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The Tree of Cellular Differentiation Major thoroughfares in obtaining differentiated cell types from human embryonic stem cells are denoted by thicker lines. Note that not all lineages are shown.
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The need to strike a better balance between free sharing and proprietary and regulatory restraint in the life sciences is becoming an important policy concern in the fields of health policy, law, and bioethics. Here we explore these issues in the field of stem cell research. Expanded funding for stem cell research and development holds unique promi...
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... researchers and institutions that want to use stem cells in their research are confronted with two major challenges: the . 69 navigation of stem cell behavior through a vast number of potential cell fates (Figure 1) and the integration of many disparate technical tools. 74 Stem cells, whether adult or embryonic, have the remarkable ability to differentiate into a large number of cell types (see Figure 1), 75 must know how mature their stem cell population is (or, in terms of Figure 1, exactly where along the cellular tree of differentiation the cell population resides). ...
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... navigation of stem cell behavior through a vast number of potential cell fates (Figure 1) and the integration of many disparate technical tools. 74 Stem cells, whether adult or embryonic, have the remarkable ability to differentiate into a large number of cell types (see Figure 1), 75 must know how mature their stem cell population is (or, in terms of Figure 1, exactly where along the cellular tree of differentiation the cell population resides). Obtaining full knowledge about differentiation is not simple: The differentiation of a stem cell is heavily dependent not only on its genome, but also on the cell's culture history. ...
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... navigation of stem cell behavior through a vast number of potential cell fates (Figure 1) and the integration of many disparate technical tools. 74 Stem cells, whether adult or embryonic, have the remarkable ability to differentiate into a large number of cell types (see Figure 1), 75 must know how mature their stem cell population is (or, in terms of Figure 1, exactly where along the cellular tree of differentiation the cell population resides). Obtaining full knowledge about differentiation is not simple: The differentiation of a stem cell is heavily dependent not only on its genome, but also on the cell's culture history. ...
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... the technical content of the stem cell patent landscape is highly complex, with stem cell lines, stem cell preparations, and growth factors subject to intense patenting activity. 104 The sheer complexity of the "tree" of mammalian cellular differentiation has important efficiency implications, with numerous lineages emanating from pluripotent stem cells and branching off to arrive at fully differentiated functional tissue cells (Figure 1). It is likely that the complex set of technologies-the growth factors, hormones, other proteins, small molecules, and culture conditions-necessary to control the early stages of differentiation (represented by the heavier lines in Figure 1) will not have many alternatives, while they are likely to be owned separately. ...
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... The sheer complexity of the "tree" of mammalian cellular differentiation has important efficiency implications, with numerous lineages emanating from pluripotent stem cells and branching off to arrive at fully differentiated functional tissue cells (Figure 1). It is likely that the complex set of technologies-the growth factors, hormones, other proteins, small molecules, and culture conditions-necessary to control the early stages of differentiation (represented by the heavier lines in Figure 1) will not have many alternatives, while they are likely to be owned separately. Nevertheless, they represent the major (patented) "thoroughfares" that will need to be traversed by many seeking different cellular destinations. ...
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This report is the culmination of a 2006 survey of U.K.- based scientists and other professionals to assess their experiences in acquiring and using or creating intellectual property (IP). Conducted by the American Association for the Advancement of Science (AAAS), the survey was undertaken not only in response to the changing landscape of IP and I...
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... In the former it is important to identify the step where human intervention stops and biological process takes over. In the latter the incremental changes make the identification of inventive step a very difficult process [8][9][10]. ...
This article enumerates the intellectual property rights (IPR) that govern Biotechnological inventions. The IPR should not only take into consideration the three criteria of patentability namely, novelty, inventive step and industrial applicability but also the moral and social aspects of the inventions. Apart from this the IPR should also focus on the benefits that the invention can bring to the society by making it more affordable and at the same time keeping in mind the costs incurred by the inventors. Keywords: Intellectual Property Rights, Biotechnology, inventions, TRIPS agreement, Patent
... Later, a standardized nomenclature for pluripotent stem cells was introduced in 2018 with unification of cell line codification and minimization of information loss and confusion regarding cell lines as goals (Kurtz et al., 2018). Nevertheless, with the growing number of registered cell lines, existing data deposition formats have made it increasingly harder for not only data depositors but also users to seek and obtain cell lines collected under different projects, disease states, and privacy issues (Godard et al., 2003;Winickoff et al., 2009). ...
