The Journal of World Intellectual Property

Published by Wiley
Online ISSN: 1747-1796
Print ISSN: 1422-2213
Publications
The adherence of sovereign states to international rules and regulations without the presence of regulatory authority which is normally the case in domestic law, has always been a matter of serious discussion in the jurisprudence of international law. Franck espoused a concept of legitimacy which is a function of perception of those in the community concerned that the rule or the institution has come into being endowed with legitimacy, that is in accordance with right process and more legitimate a rule or institution is, greater is its compliance pull. Franck analyzed legitimacy in terms of four factors: (a) determinacy, (b) symbolic validation, (c) coherence and (d) adherence (to a normative hierarchy). An analysis of the TRIPS Agreement in terms of the above four factors suggest that the TRIPS Agreement does not possess the above factors sufficiently to attract compliance. The inherent weakness of the TRIPS Agreement is in the text which does not introduce certainty and the Dispute Settlement System has not been very successful in introducing process determinacy. The circumstances in which TRIPS was prepared and adopted also impair the validity. It has been suggested that certain urgent changes are required in the TRIPS Agreement to make it a legitimate international treaty.
 
The question of protecting intellectual property rights by academic inventors was never seriously contemplated until the introduction of the Bayh-Dole Act in 1980 in the US. The Act allowed universities to retain patent rights over inventions arising out of federally-funded research and to license those patents exclusively or non-exclusively at their discretion. This particular legislation was a response to the growing concern over the fact that federally funded inventions in the US were not reaching the market place. In this paper a critical review of the US experience after the Bayh-Dole Act is presented and argues that the evidence is far from being unambiguous. [Working Paper No. 244]
 
Emerging firm strategies: a categorization 15
The year 2005 marks the end of transition period for many developing countries with competent pharmaceutical sectors that competed in supplying generic versions of patented drugs to LDCs before, thereby inducing price competition and enhancing access to medicines. In a post-2005 scenario, the critical issue is whether LDCs without adequate manufacturing capabilities can make use of compulsory licensing expeditiously to induce price competition and secure lower prices. This paper uses empirical evidence collected during a firm-level survey of the Indian pharmaceutical sector to generate evidence on emerging strategies of firms. It shows that the vigour of compulsory licensing as a price-leveraging instrument post-2005 is incumbent mainly on its economic feasibility. It shows that Indian firms view the market potential (in terms of market size and profits involved in such supply, especially if they have to make specific technological investments to produce the drug) of the mechanism much more severely than before, and may be less inclined to engage in such production if their commercial expectations are grossly unmet. The analysis assesses implications of emerging strategies of firms in the Indian pharmaceutical sector for access to medicines both domestically and internationally, and highlights the challenges involved.
 
This article is intended to reveal the root problems that prevent traditional knowledge from being effectively protected by a patent regime. A close review of the 13-year Chinese patent experience on traditional medicinal knowledge is made for this purpose. Through examination of characteristics of traditional medicinal knowledge in China, the article argues that novelty is not a primary barrier for patent protection; rather, patentability and industrial application are the key obstacles. Given the unique characteristics of traditional medicinal knowledge, it is necessary to establish a sui generis regime to protect traditional medicinal knowledge better.
 
General Comment No. 17 on authors' rights is a comprehensive assessment of the normative content of article 15, paragraph 1(c) of the International Covenant on Economic, Social and Cultural Rights (the Covenant). Also, the obligations and violations are spelled out in great detail. It is found that the General Comment makes a clear distinction in principle between standard intellectual property rights and the protection given in accordance with article 15, paragraph 1(c). At the same time, the General Comment does not outline any specific tools for determining when an intellectual effort would result in human rights protection and when it would fall outside of the scope of this protection. Two clarifications have resulted in a positive reception of the General Comment among those who expressed criticism during the drafting. First, General Comment No. 17 acknowledges the need for human rights protection for local and indigenous communities. Second, General Comment No. 17 emphasizes the balance between the private interests of the authors and the other human rights recognized in the Covenant.
 
After the introduction we discuss the European Patent Convention (EPC) provisions that are relevant to the exclusion from patentability of computer programs and the broader relevance of the fact that the European Patent Office’s (EPO’s) Enlarged Board of Appeal has recently been requested by the EPO President to interpret these provisions. Next, we comment on the relevance of the recent EPC revision, before addressing what a computer program must be taken to mean for the purposes of the exclusion from patentability. After drawing attention to the conflict in case law that has developed in relation to the patentability of the computer programs and briefly summarizing the different approaches the EPO has taken to Article 52 of the EPC, we explain the evolution of these approaches, with particular attention to the EPO’s dominant ‘‘technical character’’ approach. Subsequently, we address the questions put to the Enlarged Board and how they might be answered. We set out our proposal for what we believe is the approach the Enlarged Board should adopt. Since this approach might have effects beyond the field of computer programs, we show that the EPO case law outside computer programs would not be altered by our approach. Two alternative approaches are then critically addressed before setting out our conclusion.
 
