artificial scarcity Artificial scarcity is scarcity of items despite the technology for production or the sufficient capacity for sharing. The most common causes are monopoly pricing structures, such as those enabled by laws that restrict competition or by high fi ...

on the citizens of countries that would otherwise have had weaker intellectual property laws, are common bases for such criticisms. Other criticism has focused on the failure of TRIPS to accelerate investment and technology flows to low-income countries, a benefit advanced by WTO members in the lead-up to the agreement's formation. Statements by the World Bank indicate that TRIPS has not led to a demonstrable acceleration of investment to low-income countries, though it may have done so for middle-income countries.

Daniele Archibugi Daniele Archibugi (born 17 July 1958 in Rome, Italy) is an Italian economic and political theorist. He works on the economics and policy of innovation and technological change, on the political theory of international relations and on political ...

and Andrea Filippetti have argued that the main motive for TRIPS was a decline in the competitiveness of the technology industry in the United States, Japan, and the European Union against

emerging market An emerging market (or an emerging country or an emerging economy) is a market that has some characteristics of a developed market, but does not fully meet its standards. This includes markets that may become developed markets in the future or wer ...

s, which it largely failed to abate. They instead argue that the main supporters and beneficiaries of TRIPS were IP-intensive multinational corporations in these countries, and that TRIPS enabled them to

outsource Outsourcing is an agreement in which one company hires another company to be responsible for a planned or existing activity which otherwise is or could be carried out internally, i.e. in-house, and sometimes involves transferring employees and ...

key operations to emerging markets. Archibugi and Filippetti also argue that the importance of TRIPS, and intellectual property in general, in the process of generation and diffusion of knowledge and innovation has been overestimated by its supporters. This point has been supported by United Nations findings indicating many countries with weak protection routinely benefit from strong levels of

foreign direct investment A foreign direct investment (FDI) is an investment in the form of a controlling ownership in a business in one country by an entity based in another country. It is thus distinguished from a foreign portfolio investment by a notion of direct co ...

(FDI). Analysis of OECD countries in the 1980s and 1990s (during which the patent life of drugs was extended by 6 years) showed that while total number of products registered increased slightly, the mean innovation index remained unchanged. In contrast to that,

Jörg Baten Jörg Baten (born 24 June 1965 in Hamburg) is a German economic historian. He is the former President of the European Historical Economics Society, current co-Editor-in-chief of Economics and Human Biology and is currently a professor of economic ...

, Nicola Bianchi and Petra Moser (2017) find historical evidence that under certain circumstances compulsory licensing – a key mechanism to weaken intellectual property rights that is covered by Article 31 of the TRIPS – may indeed be effective in promoting invention by increasing the threat of competition in fields with low pre-existing levels of competition. They argue, however, that the benefits from weakening intellectual property rights strongly depend on whether the governments can credibly commit to using it only in exceptional cases of emergencies since firms may invest less in R&D if they expect repeated episodes of compulsory licensing. TRIPS-plus conditions mandating standards beyond TRIPS have also been the subject of scrutiny. These FTA agreements contain conditions that limit the ability of governments to introduce competition for generic producers. In particular, the United States has been criticised for advancing protection well beyond the standards mandated by TRIPS. The United States Free Trade Agreements with Australia, Morocco and Bahrain have extended patentability by requiring patents be available for new uses of known products. The TRIPS agreement allows the grant of compulsory licenses at a nation's discretion. TRIPS-plus conditions in the United States' FTAs with Australia, Jordan, Singapore and Vietnam have restricted the application of compulsory licenses to emergency situations, antitrust remedies, and cases of public non-commercial use.

Access to essential medicines

The most visible conflict has been over

AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual m ...

drugs in

Africa Africa is the world's second-largest and second-most populous continent, after Asia in both cases. At about 30.3 million km2 (11.7 million square miles) including adjacent islands, it covers 6% of Earth's total surface area ...

