Jorge L. Contreras

Prepublication data sharing.

Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.

Prepublication Data Release, Latency, and Genome Commons

Scientific information commons can be modulated by adjusting the twin “dials” of knowledge and rights latency. Researchers must disclose their data in order to achieve recognition and to enable others to test, validate, and challenge their hypotheses. In doing so, they create bodies of shared knowledge that are analogous to traditional public resources, such as forests and freeways, often referred to as “commons” (1, 2). The rate at which data are added to these information commons, however, varies greatly. The traditional practice has been to contribute experimental and observational data to the commons when, or shortly after, the analysis of that data is published, sometimes years after its initial collection (3, 4). Because of busy schedules, competitive pressures, and other interpersonal vagaries, the sharing of scientific data can be inconsistent even after publication (5, 6). Many traditional data-sharing practices were challenged, with significant and lasting effect, during the race to sequence the human genome.

CRISPR, Surrogate Licensing, and Scientific Discovery

Have research universities abandoned their public focus? Several institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved (1–4). But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of license agreements with commercial enterprises (see the figure). With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or “surrogate” company formed by the institution and one of its principal researchers (5, 6). Although this model, in which a university effectively outsources the licensing and commercialization of a valuable patent portfolio to a private company, is not uncommon in the world of university technology transfer, we suggest it could rapidly bottleneck the use of CRISPR technology to discover and develop useful human therapeutics.

NIH's genomic data sharing policy: timing and tradeoffs

NIHs new genomic data sharing (GDS) policy covers both human and model-organism genotypic and phenotypic data, and strives to balance rapid release of data with embargo periods to ensure that data producers have sufficient time to analyze their results. But how well does the policy achieve this balance?

Sharing by Design: Data and Decentralized Commons

Overcoming legal and policy obstacles Ambitious international data-sharing initiatives have existed for years in fields such as genomics, earth science, and astronomy. But to realize the promise of widespread sharing of scientific data, intellectual property, data privacy, national security, and other legal and policy obstacles must be overcome (1). Although these issues have attracted much attention in some circles, they have often taken a back seat to addressing technical challenges. Yet failure to account for legal and policy issues at the outset of a large transborder data-sharing project can lead to undue resource expenditures and data-sharing structures that may offer fewer benefits than hoped. Drawing on our experience with the Belmont Forum, a multinational earth change–research program, we propose a framework to help plan data-sharing arrangements with a focus on early-stage decisions including options for legal interoperability.

The International Serious Adverse Events Consortium

The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.

Fixing FRAND: A Pseudo-Pool Approach to Standards-Based Patent Licensing

Technical interoperability standards are critical elements of mobile telephones, laptop computers, digital files, and thousands of other products in the modern networked economy. Most such standards are developed in so-called voluntary standards-development organizations (SDOs) that require participants to license patents essential to the standard on terms that are “fair, reasonable and non-discriminatory” (FRAND). FRAND commitments are thought to avoid the problem of patent hold-up: the imposition of excessive royalty demands after a standard has been widely adopted in the market. While, at first blush, FRAND commitments seem to assure product vendors that patents will not obstruct the manufacture and sale of standards-compliant products, in reality these commitments are vague and unreliable. Moreover, they have proven ineffective to address the problem of patent stacking, which occurs when multiple patent holders assert rights in, and demand royalties on, the same standard. The recent surge of litigation in the smart phone and other technology sectors, much of which concerns the interpretation and enforcement of FRAND commitments, has brought these issues to the attention of regulators, industry, and the public, and many agree that a better approach to FRAND is needed. In this paper, I propose a novel solution to the SDO FRAND problem that borrows from the related field of patent pools. In patent pools, multiple patent holders agree to charge a single, collective royalty on patents included in the pool. This structure, which has been utilized in connection with several successful industry standards, allows market participants to manufacture and sell standards-compliant products with a high degree of certainty regarding their aggregate royalty burden. While the cost and administrative overhead of patent pools may make them inapposite for the majority of standards developed in the SDO setting, salient features of pools can be adapted for use in SDOs under what I term a “pseudo-pool” approach. The pseudo-pool approach includes the following principal elements: (a) SDO participants must declare patents in good faith, (b) SDO working groups that include patent holders and potential vendors are encouraged to establish aggregate royalty rates for standards, (c) patent holders continue to grant licenses on FRAND terms, subject to the aggregate royalty agreement, (d) each patent holder is entitled to a share of the aggregate royalty based on a proportionality measure, (e) there is a defined penalty for over-declaration of patents, (f) each patent holder is permitted to license its patents independently of the pseudo-pooling arrangement, and (g) patent holders can opt out of the collective royalty structure if they so choose. This proposal encourages joint negotiation of royalty rates prior to lock-in of a standard, conduct that has been viewed with approval by several regulatory agencies and acknowledged as offering various procompetitive benefits. It is hoped that the proposed structure will eliminate the current uncertainty surrounding royalty levels on standardized products, while at the same time addressing the related issue of patent royalty stacking.

