World Trade Organization's TRIPS Research Articles

Facilitating African Countries’ Participation in the Global Trading System

Africa’s relatively low economic power has meant that it has had low participation in rule-and-decision making at the most important global economic governance fora, except the World Trade Organization (WTO). The consensus nature of most WTO decisions has encouraged African countries to participate actively in that organisation and seek to influence its rules and practice in areas of strategic African political, economic, and social interest. With the support of key technical partners like the Advisory Centre on WTO Law, African Members of the WTO have been able to leave their mark on WTO negotiations, as well as participate in dispute settlement proceedings as main parties and, mainly, third parties. The Advisory Centre on WTO Law (ACWL) has also been actively involved in building the capacity of Africans in WTO law through its flagship Secondment Programme for Trade Lawyers and its sponsorship and support of the John H. Jackson Moot Court Competition. Africa, World Trade Organization, Advisory Centre on WTO Law, capacity building, negotiations, TRIPS and Access to Medicines, DSU Review, dispute settlement, ACWL Secondment Programme for Trade Lawyers, John H. Jackson Moot Competition

Trick Or Treaty?: The Australian Debate Over The Anti-Counterfeiting Trade Agreement 2011

The secretive 2011 Anti-Counterfeiting Trade Agreement – known in short by the catchy acronym ACTA – is a controversial trade pact designed to provide for stronger enforcement of intellectual property rights. The preamble to the treaty reads like pulp fiction – it raises moral panics about piracy, counterfeiting, organised crime, and border security. The agreement contains provisions on civil remedies and criminal offences; copyright law and trademark law; the regulation of the digital environment; and border measures. Memorably, Susan Sell called the international treaty a TRIPS Double-Plus Agreement, because its obligations far exceed those of the World Trade Organization's TRIPS Agreement 1994, and TRIPS-Plus Agreements, such as the Australia-United States Free Trade Agreement 2004. ACTA lacks the language of other international intellectual property agreements, which emphasise the need to balance the protection of intellectual property owners with the wider public interest in access to medicines, human development, and transfer of knowledge and technology.In Australia, there was much controversy both about the form and the substance of ACTA. While the Department of Foreign Affairs and Trade was a partisan supporter of the agreement, a wide range of stakeholders were openly critical.After holding hearings and taking note of the position of the European Parliament and the controversy in the United States, the Joint Standing Committee on Treaties in the Australian Parliament recommended the deferral of ratification of ACTA. This was striking as representatives of all the main parties agreed on the recommendation. The committee was concerned about the lack of transparency, due process, public participation, and substantive analysis of the treaty. There were also reservations about the ambiguity of the treaty text, and its potential implications for the digital economy, innovation and competition, plain packaging of tobacco products, and access to essential medicines. The treaty has provoked much soul-searching as to whether the Trick or Treaty reforms on the international treaty-making process in Australia have been compromised or undermined.Although ACTA stalled in the Australian Parliament, the debate over it is yet to conclude. There have been concerns in Australia and elsewhere that ACTA will be revived as a ‘zombie agreement’. Indeed, in March 2013, the Canadian government introduced a bill to ensure compliance with ACTA. Will it be also resurrected in Australia? Has it already been revived? There are three possibilities. First, the Australian government passed enhanced remedies with respect to piracy, counterfeiting and border measures in a separate piece of legislation – the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). Second, the Department of Foreign Affairs and Trade remains supportive of ACTA. It is possible, after further analysis, that the next Australian Parliament – to be elected in September 2013 – will ratify the treaty. Third, Australia is involved in the Trans-Pacific Partnership negotiations. The government has argued that ACTA should be a template for the Intellectual Property Chapter in the Trans-Pacific Partnership. The United States Trade Representative would prefer a regime even stronger than ACTA.This chapter provides a portrait of the Australian debate over ACTA. It is the account of an interested participant in the policy proceedings. This chapter will first consider the deliberations and recommendations of the Joint Standing Committee on Treaties on ACTA. Second, there was a concern that ACTA had failed to provide appropriate safeguards with respect to civil liberties, human rights, consumer protection and privacy laws. Third, there was a concern about the lack of balance in the treaty’s copyright measures; the definition of piracy is overbroad; the suite of civil remedies, criminal offences and border measures is excessive; and there is a lack of suitable protection for copyright exceptions, limitations and remedies. Fourth, there was a worry that the provisions on trademark law, intermediary liability and counterfeiting could have an adverse impact upon consumer interests, competition policy and innovation in the digital economy. Fifth, there was significant debate about the impact of ACTA on pharmaceutical drugs, access to essential medicines and health-care. Sixth, there was concern over the lobbying by tobacco industries for ACTA – particularly given Australia’s leadership on tobacco control and the plain packaging of tobacco products. Seventh, there were concerns about the operation of border measures in ACTA. Eighth, the Joint Standing Committee on Treaties was concerned about the jurisdiction of the ACTA Committee, and the treaty’s protean nature. Finally, the chapter raises fundamental issues about the relationship between the executive and the Australian Parliament with respect to treaty-making. There is a need to reconsider the efficacy of the Trick or Treaty reforms passed by the Australian Parliament in the 1990s.

