Intellectual Property Legislation Research Articles

TRIPS post-2005 and access to new antiretroviral treatments in southern countries: issues and challenges

Until 2005 some developing countries with pharmaceutical manufacturing capacities especially India used the transitional period allowing local manufacturers to produce and sell generic versions of first-generation ART drugs patented in industrialized countries and originally produced and sold at high prices by Western pharmaceutical companies. Thanks to international competition between generic manufacturers and these companies significant price reductions were achieved for the large majority of these drugs. This was a key factor in the implementation and strengthening of access to AIDS treatment in developing countries and a strategic element in the World Health Organization (WHO) 3by5 plan. However with the end of the extended deadline for TRIPS compliance the scenario is likely to change radically. Considering the end of the transitional period which effectively will prohibit the free manufacture of newer and innovative antiretroviral generations to mark a key episode in the history of the fight against AIDS in developing countries this review will provide an overview of the meaning and consequences of this turning point and to present some of the new challenges of the post-2005 period. (excerpt)

Challenges for Australia's Bio/Nanopharma Policies: trade deals, public goods and reference pricing in sustainable industrial renewal.

Industrial renewal in the bio/nanopharma sector is important for the long term strength of the Australian economy and for the health of its citizens. A variety of factors, however, may have caused inadequate attention to focus on systematically promoting domestic generic and small biotechnology manufacturers in Australian health policy.Despite recent clarifications of 'springboarding' capacity in intellectual property legislation, federal government requirements for specific generic price reductions on market entry and the potential erosion of reference pricing through new F1 and F2 categories for the purposes of Pharmaceutical Benefits Scheme (PBS) assessments, do not appear to be coherently designed to sustainably position this industry sector in 'biologics,' nanotherapeutics and pharmacogenetics.There also appears to have been little attention paid in this context to policies fostering industry sustainability and public affordability (as encouraged by the National Medicines Policy). One notable example includes that failure to consider facilitating mutual exchanges on regulatory assessment of health technology safety and cost-effectiveness (including reference pricing) in the context of ongoing free trade negotiations between Australia and China (the latter soon to possess the world's largest generic pharmaceutical manufacturing capacity). The importance of a thriving Australian domestic generic pharmaceutical and bio/nano tech industry in terms of biosecurity, similarly appears to have been given insufficient policy attention.Reasons for such policy oversights may relate to increasing interrelationships between generic and 'brand-name' manufacturers and the scale of investment required for the Australian generics and bio/nano technology sector to be a significant driver of local production. It might also result from singularly effective lobbying pressure exerted by Medicines Australia, the 'brand-name' pharmaceutical industry association, utilising controversial interpretations of reward of pharmaceutical 'innovation' provisions in the Australia-US Free Trade Agreement (AUSFTA) through the policy-development mechanisms of the AUSFTA Medicines Working Group and most recently an Innovative Medicines Working Group with the Department of Health and Ageing. This paper critically analyses such arguments in the context of emerging challenges for sustainable industrial renewal in Australia's bio/nanopharma sector.

How to shake the fakes [intellectual property protection

Seeming to heed the call of western diplomats, bureaucrats and politicians, the Chinese government has begun to take a tougher stance toward IP (intellectual property) protection. Chinese companies and inventors have now grasped the importance of IP legislation. The expected rise of China's own IP industry means companies will need to look more closely at the country's patent databases to avoid accidental infringement.

Access to generic antiretrovirals: inequality, intellectual property law, and international trade agreements

The governments of numerous low- and middle-income countries are currently instituting rules that strengthen changes in domestic intellectual property legislation, often made to conform to the mandates of "free" trade agreements signed with the United States. These measures frequently include intellectual property provisions that extend beyond the patent law standards agreed upon in recent World Trade Organization negotiations, which promised to balance the exigencies of public health and patent holders. In this paper, we analyze the concern that this augmentation of patent law standards will curtail access to essential medicines, particularly as they relate to the AIDS pandemic. We critically examine the potential threats posed by trade agreements vis-à-vis efforts to provide universal access to antiretroviral medications and contend that the conditioning of economic development upon the strengthening of intellectual property law demands careful attention when public health is at stake. Finally, we examine advocacy successes in challenging patent law and conclude that greater advocacy and policy strategies are needed to ensure the protection of global health in trade negotiations.

