A Global Intellectual Property Waiver is Still Needed to Address the Inequities of COVID-19 and Future Pandemic Preparedness.

In October 2020, India and South Africa submitted a proposal to the World Trade Organization (WTO) to suspend IP on all COVID-19 vaccines, therapeutics, and diagnostics until widespread vaccination could help achieve immunity among people in low- and middle-income countries. After 18 months, the final WTO Decision substantially watered down the original text proposed by India and South Africa, limiting it only to patents on vaccines and the use of protected clinical trial data for regulatory approval. We address why an IP waiver under TRIPS consistent with the one originally proposed by India and South Africa is still needed to not only meet the ongoing inequities of COVID-19, but also to ensure the right precedent for future equitable pandemic preparedness and other crises affecting the global South. To meet the multilateral goals of the WTO, an IP waiver as proposed by India and South Africa is still needed to increase manufacturing capability for vaccines, therapeutics, and other COVID-19 health-related technologies.

The COVID-19 Pandemic and the TRIPS Waiver: Patents and Flexibility.

The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for global minimum standard patents. These patents potentially limit access to products and processes for the surveillance, tracking, diagnosis and treatment of COVID-19. A possible solution currently under consideration is a TRIPS waiver of the implementation, application and enforcement for the prevention, containment or treatment of COVID-19. This article addresses the ways that TRIPS patents might be mediated including through TRIPS flexibilities. The article argues that there are sufficient means of derogating from patents (and potentially copyright, industrial designs and undisclosed information), although they alone will not resolve the access problems. The article concludes that the key patent problem is the transfer of know-how and that developing new ideas about addressing these patent know-how transfers is the presently unaddressed challenge.

A concise framework to facilitate open COVID pledge of non-disclosed technologies: In terms of non-disclosed patent applications and trade secrets.

BACKGROUND: As a result of the COVID-19 global pandemic, many intellectual property (IP) owners have signed on to the "Open COVID Pledge", an agreement that makes corporate and university IP available free of charge for the purpose of facilitating the development of technologies that will end the pandemic and minimize the impact of disease. Joining this pledge is relatively straightforward for already-disclosed IPs. However, few, if any, has considered how to encourage owners of "non-disclosed patent applications" and "trade secrets" to sign on to this meaningful pledge. In other words, so far there is no proposal to extend the Open COVID Pledge for confidential pending patents and trade secrets. METHODS: We propose an innovative and flexible framework to cover both non-disclosed patent applications and trade secrets to mobilize inventors to participate in the Open COVID Pledge. RESULTS: By focusing on immediate publication of the patent-applying technology and extending provisional right to such applications which is subject to the Open Pledge during this pandemic, our recommendations are workable for inventors who would like to pledge their non-disclosed technologies for the detection, prevention and treatment of the COVID-19, in the meantime preserving their IP rights for the post-pledge period. CONCLUSION: This paper offers a way forward to guide pledgers and implementers who are interested in supporting the effort by addressing some of the issues associated with the free sharing of non-disclosed patent applications and trade secrets in the fight against COVID-19.

Exploring the role of R&D collaborations and non-patent IP policies in government technology transfer performance: Evidence from U.S. federal agencies (1999-2016).

Around the world, governments make substantial investments in public sector research and development (R&D) entities and activities to generate major scientific and technical advances that may catalyze long-term economic growth. Institutions ranging from the Chinese Academy of Sciences to the French National Centre for Scientific Research to the Helmholtz Association of German Research Centers conduct basic and applied R&D to create commercially valuable knowledge that supports the innovation goals of their respective government sponsors. Globally, the single largest public sector R&D sponsor is the U.S. federal government. In 2019 alone, the U.S. government allocated over $14.9 billion to federally funded research and development centers (FFRDCs), also known as national labs. However, little is known about how federal agencies' utilization of FFRDCs, their modes of R&D collaboration, and their adoption of non-patent intellectual property (IP) policies (copyright protection and materials transfer agreements) affect agency-level performance in technology transfer. In particular, the lack of standardized metrics for quantitatively evaluating government entities' effectiveness in managing innovation is a critical unresolved issue. We address this issue by conducting exploratory empirical analyses of federal agencies' innovation management activities using both supply-side (filing ratio, transfer rate, and licensing success rate) and demand-side (licensing income and portfolio exclusivity) outcome metrics. We find economically significant effects of external R&D collaborations and non-patent IP policies on the technology transfer performance of 10 major federal executive branch agencies (fiscal years 1999-2016). We discuss the scholarly, managerial, and policy implications for ongoing and future evaluations of technology transfer at federal labs. We offer new insights and guidance on how critical differences in federal agencies' interpretation and implementation of their R&D management practices in pursuit of their respective missions affect their technology transfer performance outcomes. We generalize key findings to address the broader innovation processes of public sector R&D entities worldwide.

The EAES intellectual property awareness survey.

INTRODUCTION: The protection of intellectual property (IP) is one of the fundamental elements in the process of medical device development. The significance of IP, however, is not well understood among clinicians and researchers. The purpose of this study was to evaluate the current status of IP awareness and IP-related behaviors among EAES members. METHODS: A web-based survey was conducted via questionnaires sent to EAES members. Data collected included participant demographics, level of understanding the need, new ideas and solutions, basic IP knowledge, e.g., employees' inventions and public disclosure, behaviors before and after idea disclosures. RESULTS: One hundred and seventy-nine completed forms were obtained through an email campaign conducted twice in 2019 (response rate = 4.8%). There was a dominancy in male, formally-trained gastrointestinal surgeons, working at teaching hospitals in European countries. Of the respondents, 71% demonstrated a high level of understanding the needs (frustration with current medical devices), with 66% developing specific solutions by themselves. Active discussion with others was done by 53%. Twenty-one percent of respondents presented their ideas at medical congresses, and 12% published in scientific journals. Only 20% took specific precautions or appropriate actions to protect their IPs before these disclosures. CONCLUSIONS: The current level of awareness of IP and IP-related issues is relatively low among EAES members. A structured IP training program to gain basic IP knowledge and skill should be considered a necessity for clinicians. These skills would serve to prevent the loss of legitimate IP rights and avoid failure in the clinical implementation of innovative devices for the benefit of patients.

