Viewing archives for Intellectual Property, Ethics and the Market in the Era of Personalised Medicine

Collaborating with Genetic Counsellors in Primary Care

Talk entitled ‘Collaborating with Genetic Counsellors in Primary Care’ from Heather Skirton, Professor of Applied Health Genetics at Plymouth University. Recorded at our Integrating Genetics into Clinical Practice Conference, 17th April 2015.

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Personalised medicine and data sharing

Isabelle Huys is a pharmacist and doctor in pharmaceutical sciences with further specialization in IPR and regulatory sciences. She is a professor at the Faculty of Pharmaceutical Sciences and member of the Center for IT & Intellectual Property IT law of KU Leuven. She worked for several years as Advisor for European Projects, IP Officer and later as Regional Development officer at the KU Leuven Research & Development department and she performed post-doctoral research at the Law Faculty of KU Leuven in the domain of patents and genetic inventions. Enormous amounts of samples with associated data of patients are being collected within the scope of clinical research projects every day. To improve our understanding of underlying mechanisms of diseases and to develop transformative therapeutics, it is crucial that samples with associated data collected within clinical trials can be accessed and re-analyzed. This is especially true for personalized medicine strategies, where obtaining information about molecular biomarkers with corresponding clinical outcomes from both failed and successful drugs would offer the opportunity to gain understanding of an individual’s response to treatment. To safeguard personal information and respect people’s privacy, the collection, use and sharing of personal data and samples is subject to legal protection. Several legal questions remain, such as how can researchers access the existing data and sample collections today, and on which legal basis can existing data and samples collections be reused. This presentation will discuss major legal challenges in the context of data sharing and personalized medicine.

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Doing business with data

Liam Curren is Head of Data, Compliance & Legal at Genomics plc., which specialises in providing market-leading insights into human health based on sophisticated analyses of genetic and associated health data. He is a solicitor with private practice experience at leading IP law firms. He also worked for a number of years at the University of Oxford: firstly as an academic researching data, law, and privacy; and later negotiating research collaboration deals with industry. The extent and nature of data relating to individuals’ health continues to grow at a tremendous pace. How can companies make money out of this data? How should companies make money of this data? This talk will discuss various approaches to commercialising data, and the often contrasting attitudes that accompany them.

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Publicly funded biobanks and Intellectual Property Rights: Questions of access and public benefits

Aisling McMahon joined Newcastle Law School as a lecturer in law in February 2014. Her principal research areas are medical law and IP law, with a particular interest in patents and biotechnology. Aisling has recently been awarded a British Academy/Leverhumle grant to examine the legal frameworks and approaches to gene patentability in the US, Canada and Europe. She was a visiting researcher at the Hastings Center and at Yale in May 2017 and she has also recently been a Visiting Researcher at the Ethox Centre, Oxford. Human biobanks provide organized collections of human biological material, generally stored alongside health information which are increasingly seen as vital tools for the furtherance of biomedical research, including aiding better understanding of human health and disease. This paper focuses on large-scale publicly funded biobanks. It examines the intellectual property rights (IPRs) that may arise in relation to downstream research generated using biological samples from such large-scale publicly-funded biobanks. It investigates how IPRs on downstream research sit within the biobanking context and the altruistic donation models and solidarity frameworks that have come to underlie recruitment of individual participants to donate samples to such biobanks. Individuals are often encouraged to donate biological samples and data in the spirt of solidarity whereby recruitment models stress the need for participation in the interest of public health and medical research. However, access to downstream benefits generated from research using such samples may be subject to IPRs. This has the potential to act as a double-edged sword. On the one hand IPRs are viewed as essential to incentivizing innovation in the health sphere. However, if asserted in an overly restrictive manner IPRs also have the potential to limit/hinder access for individuals and researchers to downstream inventions. The paper argues that it is imperative to deliver appropriate and reasonable access for the public to benefits arising downstream from research on samples in publicly-funded biobanks. It will examine mechanisms that may support this, and calls for further discussion around the operation of IPRs in the biobank context to maximize access, while maintaining sufficient incentives for health research.

