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Pugatch, Meir Perez. "Intellectual Property." European Journal of Risk Regulation 2, no. 4 (2011): 566–71. http://dx.doi.org/10.1017/s1867299x00001628.
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This article examines the issue of risk in research and development (R&D) pertaining to new pharmaceuticals, especially those aimed at neglected diseases and/ or relevant primarily to the developing world. In particular, the article considers the role of patent pools and other forms of non-proprietary models as alternatives to patents (and other types of intellectual property rights) in R&D for new pharmaceuticals. The article concludes that that these mechanisms still achieve very little output and can therefore not currently be considered as viable alternatives to the use of patents in pharmaceutical R&D. Another relevant finding is that many of the existing collaborative initiatives and partnerships for R&D in neglected diseases actually rely on different forms of intellectual property rights.
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Verma Vikesh Kumar, Sonali. "Intellectual Property Rights and Challenges Associated in Drugs and Pharmaceuticals." International Journal of Science and Research (IJSR) 13, no. 1 (2024): 1346–49. http://dx.doi.org/10.21275/sr231023114227.
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Polana, Ramya* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "INTELLECTUAL PROPERTY RIGHTS (IPRs) -A REVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7264–71. https://doi.org/10.5281/zenodo.1341326.
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<em>Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era.</em> <strong>Keywords: </strong><em>Drugs, intellectual property Rights (IPRs), license, patent, pharmaceuticals, Copyright Forms, Trademarks</em>
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Polana, Ramya* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "INTELLECTUAL PROPERTY RIGHTS (IPRs) -A REVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7264–71. https://doi.org/10.5281/zenodo.1341338.
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<em>Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is a recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era.</em> <strong>Keywords: </strong><em>Drugs, intellectual property Rights (IPRs), license, patent, pharmaceuticals, Copyright Forms, Trademarks</em>
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Ancevska Netkovska, Кaterina. "Trips Agreement and Pharmaceutical Inventions." Macedonian Pharmaceutical Bulletin 56 (2011): 71–78. http://dx.doi.org/10.33320/maced.pharm.bull.2010.56.009.
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Existence of contemporary, modern legal regulations in a certain segment of the national legal system, such as legal regulation of intellectual property rights is an assumption, but not a guarantee for the presence of efficient protection of these rights. The Agreement on Trade-Related Aspects of Intellectual Property Rights-TRIPS is one of the most important documents related to the trade of intellectual property rights. This Agreement is one of the most important acts on harmonization and implementation of intellectual property rights at multinational level, whereby the intellectual property is assigned a new dimension-world globalization of this field, also promoted by technology development. Medical technology is an area of huge progress of concern to all of us. Finding an optimum in intellectual property protection among short-term interests in the maximum approach and long-term interests in promoting creativity and innovation is not always easy. Trying to transfer that at international level is even harder than in national, domestic conditions. Maybe the most interesting and exciting field of activity is definitely that of pharmaceutical inventions, where tension exists between the need to determine the landmark for research and development of new pharmaceuticals and the need for allowing greater availability of the existing pharmaceuticals. The acceptance of TRIPS Agreement means a way to establish legal and economic cooperation with European Union countries and all other countries. International standards oblige Republic of Macedonia to continuously harmonize our law with international conventions in the field of intellectual property rights.
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Boscheck, Ralf. "Intellectual Property Rights and the Evergreening of Pharmaceuticals." Intereconomics 50, no. 4 (2015): 221–26. http://dx.doi.org/10.1007/s10272-015-0546-y.
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Rehan, Haider, Mehdi Asghar, and Kumari Das Geetha. "Intellectual property rights." i-manager's Journal on Economics & Commerce 4, no. 1 (2024): 45. http://dx.doi.org/10.26634/jecom.4.1.20931.
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This paper explores the complex relationship between drug patents and access to medicine, highlighting the implications for public health and innovation. Patents play a crucial role in incentivizing pharmaceutical innovation by granting exclusive rights to inventors for a limited period of time. However, the monopolistic nature of patents can hinder access to essential medicines, especially in developing countries where affordability is a significant barrier. This paper examines the balance between fostering innovation and ensuring affordable access to medication, emphasizing the tension between patent care and public health objectives. Key issues discussed include the impact of patents on drug pricing, the role of generic competition in lowering prices, and the strategies employed by pharmaceutical companies to extend patent protection. The paper also discusses the role of international trade agreements and intellectual property laws in shaping access to medicine, focusing on the flexibilities in compulsory licensing and parallel imports. Through a review of case studies and empirical evidence, this paper evaluates the impact of various policy interventions designed to reconcile patent rights with public health priorities. These include initiatives to promote technology transfer, strengthen generic competition, and enhance regulatory frameworks for patent examination and enforcement. The paper also considers the importance of balancing incentives for innovation with safeguards against abuse. This ensures equitable access to medicines for all.
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Aiyer, Pranav, Iqbal Ratnani, and Salim Surani. "Patents vs. Patients: Prioritizing Equitable Access Over Intellectual Property Rights." Journal of Independent Medicine 01, no. 02 (2025): 97–102. https://doi.org/10.71189/jim/2025/v01n02a01.
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Health is the foundation of human well-being and the cornerstone of a thriving society. Good health is not merely a privilege—it is a fundamental right that underpins all other rights and freedoms. However, this right is increasingly jeopardized by patents and profit-driven pharmaceutical policies. Life-saving medications, restricted by patents and monopolies, are often accessible only to those who can afford their exorbitant prices. Intellectual property (IP) protections, initially intended to drive innovation, have instead turned life-saving drugs into luxury products, priced out of reach for the average person. Ensuring equitable access to pharmaceuticals is key to addressing deep-rooted inequalities and reducing preventable suffering. This paper explores the current public health crisis, examines the impact of intellectual property rights, and highlights the urgent need for reform, ultimately advocating for a healthcare system that prioritizes people over profit.
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Newman, Karl, and Catherine Seville. "III. Intellectual Property." International and Comparative Law Quarterly 46, no. 3 (1997): 712–16. http://dx.doi.org/10.1017/s0020589300060930.
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The period since the last note on this subject has been eventful.1 There have been some important legislative measures, and a good deal of significant case law. However, contradictory messages are being conveyed. The volume of legislation marks the Community's recognition of the economic value of intellectual property rights in international trade. Its broad aim is, as always, to achieve a level playing-field for competition, and to integrate the market by removing restrictions on the free movement of goods. Yet the unwavering adherence to the principle of free movement is being challenged in several areas, precisely because of its effect on competition, notably in the pharmaceuticals market.
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PRADHAN, JAYA PRAKASH. "STRENGTHENING INTELLECTUAL PROPERTY RIGHTS GLOBALLY: IMPACT ON INDIA'S PHARMACEUTICAL EXPORTS." Singapore Economic Review 52, no. 02 (2007): 233–50. http://dx.doi.org/10.1142/s0217590807002671.
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This paper examines the impact of stronger protection for intellectual property on the exports of a technologically imitative country such as India. The Indian experience in pharmaceutical exports can further add to the existing literature, which is otherwise largely limited to the experience of OECD countries and the USA. The empirical analysis suggests that even an imitative developing country's exports need not be negatively affected by strengthening patent regime globally, and in fact, in the case of pharmaceuticals, India stands to benefit from market expansion effects. However, this finding in the case of pharmaceutical products cannot be argued to hold for other sectors of the Indian economy, and any generalization on overall impact of stronger patent regime on aggregate exports from the Indian economy must be based on further sectoral studies.
