Intellectual Property Rights Agreement Research Articles

Self-Determination in Global Health Practices - Voices from the Global South.

Despite the commendable progress made in addressing global health challenges and threats such as child mortality, HIV/AIDS, and Tuberculosis, many global health organizations still exhibit a Global North supremacy attitude, evidenced by their choice of leaders and executors of global health initiatives in low- and middle-income countries (LMICs). While efforts by the Global North to support global health practice in LMICs have led to economic development and advancement in locally led research, current global health practices tend to focus solely on intervention outcomes, often neglecting important systemic factors such as intellectual property ownership, sustainability, diversification of leadership roles, and national capacity development. This has resulted in the implementation of practices and systems informed by high-income countries (HICs) to the detriment of knowledge systems in LMICs, as they are deprived of the opportunity to generate local solutions for local problems. From their unique position as international global health fellows located in different African countries and receiving graduate education from a HIC institution, the authors of this viewpoint article assess how HIC institutions can better support LMICs. The authors propose several strategies for achieving equitable global health practices; 1) allocating funding to improve academic and research infrastructures in LMICs; 2) encouraging effective partnerships and collaborations with Global South scientists who have lived experiences in LMICs; 3) reviewing the trade-related aspects of intellectual property Rights (TRIPS) agreement; and 4) achieving equity in global health funding and education resources.

Exploiting treaty ambiguity: Public health exceptions in the WTO TRIPS agreement

AbstractTreaty exceptions have long been viewed as essential to the design of international agreements. Yet, agreements also leave ‘room to maneuver’ through the use of constructive ambiguity, that is, by defining treaty terms with deliberately ambiguous words. When are countries more likely to exploit this treaty ambiguity? What does this exploitation look like? We argue that in democratic countries, where states face continued pressures to react to domestic needs, governments are more likely to legislate unambiguous circumstances in which they can apply international treaty exceptions. We argue this should be especially true in developing democracies facing external pressure from foreign firms and developed countries to legislate public policy with their external interests in mind. We test our theory in the context of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and compulsory licensing legislation for HIV/AIDS drugs between 2000 and 2012. We find that when public access to medicines for HIV/AIDS is limited but in high demand, democratic governments are more likely to legislate explicit public health protection under TRIPS exceptions, especially in developing countries with high rates of foreign patent ownership. We conclude that such exploitation is most likely when countries seek to prevent precedents by action, or adjudication, that better define constructively ambiguous treaty terms.

Shepard’s Validation of Antitrust Relief Framework on Patent Infringement of Novartis’ Cancer Drug Using Genomic Architectures of Legal Literature based on UK Intellectual Property Law

Comparative law is designed for alignment of constitutional law with other countries advocating public welfare and safety. The United States has an Intellectual Property provision under U.S. Fair Clause using their constitution as pre-emptive doctrine. The aim of this paper is to evaluate the applicability of UK Intellectual Property Law based on their complexed policies on Artificial Intelligence. Hence, it leads to problem statements questioning: (1) the eligibility of matters of facts did not meet UK IP Law; (2) the standard for evidence towards invention using Artificial Intelligence does not conform with UK IP Law; (3) Liability in AI patent infringement is not subsistent in UK IP Law; and (4) AI’s compliance is not subject for responsibility under creativity and non-obviousness criteria. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement promotes public welfare and safety under constitutional laws. India, as a member, is obliged to comply with the standard of evidence in patentability under World Trade Organization (WTO). The WTO is a committee responsible for advocating business law. Invention for marketability of patent product has its own complexed policy to comply for acceptance of an Intellectual Property creation. Constitutional law is designed to be made comparable with other countries, promoting the monetary success of their nation exhibiting economic progress in industrial and technological advancements. Hence, authorless works marking artificial intelligence towards public health and safety must be done in lack of any dedication to human connections, resulting in immersion of their “new” product as a work of art, making non-obviousness skills to people as part of common logic and interests, hence, a product of convenience. This intergovernmental task force is vital to implement constitutional laws comparable to other countries. Hence, the advocacy of business ethics is a highly acknowledged means of making the lives of people to be technologically advanced with convenience. Thus, inventions should be made affordable for public access.

