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Harmonizing Access to Medicine: Exploring India’s Process Patent in Intellectual Property Rights Amid Global Pressures

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Abstract
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This paper examines the impact of the pharmaceutical patent system, particularly under the TRIPS Agreement and the Indian Patent Act of 1970, on access to medicines.The TRIPS Agreement aims to balance private and public interests by protecting patent holders while allowing countries to safeguard public health.However, this balance has been contentious, especially in developing countries where patent protections can lead to high drug prices and restricted access to life-saving medications.India's approach has been pivotal, initially excluding medicine patents under its 1970 Patent Act, which fostered a robust generic drug industry and kept drug prices affordable.With the TRIPS compliance amendments in 2005, India shifted to recognizing product patents, significantly impacting the generic drug market and accessibility of affordable medicines.The amendments, however, incorporated mechanisms such as compulsory licensing and safeguards against patent abuse, reflecting attempts to maintain access to essential drugs.This study highlights the tension between global intellectual property laws and national public health objectives.It discusses India's strategic use of TRIPS flexibilities and the ongoing challenges posed by stringent global patent policies.The paper argues for the necessity of maintaining a balance that does not compromise public health for intellectual property rights, with a focus on India's role in the global pharmaceutical landscape and its efforts to navigate these competing demands.

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  • Research Article
  • 10.52468/2542-1514.2024.8(1).140-147
Intellectual property rights in international and Russian investment law
  • Mar 22, 2024
  • Law Enforcement Review
  • V N Lisitsa

The investment activity is diverse and can be carried out with the use of intellectual property rights in accordance with the current international and Russian investment law. The article aims to identify the specifics of the application of intellectual property rights as investments and the implementation of intellectual investments, i.e. investments endowed into intellectual property rights. The objectives of the study are to consider the categories of an investment and object of investment activity, intellectual property, exclusive and other intellectual rights, as well as to analyze and determine the features of legal regulation of the activity in question at the international and national levels in the Russian Federation. Based on the results of the systematic analysis with the use of formal legal, comparative and other research methods, it is concluded that investments as a property in a broad sense may include both exclusive and other non-personal intellectual property rights to the results of intellectual activity and equated means of individualization of goods, works, services and enterprises. At the same time, they exclude intellectual property itself as a set of various types of intangible products, moral and other personal non-proprietary intellectual rights by virtue of their inalienable and non-transferable character. It is argued to be the same with respect to the object of investment activity, i.e. the property which the investment is endowed in and is capable to bring income to the investor in the future. Investments into such intellectual property rights can be called as intellectual investments.The legal regulation of investment activity with the use of intellectual property rights has a dual character (in the sense that it is carried out by different investment legislative acts with the similar subject of their regulation) and depends on the type of a particular object used. If intellectual property rights are invested in fixed capital, then they are to be recognized as capital investments and are governed by the Federal Law of February 25,1999 No. 39-FZ “On Investment Activity in the Russian Federation Carried out in the Form of Capital Investments”. If intellectual property rights are used as the object of investment activity, i.e. where investments are endowed in, such intellectual investments are subject to the regulation by the Law of the RSFSR of June 26, 1991 No. 1488-1 “On Investment Activity in the RSFSR”.

  • Research Article
  • Cite Count Icon 3
  • 10.1111/jwip.12229
A critical evaluation of the interface between intellectual property rights and human rights with special emphasis on indigenous intellectual property
  • Jun 7, 2022
  • The Journal of World Intellectual Property
  • Wathsala R Samaranayake

The rendezvous between intellectual property rights and human rights has awakened slumbering legal spirits. Miscellaneous legal phenomena are now nestled in the intersection between intellectual property rights and human rights. However, the interplay between human rights and intellectual property rights is bizarrely characterized by amity and hostility. Naturally, therefore, situating indigenous intellectual property at the intersection of intellectual property and human rights becomes a daunting task. However, the dilemma is often overstated especially from the point of view of conventional intellectual property rights. At the outset of this Article, I shall be exploring the history and the development of the relationship between human rights and intellectual property rights. In the followng section, I shall be examining the extent to which intellectual property rights are entrenched in the international human rights instruments. The last section shall be devoted to exploring the phenomenon of locating indigenous peoples' rights at the interface between intellectual property rights and human rights and reflecting on the ensuing issues—an aspect which has seldom been considered in the existing literature.