Nanotechnology involves the manipulation of matter at the level of individual atoms and molecules. Nanotechnology attempts to go farther than natural mechanisms controlling molecular structures that are not manipulable by organic means. Patents conflict with traditional scientific norms of open sharing. The precedent established in biotechnology patents has to be adapted further to be applicable to nanotechnology patents, taking into account its unique characteristics. Recent nanotechnology patents cover improvements in existing industries. Scientists seek to patent more and more inputs of biomedical experimentation earlier in the development chain. New technology requires technology-specific legislation if there is no possible way to interpret it according to old legislation and so courts typically place an emerging technology in an existing context by analogizing it to previous technologies. Taking into account that one is not allowed to patent solely abstract ideas, nanotechnology as a new field creates problems because patents on basic inventions are inclined to cover larger areas than the final products, with the expectation of developing them in the future into more explicit inventions.
 
While Western countries continually criticize developing countries, especially China, for a lack of effective protection of intellectual property rights (IPRs), the IPR abuses of developed countries in developing countries are also worth paying attention to. This article takes several representative cases that have occurred in recent years in China and discusses the IPR abuses in the licensing of technology standards from developed countries to developing countries. Under de facto standards, the IPR abuses of western enterprises are mainly conducted through blocking competitors by taking advantage of the status of controlling the standards. Under de jure standards, the most urgent antitrust concerns for developing countries are being charged an excessively high patent royalty and being refused independent licensing in practice by the western patent pools under the standards. In addition, this article also shows China's responses, such as improving its legal system to restrict IPR abuses and commonweal intellectual property litigation filed by IPR scholars. A brief analysis on categories of commonweal relative to IPR abuses is also presented.
 
The implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in Egypt raised concerns over public health implications, resulting from pharmaceutical patents, especially because the Egyptian pharmaceutical industry is heavily dependent on generic production. The current level of global competition in the pharmaceutical market, together with the lack of local pharmaceutical research, threaten the industry, and, as a result, access to affordable medication is expected to be impaired. Determinants of access to medicines are analysed. An epidemiological overview of the most prevalent diseases in Egypt has been done in light of the results of surveys about changes in medicine prices and availability, to speculate about potential limitations in access to medicines. Considering domestic pharmaceutical pricing and marketing regulations, which are mainly concerned with affordability, together with the flexibilities in the TRIPS Agreement, short-term solutions to potential access problems will be possible. Egypt has the necessary theoretical safeguards against negative implications of the TRIPS Agreement on access to treatment. However, this does not necessarily mean that these safeguards will be implemented in a way that will protect against the implications of patent protection on medicines in the long term.
 
This article, based on a study commissioned by the Swiss Federal Office for the Environment, aims at identifying what legal, administrative and policy measures could be designed in a country such as Switzerland to promote compliance by users of genetic resources and traditional knowledge with measures regarding access and benefit sharing (ABS). The framework of the study is set by the existing international legal system and the international regime currently being discussed in the negotiations of the Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilization. This article states the situation as at June 2010. Stakeholders in Switzerland have already taken numerous measures in order to comply with the ABS provisions contained in the Convention on Biological Diversity, such as the declaration of the source of genetic resources and traditional knowledge in patent applications or the development of best practice guidelines and recommendations. Can more be done? Two basic options for ABS user measures in Switzerland are examined, depending on the development of the international regime, with or without international certification. Whatever system is finally chosen, it should not reduce the stimulation in research and development, ought to be as little intrusive as possible into trade activities and should avoid duplications.
 