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Kshirod, Kumar Moharana, and Laxmikanta Das Dr. "Intellectual Property Right for Making in India A Legal Right." International Journal of Trend in Scientific Research and Development 2, no. 5 (2018): 1375–83. https://doi.org/10.31142/ijtsrd17018.
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Intellectual Property Right is a legal concept which is creations of human intellect under intellectual property law owners are granted certain exclusive rights to a variety of intangible assets, such as musical, literary and artistic works discoveries and inventions of words, phrases, symbols, designs etc. Common types of intellectual property rights are copyright, trademarks, patents, industrial, trade dress and some jurisdictions secrets. So it is a most controversial term referring to a number of distinct types of expression. IPR now becomes most contentious issues in this global world. The major issues relating IPR not only dominate trade among nation in agricultural, pharmaceutical, geographical induction, sustainable development of patent right, copy right, trademark, performing Art but it also challenges various issues for reliance of the legal right and obligation of the indigenous invention, industrial product, agricultural product, geographical induction. There are so many organization for the protection of the intellectual property rights such as TRIPS agreement, WTO, GATT, WIPO, special jurisdiction etc are working under the national and international jurisdiction for protection and solving issues of intellectual property rights. Now an intellectual property right in India becomes challengeable for protection of new invention and for the making of India into a new trend. Intellectual property Right plays an important role in India by increasing broad range of areas, ranging from the Internet to health care to nearly all aspects of science and technology, literature and the arts. The role of intellectual property in these areas many of them still emerging often requires significant new research and study. The emergence of new technologies, in particular, rapid breakthroughs in biotechnology, the adoption of new business processes and methods, the spread of new software threaten entire industries. These new technologies, some of which are controversial, have either made IPR more vulnerable or rendered the existing IPR regime obsolete. This paper emphasizes the legal obligation for protection of IPR to make the India into a protective measure and current emerging trends in intellectual property regimes in the field of agriculture and pharmaceuticals, geographical induction and protection of traditional knowledge for making in India. Kshirod Kumar Moharana | Dr. Laxmikanta Das "Intellectual Property Right for Making in India: A Legal Right" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-5 , August 2018, URL: https://www.ijtsrd.com/papers/ijtsrd17018.pdf
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Kodynets, A.O., O.F. Doroshenko, I.P. Volynets, G.K. Dorozhko, V.O. Petrenko, and V.V. Belitsky. "Abuse of patent rights for pharmaceuticals in wartime conditions." Medicni perspektivi 29, no. 4 (2024): 237–46. https://doi.org/10.26641/2307-0404.2024.4.319395.
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The article addresses the issue of patent rights abuse in relation to pharmaceuticals during wartime conditions. The aim of the study is to summarize the problems of patent rights abuse in the national legislation, identify ways to resolve them, and formulate conclusions to reduce such abuses. The study employs general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, system-structural, comparative-legal methods, as well as modeling, analysis, and synthesis. Together, these methods facilitated the organization, planning, and execution of the research. The information search covered the period from 2001 to 2024. The study is based on scientific publications from databases and search engines (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic, Cairn.info), international and domestic legal acts, statistical studies of international organizations (Precedence Research, Statista, Proxima Research), patents on inventions related to pharmaceuticals, court rulings, and the recommendations of international and domestic experts. The inclusion criteria for materials were scientific articles, legal acts, court rulings, and analytical reviews related to pharmaceutical patent rights, patent monopoly abuses, "evergreening" patents, and unfair competition in the pharmaceutical industry. The following search queries were used: "abuse of patent rights on pharmaceuticals," "patent monopoly in the pharmaceutical industry," "evergreening patents," "unfair competition in the pharmaceutical market," and "intellectual property in wartime conditions." Exclusion criteria included sources unrelated to the legal regulation of pharmaceutical patents, materials not directly connected with patent rights, and publications that did not meet scientific standards and credibility. It has been determined that patent monopolies can lead to higher drug prices, the prevention of generic drug production, import dependency, reduced competitiveness, and other consequences. Additionally, the creation of "evergreening" patents affects competitive relations, representing a form of unfair competition. Examples of patent monopolies in pharmaceuticals owned by major global pharmaceutical companies (Gilead, Merck Sharp & Dohme Corp., etc.) were examined. Attention is drawn to the problematic aspects of legislative implementation to strengthen the protection of individuals’ interests in the field of intellectual property during martial law, which leads to misinterpretation and implementation of relevant provisions and requires updating. Court cases of pharmaceutical companies regarding the artificial maintenance of patent monopolies and the blocking of generic drugs entering the Ukrainian market were analyzed. The need for updating and improving the legislative mechanism for regulating the validity of invention patents has been emphasized.
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Dolle, Tobias, and Paolo R. Vergano. "Free Trade Agreements and Regulatory Change: Examples from the Generic and Biosimilar Sectors." Journal of World Trade 51, Issue 2 (2017): 205–32. http://dx.doi.org/10.54648/trad2017009.
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Comprehensive free trade agreements (FTAs) have increasing importance and impact on domestic legislation and significantly affect regulated industries, such as pharmaceuticals. Recent FTAs include provisions on regulatory cooperation and convergence, as well as intellectual property provisions going well beyond the scope of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). These rules have particular importance for the generic and biosimilar medicines’ sectors and have important links to public health objectives. A growing number of sectors are covered by the substantive provisions of FTAs, often by means of dedicated and sector-specific rules and chapters catering to country- and/or industry-specific needs and interests. The article provides the relevant background in terms of trade law, trade negotiations and FTA trends, particularly as they relate to intellectual property rights and pharmaceuticals. The article places its core emphasis on the domestic impact of FTAs. Examples are drawn from the pharmaceutical sector of generic and biosimilar medicines. The potentially decisive impact of FTAs implies the necessity that all interested parties be more pro-actively involved in order to shape the future of the applicable legal frameworks, internationally and domestically.
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Hosseini, Seyed Aref, Ahmad Mirzaei, and Esmail Abdollahi. "Criminal Guarantees for the Protection of Intellectual Property Rights." Comparative Studies in Jurisprudence, Law, and Politics 6, no. 1 (2024): 312–24. http://dx.doi.org/10.61838/csjlp.6.1.19.
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Intellectual property can be found almost everywhere, in creative works such as books, films, music, sound recordings, art, software, and even in everyday objects like cars, computers, pharmaceuticals, and industrial and commercial designs and trademarks. Society supports and appreciates the benefits derived from intellectual property and those who dedicate their time and resources to fostering innovation and developing knowledge. This support helps prevent the brain drain of the country's talented minds. The design of the intellectual property system benefits society in various ways. By providing criminal protections for this system, society can achieve the enrichment of public knowledge and culture, support for fair competition, economic growth enhancement, the sustainability of innovation and creativity, technological and cultural advancements, and, most importantly, public benefit, order, and the proper exercise of rights. Therefore, this article examines criminal guarantees against intellectual property violations in domestic law.
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Kodynets, A. O., O. F. Doroshenko, I. P. Volynets, G. K. Dorozhko, V. O. Petrenko, and V. V. Belitsky. "Abuse of patent rights for pharmaceuticals in wartime conditions." Medicni perspektivi 29, no. 4 (2024): 237–46. https://doi.org/10.26641/2307-0404.2024.4.319395.