Gene Patents at Home and Abroad: Should the WTO Take Action in Light of Myriad?

In 2012 the U.S. Supreme Court granted certiorari to the Myriad case. In doing so, the Court created an opportunity to harmonize U.S. patent law with global patent law norms regarding patents for composition claims of isolated human gene segments. The domestic importance of this case is high: it is estimated that as of 2005, 40,000 patents in the U.S encompass approximately twenty percent of the human genome.While the decision of the Myriad case is uncertain, the current global operating environment for gene patents poses a veritable minefield for practitioners in relevant industries. This article will attempt to address three questions. First: Is there a practical difference between allowing a patent on isolated genes and disallowing a patent on the method used with the isolated genes to diagnose patients? Second: Should the World Trade Organization (WTO) consider adopting a uniform approach on this issue, or is it too controversial? Third: Does a U.S. Supreme Court decision to disallow Myriad Genetics’ isolated gene sequence patents violate Article 27 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)?In part IIA, this article will examine the current posture of the Myriad case. In part IIB, the article will examine the background of international laws regarding patent law as relevant to the issue of isolated human gene segments. In part IIC, the article will examine the international law regarding patent law and human gene patents. In part IID, the article will examine the relevant U.S. domestic precedent affecting the validity of Myriad’s composition claims.In part IIIA, the article will analyze the differences between allowing a patent on isolated genes and disallowing a patent on the method used with the isolated genes to diagnose patients. In part IIIB, this article will analyze the considerations facing the WTO in considering whether to adopt a uniform approach to human gene patents.The article concludes that there is a difference between allowing a patent composition claim for on an isolated gene patent while disallowing an associated method claim. The WTO should not consider incorporating the World Intellectual Property Organization (WIPO) Substantive Patent Law Treaty into WTO TRIPS. Rather, there are existing mechanisms in the WTO TRIPS agreement that may be amended to facilitate a uniform, global treatment of human gene patents.Finally, a U.S. Supreme Court decision that disallows Myriad Genetics’ isolated gene sequence patents likely would not violate the current WTO TRIPS Agreement Article 27 because of the principle of nationality present in WTO TRIPS and other international patent agreements.

The Health Impact Fund: Enhancing Justice and Efficiency in Global Health

Some 18 million people die annually from poverty-related causes. Many more are suffering grievously from treatable medical conditions. These burdens can be substantially reduced by supplementing the rules governing pharmaceutical innovation. Established by the World Trade Organization's TRIPS Agreement, these rules cause advanced medicines to be priced beyond the reach of the poor and steer medical research away from diseases concentrated among them. We should complement these rules with the Health Impact Fund (HIF). Financed by many governments, the HIF would offer any new pharmaceutical product the opportunity to participate, during its first 10 years, in the HIF's annual reward pools, receiving a share equal to its share of the assessed health impact of all HIF-registered products. In exchange, the innovator would have to agree to make this product available worldwide at the lowest feasible cost of manufacture. Fully consistent with TRIPS, the HIF achieves three key advances. It directs some pharmaceutical innovation toward the most serious diseases, including those concentrated among the poor. It makes all HIF-registered medicines cheaply available to all. And it incentivizes innovators to promote the optimal use of their HIF-registered medicines. Magnifying one another's effects, these advances would engender large global health gains.

R&D for development of new drugs for neglected diseases in India

The world pharmaceutical industry dominated by multinational corporations has neglected research for drugs for diseases of poor countries. Introduction of stronger patent protection in India after World Trade Organization's TRIPS agreement has failed to rectify this deficiency despite the substantial increase in R&D activity. In the light of the experience of the Indian private sector and the public-private partnerships initiated in India for the development of new drugs, the paper explores some policy options and suggests the expansion of public-private partnerships to include organisations from other innovative developing countries such as Brazil and China.

Intellectual property and biotechnology innovation: To protect or not protect?

