1,720,960 research outputs found
Regulatory Competitive Shelters in the Area of Personalized Medicine
No full textMuch has been written about the ramifications of recent Supreme Court decisions in the area of patent subject matter eligibility on innovation in the area of personalized medicine. Yet, regulatory competitive shelters (RCSs) have remained largely unexplored as a mechanism for incentivizing innovation in that area, possibly in lieu of patents. Similarly, in a recent report and related guidance documents, the Food and Drug Administration (FDA) made clear its commitment to streamlining regulation in the area of personalized medicine. These documents, however, also do not address the RCSs available to personalized medicine technologies. This Article seeks to explore the existing landscape of RCSs that are currently available to personalized medicine technologies and highlight further ways in which RCSs may provide incentives for innovation in such technologies.
Published: Yaniv Heled, Regulatory Competitive Shelters in the Area of Personalized Medicine, 21 B.U. J. Sci. & Tech. L. 287 (2015)
Regulatory Competitive Shelters in the Area of Personalized Medicine
No full textMuch has been written about the ramifications of recent Supreme Court decisions in the area of patent subject matter eligibility on innovation in the area of personalized medicine. Yet, regulatory competitive shelters (RCSs) have remained largely unexplored as a mechanism for incentivizing innovation in that area, possibly in lieu of patents. Similarly, in a recent report and related guidance documents, the Food and Drug Administration (FDA) made clear its commitment to streamlining regulation in the area of personalized medicine. These documents, however, also do not address the RCSs available to personalized medicine technologies. This Article seeks to explore the existing landscape of RCSs that are currently available to personalized medicine technologies and highlight further ways in which RCSs may provide incentives for innovation in such technologies.
Published: Yaniv Heled, Regulatory Competitive Shelters in the Area of Personalized Medicine, 21 B.U. J. Sci. & Tech. L. 287 (2015)
Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.
Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012)
Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?
No full textOn March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products are based. This seeming “double dipping” raises questions regarding the need and justification, if any, for such parallel, double protection of this particular class of biological products. This article seeks to address these questions. Analyzing the fundamentals and underlying assumptions of the legal regimes of patents and statutory exclusivities, this article examines their applicability to the context of bio-pharmaceuticals. Based on the conclusions reached, this article then further examines the proposition that statutory exclusivity regimes could become a blueprint for “patentless” areas of technology, replacing the traditional patent regime with a new class of incentives to invent and invest in the development of new technology.
Published: Yaniv Heled, Patents vs. Statutory Exclusivities in Biological Pharmaceuticals - Do We Really Need Both?, 18 Mich. Telecomm. Tech. L. Rev. 419 (2012)
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Get PDFWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
Dispelling the Myths Behind First-author Citation Counts
Get PDFWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
- …
