The Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPs, was signed in Marrakesh, Morocco on April 15 1994. It is one of a number of agreements signed as part of the Uruguay Round of Multilateral Trade Negotiations from September 1986 - April 1994. TRIPs is the first major multilateral agreement aimed at universalizing intellectual property (IP) laws and setting globally enforceable standards of IP protection which has provided viable enforcement bodies and mechanisms. It entered into force January 1 1995 and applies to all members of the World Trade Organisation.
Pre-TRIPs international IP law
The Paris Convention on the Protection of Industrial Property was concluded in 1883 . It deals with the protection and regulation of intellectual property, focusing mainly on patents, trademarks, and other forms of industrial and commercial protection. The Convention possesses four key tenets or principles:
1. Anti-discrimination/national treatment: Any country signed up to the Convention must give non-nationals the same level of intellectual property protection it provides to its own citizens.
2. Framework/Right of Priority: Under this condition an applicant who files for an industrial property right or a patent in a signatory country can, within a certain period of time (usually twelve months), apply for the same protection in all other member countries. These subsequent applications are treated as if they were filed concurrently with the first application. As stated in the WIPO handbook, 'these later applications enjoy a priority status with respect all applications relating to the same invention filed after the date of the first application'. For example, say a patent is filed in France for a particular invention on January 1st 2000. Another party then files a patent application for the same invention in Switzerland three months later, followed by an application from the French inventor for a Swiss patent on June 1st 2000. The French applicant would still be awarded the patent in Switzerland because their application would be treated as dating from January 1st, the date of the first application and so would receive priority. Within a specified time frame, this provision helps to protect inventors and gives them reasonable leeway when transporting an invention across national borders.
3. Practical framework concerning patents and trademarks, including such issues as the conditions for the issuing of compulsory licensing, the right of recognition for inventors and the nature of unfair competition in industrial trade.
4. Administrative and financial provisions for the oversight and implementation of the Convention's terms - the member countries of the Paris Convention constitute a Union for the Protection of Industrial Property, with three administrative bodies: the Assembly (made up of all member countries); the Executive Committee (consisting of one-quarter of the national members, elected by the Assembly for the period between sessions); and the International Bureau of the World Intellectual Property Organisation (WIPO).
The Berne Convention for the Protection of Literary and Artistic Works, known as the Berne Convention,was signed in 1886. Its stated aim was to ensure that literary and artistic works would receive some uniform standards of international copyright protection on which to rely. This would replace the existing system under which artists, writers and creatives received extremely varying copyright protections across national jurisdictions i.e. preferential treatment given to creatives in their country of birth or residence and so on.
In terms of its strictures for minimum terms of copyright protection, the Berne Convention prescribes protection for literary and artistic works for the life of the author plus fifty years (fifty years from publication for anonymous or pseudonymous works), while cinematographic works receive fifty years either from the date at which the author makes the work public, or from the date of completion. With regards to photographic works the Convention leaves the specifics to the discretion of its signatory states, but prescribes a minimum of twenty-five years copyright.
The Berne Convention did not however create international bodies or mechanisms to enforce these standards, and did not compel member states to act in instances of copyright infringement. 
General Agreement on Tariffs and Trade (GATT)
The General Agreement on Tariffs and Trade (the GATT) is a multilateral agreement governing international trade relationships, originally signed in 1947. The stated aim of the GATT according to its preamble was 'the substantial reduction of tariffs and other trade barriers and the elimination of preferences, on a reciprocal and mutually advantageous business'. It functioned as an international organisation, holding under its auspices eight rounds of talks on international trade issues and regulation. The last of these, the Uruguay Round (1986-1994) created the World Trade Organisation to replace the GATT. 
The GATT represented the international trade forum through which the TRIPs legislation was pushed and concluded.
Factors behind the push for TRIPs
A number of trends shaping the 1970s and 1980s led to a situation in which greater protection for intellectual property became seen as essential by certain powerful countries and business organisations.
Growth of international trade
The period after the Second World War, following the institution of the Bretton Woods agreements of 1947-8, saw an unprecedented expansion in international trade. Global merchandise exports rose by more than 8% per annum in real terms 1950-1973. In this period the dominant traders/exporter were the western countries of Europe and North America, and Japan. The United States, helped by its relatively strong economic position following the close of WWII, achieved the position of global dominance in international trade. The growth of cross-border trade during this period was fuelled by political moves towards liberalization of trade arrangements, and by technological advances improving communications and transport links. 
Rise of multinational corporations
Given the increased ease of international transport and the greater fluidity of capital, many developed country companies transitioned into what are now known as multinational corporations (MNCs). These are businesses that focus a large proportion of their economic activity in countries other than their original or 'parent' country, possessing assets across the world and operating through well-established subsidiaries for foreign markets. Key examples of such companies that deal in intellectual property-related products include Pfizer, Monsanto, Microsoft and Apple.  In the 1970s, companies like Pfizer invested more and more of their business in overseas ventures in developing countries, becoming increasingly reliant on foreign markets and trade to fuel profits. 
Technological change, innovation and proliferation
Technological advances, while aiding the growth and dominance of large multinationals, simultaneously dispersed the ability to manufacture, trade and copy products and technology across countries, companies and individuals. For instance, cheap copying machinery for video and CD recordings was widely used throughout the developing world during this period, and in the pharmaceutical field developing nations began to develop their own generic manufacturing industries to produce drugs at a cheaper price than Western imports. Western big business began to see a need to safeguard their dominant position in relevant industries, which could primarily be achieved through the strengthening of international intellectual property laws.
Relative economic decline of developed countries
From the economic high point of the 1950s and 60s, during the 1970s and 80s developed countries began to see a decline in their balance of trade with the rest of the world. According to the World Trade Organisation, 'the dominant share of the United States in world trade in the early 1950s was eroded in subsequent decades.' The combined share of world trade held by Canada and the United States shrank by 10% between 1953 and 1973. Meanwhile the six key Newly Industrialized Economies (NIEs) of Asia increased their share of world merchandise exports from 2.4% to 9.7% 1963-1983. 