  • Research Article
  • Cite Count Icon 1
  • 10.33731/62019.188354
TO THE QUESTION ABOUT THE CONTENT OF THE CONCEPTS "INTELLECTUAL PROPERTY" AND "RIGHTS OF INTELLECTUAL PROPERTY"
  • Dec 13, 2019
  • Theory and Practice of Intellectual Property
  • Оксана Коротюк

The article is devoted to the content of the concepts «intellectual property» and «right of intellectual property» and to the issue of the possibility of using them as equivalent concepts. The author considersthe features of a broad understanding of the concept of intellectual property, in which it is revealed as a complex set of social relations arising at all levels of public life. With this approach intellectual relations are only one of the varieties of intellectual property relations, the totality of which is subject to legal regulation only in part.Taking into account the above, the difference between the meanings of the concepts «intellectual property» (in the sense of this concept as a social relation) and «intellectual property right» is reflected in the content of the structural elements of the relations that denote these concepts: 1) Subjects of intellectual property rights are determinedon the basis of compliance with certain legal requirements regarding legal personality, as well as the acquisition of subjective legal rights and obligations, which are provided to them by legal norms (by using their legal personality); the subjects of intellectual property become participants of social relations of different levels, including those, which are outside of the legal regulation. Such interactions may be related to realization of creative abilities of a person, mental activity, etc; 2) In the centre of understanding of the concept «object of intellectual property rights» is the content of intellectual property rights as a totality of personal non-property and property rights.The defining aspect of legal protection is the right to the created object of intellectual property rights. At the same time the object of intellectual property is a value in sociophilosophical sense that satisfies the social, cultural, mental and other needs and interests of people. In this sense the object by its nature is a good for man; 3) Social connections between the subjects of intellectual relations are revealed through corresponding rights and obligations of the participants of these relations; in the relations of intellectual property social relations manifest themselves as interaction between people in different spheres of social life, based on the corresponding social statusesand roles, in which individuals carry out creative activity, realize their mental and cultural needs, etc. Understanding the concept «intellectual property» as identical with the concept «intellectual property right» is based on a normative approach. This approach shows that the concept of «intellectual property» and «intellectual property right» are used in the legislation in the same sense and can denote both objects of intellectual property right and rights about such objects.

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  • Cite Count Icon 3
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Intellectual Property: The Promise and Risk of Human Rights
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Intellectual Property: The Promise and Risk of Human Rights

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The Colour of Copyright
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The Colour of Copyright

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Выбор способа защиты интеллектуальных прав
  • Dec 16, 2022
  • Vestnik of the St. Petersburg University of the Ministry of Internal Affairs of Russia
  • Mikhail Tregubov + 1 more

The world community recognizes that intellectual property and intellectual rights are one of the foundations of the modern business world. The issues of choosing ways to protect intellectual property rights are the subject of constant discussions. The authors analyze the problem in two aspects: from the point of view of state and international policy and from the point of view of the possibility of protecting their intellectual rights by participants in civil turnover. The purpose of the study is to study the mechanism of intellectual property rights protection, as well as to study the problems of compensation for moral damage and self-defense in the field of intellectual property. When preparing the article, general scientific logical methods were used, as well as a private formal legal method. The authors note that the conflict between the interests of the copyright holder of exclusive rights, on the one hand, and the general rights of participation and access, on the other, is a characteristic feature of modern society and culture, therefore intellectual property and intellectual rights are of interest not only as a legal institution, but also as a cultural model and socio-economic mechanism. With the development of digital technologies, the very principle of exclusivity of intellectual rights is increasingly being questioned both in theory and in practice, which naturally leads to a revision of existing ideas about the protection of these rights.

  • Book Chapter
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Security Rights in Intellectual Property in Estonia
  • Jan 1, 2020
  • Gea Lepik

This paper provides a theoretical overview of and practical guidance on the use of intellectual property (IP) rights as security in Estonia. It begins with an overview of the different IP rights in Estonia and the categories of security rights that can be granted over them. Like in other European countries, there are both non-registered and registered IP rights in Estonia. The different types of IP rights can be categorized as either copyright and related rights or as industrial property rights. In addition to national IP rights, EU-wide IP rights such as EU trademarks and Community also have effect in Estonia. The main ways to create a security right over an IP right are by establishing a pledge over IP rights or by transferring the IP rights as security. An IP right may be encumbered with a pledge through the establishment of a registered security over movables (for registered IP rights) or a pledge of rights (for non-registered IP rights). In addition, non-registered IP rights can also form part of a general commercial pledge, which is established over the entire movable property of an enterprise.

