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LML research group forthcoming in Nature Biotechnology

last modified Oct 07, 2018 01:46 PM

Nature Biotechnology has accepted a third article from an LML research group for publication. The forthcoming feature article announces empirical results about the effects of the US Supreme Court's decision in Association for Molecular Pathology v Myriad Genetics on patent practice beyond isolated DNA claims. 

The article, co-authored by Professor Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Dr John Liddicoat and Mr Matt Jordan, is the third publication accepted by Nature Biotechnology in three years. It follows their 2016 paper 'Myriad's impact on gene patents', a post-Myriad empirical patent landscape analysis, and their 2017 paper 'After Myriad, what makes a gene patent claim ‘markedly different’ from nature?', which identified the types of claim amendments which successfully transformed isolated gene claims from ineligible subject matter into patent eligible inventions following Myriad.

Empirical patent studies have become a core focus of LML research, and will feature significantly in LML's contribution to the CeBIL research programme. The announcement of this publication also coincides with the conclusion of the three-year Philomathia Social Sciences Research Programme project 'Realising Genomic Medicine: Intellectual Property Issues beyond the 'Old' DNA Patent Debates. 

 

LML hosts CeBIL Annual Symposium 2018: Precision Medicine, Artificial Intelligence and the Law

last modified Oct 05, 2018 11:17 AM

 

On Friday 7th September, LML hosted the CeBIL Annual Symposium 2018: 'Precision Medicine, Artificial Intelligence and the Law'. This was the first of five annual symposia to be held in Cambridge as part of LML's involvement in the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law, directed by Prof. Timo Minssen at the University of Copenhagen's Center for Advanced Studies in Biomedical Innovation Law.

Each year, the symposium addresses one of CeBIL's five core research projects. In 2018, the Symposium focussed on 'Precision Medicine, Artificial Intelligence and the Law', reflecting the PMAIL project led by Professor I. Glenn Cohen at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, together with Professor Nicholson Price (University of Michigan) and Professor Timo Minssen (University of Copenhagen).

The Symposium tackled some of the challenging legal and regulatory issues raised by black-box precision medicine. 

Professor Cohen opened the first session with a discussion of big data and predictive analytics. He was then joined by Sara Gerke (Research Fellow for the PMAIL project), who gave an outline of plans for future PMAIL research. This was followed by a panel discussion between Professor Chris Lowe, Dr Stuart Hogarth and Dr Richard Dybowski. Professor Chris Lowe encouraged more discussion of key definitions (such as 'black-box', and 'precision') and critical reflection on the extent to which problems are 'new' or rather echoes of familiar, long-running tensions in the practice of medicine. Dr Stuart Hogarth drew attention to the political economy of the emerging precision medicine field, and Dr Richard Dybowski urged legal, ethical and social research to monitor the way that machine learning is being put together at 'the coalface'. Dialogue has led to principles of good practice and good algorithmic 

The second session of the Symposium focused on intellectual property and the black box. Dr Kathy Liddell (Director of LML) commenced the session with a brief outline of three key US Supreme Court cases in this area: MyriadMayo and Alice, which featured heavily in the following presentations.

In particular, this session was an opportunity for LML members Professor Mateo Aboy and Dr John Liddicoat to present the results of some of LML's recent empirical research. Prof. Aboy focussed on the impact of important cases on the grant of patents, and several LML studies that have been recently published or reviewed. For instance he spoke about the magnitude of Myriad's impact on gene-related patents, isolated DNA patents and nature-based products beyond DNA. He also spoke about the magnitude of Mayo's impact on the grant of biotechnological patents, and the implications of that case for patent prosecution timelines. He also introduced current research that the LML group are doing in relation to the magnitude of Alice's impact on biotechnological inventions.

Dr Liddicoat presented recent results from interviews designed to investigate the ways in which Myriad and Mayo have affected the development of diagnostic tests in the US and in Europe. Professor Jacob Sherkow (New York Law School) rounded off the IP session by discussing concerns about surrogate licensing in the US. In the ensuing discussion is was reassuring to learn that 'Oxbridge' tech transfer licensing policies are globally-respected.

The Symposium's third session looked at regulation governing 'the black box' as a medical device. The presentations offered perspectives from academia and public authorities, including the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA). Dr Alberto Gutierrez (former Director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety), Professor Nicholson Price (Michigan Law School) and Stephen Lee (MHRA) offered different models and ideas for regulating black box medicine. Questions of liability in this area are of significant interest to LML, as Dr Jeff Skopek (Deputy Director of LML) was recently awarded a grant by the Wellcome Trust to study liability for uses of AI in the healthcare context.

The final session of the day, facilitated by Dr Tom Ling (RAND Europe), was highly interactive. Dr Ling encouraged audience members to voice what they had found most interesting and illuminating, and to debate ideas and issues drawing on their own backgrounds and perspectives. There was also a panel discussion about the future challenges of black box precision medicine, involving Professor Timo Minssen, Alison Dennis (Fieldfisher), Manuel Corpas (Cambridge Precision Medicine), Dr Victoria Chico (University of Sheffield, and Dr Jonathan Darrow (Harvard Medical School). 

The Symposium was very well-attended, with large numbers attending from the Cambridge biomedical environs as well as international representatives from Australia, Ireland, Belgium, the US, Canada. The audience was wonderfully lively and engaged, and the Symposium exceeded our expectations. 

The second Annual CeBIL Symposium is likely to take place in September 2019.