The HIV/AIDS pandemic has reached a crescendo in Sub-Saharan Africa (SSA or Saharan region). This disease threatens to exterminate the human race in the Saharan region. The situation is further exacerbated by high prices of brand name antiretroviral medicines due to the prevailing international patent regime. And, attempts to promote the manufacture and import of generic versions of antiretroviral drugs are sometimes met with stiff resistance from pharmaceutical companies who own the patents. This article, therefore, seeks to examine the subject of patent regulation of antiretroviral drugs in the light of the threat posed by HIV/AIDS in SSA. It urges the exploitation of diverse patent regulatory mechanisms to promote access to antiretroviral drugs in the region worst hit by the HIV/AIDS epidemic. Exploiting patent regulatory flexibilities implies the use of: negotiations, compulsory licensing mechanisms, public-private partnerships, collaborative initiatives among regional economic blocs, increased drug-pricing competition, and a rejection of TRIPS-Plus obligations, among others, to procure relatively cheaper versions of antiretroviral medicines for persons infected with the virus. This will enable policy makers in the Sub-Saharan region to respond more effectively to expand the capacities of HIV/AIDS-affected persons and make them more productive. It will further save the healthcare systems in SSA from imminent collapse.
 
Since the establishment of the World Trade Organization (WTO) in 1995 and implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as a result, the United States (US) sought to impose still higher levels of intellectual property rights on developing countries, a phenomenon that is commonly known today as TRIPS-Plus. The Jordan–US FTA, signed in 2001, contains several TRIPS-Plus rules that restrict the poor's access to medicines, and is today touted by US officials and the US Trade Representative (USTR) as a success, and providing a wide range of benefits. These benefits not only include a higher growth rate, but also more specific benefits to the pharmaceutical sector in particular, such as an improved ability to develop generic medicine and engage in new innovative research, as well as increasing the presence of and collaboration with multinational drug makers. This article analyzes in detail the TRIPS-Plus provisions of the Jordan–US FTA. It challenges the claims that the FTA brings general and specific benefits to developing countries, and provides fresh evidence which strongly suggests that benefits from the Jordan–US FTA have been largely exaggerated while the costs underestimated.
 
Increasing access to essential medicines has become an international priority, given the rapid spread of intractable diseases such as HIV/AIDS, tuberculosis and malaria. It follows that the quests to improve the global quality of healthcare and achieve health equity present a challenge for many countries, especially those that have been hard hit by deadly pandemics and whose populations are also still without essential drugs. Consequently, many countries have stepped up efforts to remove the obstacles to the availability and affordability of essential medicines. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) contains flexibilities that can be used as tools for enhancing access to cheap medicines and for controlling drug pricing. However, these flexibilities are not necessarily a panacea and cannot singly solve the problem of limited access to essential medicines. Put differently, cheaper medicines cannot reach the poor without the infrastructure to deliver them. For this to become a reality, commitment on the part of the member countries to adopt comprehensive and cooperative measures to tackle the burdensome barriers that limit access to critical medicines is needed. It is only then that the flexibilities in TRIPS can be optimized and a real difference made in the lives of poor patients across the developing world.
 
A central socio-economic challenge in fish breeding arises from issues relating to access to and exclusive rights of genetic resources. Breeding companies need legal or biological protection measures to assure revenues from genetic improvement and investment in genetic material. Fish farmers and fish breeders need access to genetic resources for food production and further development and sustainable use of fish genetic material. How can a balance be created between the need for unencumbered and free access, on the one hand, and, on the other hand, the need to ensure a right to the results from breeding and research?First, we provide a brief outline of the rationale for ensuring access to and for using legal measures for protection of breeding materials in aquaculture. Secondly, we examine how technological developments and biological features present options and barriers that will affect choices relating to access and property right issues to fish genetic resources.
 
Concerns have been expressed over the role of the World Intellectual Property Organization (WIPO) in influencing the intellectual property policies of other specialized agencies of the United Nations. This article reviews the policies of the Food and Agricultural Organization (FAO), World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO), in addition to WIPO itself, and finds very interesting patterns of cooperation. While intellectual property law is primarily concerned with providing incentives for the production of new, creative and applicable arts and knowledge, human rights law is primarily concerned with providing improved access to goods crucial for human well-being and survival. While UNESCO has paid less attention to intellectual property rights over the last decades, rather emphasizing cultural preservation, both FAO and WHO have increased their focus on intellectual property rights. The latter two have increased their cooperation with WIPO, but without a formal agreement with WIPO. The article finds that WIPO, as a specialized agency, has to cooperate with specialized agencies, and there is no reason to believe that the cooperation will be in the form of a “one-way” process in which WIPO instructs the other agencies. At the same time, it must be acknowledged that intellectual property rights can also hamper research, in addition to impacting on the access to the crucial goods.
 
