The Journal of World Intellectual Property

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  • Impact of patent policy changes on R&D expenditure by industries in India

    Emerging economies realizing the importance of innovation are taking steps to enhance their innovative capabilities. Among the tools used, institutional factor such as patent protection policy is being increasingly used by such economies, despite mixed research evidence linking patent protection policies and innovation. This study investigates the effects of patent policy changes on stimulating innovation in India. Panel data regression technique is used on data for 1989–1990 to 2009–2010. The results indicate that patent policy changes, specifically, increase in the protection duration, enforcement mechanism, and membership into international convention dimensions of patent policy have positive influence on the R&D intensity.

  • Open models for patents: Giving patents a new lease on life?

    This essay investigates the development of peculiar models in patents: “Open patent” licenses, patent pledges, defensive patent strategies and the like. Although using patents in an unconventional way, these models do not dispute the very existence of patents, but rather the way patents are being used. These models are not entirely new—some have been around for over a decade—but seem to find an echo with the growing criticisms of the “broken patent system”. These models might be able to go beyond the pro‐patent/against patent debate, by reconciling exclusive/inclusive mechanisms and eventually reveal the strong plasticity of patents, offering patents a new lease on life.

  • WTO “Paragraph 6” system for affordable access to medicines: Relief or regulatory ritualism?

    Regulatory Ritualism means acceptance of regulatory goals while losing focus in achieving them. In other words, it means ignoring of goals or objectives of a process or mechanism and focusing too much on regulations, rules, and formalities. Advanced countries and developing countries have been in a continuous negotiation over access to drugs ever since coming into effect of TRIPS Agreement. The Doha Declaration was a rare negotiation win for third world countries. This paper endeavors to apply the notion of Regulatory Ritualism to Paragraph 6 of the Doha Declaration 2001 and to subsequent WTO General Council's Waiver Decision 2003 which aimed at giving effect to Paragraph 6 flexibility. The first part of the paper discusses the historical background of the Doha Declaration and 2003 Decision. The second part of this paper analyses Paragraph 6 of the Doha Declaration and subsequent Waiver Decision in the light of the notion of Regulatory Ritualism and Rule Complexity, with a special focus on Apotex‐Rwanda case study, the case of India and the case of Australia. The final part of this paper sums up the discussion on the issue and provides suggestions.

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  • Japan's emerging role in the global pharmaceutical intellectual property regime: A tale of two trade agreements

    This paper explores Japan's role in reshaping the global pharmaceutical intellectual property regime by examining its position on the expansion of intellectual property rights (IPR) in negotiations for two regional trade agreements: the Trans Pacific Partnership Agreement (TPP) and the Regional Comprehensive Economic Partnership (RCEP). Through systematic analysis of leaked negotiating texts documenting its positions on key issues, we demonstrate Japan is now playing a pivotal role in promoting the adoption of expanded IPRs. We show that its position as IPR champion in the Asia Pacific region reflects a domestic strategy initiated in 2013 to bolster pharmaceutical export growth. Drawing on past experience and focusing on the RCEP negotiations, we explore ways in which low and middle income countries might respond to this shift in order to protect and promote access to medicines.

  • Combating biopiracy in Australia: Will a disclosure requirement in the Patents Act 1990 be more effective than the current regulations?

    Genetic and biochemical resources have the ability to provide considerable economic, social and environmental benefits to a nation. Traditional knowledge of these natural resources is extensive. Biopiracy occurs when commercial actors appropriate traditional knowledge without recognition or benefit‐sharing. It has faced international condemnation. The importance of acknowledging traditional knowledge and ensuring benefit‐sharing from inventions based on this knowledge is recognized. This paper explores strategies for protection of traditional knowledge and considers the adequacy of Australia's approach. It discusses the global problem of biopiracy and Australia's international obligations. It explores Australia's current protection, including part 8A of the Environment Protection and Biodiversity Conservation Regulations () (Cth). This paper then compares Australia's strategy to the protections afforded in the United States, New Zealand and Brazil. It is argued that an additional disclosure of origin and source requirement within the Australian Patents Act (Cth) would assist in better protection of traditional knowledge and the promotion of benefit‐sharing.