 

Liddell and Minssen

Workshop on "Regulating algorithms in healthcare: intellectual property and liability" jointly organised by LML, CeBIL and the PHG Foundation

last modified Sep 13, 2018 04:10 PM

On Thursday 6th September, LML co-hosted a workshop titled 'Regulating Algorithms in Healthcare: Intellectual Property and Liability' with the PHG Foundation and the Center for Advanced Studies in Biomedical Innovation Law. The workshop brought together a multidisciplinary group of academics, researchers, policy makers and regulators, to evaluate intellectual property and liability issues arising from use of algorithms and software in healthcare. This is an area of significant interest to LML, as Dr Jeff Skopek (LML Deputy Director) was recently awarded a grant to study liability for uses for AI in healthcare by the Wellcome Trust. LML was represented by Kathy Liddell, Jeff Skopek, John Liddicoat, Mateo Aboy, Cristina Crespo and Matt Jordan.

The first half of the workshop was dedicated to discussion of intellectual property protection for algorithms in healthcare. Prof. Mateo Aboy (Senior Research Scholar with LML) gave a presentation on the patentability of algorithms in the healthcare space and new empirical evidence about the impact of US cases such as Myriad, Mayo and Alice. Dr Enrico Bonadio discussed the relationship between free and open source software (FOSS) and IP. 

Dr Kathy Liddell (Director of LML) facilitated the IP panel, framing discussion in terms of identifying and refining what might be considered to be IP policy problems, assessing the size of any problems, and considering what the responses might be. Prof. Aboy and Dr Bonadio were joined by Prof. Timo Minssen (CeBIL), Iain Mitchell QC, and Andrew Katz (Moorcrofts). Several cross-cutting questions and themes emerged during the morning's session. For example, to what extent are IP policies in this landscape pitted against each other and to what extent are they complementary and capable of being integrated? Are the patent law issues primarily legal uncertainty, or are there problems with legal principles as well?  Supposing it was possible, would it actually be desirable  to increase the use of FOSS in this space as an alternative to IP protection? What are some of the complexities of 'free' and 'open' innovation systems?

The second half of the workshop concerned possible models of liability for algorithms where harm occurs as a result of their outputs. Dr Jeff Skopek introduced Professor Glenn Cohen (Harvard Law School) and Professor Nicholson Price (Michigan Law School). Prof. Cohen gave an account of the increasing role of AI and predictive analytics in healthcare, before focusing on tort law as lens through which one might debate the optimal scheme of liability, and how liability might be apportioned to the relevant actors. Prof. Price presented on medical malpractice and black box medicine, posing the question of how schemes of negligence might set the incentives for bringing algorithms into practice.

Joining the liability session speakers for a panel discussion (facilitated by Alison Hall, Head of Humanities at the PHG Foundation) were Dr Alberto Gutierrez (former Director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety), Dr Danielle Belgrave (Microsoft) and John Buyers (Osborne Clarke). They addressed  questions  of liability from the viewpoint of regulators, researchers, and lawyers respectively.

This event was the second in a series of two workshops held by the PHG Foundation on the topic of regulating algorithms in healthcare. The first focussed on the GDPR and IVDR in practice.  The PHG Foundation plans to publish reports on both events.

Dr Skopek awarded Wellcome Trust grant to study liability for uses of AI in healthcare

last modified Sep 04, 2018 12:19 PM

How will legal liability be assigned when an AI system causes harm?  Does the law need reform?  

Dr. Skopek has been awarded a Wellcome Trust grant to explore these questions in the healthcare context.  His project will focus in particular on the liability landscape for harms caused by the use of machine learning algorithms in clinical care.  

Three different types of liability frameworks might apply to these harms—negligence, product liability, and sui generis legislation—each of which raises legal and normative questions that have received insufficient attention.  

The grant will fund a post-doctoral fellow to explore these questions under his supervision.   The job advertisement will soon be posted here.

Job Opportunity: Senior Research Associate

last modified Aug 21, 2018 11:38 AM

Applications are invited for a Senior Research Associate to work with the Centre for Law, Medicine and Life Sciences (LML) at the Faculty of Law. This is a fixed term three-year position with a preferred commencement date between 1 December 2018 and 1 February 2019. The post holder will be employed by the Faculty of Law, University of Cambridge, to contribute to the Collaborative Research Program in Biomedical Innovation Law (the CeBIL Collaborative Project). The CeBIL collaborative research program is supported by a grant from the Novo Nordisk Foundation.

The post holder will work alongside the Director of LML to contribute to CeBIL's fourth study on new medical uses. Accordingly, the post holder will be expected to focus on the legal (and to some extent the ethical and social) issues surrounding the re-purposing of pharmaceuticals, particularly issues arising in patent and regulatory law.

The post holder must have completed a PhD in law (or equivalent) before starting the position (the latest commencement date is 1 February 2019), and at least three years' experience as a postdoctoral Research Associate, or equivalent. The post holder must also have a track record such that they have acquired independent standing as an internationally-known researcher and be capable of full operational responsibility for a major project if required. Broad knowledge of intellectual property law (including patents, copyright, trade marks, database rights, trade secrets) and evidence of a resourceful, quick and entrepreneurial attitude will be important in evaluating the suitability of an applicant. Highly competent knowledge of biomedical patent law is required, and knowledge of the regulatory frameworks governing market authorisations for drugs and diagnostics is also desirable. Experience in socio-legal research (such as interviews, surveys and patent landscaping), and a degree in natural or medical sciences would be advantageous.

Short listed candidates will be invited to attend interviews in Cambridge in September or October 2018. Interviews will be in person or via teleconference.

Fixed-term: The funds for this post are available for 3 years in the first instance.

