ABSTRACT
In past decades, there have been abundant discussions regarding management of medical Intellectual Patent Rights (IPRs) since India's Indira Priyadarshini Gandhi, then Prime Minister, eliminated medical product patent protection and enacted India's Patents Act, 1970. There were many changes to IPRs related to AIDS drugs during the 1980's and 1990's. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement also hosted numerous discussions over the Doha Declaration, an issuance of compulsory licensure, and product patent waivers for least developed countries (LDCs). COVID-19 emerged in January 2000, making salient this controversial issue. Should medical patents be protected, waived, or pooled? Both USA President Joe Biden and Chinese President Xi Jinpin stated that they would support waivers for COVID-19 related IPRs in May 2021. The following week, pharmaceutical industry representatives released statements arguing for the protection of pharmaceutical IPRs. Meanwhile, developing countries, the World Health Organization (WHO), and other stakeholders contend that medical IPRs should be limited. This paper will first describe the current global status of the COVID-19 pandemic and then present COVID-19 related medical patent data using a commercial database offered by Clarivate Analytics. Based on this data, we will then closely analyze stakeholder positions on COVID-19 IPRs. In this study we selected three widely used schemes of pharmaceutical IPR and drug/vaccine distribution - COVAX, Medicines Patent Pool (MPP) and voluntary licensing. After close examination, we found voluntary licensing is the most applicable solution for COVID-19 pandemic at the time being. © 2022 PICMET.
ABSTRACT
It is thought that Japan is one of a handful countries that have sufficient R&D ability to develop new pharmaceutical products. However, Japan has recently been revisiting its national policy to reinforce the local production ability for medical products combating infectious diseases, based on the failure to develop a COVID-19 vaccine. In contrast, India has a long experience exporting generic and/or voluntarily licensed pharmaceutical products to the world. However, India has not been able to fulfill its national demand, caused partly by the national provision system. Confronted with this contradiction amid the COVID-19 pandemic, India has no choice but to restrict their exportation of medical products responding to COVID-19, and India and other developing countries have proposed to the WTO TRIPS Council to ask for WTO members to recognize an IP protection waiver as far as needed to deal with the pandemic. This paper analyzes what divides the postures of these two countries, by comparing their national and global policy on pharmaceutical R&D and IP protection, before and after COVID-19. © 2022 PICMET.
ABSTRACT
The COVID-19 pandemic has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to global public health. Since the deadly virus spread out across the world rapidly, several countries experienced a collapse in their medical care systems. Not only developing countries, but developed countries as well have been suffering from a lack of medicines, hospital beds, doctors/nurses, and medical machines and equipment. Under these circumstances, managing the intellectual property rights (IPRs) of vaccines, medicines, and medical machines and equipment has become a big issue. Since developing a new product in the medical industry takes a long time and requires a huge amount of investment, the IPRs of vaccines, medicines, medical machines and equipment are highly protected. However, under national emergencies, such as the COVID-19 pandemic, how should the IPRs of these products be dealt with? This study analyzed how to handle medical IPRs, focusing on the medical machines and equipment industry. For this purpose, this study first provided an overview of the current status of the COVID-19 pandemic worldwide as well as the medical machines and equipment industry. Next, this study examined patent regulations and governmental policies, along with citizens' and industries' movements to "not to exercise"IPRs. This article presents potential solutions and/or has implications for the post-COVID-19 era and the "New Normal"era with COVID-19. © 2022 IEEE.