3D Printing: How an Emerging Technology May Help Fight a Pandemic
3D printing is the process of converting data from digital files into 3D models. Although these processes may vary, the most common ones work by using a machine that prints layer upon layer of a selected material, such as different plastics or metals amongst others.
The applications of 3D printing in the healthcare space have grown exponentially over the past few years with prosthetic hands and surgical tools now being regularly and routinely 3D printed.
The Covid-19 pandemic has accelerated the uses of 3D printing in healthcare, as many schools, universities, organisations and individuals have united together to print the equipment needed to protect key workers as they work on the front lines to combat the virus. This article considers the use of 3D printing in the fight against Covid-19 and the implications which have arisen in the legal field – as a result of intellectual property laws. Broadly stated, it seems fair to argue that key characteristics of 3D printing, like the fact that it enables possibilities for customisation and servitiszation of manufacturing, coupled with the great possibilities for co-creation with end users (prosumers), makes this technology a highly potential one for achieving great social and also environmental sustainability. Thus, the legal framework should be shaped to promote these important goals.
Use of 3D Printing During the Covid-19 Pandemic
Beginning in March 2020, the news all over the world was focused on containing the spread of Covid-19. Indeed, one of the main catastrophic effects of the pandemic was its consequences on the health systems globally and in some cases over-whelming, the health infrastructures in certain countries. In dealing with this pandemic, the scarcity of protective equipment for health care professionals as well as the short supply of respirators that were needed – and continue to be essential – in the more severe cases of the respiratory illness, has been both apparent and stark – in its reality.
In response, the 3D printing community has stepped forward by offering their services to ease the pressure on supply chains and governments.
In the UK, there have been initiatives to 3D print ventilator parts, face masks and visors for front line health workers treating Covid-19 patients. Universities in particular have stepped forward to help out and for example, in England, Bournemouth University is certainly one of those universities which provided such services and continue to do so. Furthermore, an initiative known as 3DCrowdUK was set up in a matter of weeks to further accelerate the use of 3D printing to assist with Covid-19 related equipment.
Similarly, in Finland, the Finnish Helsingin Sanomat reported on the key role of 3D printing a method for production of emergency supplies during the Covid-19 pandemic.
In USA, Formlabs, a 3D printing company based in Somerville Massachusetts has ceased its operation of manufacturing 3D printers and related software and instead is now using 250 printers in its Ohio factory to manufacture 100,000 nasal swabs for Covid-19 testing each day. Similarly, NASCAR, manufacturers of composite parts for the next generation of stock cars is using its 3D printers 18 hours a day to manufacture face shields for hospitals.Many other countries have followed suit – although rules and regulations have been seen to play a crucial role in adhering to health and safety laws. For example, most countries have had to ensure that they follow the same approvals and protocols for 3D printing as in ‘normal’ times.
Accordingly, despite these success stories surrounding 3D printing, there has also been some challenges posed inter alia by intellectual property rights on the core innovations at stake. As is often the case, the jump in technology brings a boom of ideas and uses, while the implications on existing laws can lag behind. In the context of 3D printing, Intellectual Property Rights (IPRs) and pandemics (such as Covid-19), the controversy often lies on the delicate balance between protection of innovation and access to them.
3D Printing, Covid-19 and Intellectual Property: An Incompatible Marriage?
Brescia is a city in the Lombardy region in Northern Italy, one of the areas which was hit hardest by the Covid-19 pandemic. Since the beginning of the crisis, hospitals in the region continuously faced massive overcrowding and equipment shortages. One of the most pressing problems was the lack of enough ventilators, which were vital to support the sickest patients infected with the new coronavirus.
As the outbreak progressed, the hospital of Chiari (a town in the province of Brescia) came close to running out of valves to connect patients to ventilators. The hospital reached out to the local manufacturers for more, but they could not deliver replacement valves in time. In the midst of this emergency, the hospital collaborated with the editor of a local newspaper and a tech expert to put out a call for help – and it was answered by a local engineering company. Two engineers, Cristian Fracassi and Alessandro Romaioli, founder and CEO of Isinnova, an Italian engineering startup, developed three different versions of the valve prototype in a few hours. Within 24 hours, they had used a series of 3D printers to produce 100 valves.
Fracassi and Romaioli initially made a request to the company that developed the original valves for the digital files to 3D-print the replacement valves. However, their request was turned down. Unperturbed, they went on to reverse engineer the valve before 3D printing the replacement valves. Furthermore, while a valve from the original manufacturers cost over 10.000 euros, the 3D-printed valves produced by Fracassi and Romaioli were significantly cheaper at around 1 euro.
