Authors: Prof. Aisling McMahon (Principal Investigator), Dr. Aislinn Fanning (Postdoctoral Researcher), Sharon Adedapo (Research Assistant), and Lauren Kane (Research Assistant), ERC PatentsInHumans Project, School of Law & Criminology and ALL Institute, Maynooth University.
Introduction
The European Research Council funded PatentsInHumans project led by Professor Aisling McMahon (School of Law and Criminology, Maynooth University) is a five year project which examines how patents – types of intellectual Property Right (IPR) – can impact patients’ access to and use of health-technologies, including medicines, vaccines, and medical devices. On the one hand, patents can provide incentives to rightsholders towards the development of new health-technologies. However, on the other hand, the ways patents are used can impact healthcare, because patents give rightsholders exclusionary rights to limit how others develop and provide the patented technology (which could be a medicine or other health-technology) for commercial purposes. These rights are temporary in nature, granted for up to 20 years (the patent term). Thus, rightsholders have significant control over the who can develop and produce a patented technology and on what terms (including price) during the patent term. Where patents are over health-technologies, rightsholders’ decisions on such aspects can have significant implications for access to and delivery of healthcare. The ERC PatentsInHumans project seeks to examine whether and to what extent, how patents are used in such contexts can impact patients’ health and wellbeing, specifically considering the impact of patents on patients’ bioethical interests, including dignity, bodily integrity and autonomy interests. It also explores avenues that could be used to address or ameliorate such bioethical implications of patents.
The project commenced in November 2022 and is currently in its fourth year, this blogpost will provide a snapshot of some of the main strands of research currently being conducted by the project team, and emerging research findings.
Human Rights as an Avenue to Improve Access to Patented Health-Technologies & Address Bioethical Implications of Patents over Health-Technologies
Prof Aisling McMahon and Lauren Kane are researching the role of human rights within the patent system. Specifically, this aspect of the PatentsInHumans project examines whether and to what extent human rights may be used to address the barriers faced by many patients in accessing high-priced patented health-technologies (such as medicines, vaccines, medical devices, etc.) in the contemporary healthcare context. Relatedly, it considers how human rights avenues could address bioethical issues at stake in such contexts, and the challenges/limitations around using rights-based arguments in such contexts.
Against a backdrop of increasing costs of medicines at the global level, a key aspect of research under this strand, explores whether and to what extent the right to health (focusing on the right to health protected under Article 12(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR)), may be used by patients and States at the national level to improve access to patented health-technologies. There has been considerable research on the role of the right to health in access to patented health-technologies in emergency contexts such as pandemics. Despite this, there is more limited research that explores the role of the right to health in everyday healthcare contexts (such as the treatment of non-communicable diseases (NCDs) including cancer or genetic conditions) This research aims to fill this gap.
Some of the key findings on the right to health theme, will be published as a forthcoming book chapter written by Prof McMahon and Lauren Kane in a leading peer reviewed edited collection by Professor Paul Torremans (eds) on Intellectual Property Rights and Human Rights. A pre-print version of this forthcoming chapter is available here. The chapter’s main findings suggest that the right to health has the potential to improve access to patented medicines in certain contexts; however, much depends on how the right is used. To most effectively vindicate the right to health and achieve access for patients, we argue that the right needs to be engaged with in a more strategic manner. This chapter argues that States should place greater emphasis on the collective dimension of the right to health, using this to support targeted legislative or other policy measures to ensure affordable access to health-technologies and thus address public health needs.
Enforcement of Patent Rights – Scope to Consider Patient Interests?