Emergent manufacturing capabilities of developing countries such as China and India began to challenge the dominance of developed countries in exports of goods such as clothing, textiles, office equipment and telecoms devices. This led to loss of jobs in manufacturing in developed countries as production capabilities were progressively outsourced to cheaper developing countries. The 1970s and 1980s saw increased anxiety within developed country administrations about their perceived economic decline and the need to reverse it. For instance, in the US the trade deficit had grown from US$31 billion in 1980 to US$170 billion by the mid-1980s. 
Industries dependent upon the exportation of intellectual property added an extra element of blame to fears around relative economic decline, arguing that wilful copying and reproduction of patented and copyrighted items was costing developed countries billions of dollars annually and needed to be rectified through legal action if future economic growth was to be encouraged. The US especially wanted to improve its international competitiveness by tackling infringement, both in the area of copyright (Hollywood) and patents (pharmaceuticals), given that over 25% of its exports in the 1980s contained a large level of IP content. This was compared to 10% in the immediate postwar period, and rising. 
Growing assertiveness of developing countries on IP issues
At the same time that the developed 'West' was experiencing troubling economic decline, newly post-colonial developing countries were becoming increasingly assertive at an international level about their trading and intellectual property rights, arguing strongly for terms of trade that reflected their development needs and even calling for the creation of a New International Economic Order (NIEO) in which their needs were better serviced. Successes for developing countries in this regard included a 1970 UN General Assembly Resolution on an 'International Strategy for the Second UN Development Decade'. This included a call for a programme of technology transfer and a 'review of the international conventions on patents'.  In 1974 the UN also concluded an agreement with WIPO, charging WIPO with responsibility 'for promoting creative intellectual activity and for facilitating the transfer of technology related to industrial property to the developing countries in order to accelerate economic, social and cultural development'. The developing world continued with its demands at the 1980-1984 WIPO conference, calling for revision of the patent terms of the Paris Convention to give them 'preferential treatment'. 
In addition to increasing demands regarding intellectual property on the world, developing countries also took steps in their domestic legislation to tackle the dominance of foreign firms. For instance, in 1970 India enacted the Indian Patents Act which 'gave priority to national interests over those of foreign firms'  . Many other developed countries took this piece of legislation as their model when implementing patent laws.
Key actors in the push for TRIPs
TRIPs is widely thought of as the result of the concerted lobbying efforts of a few hugely powerful MNCs and national governments. For instance, Susan Sell concluded following her study of TRIPS that 12 corporations were the main actors in lobbying for TRIPS.  In the first stage of the lobbying process, companies in particular developed countries managed to persuade their governments that higher protections for intellectual property was essential to their country's continued economic growth and prosperity. These governments than exerted their disproportionate sway in international bodies such as the GATT to counter developing country resistance and see the multilateral TRIPs agreement passed into international law.
Countries and regional organisations
The United States was the first and key country to lobby for the type of agreement that eventually became TRIPs. It pushed for a more stringent international IP regime in three ways:
1. The United States Trade Representative (USTR), (the key US government official responsible for trade policy), used its powers to pressure Third World countries into the adoption of patent laws amenable to the US.
Following campaigning by business interests, the US government passed the US Trade Act of 1974, the key part of which was Section 301. Through this Section the USTR undertook a new annual task of effectively flagging up countries which did not live up to desired US standards of IP protection. Those countries placed on Section 301 'watch lists' and 'priority watch lists' were for the first time subject to formal notification of US displeasure and that country's intention to impose trade sanctions (tariffs on exports)should the listed nations not satisfactorily reform said patent laws.
Section 301 notifications mainly befell either those developing countries that had begun to compete with US firms through generic manufacturing industries, or those that were vocal in demands for Third World-friendly patent and copyright reforms. It was thus designed as a trade 'stick' with which to overcome developing country resistance to the harmonization of their patent and copyright laws with those of the US. For instance, punishing tariff conditions were imposed on Brazil in 1987. Arguably a factor reinforcing US resolve to do so was Brazil's key leadership in the developing world's fight against the extension of intellectual property rights.
In 1988 these procedures for forcing IP compliance were strengthened by the creation of the 'Special 301' in the 1988 Trade Act, which now legally required the USTR to impose sanctions on those watch-listed countries which did not reform their patent laws.
In addition in 1984 the renewal of the United States' Generalised System of Preferences (GSP) Renewal Act added the qualification of IP protection as one of the hurdles for countries to receive GSP treatment (more amenable terms for their exports to the US)
2. Intellectual property protection became a key component of all free trade agreements concluded by the US. For instance, the North American Free Trade Agreement (NAFTA) concluded with Canada in 1993 saw the Canadians mould their patent laws into a US shape through Bill C-91.
Terms protecting intellectual property were included in the Bilateral Investment Treaty programme pursued by the US with developing countries in the 1980s.
3. The US lobbied for the inclusion of IP protection in the Uruguay Round of GATT talks, which ran from 1986 to 1994, and persuaded other developed countries to do the same. USTRs in the early 1980s, first William Brock and then his successor Clayton Yeutter (both sympathetic to the IP cause)sought to create integrated networks which could be used to persuade other developed countries to support the US position. In 1981 Brock formed the Quadrilateral Group (Quad) consisting of key developed countries: the United States, the European Union, Japan and Canada. However, at meetings in the early 1980s there was little support from the other members of the Quad for such an agenda; the key task of persuasion fell on global business networks. 
Though initially sceptical of the American IP orthodoxy, the EU began to accept some its ideas and to pursue its own pattern of IP pressure in the mid-1980s. In 1984 the EC also reformed its trade law to include provisions protecting IP, and created a '301'-style 'new commercial policy instrument'to protect European property interests. It used this new instrument against Thailand and India for record piracy and suspending Korea's trading privileges for failures in IP protection for European businesses. 
Japan, like the European Union, took onboard the message from the USTR and the IPC about intellectual property and joined the developed world campaign for the inclusion of the IP in the GATT.
