Periodic Reporting for period 1 - PatentsInHumans (Patents, Bioethics and the Human Body: Reconceptualising Bioethics in Patent Decision-Making and the Governance Function of Patents)
Periodo di rendicontazione: 2022-11-01 al 2025-04-30
The project’s core research objective is to develop a comprehensive understanding of the bioethical issues posed by patents, and how such patents are used, over ‘technologies’ related to how we treat, use or modify the human body. It aims to understand how we can – or should – better embed such bioethical considerations in patent decision-making in Europe. To achieve these aims, the project uses a novel 5 category taxonomy of patentable ‘technologies’ related to the body.
Patents allow rightsholders to stop others from using a patentable technology for the patent term (generally 20 years). This allows the rightsholders to control how that technology is provided, to whom, and on what terms. Where patents are granted over technologies related to how we treat, use or modify the body, this control poses considerable bioethical issues including implications for autonomy, bodily integrity and dignity.
The project interrogates to what extent such bioethical issues are considered, if at all, within European patent decision-making. It proposes that there is a self-reinforcing cycle where there is limited consideration of the potential broader bioethical implications posed by patents over technologies at grant stage; that there are also limited incentives for rightsholders to consider potential bioethical implications in how they license/use patents, and that patents, once granted, are often difficult to challenge if bioethical issues arise.
Ultimately, the project aims to reimagine European patent decision-making towards a person-centred approach which further embeds bioethical considerations in patent grant and licensing systems, where appropriate, for such technologies. The project develops a cross disciplinary institutional analysis to evaluate key legal, structural and cultural barriers leading to the marginalisation of bioethics in patent decision-making, and to formulate pathways to bring bioethics into patent decision-making for technologies related to the body with important conceptual and policy implications.
Patents allow rightsholders to stop others from using a patentable technology for the patent term (generally 20 years). This allows the rightsholders to control how that technology is provided, to whom, and on what terms. Where patents are granted over technologies related to how we treat, use or modify the body, this control poses considerable bioethical issues including implications for autonomy, bodily integrity and dignity.
The project interrogates to what extent such bioethical issues are considered, if at all, within European patent decision-making. It proposes that there is a self-reinforcing cycle where there is limited consideration of the potential broader bioethical implications posed by patents over technologies at grant stage; that there are also limited incentives for rightsholders to consider potential bioethical implications in how they license/use patents, and that patents, once granted, are often difficult to challenge if bioethical issues arise.
Ultimately, the project aims to reimagine European patent decision-making towards a person-centred approach which further embeds bioethical considerations in patent grant and licensing systems, where appropriate, for such technologies. The project develops a cross disciplinary institutional analysis to evaluate key legal, structural and cultural barriers leading to the marginalisation of bioethics in patent decision-making, and to formulate pathways to bring bioethics into patent decision-making for technologies related to the body with important conceptual and policy implications.
Within the first two years of the project (the reporting period), the team developed research across the three-project work-packages (WPs).
Under WP1 on bioethics, we examined the potential bioethical issues posed by patent grant/use over the 5 categories of technologies examined in the project which relate to how we treat, use and modify the human body. We examined how patent rights can apply over technologies within these categories. We then considered the types of bioethical issues which can arise around how patents are granted/used related to each of the 5 categories of technologies, and how such issues are engaged with if at all, within patent law or broader systems. This research enabled the PI to refine the conception of bioethics within the project and to develop a deeper understanding of the main types of bioethical issues that can arise over how patents are granted/used in such contexts.
Under WP2 on institutions, we commenced the development of a novel cross-disciplinary institutional framework to examine the institutional influences around how such bioethical issues are considered, if at all, within Europe patent law and practice. Relatedly, we examined the institutional framework within the European patent system, relevant legislative provisions which could be used to engage with the emerging bioethical issues, and the relevant decision-making actors/avenues. We also examined avenues outside patent law to engage with such bioethical issues, such as human rights, competition law and avenues specific to various technological categories.
Finally, within WP3 on governance, the research examined whether or to what extent patents can enable rightsholders to exercise governance functions over patentable technologies. Combining this research with research under WP1, we investigated the implications of the governance related function of patents for the types of bioethical issues that can arise over the technologies studied.
During this time, the team actively disseminated emerging research via written publications and at academic conferences, which led to: 15 written publications, comprised of: 2 peer reviewed articles (1 in press); 2 peer reviewed book chapters; 1 professional body article; 7 blog articles and 3 project reports. We delivered 33 presentations/seminars on emerging research, including: 20 invited presentations/seminars (PI), and 13 conference presentations. We established a project website : https://patentsinhumans.eu/(si apre in una nuova finestra)
Under WP1 on bioethics, we examined the potential bioethical issues posed by patent grant/use over the 5 categories of technologies examined in the project which relate to how we treat, use and modify the human body. We examined how patent rights can apply over technologies within these categories. We then considered the types of bioethical issues which can arise around how patents are granted/used related to each of the 5 categories of technologies, and how such issues are engaged with if at all, within patent law or broader systems. This research enabled the PI to refine the conception of bioethics within the project and to develop a deeper understanding of the main types of bioethical issues that can arise over how patents are granted/used in such contexts.
