GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

Compulsory Licensing: An Antidote for the Dissemination of Potential COVID-19 Cure?

This paper extensively examines the role of Compulsory Licensing in the Intellectual Property regime with regard to potential COVID-19 vaccinations. In Parts I and II, the paper analyzes the concept of compulsory licensing along with its need. Part III discusses the usage of the flexibilities laid down by the TRIPS Agreement by developing nations after the adoption of the Doha Declaration. This throws light on the status quo pertaining to its implications and repercussions and further helps in determining the situation upon invoking compulsory licensing in the current pandemic scenario. Parts IV and V discusses the pre-emptive measures taken by nations by means of laying forth foundational steps and the legal procedures involved in legitimizing the issuance of these licenses for potential COVID-19 vaccines. It discusses steps taken by various nations across the world, the reasons for doing so and their current legal status pertaining to the licenses. Part VI discusses in detail the diverging views that exist primarily between the United States of America and European Union. It entails discussions regarding accessibility and affordability of potential COVID-19 vaccines in the wake of a jurisprudential analysis of the existing legal provisions relating to compulsory licenses in both provinces. Further, Part VII lays down the negative implications which may arise while invoking compulsory licenses for potential COVID- 19 vaccines. This gives a detailed view of the need for the public healthcare to undertake a balanced approach of the interests of both, the patentee and the public at large. It also lays down the importance of adequate remuneration for the pharmaceutical companies which is often overlooked. Finally, Part VIII analyses both perspectives and lays down the importance of compulsory licensing with regard to both, accessibility and affordability.

Sustainable Development in the 2001 WTO Doha Round Debates and Beyond

In this chapter, it is argued that in the 2001 Doha Declaration launching the new trade negotiations and in subsequent dispute settlement decisions, the World Trade Organization (WTO) member States and dispute settlement mechanism (DSM) have made small steps to integrate social and environmental considerations into the work of the WTO, but progress is limited. In particular, certain exemptions have been expanded and clarified (more through subsequent disputes than through negotiations), States have agreed on frameworks for negotiations that could both liberalize trade in environmental goods and services and reduce subsidies that encourage over-fishing, and potentially also encourage greater cooperation on trade-related environment and social development challenges. Influential WTO disputes are canvassed, and concerns with regards to process and production methods (PPMs) and related technology transfer opportunities are discussed briefly. It is also demonstrated that these steps, as critiqued in legal scholarship, reveal real limits to the WTO’s progress.

The primary legal role of the United Nations on international Tax Cooperation and Global Tax Governance: Going on a new International Organization on Global Tax Cooperation and Governance under the UN “Family”(*)

This study will prove useful in expanding our understanding of the United Nations as the body with capacity, suitability, and competence to assume the role of governing and carrying out a global design of the Global Tax Governance architecture, as well as s well as to establish the bases, principles and areas of international tax cooperation. Public International Law rules and general “Principles and Purposes” of the Global Legal Order have been extrapolated to international tax law to achieve this conclusion. Furthermore, we propose the creation of an international organization on International Fiscal Cooperation and Global Fiscal Governance within the UN family itself.International tax cooperation is a crucial instrument to enhance domestic public resources and to avoid international tax fraud fighting against the flow of illicit capital, as stated in the Addis Ababa Action Agenda, in accordance with the provisions of the 2030 Agenda of United Nations, Monterrey Consensus and Doha Declaration. Nowadays, after the covid-19 pandemic, it is an unquestionable necessity.

THE IMPACT OF COVID-19 ON INTELLECTUAL PROPERTY LEGAL SYSTEM RELATED TO PUBLIC HEALTH IN CONNECTION WITH TRIPS FLEXIBILITIES IN INDONESIA

In early 2020, countries in the world was shocked by a new virus called Coronavirus Disease 2019 (COVID-19) including Indonesia. The COVID-19 pandemic gives impact to the legal system, including intellectual property (IP). Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities on public health in developing countries: Transition Periods, Compulsory License, Government Use, Parallel Imports, Exceptions to Patent Rights, Exemptions from Patentability, Limits on Data Protection, and Implementation of the Paragraph 6 of the Doha Declaration. Research problems: (1) what are the conditions for implementing the flexibilities of TRIPS in facing COVID-19 pandemic in Indonesia and (2) what are the issues that should be anticipated for future IP legal system relating to public health as a lesson from this COVID-19 Pandemic. Government Use is most effective to be used for encounter COVID-19 Pandemic, and voluntary license is recommended tobe promoted for future approach. The study is using a qualitative literature study.

THE IMPACT OF PHARMACEUTICAL INDUSTRY ON HUMAN RIGHTS

Pharmaceutical industry and human rights are opposing each other and having conflict at each point relating to access to essential medicine in developing countries. At this point of research some focal points of discord and contestation from the both sectors are tried to explain. The views from pharmaceutical industry can be explained in the form of official’s submission during negotiation surrounding the Doha Declaration and the decision that were taken after the Doha Declaration. The industry’s views can also be supported by the others who paid their vital role to support the pharmaceutical industries by their writings and morally as well. The main argument given from the pharmaceutical industry was stating that patent is not creating any kind of obstacle creating any obstacle to access essential medicine in developing countries. Actually, they try to state that there were health care issues to the citizens of the developing nations before the IP protection is given to the pharmaceutical industries. So, it can be said that the progress in the field of pharmaceutical industry in the developing countries have nothing to do with IP system and the innovation in the pharmacy cannot be achieved by undermining the IP. Most of the problems in the health sector in not related to the patent system in developing countries.

COMPULSORY LICENSING MECHANISM UNDER INTERNATIONAL AND NATIONAL LAW

The article highlights the main steps in the formation of compulsory licensing mechanism before the establishment of the World Trade Organization, and analyzes the main provisions of this mechanism implementation under the TRIPS Agreement and the Doha Declaration. Based on the analysis of examples from different regions of the world, the article determines the main advantages of using compulsory licensing with regard to expand of access to medicines, possible impact on quality of the medicinal products being produced and the investment attractiveness of the countries applying this mechanism are assessed. The purpose of this article is to analyze the main approaches to the implementation of compulsory licensing in order to determine the most effective strategy for using this mechanism in the Russian Federation in order to expand the availability of drug therapy for the treatment of life-threatening diseases. Based on the impact of compulsory licensing implementation, the author concludes that it does not correspond to the objectives of the Russian pharmaceutical industry development identified as a priority by Russian Government. Despite a possibility of using compulsory licensing under regulation of many countries, this mechanism is implemented rarely. A possibility of issuing a compulsory licensing is a strong argument in price negotiations with producers. According to the authors position, implementation of compulsory licensing has to be preceded by cost containment mechanism, primarily based on negotiations with producers.