Another key strand of the project is considering how patent rights are enforced and to what extent, if any, there is scope to consider the implications of patent use and enforcement on patient interests in the health technology context. A key mechanism for the enforcement of patent rights is via rightsholders’ seeking injunctions against technologies which are infringing their intellectual property rights. Where infringement is proven, an injunction could, for example, be sought to stop the production, use, sale etc. of the infringing (or in the case of an interim injunction application, allegedly infringing technology). However, where the infringement relates to a patented health-technology such as a medicine or medical device, an injunction could impact patients’ health and wellbeing by impacting access to and delivery of healthcare. Professor Aisling McMahon and Sharon Adedapo have been conducting research into the scope to consider the impact of injunctive relief on patients in such contexts. More specifically, they are examining the new Unified Patent Court (UPC), and the remit this court may have to consider third party interests in applications for injunctive relief where patent infringement is found over health-technologies. This research has explored the recent UPC decisions by the Munich Local Division (2024) and Court of Appeal (2025) in Edwards Lifesciences v Meril, where Edwards sought an injunction against Meril in relation to its transcatheter heart valve and related technologies. Amongst other arguments, Meril argued that the court should consider the potential impact of an injunction, if granted, on patients’ interests. These decisions highlighted that the UPC applies a high threshold when deciding whether to refuse an injunction or tailor it where patent infringement is found, whereby an injunction is typically granted unless the health-technology is the sole technology available to meet the patient’s need or where it provides a notable enhancement for patients. Professor McMahon and Sharon Adedapo recently presented findings from this research at the socio legal scholars association (SLSA) conference at the University of Sussex.
Alongside considering patent enforcement via injunctive relief, this strand of the project also considers the ways in which licensing of patent rights could offer an avenue to consider patient (and broader health system) interests. Ongoing work, is exploring developments in access licensing clauses, socially responsible licensing and initiatives by a range of public bodies, including research funder and universities, to embed access to downstream technologies developed using public funds within their intellectual property and broader funder policies.
Role of the Public and Donated Biomaterials in Development of Patented Technologies: Legal, Ethical and Conceptual Considerations
Alongside such doctrinal legal work, another key theme within the project is understanding how peoples’ lived experiences including around access to healthcare and how this may impact their broader health and wellbeing, are or could be impacted by the patent system. Several strands to this theme are currently under development by Professor Aisling McMahon and Dr Aislinn Fanning. First, a range of contemporary ‘technologies’ blur the boundaries of the body and technology, including 3D bioprinting technologies, which in turn pose complex ethical and legal questions for the patent system. One element of this research focuses on the bioethical implications of the potential patentability of 3D bioprinting technologies and ‘products’ created via such processes. At a general level, 3D bioprinting involves the use of living cells or other biomaterials as part of a ‘bio-ink’ to ‘print’ functional structures, such as tissue. For example, we are considering the bioethical implications of patentability where those technologies may potentially develop in future to enable the creation of 3D ‘bioprinted’ fully-functioning human organs and tissues – we examine the likelihood of patentability in such contexts, and where patents could apply, we consider the practical and bioethical implications of such patents, including implications for access to 3D bioprinted technologies.
Second, another element of this research strand within the project considers the role of those who contribute their biomaterials to the development of health-technologies, and the tensions that arise when patents and other IPRs contribute to inequitable access to those technologies downstream. As part of this strand, Professor McMahon and Dr Fanning are considering the possibilities of re-conceptualising the role of donors as ‘clinical labour’ where this might allow for a re-imagining of the role of IPRs in this context which recognises that labour and ultimately allows for greater public stewardship of health-technologies. Aislinn Fanning recently presented this work in progress at the SLSA conference 2026.
Exploring the Implications of Patents for Patients’ and Health-care Practitioners’ Lived Experiences: Empirical Strand
Finally, relatedly , ongoing empirical work within the project is seeking to build deeper insights around how patents can impact patients’ and healthcare providers’ lived experiences including by impacting access and delivery of healthcare, and the avenues and limitations to addressing this within the patent system (and related systems). This work aims to gain empirical insights from key actors within the patent system and non-governmental organisation (NGO) context, to understand how patents are operating in practice and potential bioethical implications of these. It also explores empirical work with patients and medical practitioners to understand further the impact of patents on the lived experiences of such groups. We will continue this empirical strand in 2026 with a view to further developing our understanding of the complex interaction between patents, health innovation systems, and health-care delivery.
Ultimately, the findings across this and other related research strands combine to seek to address the central aim within the project, namely, to develop scholarly insights and policy recommendations for how patent systems (and related systems) and be re-imagined to offer more person-centered approaches to patent grant and use within the healthcare field in a way that ensures patient health and wellbeing is the core priority.
You can find out more about the PatentsInHumans project on our website and by watching this short video.
The PatentsInHumans project is funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
