Intellectual Property Chapter Research Articles

Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement.

Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved. Three of the greatest concerns for Australia in the recent draft include provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms and extend monopoly rights over clinical trial data for certain medicines. Data from the 2013 Pharmaceutical Patents Review, and from various submissions made to it, show that pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars each year. Provisions still being considered for the TPPA would further entrench and extend costly monopolies, with serious implications for the budget bottom line and the sustainability of the Pharmaceutical Benefits Scheme.

Assessing the Impact of Alternative Patent Systems on the Cost of Health Care: The TPPA and HIV Treatment in Vietnam

In the Trans Pacific partnership Agreement (TPPA) negotiations, the United States has proposed expanded patent protections that will likely impact the affordability of medicines in TPPA partners. This includes antiretroviral (ARV) medicines used in the treatment of HIV/AIDS. Vietnam has the lowest GDP per capita of the 12 countries participating in the TPPA negotiations. Using the current Vietnamese patent regime as our base case, we analyse the potential impact of alternative patent regimes on access to ARVs in Vietnam. The two other scenarios investigated are a patent regime making full use of TRIPS flexibilities, and a regime based on the US proposals in the 2014 leaked draft of the TPPA intellectual property chapter. Using World Health Organization (WHO) treatment guidelines, we identified the most commonly used chemical entities and combinations used in the treatment of HIV. We examined patent data sets to discover patents that had been registered for these medicines and used information from examination of these patents to identify which might be granted under alternative patent regimes. We then drew on the empirical literature to estimate prices under the three patent scenarios. The current ARV budget was used as a constraint, with the consequence that the results focus on the impact of alternative patent regimes on access to treatment. Our results indicate 82% of the HIV population eligible for treatment would receive ARVs under a full TRIPS flexibility scenario, while only 30% of Vietnam's eligible HIV patients would have access to ARVs under the US 2014 TPPA proposals – more than halving the proportion treated compared to the current 68% receiving treatment. Similar price impacts can be expected for other countries participating in the TPPA, though these are less economically vulnerable than Vietnam.

Evolving trade policy and the Trans-Pacific Partnership Agreement: Does it threaten Vietnam's access to medicine and its progress towards scaling up HIV prevention, treatment and care?

The Trans-Pacific Partnership Agreement (TPP) has undergone 18 rounds of secretive negotiation between the USA and 11 Asia-Pacific countries. Aiming at a free trade area, this multilateral trade proposal covers all aspects of commercial relations among the countries involved. Despite some anticipated positive impacts in trade, specific articles in this proposal's intellectual property and transparency chapters might negatively impact access to medicine, in general, and to antiretroviral (ARV) drugs, in particular, in Vietnam. Drawing on a desk review and qualitative in-depth interviews with 20 key informants from government, academia, hospitals and civil society, we analyse various provisions of the proposal being negotiated leaked after the 14th round of negotiations in September 2012. Findings suggest that the TPP could lead to increased monopoly protection and could limit technological advancements within the local pharmaceutical manufacturing industry, resulting in higher medicine prices in Vietnam. This outcome would have a significant impact on Vietnam's ability to achieve goals for HIV prevention, treatment and care, and create barriers to universal health-care coverage. This research provides unique evidence for Vietnam to advocate for more equitable pharmaceutical provisions in and to raise awareness of the implications of the TPP among the pharmaceutical stakeholder community in Vietnam.

The study on intellectual property chapter in TPP

The study on intellectual property chapter in TPP

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.

Tailoring Patent Policy for Developing Economies

As intellectual property chapters are now regularly part of free trade agreements, countries need to have a clear view of what elements of a patent system will encourage domestic innovation and what elements will simply raise the cost of goods and services. Drawing on the range of empirical material available about patent systems this paper presents an initial analysis of critical design elements to maximize economic welfare while implementing patent policy in developing and technology-importing economies. Key issues considered are: patent policy objectives; limitations to patentable subject matter; the height of the inventive step; the privileges provided by patents; incentives, penalties and strategic gaming; and transparency issues particularly oversight, evaluation and audit. Development of a set of policy principles which align with maximizing national economic well-being goes some way to meeting the goals of the Development Agenda Group put forward in the context of WIPO's Committee on Development and Intellectual Property. Such a set of principles would also play a useful role in assessing the value of patents in trading for improved market access for goods and services thus assisting an evidence-based approach to trade negotiations.

