Patent Policy in Genomics and Human
Genetics: A Public Health Perspective
Workshop
9:00–5:10, Wednesday 11 February 2015
Venue: Haldane Room, Wolfson College, 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
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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 Oncotype Dx breast cancer test.
Dr Michael 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.
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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 3rd party 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 regarding the 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 for all 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
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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.
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Dr Wenhwa 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
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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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