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

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

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

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

Legal issues and underexplored data protection in medical 3D printing: A scoping review

Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption. Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing. Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic. Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future

Social, cultural and economic aspects of antimicrobial resistance.

Although often considered only a medical problem, antimicrobial resistance is an evolutionary challenge accelerated by social, cultural and economic factors that lead to the misuse, overuse and abuse of life-saving antimicrobial medicines. The antimicrobial resistance challenge is compounded by inadequate attention to disease prevention and response, global circulation of people and products, differences in industry and market regulations across countries, and a fragile pipeline of new antibiotics and their alternatives. While the discovery of new antimicrobials will provide temporary solutions, sustainable success requires rigorous social science research that explores the drivers of antimicrobial resistance. These solutions should promote balance between equitable access to, conservation of, and innovation for antimicrobials, adapted to local conditions across the globe

Legal issues and underexplored data protection in medical 3D printing: A scoping review

Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption. Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing. Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic. Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future

The patentability of computer-implemented simulations and implications for computer-implemented inventions (CIIs)

Abstract G 1/19 (Simulations), Enlarged Board of Appeal of the European Patent Office, 10 March 2021 The Enlarged Board of Appeal of the European Patent Office (EPO) held that a computer-implemented simulation of a technical system or process which is claimed as such can, for the purpose of assessing inventive step, solve a technical problem by producing a technical effect going beyond the simulation’s implementation on a computer; and that the established case law on computer-implemented inventions (COMVIK approach) applies to computer-implemented simulations even if these do not have an output having a direct link with physical reality.</jats:p

Mapping the Patent Landscape of Quantum Technologies: Patenting Trends, Innovation and Policy Implications

Recent technical breakthroughs underscore the potential of second-generation (2G) quantum technologies including quantum simulation, quantum sensing and metrology, quantum computation, and quantum communication. Patenting trends of such technologies are an indicator of the pace of innovation at the invention stage. Empirical studies looking at the real-world patenting activity can provide valuable evidence to help assess and guide policy proposals related to intellectual property rights (IPRs), innovation, and governance of quantum technologies. In this paper, we report the results of a study designed to map the patent landscape of quantum technologies. We evaluate the patenting trends over the last 20 years to determine: 1) the growth of quantum technology patents, 2) the technology breakdown and classification of patenting activity, 3) the choice of priority patent office, 4) the types of patent claims and strategies, 5) the subject matter of recently awarded patents, 6) the top patent owners, 7) the dominant patent portfolios, and 8) the geographical distribution of this patent activity. Based on our patent landscape study, we critically examine if patent protection is posing a problem in the technical field of quantum technologies. We show how quantum patent disclosure is moving us to an emerging quantum information com- mons, gradually reinforcing the public domain. Additionally, we examine the innovation and policy implications of these results in the broader context of quantum innovation initiatives, market competition, the patent/trade secret interface, and governance of quantum technologies

When does Stand-Alone Software qualify as a Medical Device in the European Union? - The CJEU’s Decision in SNITEM and what it implies for the next generation of Medical Devices

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates. It also signifies a paradigm shift with a rapidly increasing digitalization of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical AI and Big Data