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The article addresses the issue of patent rights abuse in relation to pharmaceuticals during wartime conditions. The aim of the study is to summarize the problems of patent rights abuse in the national legislation, identify ways to resolve them, and formulate conclusions to reduce such abuses. The study employs general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, system-structural, comparative-legal methods, as well as modeling, analysis, and synthesis. Together, these methods facilitated the organization, planning, and execution of the research. The information search covered the period from 2001 to 2024. The study is based on scientific publications from databases and search engines (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic, Cairn.info), international and domestic legal acts, statistical studies of international organizations (Precedence Research, Statista, Proxima Research), patents on inventions related to pharmaceuticals, court rulings, and the recommendations of international and domestic experts. The inclusion criteria for materials were scientific articles, legal acts, court rulings, and analytical reviews related to pharmaceutical patent rights, patent monopoly abuses, "evergreening" patents, and unfair competition in the pharmaceutical industry. The following search queries were used: "abuse of patent rights on pharmaceuticals," "patent monopoly in the pharmaceutical industry," "evergreening patents," "unfair competition in the pharmaceutical market," and "intellectual property in wartime conditions." Exclusion criteria included sources unrelated to the legal regulation of pharmaceutical patents, materials not directly connected with patent rights, and publications that did not meet scientific standards and credibility. It has been determined that patent monopolies can lead to higher drug prices, the prevention of generic drug production, import dependency, reduced competitiveness, and other consequences. Additionally, the creation of "evergreening" patents affects competitive relations, representing a form of unfair competition. Examples of patent monopolies in pharmaceuticals owned by major global pharmaceutical companies (Gilead, Merck Sharp & Dohme Corp., etc.) were examined. Attention is drawn to the problematic aspects of legislative implementation to strengthen the protection of individuals’ interests in the field of intellectual property during martial law, which leads to misinterpretation and implementation of relevant provisions and requires updating. Court cases of pharmaceutical companies regarding the artificial maintenance of patent monopolies and the blocking of generic drugs entering the Ukrainian market were analyzed. The need for updating and improving the legislative mechanism for regulating the validity of invention patents has been emphasized.
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Minchenko, Nataliia. "Protection of trademark property rights in pharmaceuticals. Analysis of judicial practice." Theory and Practice of Intellectual Property, no. 6 (February 27, 2023): 56–63. http://dx.doi.org/10.33731/62022.274635.
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Keywords: trademarks in the pharmaceutical industry, trademarks ownershipviolations, trademarks protection, case law, trademarks protection cases, invalidationof the trade mark certificate, early termination of the certificate
 The relevance of this article is that the largest number of legal disputes in the sphere of intellectual property are disputes concerning violation of property rights for trademarks. At the same time, in economicproceedings, part of the court cases on the protection of trademark rights in the pharmaceutical industry represents about 40% of the total number of court cases on the protection of rights to trademarks. The article studies theoretical provisions of protection of trademark rights in the field of pharmaceuticals, as well as practical issues of violations of these rights. Special attention is paid to the analysis of court practice of protection of trademark rights in the field of pharmaceuticals. It has been found that the overwhelming number of cases investigated concerns recognition of the Ukrainian trademark certificateas invalid. The analysis of judicial practice made it possible to establish the following statistical data in economic proceedings: cases of invalidation of a trademark certificate are 70%; cases on termination of infringement of rights to the trademark are 12%; cases on early termination of the trademark certificate are 15%; other cases on protection of rights to trademarks make 5%. The article details the legal requirements for each category of court cases. What additional claims are submitted for each category of court cases.
 The case law analysis revealed that courts for the protection of trademark rights in the pharmaceutical industry are most often sued for declaring the Ukraine trademark invalid in whole or in part and for an obligation to act. In addition, it was found that 70 percent of trademark cases in the pharmaceutical industry resulted in a full or partial award. In civil proceedings it is almost 90 percent. Thus, litigation is a very effective way of protecting trademark rights in the pharmaceutical industry.
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Bican, Peter M., Carsten C. Guderian, and Anne Ringbeck. "Managing knowledge in open innovation processes: an intellectual property perspective." Journal of Knowledge Management 21, no. 6 (2017): 1384–405. http://dx.doi.org/10.1108/jkm-11-2016-0509.
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Purpose As firms turn their innovation activities toward collaborating with external partners, they face additional challenges in managing their knowledge. While different modes of intellectual property right regimes are applied in closed innovation systems, there seems to be tension between the concepts of “open innovation” and “intellectual property rights”. The purpose of this paper is to investigate how firms best manage knowledge via intellectual property rights in open innovation processes. Design/methodology/approach Following a mixed methods approach, the authors review relevant literature at the intersection of knowledge management, intellectual property rights, strategic management of intellectual property rights and the open innovation process. The authors identify success drivers through the lenses of – but not limited to – intellectual property rights and classify them in five distinct groups. Expending the view on open innovation beyond its modus operandi, the authors develop the Open Innovation Life Cycle, covering three stages and three levels of the open innovation process. The authors apply their findings to a case study in the pharmaceutical industry. Findings The authors provide four key contributions. First, existing literature yields inconclusive results concerning the enabling or disabling function of intellectual property rights in open innovation processes, but the majority of scholars detect an ambivalent relation. Second, they identify and classify success drivers of successful knowledge management via intellectual property rights in open innovation processes. Third, they advance literature on open innovation beyond its modus operandi to include three stages and three levels. Fourth, they test their findings to a case study and show how management leverages knowledge by properly using intellectual property rights in open innovation. Practical implications The findings support firms in managing knowledge via intellectual property rights in open innovation processes. Management should account for the peculiarities of open innovation preparation and open innovation termination to prevent unintentional knowledge drain. Originality/value This is one of the first studies to view open innovation as a process beyond its modus operandi by considering the preparations for and termination of open innovation activities. It also addresses the levels involved in managing knowledge via intellectual property rights in open innovation from individual (personal) to project and firm level.
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Ecer, Sencer, and Darnita York Akers. "The TRIPS Agreement and Its Effects on the R&D Spending of US-Owned Multinational Companies in Developing Countries." Journal of World Trade 43, Issue 6 (2009): 1173–92. http://dx.doi.org/10.54648/trad2009046.
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We test whether the strict intellectual property protection regulations required by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement benefit developing countries, specifically by attracting private US research and development funds. We examine the level of country-specific research and development (R spending by foreign affiliates of US-owned multinational companies between 1989 and 2003 as a function of whether the country has adopted two of the major patent protection regulations required by TRIPS – patent protection for a duration of twenty years and patent protection for pharmaceuticals. Results from the regression analysis suggest that providing a patent protection duration of twenty years positively impacts the R&D spending while providing patent protection for pharmaceuticals does not impact it. As such, pharmaceutical patent protection should be enforced in a case-by-case manner, whereas twenty-year patent protection should be broadly undertaken.
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Gaurav, Abhishek. "Intellectual Property Right (IPR) And Patent in Pharmaceuticals Industry in India." INTERNATIONAL JOURNAL OF SCIENTIFIC RESEARCH IN ENGINEERING AND MANAGEMENT 09, no. 04 (2025): 1–9. https://doi.org/10.55041/ijsrem45176.
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Patent is granting property right by the authority to the inventor. This grant provides the inventors exclusively right to the patent process. Design or inventions for a particular period especially in the pharmaceutical industry. Government agencies typically handle and approve the patent. In the United States the US patent and trademark office, which is the part of the department of commerce, handles the applications and grants the approval. Similarly in India the patents are controlled by the registrar of the patent department under the control of the central government. The pharmaceutical sector in India is a prosperous, high-tech sector that has grown steadily during the previous thirty years. Due to favourable government policies and little rivalry from overseas, an array of privately held Indian enterprises has seized a significant share of the domestic pharmaceuticals the marketplace, making them the contemporary industry players. However, when Indian businesses start expanding behind domestic markets and prepared for global competitiveness, the liberalization that has impacted the Indian economy continues to impact them. India, an important player in the worldwide pharmaceutical sector, must strike an appropriate compromise between meeting the urgent demand for affordable pharmaceuticals and encouraging development by means of intellectual property protection. The study analyses the influence on the public's health, investigates important legislative structures, and digs into the lengthy history of pharmaceuticals patented in India. This essay seeks to add to the continuous conversation on finding an equilibrium between innovation and affordability in the drug sector by looking at case studies, global viewpoints, and viable solutions. Key words: - IPR (intellectual property right), WTO (world trade organisation), TRIPS, Patent filling, Property, Pharmaceutical products, Protection.