Further particulars and details of the application procedure are available at http://www.jobs.cam.ac.uk/job/18583/. Online application is available via that site.

If you have any questions about this vacancy or the application process, please contact Dr Kathy Liddell by email k.liddell@law.cam.ac.uk.

Please quote reference JK16540 on your application and in any correspondence about this vacancy.

Quote Reference: JK16540
Salary: £39,992-£50,618
Closing Date: 20 September 2018

The University values diversity and is committed to equality of opportunity.

The University has a responsibility to ensure that all employees are eligible to live and work in the UK.

Nuffield Council on Bioethics publishes Dr Yotova's Report on the Regulation of Genome Editing under International Law

last modified Aug 21, 2018 11:41 AM

The Nuffield Council on Bioethics has published Dr Rumiana Yotova's report on 'The Regulation of Genome Editing and Human Reproduction under International Law, EU Law and Comparative Law'.

Dr Yotova was commissioned to write the 25,000 word report by the Nuffield Council's Working Party on Genome Editing and Human Reproduction to help inform their evidence-gathering and deliberations. The aim of the report was to identify and analyse the relevant legal frameworks governing the research and possible clinical applications of human genome editing on the levels of public international law, EU law, and a comparison between selected domestic jurisdictions. It focused in particular on the legality of genome editing and on the requirements and restrictions imposed by international legal frameworks on the use of the technology.

Dr Yotova's contribution was one of two background papers to the Nuffield Council’s report on 'Genome Editing and Human Reproduction: Social and Ethical Issues' and serves as the basis for Chapter 4, section 2 on International Law and Governance.

In addition to discussing her findings at a research interview conducted by the Nuffield Council, Dr Yotova was also invited to present her report at the stakeholder conference on 'Genome Editing and Human Reproduction: Social and Ethical Issues' organised by the Nuffield Council in London on 23 July 2018.

Dr Palmer discusses developments concerning the legal status of abortion in Ireland and Northern Ireland

last modified Sep 13, 2018 03:41 PM

Dr Stephanie Palmer has written a blog post for the International Association of Constitutional Law (IACL/AIDC) on the repeal of the Eighth Amendment in Ireland, and the recent human rights challenge brought by the Northern Ireland Human Rights Commission against current criminal law provisions on abortion.

Looking first at the Republic of Ireland, Dr Palmer outlines a range of policy influences contributing to the repeal of the Eighth Amendment. Moving on to Northern Ireland, Dr Palmer describes the decision of the UK Supreme Court in In Re Northern Ireland Human Rights Commission’s Application for Judicial Review [2018] UKSC 27 as a pyrrhic victory. While the Northern Ireland Human Rights Commission were thought not to have standing in this case, the judgment indicates that if a 'victim' with standing were to challenge the existing legislation which criminalises abortion, they would obtain a declaration of incompatibility between the national legislation and the ECHR.

Dr Palmer's post can be found here.

The Development of Abortion Rights in a Changing Europe

last modified Jul 16, 2018 02:28 PM

Tickets are now available for the upcoming conference "The Development of Abortion Rights in a Changing Europe", to be held in at the Faculty of Law on September 28 2018. 

The conference, organised by a team headed by Cambridge Law student Helen Jennings, will explore what human rights law has to say on the issue of abortion in 2018, with consideration given to issues including the upcoming referendum on Ireland's 8th Amendment, and the impact of Brexit on abortion law across the UK and Ireland. Discussion will not be limited to the legal framework in Ireland and Northern Ireland, although the issue is currently at the cutting-edge of legal debate there.

The provision of abortion services for women, including the extent to which one can consider abortion a "right", is one of the foremost human rights issues facing citizens of the United Kingdom and Ireland today. To this end, the conference will be entirely focused on the legal frameworks in place, their interaction with human rights law, and the potential of recent legal and political developments and litigation to change the law.

Confirmed speakers include:

  • Lord Kerr
  • Professor Dalia Lienarte
  • Dr Stephanie Palmer
  • Máiréad Enright
  • Benedict Ó Floinn BL
  • Dr Ruth Fletcher
  • Venetia Taylor BL

Tickets and further information are available here.

Dr Kathy Liddell teaches new course on Health Law and Emerging Technologies at Melbourne Law School

last modified Apr 27, 2018 01:58 PM

           University of Melbourne Banner

 

Dr Kathy Liddell (LML Director) has recently returned from teaching a new Health Law and Emerging Technologies subject at the University of Melbourne; strengthening the already substantial links between the University of Cambridge's Faculty of Law, and Melbourne Law School.

The subject examined ways in which law is affecting, and being affected by, the latest advances in medical technology. It covered a variety of fascinating technologies including genetic, big data analytics, regenerative, therapeutic, and reproductive technologies. It challenges students to think not only about the future of medicine, but the future of human life itself. Are legal systems dealing with these issues in adequate, legitimate, and strategic ways? 

Classes were highly discursive, and utilised literature and case studies to cover controversial topics such as precision medicine, gene editing, the role of intellectual property law in facilitating medical innovation, the shifting boundaries of human reproduction, and replacement and regenerative technologies  for human organs and tissue.

The course was attended by lawyers of various seniority and senior medical professionals, which made for stimulating interdisciplinary discussions and debates. 

The subject can be taken by JD students, Masters of Law students, Specialist Health Law Masters students (who have two years professional practice in a relevant degree) and as a single subject by students studying at Melbourne University. Contact at Melbourne Law School for more information. 