Intellectual property right protection of Bantaeng Robusta Coffee through geographical indications

Based on the Trade Related Aspect of Intellectual Property Rights (TRIPs) agreement, manufacturers are prohibited from using labels or brands on their production goods that do not comply with geographical indications. Member countries must provide legal means prohibiting signs on goods that can mislead the public that the goods in question originate from other regions than the actual origin of the goods. The primary purpose of registering geographic indications is to protect producers and consumers from product counterfeiting specific to the region. In addition, the registration of geographical indications also aims to increase the income of the business community for typical regional products. This research is an empirical law study to identify the potential of Robusta Coffee in Bantaeng to obtain Geographical Indication protection. The study results found that Robusta Coffee of Bantaeng has qualifications in the premium grade category, with a final score of 81.92. Therefore, the Regional Government of Bantaeng Regency can apply for registration of geographical indications because Bantaeng Robusta Coffee has a reputation and characteristics influenced by geographical and human factors.

Shepard’s Validation of Antitrust Relief Framework on Patent Infringement of Novartis’ Cancer Drug Using Genomic Architectures of Legal Literature Based on UK Intellectual Property Law

Purpose: Comparative law is designed for alignment of constitutional law with other countries advocating public welfare and safety. The United States has an Intellectual Property provision under U.S. Fair Clause using their constitution as pre-emptive doctrine. The aim of this paper is to evaluate the applicability of UK Intellectual Property Law based on their complexed policies on Artificial Intelligence. Hence, it leads to problem statements questioning: (1) the eligibility of matters of facts did not meet UK IP Law; (2) the standard for evidence towards invention using Artificial Intelligence does not conform with UK IP Law; (3) Liability in AI patent infringement is not subsistent in UK IP Law; and (4) AI’s compliance is not subject for responsibility under creativity and non-obviousness criteria.
 Methodology: The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement promotes the public welfare and safety under constitutional laws. India, as a member, is obliged to comply with the standard of evidence in patentability under World Trade Organization (WTO). The study employs comparative contextual assessment using Novartis’ case as trial proceedings for disclosing theoretical framework vital to socio-legal integration of WTO principles.
 Findings: The World Trade Organization is a committee responsible to advocate business law. Invention for marketability of patent product has its own complexed policy to comply for acceptance of an Intellectual Property creation. Constitutional law is designed to be made comparable with other countries promoting monetary success of their nation exhibiting economic progress in industrial and technological advancements. Hence, authorless works marking artificial intelligence towards public health and safety must be done in lack of any dedication to human connections resulting to immersion of their “new” product as a work of an art making non-obviousness skills to people as part of common logic and interests, hence, a product of convenience.
 Recommendations: WTO is an intergovernmental task force important to implement constitutional laws comparable to other countries resulting to theory integration of socio-legal aspects based on trade-related principles. Hence, the advocacy of business ethics is a highly acknowledged means of making the lives of people to be technologically advanced with convenience, thus, inventions should be made affordable for public access.

How to Study Global Lawmaking: Lessons from Intellectual Property Rights and International Health Emergencies

International agreements on Intellectual Property (IP) have proven to be a good example to study global lawmaking. Beginning by looking at the 1990s Trade-Related Intellectual Property Rights (TRIPS) agreement and into the negotiation and implementation of regional and national trade agreements, this article reflects on the intricate relationship between international IP agreements and public health. The comprehensive analysis of these international rules and their effect provides valuable insights into the dynamic interplay between domestic and international factors in shaping health policies. Building upon the IP case, we categorize existing scholarship on global lawmaking into three methodological approaches: ( a) methodological internationalism, ( b) methodological nationalism, and ( c) the interplay between domestic and international factors. We close with a call for researchers to advocate and integrate into their methods a co-constitutive approach that considers the simultaneous shaping of domestic and international elements.