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The phantom menace of gene patents arises?

John Liddicoat is the Philomathia Research Associate in Law at the University of Cambridge. He is currently working on a research project analysing intellectual property issues that interface with the realisation of genomic medicine. His research is funded by the Wellcome Trust, Cambridge University and the Philomathia Foundation. John adopts a variety of research methodologies including doctrinal legal research and established empirical methods, as well as developing new, science-inspired quantitative methods. The patentability of DNA-related discoveries has been socially, legally and ethically controversial for many years. The debates have recently re-ignited following some high-profile events on both sides of the Atlantic. In Association for Molecular Pathology v. Myriad Genetics, the US Supreme Court held that isolated gDNA is not patent eligible subject matter. In addition, the US Federal Circuit Court recently held invalid a patent for non-invasive prenatal testing (NIPT), directed to ‘a method for detecting inherited nucleic acid’, because it claimed a natural phenomenon. By contrast, a patent with claims to isolated forms of the FLT3 gene has been successfully enforced in Germany. Furthermore, the European version of the NIPT patent found invalid in the US is currently the subject of license fees and enforcement in the UK. In the 2000s, a number of studies examined whether patents were adversely affecting the provision of molecular genetic diagnostic tests in Europe. Broadly speaking, these studies found little enforcement activity and limited evidence that laboratories were paying licences or being prevented from supplying tests. As a result, the authors of one survey-based study concluded that the phantom menace of gene patents had not arisen — “yet”. In light of the events above, however, this situation may have changed. In early spring this year we deployed a survey that is designed to update and extend these studies. The results from the survey will be presented for the first time during this talk.

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Commercialising university technologies for clinical benefit

Richard Reschen is a Senior Technology Transfer Manager in the Licencing & Ventures group of Oxford University Innovation (OUI), one of the world’s leading technology transfer organisations, responsible for commercialising novel technologies arising from the world-class research at Oxford University. He is a key member of the Pharma/Biotech team and specialises in commercialising technologies in this sector. Richard has a PhD in Genetics from the University of Cambridge. British universities are highly regarded for their world-leading biological and medical research output. Exploiting this university innovation is of critical importance in producing the ground-breaking technologies that will revolutionise future clinical practice. This talk will highlight the process, importance and impact of technology transfer from universities and showcase a range of real-world examples (covering both patented and copyrighted technologies) that may lead to benefits in clinical practice.

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Patents and non-invasive prenatal testing: Is there cause for concern?

Naomi Hawkins is a Senior Lecturer in Law at the University of Exeter, as well as a Research Fellow of the Oxford Intellectual Property Research Centre and a Research Associate at the Centre for Health Law and Emerging Technologies at Oxford. Her research focuses on the interaction of law and biomedical science, particularly around IPR. She uses traditional legal research and empirical methods to investigate the impact of patents on the development of translational outcomes of genetics and genomics research. Non-invasive prenatal testing (NIPT) is an exciting new technology enabling safe and accurate testing of the fetus from maternal blood samples, without risk of harm to the fetus. NIPT is one of the first applications of genomic medicine to reach widespread clinical application, and its development and widespread adoption in the clinic around the world has been very rapid. Alongside enthusiasm about the potential of this technology to improve prenatal care, there is also considerable concern about the legal and ethical implications. This paper will report the results of empirical work considering the role of patents in the development and delivery of NIPT. It will examine the results of a qualitative interview study of stakeholders in the translational research process for NIPT in Europe and the USA, exploring their approach to patents. It will then consider the differences in the role of patents between the fields of single gene testing as opposed to NIPT, and analyse the reasons for those differences. The research explores the behaviour of individuals and motivations for compliance with law, in cultural and institutional context. Single gene testing and NIPT are two of the earliest innovations in genomic medicine to be implemented into clinical practice, and are the precursors of many new technologies which are predicted to transform medical practice in the near future. The role that patents play in these two fields therefore constitutes an excellent case study to predict the impact of patents in practice in the burgeoning field of genomic medicine.