Health Lae Class Melbourne

LML members to speak at symposia at the University of Hong Kong

last modified Mar 28, 2018 05:27 PM

On Wednesday 11th April 2018, Dr Jeffrey Skopek (LML Deputy Director) and Dr David Erdos will present at a one-day symposium hosted by the University of Hong Kong's Centre for Medical Ethics and Law.

The day will be split into two half-day symposia:

Part I, Policy and Regulatory Responses to New Genomic and Reproductive Technologies seeks to explore the likely shape of public policy and regulatory responses to the challenges posed by new genomic and reproductive technologies in clinical practice and biomedical research.  Here, Dr Skopek will speak on the topic of "The Ethics of Enhancement".

Part II, Privacy, Data Protection and Data-Sharing in Biomedical Research will examine the impact of new technologies on current regulatory paradigms for the protection individual privacy, data protection and data-sharing in the context of biomedical research.  Here, Dr Skopek will speak on "What is Privacy? (What is Data Protection?)". Dr Erdos will speak on "Going Global? The General Data Protection Regulation and Transborder Data Flow in an Interconnected World".

LML Members attend PHG Foundation Workshop on Regulating Algorithms in Healthcare

last modified Apr 24, 2018 03:56 PM

As the fundamental basis of all computerised tasks, algorithms are increasingly integral to healthcare. They perform functions at every level, from the research laboratory to the clinic; in rudimentary operating system processes to highly advanced analytical systems. Despite their prevalence, the precise definition of an algorithm is increasingly contentious, and this lack of clarity has ramifications for how algorithms in healthcare are developed and regulated.

Determining the ownership of an algorithm, who is liable if it fails, how patient data is handled and the patient’s right to explanation when looking at black box techniques are all major concerns, with unclear answers.

Working to address these issues, the PHG Foundation - a close collaborator with LML - hosted the first of two stakeholder workshops on Tuesday 20th March. 'Regulating algorithms in healthcare - the GDPR and IVDR in practice' was attended by Dr Kathy Liddell (LML Director), Dr Jeff Skopek (LML Deputy Director), Prof. Mateo Aboy, Dr Cristina Crespo, and Dr David Erdos. During this workshop, academics and regulators convened to consider such key issues as:

  • Does the GDPR contain a right to explanation?
  • Might counterfactual explanation satisfy a right to explanation?
  • How does the IVDR (and MDR) intended purpose test for the definition of IVD compare with the FDA’s risk-based strategy?
  • Is the intended purpose text flexible enough to adequately regulate mHealth and other algorithms that might be used for human health?
  • Consider the difficulties of validation of software under the MDR/IVDR.
  • Consider the difficulties of surveillance of software under the MDR/IVDR.

The PHG Foundation will publish a briefing note on 'what is an algorithm' in April 2018, and the next stakeholder workshop ('Regulating algorithms in healthcare - Liability and intellectual property') is scheduled for September 2018.

The Development of Abortion Rights in a Changing Europe

last modified Mar 28, 2018 10:10 PM

LML is delighted to announce our collaboration on an upcoming conference on "The Development of Abortion Rights in a Changing Europe", to be held in Cambridge in September 2018. 

The conference, organised by a team headed by second year Law student Helen Jennings, will explore what human rights law has to say on the issue of abortion in 2018, with consideration given to issues including the upcoming referendum on Ireland's 8th Amendment, and the impact of Brexit on abortion law across the UK and Ireland. Discussion will not be limited to the legal framework in Ireland and Northern Ireland, although the issue is currently at the cutting-edge of legal debate there.

The provision of abortion services for women, including the extent to which one can consider abortion a "right", is one of the foremost human rights issues facing citizens of the United Kingdom and Ireland today. To this end, the conference will be entirely focused on the legal frameworks in place, their interaction with human rights law, and the potential of recent legal and political developments and litigation to change the law.

The conference team has launched a crowdfunding page which can be found here, and are welcoming donations from any interested parties.

Professor Glenn Cohen Delivers 2018 Baron de Lancey Lecture

last modified Mar 15, 2018 12:26 PM

Glenn Cohen BdL cropped

 

On Friday March 9th, the Centre for Law, Medicine and Life Sciences hosted the 2018 Baron de Lancey Lecture, organised in collaboration with Cambridge Family Law, and kindly sponsored by the Ver Heyden de Lancey Fund. This year, Professor Glenn Cohen delivered his thought-provoking talk 'Parenthood Disrupted(?) Dilemmas of Reproductive Technologies'.

Professor Cohen began by explaining - from a technological perspective - the progress of human reproduction and what the future may hold. He covered topics including in vitro fertilisation, uterine transplantation, mitochondrial replacement therapy, and in vitro gametogenesis. 

He then discussed how reproductive technology has 'unbundled' the rights associated with gestational, genetic and legal parentage.

Whereas in the past one's genetic, gestational and legal mother was one and the same woman, and one's genetic and legal father would often be the same man, this is often not the case with modern and emerging reproductive technologies. Already there are technologies which result in a child having a handful of 'parents'.  And in the future, one's genetic 'mother' and even one's gestational 'mother' could be a man. 

In the third and final part of his lecture, Professor Cohen discussed whether and how legal and political theory can help resolve the controversies which arise from the 'unbundling' of parentage. He also discussed different regulatory approaches by which the State could facilitate or limit modern reproductive technologies. He also noted a variety of ways in which the State's regulatory decision could be made. He showed how the judgement of which approach is 'preferable', links to one's preferred view of the State and its place in supporting, or controlling, reproductive freedoms. And also to ones view about the importance of reproductive choices for equality, and human well-being.  

