The Impact of Patents on Translational Research - Non-Invasive Prenatal Diagnosis in Europe and US

Lead Research Organisation: University of Exeter
Department Name: The Law School

Abstract

Patent law is the first area of law that comes into contact with new innovation, because patents are the main means by which the state incentivises innovation. In return for disclosure of an invention, the state grants a monopoly to the patent holder. Whilst patents may work as intended to provide that incentive to innovation, patents may also work against the public interest by reducing public access to technology, or by shaping the development of technology in inappropriate ways.

The intersection of patent law with modern innovation such as genomics poses particular challenges, and the traditional principles of law are being strained almost to breaking point by patents claiming the very building blocks of life itself. Despite the publicly funded nature of this research, technologies in this area, and many genes themselves, are the subject of patent rights, and the patent owner has the potential to control the development of, and access to, the technology in question. At the same time, medicine is failing to accommodate patent rules, and there is divergence between law and practice.

Through the Human Genome Project and continuing research, we now have the most detailed map to date of the information programmed in our DNA - the information that makes us who we are. DNA abnormalities can lead to many common conditions such as Down's Syndrome and Cystic Fibrosis, and we are currently able to diagnose these conditions in adults by genetic tests, or in unborn children by testing foetal tissue. Soon, we will be able to diagnose disorders, and decipher a baby's entire genetic make-up by the simple procedure of analysing a sample of blood from a pregnant woman; a process called Non-Invasive Prenatal Diagnosis (NIPD), which will revolutionise the clinical management of pregnancy worldwide.

Understanding how patents in this field in Britain, Europe and the USA are enforced, and how companies, healthcare organisations and individuals interact with the system, is important to facilitate the development of, and public access to, NIPD. Perhaps more importantly, this research, and previous work of the PI investigating patents in single gene testing will be used as case studies to explore the wider issues surrounding the translation of innovations in genomic medicine into clinical practice. How patent law operates in practice has implications for delivery of technologies to the public, how companies and researchers innovate, how individuals decide to act, and how healthcare evolves in the face of emerging research that promises to change the face of medicine. The research will further make an important contribution to patent law scholarship, by an empirically informed conceptualisation of the role of patents in practice in frontier technologies.

The applicant has extensive experience in the legal issues surrounding genomic medicine. She will employ and develop socio-legal research methods to develop a theory of the role that patents play in emerging fields of genomic medicine, and foster improved international awareness and discussion of the subject. She will interview the leading international players in the field, as well as investigating the relationships between them through social network analysis. The analysis will be used to tease out how an appreciation of patents shapes day-to-day practice and future direction in translational research in NIPD.

This work is necessary to protect the interests of the public without impinging on innovation in the private sector. This project investigates an emerging and relatively young aspect of law which is set to become much more important as genomic medicine becomes a routine part of medical practice and as other frontier technologies challenge patent law in practice. Little legal work has been done in the area - this project will strengthen the applicant's position as a future leader in the field.

Planned Impact

Patents are an integral part of western systems of technology innovation, but law can lag behind practice given the length of time it takes for patents to be granted, and for the resolution of contested litigation. However, empirical investigation in this field is rare. Therefore, this research will be vital to bring an empirically informed perspective to consideration of patent law in practice, which has implications for changing policy and practice around innovation.

Innovation is important for the realisation of public benefit from research as well as economic benefit in all fields, and particularly in medicine. Genomic medicine is anticipated to become an integral part of medical practice in the near future, and the process of translating innovation into routine clinical care is important for the health of the population. The research in this project will be of benefit to those who are involved in the translational research pathway for innovations in diverse fields, and particularly genomic medicine. Ultimately, it is anticipated that the research will benefit the public, and particularly patients, because the purpose of this research is to uncover the role that patents play in the translational process, and make recommendations to address any negative impact. The impact will be attained through changes to policy and practice at relevant points in the translational pathway.

The research will have impact through its relevance to three broad groups: those who are actively involved in developing and delivering patented technology; policy makers; and finally those who are involved in 'using' patented technology.

Development and delivery of patented technology: This group incorporates scientists (both research and commercial), as well as professional advisors to those developing technology. It is anticipated that this research will have impact through informing professional advisors (lawyers, patent attorneys and technology transfer professionals) of the ways in which patents influence the translational process beyond what they are aware of through their professional experience, such that they improve or develop their professional practice. Similarly, scientists and companies developing tests will be informed by the research in ways that will permit them to organise their technology development and licensing in a more appropriate way to maximise health outcomes as well as economic competitiveness.