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Decentralizing the Lawmaking Function: Private Lawmaking Markets and Intellectual Property Rights in Law
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Decentralizing the Lawmaking Function: Private Lawmaking Markets and Intellectual Property Rights in Law

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  • Cite Count Icon 2
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Decentralizing the lawmaking function: Private lawmaking markets and intellectual property rights in law
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  • International Review of Law and Economics
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Decentralizing the lawmaking function: Private lawmaking markets and intellectual property rights in law

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  • Cite Count Icon 127
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Individual Differences in the Acceptability of Unethical Information Technology Practices: The Case of Machiavellianism and Ethical Ideology
  • Oct 1, 2004
  • Journal of Business Ethics
  • Susan J Winter + 2 more

While information technologies present organizations with opportunities to become more competitive, unsettled social norms and lagging legislation guiding the use of these technologies present organizations and individuals with ethical dilemmas. This paper presents two studies investigating the relationship between intellectual property and privacy attitudes, Machiavellianism and Ethical Ideology, and working in R&D and computer literacy in the form of programming experience. In Study 1, Machiavellians believed it was more acceptable to ignore the intellectual property and privacy rights of others. Programmers and R&D workers considered violating intellectual property rights more acceptable. Programmers did not consider violating privacy rights more acceptable, but R&D workers did. Finally, there was an interaction between Machiavellianism, programming and R&D. Machiavellians who also had programming experience or worked in R&D found violations of intellectual property much more acceptable. The effect of Machiavellianism on attitudes toward violations of privacy was enhanced by working in R&D, but not by programming experience. In Study 2, idealists believed it was less acceptable to ignore the intellectual property and privacy rights of others. Relativists found it more acceptable to violate intellectual property rights, though they did not consider it more acceptable to violate privacy rights. Those with programming experience were more accepting of intellectual property rights violations, but not of privacy violations. Finally, programming experience moderated the relationship between idealism, relativism and attitudes toward these unethical information practices. Implications for diminishing unethical behavior among Machiavellians, Relativists, programmers and those in R&D are discussed.

  • Research Article
  • 10.24260/al-usroh.v4i1.961
WAKAF HAK ATAS KEKAYAAN INTELEKTUAL DALAM TINJAUAN HUKUM ISLAM DAN UNDANG-UNDANG NOMOR 41 TAHUN 2004 TENTANG WAKAF
  • Jul 17, 2024
  • Al-Usroh
  • Imam Syafi'Ie + 2 more

This research explains waqf for intellectual property and reviews of Islamic law. As well as answering and knowing: 1) the position of intellectual property rights as an object of waqf in the concept of Islamic law. 2) implementation of the endowment of intellectual property rights if the wakif dies. The position of intellectual property rights as an object of waqf is explained in the Case Study of Article 16 paragraph 3 Letter E of Law Number 41 of 2004 concerning Waqf, as well as the Islamic religious perspective. This research is included in the descriptive qualitative research cluster using a library research approach (literature study), a way of collecting data in research by collecting literary sources such as books that explain waqf, journals related to research, and books that discuss waqf. intellectual property rights, the method of validating data from this research uses four criteria, namely reliability, transferability, reliability and verifiability, and data analysis techniques with data reduction, data display, and data withdrawal. This research shows that: 1) the position of Intellectual Property Rights in Islamic law. The position of intellectual waqf property rights when they become the object of waqf. There are many opinions about this, but in essence, all of them allow or are legal in waqf rights. Even though IPR waqf is basically rarely done, it is permitted by all Islamic schools of thought. Waqf that does not materialize, such as art or the identity of an item, is legally waqf, and the terms return to the basic law of waqf. 2) Implementation of the endowment of Intellectual Property Rights when the person providing the endowment dies. The position of giving IPR is if the waqf is issued before death, then the gift is continued based on the deed, because the gift is a legal act of waqf to separate/transfer part of one's property rights to be used according to the rights and values ??of worship of both the living and the dead. The reward is then received by the reward waqif, so that the reward continues and the waqf remains valid in religious law and in the context of the state.

  • Research Article
  • Cite Count Icon 2
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Intellectual property rights in e‐commerce industry of Bangladesh
  • Sep 21, 2021
  • The Journal of World Intellectual Property
  • Sadiya S Silvee + 1 more

Evolution of internet and technology has led to an increase in electronic commerce (e‐commerce). Consequently, disputes regarding commercial use of the internet are emerging in many developed and developing countries. Many of these disputes concern the infringement of intellectual property (IP) rights. However, IP rights are, perhaps, spurned by many developing countries when it comes to e‐commerce—making it a timely study for many developing countries such as Bangladesh; whose e‐commerce industry is experiencing extraordinary growth in the past few years. Although Bangladesh embarked into e‐commerce years ago, however, judiciary of the country has not yet experienced disputes addressing IP rights in the e‐commerce industry. Mostly, because the significant connection of IP rights with e‐commerce are yet to comprehend. Against this backdrop, focusing on the propinquity between e‐commerce and IP rights, this paper examines the adeptness of the contemporary IP rights enactments of Bangladesh in protecting IP rights in e‐commerce industry of Bangladesh. Arguing that IP rights are the most essential and value‐bearing component of e‐commerce industry, the paper presents how IP rights are violated by various entities of the industry every now and then. The paper delineates the disputes of such nature which already exist but remained unaddressed because of the inadequate understanding of IP rights and loopholes in the Bangladesh IP enactments. The paper concludes by giving a persuasive guideline to protect the legitimate rights and interests of various entities of the e‐commerce industry in Bangladesh.