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Khaustov, Volodymyr. "Economic aspects of strengthening the protection of intellectual property rights." Ekonomìčna teorìâ 2023, no. 1 (2023): 31–46. http://dx.doi.org/10.15407/etet2023.01.031.
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The present stage of development of the world economy is characterized by a spread of innovation, a rapid development of global and national protection systems and, especially, the protection of intellectual property. The dynamism of interstate relations is accompanied by an increase of various violations of intellectual property rights, including counterfeiting, falsification, piracy, and plagiarism. The purpose of the study is to generalize the global trends in the violation of intellectual property rights, identify the main problems in the protection of intellectual property rights in Ukraine within the context of strengthening the fight against violation of copyright and industrial property rights by the world's leading countries. Violations of intellectual property rights, including patent theft, trademark counterfeiting, copyright piracy, and trade secret theft, cause considerable material and financial damage to the rights holders. The problem of counterfeiting is currently spreading on a global scale and occurs in the production, transshipment and in the sale of large quantities of counterfeit goods. Counterfeit goods, especially foodstuffs and pharmaceuticals, bear risks to the health and safety of consumers. Online sales have become the newest channel for trading fraudulent and counterfeited goods. The bulk of counterfeited produce originate from a small group of economies, among which China, Hong Kong (province of China), Turkey, Singapore and the United Arab Emirates are in the lead. Escalated violations of intellectual property rights lead to a stronger protection of intellectual property rights in the USA and EU countries, and the appearance of special reports based on the results of monitoring and supervision of violations in trading partner countries. In recent years, Ukraine has been included in the US Priority Watch List of countries that do not ensure a proper protection of intellectual property rights and are monitored by the Office of the US Trade Representative. Besides, this country is in the second category of the European Commission’s Counterfeit and Piracy Watch List, which includes countries with the most serious problems in intellectual property protection. The status of a candidate country for EU membership requires Ukraine to harmonize its national legislation with the EU legislation in the field of intellectual property protection.
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Mercurio, Bryan. "‘SEIZING’ PHARMACEUTICALS IN TRANSIT: ANALYSING THE WTO DISPUTE THAT WASN'T." International and Comparative Law Quarterly 61, no. 2 (2012): 389–426. http://dx.doi.org/10.1017/s0020589312000073.
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AbstractSeveral recent detentions of generic pharmaceutical products transiting through the European Union (EU) for suspected infringements of intellectual property rights raised serious concerns for public health advocates and threatened to expose systemic problems existing in the World Trade Organization's (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The detentions not only garnered international attention, but India and Brazil formally began WTO dispute settlement proceedings against the EU. The parties recently reached a mutually agreed solution to the matter and the proceedings have been halted, leaving unanswered the complex legal and technical questions raised by the detentions of pharmaceuticals in transit. Despite a solution being reached in this dispute, the matter will undoubtedly resurface in the near future for a number of reasons. For instance, the EU is attempting to export its laws to its trading partners through the negotiation of free trade agreements and in other forums such as the recently concluded Anti-Counterfeiting Trade Agreement which increases the likelihood that similar detentions will occur at some point in the future. Moreover, recent trends in international intellectual property law indicate a move towards increased protection and enforcement in at least the short and medium term. The issue therefore offers the opportunity for rich legal analysis into an underexplored, yet increasingly important, aspect of WTO law.
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Lexchin, Joel. "Intellectual Property Rights and the Canadian Pharmaceutical Marketplace: Where Do We Go from Here?" International Journal of Health Services 35, no. 2 (2005): 237–56. http://dx.doi.org/10.2190/y8ur-ywvr-budp-cdr0.
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Patent protection for prescription drugs has a long and contentious history in Canada. Bills C-22 and C-91, passed as part of Canada's commitment to various trade deals, first weakened and then abolished compulsory licensing. In order to decide on a future course of action that Canada should take on intellectual property rights (IPRs), it is useful to review downstream effects that resulted from C-22 and C-91. This article examines changes to employment, Canada's balance of trade in pharmaceuticals, investment in research and development, and drug expenditures. The author then reviews the arguments advanced by the pharmaceutical industry in favor of stronger protection for IPRs, the recent complaints made against Canada at the World Trade Organization regarding pharmaceutical IPRs, and the continuing argument about the “evergreening” of patents. Also discussed are the second-draft text agreement of the Free Trade Area of the Americas, which will, if implemented, have significant repercussions for pharmaceutical IPRs in Canada, and some ways in which patents distort the marketplace for drugs. The article concludes with some alternative recommendations on the future of IPRs.
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Curti, Andrea M. "The WTO Dispute Settlement Understanding: An Unlikely Weapon in the Fight Against AIDS." American Journal of Law & Medicine 27, no. 4 (2001): 469–85. http://dx.doi.org/10.1017/s0098858800008224.
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One of the most controversial aspects of the World Trade Organization (WTO) is its trade policy governing pharmaceutical products that treat AIDS and other diseases. Critics contend that the WTO unreasonably restricts the trade of pharmaceuticals in order to protect the profit margin of western drug producers at the expense of infected populations in developing countries. Supporters of the WTO's trade policy argue that protecting the intellectual property (IP) rights of pharmaceutical products is essential to providing an incentive for further drug research and development.
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Juriti, Saharia. "The Role of Traditional Knowledge in Sustainable Development and Implications of Intellectual Property in Pharmaceuticals." Annual International Journal on Analysis of Contemporary Legal Affairs (AIJACLA) 1 (June 5, 2023): 128–31. https://doi.org/10.5281/zenodo.10790441.
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Traditional knowledge (TK) encompasses the accumulated wisdom, skills, and practices passed down through generations within communities. It plays a pivotal role in environmental conservation and is vital for sustainable development, which seeks to meet present needs without compromising those of future generations. Both at international and national levels, efforts are being made to ensure sustainable development that respects the rights of future generations while addressing current needs. Traditional knowledge supports these mechanisms and is a valuable asset for indigenous and local communities, making it a candidate for protection through intellectual property rights. This article explores how traditional knowledge contributes to sustainable development and delves into the implications of intellectual property, especially in the pharmaceutical sector. The analysis is based on a doctrinal methodology, utilizing secondary sources, published and unpublished data, as well as seminar papers presented during a session held on April 24, 2022
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Miglo, Anton. "The Development of Property Rights for Intellectual Property." Journal of Economics and Behavioral Studies 3, no. 4 (2011): 224–34. http://dx.doi.org/10.22610/jebs.v3i4.275.
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This article analyzes the development of property rights (PR) for intellectual property (IP). There is a fundamental tension between competition policy and IP. IP rights confer a certain degree of monopoly power on the owner of IP rights. Some authors found that there are too many patents in Biotechnological or Internet industry. The regulation of intellectual property has expanded dramatically in many countries in recent years and competition authorities are increasingly asking for methodological help in determining the duration and scope of patents. The issue has taken on an increased importance and visibility in the wake of the numerous high profile court cases in the pharmaceutical and internet industry. This paper analyzes a model of PR development for IP. We consider an environment where two agents (researchers) decide whether to determine the allocation of PR or work without establishment of property rights. Both agents may be involved both in research and "political" fight for intellectual property. PR can improve the incentive of one party and worsen the incentive of another party. The main results are: 1) PR do not always emerge and; 2) their emergence is more probable when the more productive party has poor political skills.