Policymakers: The research results enable policymakers, including funding bodies, to arrange the licensing of technology, for optimum health outcomes and economic competitiveness. Funding bodies are concerned to maximise the health benefits of the research they fund, and at the same time to contribute to the economic competitiveness of the UK, and this research will neatly fit with this agenda.
User groups: This research will achieve impact in user groups, including medical professionals and patients partly through the impact on the previous two groups of stakeholders, which will ultimately improve the delivery and availability of genomic medicine. In addition, impact will be achieved through engagement with medical practitioners to raise awareness of the relevance and role of patents in the translational research process, in order that their medical practice is influenced by appropriate clinical considerations rather than invisible or inappropriate patent concerns. Interest groups, including genetic and disability interest groups are often involved in translational research for the benefit of their population, and have a keen interest in intellectual property and its uses and implications. This research will inform and improve these practices.
 
Description Intellectual property rights, notably patents, have had, and continue to have, an important influence on the development of new biomedical technologies. The intersection of patent law with genomic medicine presents particular challenges, and this project has explored the role that patents play in the development and delivery of new innovations in genomic medicine, through empirical work into non-invasive prenatal testing (NIPT) as a case study. NIPT based on cell free DNA sequencing technology has developed rapidly, and is being incorporated into prenatal screening globally. Key commercial players hold patent portfolios, and most have engaged in extensive litigation and licensing. Patents have played a key role in shaping the development and delivery of NIPT, and will continue to do so, but that role is neither simple nor certain. This study has explored how those working in the field of development and delivery of NIPT work with and use patents held by others. It found that there was some awareness of the general rules of patent law, and some specific knowledge of the implications of particular patents for freedom to operate. Moreover, those working in the field carried out a balancing of the perceived costs and benefits of compliance and engagement. On the whole, law and law-in-practice in non-invasive prenatal testing are much more convergent than found in single gene testing. Those involved in the development and delivery of non-invasive prenatal testing are more aware of patents, and balance the costs and benefits of greater engagement or compliance with patent law, in relation to factors such as freedom to operate, litigation and licensing, in favour of compliance. Compliance can take different forms; licensing is compliance, as is forbearance from using a patented invention in the absence of a patent licence. The field of genomic medicine thus appears to be moving from a position of wilful blindness, to greater engagement with patent law, including openness to negotiation and licensing. Law and law-in-practice are more congruent. However, such congruence between the law and the law and practice does not necessarily mean optimum levels of patient access to the fruits of innovation.
As the prevalent means to promote openness, access and affordability in biomedicine are founded on the existing legal structures of intellectual property rights, such solutions will only be fully effective and adopted when these existing legal structures of intellectual property law are engaged with. It is therefore essential that such solutions only be deployed with a nuanced understanding of the operation of the law-in-practice. In her work, the PI explores whether legal and policy solutions can better accommodate a more nuanced approach to compliance, and ultimately patient access to innovation.
These findings have been presented and published throughout the life of the project, as detailed elsewhere. The PI has also undertaken work with a view to impact, as discussed below.
As a future research leaders award, one of the key objectives of the award was to strengthen the PI's role as future research leader. During the course of the award, the PI has undertaken a number of activities which have enhanced her network and reputation. The award has provided valuable time and space for her to undertake a substantial research project and publish the results. It has provided funding for substantial travel to build networks and research collaborations. During the life of the award, the PI has obtained further significant research funding, and been promoted, first to Senior Lecturer (2014) and then to Associate Professor (2019).
Exploitation Route This study represents a significant intellectual contribution to the nascent field of the socio-legal examination of patent law. It develops a methodology for analysis of questions of compliance and engagement with law which can be used and further developed by other scholars in IP law. Moreover, the considerations of how lack of compliance and engagement are relevant to policy questions and public interest in patent law advance the field, and it is anticipated that other scholars will build on this work.
In terms of non-academic use, the findings of this study are relevant to three broad groups: those who are involved in 'using' patented technology; those who are actively involved in developing and delivering patented technology and finally, policy makers.
Those involved in public and private sector genomics laboratories and research institutes may apply the results of this research in relation to decisions about how to deal with patented technology, such in licensing decisions.
Professionals, including lawyers and patent attorneys and technology transfer professionals may use the empirical research to understand behaviours and practices amongst their clients and parties to negotiations. Finally, policy makers, such as the Department of Health, UK Intellectual Property Office and the Organisation for Economic Co-operation and Development may have regard to both the empirical findings and the policy recommendations about the ways in which lack of compliance and engagement with patent law is relevant for policy and legal solutions to concerns about patient access to medicine.
Sectors Financial Services, and Management Consultancy,Healthcare,Government, Democracy and Justice,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description The impact from this project is projected to arise in relation to three user groups: those who are involved in 'using' patented technology; those who are actively involved in developing and delivering patented technology and finally, policy makers. As this award has only recently finished, it is early days for impact. However, some impact is beginning to crystallize. The research has been disseminated to each of these groups, and some impact is anticipated to arise in this respect. Perhaps most relevantly in relation to impact, the work is already influential with respect to policymakers. The research has been discussed with Department of Health and Genomics England policymakers, and verbal confirmation of its relevance has been given. Moreover, in light of my existing body of research, my input into a project with OECD on business models and collaborative platforms has been sought. I have been commissioned to co-author a policy report on this area, which draws on my expertise in relation to intellectual property and governance in genomics. The report is currently in preparation and will be published in 2020. This report draws on the project, and will be influential and impactful. As yet, it is still early days for impact to arise. Policy brief and videos were commissioned and are in production, and it is anticipated that their dissemination to the three user groups identified in the Pathways to Impact document will result in some additional non-academic impacts.
First Year Of Impact 2019
Sector Digital/Communication/Information Technologies (including Software),Healthcare,Government, Democracy and Justice,Pharmaceuticals and Medical Biotechnology
Impact Types Policy & public services