Under WP2 on institutions, we commenced the development of a novel cross-disciplinary institutional framework to examine the institutional influences around how such bioethical issues are considered, if at all, within Europe patent law and practice. Relatedly, we examined the institutional framework within the European patent system, relevant legislative provisions which could be used to engage with the emerging bioethical issues, and the relevant decision-making actors/avenues. We also examined avenues outside patent law to engage with such bioethical issues, such as human rights, competition law and avenues specific to various technological categories.
Finally, within WP3 on governance, the research examined whether or to what extent patents can enable rightsholders to exercise governance functions over patentable technologies. Combining this research with research under WP1, we investigated the implications of the governance related function of patents for the types of bioethical issues that can arise over the technologies studied.
During this time, the team actively disseminated emerging research via written publications and at academic conferences, which led to: 15 written publications, comprised of: 2 peer reviewed articles (1 in press); 2 peer reviewed book chapters; 1 professional body article; 7 blog articles and 3 project reports. We delivered 33 presentations/seminars on emerging research, including: 20 invited presentations/seminars (PI), and 13 conference presentations. We established a project website : https://patentsinhumans.eu/(si apre in una nuova finestra)
The emerging research to date within the PatentsInHumns project has potential to advance the field beyond the state of the art in several ways. Four potential breakthroughs are highlighted here:
First, the project has developed a comprehensive analysis of the potential bioethical implications which patents over technologies that relate to how we treat, use and modify the body can pose, focusing on implications for autonomy, bodily integrity and dignity interests. The PI has developed a novel five category taxonomy of such technologies, and developed a critical analysis of the types of bioethical issues that could arise around how patents are granted/used under each category. This goes beyond the state of the art by illuminating to a health law/bioethics audience the types of bioethical issues which can arise, and making the case for greater scrutiny of such issues.
Second, and relatedly, there is limited work examining how patents over medical devices could impact the bioethical interests of medical device users. We have developed a detailed mapping of the bioethical issues posed by patent grant/use in medical device contexts and this has potential to advance the field by demonstrating the importance of considering bioethical issues around patents and medical devices.
Future research will build upon these contributions by developing further case studies around patents and specific technologies within each of the 5 categories studied. We will also build upon this conceptual work by using empirical research to develop empirical insights around the bioethical issues arising.
Third, a key emerging finding is around the potential impact of patents and bioethical issues at the early stages of the health research cycle. A key contribution we have made in the first two years is examining the bioethical issues that can arise around donors’ contribution of biological samples to health research with how access to downstream technologies developed may be impacted by how patents operate.
Fourth, the project develops research on the institutional avenues to consider bioethical issues in the European patent system. The PI published a chapter examining how the new unitary patent system could offer avenues to engage with the bioethical issues posed by patents in Europe. Further research will be conducted on decision-making actors as the project develops to expand this contribution around the importance of institutional factors for how bioethics is engaged with.
First, the project has developed a comprehensive analysis of the potential bioethical implications which patents over technologies that relate to how we treat, use and modify the body can pose, focusing on implications for autonomy, bodily integrity and dignity interests. The PI has developed a novel five category taxonomy of such technologies, and developed a critical analysis of the types of bioethical issues that could arise around how patents are granted/used under each category. This goes beyond the state of the art by illuminating to a health law/bioethics audience the types of bioethical issues which can arise, and making the case for greater scrutiny of such issues.
Second, and relatedly, there is limited work examining how patents over medical devices could impact the bioethical interests of medical device users. We have developed a detailed mapping of the bioethical issues posed by patent grant/use in medical device contexts and this has potential to advance the field by demonstrating the importance of considering bioethical issues around patents and medical devices.
Future research will build upon these contributions by developing further case studies around patents and specific technologies within each of the 5 categories studied. We will also build upon this conceptual work by using empirical research to develop empirical insights around the bioethical issues arising.
Third, a key emerging finding is around the potential impact of patents and bioethical issues at the early stages of the health research cycle. A key contribution we have made in the first two years is examining the bioethical issues that can arise around donors’ contribution of biological samples to health research with how access to downstream technologies developed may be impacted by how patents operate.
Fourth, the project develops research on the institutional avenues to consider bioethical issues in the European patent system. The PI published a chapter examining how the new unitary patent system could offer avenues to engage with the bioethical issues posed by patents in Europe. Further research will be conducted on decision-making actors as the project develops to expand this contribution around the importance of institutional factors for how bioethics is engaged with.