The intellectual property protection differences between countries is a contentious issue. Countries with strong innovation systems (technology producers) often favor strong intellectual property protection because it motivates innovation by granting innovators temporary market exclusivity for their new, nonobvious and useful inventions; countries with less-developed innovation systems (technology consumers) often prefer weaker patent protection, as it enables them to access inventions developed elsewhere without having to pay licensing or manufacturing fees that may be beyond their capacity (or desire) to pay. Although the World Trade Organization's TRIPS agreement does provide governments the right to use patented technologies without authorization, this compulsory licensing is limited to cases of ‘national emergency or other circumstances of extreme urgency’. Furthermore, there is often disagreement on what constitutes a national emergency or circumstance of extreme urgency. The central question underlying TRIPS claims or unauthorized use of patents is that of their greater impact on a country's industry and economy. A common rationale for unlicensed patent use is that improving their citizen's health is a national priority, so governments ought to produce high-value drugs domestically, without license if necessary, to serve their national interests. Price controls can be seen as a less-extreme version of unlicensed use as, instead of denying innovators profits from domestic sales, price controls give governments greater power in dictating terms. The downside of these strategies, however, is that they can deprive countries of patented technologies; several years ago AstraZeneca responded to pressures from the New Zealand government to lower prices for Zoladex by announcing that they would simply stop selling the drug in that market. Domestic industries can also be affected; Novartis recently bypassed the appeals courts in India and responded to the Indian patent office's decision not to grant its patent for Glivec (sold as Gleevec in the United States) by announcing that it would redirect hundreds of millions of dollars of R&D investments to other countries. India and New Zealand are not alone. There are plenty of other examples of drug companies threatening to withdraw drugs or R&D investments from other developed and developing countries. The common theme in these battles is that these decisions can have broader impacts than the individual products or patents involved. While licensing decisions are often based on individual drugs or individual diseases, they can signal to companies that a given country represents a poor market and can discourage a company from domestic R&D investments or developing of drugs for endemic conditions. The result is that near-term benefits are exchanged for long-term deficits. Although simple logic suggests that all countries – developing and developed – should offer the strongest intellectual property protection possible, that solution is rarely practical for economic reasons, and it deprives government-backed health-care systems a valuable bargaining tool. So, the battle between countries and drug manufacturers will likely continue, using patents, price controls, R&D investment and other levers. What is of particular interest is how the dynamics change as countries transition from being technology consumers to technology producers (or, possibly, the reverse). As countries that were once broad technology consumers develop technology-innovation capacity and find it increasingly favorable to strengthen their patent laws, how can they strengthen these laws while protecting legacy companies and their domestic interests in areas in which they are still net technology consumers? Additionally, as low wage-cost countries face competition from each other, how can they motivate foreign investment in a way that promotes the growth of domestic companies? Furthermore, how much leverage can countries with large markets wield?

Intellectual property and biotechnology innovation: To protect or not protect?

The intellectual property protection differences between countries is a contentious issue. Countries with strong innovation systems (technology producers) often favor strong intellectual property protection because it motivates innovation by granting innovators temporary market exclusivity for their new, nonobvious and useful inventions; countries with less-developed innovation systems (technology consumers) often prefer weaker patent protection, as it enables them to access inventions developed elsewhere without having to pay licensing or manufacturing fees that may be beyond their capacity (or desire) to pay. Although the World Trade Organization's TRIPS agreement does provide governments the right to use patented technologies without authorization, this compulsory licensing is limited to cases of ‘national emergency or other circumstances of extreme urgency’. Furthermore, there is often disagreement on what constitutes a national emergency or circumstance of extreme urgency. The central question underlying TRIPS claims or unauthorized use of patents is that of their greater impact on a country's industry and economy.A common rationale for unlicensed patent use is that improving their citizen's health is a national priority, so governments ought to produce high-value drugs domestically, without license if necessary, to serve their national interests. Price controls can be seen as a less-extreme version of unlicensed use as, instead of denying innovators profits from domestic sales, price controls give governments greater power in dictating terms. The downside of these strategies, however, is that they can deprive countries of patented technologies; several years ago AstraZeneca responded to pressures from the New Zealand government to lower prices for Zoladex by announcing that they would simply stop selling the drug in that market. Domestic industries can also be affected; Novartis recently bypassed the appeals courts in India and responded to the Indian patent office's decision not to grant its patent for Glivec (sold as Gleevec in the United States) by announcing that it would redirect hundreds of millions of dollars of R&D investments to other countries.India and New Zealand are not alone. There are plenty of other examples of drug companies threatening to withdraw drugs or R&D investments from other developed and developing countries. The common theme in these battles is that these decisions can have broader impacts than the individual products or patents involved. While licensing decisions are often based on individual drugs or individual diseases, they can signal to companies that a given country represents a poor market and can discourage a company from domestic R&D investments or developing of drugs for endemic conditions. The result is that near-term benefits are exchanged for long-term deficits.Although simple logic suggests that all countries – developing and developed – should offer the strongest intellectual property protection possible, that solution is rarely practical for economic reasons, and it deprives government-backed health-care systems a valuable bargaining tool. So, the battle between countries and drug manufacturers will likely continue, using patents, price controls, R&D investment and other levers. What is of particular interest is how the dynamics change as countries transition from being technology consumers to technology producers (or, possibly, the reverse). As countries that were once broad technology consumers develop technology-innovation capacity and find it increasingly favorable to strengthen their patent laws, how can they strengthen these laws while protecting legacy companies and their domestic interests in areas in which they are still net technology consumers? Additionally, as low wage-cost countries face competition from each other, how can they motivate foreign investment in a way that promotes the growth of domestic companies? Furthermore, how much leverage can countries with large markets wield?