Corporations and business organisations
The pharmaceutical corporation Pfizer had become a wholly global company by the 1980s, with 21 manufacturing plants located in developing countries and 4-6 research and development (R&D laboratories) located outside the US.  In the early 1980s Pfizer executives were part of an elite group of business leaders who began to lobby the US government for an inclusion of intellectual property in the GATT. Top employees, including Edmund Pratt (Chairman of Pfizer 1972-1992 and CEO 1972-1991) became outspoken proponents of 'a trade-based approach to IP'. Pratt, for instance, began to deliver speeches to business organisations such as the National Foreign Trade Council and the Business Round Table in which he presented a symbiotic vision of trade, IP and investment. 
Pfizer also sought to dominate the influential business organisations that possessed access to and influence with the highest levels of American government. Pratt became a member of the influential Advisory Committee on Trade Negotiation (ACTN) in 1979 and became its Chairman in 1981. Other Pfizer executives also held influential positions. Gerald Laubach, President of Pfizer Incorporated was a board member of the Pharmaceutical Manufacturers Association and also on the Council of Competitiveness created by US President Ronald Reagan. Pfizer’s General Counsel Lou Clemente headed the Intellectual Property Committee of the US Council for International Business and Bob Neimeth, the President of Pfizer International, was the Chair of the US side of the Business and Industry Advisory Committee to the OECD. Through such high-level positioning and membership, Pfizer began to put forward its view of IP as a key facet of trade policy. 
As well as pushing the issue with government officials, Pfizer communicated the new IP message throughout the American business community, to business councils, chambers of commerce, trade associations, business committees and so on. Pfizer also sought to frame the debate over intellectual property and win over ‘hearts and minds’ by funding numerous thinktank projects on IP, giving conferences to such academic bodies and through articles in the media like Barry MacTaggart’s (then Chairman and President of Pfizer International) 9 July 1982 op-ed piece ‘Stealing from the Mind’ in the New York Times. This reiterated the charge that other governments, such as Brazil, Taiwan and South Korea, were effectively stealing American knowledge and research. 
Headed by its then CEO, John Opel, IBM came to follow closely in Pfizer’s footsteps in pressing the IP agenda, specifically emphasising international copyright over software and the express forbidding of reverse engineering. This represented a reverse from its position in the 1960s and early 1970s that argued against restrictive IP controls on software. Opel served on ACTN and acted as the head of its Task Force on IP in relation to trade and investment.  He and Pratt formed the Intellectual Property Committee (IPC) for the purpose of pushing the IP agenda across international business.
Committees and business groups
The Intellectual Property Committee (IPC) was created in 1986 by Pratt and Opel to garner support from foreign business communities for the new US orthodoxy on IP. It was an 'ad hoc coalition' of 13 key US corporations: Pfizer, IBM, DuPont, Monsanto, General Electric, General Motors, Hewlett-Packard, Bristol-Myers, FMC Corporation, Johnson& Johnson, Merck, Rockwell International and Warner Communications. The IPC described itself as 'dedicated to the negotiation of a comprehensive agreement on intellectual property in the current GATT round of multilateral trade negotiations'. The committee built up regular contact with European and Japanese business and government officials. In November 1986 it established a line of communication with the Union of Industrial and Employers' Confederations of Europe (UNICE), the most influential business organisation for European companies.
As Peter Drahos describes, the IPC remained active throughout the Uruguay Round negotiations, sending delegations to Europe in June 1986 and Japan in August 1986. In 1988 it submitted an exhaustive proposal for a draft TRIPS agreement to their respective governments and proceeded to campaign to build momentum behind this draft legislation. The IPC was successful in winning over European and Japanese business, which began to pressure their own governments to push for intellectual property protection. 
The Advisory Committee on Trade Negotiation (ACTN) was created in 1974 by the US Congress. Under American trade law its role was to act as the top committee in the hierarchy of a ‘private sector advisory system’ (Drahos FTA article). It gave key business executives and representatives direct access to the USTR and the ability to advise on trade policy. The system had been created to ensure correspondence between the goals of US business and official government trade policy. In the 1980s, under the leadership of Edmund Pratt (CEO of Pfizer) from 1982 ACTN began to strongly push the doctrine of increased IP protection.  Through its concerted efforts, the US trade message began to be: no inclusion of intellectual property on the agenda, no new GATT trade round.
With ACTN a Task Force on Intellectual Property was established. Peter Drahos and John Braithwaite summarise its recommendations as follows:
- that the link between trade and intellectual property be recognised and that its legitimacy by accepted by the IP community
- that as an interim measure the US pursue bilateral and unilateral efforts to improve IP standards in 'problem' countries
- that work on a counterfeiting code continue
- that a broader IP code with minimum standards and dispute settlement procedures be developed
- that the negotiations take into account the hostility of certain developing countries and that consideration be given to pursuing negotiations of an IP code on a plurilateral basis amongst like-minded developed countries
- that a rapprochement be sought between the WIPO and GATT secretariats
- that the USTR draft a policy statement making clear the importance of the IP issue to the US and that the USTR establish a separate policy committee on IP
In March 1986 the Task Force released its Phase Two recommendations:
- that there be development of an overall IP strategy by the US government endorsed by the President and Cabinet
- that there was a need for a massive consensus-building exercise, especially with the US' major trading partners in the first instance. The Task Force welcomed the consensus among the Quad Group to get IP on the agenda for the next trade round, but pointed out that that consensus had to be expanded to include developing countries
- that there should be use of Section 301 and the Generalised System of Preferences to link access to the US market to improved IP protection, including any other 'stick' measures such as the use of US votes at the IMF and the World Bank when voting on access by countries with poor IP protection to those facilities
- that the US join the Berne Convention in order to give it a stronger voice in WIPO
- the need to continue supporting WIPO because more than any other organisation it had the technical expertise to develop IP regimes as well as money to fund technical assistance programmes that would spread the institution of IP to developing countries 
The International Intellectual Property Alliance was formed in 1984, consisting of 8 trade associations and representing approximately 1500 American companies.  The IIPA delivered economic reports and legal analysis to further support the IP arguments. In effect it became the investigative and analytical arm of the USTR, providing that office with data regarding intellectual property as a whole, and the 301 and GSP processes in particular, which it simply did not have the resources to compile itself. For instance, the IIPA prepared a significant economic report on piracy in 1985, entitled 'Piracy of US Copyrighted Works in Ten Selected Countries' which marked the beginning of this 'symbiotic relationship'.  It provided the quantitative data to be used to support the IP cause.
