My past two posts on ethics in intellectual property (Part One, and Part Two on biotechnology) were essentially online brain dumps in advance of the Dubrovnik conference on Data Science and the Right to Science, hosted by the Inter-University Center. The IUC sits perched just outside the historic walls of Dubrovnik (thankfully still standing despite the damage done to its on screen simulacrum in Game of Thrones). My presentation at the conference had a simple goal: stop intellectual property law being used as a excuse for issues with access to medicine, inefficiencies in research, or overemphasis on technological solutions to social problems
It was a productive weekend. Keynote talks included appearances from Mildred Solomon, President of the Hasting Center at Harvard Medical School; Matthias Mann, Director of Proteomics at the Max Planck Institute; Jason Bobe, founder of DIYBIo and Director of Democratized Health Innovation at Mount Sinai School of Medicine; as well as others from national health institutes across Europe, policy experts, and leading academics. Industry was slightly under-represented, with a single speaker from each of IBM and Microsoft.
This post features some of the interesting takeaways from the talks at the conference, followed by the role of IP in the right to science, and finally a summary of the key areas of concern for IP lawyers and professionals.
Talks touched on the changing models of healthcare and science funding, research, and commercialisation. There was much attention for the role of technology in transforming healthcare, with the crowd particularly impressed by the progress made in healthcare in digitising the Estonian health service. Rain Laane said that the service’s performance has been so reliable that when there was a 22 minute outage of the nationwide digital prescriptions system it was such an outrage the incident received widespread TV coverage.
The EU’s 1 million genome project also received some hype – though the target looks a bit under-ambitious compared with US and Chinese efforts. Estonia has already managed 150,000 genomes on its own…
Prof. Mann of the Max Planck spoke about the complexities of managing the complex proteomic data produced by his novel analytical techniques, and the differences in perception people have between that infromation and genomic information. Studies undertaken with his group’s tech are linking changes in the environment with changes in the proteome to better understand how e.g. weight loss affects the body. There is a real focus on improved methods of diagnosis and prevention, and the statistics in spending back up that shift in European healthcare priorities. Proteomic data can help improve our understanding of the factors involved in chronic and acute diseases.
Tin Oreskovic told us how there is a growing herd immunity crisis in the EU – why is this happening? Now more than twenty countries are below the herd immunity rate for some diseases. Stories like this are putting paid to the myth that medicine usage and affordability go hand in hand. Education is a vital part of the scheme, as are social measures to encourage adoption, particularly for infectious diseases.
Seb Porsdamm-Mann spoke on our ethical obligations in data science and science. he began with a thought experiment: He asked the attendees to imagine a child drowning in a lake – is it deep and dangerous, such that you would surely also die if you entered? Or is it so shallow you will only wreck your nice shoes? As a society we set clear standards for when you are expected to make a personal sacrifice for the greater good. We have not yet translated this standard adequately to data science. Medical data that could save lives will never be used because the cost of finding and getting consent from the people who provided it is too great, or the reply rate is too low, fatally biasing the dataset. Dr Porsdamm Mann said:
Data sharing may in fact be the shallow pond. Where it is easy to contribute without risk or burden we must do so. The lack of immediacy of the benefits cannot hide the moral imperative.Dr Sebastian Porsdamm-Mann, Harvard University & University of Copenhagen
Valerie Bradley, founder of the Human Services Research Institute, spoke about the importance of ensuring technological development was inclusive and in line with the 2006 Convention on the Rights of Persons with Disabilities. Too often science and technology is developed with regard to the standard customer. Those with disabilities are inappropriately barred from clinical trials and it skews results. There are also serious issues with the entire informed consent concept for those with intellectual disabilities. – we therefore need more consultation in the development and implementation of science and technology, as it has great potential to improve the lives of those with disabilities.
The role of Intellectual Property
The spark that initiated the conference was the formation of an international reading group on the Right to Science, which is embodied in Article 27 of the Universal Declaration on Human Rights with an obligation on signatory states to respect the right to share in scientific advancement and its benefits. Then followed two days of working groups on the direction that would be taken by an association on the Right to Science.
Article 15 of the International Covenant on Economic, Social, and Cultural Rights goes even further: it creates an obligation on its signatories to help realise this right by supporting the development and diffusion of science and respecting freedom in scientific research. In 2015 the UN special rapporteur, Farida Shaheed, published two reports on patent and copyright policy and the Right to Science. The UN’s committee on Economic, Cultural and Social Rights is now producing a comment on Article 15 and the relationship between science and economic, social and cultural rights.
Given that patent law has been the dominant method of rewarding innovation since the Venetian Statute of monopolies in 1474, it is surprising and concerning how little involvement IP professionals have had in the debate on the Right to Science.