China’s Insertion in the International Patent Regime: Shaking the Rules Widens the Development Policy Space

Much has been written about the effects of China’s rising role in global economic governance, but the consequences for the development policy space have received little attention. This article examines whether China’s mode of insertion in the international patent regime widens the restricted policy space of its developing country partners to shape their national patent system in a way that facilitates technical progress. Results show that China adopts a minimalist interpretation of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement as it incorporates its flexibilities at the bilateral and national levels, thus preserving and potentially widening its partners’ development policy space.

Challenges to the Availability and Affordability of Essential Medicines in African Countries: A Scoping Review.

The availability and affordability of safe, effective, accessible, and high-quality essential medicines is a critical benchmark for achieving the right to good health, and it is also one of the goals of the global health development agenda. To that end, it is critical to conduct rigorous studies to identify the major challenges confronting developing countries, particularly those in Africa. The purpose of this review was to identify the major challenges that Africans face in obtaining reasonably priced and readily available essential medicines. Generally the Boolean operators "AND" and "OR" were employed. Making progress also involves using duplicate checks, field definitions, and comparisons of articles and criteria. The analysis included all English-language papers published in any African country between 2005 and 2022, depending on the year of publication. The technique searches electronic databases for key phrases related to essential medication availability and affordability, such as PubMed, Web of Science, Scopus, Science Direct, Plos Medicine, and Google Scholar. A total of 91 articles; by using search engines and handpicking including duplicates, were primarily searched. The electronic database search earned 78 articles while only eleven studies met the criteria for review and were reviewed of which 5 (50%) were from East African countries. Inadequate human resources, financial constraints, high cost of available medications on the market, poor inventory management, manual consumption forecasting, inefficiencies in drug registration, and trade-related aspects of intellectual property rights agreement regulations are all obstacles to the availability of essential medicines in African nations. This review revealed that in Africa, the availability and affordability of essential medicines face numerous challenges. The primary challenge, according to the review research, is a lack of adequate financing to pay for an appropriate set of essential medications, which account for a significant portion of household spending.

In the name of TRIPS: The impact of IPR harmonisation on patent activity in Latin America

We analyse the effect of country-specific regulatory changes consistent with mandates included in the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement on patenting activities in Latin America (LA) with the aim of contributing to the ongoing debate on patent regimes, innovation and development. TRIPS implied tight negotiations between developed and developing countries. By analysing national legislation on IPR in 36 countries, we build a variable that captures when each country exhibits “the spirit of TRIPS”, which may occur before or after signing TRIPS. We follow two goals: i) to assess whether the impact of changing regulation was different in LA in contrast to developed countries; ii) to analyse specifically the impact on patent activities of residents and non-residents in LA in contrast to developed countries. Our results show that regulatory changes aligned with TRIPS increased patent activities in LA more than in developed countries, but only by non-residents. This is consistent with the political economy argument stating that the international agenda on intellectual property rights was pushed by large multinational corporations headquartered in developed countries as part of their globalisation strategies. Our results are also consistent with the economics of innovation literature that suggests that stronger patent regimes only have positive effects on innovation after some national income threshold is attained.

A primer on performers’ rights—for the sixth time

Richard Arnold, currently serving at the Court of Appeal, also known as one of the most experienced judges of IP cases in UK, published the first edition of his seminal monograph on performers’ rights in 1990. Since then, the system of copyright law and related/neighbouring rights has gone through enormous changes. On the one hand, this is due to the rapid advancement of technologies, especially the internet (which coincidentally emerged around the time the first edition of Arnold’s book came out). On the other hand, this field of law went through significant harmonization both at the regional level (especially in the European Union) and at the international forum (mainly via the Trade-Related Aspects of Intellectual Property Rights Agreement and the World Intellectual Property Organization [WIPO] Internet Treaties). Well, the original WIPO Internet Treaties (namely, the Copyright Treaty and Performances and Phonograms Treaty) did not provide a complete coverage of performers’ interests though. Until the conclusion of the Beijing Treaty, performers’ rights were lagging behind copyright holders’ and related rightholders’ (other than performers’) rights. Needless to say, they are still several steps behind those stronger rightholders, but more on this later.

