Search results

The purpose of this paper is to examine the extent to which developing countries could build national initiatives of compulsory licences.

The focus of this article is only on developing countries. The author reflects on the Indian patent jurisprudence regarding the operational relationship between the general principles applicable to working of patented inventions locally and the grant of compulsory licences. The discussion that follows is based on a review of the case: Bayer Corporation versus Natco Pharma with a view to presenting a model for developing countries to maintain that the public interest principle of patent law is well-founded in their domestic patent regimes.

The analysis confirms that failure to work locally continues to be abusive of the patent right under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, and remains a valid condition on which to grant a compulsory licence. Thus, this reverses the often-contrary misconception that has become almost a unanimous assumption that failure to work basis for granting compulsory licensing would violate Article 27(1) of TRIPS and its enforcement provisions on patent.

The author argues that as no member state has challenged the legality of Indian’s decision in the World Trade Organisation, under the dispute settlement understanding (DSU) system is more supportive of the contention that failure to work locally continues to be permissible under TRIPS and remains valid conditions on which member states can grant compulsory licences. This further adds weight to the understanding that nothing in the light of TRIPS would, in fact, preclude any possibility of developing countries amending their patent laws accordingly to maintain that the public interest principle underlining patent law is well-founded in their domestic patent regimes.

The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

The COVID-19 pandemic has devastated economies and public health systems across the globe, increasing the anticipation for the creation of an effective vaccine. With this comes the reinforcement of debates between the right to health and pharmaceutical patent rights. The purpose of this study is to illustrate how the Philippines could attempt to balance the right to health with pharmaceutical patent rights in the introduction of a potential COVID-19 vaccine into the country.

This will be accomplished through an examination of the flexibilities allowed by international agreements and domestic patent laws.

With the economic and health challenges brought about by the COVID-19 pandemic, the Philippine Government will have a strong justification to pursue parallel importation and compulsory licencing under the Agreement on Trade-Related Aspects of Intellectual Property Rights. This is exacerbated by the bold leadership of President Duterte, whose administration has so far shown a propensity to decide in favor of the right to health at the expense of other rights in dealing with the pandemic.

While this paper focuses on the Philippines, it has a potential application in the least developed and developing countries which aim to gain access to a prospective COVID-19 vaccine. Moreover, while this study discusses the harmonization of laws on the right to health and patent laws as a solution to the COVID-19 pandemic and the lack of access to vaccines, it also calls for solutions that go beyond the application of the law.

Licensing from US universities is done within the overall legal framework of the Bayh–Dole Act of 1980 and the employment agreements of universities. This chapter explains common contracts used by universities to license technologies developed by their faculty and students within the context of these laws. In addition to the legal framework, the nature of license agreements is affected by the embryonic nature of most university inventions, which necessitates faculty and student involvement in development, and the entrepreneurial goals of the university. Universities have diverse goals in terms of revenue, licenses executed, inventions commercialized, patents filed, and number of startups formed. The somewhat obvious problem is that the goals of faculty, students, the university, and the licensee may not be aligned. Common contracts used are meant to align these goals. While some contracts include multiple terms such as upfront fees, running royalties, annual payments, and equity, Express Licenses are increasingly being used to accommodate the entrepreneurial environment. This chapter discusses these issues and also the importance of the rights to sublicense inventions.

This paper aims to give a snapshot of the copyright and neighboring rights law of the United Arab Emirates (UAE), illustrating the provisions governing the law. It seeks to frame UAE copyright provisions within the context of the principles of copyright and the structure of international copyright protection.

The article begins with an overview of copyright laws. It highlights the central issues of concern to education, librarianship, and scholarship, depicting the complexity that the digital era has brought on copyright doctrines. It then explains the exclusive rights granted under the law, showing its orientation toward the civil law tradition with its emphasis on moral rights.

The author observes that a key effort to making practical sense of copyright in this region entails educating key communities, and emphasizing the importance of copyright limitations and exceptions pertaining to educational institutions and libraries. He advocates for applying copyright to the advantage of academic and research communities, and offers strategies strengthening the right of use in favor of these communities. Understanding the concepts and principles of copyright will make these communities proponents of sound copyright policies that will safeguard the promotion of learning and the right of public access, while still protecting intellectual property rights.