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Hegedus-Gáspár, Máté. "Data Exclusivity for Biological Pharmaceuticals: Is New Zealand in Breach of World Trade Organization Law?" Journal of World Trade 50, Issue 5 (2016): 909–34. http://dx.doi.org/10.54648/trad2016037.
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The protection of intellectual property (IP) rights is riddled with conflicts of interests. The Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter ‘TRIPS Agreement’) introduced standards in order to harmonize IP law enforcement simplifying the task of finding the appropriate level of protection. In some cases IP protective measures result in severe trade restrictions, which can, nevertheless, be justified by virtue of their compliance to TRIPS. However, some trade restrictive intellectual property rights (IPRs) are not covered by TRIPS. This research explores a way in which the enforcement of IPRs falling outside TRIPS can be reconciled with obligations relating to the elimination of trade barriers under the General Agreement on Tariffs and Trade (GATT). The rationale is that TRIPS provides guidance as to the application of Article XX(d) GATT in relation to trade restrictive measures that enforce IPRs. This approach is applied in this article to determine whether, in granting protection to IP in clinical test data relating to biological pharmaceuticals, New Zealand complies with its obligations under the GATT, given that TRIPS does not recognize this IPR and does not provide for its protection.
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Komatani, Takeshi S. "Patent and intellectual property rights related to pharmaceuticals: global future perspectives: Japan." Pharmaceutical Patent Analyst 5, no. 4 (2016): 227–35. http://dx.doi.org/10.4155/ppa-2016-0006.
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Boscheck, Ralf. "Intellectual Property Rights & Compulsory Licensing: The Case of Pharmaceuticals in Emerging Markets." World Competition 35, Issue 4 (2012): 621–34. http://dx.doi.org/10.54648/woco2012047.
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On 9 March 2012, India's Controller General of Patents, Designs and Trademarks granted a non-exclusive and non-assignable compulsory license to NatcoPharma to manufacture and sell a generic version of Bayer's cancer drug Nexavar at a discount of 97% on the innovator price. The ruling revives a drawn-out debate on the use and abuse of intellectual property rights in international commerce. The inclusion of the agreement of trade-related aspects of intellectual property rights (TRIPS) in WTO rules in 1994 committed member countries to honour patent rights and to apply common compulsory licensing standards when seeking market relief. Lately, however, the criteria for such interventions seem to have been slipping. Applying the 'public non-commercial use' rationale to non-emergency, non-infectious diseases, Thailand converted compulsory licensing into an effectively unconstrained method of pure cost containment. Widespread use of that model would require the developed world to shoulder a disproportionate share of the necessary R&D expenditures while simultaneously presenting it with an attractive option to shed that burden. The decision taken by India's Controller General of Patents, Designs and Trademarks in the case of Nexavar may present a first step into that direction. The US Hatch-Waxman Act provides a means for India Inc. to sustain its generic business model in a TRIPS-compliant fashion. Advancing from here requires the country or any other emerging economy to refocus R&D efforts on product technology and, for their own benefit, to insist on a nation-blind enforcement of intellectual property rights. Compulsory licensing is not an alternative to this. Neither is it a substitute for indigenous technology, nor does it provide a solid foundation for upgrading a country's pharmaceutical sector. It is legitimate in a range of circumstances, but standards and implementation principles must be clear to avoid stifling the benefits of technological progress and global commerce. Going forward there is a need to recall some of the principal differences between corporate and political responsibility in attaining socially preferred outcomes, to clarify the role of WTO rules as constituting global trade, and to promote genuine national debates on healthcare and funding.
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Rashmi, Mishra*. "IMPORTANCE OF IPR IN BIOTECHNOLOGY." INTERNATIONAL JOURNAL OF ENGINEERING SCIENCES & RESEARCH TECHNOLOGY 5, no. 6 (2016): 400–401. https://doi.org/10.5281/zenodo.55526.
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The objective of this review is to highlight and explore the inter-relationship and the functioning of the intellectual property right in the pharmaceutical and biotechnology industry. The rising tide of patent applications can be witnessed globally in this industry as the need for such protection and licensing has become imperative so as to safeguard the rights of the inventor and also to encourage and promote new talents, inventions and innovations which can be a boon for the economy. The field of biotechnology is an upcoming science which is still at the initial stage of establishing a foundation but it promises a revolution in the fields of medicine, agriculture, pharmaceuticals and industrial sector amongst other sectors of the economy.
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Msomi, Zuziwe, and Sally Matthews. "PROTECTING INDIGENOUS KNOWLEDGE USING INTELLECTUAL PROPERTY RIGHTS LAW: THE MASAKHANE PELARGONIUM CASE." Africanus: Journal of Development Studies 45, no. 1 (2016): 62–77. http://dx.doi.org/10.25159/0304-615x/645.
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The use of indigenous knowledge (IK) and indigenous bio-resources by pharmaceutical and herbal industries has led to concerns about the need to protect indigenous communities’ interests in regards to the use of IK and indigenous bio-resources. Some commentators believe that intellectual property rights (IPR) law can effectively be used to protect IK and indigenous bio-resources, while others are more sceptical. An analysis of the Masakhane Pelargonium case reveals that while the Masakhane community’s successful use of IPR law in a case against Schwabe Pharmaceuticals has been lauded as a successful example of a marginalised community using IPR law to protect IK, the facts and results of the case are more ambivalent than they seem on first consideration. The paper discusses some of the factors affecting how beneficial IPR law can be in the protection of IK and indigenous bio-resources. Importantly, the Masakhane case shows that existing community resources and the level of mobilisation of the community affect the community’s ability to use IPR law effectively. The article suggests that we should neither be too quick to celebrate or to condemn the use of IPR law by indigenous communities and that a consideration of the broader context in which IPR law is used is required in order to determine how useful IPR law may be for a particular indigenous community seeking to protect its knowledge and bio-resources. In addition it also indicates we need to start recognising communities' existing resources and their determination to being more pivotal to the success of IK-IPR cases.
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Jung, Youn, and Soonman Kwon. "How Does Stronger Protection of Intellectual Property Rights Affect National Pharmaceutical Expenditure? An Analysis of OECD Countries." International Journal of Health Services 48, no. 4 (2018): 685–701. http://dx.doi.org/10.1177/0020731418786095.
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Intellectual property rights (IPR) protection for pharmaceuticals has been comprehensive and strict since the establishment of the World Trade Organization in 1995 and the subsequent implementation of the TRIPS Agreement. This study investigated the relationship between the level of IPR and national pharmaceutical expenditure using panel data of 22 OECD countries from 1970 to 2009. The patent index was used to measure the level of national protection for IPR along with other covariates: GDP per capita, the percentage of population aged over 65, number of doctors, proportion of public financing among total pharmaceutical expenditure, under-5 mortality, price index, and period indicators. The regression analysis results showed that the level of IPR protection was significantly correlated with pharmaceutical spending even after controlling for various factors that affect pharmaceutical expenditure. The results were consistent in OLS regression and GLS regression. However, the effect of IPR was stronger and more significant in countries with a relatively small-sized pharmaceutical market than in those with big market. Many developed countries incur a financial burden due to rapidly growing pharmaceutical expenditure; therefore, the results of this study present the possibility that stronger IPR would produce welfare loss in developed countries.