Examining 14 US free trade agreements (FTAs), this article presents a text analysis of their intellectual property (IP) provisions with reference to patents and data protection. For each type of provision present in a given FTA, a “unit of protection” is assigned in that category. This method allows us to estimate the evolution in protection for each type of provision, both relative to the Agreement on Trade-Related Aspects of Intellectual Property Rights standard and from one agreement to the next. The analysis reveals a global increase in IP rights (IPR) protection, as the agreements get more stringent and specific provisions get more intricate and complex. But it also shows that the increase of IPR protection is not strictly linear over time and that some variation does exist in the outcomes of the negotiations. Nevertheless, IPR is clearly on the rise, and close comparative analysis of the different texts sheds light on the process of the setting of these new standards. Ultimately, this analysis provides a snapshot of the challenges that will soon be brought to bear on the policies on access to medicine in developing countries.
 
Over the last few decades, the World Health Organization (WHO) has played a significant role in the prevention and control of new strains of influenza virus in the human population. Beginning in the 1950s, it has coordinated a network of WHO-linked laboratories, charged with monitoring the changes in influenza viruses and favouring the timely sharing of virus samples, which is necessary for the development and production of vaccines. In December 2006, the said system was brought into question by Indonesia, according to which it was unfair and in conflict with the principle of state sovereignty over biological and genetic resources. Although very controversial, the Indonesian decision to interrupt the supply of candidate influenza vaccine strains boosted intergovernmental negotiation, until then not achieved, aimed at establishing a new WHO framework. This article examines the outcome of such a negotiation, as well as the aspects of the framework still under discussion. It emphasizes the innovative nature of the proposed benefit-sharing mechanism, which would promote access to vaccines mainly through the multilateralization of intellectual property rights governance. Similarities and differences between the envisaged framework and the benefit-sharing mechanism established by the Food and Agricultural Organization International Treaty on Plant Genetic Resources for Food and Agriculture in the field of access to plant genetic resources are analysed.
 
Antiretroviral (ARV) drugs, where they are accessible, have been shown to prolong the lives and increase the health and well-being of people living with human immunodeficiency virus/acquired immunodeficiency syndrome. In general terms, whether a country is able to provide affordable ARVs to people in need is determined by the pricing structure of the drugs, which is in turn based on the patent environment that regulates them. Increasing access in many developing countries, including Vietnam, requires a thorough understanding of the patent environment and of the legal options that will allow the production and/or importation of affordable treatments. This article provides an analysis of current patent law in Vietnam with regard to the production and importation of pharmaceuticals. It then reviews the current situation of supply of ARVs with regard to pharmaceutical patents and Vietnam's obligations and practices against international agreements. The study concludes by suggesting options for utilizing current law to improve access to ARVs and makes recommendations for the implementation of Vietnamese patent law.
 
In implementing its patent-related obligations to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), India opted for the optional additional transitional provisions in article 65.4. This, delayed the introduction of product patents in exempt technologies, notably pharmaceuticals, until 1 January 2005. Ostensibly, this gave India the opportunity to exploit changing circumstances to and emergent views on TRIPS implementation, in particular exploring new interpretations to residual flexibility in TRIPS and any continuing legal ambiguity in TRIPS obligations. Here, the Panel Report in Canada: Patent Protection of Pharmaceutical Products is pertinent in having exhibited rare reticence in stepping back from defining the principle of non-discrimination in article 27.1 of TRIPS. In maintaining legal ambiguity, this reticence also provides space for law-making and regulatory diversity. The article reviews the three amendments to India's Patent Act 1970 and finds mixed use of residual flexibility and some evidence of efforts to explore legal ambiguity. Thus, despite a favourable climate to TRIPS implementation and an active transnational access to medicine campaign, legislators in India have demonstrated a degree of caution. The article concludes that this caution is best explained in terms of deepening ambivalence concerning intellectual property within the government and the changing economic interests of sections of Indian pharma.
 
The Republic of Uganda is presently engaged, as many other developing countries, in reform of its intellectual property laws. The process raises a number of questions as to whether it addresses priorities besides the legal framework. What has prompted the reforms and what systems of innovation does the country have so as to harness the power of patents in enhancing Uganda's technological capacity? The article also challenges the philosophy and orthodoxy that underpins the basis for patent protection in facilitating the transfer of technology to developing countries and stimulating innovations. In particular, it is argued that patent legislation reform can be meaningful if it is met with marching reforms outside the ambit of the law.
 
On 17 May 2006, the European Union adopted new legislation implementing the World Trade Organization (WTO) General Council Decision of 30 August 2003: Council Regulation 816/2006. This regulation aims to reflect faithfully the compromise negotiated at the WTO without creating an unnecessary burden for importing countries. Not all expectations articulated by the non-governmental organization community could be met. Yet, criticism against the regulation seems premature: the value of compulsory licensing rules does not depend on the number of compulsory licences granted, but on the pressure such provisions exert on patentees to make their product available at a reasonable price.
 