 
Description ESRC IAA Business Boost Fund: Seeking out a new frontier of research at the intersection of space law, intellectual property and space technology
Amount £7,392 (GBP)
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 11/2018 
End 07/2019
 
Description ESRC IAA Social Policy Network: Putting it into Practice - recontacting and personal information management in mainstreaming genetics in the NHS
Amount £2,960 (GBP)
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 11/2017 
End 12/2018
 
Description ESRC Impact Acceleration Award, Co-Creation Award:Collaborative platforms in genomics - institutional arrangements and business models
Amount £10,364 (GBP)
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 01/2020 
End 12/2020
 
Description Mainstreaming Genomics: Re-contacting patients in a dynamic healthcare environment
Amount £630,329 (GBP)
Funding ID ES/L002868/1 
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 05/2014 
End 07/2017
 
Description SLS Small Projects and Events Fund
Amount £2,000 (GBP)
Organisation Society of Legal Scholars 
Sector Learned Society
Country United Kingdom
Start 11/2017 
End 07/2018
 
Description SLS Small Projects and Events Fund - Patent Scholars Network
Amount £1,700 (GBP)
Organisation Society of Legal Scholars 
Sector Learned Society
Country United Kingdom
Start 09/2019 
End 08/2020
 
Description Affordable medicines 
Organisation University of Oxford
Country United Kingdom 
Sector Academic/University 
PI Contribution I am working with researchers at the University of Oxford on the topic of affordable medicines. The team is interdisciplinary, and drawn from the Law School, Oxford Martin School, Medical School and geography, among other areas. As part of this work, I led a session at the recent UK Spine First Annual Conference on Affordable Medicines, exploring with researchers, industry professionals and clinicians about how to ensure access to affordable medicines. The UK Spine is a national network of research and clinical collaborators focused on developing new medicines to support healthy ageing and includes partnerships between academia, industry and the charitable sectors. The UK Spine Conference was held on 16 and 17 April 2019 at the British Library in London, focusing on the development of affordable medicines. Speakers and attendees were professionals active in knowledge exchange, technology transfer and the pharmaceutical industry as well as researchers and clinicians working and interested in the fields of healthy ageing and affordable medicines. The conference covered issues such as knowledge exchange and open innovation, with a view to enhancing patient access to medicine. Dr Hawkins led a session with Dr Michael Morrison, of the Centre for Health Law and Emerging Technologies (HeLEX) at the University of Oxford, exploring ways to enhance open innovation in drug discovery. I am a co-editor of a special issue arising from this conference, which also draws on the research of my ESRC Future Research Leaders funding award. The Special Issue will be published as a Supplement in BMC Journal of Pharmaceutical Policy and Practice and Life Sciences, Society and Policy (a single Supplement, split across two journals, but published under a single issue). The supplement will be published in 2020.
Collaborator Contribution Financial contributions (in running the conference, funding the journal special issue); In kind contributions in hosting meetings; Academic contributions as outlined above.
Impact Conference - FIRST EVENT IN KNOWLEDGE EXCHANGE FOR HEALTHY AGEING AND AFFORDABLE MEDICINES, 16-17 April 2019 Journal special issue - I am a co-editor of a special issue which will be published as a Supplement in BMC Journal of Pharmaceutical Policy and Practice and Life Sciences, Society and Policy (a single Supplement, split across two journals, but published under a single issue). The supplement will be published in 2020. Ongoing meetings and workshops (various) The team is interdisciplinary, and drawn from the Law School, Oxford Martin School, Medical School and geography, among other areas.
Start Year 2019
 
