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3D Printing, Intellectual Property Rights and Medical Emergencies: In Search of New Flexibilities

Ballardini, R. M., Mimler, M. ORCID: 0000-0002-9457-2506, Minssen, T. & Salmi, M. (2023). 3D Printing, Intellectual Property Rights and Medical Emergencies: In Search of New Flexibilities (City Law School Research Paper 2023/04). London, UK: City Law School, City University of London.


The COVID-19 pandemic has exponentially accelerated the use of 3D printing (3DP) technologies in healthcare. Surprisingly, though, we have seen hardly any public intellectual property right (IPR) disputes concerning the 3D-printed medical equipment produced to cope with this crisis. Yet it can be assumed that a great variety of IPRs could potentially have been enforced against the use of various items of equipment printed out without express consent from IP holders. Many reasons might have motivated IP owners not to enforce their rights during the pandemic, such as the fear of acquiring a bad reputation during a declared situation of national emergency. There is no internationally recognised general exception to IPR enforcement for health emergencies, while several − sometimes ineffective − tools, like compulsory licensing, voluntary licensing arrangements and potential TRIPS waivers, have been considered or used to facilitate access to and the distribution of innovations in critical situations. During the COVID-19 emergency, this has meant that the 3DP community has been operating in a state of relative uncertainty including with regard to the risks of IP infringement. This study contextualises these issues for pandemic-relevant 3DP. Building upon experience gathered during the COVID-19 pandemic, we look to the future to see what novel mechanisms within the IPR system could provide the additional flexibility required for dealing more smoothly, with the help and support of digital technologies, with situations such as global health emergencies.

Publication Type: Monograph (Working Paper)
Additional Information: All rights reserved. © 2023
Publisher Keywords: Pandemics, Supply chain regulation, 3D printing, Intellectual property Rights, IP exceptions
Subjects: K Law > K Law (General)
R Medicine > R Medicine (General)
Departments: The City Law School > Academic Programmes
The City Law School > CLS Working Paper Series
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