Negotiations of TRIPS
The Uruguay Round talks
Negotiations for what eventually became TRIPS were part of the agenda of general trade talks at the Uruguay Round of multilateral GATT conferences, held from 1986 to 1994. The talks were launched in Punta del Este in September 1986. The lobbying efforts beginning with American business had succeeded in achieving a reference to 'trade-related aspects' of intellectual property in the Ministerial Declaration of 20 September setting up the conference. The Declaration announced that 'the negotiations shall aim to clarify GATT provisions and elaborate as appropriate new rules and disciplines'. 
Initial drafts and submissions
On the 14 June 1988 the Intellectual Property Committee released a legislative proposal: the 'Basic Framework of GATT Provisions on Intellectual Property: Statement of Views of the European, Japanese and United States Business Communities'. This Basic Framework was described by Edmund Pratt as a 'multilateral blueprint' for negotiations over intellectual property and trade. The Framework called for the elimination of piracy, the criminalisation of infringement of IP rights, strict limits on public interest exceptions to such property rights and the agreement of stringent enforcement procedures in the IP field.
A mid-point review of the Uruguay Round talks also produced a short framework agreement stating that negotiations would include 'adequate standards and principles' of IP protection and would provide for the 'settlement of dispute between governments, including the applicability of GATT procedures'. 
In May 1990 Lars Anell, the Chairman of the TRIPS Group, produced a 'Chairman's Draft' collating both developed and developing country submissions and aims into one draft. He wanted to create sufficient support for a single draft to enable the conclusion of a binding multilateral agreement for all countries, rather than optional code on IP. 
The Dunkel Draft and final versions
On 20 December 1991 the Director-General Arthur Dunkel produced a compromise legislative draft, the 'Draft Final Act Embodying the Result of the of the Uruguay Round of Multilateral Trade Negotiations'. It became known as the Dunkel Draft or the DFA.
The Dunkel Draft tried to draw the somewhat stalled IP talks towards a compromise agreement. Dunkel attempted to build consensus on contentious areas by awarding the major states each some success, while balancing it with the wishes of the others. For instance, the European Community failed to achieve the inclusion of the key European intellectual notion of authorial rights in the terms relating to copyright, but instead received concessions on appellations of origin for wines and spirits. Likewise, the Japanese retained their practice of CD rental, and the US achieved the extension of patentability across all fields, but had to accept that countries could exclude some objects from patentability. While the national members of the developed Quad received these meaningful advantages however, the developing countries received only the benefit of transitional periods before having to comply with these terms. 
Nevertheless, with the backing of the Quad, the Dunkel Draft in nearly its complete form was able to overcome developing country opposition and became 'more or less the final deal on intellectual property' ; the Dunkel Draft became TRIPS. The only adjustment to its terms was achieved by the semi-conductor industry through the Semiconductor Industry Association (SIA), by which compulsory licensing of semi-conductors was defined with a much more limited scope. 
The TRIPS Agreement
On the 15 April 1994 the Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations was signed. TRIPS was one of the key 28 agreements making up this Act. TRIPS came into force on January 1 1995, the same day that the World Trade Organisation (which oversees TRIPS) was created.
Key terms of TRIPS
Section 5 of the Agreement deals with patents. Under TRIPS patents should be available for a uniform term of twenty years from the date of filing across all areas of technology (with certain limited exceptions). The Dunkel Draft states: ‘...patents shall be available for inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application’.  Patent rights are also made universally enforceable across signatories’ borders, applyling ‘without discrimination as to place of invention, field of technology, or whether the products are imported or locally produced.’ 
Article 28, Paragraph 1 outlines the patent rights conferred by TRIPS. These stipulations give the patent holder exclusive commercial control: ‘A patent shall confer on its owner the following exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having his consent from the acts of: making, using, offering for sale, selling, or importing for these purposes that product; (b) where the subject matter of a patent is a process, to prevent third parties not having his consent from the act of using the process, and from the acts of: using, offering for sale, selling or importing for these purposes at least the product obtained directly by that process.’  Importation of a patented product is now automatically considered to be working of the patent, unlike under the Paris Convention. This means that patent rights become global, not dependent upon and confined to the country of issue.
However, countries can deny patents when it is considered essential for ‘ordre public’ that a certain invention is not commercially exploited. Article 27.3 provides important specific exceptions to patentability.
Article 27.3(a): Countries can deny patents for diagnostic, therapeutic and surgical methods for the treatment of humans or animals. For public health purposes, ‘members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by domestic law.’
Article 27.3(b): Countries can deny patents for plants, animals and ‘essentially biological processes’ for producing plants or animals. (However, non-biological and microbiological processes for plant or animal production must be patented.) Micro-organisms i.e. genes and cells must be patented, though TRIPS does not specify the manner in which this should be carried out.
Article 30 defines the requirements for legitimate exceptions to patent right: ‘members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of the patent owner’.