The International Serious Adverse Events Consortium's data sharing model

17 The mission of the iSAEC is to coordinate and fund research on the identification of DNA markers that confer a risk on individuals for drug-induced serious adverse events. The iSAEC engages academic collaborators and networks around the world to collect DNA samples and associated phenotypic data, and then to conduct genome-wide association studies (GWAS), targeted sequencing and statistical analyses to identify potential markers and associations of interest, including drug-induced liver injury12,13 and serious skin rash14. Because drug-induced serious adverse events for marketed substances are rare and occurrences are geographically scattered and symptoms are often underdiagnosed or misdiagnosed, the iSAEC faces numerous challenges in assembling properly sized sample collections to conduct statistically meaningful analyses. Fostering collaboration with academic and clinical networks around the world has thus become a critical element of iSAEC’s research program (Supplementary Table 1). To date, the iSAEC has established relationships with more than 50 academic and clinical groups and has formed two dedicated clinical networks (the International DILI (drug-induced liver injury) Consortium and the International Consortium on Drug Hypersensitivity) to accelerate the collection of suitable cases and related DNA samples. It has also supported phenotype standardization efforts15–17 to promote the rational and consistent identification of case subjects across multiple collection sites. Given the importance of iSAEC’s research to overall drug safety, the US Food and Drug Administration (FDA) has been an active participant in the consortium’s programs, though neither FDA nor any other governmental entity has provided financial support for iSAEC’s activities. Although the members of the iSAEC are primarily commercial entities that individually hold important patent assets, the express policy of the iSAEC is to make its research results available to the public free of any patent encumbrances. By removing IP protection constraints, this policy aims to provide both members and nonmembers with unfettered access to valuable data and to promote biomedical research in drug-induced serious adverse events. This public commitment of IP serves as a cornerstone of iSAEC’s charitable tax-exempt status and also alleviates concerns regarding potential 4. Topol, E. The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care (Basic Books, 2012). 5. Kaphingst, K.A. et al. Genet. Med. 14, 681–687 (2012). 6. Bloss, C. et al. N. Engl. J. Med. 364, 524–534 (2011). 7. Anonymous. Lancet 379, 386 (2012). 8. Borry, P. et al. Eur. J. Hum. Genet. 20, 715–721 (2012). 9. European Academies Science Advisory Council & the Federation of European Academies of Medicine. Direct-to-Consumer Genetic Testing for Health-Related Purposes in the European Union: The View from EASAC and FEAM (EASAC policy report 18) (EASAC, 2012). <http://www.easac.eu/home/reports-and-statements/ detail-view/article/direct-to-co.html> Effy Vayena1 & Barbara Prainsack2 1University of Zurich, Institute of Biomedical Ethics, Zurich, Switzerland. 2King’s College London, Department of Social Science, Health and Medicine, London, UK. e-mail: vayena@ethik.uzh.ch

Intellectual property issues and synthetic biology standards

In response to a recent article describing the Synthetic Biology Open Language (SBOL), a mechanism for enabling collaboration among synthetic biology researchers, the authors draw attention to the growing number of intellectual property issues that may affect technical standards for biomedical research. They point out that similar data exchange and interoperability frameworks in fields such as telecommunications and semiconductors have been fraught with patent disputes. They urge the biomedical research community to take heed of the lessons learned from other fields and give due consideration to policies concerning the use and exploitation of patents prior to the development of key interoperability standards.

Patent Pools for CRISPR Technology — Response

It appears that Horn concurs with our assessment of the potential development bottlenecks arising from the current CRISPR licensing model. We welcome his creative thinking about further ways to open CRISPR technology to a broader market. We are aware that patent pools have been successfully