The UK National Health Service’s 'innovation agenda': lessons on commercialization and trust

The UK National Health Service (the 'NHS'), encouraged by the 2011 report Innovation Health and Wealth, Accelerating Adoption and Diffusion in the NHS, and empowered by the Health and Social Care Act 2012, is in the process of adopting a new agenda for stimulating innovation in healthcare. For this, the bodies, body materials, and confidential health information of NHS patients may be co-opted. We explain why this brings the NHS into a moral conflict with its basic goal of providing a universal healthcare service. Putting NHS databases at the disposal of industry, without addressing ethical concerns regarding the privacy, autonomy, and moral integrity of patients and without requiring a 'kick-back' to enhance the service that the NHS provides, is inappropriate. As this article shows, with reference to the commercial arena of direct-to-consumer genetic testing, it is crucial that patient and public trust in the NHS is not eroded

Assessing the morality of the commercial exploitation of inventions concerning uses of human embryos and the relevance of moral complicity

In late 2008, the Enlarged Board of Appeal of the European Patent Office (EPO) reached a decision supporting the rejection of a patent application on human embryonic stem cells filed by the Wisconsin Alumni Research Foundation (WARF). This article comments on some of the shortcomings of the decision. The key legal provisions at issue in this case were Rule 28(c) EPC, which forbids the granting of patents in respect of biotechnological inventions which concern uses of human embryos for industrial or commercial purposes, and Article 53(a) EPC, the morality provision of the European Patent Convention. The Board rightly found the Rule to exclude WARF’s claims (but, we argue, left a “deposit loophole”). However, one of the issues the Board had to address was whether the Rule might not apply because it extended the scope of prohibited subject matter beyond that prohibited by the Article. We argue that, unless the Article had been found to exclude patentability, the applicability of the Rule could not be determined. Even though at the oral hearing before the Board, both WARF and the EPO President identified the question whether the Article (the morality provision) constituted a barrier to patentability as the core issue in this case, the Board astonishingly decided that this question did not need answering (even though the Board did hint at the basis for the answer). We argue that this is a major shortcoming of the decision. Finally, we comment on the relevance of moral complicity to the question of patentability

Something more is necessary: are genes and genetic diagnostic tests statutory subject matter for US patents?

In a recent decision (AMP v. USPTO) from the US District Court, patent claims directed at DNA sequences corresponding to human genes and to diagnostic tests based on such genes have been found to be invalid, primarily on the basis that the DNA molecules claimed, which included cDNA, primers and probes, are 'products of nature' and are thus unpatentable. If upheld, this decision will have considerable impact on the ability of biotechnical companies and universities to patent the results of their research. In this article, we will explain the basis for this decision and discuss the appropriateness of patenting discoveries and their (obvious) uses in the light of this fascinating case. While our focus will primarily be on the product claims, diagnostic method claims were also revoked in AMP v. USPTO on the basis that they were for mental acts or did not involve any 'transformation of matter'. This will be discussed in the light of the recent US Supreme Court decision in Bilski v. Kappos, which focused on the patent-eligibility of process claims

Is the enlarged board of appeal of the European patent office authorised to extend the bounds of the patentable? The G-3/85 second medical indication/EISAI and G-2/08 dosage regime/ABBOTT RESPIRATORY cases

The European Patent Convention (EPC), which governs the grant of European patents by the European Patent Office (EPO), forbids the grant of patents for methods of medical treatment. In 1984, in an attempt to find a manner in which European patents could be granted to those who found new medical treatments using existing drug compounds, the Enlarged Board of Appeal (EBoA) of the EPO sanctioned a novel form of patent claim, the "Swiss-type use claim", under which a known process for producing a known drug product was considered to acquire novelty by virtue of the new use to which the drug product was to be put. Following the revision of the EPC in 2000, in a 2010 decision, the EBoA has declared that the Swiss-type use claim is no longer to be permitted. In this article we explore the 1984 and 2010 decisions and their ramifications for the many European patents already granted with Swiss-type use claims. We conclude that the 2010 decision is both courageous and correct

Quis custodet custodes? Referral G-3/19 before the EPO Enlarged Board of Appeal and the imperative of challenging the board's interpretation of Art. 53(b) EPC

The European Patent Office Enlarged Board of Appeal was asked in April 2019 to answer two questions regarding the exclusions from patentability under Art. 53 European Patent Convention (EPC), the dominant patent law in Europe. The first related to the manner in which EPC Articles should be interpreted, and the second to whether Art. 53 EPC excluded plants and animals that are the products of the excluded "essentially biological processes." Since product claims are infringed by all processes for making the product, the second question was important-if the products are patentable, the exclusion of the processes is rendered meaningless, something which cannot have been the intention of the legislators drafting the EPC. The questions are in case G-3/19 Peppers and the Enlarged Board of Appeal handed down its opinion on May 14, 2020. In this paper we examine the background to this case, the strength of the arguments presented, and the Enlarged Board's decision which we find to dangerously undermine the Article of the EPC, Art. 164 EPC, which requires changes to the principles of what can be patentable to be democratically agreed by the parliaments of the EPC member states rather than by an administrative body of government-appointees

“You hoped we would sleep walk into accepting the collection of our data”: controversies surrounding the UK care.data scheme and their wider relevance for biomedical research

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. We will sketch the background of the scheme and look at the responses it has elicited from citizens and medical professionals. In Autumn 2013, NHS England set up a care.data website where citizens could record their concerns regarding the collection of health-related data by the Information Centre. We have reviewed all the comments on this website up until June 2015. We have also analysed the readers’ comments on the coverage of the care.data scheme in one of the main national UK newspapers. When discussing the responses of citizens, we will make a distinction between the problems that citizens detect and the solutions they propose. The solutions that are being perceived as the most relevant ones can be summarized as follows: citizens wish to further the common good without being manipulated into doing it, while at the same time being safeguarded against various abuses. The issue of trust turns out to figure prominently. 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. These concerns, moreover, have a more general relevance in relation to other contexts of medical data-mining as well as biobank research. Our analysis also offers important pointers as to how those concerns might be addressed