Professor Cohen commended several aspects of the UK regulatory system and the way that the State in this country has made a serious effort to consult the public as well as a wide variety of experts. On the other hand, he challenged the UK legal system for requiring decision-makers to consider the welfare of the future child as if this was the most central consideration. His point was that: provided the future child is better off alive than not alive, the future child's welfare is not harmed by the reproductive technology. There are however many other issues which the law and the State should be considering. By focussing so much on the welfare of the future child, the UK legal system was at risk of overemphasising the unimportant, and overlooking the important.  The audience found this part of his lecture highly controversial. To put less emphasis on the importance of the future child struck them as uncaring, politically unacceptable, and ignorant. In a lively Q&A session, Professor Cohen defended his point in a robust and thoughtful way. (Interested readers are encouraged to view the lecture!)

Video recording of the lecture is available here and on the University SMS site.

A full gallery of photographs from the evening can be viewed here

LML participates in thought-provoking conference on bio-innovation law in Copenhagen

last modified Sep 14, 2018 05:10 PM

LML CeBIL

 

On Monday 5th March 2018, three LML members (Dr Kathy Liddell, Professor Mateo Aboy, and Dr John Liddicoat) participated in an international conference on bio-innovation law, hosted by the University of Copenhagen.

The event marked the commencement of CeBIL, the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law; a substantial international collaboration between the University of Copenhagen's Law Faculty (principal organisation), Harvard Law School, Harvard Medical School, the University of Cambridge's Centre for Law, Medicine and Life Sciences, the University of Michigan, and the University of Copenhagen's Department of Food and Resource Economics (IFRO), alongside a broad network of stakeholder organisations and international experts within law, economics, life sciences, medicine, sociology, and pharmacy. The collaboration is led by Professor Timo Minssen from the University of Copenhagen (formerly a LML Visiting Scholar).

Dr Kathy Liddell (Director of LML) will head CeBIL’s study on Repurposing Known Drugs (one of its five core studies), which will focus on the challenges of new medical use patents and feasible alternatives to support repurposing. She gave an introduction to the New Uses Study, and chaired a panel debate on Synergy and Policy Solutions.

Kathy’s presentation set out several reasons why new medical purpose patents are socially, ethically and legally controversial. Her presentation also sought to describe the contribution that LML hopes to make via its forthcoming CeBIL project, namely to: investigate the landscape of new medical purpose incentives including the corporate innovation context, national legal variations; analyse the implications of recent case law (for example, Warner-Lambert); assess the nature, source and extent of the incentive gap for developing new medical treatments; assess and evaluate the feasibility, efficacy and lawfulness of proposed legal policy solutions; and examine the ethical implications of alternative solutions and in particular their distributive 
consequences. 

Professor Mateo Aboy (Senior Research Scholar with LML) acts as a CeBIL special advisor, and  delivered the talk "Myriad's Impact on Gene Patents: Lessons to be learned from empirical studies".   Professor Aboy's topic has close links with two recent LML publications in Nature Biotechnology co-authored by Mateo, John Liddicoat, Kathy Liddell and Cristina Crespo. Mateo's presentation showcased LML's pioneering methodologies for patent landscaping, claims analysis and prosecution studies. The CeBIL team plan to use these methodologies to inform each of the five core studies, and to develop a sub-project in a sixth overarching study on Synergy and Policy Solutions.  

Presentations of particular interest to LML were Timo Minssen's talk and his explanation of how he sees CeBIL's research programme taking shape. Glenn Cohen's presentation was also of special interest as he spoke on a topic which has been at the heart of LML's research over the past 3 years, namely precision medicine. Glenn will lead CeBIL's study on precision medicine together with Nicholson Price (University of Michigan), Carmel Schacher (Petrie-Flom Centre, Harvard Law School) and Timo Minssen (University of Copenhagen). They plan to focus on legal and ethical issues which arise in the regulation of algorithms used in 'black box' precision medicine. It was also very interesting to hear Ben Roin's perspective on new medical use patents in the US. Kevin Outterson (a Cambridge Alumni) spoke on antibiotic innovation as did Aaron Kesselheim. A set of issues emerging for life science legal academics is those surrounding the manufacturing of biologics. Nicholson Price spoke informatively on these.

The next CeBIL event will be an Annual Symposium on Precision Medicine, to be hosted by LML in Cambridge in September 2018. If you are interested in attending please contact lml@law.cam.ac.uk.

LML awarded large research grant with University of Copenhagen

last modified Jan 24, 2018 04:17 PM

The Centre for Law, Medicine and Life Sciences (LML) within the Faculty of Law has signed a ground-breaking collaboration agreement with the University of Copenhagen to address challenges in biomedical innovation law.

The collaboration is generously supported by a £4m grant awarded by the Novo Nordisk Foundation to Professor Timo Minssen, Director of the University of Copenhagen’s Centre for Advanced Studies in Biomedical Innovation Law (CeBIL). The collaboration is the foundation for a 5-year Research Programme. Other key partners include Harvard Law School, Harvard Medical School, and University of Michigan Law School. Specialist advisors are based at the Max Planck Institute for Innovation & Competition, Massachusetts Institute of Technology, Boston University, the University of Oxford, the University of Pennsylvania, the University of Hong Kong, the University of Copenhagen’s Department of Public Health, and the Copenhagen Centre for Regulatory Sciences.

Headed by Professor Professor Minssen (Professor of Biotechnology Law at UCPH, and previous Visiting Scholar of the LML), CeBIL will contribute to the translation of biomedical research into safe, effective and affordable therapies. The partnership will analyse the most significant challenges facing pharmaceutical innovation and public health from a cross-disciplinary perspective, drawing on legal, biomedical, societal, and economic perspectives.