Protection of intellectual property and human rights during health emergencies: an assessment of the patent waiver proposal

Purpose Several countries, such as South Africa and India, believe that intellectual property rights (IPRs), including patents, impede the efficient increase in vaccine production to inoculate the global population as they scramble to recover from the COVID-19 pandemic. Their proposal at the World Trade Organization (WTO) to waive these pharmaceutical patents has been met with resistance from a few developed countries, who believe that the abrogation of IPRs is unnecessary, even during a pandemic. The purpose of this paper is to discuss the impact of a potential waiver of medical patents at the WTO versus the status quo of IPR laws in the global economy. Design/methodology/approach This study examines key arguments from economic and moral standpoints regarding the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and other related international agreements and their validity based on the premise of the internalisation of positive externalities posed by vaccines. Findings The effectiveness of the TRIPS agreement in securing medical access is weak on account of the ability of profit-making multinationals to secure IP rights and on account of the Trans-Pacific Partnership, a multilateral agreement that supports patent evergreening and a period of protection on test data which challenges the access to medicines and the fundamental human right to health. Originality/value This study examines international IPRs through the lens of human rights and proposes a new system that balances the two.

Geographical Indications Laws In India: Issues And Challenges

Geographical Indications (GI) for Products are described as IPR type that typically refers to a nation’s geographical indications. A name like this provides a sense of quality and uniqueness, primarily due to its roots in a specific geographical location, region, or nation. Geographic indicators are protected as an aspect of IPRs under Articles 1(2) and 10 of the Paris Convention regarding the Preservation of Industrial Property. They are also covered by Articles 22 to 24 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which was included in the Uruguay Round of GATT discussions’ final agreements.[i] Perhaps as a signatory to the World Trade Organisation (WTO), India passed the Geographical Indications of Goods (Registration and Protection) Act in 1999. GI is an essential intellectual property right used in commerce to indicate the source of the goods. The inability to accomplish the goal is due to a lack of knowledge among GI stakeholders and the absence of qualitative check procedures.

Whether Indian Patent Act TRIPs compliant for Pharmaceutical Business: A Case-based approach

Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement was negotiated during Uruguay round and GATT was replaced by WTO. All the signatory countries had to abide to the norms of the agreement. They were asked to modify their national IP laws as per the requirement. India too incorporated the required changes and finally, Indian patent act became TRIPs compliant in 2005. Although, it was claimed that India has designed its action in a most exhaustive form still, Indian companies face lot of litigation suits concerning infringement of patented products. Issues were raised at international forums stating that Indian IP laws are not fully TRIPs compliant and lot of flexibilities are given for the domestic firms which creates an unequal platform for trade. In order to reach to the substantial-conclusion on the impact of TRIPs implementation on the functioning of Indian pharmaceutical industry (IPI) and the impact it may carry with respect to the socio-economic life of the citizens of India. The study considered some of the court cases related to the infringement of patents that were raised in Indian court by MNC’s along with their decision. Through these cases and the judgements thereafter it was found out that Indian patent act is well in place and judiciary plays an important role in monitoring its effective implementation.

Intellectual property rights and us-china trade relations, 2016-2022

Over the years, global politics has revolved around economic control to seize power and determine who gets what, when and how. This is not farfetched in the global politics between the United States and China glaring trade war that is aimed at dominating and maintaining global relevance. On this note, this study examined Intellectual Property Rights and the US-China Trade Relations between 2016 and 2022. The study specifically investigated the US theft claim of Trade Secrets and violation of trade agreement by China and the US Trade Representative Office imposition of tariff on imports from China. The Neo-realist Paradigm, as articulated by Kenneth Waltz was adopted as a framework of analysis, with its basic assumptions revealing that: firstly, the global system is viewed as completely and always anarchic, and war is a possibility at any time. Secondly, States tends to seek for their own survival as this is a requirement to pursue other goals. Thirdly, States are deemed similar in terms of needs but not in capabilities for achieving them. The study employed the documentary method of data collection and analysed the generated data using content analysis, while the time series research design was adopted. Our findings revealed that the US government has not been able to adequately establish China’s violation of trade agreement especially the originality of claimed Trade Secrets theft by China; also, the US government has not been able to adequately gain dominance despite their strict trading measures on the Chinese government as China still holds a significant value in global economic order and still a major threat to US relevance and dominance. The study therefore, strongly recommends a strict adherence to the provisions of the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement by both parties as established by the World Trade Organisation and the World Intellectual Property Organisation.