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Mrs., Shraddha Dinkarao Tandle. "International Trade And Intellectual Property Rights: Political Implications Of Globalization." International Journal of Advance and Applied Research S6, no. 13 (2025): 150–54. https://doi.org/10.5281/zenodo.14912939.
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<em>In the era of globalization, intellectual property rights (IPRs) play a crucial role in shaping India’s international trade policies and economic strategies. As a member of the World Trade Organization (WTO) and a signatory to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), India has had to align its IP laws with global standards while balancing domestic interests. This alignment has significantly impacted key industries such as pharmaceuticals, information technology, and biotechnology, influencing India's trade relations with developed and developing nations.</em> <em>Politically, IPRs affect India's position in global negotiations, particularly in areas like patent protection, compulsory licensing, and access to essential goods. While developed countries advocate for stringent IP enforcement to protect their innovations, India has often championed a more flexible approach to ensure affordable access to medicines and technology for its population. This has led to trade tensions, especially with the United States and the European Union, over issues like generic drug exports and software protection.</em> <em>This paper examines the political implications of globalization on India's intellectual property framework, analyzing its impact on economic growth, diplomatic relations, and national innovation policies. It also explores how India navigates global trade pressures while safeguarding its developmental priorities.</em>
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Dr., Y. Venkateswara Rao, and Srirekha G. "Intellectual Property Rights in Business Organizations." International Journal of Engineering and Management Research 8, no. 1 (2018): 118–24. https://doi.org/10.5281/zenodo.3362786.
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Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. Recently, intellectual property rights (IPRs) has become one of the hottest, most significant issues of trade negotiations. Despite the continued claim that IPRs facilitate research activities and encourage technology transfer, the impact of IPRs on socio-economic development process of developing countries has evidently reflected in many areas, including health, agriculture and education. IPRs will no doubt continue to have a significant impact on developing countries for many years to come. The developing countries have faced the challenge of constraint optimization on how to implement the WTO TRIPS Agreement in such a way to minimize the socio-economic costs and maximize the national benefits. The third world states are now facing increased pressure toward higher standards of IPRs protection (i.e. the so-called TRIPS-plus). The attempts of the developed countries to evolve the TRIPSplus regime, which appears in the form of free trade agreement (FTA), provide opportunities for those countries to negotiate rules and commitments that go beyond what was not possible on the multilateral level. By entering into an FTA with the developed countries, the developing countries see some advantages in tariff reductions of agricultural, clothing and other products, but at the same time it closes down the opportunity for the latter to put forward the issues of their concern through the WTO including the harmonization of TRIPS and CBD, access to medicines, and protection of genetic resources, farmers’ rights and traditional knowledge.
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Ancevska Netkovska, Katerina, Jasmina Tonic Ribarska, Aleksandra Grozdanova, and Zoran Sterjev. "Patents and licensing in pharmaceutical industry." Macedonian Pharmaceutical Bulletin 61, no. 01 (2015): 51–59. http://dx.doi.org/10.33320/maced.pharm.bull.2015.61.01.006.
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Intellectual property rights (IPR) have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property. IPR provide certain exclusive rights to the inventors or creators of that property, in order to enable them to reap commercial benefits from their creative efforts or reputation. There are several types of intellectual property protection like patent, copyright, trademark, etc. Patent is recognition for an invention, which satisfies the criteria of global novelty, non-obviousness, and industrial application. IPR is prerequisite for better identification, planning, commercialization, rendering, and thereby protection of invention or creativity. Each industry should evolve its own IPR policies, management style, strategies, and so on depending on its area of specialty. Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. The protection of inventions with patents in the pharmaceutical industry have a specific role in the development of society and represent one of the drivers of economic development. The license agreements are considered as one of the most common types of transfer of industrial property rights. The right holders often transfer their rights to patents by concluding licensing agreement. While the patent license may give the license a right to use the technology many license agreements have provisions for the transfer of know-how in addition to the patent.
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Wang, Y. Richard, Lei Ji, and Y. Aileen Lin. "Intellectual Property Right Protection for Pharmaceuticals in Developing Countries." Pharmaceutical Development and Regulation 1, no. 4 (2003): 277–82. http://dx.doi.org/10.1007/bf03257387.
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Qureshi, Asif H. "United States Special 301 – A Deeply Flawed Tool for IPR Regulation?" Journal of World Trade 55, Issue 3 (2021): 499–520. http://dx.doi.org/10.54648/trad2021021.
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In this article an International Law and policy perspective is applied to the US Special 301 approach to the management of intellectual property rights of foreign States – with emphasis on the pharmaceutical sector and transfer of technology against the backdrop of US China trade tensions. In particular, the article draws upon the US Special 301 Reports between 2018 to 2020. The paper sets out to take a critical stance of Special 301. This evaluation is intended to equip in particular those who are at the receiving end of the Special 301mechanism. The paper concludes that Special 301 is lacking in informed, expert and empirically based inputs. Above all it lends itself to being hijacked by the narrow agenda of the executive without adequate international, constitutional and due process safeguards for those it is targeted at. US Special 301, Intellectual Property, WTO, Technology Transfer, Pharmaceuticals, TRIPS, China, International Law, Due Process
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Lakani, Arsan. "Intellectual Property and Economic Development: Catalysts for Innovation and Growth." International Journal of Advanced Research in Humanities and Law 1, no. 2 (2024): 83–85. http://dx.doi.org/10.63053/ijrel.15.
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This article explores the complex relationship between intellectual property (IP) and financial growth, explaining how strong IP laws promote entrepreneurship, innovation, and sustainable development. It explores how intellectual property rights facilitate technology transfer, encourage R&D investments, and support the growth of knowledge-driven economies by referencing recent studies and policy initiatives. It also addresses important IP disputes and challenges, such as the availability of essential pharmaceuticals, the spread of technology, and the fine line that must be drawn between protecting the public interest and promoting innovation. This study emphasizes the critical role that intellectual property plays in determining the direction of global economic growth and prosperity from a multidisciplinary standpoint. To better understand the intricate connection between intellectual property (IP) and the development of the economy, this article looks at how strong IP laws can promote entrepreneurship, innovation, and long-term growth. It examines how intellectual property rights encourage investment in R&D, ease technology transfer, and promote the establishment of knowledge-based economies, drawing on recent studies and legislative initiatives. It also discusses important IP-related issues and debates, including as the distribution of technology, the difficulty of obtaining necessary medications, and how to strike a balance between fostering innovation and protecting the interests of the general public. This study emphasizes the relevance of intellectual property in determining the course of future global prosperity and economic growth through a multidisciplinary perspective.v
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Krukowska-Siembida, Paulina. "Patent Protection in the TRIPS Agreement and the Right to Health: Can They Be Reconciled?" Studia Iuridica Lublinensia 28, no. 4 (2019): 89. http://dx.doi.org/10.17951/sil.2019.28.4.89-100.
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<p>The monopoly enjoyed by pharmaceutical manufacturers, resulting from the protection of intellectual property, directly affects the price of medicinal products and thus their availability, especially in developing and least-developed countries. The aim of the article was to examine the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights adopted under the World Trade Organization, an attempt to answer the question of whether it is possible to reconcile the protection of intellectual property with the human right to health.</p>
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Kashyntseva, Oksana, and Yaroslav Iolkin. "Keeping the balance of public interests and the interests of the subjects of patent rights in the codification of legislation in the field of intellectual property." Theory and Practice of Intellectual Property, no. 6 (December 27, 2021): 87–93. http://dx.doi.org/10.33731/62021.249080.