. Despite the role that patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPS. Instead, an interpretive statement, the

, was issued in November 2001, which indicated that TRIPS should not prevent states from dealing with public health crises and allowed for

s. After Doha,

PhRMA Pharmaceutical Research and Manufacturers of America (PhRMA, pronounced ), formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 195 ...

, the United States and to a lesser extent other developed nations began working to minimize the effect of the declaration. A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy. Drugs exported under such a regime may be packaged or colored differently in order to prevent them from prejudicing markets in the developed world. In 2003, the US Bush administration changed its position, concluding that generic treatments might in fact be a component of an effective strategy to combat HIV. Bush created the

PEPFAR The United States President's Emergency Plan For AIDS Relief (PEPFAR) is a United States governmental initiative to address the global HIV/AIDS epidemic and help save the lives of those suffering from the disease. Launched by U.S. President Geo ...

program, which received $15 billion from 2003 to 2007, and was reauthorized in 2008 for $48 billion over the next five years. Despite wavering on the issue of compulsory licensing, PEPFAR began to distribute generic drugs in 2004–05. In 2020, conflicts re-emerged over patents, copyrights and trade secrets related to

COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...

s, diagnostics and treatments.

South Africa South Africa, officially the Republic of South Africa (RSA), is the southernmost country in Africa. It is bounded to the south by of coastline that stretch along the South Atlantic and Indian Oceans; to the north by the neighbouring countri ...

and

proposed that WTO grant a temporary waiver to enable more widespread production of the vaccines, since suppressing the virus as quickly as possible benefits the entire world. The waivers would be in addition to the existing, but cumbersome, flexibilities in TRIPS allowing countries to impose compulsory licenses. Over 100 developing nations supported the waiver but it was blocked by the G7 members. This blocking was condemned by 400 organizations including

Doctors Without Borders Doctor or The Doctor may refer to: Personal titles * Doctor (title), the holder of an accredited academic degree * A medical practitioner, including: ** Physician ** Surgeon ** Dentist ** Veterinary physician ** Optometrist *Other roles ** ...

and 115 members of the

European Parliament The European Parliament (EP) is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts ...

Software and business method patents

Another controversy has been over the TRIPS Article 27 requirements for patentability "in all fields of technology", and whether or not this necessitates the granting of

software Software is a set of computer programs and associated documentation and data. This is in contrast to hardware, from which the system is built and which actually performs the work. At the lowest programming level, executable code consists ...

and

business method patent Business method patents are a class of patents which disclose and claim new methods of doing business. This includes new types of e-commerce, insurance, banking and tax compliance etc. Business method patents are a relatively new species of paten ...

References

Sources

* Braithwaite and Drahos, ''Global Business Regulation'',

Cambridge University Press Cambridge University Press is the university press of the University of Cambridge. Granted letters patent by Henry VIII of England, King Henry VIII in 1534, it is the oldest university press A university press is an academic publishing hou ...

, 2000 * Westkamp, 'TRIPS Principles, Reciprocity and the Creation of Sui-Generis-Type Intellectual Property Rights for New Forms of Technology'

003 003, O03, 0O3, OO3 may refer to: *003, fictional British 00 Agent *003, former emergency telephone number for the Norwegian ambulance service (until 1986) *1990 OO3, the asteroid 6131 Towen * OO3 gauge model railway *''O03 (O2)'' and other related ...

6(6) The Journal of World Intellectual Property 827–859, * Banerjee and Nayak, 'Effects of trade related intellectual property rights on the research and development expenditure of Indian pharmaceutical industry' 0145 Journal of Pharmaceutical Health Services Research 89–94. * A free textbook for download.

External links

TRIPS agreement
(PDF version)

(html version) * World Trade Organization links *

*

Audio presentation by Professor Susan Sell, George Washington University, on intellectual property rights in the global context.

WTO TRIPS Agreement profile on database of Market Governance Mechanisms
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