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Patenting diagnostics and the future of personalised medicine: Private property and the romance of the public domain

Katerina Sideri teaches IP law and strategy at the University of Crete and the University of Cyprus. In the past she was associate research fellow at the Centre for Sociolegal Studies at the University of Oxford and lecturer in IP law at the University of Exeter. She earned her PhD at LSE. Her research interests are in the areas of Intellectual Property Law and Knowledge Commons, Biomedical Patents and Public Policy, Deliberative Governance and Bioethics. She has published widely in these and related areas including Bioproperty Biomedicine and Deliberative Governance. After a series of decisions by the US supreme court it seems that most diagnostics lie outside the boundaries of patent-eligible subject matter, as the court said that such patents claim (and attempt to monopolise) laws of nature. Eligible subject matter is a fascinating subject denoting the appropriate bounds of intellectual property protection for scientific insights and innovations. It is about what can be turned into private property and what is non-property, or, if we go back to Roman law, it is about what cannot be privately owned and what is common property and property open to all by operation of the law. The talk will concentrate on the US to discuss is the logic of eligible subject matter. I will argue that whether a scientific product is patentable is a matter of patent law’s internal ‘legal’ logic , whose basis can be found in the theories justifying property and which of course encompasses sociological, economic, and philosophical elements, hence its contextuality. Yet, extending legal rights to one type of scientific research product that we withhold from another affects how societies innovate. Moreover, placing a resource to the public domain by force of law does not automatically guarantee that it will be equally exploited by all ( the romance of the commons), as knowledge, power, and ability render some better able than others to exploit a commons. The talk will examine these propositions to discuss the future of innovation in perosnalised medicine.

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A charitable funder’s perspective on personalised medicine and the appropriate exploitation of IP

Chris Moran is a senior legal counsel at the Wellcome Trust, specialising in intellectual property. He began his career in private practice, at Bristows solicitors, primarily working on patent litigation matters. He then moved in-house and worked for 7 years at BP. At the Wellcome Trust, an independent charitable foundation existing to improve human health, he handles IP matters across the Trust. He is currently working on a refresh of Wellcome’s IP policy and a range of policy and funding initiatives to help researchers translate their research outputs into new products. Wellcome is a global charitable foundation, both politically and financially independent. We believe that good health makes life better and we want to improve health for everyone by helping great ideas to thrive. Our funding supports over 14,000 people in more than 70 countries. In the next five years, we aim to spend up to £5 billion helping thousands of curious, passionate people all over the world explore ideas in science, population health, medical innovation, the humanities and social sciences and public engagement. Whilst much of our funded research is of a pre-commercial, fundamental nature, we also provide significant funding to support IP creation and its translation into products delivering health benefits. Under our new Innovation for Impact strategy we will provide up to £500 million over the next five years to help researchers and organisations from around the world to turn great ideas, discoveries and inventions into treatments, products and cures for disease. As a charitable organisation we have an obligation to ensure that the results from our funded research, including IP, are used for public benefit. This talk will consider how such public benefit can be delivered by personalised medicine and how IP (together with an appropriate commercialisation strategy) can serve as a tool to help achieve this goal.

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Expanding the scope of patentability for personalised medicine

Filmed on 12th June 2017 at St Anne’s College, Oxford. Graham Dutfield is Professor of International Governance at the School of Law, University of Leeds. He is founder Director of both the LLM in Intellectual Property Law, and of the School’s interdisciplinary Research Group on Emerging Technologies in Law and Society. He has published widely on various subjects including intellectual property and health, food, agriculture, development, and traditional knowledge. He has advised numerous governments and international organisations on their intellectual property laws and regulations.

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