Julian Cockbain

Trust is not something you can reclaim easily: patenting in the field of direct-to-consumer genetic testing.

Purpose:Recently, 23andMe announced that it had obtained its first patent, related to “polymorphisms associated with Parkinson’s disease” (US-B-8187811). This announcement immediately sparked controversy in the community of 23andMe users and research participants, especially with regard to issues of transparency and trust. The purpose of this article was to analyze the patent portfolio of this prominent direct-to-consumer genetic testing company and discuss the potential ethical implications of patenting in this field for public participation in Web-based genetic research.Methods:We searched the publicly accessible patent database Espacenet as well as the commercially available database Micropatent for published patents and patent applications of 23andMe.Results:Six patent families were identified for 23andMe. These included patent applications related to: genetic comparisons between grandparents and grandchildren, family inheritance, genome sharing, processing data from genotyping chips, gamete donor selection based on genetic calculations, finding relatives in a database, and polymorphisms associated with Parkinson disease.Conclusion:An important lesson to be drawn from this ongoing controversy seems to be that any (private or public) organization involved in research that relies on human participation, whether by providing information, body material, or both, needs to be transparent, not only about its research goals but also about its strategies and policies regarding commercialization.Genet Med 2013:15(5):382–387

“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

AbstractAn ‘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. 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.

“I prefer a child with …”: designer babies, another controversial patent in the arena of direct-to-consumer genomics

“I prefer a child with …”: designer babies, another controversial patent in the arena of direct-to-consumer genomics

Access to human tissues for research and product development

Human organs and tissues differ in regard to their clinical and research uses and the regulatory legislation controlling their use. Organs such as livers and hearts are usually taken from donors who are brain‐dead; in addition, kidneys can also come from live volunteers. Organs decay rapidly and need to be transplanted quickly. Surgeons and coordination teams in transplantation centres control the procurement, while dedicated national and international organisations facilitate their allocation. Human tissues such as bone, skin and heart valves are usually removed from cadavers in hospitals, morgues or even funeral homes and, unlike organs, can be stored—sometimes for years—in tissue banks. These tissues can be used in numerous recipients as and when they are needed. In the early days of human tissue banking, not‐for‐profit banks, mostly located in hospitals, dominated the field. The tissues they stored—heart valves and skin, for example—saved many lives. > Human tissues for research are said to be worth more than diamonds, being valued at US

Ethical sharing of health data in online platforms – which values should be considered?

500/g. Since the 1980s, the demand for human tissues has increased dramatically. The first tissue in significant demand was human bone for use in allografts in orthopaedic surgery. In the 1990s, the emerging field of regenerative medicine, which generates human tissue‐engineered products (hTEPs), began to require access to human tissues. Eventually, pharmaceutical companies began using human tissue instead of animals in the early stages of medical product testing. Human tissues for research are said to be worth more than diamonds, being valued at US

Raising the barriers to access to medicines in the developing world : the relentless push for data exclusivity

500/g. ![][1] Inevitably, commercial tissue banks were set up to capitalise on this demand, starting in the USA. Most US tissue bank companies obtain their material through Willed Body Donation programs, run by the bank itself or through offshoots. They are allowed to charge processors and distributors “reasonable fees” for the procurement of cadaver tissue—harvesting, transportation, refrigeration and so … [1]: /embed/graphic-1.gif

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

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology (ICT) platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes.With this in mind, the Science and Values Working Group of the COST Action CHIP ME ‘Citizens Health through public-private Initiatives: Public health, Market and Ethical perspectives’ (IS 1303) identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research.We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment.

Similar or the Same? Why Biosimilars are not the Solution

Abstract Since the adoption of the WTO‐TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originators data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industrys arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industrys appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free‐riding’ encounters some important problems: Neither legitimize excluding all others.

The Natural, the Informational, the Claimable? Human Body Material in US and European Patent Law

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.

Are natural products and medical diagnostic tests still eligible for patents in the USA

Advancements in the field of biotechnology have accelerated the development of drugs that are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to the complexity of the production process, generic biologics are unlikely to be chemically identical to the reference product, and accordingly are referred to as “biosimilars.” Encouraging the development of biosimilars has been presented as the key solution to decrease prices and increase access to biologics, but the development and use of biosimilars continues to raise problems, none of which can easily be addressed. Developing a biosimilar requires considerable time and financial resources, and legitimate safety concerns necessitate elaborate clinical testing of biosimilars. As a consequence, the introduction of biosimilars onto the market has not resulted in significant price reductions, and concerns regarding the substitution and interchangeability of original biologics with biosimilars persist. This article will explain how the biologics production process distorts the trade-offs that traditionally guided both patent protection and regulatory exclusivities: disclosure as a key condition for benefiting from the corresponding monopoly position. Hence, we propose establishing a mechanism of mandatory deposit of the original biologics cell line at the stage of the regulatory approval as the most effective remedy.