One of the main reasons for the price disparity between the original valves and the 3D-printed ones, stemmed from the legal framework around technology use.
According to international intellectual property laws – which have been implemented in very similar ways in virtually all countries around the world – inventors who successfully apply for a patent are granted exclusive rights over the commercialisation of their inventions. This allows inventors to charge higher prices than they otherwise would be able to do, even when their products are critical to the provision of healthcare. Similarly, the 3D model (artistic drawing) contained in digital files like the ones used, is often protected by another form of intellectual property – copyright.
In general, commentators view intellectual property as necessary for encouraging innovation in technical or complex scientific areas. However, the case study from Brescia, Italy presented above, showcases one of the starker realities of over-reliance on intellectual property rights: life-saving technologies may not be available to those in need.
This might happen because there is no competition or, as was the case with the ventilator valves, because those with the ability to provide cheaper copies of existing technology are afraid to infringe those intellectual property rights. For instance, Fracassi and Romaioli have stated that they do not plan to release the digital files containing the instructions on how to 3D-print the valves for fear of being sued. Indeed, this is an emblematic example that shows the importance of striking a proper balance between IPR protection and access. Arguably, such events also demonstrate the tendency of most Western IPR systems to rely on some form of utilitarian or incentive based theories, where economic efficiency overrides other societal values such as social (or environmental) sustainability.
3D Printing and Public Health after the Covid-19 Pandemic: Looking Ahead to the Future
The ongoing pandemic has illustrated the need for interventions that maximise the potential of emerging technologies like 3D printing. At a time in which there is great legal uncertainty about how 3D printing in general will be regulated worldwide, it is important to think ahead to future scenarios of infectious disease outbreaks, particularly pandemics – where intellectual property laws may appear to stand in the way of critical health issues. More generally, emergency situations such as the one caused by the Covid-19 outbreak (or even those caused by climate change and the environmental crises) forces us to rethink the foundations of our IPR system – in a more holistic manner. As Fisher points out, does a system that prioritise economic efficiency (over any other societal value), with a strong focus on individual right owners, serve the purpose of promoting a ‘just and attractive’ society? Or has the unprecedented circumstances brought about as a result of the Covid-19 pandemic, highlighted that a change is now needed?
One option would be the adoption of an explicit provision that encourages follow-on innovators to step in quickly in situations such as a pandemic in order to save lives during a given period. In the context of 3D printing, for instance, a possible way forward would be to create a carve-out which would be applicable to non-commercial uses of 3D printing technology, when needed during public health crises. This carve-out would become applicable, for instance, when there is a declaration of emergency by local or national authorities. In such a scenario, it is proposed that making copies of life-saving medical equipment could be exempt from liability for the duration of the crisis, and in the current context, the pandemic. However, to avoid an abuse of the exception post- crisis, follow-on innovators will be forbidden from releasing the digital files containing the instructions for 3D printing the required medical equipment or drugs amongst others. This would continue to encourage innovation and promote access to inventions and maximize the use of 3D printing as well as intellectual property rights for the greater public good at a time of a health crisis. More fundamentally, however, the current situation could also be seen as another (of the already many) indications that a radical change in how we actually conceive and justify our intellectual property rights system needs a change. Indeed, a switch from a system strongly based on economic incentives and rational homo economicus as the driving force of innovation, towards one that would better reflect societal values, such as sustainability, is highly desirable for our society, in moving forward.
 Mendis D and Rutschman A, 3D printing of body parts is coming fast – but regulations are not ready, The Conversation (January 2020) at https://theconversation.com/3d-printing-of-body-parts-is-coming-fast-but-regulations-are-not-ready-128691
 George M, Aroom K R, Hawes H G et al, 3D printed surgical instruments – The design and fabrication process (2017) 4(1) World Journal of Surgery 314-319
 World Health Organisation, Best practices for infection prevention and control, with a spotlight on Covid-19: countries share experiences (3 March 2020) at http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/news/news/2020/3/best-practices-for-infection-prevention-and-control,-with-a-spotlight-on-covid-19-countries-share-experiences
 Ramsay S, Coronavirus: Italy’s hardest hit city wants you to see how Covid-19 is affecting its hospitals (22 March 2020) Sky News at https://news.sky.com/story/coronavirus-they-call-it-the-apocalypse-inside-italys-hardest-hit-hospital-11960597
 See a summary of some major initiatives for e.g. at: https://3dprintingindustry.com/news/3d-printing-community-responds-to-covid-19-and-coronavirus-resources-169143/.
