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Building upon a case study of the Medicines Patent Pool, this blogpost aims to set the Medicines Patent Pool/Merck License for Molnupiravir in a processual context.

About the License Agreement

Recently, on October 27, 2021, the Merck & Co., Inc. Kenilworth NJ USA (MSD) and the Medicines Patent Pool (MPP) jointly announced the signing of a license agreement for Molnupiravir. Molnupiravir is an “an investigational oral antiviral medicine“ against Covid-19 that has shown promising results in Phase 3 clinical trials. The drug is currently under review by the European Medicines Agency (EMA). The voluntary license and technology transfer agreement for Molunpiravir allows generic manufacturers from anywhere in the world to produce the drug and supply it to 105 low-and middle income countries (the “territory”). Manufacturers can license royalty free for the time of the pandemic

While the medical non-governmental organization Médecins Sans Frontières (MSF) criticizes the agreement for excluding “half of the world’s population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as Brazil and China”, other medicine policy experts such as James Love or Peter Maybarduk celebrate the agreement as an “impressive achievement” or a “starting point and an example” to increasing access to Covid-19 therapies in LMICs. James Love commented that the “licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale”. 

To understand the impacts of this license agreement, we take a closer look on the patent pool mechanism that is leveraged here. 

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At this year’s Global Congress on Intellectual Property and the Public Interest, which takes place October 25th-29th 2021, Konstantin Hondros and myself presented a working paper titled “Tinkering and Repurposing: How Open Source Vaccine Initiatives Alternatively Organize for Novelty“.

While the innovation brought forward by biotech and pharmaceutical companies was exceptional, many countries still lack access to vaccines. Public debates arose discussing alternative ways of handling IP in vaccine R&D beyond the prettified standards of the western dominated pharmaceutical industry.

Building upon literature on organizational isomorphism (DiMaggio & Powell, 1983) and literature about the emergence of novelty in organizations (Cattani, Ferriani, & Lanza, 2017), we argue that the westernized pharmaceutical industry – mainly in response to regulative standards – has developed highly isomorph organizational practices that might make the entering of outsiders, who apply alternative approaches to vaccine R&D (e.g., open source approaches), quite difficult. Puzzled by the question of how alternative ways of fostering novelty can be embraced and gain legitimacy in organizational fields deeply relying on isomorphism, we ask: how do open source vaccince R&D initiatives alternatively organize for novelty?

Source: PPT Presentation by Milena Leybold

We compare two empirical cases that both build on an open source practice: Vaccinuum and RaDVaC (Rapid Deployment Vaccine Collaborative). Vaccinuum (formerly OpenVax) was initially focused in developing a vaccine against SARS-CoV-2  and is now trying to discover an “Ultra-Broad Spectrum Open Source Vaccine for SARS-CoV-2 Variants and Future Epidemics” through processes of repurposing of already existing, “widely-available, approved, licensed, widely-accepted, non-exclusively manufactured, off- patent, live attenuated vaccines“.

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The Book

Governance across borders: transnational fields and transversal themes. Leonhard Dobusch, Philip Mader and Sigrid Quack (eds.), 2013, epubli publishers.
October 2021
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