  • Research Article
  • 10.1108/eemcs-03-2023-0090
IPR of Lays variety potato – Is it a matter of public or private interests?
  • Dec 11, 2023
  • Emerald Emerging Markets Case Studies
  • Jayakrishnan S

Learning outcomes The objectives of the case study are to provide an overview of intellectual property rights and intellectual property rights in Indian context; understand the intellectual property rights implementation and challenges for implementing it in emerging economies; understand what would be the best approach that companies can adopt when the companies face backlash in such circumstances; and explore the scope for redefining the intellectual property rights in the changing global environment. Case overview/synopsis In December 2021, the Protection of Plant Varieties and Farmers’ Rights Authority (PPV&FRA) in India revoked the plant variety protection (PVP) certificate granted to PepsiCo India Holding (PHI) for its Lays variety potato (FL-2027, known as FC-5). The FC-5 variety possessed low moisture content which made it suitable for making potato chips. The controversy started with Pepsi suing the small and marginal farmers of Gujarat for alleged patent infringement and cultivating the patented variety. Pepsi’s legal suit against nine marginal potato farmers in Gujarat initiated the dispute over how intellectual property (IP) rights are used to intimidate small, marginal farmers and its infringement of farmers’ rights. But, on the other side, the interesting aspect was how IP infringement could be a setback for the companies that made the capital investment to develop the variety. The case study discusses the backlash Pepsi faced due to this IP rights legal suit and the punitive aspects of IP rights (IPR) law. Moreover, in the context of the global pandemic, the case study helped discuss the need to redefine the intellectual property rights regime keeping in mind global welfare. Complexity academic level The case is intended for use in postgraduate-level management courses in agricultural marketing, agribusiness, international business and economics. This study can help management students understand how IPR is defined, the apparent complexities associated with it and the adverse effect of it on small and marginal farmers in emerging economies. Supplementary materials Teaching notes are available for educators only. Subject code CSS 5: International business.

  • Book Chapter
  • 10.2174/9789815274769125010004
Historical Perspective on Vaccines and IP Rights
  • Jul 30, 2025
  • Sandhya Bagde + 4 more

As an efficient means for the prevention and management of infectious diseases, vaccines are the most notable achievements in the field of public health. This chapter explores the relationship between intellectual property (IP) rights and vaccines, including their historical development and current implications for global health. The chapter also discusses the importance of vaccinations for public health, highlighting how they can prevent disease and save lives. Simultaneously, it presents intellectual property and its significant impact on vaccine development in the pharmaceutical sector. A history of vaccines is presented, starting with important events like Edward Jenner's ground-breaking research on the smallpox vaccine. The 20th century witnessed the development of contemporary vaccines, which indicated a turning point in medical research and advances against illnesses including influenza, measles, and polio. Early IP strategies in the vaccine industry that focused on collaboration and information exchange enabled quick advancement. The contribution of intellectual property to pharmaceutical innovations and how IP rights act as vital inducements to investment in and innovation within the field of vaccine development. The impact of vaccination accessibility under the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) is examined. Difficulties and disputes about vaccine patents and intellectual property rights are further explored, focusing on negotiating the complicated intellectual property environment for vaccine distribution. Public-private partnerships and collaborative techniques are two recent developments in vaccine research that are also covered. Lastly, a case study is provided for examining the function of intellectual property in the creation, manufacturing, and distribution of vaccines. The pandemic's effect on how the world views intellectual property rights related to vaccines highlights the continuous discussion about fair access to vaccines during public health emergencies. Overall, this chapter offers a thorough analysis of the historical viewpoint on vaccinations and their beneficial association with intellectual property rights, highlighting the difficulties and complexities present at the junction of public health, science, and innovation.

  • Research Article
  • Cite Count Icon 8
  • 10.2139/ssrn.1357045
Does Enforcement of Intellectual Property Rights Matter? Evidence from Financing and Investment Choices in the High Tech Industry
  • Mar 12, 2009
  • SSRN Electronic Journal
  • James S Ang + 2 more

Does Enforcement of Intellectual Property Rights Matter? Evidence from Financing and Investment Choices in the High Tech Industry

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