Since the start of the millennium, the Australian federal government has engaged in repeated reforms of the nation's copyright laws as part of a broader response to the national and international challenges created by the advent of the internet and the wider digital revolution. This reform process has at times been both chaotic and confusing. Substantial amendments enacted in only 2001 to bring Australian copyright law into the digital age were changed substantially in response to the Australia–United States Free Trade Agreement (AUSFTA) of 2004. Concurrent to meeting the obligations created by the AUSFTA, the Australian government also conducted several reviews with a view to introducing new user-based exceptions to copyright infringement in an attempt to balance Australia's increasingly copyright-owner-focused legislation. These changes were enacted as part of the Copyright Amendment Act 2006 (Cth). However, any benefit that these new exceptions created for copyright users and consumers has arguably been outweighed by the implementation of stronger technological protection measures and digital rights management protection and criminal sanctions that have been accompanied by few exceptions for legitimate use. Now, at the end of an often rushed and inadequately debated reform process, few parties are expressing satisfaction with the resulting amendments.
 
The Standing Committee on the Law of Patents (SCP), a specialized committee on patent law under the World Intellectual Property Organization (WIPO), is presently negotiating a Substantive Patent Law Treaty (SPLT). Although its objectives are not expressed in clear language, these negotiations can be assumed to aim at achieving international harmonization on outstanding topics in patent law, such as a common understanding of standards governing the patent criteria, patent applications and patent claims, and their equivalent interpretation.1 The SPLT negotiations cover three separate legal documents: the draft Treaty (i.e. the SPLT), the draft Regulations under the SPLT and the draft Practical Guidelines. Probably only the draft Treaty will be legally binding in the classic sense of international law, while the Regulations and Practical Guidelines will likely not have treaty status and will therefore probably not be subject to ratification by the legislatures of the contracting parties. However, they will have a normative effect when the SPLT enters into force. In the effort to harmonize outstanding topics of patent law, the negotiations and future interpretations will necessarily touch on some controversial areas. One such area is that of patenting living organisms and genes.2 There is an international debate addressing how to keep a publicly available, vital room for manoeuvre in research on genetic resources and living organisms. The term "genetic resources" is defined as a legal term in the Convention on Biological Diversity (CBD), whereas "biological material" is
 
The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights in article 7 states that the protection and enforcement of intellectual property rights (IPRs) “should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare”. This article examines the developmental claims for IPRs in developing countries and least developed countries with a particular focus on sub-Saharan Africa.
 
In the era of globalization, trade disputes can often pit the economic interests of one country against the social and economic interests of another. One such example involves trade relations between South Africa and the United States. Recently, the South African government has come under pressure from the Clinton Administration to adjust its domestic patent laws in order to continue pharmaceutical patent protection. The disagreement between South Aftica and the United States revolves around changes to the 1965 Medicines and Related Substances Control Act (1965 Medicines Act), which allows the Health Minister to abrogate patent rights for pharmaceuticals, to issue compulsory licences and to allow parallel imports of pharmaceuticals with the goal being to lower pharmaceutical prices. The U.S. government wants the offending clauses repealed, guaranteeing full protection to foreign pharmaceutical patents. However, the South African government maintains that it needs these tools in order to combat various problems in its health care system, including the burdens inflicted by the Acquired Immune Deficiency Syndrome (AIDS) crisis. Because of the patent issue, the United States has removed privileges for South Ahca under the generalized system of preferences (GsP) and could move to impose harsher economic sanctions later. The primary question to be answered is: What options does the South African government have against the cconomic power of the United States?
 
Copyright law in the member states of the African Intellectual Property Organization (OAPI) is not supposed to be standardized but harmonized. As a result, many differences remain between national laws of “OAPI space”. Some of those differences could be reduced by the transposition of regional rules. Such is the case notably concerning audiovisual work. Although the rules regarding this work differ from one state to another, audiovisual work is subjected to particular rules in all OAPI countries. It may be asked whether these specific rules are always justified.
 
Top-cited authors
Peter Drahos
  • European University Institute
Morten Walløe Tvedt
  • Fridtjof Nansens Institutt
Rachel Wynberg
  • University of Cape Town
Felix Addor
  • Swiss Federal Institute of Intellectual Property
Alexandra Grazioli
  • World Intellectual Property Organization