Article 31 provides for compulsory licensing under products such as pharmaceuticals, provided a number of specified criteria are met. The conditions specified for the issuing of a compulsory licence are: 1. That authorisation for compulsory licensing be considered on the merits of each individual case 2. That the licensee has ‘made efforts to obtain authorisation from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time’ 3. That the scope and timeframe of the licence is limited and only for specifically authorised purposes 4. That the licence is ‘non-exclusive’ 5. That the licence is ‘non-assignable’ 6. That the use of the license is predominately for the supply of the country’s domestic market only 7. That the licence does not exceed its limited purpose; it should ‘be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur’ 8. That the right holder receives sufficient compensation: ‘the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorisation’ 9. That the compelling of the licence is open to judicial review 10. As is the amount of remuneration 
Plant variety protection
Under TRIPS plants must be protected ‘either by patents or by an effective sui generis system or by any combination thereof’. For this purpose countries may either incorporate the terms of the International Convention for the Protection of New Varieties of Plants (UPOV) or create their own sui generis system. 
Data protection and competition policy
Under Article 8.2 of TRIPS countries may adopt measures designed to prevent unfair abuse of IP rights or anti-competitive practices. States must takes measures to protect against the illegitimate acquisition of undisclosed data and its ‘unfair commercial use’. 
TRIPS extends the term of copyright for literary and artistic works to the life of the author plus fifty years. In addition, copyright protection must now be provided for computer software and original date compilations (databases) and rental rights provided for sound recordings, films and computer programmes. 
It does continue a number of the provisions of the Berne Convention dealing with the allowance of ‘fair use of copyrighted works’. This includes the legitimacy of the use of literary or artistic works for educational purposes in publications, broadcasts and sound or visual recordings, if such use is compatible with fair practice. Governments may also allow limited reproduction of copyrighted works in specific circumstances if this does not infringe either the normal exploitation of the work or the legitimate interests of the author. TRIPS includes the Berne Appendix, which provides developing countries with the carefully delineated option of compulsory licensing, in order to purchase or copy imports of literary or artistic works from abroad, in order to promote educational access. 
While software must now be copyrighted in the same manner as literary works, TRIPS makes no mention of whether or not it is acceptable to licence both reverse engineering of software or activities to promote software interoperability. This ambiguity leaves governments with the option to permit both in order to take advantage of software developments. 
Monitoring, enforcement and dispute settlement
In terms of monitoring and enforcement at the national level, TRIPS prescribes that all members must set up an industrial property service and central patents office for the oversight of IP issues. Article 61 states that signatories must put in place criminal penalties and procedures to deal with trademark counterfeiting and copyright piracy, including the imposition of ‘imprisonment and/or monetary fines sufficient to provide a deterrent’ . However, beyond these limited specifications, and the legal and administrative obligations that improvement of enforcement measures does take place, TRIPS is somewhat ambiguous about the specific national systems to be set up for enforcement. For instance, there is no requirement that member states set up a system of courts to prosecute IP matters, and a number of key enforcement terms, such as ‘expeditious remedies’, ‘adequate remuneration’ and ‘effective action’ are left undefined and to the discretion of individual governments. 
International oversight and monitoring is undertaken by the Council for TRIPS (TRIPS Council). This is composed of representatives from each WTO member, and meets formally in Geneva five times annually, as well as informal meetings as and when required. TRIPS stipulated a thorough review of the Agreement in 2000, and every two years thereafter. 
The TRIPS Council is also the body to which any member state can take a complaint about the conduct of other members, after which it becomes subject to the Dispute Settlement Understanding (DSU) of the WTO . The complaint will be referred to a three-person dispute settlement panel, composed of experts on trade matters, who investigate and issue a decision on whether or not the accused country has violated the terms of TRIPS. A panel decision can be appealed to a seven-member standing committee, the Appellate Body. The verdict of this body in a dispute is final unless all the members of the WTO - including the country that brought the grievance in the first place - vote to reject its decision, a process known as ‘reverse consensus’. This requirement is in sharp contrast to the previous GATT system in which all members had to vote in favour of a dispute settlement recommendation; in effect these decisions are now assumed approved until proven otherwise. Following such a decision, if the violating country does not amend its actions or legislation to comply with TRIPS it must pay perpetual compensation to the complainant country, which can take the form of ‘cross-sectoral retaliation' in which sanctions are instigated against another area of its economy, even if this industry is compliant with TRIPS regulations. 
Administrative role of WIPO
The WIPO Secretariat helps with technical assistance for implementation of IP agreements, dispute settlement services and training and advice. It also operates a series of standing expert of intergovernmental committees which investigate specific topics within the IP field and recommend potential courses of action in dealing with these issues. Both the WTO and WIPO Secretariats are a key part of fulfilling the obligation placed on developed countries under TRIPS to provide technical support and assistance to developing countries in implementing IP agreements. 
The key initial flexibility of TRIPS was the differential time periods it allowed for countries to bring their legislation in line, based on differences in economic development. Developed countries were given one year from the date that TRIPS came into force (January 1 1995), while developing countries generally had until the year 2000, and those on the UN’s list of least-developed countries (LDCs) until 2006. In countries that did not pre-TRIPS extend patent protection to certain areas e.g. pharmaceutical and chemical agricultural products, were given until January 1 2005 to do so, though from 1995 they had to establish a 'mailbiox' system via which patent applications in these areas could be filed and stored until a working patent system was in place. LDCs were given until 2006 to advance patents for pharmaceutical protection and did not have to create a mailbox system for the intervening period. In 2005 the deadline for LDCs was extended to 2013, and 2016 for pharmaceutical patents. In addition developed countries were required to provided technical assistance to their less developed counterparts in this process. 
Exhaustion of rights
As outlined above, TRIPS does permit a number of exceptions to patent and copyright. It allows for compulsory licensing subject to a number of conditions, and does not directly address the issue of price controls, allowing member countries to implement ‘non-discriminatory’ price control strategies to counteract effects of patenting. Article 6 also allows countries to engage in parallel importing, in which countries can import the cheapest version of a product available without the express consent of the patent-holder in their country, provided the licence has been approved in the exporting country. 