Free Trade Agreements and Access to Medicines: Need for Regulation

TRIPS Agreement was entered into by WTO members as a means to create a unified Intellectual Property regime across the world. The provisions of TRIPS act as a minimum standard which has to be followed by the member countries. TRIPS provisions had forced the developing and least developed countries to create and follow an IP regime which was not suitable for their technology and needs. One of the severe impacts of following such a regime was on the public health sector. Before TRIPS came into being, a large number of countries had refused to grant patents for pharmaceutical products and even if the same was granted the countries provided for a flexible compulsory licensing procedure, enabling the growth of generic drug industries, thus allowing the manufacture of essential drugs at a cheaper cost. This flexibility was taken away by the TRIPS agreement which hampered the capability of the developing and least developed countries to provide for an effective public healthcare system. This disparity led to the Doha Declaration and WTO Para. 6 decision in 2003, allowing more flexible provisions regarding compulsory licensing and thereby to some extends resolving the issues. While these measures were being adopted which were lauded by organs of UN and WHO, the developed countries went on with TRIPS plus provisions in their countries. Recent years have shown the world a new trend amongst the developed countries, wherein they, through the Free Trade Agreements (FTAs) with the developing countries, impose TRIPS Plus Intellectual Property Standards. The Regional Trade Agreements (RTAs) and Bilateral Trade Agreements envisaged under GATT Agreement, had been negotiated mainly for favourable tariff rates and lower customs barriers in the initial stage acting as an exception for the MFN Rule. But recently as mentioned earlier these Agreements are including within them Intellectual Property chapters involving TRIPS Plus provisions. Unlike the GATT and GATS Agreements, TRIPS Agreement does not include any provisions which exempt the application of MFN principle for the Intellectual Property provisions in FTAs. Thus the inclusion of IP chapters in these FTAs results in an increase of the Intellectual Property standards prevailing around the globe. This practice is defeating all the efforts taken by the developing countries including India in Doha to ensure access to medicines for the people of the developing countries and least developed countries (LDCs) and is nullifying the flexibilities under Doha Declaration. If such a policy is allowed to be followed, the flexibilities and the safeguards under TRIPS will remain as a mere scarecrow and in near future itself the TRIPS will lose its significance.

The U.S. Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement

This article takes advantage of the breach in the Trans-Pacific Partnership negotiation’s secrecy to contribute to a new and growing collection of published scholarship on leaked proposals for international intellectual property agreements as they are being negotiated. We begin with the general provisions of the agreement, which define its relationship to the multilateral system. We then progress to analysis of some of the most important copyright, patent and data protection, and enforcement sections of the proposal, before providing some concluding observations. Our ultimate conclusion is that the U.S. proposal, if adopted, would upset the current international framework balancing the interests of rights holders and the public. It would heighten standards of protection for rights holders well beyond that which the best available evidence or inclusive democratic processes support. It contains insufficient balancing provisions for users, consumers, and the public interest.

Public Interest Analysis of the US TPP Proposal for an IP Chapter

This briefing paper provides preliminary analysis of two leaked U.S. proposals for an intellectual property chapter in the Trans Pacific Partnership (TPP) agreement. The U.S. proposal, if adopted, would create the highest intellectual property protection and enforcement standards in any free trade agreement to date. Its provisions are primarily based on, and frequently go beyond, the maximalist and controversial standards of the Korea-US Free Trade Agreement (KORUS), the Anti-Counterfeiting Trade Agreement (ACTA) and US law, while negating the development-oriented flexibilities required by the 2007 New Trade Deal for developing countries and included in the US-Peru Free Trade Agreement. If adopted, the provisions would predictably lead to higher prices and decreased access to a broad range of consumer products in many TPP member countries, from medicines to textbooks to information on the internet, with little or no benefit from increased innovation, creativity or local economic activity. No country, including the US, has an interest in ceding this much policy flexibility to an international agreement. The proposal is particularly inappropriate for developing countries where the risks and effects of exclusionary pricing by monopolists are most acute.

The Untapped Potential of Investor-State Dispute Settlement Involving Intellectual Property Rights and Expropriation in Free Trade Agreements

Much has been written about numerous aspects of investor-state dispute settlement, and the literature grows larger with the release of every publicly available arbitral ruling. One exception, however, is intellectual property provisions in international investment agreements. The absence of scholarly literature in this area is surprising given not only the voluminous amount of literature written on Intellectual Property Chapters of FTAs but more importantly due to the potential effect the provisions may have on intellectual property rights (IPRs) and on governments to adequately protect areas of domestic interest such as public health.The aim of this article is to draw attention to the potential effect of intellectual property provisions in FTA Investment Chapters on governmental regulatory sovereignty as well as to highlight potential issues and inconsistencies between FTAs and other intergovernmental and multilateral agreements. The article is narrowly focused on recent FTAs, as opposed to longstanding BITs, in order to highlight the modern trends in international trade agreements such as regard for TRIPs standards of IP protection and the recent appearance of TRIPS-Plus provisions. Particular attention is focused on FTAs involving the US, South Korea, Switzerland, China, Australia and Chile. Where applicable, the recently negotiated but not yet implemented South Korea-US FTA (KORUS) will be used as an illustrative example. Both South Korea and US FTAs demonstrate a pro-active approach to negotiating international investment agreements and both nations also have an interest in protecting and enforcing IPRs.

Intellectual Property: benefit or burden for Africa?

This paper highlights some of the issues affecting access to knowledge in South Africa and other African countries, as well as the implications of international intellectual property agreements, focusing mainly on copyright. It will show that the majority of these countries are struggling to meet the very basic requirements of international intellectual property agreements, yet some of them are being pressured by developed countries to adopt even stricter intellectual property regimes through the Intellectual Property Chapter or ‘TRIPS-Plus’ in Free Trade Agreements. The paper highlights the impact of the some of the TRIPS-Plus provisions on education, libraries, and people with sensory-disabilities, as well as public health and development in general.

Pharmaceuticals, intellectual property and free trade: the case of the US–Australia free trade agreement

Australia did poorly in several key areas of the recently completed free trade agreement with the US. It failed to insulate the Pharmaceutical Benefits Scheme (PBS) from significant change, and conceded to increased intellectual property standards. The PBS, as a system of effective bargaining with multinational pharmaceutical firms, has been deeply compromised and higher drug prices can be expected over time. The intellectual property chapter strengthens the position of patent owners and undermines the evolution of a competitive generics industry. These developments are part of a broader and internationally coordinated strategy being pursued by pharmaceutical multinationals to globalize and strengthen patent rights and monopoly profits.