Dr Kathy Liddell (Director of the Centre for Law, Medicine and Life Sciences) is Cambridge’s Principle Investigator. Welcoming the partnership, she said, “The overall vision and aim of CeBIL is well-matched with the research strategy of our own Centre for Law, Medicine and Life Sciences; which was founded to advance our understanding of legal and ethical controversies at the forefront of medicine and the life sciences. The research undertaken by CeBIL will make a pioneering contribution to the field of biomedical innovation. We are delighted to be part of the enterprise”.

Drawing on her expertise in IP rights and the translation of medical discoveries, Dr Liddell will head CeBIL’s study on Repurposing Known Drugs (one of its five core studies), and will make significant contribution to its study on Synergy and Policy Solutions (a sixth overarching study). Dr Liddell said, “We look forward to appointing world leading research associates to work on the projects in Cambridge and to inviting world experts to speak at our annual symposia. We are fortunate to have an unmatchable environment for discussing the legal, ethical and economic challenges of biomedical innovation.”

Dr Jeffrey Skopek (Deputy Director of the LML) is a Co-Investigator at Cambridge. Speaking about the potential impact of the grant, he said: “Rapid advances in medicine and the life sciences, alongside changing societal attitudes towards health and medical care, pose deeply challenging questions of law, ethics, and policy. If CeBIL can help solve some of the challenges facing pharmaceutical innovation, the public benefit will be substantial.”

In developing this new research programme, LML will build on the foundations developed by a research group in the Centre that has been studying intellectual property issues surrounding genomic medicine for the past two years.  This group (consisting of Dr Kathy Liddell, Dr John Liddicoat, Dr Mateo Aboy, Dr Cristina Crespo, and Mr Matt Jordan) has published the results of some of its research in two articles in Nature Biotechnology: ‘Myriad’s impact on gene patents’ and ‘After Myriad, what makes a gene patent claim ‘markedly different’ from nature?’.

In addition, LML will draw on the rich intellectual environment provided by the wide range of Cambridge academics in the humanities and social sciences who are conducting research with relevance to biomedical innovation, past, present and future. These include colleagues in the Centre for Intellectual Property and Innovation Law (co-directed by Professor Lionel Bently and Dr Henning Grosse Ruse-Khan); the Cambridge Academy of Therapeutic Sciences; the Department for History and Philosophy of Science; and the PHG Foundation

 

CeBIL launched formally on January 1st 2018.

For more information, please visit the CeBIL website.


Stephanie Palmer joins Advisory Board on Behaviour Change Research

last modified Jan 23, 2018 09:10 AM

Dr Stephanie Palmer (LML Member) has been appointed to the Scientific Advisory Board for Behaviour Change by Design, a four-year research programme investigating "ways to 'nudge' people towards healthier behaviour". Dr Palmer will be contributing expertise in the area of Law and Public Health.

More information about the programme, which launched on January 17th, can be found here.

LML and CMEL publish report on Precision Medicine: Legal and Ethical Challenges

last modified Nov 17, 2017 10:25 AM

Following a conference hosted at the University of Hong Kong in April 2016, the Centre for Law, Medicine and Life Sciences and Centre for Medical Ethics & Law (University of Hong Kong) have published a report on 'Precision Medicine: Legal and Ethical Challenges'.

The aim of precision medicine is to revolutionise disease treatment and prevention by utilising personal variation in factors such as an individual’s genetic information, biochemistry, environment and lifestyle. Genomic data, for example, can be used to determine predispositions to particular diseases, predict the efficacy and safety of different treatment options, and help develop drugs that are targeted to the causes of diseases rather than their clinical manifestations. In these and other ways, scientific and technological advances have the potential to bring about an unprecedented tailoring of health care to the individual characteristics of patients.

In order to realise the potential of precision medicine, however, we must rethink components of the legal and ethical foundation on which it will be built. The reason for this is that our current legal and ethical frameworks were built with a very different generation of medical products and practices in mind. At this conference, world experts convened to identify and explore the challenges that precision medicine brings to the fore.

This report provides a summary of the presentations that were given at the conference, and the key challenges that were explored in the roundtable discussions that followed the four categories of presentations, as well as some of the broader questions that emerged out of the conference.

LML Members to present at international synthetic biology and gene editing conference.

last modified Nov 13, 2017 11:19 AM

Two members of the LML are scheduled to present at an upcoming conference on 'Legal Perspectives on Synthetic Biology and Gene Editing', hosted by the Centre for Information and Innovation Law at the University of Copenhagen.

On November 20th, Dr Kathy Liddell (Director of the LML) will deliver a keynote speech on the topic of 'IP Policies for Large Bioresources: the fiction, fantasy and future of openness'. Dr John Liddicoat (LML Member) will participate in the panel 'IP and regulation in Gene Editing and Synthetic Biology', presenting 'A deep dive into the regulatory soup of precision medicine: are new gene-based technologies drowning?'.

Further information about the conference can be found here.

Publication success for recent Tripos student

last modified Nov 06, 2017 01:03 PM

An article written by Abby Selden, a recent Law Tripos Student and current Trainee Solicitor at Clifford Chance, has been published in the European Human Rights Law Review.

Selden's article titled 'Compulsory health checks, female genital mutilation and rights balancing at the European Court of Human Rights' was based upon her earlier dissertation, which was supervised by Dr Kathy Liddell (Director of LML) and completed as part of the Medical Law and Ethics seminar paper in 2014-15. Further assistance was provided by Dr Stephanie Palmer (LML Member) in preparing the dissertation for publication.