Opposing Trade-Related Intellectual Property Rights and Dependency: Back to the Future?

ABSTRACT Few publications have related issues raised by the globalization of intellectual property legislation to the broader movement against economic globalization, or sought to situate such concerns within a theoretical framework. This paper illustrates unifying critiques among networks within the movement and applies a historical structuralist framework on the emerging global intellectual property rights regime in the area of medicinal and agricultural plants. The analysis highlights contemporary processes that might repeat colonial patterns of economic exploitation and underdevelopment. Ways in which anti-globalization networks have addressed concerns at the global and local level are illustrated. A new research agenda that would document and assess such alternatives is proposed.

A Different Kind of War: Internet Databases and Legal Protection or How the Strict Intellectual Property Laws of the West Threaten the Developing Countries' Information Commons

This paper describes intellectual property legislation in the European Union, the US and the Draft Treaty on the legal protection of unoriginal databases, usually available in the Internet. I argue that this type of legislation, if enforced upon developing countries and countries in transition through international 'agreements,' could in effect deprive them of their own information commons, their own public domain. With examples from China, India, Africa and Iceland, I argue that this deprivation in the case of developing countries is, morally, equal to a virtual war against them by the West, wholly unjustified and dangerous-an example of virtual imperialism.

Modernisation of national Intellectual Property legislation in I.R. Iran and its effect on technology transfer through Foreign Direct Investment

This paper will begin with a background review of current Iranian science, technology, investment and Intellectual Property (IP) activities, followed by a discussion of the role of IP protection in technology transfer through Foreign Direct Investment (FDI) from the perspective of both Iran as a developing country and transnational firms from industrial countries. As an example the model of technology transfer in the Iranian car industry has been reviewed by comparing the route of mechanism with other models, assuming that Iranian recent policy toward open market and export oriented industries will be continued. In this paper the costs and benefits of modernisation of IPRs was investigated and it was emphasised that IPRs without technology capacity building can do little for Iran.

Third-Party Trade Marks as a Violation of Indigenous Cultural Property

This article discusses the New Zealand Trade Marks Act 2002. The statute provides a mechanism by which interests of sections of the community, particularly Maori (the indigenous population of New Zealand) can be taken into account within the framework of the trade mark registration process. This provision is important both in New Zealand and internationally as cultural property interests are rarely included in key intellectual property legislation. This article discusses the arguments for and against the inclusion of such a provision in central intellectual property legislation and why it is important to have provisions for cultural protection.

The penguin in peril: SCO’s legal threats to Linux

This thesis reviews the novel licences employed by open source developers. The paper examines how the success of the open source Linux operating system has led to conflict with traditional closed source software firms through the case study of SCO v. IBM, currently before the United States Federal District Court. Apart from exposing weaknesses in open source licensing, the case highlights the need to consider the intellectual property laws governing inputs into software development. The thesis further explores future intellectual property legislation that may forestall open collaboration. It is argued that proponents of such development methods must engage in policy discussions to limit the exclusionary authority of intellectual property licensors, by ensuring broad user rights to protected works.