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Keywords: intellectual property, codification, human rights, private interests, publicinterests, exclusions, medicines, patents
 The article concerns the expediency of codificationof legislation in the field of intellectual property on the basis of the principles ofpolicy development of pharmaceutical nationalism or pharmaceutical independence ofthe state. Modernity encourages to determine the principles of intellectual propertylaw on the basis of «collective knowledge», to put the intellectual property right toserve the interests of society and provide appropriate incentives for scientific activity.The new spirit of intellectual property dictates the policy of introducing exceptions tointellectual property rights for objects used in the fight against COVID-19.Special attention should be paid to the formation in the world, on the one hand, ofa policy of «pharmaceutical nationalism», which provides for protectionism in relationto the national producer, and on the other — the policy of priority of public interestsover intellectual property rights. Today, this issue is particularly acute in the contextof limited access to vaccines against the background of free production sites of genericcompanies. Therefore, when determining the conceptual approaches to the codificationof legislation in the field of intellectual property, the international experience ofmaintaining such a balance should be taken into account.The path of harmonization of human rights and intellectual property rights hascertain social and economic obstacles, overcoming which requires significant efforts ofpublic organizations, rethinking the established paradigms of the scientific communityand the political will of international organizations.
 The pandemic has only strengthened our sense that modern science is supranational,it has long been beyond the geographical and beyond the human imagination.That is why the monopolization of its results has become a dangerous phenomenon fora society that has lost the ability to control the processes within itself and has becomedependent on external processes, which are controlled by a small percentage of intellectualproperty market participants.Today, Ukraine has become an Eastern European hub in the field of harmonizationof private and public interests in the field of health care with the mechanisms ofintellectual property rights, and the ongoing patent reform is a breakthrough success.It should be noted that although it is extremely important for Ukraine to be able touse the flexible provisions of the TRIPS Agreement, both for the production of vaccinesand over time for drugs for specific treatment KOVID, the Government shouldkeep in mind the need to clarify the production capacity of domestic producers. , toallow the production of such vaccines and drugs exclusively for the national market,at least at the first stage, as the priority is to meet the needs of the national patient.And, of course, compulsory know-how licenses (trade secrets) should contain provisionslimiting the time and number of doses produced by analogy with compulsory licensesfor inventions.
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Azam, M. Monirul. "The impacts of TRIPS on the pharmaceutical regulation and pricing of drugs in Bangladesh." International Journal of Law and Management 59, no. 3 (2017): 376–93. http://dx.doi.org/10.1108/ijlma-01-2016-0002.
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Purpose This paper aims to analyse the impacts of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as adopted by the World Trade Organization (WTO) on the pharmaceutical regulation and pricing of drugs in Bangladesh. The purpose of this paper is to explore how Bangladesh could adjust obligations for patent and pharmaceutical law reforms in the context of TRIPS Agreement while maintaining societal goals to ensure access to medicines. Another prime objective of this study is to examine viability of arguments regarding pharmaceutical patents for affordability and accessibility of pharmaceuticals in Bangladesh. Design/methodology/approach This paper used doctrinal research and case study using surveys and interviews in Bangladesh to understand the perceptions of different stakeholders regarding TRIPS and possible impacts on the local pharmaceutical industry and also consequences as to access to pharmaceuticals in terms of pricing, availability and affordability. Findings This study suggests that in the case of Bangladesh, the main health bottleneck is not patents or any drugs, but the lack of proper healthcare service, health infrastructure and lack of efficient healthcare personnel. Again, most of the necessary drugs for the local market are off patent, but patented drugs, issues of price, availability and affordability could become a concern for Bangladesh in situation of multi-drug resistance and for diseases like HIV AIDS, cancer and cardio-vascular problems. Research limitations/implications This study was based on randomly selected interview and surveys. To get a broader picture of the impacts of TRIPS compliant patent law and pharmaceutical patents in a country like Bangladesh, more in-depth socio-legal studies need to be conducted. Due to shortage of time and resources, it was not possible to conduct broader socio-legal studies; therefore, this study may not reflect views of all related stakeholders. Practical/implications This paper will guide how countries like Bangladesh could adopt intellectual property policies for pharmaceuticals in a way not only adjusting societal goals for accessibility and affordability of pharmaceuticals but also promoting innovation and capability of local industries. Social/implications Countries like Bangladesh should adopt intellectual property policies balancing not only investment and innovation side but also societal goals to ensure access to medicines for the vast majority of poor populations. Originality/value This study is an original study based on primary sources as collected during field studies in Bangladesh. It also used doctrinal research, and related materials are duly referred.
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Lybecker, Kristina M., and Elisabeth Fowler. "Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules." Journal of Law, Medicine & Ethics 37, no. 2 (2009): 222–39. http://dx.doi.org/10.1111/j.1748-720x.2009.00367.x.
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The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.
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Krishna, Pasupuleti Dheeraj, Deeksha Kethareshwara Sujatha, and Balamuralidhara Veeranna. "Indian Pharmaceutical Product Protection by Utilizing Intellectual Property Rights." Indian Journal of Pharmaceutical Education and Research 56, no. 4 (2022): 950–58. http://dx.doi.org/10.5530/ijper.56.4.175.
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Medhi, Bikash, Ajay Prakash, Phulen Sarma, and Subodh Kumar. "Intellectual property rights and Indian pharmaceutical industry: Present scenario." Indian Journal of Pharmacology 50, no. 2 (2018): 57. http://dx.doi.org/10.4103/ijp.ijp_320_18.
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Goldberg, Pinelopi Koujianou. "ALFRED MARSHALL LECTURE INTELLECTUAL PROPERTY RIGHTS PROTECTION IN DEVELOPING COUNTRIES: THE CASE OF PHARMACEUTICALS." Journal of the European Economic Association 8, no. 2-3 (2010): 326–53. http://dx.doi.org/10.1111/j.1542-4774.2010.tb00506.x.
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Volynets, Inna. "Administrative principles of intellectual property rights protection against unfair competition on the pharmaceutical market in Ukraine." Theory and Practice of Intellectual Property, no. 4 (October 25, 2021): 54–61. http://dx.doi.org/10.33731/42021.243146.
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Keywords: administrative protection of intellectual property rights, unfair competition,pharmaceutical market, AMCU, NIPA Appeals Chamber, post-grant opposition,pre-grant opposition
 The article is dedicated to study for peculiarities of intellectual propertyrights protection on pharmaceutical market under administrative procedure. Thepaper enlightens importance of balancing the regulation of antitrust and intellectualproperty law, through legislative reform as well. It is emphasized on the specifics ofthe jurisdictional form of rights protection, which is comprised from judicial protectionand administrative protection of infringed intellectual property rights. The authordenotes that the administrative procedure is a special form of protection, whichinvolves appealing to government agencies for violated rights protection. The studyuncovers the following main state bodies, entrusted with the relevant functions andwhich consider applications on measures for violated rights protection: The AntimonopolyCommittee of Ukraine and the Appeals Chamber of the National IntellectualProperty Authority (NIPA Appeals Chamber). It is stated that the AntimonopolyCommittee of Ukraine is qualified to consider offences in terms of protection againstunfair competition, respectively, the NIPA Appeals Chamber considers objectionsagainst the National Intellectual Property Authority, appeals and applications forrecognition of the trademark to be well-known in Ukraine. Emphasis is placed on themechanisms of «post-grant opposition» (recognition of rights to inventions (utilitymodel), industrial designs invalid) by the NIPA Appeals Chamber and «pre-grant opposition» (possibility of appealing decisions by third party to the NIPA Appeals Chamber).It is proved that the NIPA Appeals Chamber is a competent and qualified bodyin the intellectual property field, enabled to protect intellectual property rights, includingagainst «patent trolling», «evergreen» patents and counteract indirectly withunfair competition. The paper proves that the administrative procedure for the intellectualproperty rights protection is speedier than the judicial procedure, but is as effectiveand efficient as judicial protection.