The LML extends its warmest congratulations to Abby on her recent publication success, the full citation for which is below:

A Selden, 'Compulsory health checks, female genital mutilation and rights balancing at the European Court of Human Rights', E.H.R.L.R. 2017, 5, 480-491.

 

LML Expands Consulting & Contract Services

last modified Nov 06, 2017 01:24 PM

The LML is pleased to announce that the Centre is expanding the range of consulting and contract services it is able to provide. Complementary to our 'Evidence-based IP' research area (led by Dr Mateo Aboy and Dr Kathy Liddell), examples of new services include patent searches and landscapes, and empirical IP legal studies.

The full range of consulting and contract services, and details about how to contact the LML to express interest, can be found here.

Colm McGrath debates whether THBT brain activity should be regarded as the indicator of human life

last modified Oct 13, 2017 09:36 AM

LML member Colm McGrath has been invited to participate in a public debate at University College London (UCL) on Monday 16th October. He will be opposing the motion ‘THBT brain activity is the measure of human life’.

More information about the public debates held by the UCL Debating Society can be found here.

Dr Liddell featured in University of Cambridge film: The Future of Medicine

last modified Oct 11, 2017 12:38 PM

The University of Cambridge has produced a short film, 'The Future of Medicine', documenting some of the research being undertaken at the university which is helping to guide and shape developments in this field. Dr. Kathy Liddell (Director of the LML) features in this production. She speaks about the importance of involving perspectives additional to scientific expertise when responding to the the risks, benefits, and trends with modern medicine. Legal and ethical perspectives are at the forefront of LML's work, and have a key role to play in the future governance of medicine. 

Nature Biotechnology publishes another article from LML Research Group

last modified Oct 05, 2018 12:46 PM

The LML is delighted to announce that Nature Biotechnology has accepted for publication a second article from an LML Research Group concerning the impacts of the US Supreme Court's decision in Association for Molecular Pathology v Myriad Genetics on patent practice.

The article, co-authored by Prof Mateo Aboy, Dr Jonathon Liddicoat, Dr Kathy Liddell, Dr Cristina Crespo, and Mr Matt Jordan, is the second in a series of publications by this team on the topic of the Myriad decision. The team's first paper, 'Myriad's impact on gene patents', was the first post-Myriad empirical patent landscape analysis, the findings which, published in November 2016, empirically confirmed previously untested predictions as to the impact of Myriad, and made methodological contributions to gene-related patent search strategies.   

The newly published article, 'After Myriad, what makes a gene patent claim ‘markedly different’ from nature?', builds upon this earlier study, with the aim of identifying the types of claim amendments which have successfully transformed isolated gene claims from ineligible subject matter into patent eligible inventions following Myriad. This empirical study analyses Myriad's impact at the claim level, and provides empirical answers to previously unanswered questions; including whether it is possible to draft around Myriad to obtain claims of an equal or similar scope, and how claims for simple, isolated nucleic acid sequences have been amended to become patent-eligible. 

Dr Palmer discusses recent Supreme Court decision on abortion funding

last modified Sep 22, 2017 12:29 PM

Dr Stephanie Palmer has written a blog post for the International Association of Constitutional Law (IACL/AIDC) on  the question of whether women from Northern Ireland should have access to free National Health Service-funded abortions in England.  This issue addressed in the Supreme Court decision of R (on the application of A and B) v Secretary of State for Health,  raises important constitutional and human rights issues concerning the nature of devolution and the equality of women.

Dr Palmer's post can be found here.

David Erdos contributes to safeguarding academic research in new Data Protection framework

last modified Jul 20, 2017 03:49 PM
David Erdos contributes to safeguarding academic research in new Data Protection framework

Image courtesy of HKU/WYNG Foundation

David Erdos, a member of LML and incoming Deputy Director of CIPIL, has been engaged in a variety of activities during 2016-17 which have been aimed at ensuring that all types of academic research are effectively safeguarded when the new General Data Protection Regulation (GDPR) comes into force in May 2018.  Much of this work has focused on the governance of humanities and social science scholarship, a wide-ranging area that can include certain types of health and medical humanities research. Other aspects of David’s work have specifically focused on the appropriate regulation of biomedical research within data protection.

  

Summary of Activities during 2016-17

In November 2016, David posted slides exploring the regulation of biomedical research under European data protection including an analysis of existing laws, Data Protection Authority (DPA) legal interpretations and DPA enforcement activity combined with some pointers to how things might and should evolve in the era of the GDPR. He also presented on “Reconciling Humanities and Social Science Research with Data Protection” at a workshop held at the University of Hong Kong.  The slides from this are available here.

In February 2017, David presented more generally on the interface between data protection and University research at a JISC Workshop on the GDPR held at the University of Leeds.

In May 2017, he also helped with the drafting of a joint British Academy/ESRC submission on the British Government’s Call for Views on the implementation of the GDPR in the UK which specifically focused on issues arising for humanities and social science research.

Finally, in June 2017, David spoke on a similar theme at a Full Fabric Workshop on The Impact of the GDPR in Higher Education which took place at Imperial College London as part of London EdTech week. He also spoke and took part in a CSaP Policy Workshop on ʻTransforming consent – legal and ethical aspectsʼ held at Trinity Hall Cambridge, which looked at changing the technical, legal and social context for the mobilisation of the use of personal data in medical research including, in particular, the coming impact of the GDPR.