Intellectual Property Enforcement in Asia: A Reality Check

In recent decades, Asian nations have raced against each other in enacting the latest intellectual property (IP) laws borrowed from the West on the assumption that the laws would function in the same manner as those in the West. However, the Asian nations` dismal record of implementation of IP laws has become apparent and turned into a source of dispute with their trading partners, chiefly the US, the European Union (EU) and Japan. The fundamental reason for the impasse in enforcement of IP in Asia, as elsewhere in the non-industrial world, lies in the huge economic and technological gap between them and those of the industrial nations. Historically, the need for international protection of IP grew out of the desire of a few West European states in the early 19 century to stop imitations of creative products of their citizens beyond national borders. The first form of such protection was therefore an attempt to suppress, within national borders, illegitimate products affecting businesses operating beyond those borders. The major concern of countries that became parties to IP treaties (whether bilateral, earlier on, or multilateral, from the 1880s onwards) was not however about providing the same level of protection among treaty-members but extending any available measure or form of protection to non-nationals. The recognition and extent of international protection ultimately hinged on the assimilation of non-national goods to those produced within the national borders. th The forms and scope of international IP protection changed dramatically with the introduction of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). What TRIPs did was to provide a level of cross-border protection that may or may not have been existing previously within the national setting. In other words, TRIPs substituted a structure and mode of protection that never considered the necessity of linking with or extending national IP forms and scopes as a pre-condition. In short, TRIPs became instrumental in planting a veritable disconnect between the IP laws of non-industrial countries (Non-ICs) and their social and economic conditions. It did not proceed from the nation-state`s willingness or determination to have forms of protection adequate for its needs (with the discretion of not introducing any if it did not deem such to be necessary) but regardless of such needs. The pressure on Non-ICs to legislate on a par with the major industrial nations (disguised as compliance with TRIPs requirements), lest they be treated as outlaws and pirates or the like, burdened them with an obligation unheard of in international law-that nations must be willing to take on board legal standards and measures even if the latter might be detrimental to their own domestic interests. The obligation to adopt standards and measures consonant with the requirements of the major industrial states but not necessarily with those of the Non-ICs was not only a major blow to the pursuit of development in Non-ICs but also a deadweight they have to carry forever. The circumstances in which most non-industrial nations were forced to forego their domestic interests and accede to treaty obligations without being given corresponding minimal benefits deserving of sovereign contracting parties lies at the bottom of the disconnect in the protection of IP internationally. The denial of the prerogative of non-industrial nations as purportedly full sovereigns in international law to demand or foster mutually beneficial arrangements in IP protection has generated the disconnect and fuelled the continuity of so-called piracy across the non-industrial world. This paper attempts to examine whether and how Asian nations have succeeded in managing the disconnect. It starts, in section 1, with a survey of the common misperceptions about the role of IP. Section 2 then attempts a brief appraisal of the conflicting interests and forces that condition the level, or lack, of IP lawmaking and enforcement in Asia. Section 3 briefly looks at the external pressure on Asian Non-ICs in both IP lawmaking and enforcement. Section 4 traces the signs of change in IP enforcement in Asia. The paper concludes that, despite some emerging signs of change in attitudes and levels of IP enforcement, the very same issues will remain at the forefront of IP in Asia and as a major source of dispute with the US and, to a lesser extent, the EU and Japan. It stresses that progress will continue to elude all parties, whether Asian or foreign.

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.

A different kind of war: Internet databases and legal protection or how the strict intellectual property laws of the West threaten the developing countries’ information commons

This paper describes intellectual property legislation in the European Union, the US and the Draft Treaty on the legal protection of unoriginal databases, usually available in the Internet. I argue that this type of legislation, if enforced upon developing countries and countries in transition through international ‘agreements’, could in effect deprive them of their own information commons, their own public domain. With examples from China, India, Africa and Iceland, I argue that this deprivation in the case of developing countries is, morally, equal to a virtual war against them by the West, wholly unjustified and dangerous-an example of virtual imperialism.

The International Intellectual Property Law System: New Actors, New Institutions, New Sources

It is now ten years since the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement was concluded, subsuming that seemingly comprehensive intellectual property treaty into the institutional apparatus of the World Trade Organization (WTO). For many ob servers, TRIPS and the WTO established the framework of a new international intellectual property system. They were the center of the new system, into which other institutional com ponents would feed, and from which other institutions would draw their agenda. The norms that TRIPS and the WTO articulated would inform all aspects of international intellectual property lawmaking. Indeed, around that time, a group of scholars published a collection of essays under the title GATT or WIPO, contemplating the extent to which the WTO would displace the World Intellectual Property Organization (WIPO) as the dominant institution of international intel lectual property law. Ten years on, the answer to that question is neither the WTO, nor WIPO. It is the WTO WWIPO