In particular, the Agreement gives countries the discretion to decide the point at which they deem IP rights to have been exhausted (the point at which the patent rights are no longer exclusive and third party use is permitted). TRIPS gives countries three avenues to follow when constructing their exhaustion regime: 1. National – IP rights are considered exhausted when the protected product has been placed on the market either by or with the consent of the right-holder in the country in which the right was granted 2. Regional – this extends the above national exhaustion regime to other countries within a region 3. International – the rights of a particular product are considered exhausted following its consensual commercial exploitation anywhere in the world. Under a national or regional exhaustion system right-holders can take action against parallel imports from outside those specified borders; they do not have this option under an international exhaustion system. 
Moratorium on non-violation complaints
Under other WTO agreements countries may initiate a complaint in what is known as a situation of ‘non-violation’: where the complaint is not that a violation has occurred, but instead that a potential benefit that should be enjoyed by a member is being countered or diminished by the actions of another, even if on the face of it this practice seems compliant. It is a complaint about the lack of a potential advantage rather than an actually-occurring harm. However, in 1993 it was agreed that there would be moratorium on these sort of complaints for the first 5 years of TRIPS (Article 64.2). it was extended in 1999 and remains in effect today. 
Implementation and Effects of TRIPS
Timing of implementation and national variation
Amongst signatories to TRIPS, there has been a large amount of variation in the time taken to actually integrate TRIPS into their domestic legislation. Of the 73 developing countries given a deadline of 2000 for implementation, over half of these 73 had not enacted the minimum of 4 major legislative reforms required for TRIPS compliance by the January 1 2000 deadline. At the end of 2007 more than a dozen developing countries had still not completed the necessary reforms. At the end of 2007 more than a dozen developing countries had still not completed the necessary reforms. However, in contrast, some developing-country members of the WTO had completed the reforms needed to bring their domestic law in line with TRIPS either before or during the TRIPS negotiation process. At least 6 developing countries, including Chile, Mexico and South Korea had reached this stage by the time the WTO was instituted (1 January 1995). The WTO counts 32 LDCs as members. Of these, 14 – 12 African states, Cambodia and Nepal – had brought their legislation in line with TRIPS prior to their original 2006 deadline, well in advance of the extended 2013 deadline. When in 2001 LDCs were given until 2016 to extend patent protection to pharmaceutical products, only 3 African LDCs (Angola, Ghana and Malawi)had yet to do so already. To date only Cambodia and Nepal have taken advantage of the 2016 extension for pharmaceuticals.
What has been surprising in the cross-national implementation of TRIPS is the fact that most countries have not actually taken advantage of the potential flexibilities contained in the agreement. For instance, Carolyn Deere points out that by the end of 2007 less than 15 governments had actually issued a compulsory licence, though as of December 2007 the majority of developing-country signatories to TRIPS had included options for third party use of a patented invention for research, scientific or experimental use. 
Since its enactment TRIPS has faced severe criticism from multiple quarters, including the UN and its constituent bodies, developing-country governments and non-governmental organisations (NGOs). The criticisms of TRIPS have largely focused on three areas: its perceived unfairness and inapplicability to developing countries; public health concerns and human rights issues.
Unfairness to developing countries and infringement of sovereignty
The ethos behind TRIPS – that the stronger the rights the better where intellectual property is concerned –has been analysed as disproportionately benefitting developed countries (so-called net exporters of products involving intellectual property) while disadvantaging net importers of IP products, often those countries which are less developed economically and reliant on foreign expertise in areas like heavy industry and medicine. In particular the United States was the main beneficiary of TRIPS, with some 3676 scientists and engineers in R&D per million people in 2003, compared with Rwanda’s figure of 35 per million. 
In its willingness to classify ‘importation as working of the patent’, Tarun Kabiraj argues that TRIPS will restrict both transfers of technology to developing countries and their own ability to emulate technological advances. The extension of patentability to plant and seed varieties in particular raises the costs of agriculture, upon which many of the economies of the developing world rely.  In February 2003 the UN Development Programme (UNDP) articulated many of these concerns in a report on the global trading system, stating that the ‘relevance of TRIPS is highly questionable for large parts of the developing world’.  In 2002 the World Bank estimated that TRIPS would lead to annual net losses of US $530 million for Brazil, US $5.1 billion for China, US $903 million for India and US $15.3 billion for South Korea. In 2005 developing countries paid net US $17 billion in royalty and licensing fees, while the US alone made $33 billion from IP fees.  Such an unequal system has drawn stark criticism, especially as it is highlighted that TRIPS regulations have been imposed upon the majority of developing countries without their fully informed sovereign consent. Of the 106 developing-country members of the WTO, less than 20 were involved in the negotiations for TRIPS. 
The most prominent area of TRIPS criticism has been its perceived detrimental effects for public health, particularly for citizens of developing countries. It is argued that the terms of TRIPS regarding patents have driven up the costs of drugs for developing countries and made it extremely difficult to tackle public health crises. Third World countries are unable to afford the licensing fees for much-needed medicines in the short term, and in the longer term this lack of purchasing power results in a lack of research by pharmaceutical countries into developing new treatments for developing country health problems.
More specifically, paragraph (f) of the section on compulsory licensing, a provision which is supposed to alleviate costs of pharmaceuticals in situations of public health crises, states that compulsory licensing should be used ‘predominately for the supply of the domestic market of the Member authorising such use’. This effectively outlaws the manufacture and supply of compulsorily licensed drugs by developed countries to developing countries, meaning that developing countries would have to manufacture the drugs themselves or be unable to procure them. This option is impossible for many poor countries, which simply lack the appropriate infrastructure for such manufacturing. The level of concern on this issue has led to further amendments of TRIPS to provide for compulsory licensing partnerships between developed and developing countries, discussed in more detail below. Also, for a product to be legitimately denied patentability under TRIPS it cannot be commercially exploited. Robert Weissman points out that this requirement limits the options available to developing countries to tackle public health issues, for example ruling out production of generic drugs by private companies, compulsory licensing schemes and shortening of patent systems.  The World Health Organisation (WHO) published a 1998 report critical of the health implications of TRIPS and urging the further development and retrenchment of TRIPS flexibilities in this area. 