  

Need to Look Beyond the ʻResearchʼ Derogations

These various interventions have emphasised that both policy makers in Government and policy stakeholders - including within the Universities themselves – need to look beyond the specific ʻresearchʼ derogations set out in Article 89 of the GDPR when seeking to balance rights and interests in this area. Whilst Article 89 does grant certain derogations which recognise the role that research plays in knowledge production of all kinds, these are quite limited in nature.  This reflects the fact that Article 89 can be claimed even by certain forms of purely economically-motivated, commercial research. In contrast, academic biomedical research furthers “important objectives of general public interest” as well as constituting the exercise of the freedom of sciences as set out in the EU Charter (Article 13).  It therefore can and should benefit from further derogations under the Restrictions clause of the GDPR (Article 23). Finally, through its concept of “academic … expression” as set out in Article 85 (2), the GDPR recognises that humanities and most forms of social research must benefit from wide-ranging derogations “as necessary to reconcile the right to protection of personal data with the freedom of expression and information”. These derogations should mirror the existing protections for journalistic, literary and artistic purposes which are similarly safeguarded in Article 85 (2).

Dr Fenton-Glynn consulted by the media in relation to the Charlie Gard case

last modified Jul 10, 2017 12:00 PM

Over the last week, LML Member Dr Claire Fenton-Glynn has been quoted in a variety of media sources and conducted a radio interview on the case of Charlie Gard. Gard is an eleven month old infant born with a genetic disorder which leaves him unable to breathe unaided and with severe brain damage. The London hospital treating him have asked permission to remove the child from life support, and now have the backing of both domestic courts and the European Court of Human Rights; while his parents are seeking to take their son to the USA for an experimental treatment that may prolong his life. Dr Fenton-Glynn comments on the role of the courts as the final arbiter in medical disputes about the treatment of children, and parental responsibility in English law.

Newspaper articles:

Radio interviews:

 

Dr Liddicoat presents at Oxford Precision Medicine Conference

last modified Jul 11, 2017 03:03 PM

On June 13th, Dr Liddicoat presented at the conference Intellectual Property, Ethics and the Market in the Era of Personalised Medicine, held at St Anne’s College, Oxford. His talk was titled ‘The Phantom Menace of Gene Patents Arises?’, and the abstract can be found below. Dr Liddicoat and colleagues are now in the midst of translating the talk into a peer-reviewed article, the publication of which will be announced as soon as it becomes publicly available.

 

Abstract:

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 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, we will deploy a survey that is designed to update and extend these studies. This presentation will present preliminary results.

Colm McGrath appointed to a Lectureship at King's College London

last modified Jun 12, 2017 02:17 PM

LML is happy to announce that Colm McGrath has been appointed to a Lectureship at the King's College London Dickson Poon School of Law. He will take up the position in January 2018.  At KCL, he looks forward to contributing to the School’s teaching in tort law and medical law and to continuing his research into the modern, historical and comparative development of the law of medical malpractice.  He also looks forward to retaining close links with LML and joining the centre's growing network of researchers and stakeholders beyond Cambridge.

Dr Scherpe delivers plenary lecture at the Academy of European Law on the legal status of transexual, transgender and intersex persons

last modified Jul 10, 2017 12:01 PM

On May 29th and 30th 2017, a seminar for university professors and law lecturers took place at the Academy of European Law in Trier, Germany. The general topic of the seminar was ‘Current Reflections on EU Anti-Discrimination Law’, and Dr Scherpe delivered a lecture on ‘The Legal Status of Transsexual and Transgender Persons’, based on his book of the same title. He also extended his lecture to cover ‘The Legal Status of Intersex Persons’ (book forthcoming in Autumn 2017), highlighting in particular the Malta Declaration of the Third International Intersex Forum and related statements by Organisation Intersex International. Dr Scherpe concluded that the current discrimination, stigmatisation and pathologisation of transsexual and transgender persons as well as intersex persons is unacceptable and that the existing European and international human rights frameworks require immediate action.

Kathy Liddell participates in CSaP Senior Policy Fellows Meeting on Genetic Technologies

last modified May 24, 2017 09:47 AM

Kathy Liddell, Director of the LML, was invited to participate in 
the fourteenth Policy Leaders Fellowship Roundtable organised by the 
Centre for Science and Policy which will take place at Trinity College 
Cambridge on 12 May 2017, chaired by Lord Wilson of Dinton, former UK 
Cabinet Secretary.

The subject for discussion on 12 May was “advances in genetic 
technologies”. Each of the Fellows was asked to summarise in two minutes the questions are of interest to him or her, following which the academics then spoke for five minutes each on the relevance of their research to those questions.

Some of the questions which arose with direct relevance to LML research included: (i) what are the possibilities and risks associated with gene-editing and gene-drive? (ii) in additions to systems to review safety, are  systems of ethical review robust enough? (iii) which organisations and legal frameworks (e.g. IP rights) are the primary source of capital and source funding for genomic technologies (political economy and business models)? (iv) who wins and loses with gene editing and genetic testing (social equity; distributive justice); (v) how might regulation steer a middle way that avoids polarisation and neither exaggerates the potential benefits nor is over-cautious about the risks? (vi) who/what is informing policy currently? (vii) who/what should be informing policy? (viii) how are risks and benefits managed globally? 

The Policy Leaders Fellowship brings together the most senior members of 
CSaP's network of policy professionals to form a select group which 
meets, together with leading researchers from the University and other 
institutions, to share insights into the development of open and 
evidence-based policy making. In line with the objectives of the Civil 
Service Reform Plan, it promotes the value of evidence, and progresses 
the move towards open policy making by opening up new ways of thinking 
and fresh perspectives; exercising “open minds” at the top of the policy 
making process; exploring new models for implementation; and creating 
engagement between policy, expertise and delivery.