[Consideration on Academia Environments for Creating Medical Innovation].

The spread of COVID-19 has re-affirmed the crucial importance of the pharmaceuticals industry in improving the level of citizens' health and medical care, as well as the industry's importance in terms of contribution to economic growth and tax revenues. Although some time has passed since the importance of industry-academia collaboration was first raised in relation to the creation of innovative new drugs and the continuation of global competitiveness, conflicts between academia and companies have also been highlighted as barriers that hinder efforts to promote the practical realization of academia-initiated seeds. The authors have hypothesized that conflicts between academia and companies can be attributed to the vulnerability of innovation creation environments, including drug discovery, on the academia side, insufficient awareness concerning human resources that will undertake industry-academia operations, and inadequate development of structures. Consequently, we implemented fact-finding investigations in relation to universities and public research institutions in Japan, with the objective of ascertaining the actual status of innovation creation environments, including drug discovery, on the academia side. From the results of these investigations, we will clarify the issues that may present barriers to innovation creation, and consider policies, etc. for the enhancement of innovation creation environments.

Intellectual Property Rights and Vaccines.

Over the past 20 years, there has been steady, year-on-year growth in the number of granted vaccine-related patents. It is therefore important that those involved in vaccine research should be aware of both the risks and opportunities that patents create. The aim of this chapter is to offer a brief introduction to how, and when, patent rights might become available to vaccine developers and to explain the potential risk of infringement of third-party patent rights and the potential consequences.This chapter begins with a brief introduction to the patent application process and the international patent systems. The advantages and drawbacks of patent protection are discussed, followed by an overview of patent infringement and the various legal safe-harbors that may be available for certain research activities. Other features of the patent system which may be of particular relevance in the vaccines context are also discussed, such as compulsory licensing, sovereign states' rights to use patented inventions and voluntary technology sharing agreements. The chapter concludes with a discussion of the SARS-CoV-2 (COVID-19) pandemic and recent developments in the field of vaccine patents that have arisen as part of the international response.

Waiving intellectual property rights: Boom or bust for medical innovation?

Proposals to waive intellectual property rights (IPRs) on coronavirus 2019 (COVID-19)-related developments have gained considerable support among politicians, including from US President Biden, academics, nongovernmental organizations (NGOs), the media, and the general public. However, there are surprisingly few reflections about the short- and long-term consequences for medical innovation, particularly the development of new drugs and vaccines. In this feature, I reflect on the consequences for innovative entrepreneurial companies, the incentives to innovate, and consequences for international knowledge flows to low- and middle-income countries. I conclude that waiving IPRs reduces opportunities for entrepreneurial companies to attract sufficient funding for developing medical innovations. Low- and middle-income countries might suffer reduced knowledge inflows in the absence of IPRs that undermine their ability to develop medical innovations.

The economic and public health impact of intellectual property licensing of medicines for low-income and middle-income countries: a modelling study.

BACKGROUND: Non-exclusive voluntary licensing that is access-oriented has been suggested as an option to increase access to medicines to address the COVID-19 pandemic. To date, there has been little research on the effect of licensing, mainly focused on economic and supply chain considerations, and not on the benefits in terms of health outcomes. We aimed to study the economic and health effect of voluntary licensing for medicines for HIV and hepatitis C virus (HCV) in low-income and middle-income countries (LMICs). METHODS: A robust modelling framework was created to examine the difference between scenarios, with (factual) and without (counterfactual) a Medicines Patent Pool (MPP) licence for two medicines, dolutegravir and daclatasvir. Data were obtained from MPP licensees, as well as a large number of external sources. The primary outcomes were the cost savings and health impact between scenarios with and without MPP licences across all LMICs. Through its licences, MPP had access to the volumes and prices of licensed generic products sold in all covered countries on a quarterly basis. These data informed the volumes, prices, and uptake for the past factual scenarios and were the basis for modelling the future factual scenarios. These scenarios were then compared with a set of counterfactual scenarios in the absence of the studied licences. FINDINGS: Cumulatively, between 2017 and 2032, the model's central assumptions predicted an additional uptake of 15·494 (range 14·406-15·494) million patient-years of dolutegravir-based HIV treatments, 151 839 (34 575-312 973) deaths averted, and US$3·074 (1·837-5·617) billion saved through the MPP licence compared with the counterfactual scenario. For daclatasvir-based HCV treatments, the cumulative effect from 2015 to 2026 was predicted to be an additional uptake of 428 244 (127 584-636 270) patients treated with daclatasvir, 4070 (225-6323) deaths averted, and $107·593 (30·377-121·284) million saved with the licence compared with the counterfactual scenario. INTERPRETATION: The chain of effects linking upstream licensing to downstream outcomes can be modelled. Accordingly, credible quantitative estimates of economic and health effects arising from access-oriented voluntary licensing were obtained based on assumptions that early generic competition leads to price reductions that influence procurement decisions and enable the faster and broader uptake of recommended medicines, with beneficial economic and health effects. FUNDING: Unitaid.