The licensing of DNA patents by US academic institutions: an empirical survey.
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ABSTRACT:
SUBMITTER: Pressman L
PROVIDER: S-EPMC2726797 | biostudies-literature | 2006 Jan
REPOSITORIES: biostudies-literature
Publications
The licensing of DNA patents by US academic institutions: an empirical survey.
Pressman Lori L Burgess Richard R Cook-Deegan Robert M RM McCormack Stephen J SJ Nami-Wolk Io I Soucy Melissa M Walters LeRoy L
Nature biotechnology 20060101 1
Similar Datasets
Project description:A well-developed theoretical literature - dating back at least to Nordhaus (1969) - has analyzed optimal patent policy design. We re-present the core trade-off of the Nordhaus model and highlight an empirical question which emerges from the Nordhaus framework as a key input into optimal patent policy design: namely, what is the elasticity of R&D investment with respect to the patent term? We then review the - surprisingly small - body of empirical evidence that has been developed on this question over the nearly half century since the publication of Nordhaus's book.
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Project description:Today's colleges and universities consist of highly complex structures that dictate interactions between the administration, faculty, and student body. These structures can play a role in dictating the efficiency of policy enacted by the administration and determine the effect that curriculum changes in one department have on other departments. Despite the fact that the features of these complex structures have a strong impact on the institutions, they remain by-and-large unknown in many cases. In this paper we study the academic structure of our home institution of Trinity College in Hartford, CT using the major and minor patterns between graduating students to build a temporal multiplex network describing the interactions between different departments. Using recent network science techniques developed for such temporal networks we identify the evolving community structures that organize departments' interactions, as well as quantify the interdisciplinary centrality of each department. We implement this framework for Trinity College, finding practical insights and applications, but also present it as a general framework for colleges and universities to better understand their own structural makeup in order to better inform academic and administrative policy.
| S-EPMC6245131 | biostudies-other
Project description:ObjectiveThe purpose of this study is to describe the volume, topics, and methodological nature of the existing research literature on research data management in academic institutions.Materials and methodsWe conducted a scoping review by searching forty literature databases encompassing a broad range of disciplines from inception to April 2016. We included all study types and data extracted on study design, discipline, data collection tools, and phase of the research data lifecycle.ResultsWe included 301 articles plus 10 companion reports after screening 13,002 titles and abstracts and 654 full-text articles. Most articles (85%) were published from 2010 onwards and conducted within the sciences (86%). More than three-quarters of the articles (78%) reported methods that included interviews, cross-sectional, or case studies. Most articles (68%) included the Giving Access to Data phase of the UK Data Archive Research Data Lifecycle that examines activities such as sharing data. When studies were grouped into five dominant groupings (Stakeholder, Data, Library, Tool/Device, and Publication), data quality emerged as an integral element.ConclusionMost studies relied on self-reports (interviews, surveys) or accounts from an observer (case studies) and we found few studies that collected empirical evidence on activities amongst data producers, particularly those examining the impact of research data management interventions. As well, fewer studies examined research data management at the early phases of research projects. The quality of all research outputs needs attention, from the application of best practices in research data management studies, to data producers depositing data in repositories for long-term use.
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Project description:Citations measure the importance of a publication, and may serve as a proxy for its popularity and quality of its contents. Here we study the distributions of citations to publications from individual academic institutions for a single year. The average number of citations have large variations between different institutions across the world, but the probability distributions of citations for individual institutions can be rescaled to a common form by scaling the citations by the average number of citations for that institution. We find this feature seems to be universal for a broad selection of institutions irrespective of the average number of citations per article. A similar analysis for citations to publications in a particular journal in a single year reveals similar results. We find high absolute inequality for both these sets, Gini coefficients being around 0.66 and 0.58 for institutions and journals respectively. We also find that the top 25% of the articles hold about 75% of the total citations for institutions and the top 29% of the articles hold about 71% of the total citations for journals.