Description Collaborative platforms in Genomics 
Organisation Organisation for Economic Co-operation and Development OECD
Country France 
Sector Public 
PI Contribution I was approached to contribute to this OECD project exploring the role of collaborative platforms in genomics, drawing on my expertise in governance and IP in genomics. I attended a workshop in September 2019 in Sweden, where I acted as Rapporteur. I have also been commissioned to develop a policy document and conduct further research, drawing on and further developing the workshop findings. I am currently preparing this report, which will be published in 2020. The work is subject to a research consultancy agreement, between the OECD and the University of Exeter, which funds my research time.
Collaborator Contribution organising Sweden workshop connections with key collaborators in different countries contributing to the report funding travel etc to workshops
Impact The following outputs have arisen: - Sweden workshop in September 2019 - Draft report circulated December 2019 - Final report (draft March 2020, final version to be completed August 2020) The collaboration is multidisciplinary, and includes research scientists in genomics, lawyers, business and economics specialists and policy makers from national governments and the OECD.
Start Year 2019
 
Description Patent Scholars Network 
Organisation Maynooth University
Country Ireland 
Sector Academic/University 
PI Contribution Working with Dr Aisling McMahon (Maynooth University) and Dr Karen Walsh (Exeter) to set up, develop and maintain a Patent Scholars Network of academic researchers interested in the field of patents in intellectual property law.
Collaborator Contribution Conceptualising and establishing the network, including organising funding.
Impact 2 Workshops in 2019, one in Exeter, one in Maynooth. 2 Workshops in 2020, one in Maynooth, one in Exeter. The collaboration brings together academic scholars from the UK and Republic of Ireland to share and develop academic work and collaboration in the field of patent law. We have also involved practitioners and the UKIPO in our meetings and ongoing network, with a view to more closely integrating academia and patent practice.
Start Year 2018
 
Description Professor Robert Cook-Deegan 
Organisation Arizona State University
Country United States 
Sector Academic/University 
PI Contribution I am collaborating with Professor Robert Cook-Deegan, a professor in the School for the Future of Innovation in Society, and with the Consortium for Science, Policy and Outcomes at Arizona State University. We share interests in intellectual property in genomic medicine, and we have co-authored a publication, published in Prenatal Diagnosis, on patents in NIPT. I also spoke about the European position on patents at a Workshop on Patents and Data Sharing/Access for Molecular Diagnostics in December 2018, following an invitation from Professor Cook-Deegan. Previously, we have collaborated and shared work about gene patents. This included me attending a workshop in 2009 about gene patenting, which fed into Professor Cook-Deegan's report to the US Government Secretary's Advisory Committee on Genetics, Health and Society.
Collaborator Contribution Professor Cook-Deegan has co-authored a paper with me on patents in NIPT, published in Prenatal Diagnosis. He has invited me to speak about the European position on patents at a Workshop on Patents and Data Sharing/Access for Molecular Diagnostics in December 2018.
Impact Paper published in Prenatal Diagnosis Workshop on Patents and Data Sharing/Access for Molecular Diagnostics in December 2018 in Phoenix Arizona
Start Year 2014
 
Description University of Queensland 
Organisation University of Queensland
Country Australia 
Sector Academic/University 
PI Contribution In October 2018 I visited the University of Queensland to build collaboration between the TC Beirne School of Law and the University of Exeter, particularly in relation to the Science, Culture and the Law research group, which I lead, supported by University of Exeter institutional funding. I have had ongoing informal research links to UQ through Professor Brad Sherman for a number of years.
Collaborator Contribution The TC Beirne School of Law hosted my 1 week research visit. They provided me with an office, and hosted a number of meetings and introduced me to relevant researchers at UQ in other departments.
Impact The collaboration has resulted in continuing links between the Science, Culture and the Law research group (SCuLE) and researchers at the TC Beirne School of Law at UQ. A member of SCuLE has subsequently undertaken an extended research visit of 6 months to UQ. The University of Exeter and the University of Queensland have an institutional partnership, and the opportunities within the scope of this partnership agreement to pursue social sciences research are being explored. Our discussions are ongoing.
Start Year 2018
 