There has not been any discussion in the library literature on copyright in the UAE and other Gulf Cooperation Council (GCC) members – Bahrain, Kuwait, Oman, Saudi Arabia, and Qatar. Therefore, this case study of the UAE copyright and neighboring rights law aims to provoke such discussion. It should be useful to the whole library community, and particularly those in the UAE and other GCC countries.

Many people in developing countries are suffering from serious diseases, such as HIV and tuberculosis. On the other hand, drug patents impact the availability of the drug for patients. Pharmaceutical technology transfer is widely used by domestic and foreign pharmaceutical enterprises because it promotes the availability of the drug for patients. The purpose of this paper, which is on drug technology transfer, is mainly to discuss how to solve the conflict between drug patent protection and public health from the perspective of the law, but not from the perspective of economics. To fill this gap, the authors introduce a model in the prescription drug market and analyze how a foreign manufacturer that produces brand name drugs authorizes a domestic enterprise that produces common drugs.

In this paper, the authors consider a situation that if the patent holders are provided a certain amount of compensation, then whether compulsory licensing would be an effective tool to promote competition and improve the availability of drugs. Furthermore, they also consider three different cooperation mechanisms, namely, fixed-fee contract, royalty contract and two-part tariff contract, under the case of technology transfer and give the condition of which contract would be better under different scenarios.

It is found that the product differentiation and the agent behavior of doctor in the domestic market have a deep impact on the foreign enterprise’s decision on technology transfer. If both fixed-fee contract and royalty contract are permitted, foreign enterprise will choose different transfer contracts under different conditions. Under two-part tariff contract, it is equivalent to a fixed-fee or royalty contract under certain conditions. Furthermore, all contracts can improve patients’ benefits, while the royalty contract and the two-part tariff contract would reduce importer’s social welfare under certain conditions.

Prescription drugs can treat many acute diseases and improve people’s quality of life. On the other hand, it requires investment in pharmaceutical research and development and is hard to afford the drug for the people living in poverty. This paper tries to solve the problem by introducing three cooperation contracts. The authors consider an innovative drug company and a regular drug company. The regular drug company can improve the quality of its drug by signing a technology transfer agreement with the innovative company. Three contracts are discussed in this paper; they are fixed-fee contract, royalty contract and two-part tariff contract. The authors examine the impact of different contracts on the companies’ profit, patients’ benefit and social welfare. It is found that quality differentiation of drugs and doctor behaviors can have large impacts on the company’s decision about technology adoption as well as contract choice strategies. In all of the three contracts, patients’ benefit improves, while the profit of the two companies and social welfare can increase or decrease under different contracts.

Knight's Industrial Law Reports goes into a new style and format as Managerial Law This issue of KILR is restyled Managerial Law and it now appears on a continuous updating basis rather than as a monthly routine affair.

The spread of bird flu outside of Asia, particularly in Africa and Europe, topped headlines in 2006. The migration of wild birds brought the virus to Europe, where for the first time it spread to productive livestock, bringing it closer to the Western world. Due to today's globalized and highly interconnected world, the consequences of a potential bird flu pandemic are expected to be much more severe than those of the Spanish flu, which killed 50-100 million people between 1918 and 1921. A vaccine for the bird virus is currently not available. As of July 2006, 232 cases of human infection had been documented, mostly through direct contact with poultry. Of those, 134 people died. The best medication available to treat bird flu was Roche's antiviral drug Tamiflu. However, Tamiflu was not widely available; current orders of government bodies would not be fulfilled until the end of 2008. Well aware that today's avian flu might become a global pandemic comparable to the Spanish flu, Roche CEO Franz Humer had to decide how Roche should respond. While the pharmaceutical industry continued its research efforts on vaccines and medications, Tamiflu could play an important role by protecting healthcare workers and helping to contain the virus---or at least slow down its spread. Due to patent protection and a complicated production process with scarce raw ingredients, Roche had been the only producer of the drug. Partly in response to U.S. political pressure, in November 2005 Roche allowed Gilead to produce Tamiflu as well. Even so, it would take at least until late 2007 for Roche and Gilead to meet the orders of governments worldwide. The issue was a difficult one for Roche: What were the risks; what were the opportunities? If a pandemic occurred before sufficient stockpiles of Tamiflu had been built up, would Roche be held responsible? What steps, if any, should Roche take with respect to patent protection and production licensing in the shadow of a potential pandemic?

