Purpose: This paper investigates the technology, business and intellectual property issues surrounding the production of spare parts through Additive Manufacturing (AM) from a digital source. It aims to identify challenges to the growth of the AM spares market and propose suitable solutions. Methodology:The paper begins with a systematic literature review and theoretical analysis. This is followed by case study research (CSR) through semi-structured interviews, forming the basis of a triangulated, cross-case analysis of empirical data. Findings:The paper identifies several obstacles to the development of the AM-produced digital spares market. The manufacturing industry will soon be forced to rethink AM as a real manufacturing alternative. Short-term, AM technology has implications for the production of components for legacy systems for which tooling facilities no longer exist. Long-term, AM will be used to produce a wide range of components especially when product and/or service functionality can be increased. To enable companies to navigate current uncertainties in the patent framework (especially the 'repair versus make' doctrine), new IPR strategies could be developed around patenting both complex devices and their individual components, and seeking patent protection for CAD files. Further harmonization of the EU legal framework, the interpretation of claims and the scope of protection offered in the context of spare parts, will also be important.Originality/value: This study pinpoints key issues that need to be addressed within the European AM business environment and the patent system and proposes recommendations for business and legal frameworks to promote the growth of a stable European digital spare parts market.

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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.

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