Description University of Tasmania Law School 
Organisation University of Tasmania
Country Australia 
Sector Academic/University 
PI Contribution I am collaborating with Professor Dianne Nicol and Dr Jane Neilsen at the University of Tasmania Law School on research into law and non-invasive prenatal testing. I have given a guest lecture to staff and students at the University of Tasmania. I am also involved in the preparation of two publications with Professor Nicol and one publication with Dr Neilsen.
Collaborator Contribution Invitation to give guest lecture at University of Tasmania in September 2016. Preparation of 2 collaborative papers.
Impact Invited Guest Lecture by Naomi Hawkins at University of Tasmania Law School, September 2016. Paper published in Prenatal Diagnosis
Start Year 2016
 
Description End of project workshop 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact In November 2019, I ran a workshop entitled "Patents and Emerging Technologies" in London.

Patent law has always been inextricably linked to emerging technologies - to get a patent, you have to demonstrate that your invention is novel. But recent developments, particularly in modern biotechnology, and now in areas such as artificial intelligence, are raising increasingly challenging questions for the patent system. Some of these difficulties relate to the operation of patent law in relation to these new areas of technology, and raise questions as to how the traditionally conceived of patentability criteria can fit with these new types of technologies. Other concerns relate to the operation of the patented invention in society: about the invention itself, or about the way in which the patent is exploited.

In this workshop, we explored the nature of these problems, as well as some of the solutions offered within patent law. We will also explore the issues against the broader social and political context, and consider the ways in which areas not necessarily seen as core to patent law might offer important insights or potential solutions.

Although most participants at the workshop were academics, reflecting the academic nature of the questions explored, representatives of the UK Intellectual Property Office Policy Unit were also in attendance.
Year(s) Of Engagement Activity 2019
URL http://sculecentre.ex.ac.uk/patents-and-emerging-technologies-workshop/
 
Description Presentation at Research, Innovation, Learning and Development, Royal Devon & Exeter Hospital and University of Exeter, November 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact I gave a presentation entitled "Intellectual Property and NIPT: Controversies and Concerns" at the Research, Innovation, Learning and Development Department, Royal Devon & Exeter Hospital and University of Exeter in November 2016. The particular seminar series at which I presented is a seminar which combines university researchers and clinicians in the biosciences. The main audience for this presentation was clinical laboratory staff as well as academic researchers working in human genetics research, and clinicians.
The presentation focused on the key intellectual property issues relevant to those working in these fields. It sought to disseminate important findings of the project, and to make them relevant and accessible to the audience at the meeting. There was a lot of interesting discussion, and those present said that they thought that I had presented the issues clearly and that they had a much better understanding of the issues and the implications for their work than they had previously.
Year(s) Of Engagement Activity 2016
 
Description Presentation at the Medical School, University of Pavia, Italy, April 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact I gave an invited lecture entitled "Are gene patents an obstacle to health care?" to the Medical School at the University of Pavia, Italy in April 2014. The purpose of the lecture was to engage medical students to think about the ethical, legal and social implications of key developments in biotechnology.
Year(s) Of Engagement Activity 2014
URL http://www.collegiovolta.org/articles/gene-patents-seminar
 
Description Royal Devon and Exeter Hospital Department of Obstetrics and Gynaecology visit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact I gave a presentation entitled "Non-invasive prenatal testing - Legal issues" at the Royal Devon and Exeter Hospital Department of Obstetrics and Gynaecology. The audience included mostly clinicians, but also representatives from industry, genetics laboratory staff, and students. I presented aspects of my research to inform and engage clinicians about the legal issues relevant to their clinical practice. The audience were unaware of some of the legal issues raised, and expressed interest in the issues raised. I was able to learn about aspects of clinical practice relevant to my project from the audience.
Year(s) Of Engagement Activity 2015
 
Description Talk at Clinical Genetics Department, Royal Devon & Exeter Hospital, October 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact I gave a presentation to the Clinical Genetics Department of the Royal Devon and Exeter Hospital entitled "A duty to warn relatives? The implications of ABC v St George's for clinical genetics" in October 2017. There was a great deal of interesting discussion during and following the presentation. The clinicans reported that they learnt more about the impact of law on their practice, and that they would evaluate and consider their practice in light of the legal and ethical duties discussed at the meeting.
Year(s) Of Engagement Activity 2017