The UN’s special rapporteur stated in her recommendations that:
deprivations through patent exclusivity may be deemed as arbitrary, discriminatory or disproportionate, depending on the extent to which human rights interests are implicated by the specific technologies at stake, and the degree to which patent exclusivity, rather than production costs, create the high pricesFarida Shaheed, §87 of the UN Report on Patent Policy and Right to Science
It is therefore important that the IP world, including practitioners, get involved in the discussion about the Right to Science. My personal opinion is that intellectual property rights can be used to create immense social value and that these rights are vital for the economic integration of science and technology into society. It is incumbent on IP professionals to make the case for the social value of their work, else intellectual property law is in danger of being seen as an obstacle rather than as a tool.
Patents are one policy tool among many for encouraging innovation and technological research and development. More caution is required in assessing their positive versus negative effects depending on the context and the technologies at stakeFarida Shaheed, §90 of the UN Report on Patent Policy and Right to Science
One of the key reasons that there is a growing misconception about the negative effects of intellectual property is a failure by IP industries to make a positive case. For example, the pharmaceutical industry has complained widely about the growing cost to develop a medicine through to stage 3 clinical trials (see Eroom’s law), but have failed to explain efforts to reduce R&D costs using new technologies such as AI, to increase spending on preventative and diagnostic technologies with greater impact on quality-adjusted years of life, and to move to fairer models of drug pricing.
Companies such as Merck and Co. are leading the way in pricing transparency but more needs to be done to explain the role and value of the intellectual property system. For example, many who complain that IP protection leads to excessive pricing in the developing world fail to appreciate that strong territorial separation and customs enforcement is necessary for GDP-linked (or otherwise wealth/need adjusted) drug pricing.
Furthermore, many of the issues with access to medicines, for example, are incorrectly linked to patent protection, when there are actually more pressing issues with public awareness, vaccine cold chain technology, and prioritisation of healthcare spending.
What can we do to make the case for intellectual property law in a Right to Science context?
The key areas in which intellectual property law can go hand-in-hand with the right to science are in developing effective models of ownership, licensing and enforcement. This 2017 article by Stevens and Huys gives an idea of the kind of innovative thinking that is required.
One of the key concepts in that article from a right to science approach perspective is the public-private partnership. Collaboration between pharmaceutical R&D functions, non-profits, and governments in the developing world are key to tackling neglected diseases effectively. Another interesting example of partnership in development and ownership of intellectual property is reported in a 2002 paper in the Lancet:
“a group representing patients with pseudoxanthoma elasticumGold & Caulfield: The moral tollbooth: a method that makes use of the patent system to address ethical concerns in biotechnology, The Lancet, 2002
(PXE) entered into an agreement with the University of
Hawaii under which patients donated blood and tissue
samples for research purposes in return for joint control
over the eventual patent of the PXE-related gene. The
patients provided samples to ensure that gene tests would
be inexpensive and widely available”
Another issue addressed in Stevems and Huy’s article is the idea of compulsory licensing. This is something TRIPS leaves room for, but there is concern that it is being prevented by terms in bilateral trade agreements, the text of which may never be public. A WHO report in 2004 on the implementation of TRIPS in Carribean and Latin American Countries found that they had failed to implement TRIPS in the most economically favourable or socially beneficial way (Oliveira et al., Bulletin of the World Health Organization 2004;82:815-821). Even where there is flexibility in IP law for developing countries, it is often not effectively deployed. Effective use of provisions such as compulsory licensing can play an important role in Right to Science thinking in developing countries.
A third way in which intellectual property law can address public concerns is in relation to enforcement. We have a great example of this in the recent case of Edwards Lifesciences v Boston Scientific  EWHC 1256 (Pat) in which Arnold J created a bespoke injunction which respected clinical need for the infringing Sapiens 3 artificial heart valve:
“The remedy … must strike a balance between Boston’s interest in maintaining the monopoly conferred by [the patent] and the public interest in ensuring that patients with aortic stenosis receive appropriate treatment.”Arnold J
This concern was based in statutory terms on the need for proportionality in relief under the IP Enforcement Directive. The resulting injunction therefore provided time for clinicians to be re-trained on non-infringing devices. The concept of proportionality in this context has not been widely explored, but could be a productive avenue for a common sense approach to IP enforcement. This might be of particular value in cases where the infringement appears to be delivering a public benefit that the patentee cannot themselves provide.
The developing “Right to Science” perspective is important for IP lawyers. It is our responsibility to make the case for an ethical and responsible use of intellectual property rights. A key part of this is ensuring that public and non-profit entities understand the benefits that their work can derive from a more commercial approach to intellectual property. Not just in terms of ownership and funding, but from alignment of commercial interests and incentives with public benefit.