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Boru, Zeleke Temesgen. "The Trans-Pacific Partnership’s patent linkage: Unfriending or befriending the right to biologics?" Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 15, no. 2 (2019): 61–68. http://dx.doi.org/10.1177/1741134319839447.
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The World Trade Organization brought Intellectual Property Rights into the multilateral trading system. The adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which formed part of the Agreement Establishing the World Trade Organization, established a minimum level of protection with respect to various forms of Intellectual Property Rights. However, in the aftermath of its adoption, several Free Trade Agreements, which include Intellectual Property Rights provisions of different potency, have come into existence. These Free Trade Agreements have given rise to what is commonly known as TRIPS-plus IP provisions. The provisions may renege on States’ obligation to promote access to biologics, medicines which are derived from proteins through biotechnological process. In this light, one recent Free Trade Agreement is the Trans-Pacific Partnership Agreement, which requires its Parties to implement a number of TRIPS-plus obligations, including data exclusivity and patent linkage. Against the aforementioned backdrop, this article focuses on patent linkage and explores whether the provision allows the Trans-Pacific Partnership Parties to utilize TRIPS flexibilities to promote the right to biologics. In doing so, the article provides potential responses to the question, does patent linkage deter the realization of the right to biologic? With the purpose to do so, while the first section provides a concise introduction into the agreement, the second section discusses the TRIPS standard on patent. While the third part demonstrates the nature of obligations enshrined in the Trans-Pacific Partnership’s rule on patent linkage, the fourth section investigates the obligations’ implication on the right to biologics. The last section provides the conclusion.
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Duggan, Mark, Craig Garthwaite, and Aparajita Goyal. "The Market Impacts of Pharmaceutical Product Patents in Developing Countries: Evidence from India." American Economic Review 106, no. 1 (2016): 99–135. http://dx.doi.org/10.1257/aer.20141301.
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In 2005, as the result of a World Trade Organization mandate, India implemented a patent reform for pharmaceuticals that was intended to comply with the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS). Exploiting variation in the timing of patent decisions, we estimate that a molecule receiving a patent experienced an average price increase of just 3–6 percent, with larger increases for more recently developed molecules and for those produced by just one firm when the patent system began. Our results also show little impact on quantities sold or on the number of pharmaceutical firms operating in the market. (JEL K33, L11, L13, L65, O14, O34, O38)
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Iakovets, Iryna. "International threats to access to treatment: implementation of TRIPS-plus in Ukraine and the world." Theory and Practice of Intellectual Property, no. 1 (March 29, 2024): 52–59. https://doi.org/10.33731/12024.300902.
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Effective realization of the right to health is conditioned on the availability and affordability of health products. Local manufacturing development is significantly dependent on intellectual property rules used by the country. Balancing between the intellectual property rights protection and the right to health is rarely on the side of right to health, and the most suffering from such imbalance are patients. The article analyses the provisions of TRIPS-plus (supplementary protection certificates, data exclusivity, patent linkage, measures of customs authorities to facilitate the protection of intellectual property rights during the movement of goods across the customs border of Ukraine) in the context of their impact on the market of medicines and access to treatment. The TRIPS Agreement, while establishing minimum standards for the protection of intellectual property rights, reserves the right of WTO members to resort to higher protection measures at the level of national jurisdictions. The provisions of TRIPS-plus create barriers to access to treatment by promoting the formation of monopolies in the pharmaceutical market, high prices for medicines, and blocking the entry of generics into the market. Ukraine has implemented many of the TRIPS-plus provisions being pushed in international agreements by developed countries, including patent term extensions in the form of supplementary protection certificates (harmonized to EU standards), 5-year data exclusivity of clinical trials data, patent linkage and border measures. At the same time, the approach to TRIPS plus measuresdiffers between countries. Similarly, patent linkage is not implemented in the European Union. While data exclusivity protection exists in the US, EU and Türkiye, there is no such TRIPS provision in many other countries, like Argentina, Brazil, Bolivia, Ecuador. The author concludes that it is necessary to rethink legislative approaches to the protection of intellectual property rights to medicinal products, with a view that the right to health should be prioritized over intellectual property rights protection. Moreover, the author suggests that in a situation of war, Ukraine should fully use all the avenues that TRIPS Agreement flexible provisions can offer and use the opportunity to protect its essential security interests.
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Kostenko, I., and S. Ogyewuch. "Gap of intellectual property regulation in the field of generic registration." Uzhhorod National University Herald. Series: Law, no. 69 (April 15, 2022): 118–21. http://dx.doi.org/10.24144/2307-3322.2021.69.20.
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The work is devoted to the analysis of problems related to intellectual property rights in the field of pharmaceuticals. In particular, the indicators of low effectiveness of Ukrainian legislation and the practice of its implementation were noted on the basis of the analysis of the annual report of the European Commission on the situation with protection of intellectual property in third countries, which was conducted in 2020. In the course of scientific work the problem of registration of generic drugs before the expiration of the patent for the original drug is covered and the ineffectiveness of the system of protection of the rights of persons-owners of original drugs is noted. In this context, the experience of the United States is considered, in particular in the functioning of the patent linkage system and the Orange Book, as well as their main features are analyzed and the feasibility of such experience for Ukraine is substantiated. The situation with the registration of generics before the expiration of the patent for the original drug, where the Law of Ukraine "On Protection of Inventions and Utility Models" noted the vagueness of legislation on the legality or, conversely, the illegality of patent for the original drug. For the practical value of the work and detailed coverage of the problem, the case law in disputes between manufacturers of originals and manufacturers of generics was reviewed and summarized, based on which the negative aspects that are characteristic of the practice of resolving such disputes were identified. In addition, it was noted what is the main economic interest of the parties to the dispute in resolving the case in their favor, including the possibility for the manufacturer of the original drug to hold a monopoly position in the market for some time, and for manufacturers of generic drugs - to accelerate market entry. and cover the costs of creating and distributing a generic drug. In conclusion, the main results of the study are described and the proposed measures necessary for reforming the system of intellectual property rights in the field of pharmaceuticals and achieving a result that does not differ from developed countries and would ensure a high level of protection of life and health countries.
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Dr., Sayyad Mahejabin. "Economic Impact Of Intellectual Property Rights On India's GDP: A Sector-Wise Analysis." International Journal of Advance and Applied Research S6, no. 12B (2025): 54–63. https://doi.org/10.5281/zenodo.14909741.
Full textAbstract:
<em>Intellectual Property Rights (IPR) play a crucial role in shaping economic growth by promoting innovation, encouraging investment, and strengthening industry competitiveness. This study examines the impact of IPR on India’s GDP through a sector-wise analysis, focusing on industries such as pharmaceuticals, IT, manufacturing, and agriculture. By analyzing data from 2014 to 2024, this research highlights the correlation between IPR enforcement and economic performance, considering key indicators such as patent filings, FDI inflows, sectorial GDP contributions and employment generation. The study reveals that stronger IPR protection has led to higher innovation output and FDI in technology-driven sectors, while weaker enforcement in traditional industries hampers growth potential. This paper studies the need for policy reforms to enhance IPR frameworks and maximize economic gains. The findings contribute to policymaking by suggesting strategic measures to strengthen India’s position as an innovation-driven economy.</em>