 Bournemouth University uses 3D printer to create hundreds of face shields to protect against coronavirus (8 April 2020) at https://www.bournemouth.ac.uk/news/2020-04-08/bu-student-uses-3d-printer-create-hundreds-face-shields-protect-against-coronavirus
 Banker S., Covid-19 and 3d printing (13 April 2020) Forbes at https://www.forbes.com/sites/stevebanker/2020/04/13/covid-19-and-3d-printing/#4bc5f5303f7a
 Cooley LLP, UK-specific guidance for the manufacture and supply of certain medical devices for Covid-19 (3 April 2020) at https://www.lexology.com/library/detail.aspx?g=0d29f16f-30f8-4e2e-89ed-f28b9423c138
 Vogt A, Inside Italy’s most infected province: ‘To see an entire generation of residents taken is unthinkable’ (15 March 2020) at https://www.telegraph.co.uk/news/2020/03/14/elderly-left-isolated-abandoned-italy-death-rate-soars/
 Horowitz J, Italy’s healthcare system groans under coronavirus – a warning to the world (17 March 2020) The New York Times at https://www.nytimes.com/2020/03/12/world/europe/12italy-coronavirus-health-care.html
 Kirky S., Who gets the ventilator? Doctors say we need to decide now who gets care if Covid-19 overwhelms ICU (17 March 2020) Journal Pioneer at https://www.journalpioneer.com/lifestyles/health/who-gets-the-ventilator-doctors-say-we-need-to-decide-now-who-gets-care-if-covid-19-overwhelms-icus-425669/
 Essop A, Hospital in Italy turns to 3D printing to save lives of coronavirus patients (18 March 2020) at https://3dprintingindustry.com/news/hospital-in-italy-turns-to-3d-printing-to-save-lives-of-coronavirus-patients-169136/
 Moody G, Volunteers 3D print unobtainable $11,000 valve for $1 to keep covid-19 patients alive; original manufacturer threatens to sue (17 March 2020) Techdirt at https://www.techdirt.com/articles/20200317/04381644114/volunteers-3d-print-unobtainable-11000-valve-1-to-keep-covid-19-patients-alive-original-manufacturer-threatens-to-sue.shtml
 Feldman A, Meet the Italian Engineers 3D printing respirator parts for free to help keep coronavirus patients alive (19 March 2020) Forbes at https://www.forbes.com/sites/amyfeldman/2020/03/19/talking-with-the-italian-engineers-who-3d-printed-respirator-parts-for-hospitals-with-coronavirus-patients-for-free/#2266093178f1
 For example, under the Patent Cooperation Treaty (PCT) an applicant can file a single patent application and simultaneously seek protection for an invention in a large number of countries.
 Mendis D, In pursuit of clarity: the conundrum of CAD and copyright – seeking direction through case law  40(11) European Intellectual Property Review, 694-705
 See also, ibid n. 18. Generally, this relates also to the issues of compulsory patent licenses or patents and public health. See e.g. Correa C, Public Health and Intellectual Property Rights, Global Public Policy 2 nr. 3 (2002):261; Li P, Health Technologies and International Intellectual Property Law. A Precautionary Approach (Routledge, 2015).
 See above, n. 20
 Ballardini R M, Kaisto J and Similä J, Private Law, Sustainability and the Circular Economy – Towards More Social-Planning Types of Practices, Journal of Cleaner Production (Accepted; forthcoming in 2020). See also Pihlajarinne T and Ballardini R M, “Paving the way for the Environment – Channeling ‘Strong’ Sustainability into the European IP System”, (2020) 42 European Intellectual Property Review 239.
 See, Mendis D, Nordemann J, Ballardini R M, Brorsen H, Calatrava-Moreno M, Robson R and Dickens P, The Intellectual Property Implications of the Development of Industrial 3D Printing, Publications of the European Commission (April 2020), available at: https://op.europa.eu/en/publication-detail/-/publication/e193a586-7f8c-11ea-aea8-01aa75ed71a1/language-en/format-PDF/source-124493516.
 See for e.g. “Social planning theory” in Fisher, W.: Theories of Intellectual Property, in New Essays in the Legal and Political Theory of Property (Cambridge University Press, 2001).
Writers on Twitter:
Rosa Ballardini @BallardiniRM
Ana Santos Rutschman @a_rutschman
Dinusha Mendis @LawTechGadget