THE IMPACT OF TRIPS AGREEMENT ON THE DEVELOPMENT OF INTELLECTUAL PROPERTY LAWS IN INDONESIA

The purpose of this study is to analyze the impact of the TRIPs agreement on the development of intellectual property law in Indonesia. In the current era of globalization, the protection of intellectual property rights is related to global-scale trade at the international level. Protection of intellectual property rights becomes an important issue wherein the current era the development of technology, information and communication have developed very rapidly which gave rise to innovations. Therefore, it is necessary to study how the impact regarding the emergence of TRIPs and how the adjustments made by Indonesia so that the WTO/TRIPs Agreement is in accordance with the political dynamics of intellectual property law in Indonesia. This research is a doctrinal legal research based on secondary data. The materials used come from literature studies that focus on the study of intellectual property. Property rights become an important issue in the business world where business actors offering services or a product want to get guaranteed protection of intellectual property rights. One of the developments in intellectual property protection in Indonesia was affected by the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPs Agreement) which was found in the Uruguay Round agreement in the framework of GATT (General Agreement on Tariffs and Trade). Indonesia also agreed to the Uruguay round of GATT by adjusting intellectual property laws that have been regulated in TRIPs which marked the opening of provisions regarding TRIPs with in Indonesian legal system. Therefore it becomes Indonesia's obligation to harmonize and synergy exiscing the legal instruments and strict law enforcement in the protection of intellectual property in Indonesia.

Compulsory licensing of patents.

Compulsory licensing (CL) is a mechanism made by the government to provide balance between the monopoly right holders and the third person with public interest by ensuring the ease availability of the patented products at reasonable rate. This paper discusses the background criteria for getting CL in India as per the Indian Patent Act, 1970 starting from the concepts outlined in the Trade-Related Aspects of Intellectual Property Rights agreement. We reviewed thecase studies for the accepted and rejected CL in India. We also discussimportant CL cases that werepermitted internationally, including the present COVIDpandemic CL. Finally, we provideour analyticalperspectives regarding the pros and cons of CL.

Artificial Intelligence for Mitigating Patent Process Hurdles

New thrust by the government to develop skill sets and entrepreneurship has resulted in massive inventions and rapid advancement of science and technology. complexity in monitoring, managing adapting, and registering innovations is becoming increasingly difficult due to a massive number of inventions. Maintaining standards for new innovations along with increased time for their scrutiny is causing delays in the adaptation of new inventions. The Intellectual property rights scrutiny towards judging the uniqueness of a particular innovation and prior art search has been made considerably easy by using artificial intelligence and machine learning. This latest technology can help to overcome the cumbersome processes for the allotment of intellectual property rights. This technology eases the burden of managing a large number of innovations filed as patent applications. Data mitigation becomes easy in the area of prior art searches. The world trade organization has announced certain stipulations in the form of law to avoid overlapping of the inventions and grant patents in line with the geographical restrictions. This article makes a concrete proposal to understand the complex interrelationship between trade law, jurisprudence, and the application of artificial intelligence in overcoming the hurdles concerning the patent grant process. The paper also proposes the use of artificial intelligence for patent-related dispute settlement in line with Trade-related aspects of intellectual property rights agreements. The paper advocates the use of artificial intelligence in the area of application and grant of patents.

