Patent Policy in Genomics and Human Genetics: A Public Health Perspective
Workshop
9:00–5:10, Wednesday 11 February 2015
Venue: Haldane Room, WolfsonCollege, Linton Road, Oxford
Abstracts
Dr Julian Cockbain
'Genetic Patenting in Europe and the USA’
Patent applications relating to natural products, typically in the field of biomedicine, pose particular problems to the patent examination systems of the world’s patent offices. Such ‘inventions’ generally are unaffected by the standard gatekeepers to patentability of novelty, non-obviousness, utility, and sufficiency of disclosure and yet there is a clear recognition that simply finding something that already existed in nature should not be enough to warrant the grant of a patent. For the last century in the US, the patent office has usually applied the reasoning of Parke-Davis v Mulford and allowed patents to ‘isolated’ or ‘purified’ natural products. In 2013, in AMP v Myriad, the US Supreme Court decided that isolation was not enough. In Europe, the European Patent Convention specifies that ‘discoveries’ are not inventions and are thus not patentable, but, following the European Biotech Directive in 1998, the Rules of the EPC were amended to make clear that isolation was indeed enough.
Prof Ingrid Schneider
'Epistemic communities, courts, and the democratic shaping of patent law.'
The presentation will first introduce the concept of epistemic communities (by Haas 1992) and apply it empirically to the patent community. The normative and cognitive principles as well as beliefs of this epistemic community will be analysed.
In the second part, some recent judgments of the CJEU will be considered which interpret the order public exclusions of Directive 98/44/EU in the field of biomedicine. It will be demonstrated how the patent community is working around these exclusions to patent eligibility.The third part will discuss the interaction between legislation and jurisdiction, and propose a new perspective on the democratic shaping and public legitimacy of patent law.
Dr Stuart Hogarth
'Biomarker patents and diagnostic monopolies in comparative perspective – Stories from the USA and the UK.'
The diagnostics industry has traditionally operated with a high-volume, low-profit margin business model, in stark contrast to the rather more lucrative pharmaceutical sector. Many hoped that a new wave of diagnostic innovation based on molecular technologies would transform the economics of the industry. The exploitation of biomarker patents was central to this new business model, allowing firms to create diagnostic monopolies akin to those enjoyed by pharmaceutical firms. But what has happened in practice? I will argue that few firms have successfully prosecuted this model, and that this limited success has largely been restricted to the USA. Why have countries like the UK proved a more hostile environment for this new wave of firms?
Rather than focusing on the most well-studied of cases (Myriad Genetics’ patents on BRCA1/2), I will explore the answers to this question by describing the trajectories of two lesser-known but highly successful US companies and their respective technologies: Digene’s Hybrid Capture test for human papillomavirus and Genomic Health’s OncotypeDx breast cancer test.
DrMichael Hopkins
'Biomarker patents versus hidden innovation: What type of diagnostics do we want to pay for?'
The paper explores the context for diagnostic innovation in UK by drawing together recent research on trends in biomarker patenting and on the role of NHS laboratories in the development of novel tests. The paper shows that there is a strongly increasing trend in the numbers of patents being filed in the UK which seek to claim diagnostic applications.
The majority of these applications are by non-UK organisations, often motivated by therapeutic as well as diagnostic market potential. One group of organisations that are rarely motivated to patent novel applications of biomarkers appear to be UK hospitals. These organisations are strongly involved in diagnostic development but such activity is hidden from view when using metrics of innovation such as patenting activity. Survey results show that hospital laboratories are hostile to patenting, frequently infringe patents, and tend to regard IP as a barrier to innovation.
The paper concludes that UK government policy does not give clear guidance to firms or hospitals on how to negotiate increasingly a complex IP landscape or on what type of innovative activity is supported.
Dr Adam Stoten
'Responsible IP management – a university perspective.'
Universities are under increasing pressure to demonstrate societal and commercial impact generated by their research activities, with 20% of the latest UK REF score allocated to Impact. University technology transfer offices are challenged with balancing the need to find commercial development partners for new technologies and upholding certain principles which reflect a university’s charitable status, protect its academic freedoms and meet obligations to 3rdparty funders. Adam Stoten will discuss considerations for licensing university IP in this context and the different approaches used to ensure that such IP is managed and exploited in a socially responsible manner.
Dr Harry Thangaraj
'Health, patents and responsibility.'
Access to the best possible standards of healthcare is a fundamental right is enshrined by international treaties on human rights. The output of public funded patented research should responsibly be made available, accessible and affordable globally through policy and practical measures. We discuss means to achieve this and also analyse efforts by public funded research organisations to advocate and practice socially responsible licensing.
Prof Sigrid Sterckx
'“I thought our records were private not up for auction to the highest bidder”:
Ongoing controversies regardingthe UKcare.data scheme.'