The past decade has witnessed an extremely rapid increase in the number of newly established stem cell lines. However, due to the lack of a standardized format, data exchange among stem cell line resources has been challenging, and no system can search all stem cell lines across resources worldwide. To solve this problem, we have developed the Integrated Collection of Stem Cell Bank data (ICSCB) (http://icscb.stemcellinformatics.org/), the largest database search portal for stem cell line information, based on the standardized data items and terms of the MIACARM framework. Currently, ICSCB can retrieve >16,000 cell lines from four major data resources in Europe, Japan, and the United States. ICSCB is automatically updated to provide the latest cell line information, and its integrative search helps users collect cell line information for over 1,000 diseases, including many rare diseases worldwide, which has been a formidable task, thereby distinguishing itself from other database search portals.
... There are other groups working to give access to patent information in the crop innovation landscape, such as the Public Intellectual Property Resource for Agriculture. This organisation is mapping agricultural biotechnology patents to inform the development of strategies that 'improve access to intellectual property, particularly for humanitarian purposes' (Delmer et al. 2003(Delmer et al. , 1670; see also Atkinson et al. 2003;Winickoff et al. 2009). Proposed strategies include the pooling of public sector technologies and development of substitute technology (Atkinson et al. 2003;Winickoff et al. 2009). ...
... This organisation is mapping agricultural biotechnology patents to inform the development of strategies that 'improve access to intellectual property, particularly for humanitarian purposes' (Delmer et al. 2003(Delmer et al. , 1670; see also Atkinson et al. 2003;Winickoff et al. 2009). Proposed strategies include the pooling of public sector technologies and development of substitute technology (Atkinson et al. 2003;Winickoff et al. 2009). Another example is the work of the International Science and Technology Practice and Policy group at University of Minnesota. ...
One method for determining investment targets in any business sector is to determine where entities are focusing their development strategies to enhance innovation. One signal that can be used to judge where companies are innovating is publically available patent information. Using patent data is a complex process, but one that has become more viable over the last decade due to the open availability of patents online, and importantly the enhancement in software and hardware tools. This paper looks at the evolution of such tools, using research and development in crops as an example.
Crop development is one element of global food security. It may require access to plant genes data, plant patents and related information. When access to such data is restricted, innovation may stall. There are many hindrances to access, such as economic power, but they also include the legal rights created by patents, copyright and contracts. The mapping of legal rights in the innovation landscape, one that is dominated by patents, is one tool to help understand the scientific directions and investment in the field.
This paper reviews the legal rights mapping in the crop innovation landscape as an example of how patent cartography can aid knowledge of sector directions. Following an introduction, some of the literature on mapping patent data is surveyed. This is followed by a review of the research on mapping legal rights in materials from databases. The fourth part explores the potential of a cartography tool we have developed to enhance our understanding of innovation landscapes. The chapter concludes by drawing together the current state of knowledge on mapping legal rights in the crop innovation landscape.
... The VIF test shows us how much the variance of the coefficient estimate is being inflated by multicollinearity (Williams 2015). As a rule of thumb, a variable whose VIF values are greater than 10 may merit further investigation. ...
The purpose of this study is to examine the link between collaboration and innovation. Recent years have witnessed hype over the need for collaborations in the innovation process. A vast literature supports the notion that collaboration leads to more innovations. Less heard claims that collaboration might hinder innovation. This study offers empirical data on the sectoral level for two reasons: scientific research is mostly corporate; the data are collected from the stem cell industry in Israel, in which the research is conducted by research organizations. No inventors work in this field alone due to high costs of research and development (R&D). The focus on this industry provides a unique opportunity to examine the entire population and not make do with just a sample. The data include patent-based indicators of the value of innovations. Regression results support the notion of collaboration as an innovation generator, but also shed light on the nature of knowledge produced by collaborations. Collaborative patents are cited more, and they also encompass more primary and groundbreaking knowledge, as opposed to knowledge embedded in non-collaborative patents. For the first time, this study provides systematic evidence of the innovative value of collaborative patents, and thus tips the scale in favor of those supporting the establishment of collaborations. From a policy perspective, a sound innovation policy should take into account that the innovation ecosystem is organized in the form of Quadruple Helix, but more impotently, that to foster cross-sectoral collaborations, an emphasis must be placed especially on motivating firms to include in their Targeted Open Innovation Strategy, the main strategy employed by firms operating in the Quadruple Helix ecosystem, the initiation of cross-sectoral collaborations. This paper shows the need for a more open innovation ecosystem and calls for further research to assess the targeted partners.