  • Broadening the conversation on the TRIPS agreement: Access to medicines includes addressing access to medical devices

    Patent laws determine access to medicines and medical devices, and all members of the World Trade Organization (WTO) are obligated to introduce minimum standards of intellectual‐property protection into their national patent laws. In the negotiations that led up to the Trans‐Pacific Partnership Agreement (TPP), in 2016, the United States attempted to introduce patents for diagnostic, therapeutic, and surgical methods to promote the interests of its pharmaceutical and medical‐device industries. These attempts were unsuccessful; however, these actions demonstrate the determination of those who advocate for higher standards of intellectual‐property protection to push for a TRIPS‐plus agenda. The United States has sought to limit the use of flexibilities in the TRIPS Agreement, including the use of compulsory licenses which allows the generic industry to produce cheaper pharmaceuticals. Despite these US actions, many developing countries are becoming emboldened and are issuing compulsory licenses. The position of this paper is to show that, while access to pharmaceuticals and the ability to issue compulsory licenses is crucial to administering proper health care to people living in developing countries, medical devices are equally essential. Therefore, the conversation around access to medicines should be broadened to include access to medical devices in developing countries.

  • Monopoly v. Openness: Two sides of IP coin in the pharmaceutical industry

    The pharmaceutical industry extensively relies on the patent system. It actively lobbies for the strengthening of patent protection of its medical products and the results of its efforts may be found in the majority of bilateral and multilateral agreements, including the TRIPS and the most recent TPPA, augmented by private patent strategies pursued by pharmaceutical companies. However, some recent developments show the emerging tendency of implementing different business models by pharmaceutical companies that may mark the beginning of transformation of this industry. Among these developments is an “Open innovation” model, which has increasingly been followed by some research institutions and pharmaceutical companies aiming at facilitating the creation of new and affordable medicines, as well as providing transparency in order to enhance safety and efficacy of drugs. This article will discuss these two current developments in the pharmaceutical industry, that is, strong IP protection against open innovation.

  • A patent defence approach to sharing aquaculture genetic resources across jurisdictional areas

    Access and benefit sharing (ABS) of genetic resources is a concept that is increasingly important for product development in aquaculture. ABS regulates the way aquatic genetic resources can be accessed from the world's waters and how the benefits that result from their use are shared between the providers and users of genetic resources and their derivatives. This article gives an overview of the multiple approaches to sharing aquaculture genetic resources under ABS regimes across the three jurisdictional areas in which they are found—waters within national jurisdiction, beyond national jurisdictions and in the Antarctic Treaty Area. It highlights the complexity and inconsistencies relating to obligations for technology transfer across the various regimes and the implications this has for sharing genetic resources for use in aquaculture. It offers a practical solution to navigating this complexity by using an evolving patent defence approach consistent with the World Trade Organisation's Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS). It concludes that this approach can guide the resolution of legal challenges that ABS regimes across the jurisdictional areas have in common, which concern derivatives and commercial use of genetic resources.

  • The room for ethical considerations in patent law applied to biotechnology

    Since the advent of the so‐called “patents on life” debate there have been frequent calls for patent policy to take into account ethical concerns over and above the ethically relevant justifications for issuing patents generally. The degree to which the patent system is respondent to including these ethical concerns varies. Ethical arguments frequently encounter attitudes within the patent system that ethics has little to do with patenting and that ethical issues concerning biotechnology must be regulated in other areas of society than in IPR law and practice. In this article, we explore the room for ethical considerations in patent law‐making, and show that there is limited ability or will to use this room in practice. We explore global, European and Norwegian institutions and illustrate our point by looking at law‐making, administrative, and judicial practices (courts/boards of appeal). We particularly assess the success of the “countermeasures” to undesired ethical effects of accepting the EU Biotech Directive implemented by the Norwegian government in 2003/4. We end the article by pointing to some key tensions between the law‐making and executive level in the patent system when it comes to ethical considerations.

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