Intellectual property and price discrimination: a challenge for Australian competition law

Price discrimination usually requires a mechanism to prevent arbitrage. In respect of intellectual property, the mechanisms include bans on parallel importation in intellectual property legislation and licensing and distribution contracts that separate one group of users from another. A reasonable thesis would be to expose all market segmentation of intellectual property to the full force of competition law. Australian experience of the repeal of parallel import bans on CDs and the review of an intellectual-property specific provision in the competition legislation suggests otherwise.

Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking

This Article draws upon the international relations theory of regimes to analyze the growing chorus of challenges to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), and to the expansion of intellectual property rights more generally. The few years since TRIPs entered into force have seen nothing less than an explosion of interest in intellectual property issues in international fora not previously concerned with the products of human creativity or innovation. Intellectual property is now at or near the top of the agenda in intergovernmental organizations such as the World Health Organization and the Food and Agriculture Organization, in international negotiating fora such as the Convention on Biological Diversity's Conference of the Parties and the Commission on Genetic Resources for Food and Agriculture, and in expert and political bodies such as the United Nations Commission on Human Rights and its Sub-Commission on the Protection and Promotion of Human Rights. In some of these venues, intellectual property lawmaking has led to the negotiation of new treaties; in others, challenges to TRIPs are framed through reinterpretation of existing agreements and the creation of nonbinding declarations, recommendations, and other forms of soft law. The theoretical and practical consequences of these new developments have yet to be fully explored. I argue in this Article that the expansion of intellectual property lawmaking into these diverse international fora is the result of a strategy of by developing countries and NGOs that are dissatisfied with many of the provisions in TRIPs and are actively seeking ways to recalibrate, revise, or supplement them. State and non-state actors shift lawmaking initiatives from one international regime to another for many reasons. In the case of intellectual property rights, developing countries and their allies have shifted negotiations and hard and soft lawmaking initiatives to four international regimes - those governing biodiversity, plant genetic resources, public health and human rights - whose institutions, actors, and subject matter mandates are more closely aligned with these countries' interests. Within these four regimes, developing countries are questioning established legal prescriptions and generating new principles, norms, and rules of intellectual property protection for states and private parties to follow. Intellectual property regime shifting thus heralds the rise of a more complex international environment in which seemingly settled treaty bargains are contested and new dynamics of lawmaking and dispute settlement must be considered.

Human Rights and Intellectual Property: Conflict or Coexistence?

Human rights and intellectual property, two bodies of law that were once strangers, are becoming increasingly intimate bedfellows. Over the past three years, human rights bodies within the United Nations have devoted unprecedented attention to intellectual property issues, including patented medicines, digital copyrights, technology transfers, economic, social and cultural rights, plant variety protection, and economic development. Unlike the approaches adopted in established intellectual property lawmaking organizations such as the WTO and WIPO, the new human rights approach to intellectual property is often critical of existing standards of protection and it seeks to address legal and policy issues that intellectual property treaty makers and legislators often ignore. In this essay, I analyze two competing frameworks that governments, NGOs, and intergovernmental organizations are using to conceptualize the intersection of human rights and intellectual property. The first approach views the two areas of law as in fundamental conflict, with strong intellectual property protection standards - in particular those of the TRIPs Agreement - undermining a broad spectrum of human rights. The second approach sees both areas of law as concerned with the same basic question: defining the appropriate scope of private monopoly power to give authors and inventors a sufficient incentive to create and innovate, while ensuring that the consuming public adequate access to the fruits of their efforts. The essay traces the evolution of these two competing approaches and explores their consequences for future international lawmaking.