Human rights issues
Human rights concerns regarding TRIPS centre around the protection of indigenous knowledge and culture, effects on national sovereignty and impacts on quality of life in developing countries. In July 2000 the UN Sub-Commission released a unanimous resolution condemning the TRIPS Agreement in relation to human rights. The resolution stated that ‘actual or potential conflicts exist between the implementation of TRIPS and the realisation of economic, social and cultural rights’. They outlined the negative effects of TRIPS on human rights as including: ‘impediments to the transfer of technology to developing countries, the consequences for the enjoyment of the right to food of plant variety rights and the patenting of genetically modified organisms, ‘bio-piracy’ and the reduction of communities (especially indigenous communities) control over their own genetic and natural resources and cultural values, and restrictions on access to patented pharmaceuticals and the implications for the enjoyment of the right to health.’ Another resolution stated that TRIPS also undermined ‘the rights to self-determination, food, housing, work, health and education, and...transfers of technology to developing countries’. More specific UN reports have focused on individual human rights issues, such as access to medicine and the right of indigenous peoples to ‘the full ownership of their cultural and intellectual property’ and protection against having their property ‘taken without their free and informed consent or in violation of their laws, traditions and customs’. 
On December 12 1997 the South African government passed the South African Medicines and Restricted Substances Act. This allowed the South African health minister to authorise parallel importation of patented medicines, with a view to tackling South Africa’s AIDS crisis, with the highest level of HIV infection in Africa. The Act drew ire from pharmaceutical companies, who argued that it breached the terms of TRIPS regarding patents. The US responded by pressing South Africa to repeal the legislation, placing the country on its 1998 USTR watch-list for possible trade sanctions. In February 1998 41 pharmaceutical companies initiated legal proceedings against the South African government in the South African courts, naming Nelson Mandela as the defendant, in an attempt to force the dropping of the law. The court case drew global outcry against the pharmaceutical industry and in April 2001 the companies involved withdrew from the litigation, worried by the scrutiny of drug prices and company profits it had prompted. 
On 29 November 2006, Thailand issued a compulsory licence for Stocrin (efavirenz), the anti-retroviral AIDS drug patented by the drug company Merck. In January 2007 it did the same with the anti-AIDS drug Kaletra, owned by Abbott. It did this under the provisions contained in TRIPS Article 31. In response Abbott announced that it was withdrawing its applications for licenses for 7 medicines it had been trying to make available in Thailand, including a new version of Kaletra (Aluvia)that did not need to be refrigerated. In April 2007 the USTR placed Thailand on its Section 301 priority watch-list. Thailand refused to alter its decision and the compulsory licence remains in effect today.  
Reforms and adjustments of TRIPS
Doha Declaration on Public Health
Following global agitation around TRIPS and public health, the WTO issued a public health release on November 14 2001 in the Doha Round of GATT talks, known as the Doha Declaration. The Declaration sought to assuage concerns about global public health by reiterating the compatibility of TRIPS with health goals and the sovereign right of countries to interpret its terms in a way designed to address health concerns (Paragraph 4). In dealing with the individual practicalities of public health measures, Paragraph 5(d) of the Declaration outlined the right of nations to practice parallel importing free from external interference. To deal with the potential problems of restricting compulsory licensing to a domestic field in the case of LDCs, Paragraph 6 stated:
‘We [the members of the WTO] recognise that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.’ 
This paragraph was known as the Doha Assignment. Though it missed the deadline of the end of 2002 set out in the Assignment, the WTO did succeed in reaching concrete agreement on this issue, detailed below.
2003 ‘30th August’ amendment
The so-called ‘30th August’ waiver authorised the issuing of a compulsory licence for the supply of necessary medicine to a developing country by a developed country, provided that the patented drug is licensed in the developed jurisdiction and there is evidence of 1) a public health concern; 2) that the importing country’s pharmaceutical industry is lacking or non-existent; 3) that the drug supplied under compulsory licence will be used solely for public, nor-commercial purposes.  In this manner it aimed to ensure an adequate supply of medicines to LDCs where there was insufficient capacity for domestic production as specified in the original agreement. However, this amendment has itself been criticised as being overly complicated and not representing a general exception to the strict compulsory licensing terms, rather a hard-to-negotiate judicial process ‘riddled with practical hurdles and red tape’ (Jorn Sonderholm). In December 2005 the ‘30th August’ waiver was made official and permanent.
Since the conclusion of TRIPS developed countries – particularly the US and to some extent the EU – have continued to push bilaterally for even more stringent IP protection, referred to collectively as ‘TRIPS-‘’Plus’’ legislation. Major IP campaigns undertaken by the US and EU since 2000 include:
- 2004: Launch by the US of a STOP! Initiative aimed at cracking down on global piracy.
- 2006: Announcement of a EU-US Joint Action Strategy for Enforcement.
- June 2006: The EU submits a detailed proposal for the extension of border measures to all kinds of IP in export and transit (under TRIPS border measures apply only to the importation of trade-marked and copyrighted goods). 
Some TRIPS-‘Plus’ free trade agreements (FTAs) concluded by the US in the years since TRIPS include: US-Jordan 2001; US-Chile 2003; US-Singapore 2003; US-Southern African Customs Union; the US-Central American Free Trade Agreement; US-Morocco and US-Australia. Such agreements minimise or remove the flexibilities contained under TRIPS, further limiting the exceptions to patentability. For instance, the US-Singapore FTA substantially limits the potential for compulsory licensing of patented products. This is left rather open under TRIPS Article 30, but under the US-Singapore agreement Singapore can only issue a compulsory licence under tightly drawn and limited specifications: to rectify anti-competitive acts, for public non-commercial use or in situations of national emergency. Some FTAs have required levels of data exclusivity linked to patent protection, preventing generic manufacturers from being able to marketed patented products at any point while it is still under patent, even if a compulsory licence has been granted.  Copyright is a key area in which TRIPS-‘Plus’ measures have been adopted, usually under pressure from the developed world. Of 106 developing countries studied, more than 65 provide a copyright term greater than the minimum required under TRIPS e.g. Mexico and Colombia provide a copyright term of the author’s life plus eighty years, thirty years more than the TRIPS standard. 
