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“.

RadVac also focused on a SARS-CoV-2 vaccine at the beginning of the pandemic with the aim to bridge time until commercial vaccines are on market. They now aim for providing a more rapid, more accessible, and globally oriented vaccine R&D alternative by developing a vaccine platform that relies on the multiple and scattered tinkering of citizen scientists throughout the world. We call Vaccinuum’s practice that they apply to organize for novelty “repurposing” and RadVaC’s “tinkering“.

Both initiatives don’t rely on traditional IP to protect their R&D and rather build on openly sharing knowledge. However, their practices differ while facing similar challenges and situations during the pandemic. The initiatives apply practices of open source R&D that are as different as possible and as similar as needed for coping with uncertainties and gaining legitimacy in an isomorphic field. When repurposing, they apply already existing off-patent vaccines and use it for different diseases. The outcome of this approach is not a protectable invention. Tinkering, in contrast, allows for multiple and parallel incremental variations of the initial vaccine that are usually not protectable themselves. However, there could be room for commercialization when variants are modified enough. Comparing both, we argue that the source of legitimacy and uncertainty reduction in repurposing is the use of knowledge that is already approved. For tinkering, it could be the outlook to rather traditional commercialization that provides a source for legitimacy in the field.

The Global Congress on Intellectual Property and the Public Interest is the “largest and most important global meeting of academics and advocates working at the intersection of intellectual property law and the promotion of public interest“. The congress offers a great program covering five topic areas: copyright, access to medicines, digital rights, trade agreements and traditional and diverse knowledge. All contents are openly accessible on YouTube. They offer a live translation to Spanish and Portuguese in the Zoom sessions.

(milena)