Copyright’s Modest Ontology—Theory and Pragmatism inEldred v. Ashcroft

Focusing on the recent U.S. Supreme Court decision, Eldred v. Ashcroft, which held that the U.S. Congress acted constitutionally when it extended copyright terms by twenty years, this article argues that copyright law in the United States for the most part responds to pragmatic imperatives. The article examines the theoretic/pragmatic distinction at an institutional level and argues that intellectual property lawmaking is at its most pragmatic in the legislative realm. While there is greater potential for theoretical concerns to influence intellectual property law-making in the judicial review context, in Eldred v. Ashcroft, the Court declined to allow grand intellectual property theories to dictate the freedom Congress enjoys to craft copyright legislation in the light of its rational view of the best (pragmatic) cultural and economic policies. The article concludes that in Eldred v. Ashcroft there can be detected an ontological approach to the “Copyright Clause” in the U.S. Constitution. The Court’s role is to ensure that Congress acts consistently with what copyright “is”; that is, a vehicle for motivating the “creative spark” of authorship. Congress has relatively free rein to determine what copyright should “do”. Moreover, any limitations on what copyright is meant to achieve are certainly not to be determined by theoretical concerns. Even the Court’s ontological approach to copyright law should be regarded as “modest,” however, given the Court’s general deference to the policy and cultural choices legislators make in the copyright field.

Competition in Information and Computer Technology Markets: Intellectual Property Licensing and s 51(3) of the Trade Practices Act 1974

Intellectual property licensing presents competition lawyers and regulators with something of a puzzle. The practice is both pervasive and necessary and yet will often take forms which on their face appear to run foul of the sometimes broadly expressed prohibitions through which most jurisdictions enact their competition policy. While most of these prohibitions have long been tamed into rules of reason, they can, as currently in Australia still induce panic (a panic largely borne of confusion) in right holders and licensees who confront them for the first time. Panic rises to even higher levels when intellectual property owners are threatened with the sudden removal of the statutory shield which up until now has protected most (but significantly not all) of their dealings with licensees from the attention of regulators and competitors. Feeling more than usually exposed by this proposed legislative disarmament are suppliers of computer software and other forms of information and communications technology, accustomed as they have been to the steady expansion of legal protection (the lifting of parallel importation restrictions being one of the rare examples of retreat) rather than the contraction they wrongly assume to be imminent unless fended off by intensive lobbying. How justified are these fears? For the most part, not very. Only where the Trade Practices Act 1974 imposes per se liability do the lobbyists have a case and here the proposed changes improve the position of right holders rather than the contrary. Indeed if there is a criticism to be made of the suggestions of the Intellectual Property and Competition Law Review Committee's (the 'Ergas Committee') in its Review of Intellectual Property Legislation under the Competition Principles Agreement and the government's response to them ('Government Response') is that the changes are prompted by long standing problems with the whole of Part IV itself (still under review at the time of writing).

Who owns life?

With the mapping of the human genome and the development of cloning and other genetic engineering techniques, scientists have embarked upon a whole new era of biomedical research and with it a maze of complex ethical and legal questions. This excellent collection of articles by scientists, ethicists, and legal experts analyses the convergence of biotechnology and intellectual property legislation, which has given rise to these new moral dilemmas. It will serve as a valuable reference work to give educated lay readers a starting point to make their own judgements about matters we will all face in the near future.

Understanding Copyright Law for Slavic, East European, and Eurasian Materials

ABSTRACT In the last decade the issue of copyright has become more complex for Slavic and East European librarians for a number of reasons. Technological advances have led to new forms of publication and new options for document distribution, and have also had a major impact on intellectual property law in the U.S. and abroad. As the technical means for copying and distributing materials in various formats have increased, and as electronic resources comprise a steadily increasing proportion of the material used in libraries, copyright law has become more integral to the work of librarians. In the background of technological progress, the newly independent states which emerged after the dissolution of Communism have all adopted new copyright laws within the context of global developments in intellectual property legislation. This paper provides a context for copyright as it relates to the work of Slavic and East European librarians in the U.S., by offering a framework for understanding the main issues surrounding copyright and a method for approaching questions related to copyright protection of library materials. The emphasis of this article is on use by U.S. libraries of textual material created or published in Slavic and East European countries.