Civil-law characteristics of the terms of wrap license agreements

The article is devoted to the study of the most significant features of the terms of wrap license agreements. In the domestic civil law science, the outlined topics are not properly developed. At the same time, the process of Ukrainian Civil Law recoding, attempts to reform both the Contract Law general principles and the provisions on disposal of intellectual property rights agreements, as well as globalization and European integration processes strengthening require intensification of scientific efforts. The author considers the features of wrap license agreements that directly affect their content. The contract theory and practice of the USA, Canada and the United Kingdom in the relevant field are analyzed and generalized. On this basis, the subject of wrap license agreements is formulated as the permission to use the objects of copyright and (or) related rights. It is proposed at the Civil Code of Ukraine level to consolidate the possibility of granting only non-exclusive licenses under the studied agreements. It is emphasized that under these agreements only the right to use the object of intellectual property rights could be provided. It is proved that the use of the object of copyright and (or) related rights for functional purposes coexists with its proper legal use. It is pointed to the need to ensure the possibility of temporary use of such an object outside Ukraine, if there is no term concerning the territory in the agreement. It is noted that when the licensor establishes the auto-prolongation of wrap license agreements, the licensee must be duly warned about this and provided with a transparent possibility to refuse the prolongation. The importance of establishing the non-paid presumption of wrap license agreements is substantiated. The most common in the software and databases mass markets payment models for the use of copyright and (or) related rights are named. Finally, it is concluded that it is necessary to conduct further research of the wrap license agreements and to enshrine them into the civil legislation of Ukraine.

What determines foreign direct investment to India's pharmaceutical sector? Intellectual property implementation versus inherent institutional strength

AbstractThe Indian pharmaceutical industry has assumed importance during the time of the pandemic. Historically, the absence of an intellectual property rights (IPR) regime in India helped reverse‐engineer products, leading to an exponential growth of the industry. This, however, disincentivised foreign direct investment (FDI) needed for innovation. The ratification of the Trade‐Related Aspects of Intellectual Property Rights (TRIPS) agreement in 1995 increased the confidence of foreign investors, allowing FDI inflow into the sector. However, we argue that the mere adoption of TRIPS is not sufficient for FDI and that its enforcement along with other institutional factors such as corruption and political stability play a crucial role. We also take into account competition for FDI among similarly placed nations, in this case from China. Methodologically, we construct a pharmaceutical patent index that measures the legal framework of IP protection specifically for the sector. An ARDL model using data from 1990 to 2019 shows that while the introduction of IPRs helped the inflow of FDI, the enforcement of these rights, as measured by the strengthening of the patent index, has led to a decrease in FDI. Interestingly, our results also show that India's own core competencies such as improving political stability while reducing corruption and trade barriers were the most dominant determinants. Through developing a concise sector‐specific patent index and taking into account institutional determinants, FDI inflow is analysed in a manner not studied otherwise.

Consequences of the CJEU’s Bayer v Richter decision

The decision Bayer v Richter of the CJEU has consequences for the national court practice of the EU Member States on the liability of the patent proprietor for damages in case an interim injunction is lifted due to the revocation of the patent. An in-depth analysis of the decision seems necessary. The practice of the European Union (EU) Member States on the liability for damages of a patent proprietor who has obtained an interim injunction which is then lifted due to the revocation of the patent continues to differ,1 despite Article 50(7) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which is binding on all these states, and despite Article 9(7) of Directive 2004/48/EC (Enforcement Directive), which is also binding on these states. Two examples of differences suffice here. In ‘Germany’, if an injunction based on a patent is lifted because the patent has been revoked, the claimant is obliged under Section 945 of the Code of Civil Procedure to compensate the defendant for the damage he suffers as a result of the enforcement of the injunction. The provision does not contain any requirement of considering the applicant’s conduct (fault) or that of the respondent (contributory negligence2). According to court practice, the provision in principle does not apply if the reason justifying the procedural measure subsequently ceases to exist.3 However, since the revocation (Art. 138 European Patent Convention (EPC), Sec. 64 (1) Patent Act) has retroactive effect, it is consistently held in case law,4 against objections raised by considerable parts of the literature on procedural law,5 that the claimant is liable for damages under Sec. 945 ZPO irrespective of the foreseeability of the destruction, namely with regard to the entire damage caused by enforcement (‘strict liability’). The Court of Justice of the European Union (CJEU) decision Bayer v Richter,6 analysed below, gives reason to reconsider this court practice.