Students will weigh the benefits of short-term profit maximization against the risks that a highly uncertain event could pose to a business and consider nonstandard approaches to mitigate these risks. Students will discuss the challenges of addressing low-probability, high-impact events; potential conflicts with the short-term view of the stock market and analyst community; and challenges of the patent protection model for drugs for life-threatening diseases.

The purpose of this study is to contribute towards the debate about global access to COVID-19 vaccines, therapeutics and diagnostics.

The global scramble for COVID-19 vaccine and other related pharmaceutical products have once again exposed the limitations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). High-income countries are claiming a lion’s share of the first available batches of the COVID-19 vaccine in total disregard of the consequences such approach would have on the low-income countries that lack both the manufacturing wherewithal and the financial resources to purchase the vaccine and other products needed to combat the pandemic. This paper reviews the existing TRIPS Flexibilities and analyses their limitations with respect to equitable access of pharmaceutical products in times of health emergencies. This paper then considers the unique challenges that have been brought to the fore by the COVID-19 pandemic. Finally, this paper analytically explores some options that have been proposed so far that the World Trade Organization (WTO) or governments can take in the immediate to near term to facilitate equitable access to COVID-19 pharmaceutical products and technologies. This research is non-empirical, desk-based research. It is, therefore, based on the literature review of existing body of work that is relevant to the topic under discussion. Mindful of the epistemological challenges that are always associated with desk-based research, part of the methodology of this work is to seek support from related empirical studies based on different philosophical underpinnings but that confirm the working hypothesis of this research.

This paper finds that there is still a need for a comprehensive reform of TRIPS Agreement to streamline the voluntary licencing system which is an important tool for low-income countries’ access to affordable pharmaceuticals. However, for purposes of dealing with COVID-19, WTO members should consider establishing pooled Licencing Facilities and procurement strategies via already existing political, economic or regional trade groupings.

This research is original. All sources have been acknowledged. This research synthesises different research papers and applies different viewpoints to the debate on the impact of the TRIPS Agreement on equitable access to COVID-19 vaccines, therapeutics and diagnostics.

There is sufficient evidence to prove that the improved health status of a nation’s citizens results in economic growth and development via improved functionality and productivity of labor. It is also commonly accepted that healthcare expenditure significantly influences health status through, for instance, improving life expectancy at birth and reducing morbidity, death, and infant mortality rates. Within healthcare, medicines account for a considerable share of health-related expenditure in both developed and developing countries. Therefore, it seems reasonable to assume that improved access to medicines is likely to contribute not only to the well-being of families and individuals but also to the economic growth and development in all societies. It has been widely advocated that pharmaceutical multinational enterprises (MNEs) can play an important role to address this problem, as they develop and supply a significant proportion of the drugs imported by low- and middle-income countries. This chapter is dedicated to a systematic review of literature in order to identify the strategies implemented by pharmaceutical MNEs to improve access to medicines in the low- and middle-income countries. A total of 76 research articles have been identified, and we have found that the main strategies of pharmaceutical MNEs are related to improving health outcomes through R&D, establishing partnerships for product development, pricing strategies to improve access to medicines, technology transfer, licensing agreements, and nonmarket efforts to improve access to medicines, among other strategies to overcome barriers imposed by intellectual property rights. We have also found that pharmaceutical MNEs’ strategies take place within a complex system and often involve interactions with a wide range of actors, such as international organizations, governments, private not-for-profit sector, universities and research institutes, and generic manufacturers. However, there is still a need for major progress in the field of access to medicines, and pharmaceutical MNEs should be more active in this field in order to avoid potential negative consequences, such as loss of legitimacy and compulsory licensing of their patented medicines.