... Second, patent thickets-in which there are a large number of overlapping patents that cover a research area-may make it impossible to identify all the patent holders and negotiate licenses with all of them. Patent thickets appear to be emerging, for example, around human embryonic and induced pluripotent stem cell lines (20), and this concern is of particular relevance with respect to microarray DNA testing and whole-genome sequencing, in which technology platforms aggregate data across large numbers of genes, many of which are patented (21). Although academic institutions are o en the victim of the resulting high licensing costs, they also contribute to thickets by patenting products and processes with little or no commercial value (13). ...
Multisectoral collaborative models for drug and therapeutic research and development (R&D) are emerging, requiring a recalibration of how intellectual property rights (IPRs) are used. Although these models appear promising, little study has been conducted on the optimal blend of sharing and exclusion as mediated through the proactive use or nonuse of IPRs. This Commentary is a call for a combination of theoretical and empirical analyses to build a comprehensive understanding of the interplay between formal IP laws, institutions that administer and manage IPRs, and the use of IPRs in practice to better construct and manage collaborations. Such analyses require outcome metrics formulated to measure the success of therapeutic outcomes and to capture the complexity of a highly networked R&D environment.
... However, in other areas such as research standards, clinical readiness, cell line quality and scientific integrity, policy uniformity appears more attainable and beneficial. The International Stem Cell Banking Initiative, the ISSCR's Registry of Provenance of Human Embryonic Stem Cell Lines and the European Commission's European Human Embryonic Stem Cell Registry serve as examples of efforts to promote international cooperation for research and clinical purposes [43]. The varying opportunities to find common ground on particular issues can be viewed on a continuum of flexibility, as represented in Fig. 1. ...
Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.
... Assessing the stem cell patent patchwork could identify hurdles in different forms of patent landscapes, in order to shape future policy . 13 14,15 16 17,18 19 20,21 22,23,24,25,26,27 What potential human and ethical costs are associated with policy patchworks and how can they best be addressed? For example, international stem cell tourism, where patients seek unproven and potentially risky stem cell treatments in countries with lax regulations, is a growing concern . ...
... In some niches of drug development the risk of anticommons has given way to the promotion of public disclosure of findings or alternatively the use of patent pools. Examples are, respectively, the Wellcome Trust (associated with the HGP) that set up a public database of single nucleotide polymorphisms (SNP, base-points of individual variation in the DNA) and the Public Intellectual Property Resources for Agriculture (PRIPRA) that organizes bundling and pooling of patents in agribusiness (seeWinickoff, Saha, and Graff, 2009). ...
This paper aims to contribute to the study of practical pursuit-worthiness in science by engaging with a case in therapeutic stem cell biology. Induced pluripotent stem cell (iPSC) research emerged from research in developmental biology and the molecular biology of cell fate conversion. It took on practical significance when proposed as an alternative to therapeutic stem cell research that used human embryonic stem cells. The supposed ability of iPSC research to tackle ethical and regulatory constraints on research at the beginning of the twentieth century was a central part of the heuristic assessment of iPSC. However, the development and transfer of knowledge from experimental and theoretical biology to preclinical pursuit conflicted with the framing of biomedical innovation in public policy. The framing of innovation operated as part of the heuristic assessment of the pursuit-worthiness of iPSCs in the United States and was characterized by attempts to underdetermine conflicting ethical and socio-economic values – to seek innovations that are “incompletely theorized” in the sense that they purportedly allow stakeholders to refrain from engagement with the divisive values that created impediments to research in stem cell biology. When conflict arose with the epistemic standards in preclinical pursuit required to ensure the safety and efficacy of biomedical innovations, it resulted in the critical appraisal of the values used to rationalize policies for the distribution of federal resources for biomedical research. The case demonstrates how non-epistemic values impinge on standards of assessment in translational science, how background assumptions about innovation can drive practical pursuit, and how conflicting values and goals in research creates an important context for the appraisal of emerging science, technology and policy.
Each cell in the human body has a distinguishable fate. Pluripotent stem cells are challenged with a myriad of lineage differentiation options. Defects are more likely to be fatal to stem cells than to somatic cells due to the broad impact of the former on early development. Hence, a detailed understanding of the mechanisms that determine the fate of stem cells is needed. The mechanisms by which human pluripotent stem cells, although not fully equipped with complex chromatin structures or epigenetic regulatory mechanisms, accurately control gene expression and are important to the stem cell field. In this review, we examine the events driving pluripotent stem cell fate and the underlying changes in gene expression during early development. In addition, we highlight the role played by the epitranscriptome in the regulation of gene expression that is necessary for each fate-related event.