Other IP Agreements
The first multilateral act to give copyright protection to databases at a regional European level (shortly followed by the international WIPO Copyright Treaty a year later, discussed below), gave copyright protection to databases defined as ‘a collection of independent works, data or other materials arranged in a systematic or methodical way and individually accessible by electronic or other means’. The Directive introduced a new sui generis right for the creators of databases, regardless of whether their compilations possess ‘an intrinsically innovative nature’.  
1996 WIPO Copyright Treaty
The WIPO Copyright Treaty (WCT) was signed on December 20th 1996 and constitutes a special agreement under the Berne Convention. All signatories to the WCT – even those not signed up to Berne – must adhere to the terms of the 1971 Paris version of the original 1886 Convention. The WCT makes two bold advances in the name of copyright: 1) it extends copyright protection to computer programmes, ‘whatever may be the mode or form of their expression’; 2) it does the same for ‘databases’, defined under its terms as those ‘compilations of data or other materials, in any form, which by reason of the selection of arrangement of their contents constitute intellectual creations.’
The WCT also enlarges authorial control over copyrighted works. It gives authors exclusive control over the ‘right of distribution’ (‘making available to the public the original or copies of work through sale or other transfer of ownership’), the ‘right of rental’ and the ‘right of communication to the public’. In particular the WCT obliges signatories to put in place legal consequences in case of circumvention of technological measures e.g. encryption designed to safeguard these rights of authors.
The Treaty became law on March 6 2002 and is overseen by an Assembly of the Contracting Parties in terms of development and decision-making, and the WIPO Secretariat in a bureaucratic capacity.  
2002 Bonne Convention
In 2002 action was taken by the vast majority of states to address concerns about the degradation of traditional cultures and the misuse of traditional knowledge. The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising Out of their Utilisation followed on from the 1992 Convention on Biological Diversity (CBD), which had been adopted by the majority of states. The key aims of the Convention were: ‘the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources’. Developing-country signatories to the CBD had pointed out in the Conference of the Parties (COP) – the total grouping of Convention members responsible for overseeing its implementation and manner of application – that the terms of TRIP undermined these objectives. For instance, TRIPS mentions nothing about the sharing of benefits derived from the patenting of biogenetic resources, and has no requirements for the protection of indigenous knowledge or even the disclosure of the sources of such knowledge. For instance, the agreement does not mandate the classification of unwritten traditional knowledge as ‘prior art’, meaning that it can be patented in this original form, rendering the rights of control over such knowledge in the hands of the developed-country individual who discover and patent this, rather than its indigenous creators.
The adoption of the Bonne Guidelines was designed to address some of these problems, for instance in its avocation of encouraging ‘the disclosure of the country of origin of genetic resources [and traditional knowledge and information] in applications for intellectual property rights, where the subject matter of the application concerns or makes use of genetic resources [or such knowledge] in its development.’ The guidelines recommend monitoring of these disclosures to check whether or not applicants for patents involving such material have followed the rules of access and have the consent of the country concerned. 
Described as ‘the most important intellectual property agreement concluded in more than a decade’, the Anti-Counterfeiting Trade Agreement (ACTA) was finalised in December 2010. ACTA is represents the most ambitious piece of ‘TRIPS-Plus’ multilateral legislation to date. ACTA has been signed by the US, Canada, 22 European countries including the UK and France, Japan, South Korea, Mexico, Morocco, New Zealand, Singapore and Switzerland.
The provisions of ACTA involve the imposition of higher penalties for copyright infringement across all kinds of intellectual property, for instance, requiring states to criminalise commercial activities with only ‘indirect economic or commercial advantage’ as copyright piracy or trademark counterfeiting and extending criminal liability to ‘third parties’, potentially including Internet Service Providers (ISPs). Potential punitive consequences for such actions under ACTA can involve BOTH monetary fines and imprisonment, as opposed to under TRIPS, which specifies either/or. More stringent border enforcement is another main aspect of the Act, as it requires contracting states to give customs officials ex officio authority to detain suspected contravening items. In terms of ‘technological borders’ such as encryption techniques and other technical protection measures, more extensive monitoring and policy is required.   
Current status and prospects
In 2012 the issues exercising the members of the TRIPS Council are still focused on the issues of public health, LDC transition and copyright access. Specifically, numerous concerns have been raised in the TRIPS Council, primarily by developing countries, regarding the impact of the Anti-Counterfeiting Trade Agreement of 2011, the relationship of TRIPS to the CBD and the practical issues surrounding implementation review and technical assistance in LDC transition. Below are the main problems and directions discussed at the TRIPS Council meeting in February 2012.
TRIPS and ACTA
At the February 2012 meeting of the Council various concerns were raised about the implications of ACTA for TRIPS. Among the potential concerns with ACTA raised at this meeting were that the seizure of suspected counterfeit goods at borders could undermine the access of poor countries to affordable medicines (India), when these goods were generic medicines, despite efforts to secure their availability under TRIPS. Brazil, Bangladesh, Ecuador, Egypt and Thailand also voiced issues regarding ACTA’s applicability to all regions and its effect on public health.
TRIPS and biological diversity
In 2012 there has been continuing discussion regarding the role of TRIPS in relation to the protection of traditional knowledge and folklore, and its relationship to the CBD. Closer cooperation was called for between the WTO apparatus and the CBD Secretariat in the review of TRIPS Article 27.3(b) at the February meeting.
Continuing management of transitional periods and implementation
In February 2012 the TRIPS Council requested that consultation should be carried out on its ‘continued examination of the scope and modalities’ for non-violation and situation complaints, ahead of the review of their moratorium to be held at the 9th Session in 2013.
The Council continued to focus on the process of LDC transition towards compatibility with TRIPS, reiterating the priority of technical assistance. The EU presented a comprehensive report of its technical cooperation activities. 
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- See Reference 8, pp134-135
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