An ‘Information Centre’ has recently been established by law which has the power to collect, collate and provide access to the medical information forall patients treated by the National Health Service in England, whether in hospitals or by General Practitioners. This so-called ‘care data’ scheme has given rise to major and ongoing controversies.
After sketching the background of the scheme, we will look at the responses it has elicited from citizens and medical professionals. When discussing the responses of citizens, we will make a distinction between the problems that citizens detect and the solutions they propose. Our analysis of reactions to the scheme in no way pretends to be exhaustive, yet it provides various relevant insights into the concerns identified by citizens as well as medical professionals. The main concerns are: lack of transparency; lack of respect for confidentiality and privacy; misgivings about the opt-out scheme; erosion of trust in GPs and the healthcare system; appropriation of personal (i.e. patient) property; and commercialization and for-profit activities. These concerns, moreover, have a more general relevance in relation to other contexts of biomedical research and innovation.
Our analysis also offers important pointers as to how those concerns might be addressed, bearing in mind the broader context of the care.data scheme, viz. the 2012 Health and Social Care Act and its associated ‘innovation agenda’ which strongly emphasises the need for the National Health Service to pursue a competitive intellectual property strategy.
Dr Mark Bale
'Diagnostics and IP in the genomics era.'
The implications of intellectual property have been a constant theme throughout the development of human genomics. The UK 100K genomes project raises some key challenges which extend beyond gene sequence patents to include software patents, copyright and database rights. The project requires agreement on IP across Genomics England, NHSE England, NHS Genomic Medicine Centres, universities and commercial users. Licensing strategies need ideally to ensure that Genomics England, NHS and commercial users have freedom to operate for diagnostic purposes and commercialisation. There will need to be appropriate recognition of IP generated or worked by the NHS, collaborative academic research or commercial users.
Beyond the 100K genomes project there remain some challenges to the appropriate licensing of diagnostic patents for NHS laboratory use. The amount of ‘legacy’ IP that exists around gene sequences that might be valuable for diagnostic and/or be invoked as the NHS begins to commission diagnostic services that involve clinical sequencing or even full genomes is unknown.
We are still exploring practical approaches that respect IP rights and the need to balance the diagnostic uses of genomics with building a vibrant genomics industry in the UK. Policy on gene patent, IP and licensing strategies must reflect the wider aim of maintaining public trust and confidence in genomics.
DrWenhwa Lee
'50 shades of grey and open Innovation: Why open access science is the only way to accelerate drug discovery.'
The rate at which new drugs are being discovered has flatlined despite massive investment in R&D and new technologies, and there is a common belief that the pharmaceutical business model is flawed. The fundamental problem is that our understanding of human pathophysiology is too poor to be able to predict the right drug targets for the right patient populations. With our collective ignorance being a main problem, the push by institutions, public and private funders to patent their findings in order to provide “return on investment”, has proven counter-productive to the discovery of new medicines. This strategy is at odds with the evidence for enhancing commercial outcomes as well. Most Universities lose money through their technology transfer activities, most start-up companies do not have a patent at the outset, and most of the current patenting activities are used to restrict and limit possible uses of usually underdeveloped discoveries– a true Tragedy of the Anticommons. If our ignorance of biology is the major problem, it is followed by the secrecy engendered in seeking patents, and significantly inhibits progress towards a solution.
Despite the establishment of several ‘open innovation’ models by the industry, most of these are still rather closed and are not driving fundamental changes quickly enough. Interestingly, several initiatives in the biomedical research area are true to the public’s understanding of the term ‘Open’ and practice a genuine open access and pre-competitive scientific commons approach.
In this talk I will share the model practised by the Structural Genomics Consortium, its successes and impact across different sectors through the adoption of patent-free that is genuinely transforming the existing drug discovery model.
Prof Graham Dutfield
'Synthetic Biology:Innovation, patents and business in an emerging technology.'
Synthetic biology as an emerging field of technology is often presented as one having great promise, with numerous possible applications including the more efficient production of biofuels and natural products like therapeutic plant metabolites and protein drugs (biologics). Despite also attracting suspicion, fear and loathing, synbio’s promise is enticing for many and for good reason. Much of the literature implies that open source-type licensing models are ascendant and sharing moral economies predominate, which of course helps cast synbio in a favourable light.
The paper questions whether this picture is accurate or not. It will then consider whether openness models can effectively compete with the “fortress IP” business models tending to dominate other life science fields. Among the key challenges are the often understated complexity and unpredictability of synbio, which among other things casts doubt on the viability of modular parts approaches which the open licensing schemes tend to depend on. However, these issues challenge the viability also of fortress IP, implying that the future of industrial synbio is far from settled.
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