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Project description:There is national and international recognition of the importance of innovation, technology transfer, and entrepreneurship for sustained economic revival. With the decline of industrial research laboratories in the United States, research universities are being asked to play a central role in our knowledge-centered economy by the technology transfer of their discoveries, innovations, and inventions. In response to this challenge, innovation ecologies at and around universities are starting to change. However, the change has been slow and limited. The authors believe this can be attributed partially to a lack of change in incentives for the central stakeholder, the faculty member. The authors have taken the position that universities should expand their criteria to treat patents, licensing, and commercialization activity by faculty as an important consideration for merit, tenure, and career advancement, along with publishing, teaching, and service. This position is placed in a historical context with a look at the history of tenure in the United States, patents, and licensing at universities, the current status of university tenure and career advancement processes, and models for the future.
| S-EPMC4020064 | biostudies-literature
Project description:BackgroundThe contributions of Academic Medical Centers (AMCs) to biomedical innovation have been difficult to measure because of the challenges involved in tracing knowledge flows from their origin to their uses.MethodsThe authors examined patent citation linkages between AMC research funded by the National Institutes of Health (NIH) and patents. In prospective analyses, they examine the extent to which articles resulting from NIH grants to AMCs awarded between 1990 and 1995 were cited in drug and medical patents. The authors then examine the extent to which these patents are associated with marketed drugs. In retrospective analyses, they examine the share of drugs approved between 2000 and 2009 that have citation links to NIH-funded AMC research.ResultsThe prospective analyses show over a third of AMC grants resulted in publications that were cited in patents. Most the patents are drug and biotechnology patents, and are assigned to private firms. Patents citing NIH-funded AMC publications were associated with 106 new FDA approved drugs, half of which are new molecular entities and a quarter of which are priority NMEs. The retrospective analyses showed that about half of the new molecular entities approved over the 2000-2009 period had citations links to NIH-funded AMC research.ConclusionsThere are strong links between articles from NIH-funded AMC research and private sector medical patenting, including drugs. More research is needed to better understand the types of links the citations represent and their implications for public policy.
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Project description:BackgroundWhile there has been much discussion by policymakers and stakeholders about the effects of "secondary patents" on the pharmaceutical industry, there is no empirical evidence on their prevalence or determinants. Characterizing the landscape of secondary patents is important in light of recent court decisions in the U.S. that may make them more difficult to obtain, and for developing countries considering restrictions on secondary patents.Methodology/principal findingsWe read the claims of the 1304 Orange Book listed patents on all new molecular entities approved in the U.S. between 1988 and 2005, and coded the patents as including chemical compound claims (claims covering the active molecule itself) and/or one of several types of secondary claims. We distinguish between patents with any secondary claims, and those with only secondary claims and no chemical compound claims ("independent" secondary patents). We find that secondary claims are common in the pharmaceutical industry. We also show that independent secondary patents tend to be filed and issued later than chemical compound patents, and are also more likely to be filed after the drug is approved. When present, independent formulation patents add an average of 6.5 years of patent life (95% C.I.: 5.9 to 7.3 years), independent method of use patents add 7.4 years (95% C.I.: 6.4 to 8.4 years), and independent patents on polymorphs, isomers, prodrug, ester, and/or salt claims add 6.3 years (95% C.I.: 5.3 to 7.3 years). We also provide evidence that late-filed independent secondary patents are more common for higher sales drugs.Conclusions/significancePolicies and court decisions affecting secondary patenting are likely to have a significant impact on the pharmaceutical industry. Secondary patents provide substantial additional patent life in the pharmaceutical industry, at least nominally. Evidence that they are also more common for best-selling drugs is consistent with accounts of active "life cycle management" or "evergreening" of patent portfolios in the industry.
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Project description:Higher academic institutions in the UK need to drive improvements in equity, diversity, and inclusion (EDI) through sustainable practical interventions. A broad view of inclusivity is based on an intersectional approach that considers race, geographical location, caring responsibilities, disability, neurodiversity, religion, and LGBTQIA+ identities. We describe the establishment of a diverse stakeholder group to develop practical grass-roots recommendations through which improvements can be advanced. We have developed a manifesto for change, comprising six domains through which academic institutions can drive progress through setting short, medium, and long-term priorities. Interventions will yield rewards in recruitment and retention of a diverse talent pool, leading to enhanced impact and output.
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Project description:BackgroundThis study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since its first marketing authorization.MethodsA retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization.ResultsOur search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion's revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company's portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues.DiscussionOur findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.
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Project description:According to the EU Directive 2010/63, all animal procedures must be classified as non-recovery, mild, moderate or severe. Several examples are included in the Directive to help in severity classification. Since the implementation of the Directive, different publications and guidelines have been disseminated on the topic. However, due to the large variety of disease models and animal procedures carried out in many different animal species, guidance on the severity classification of specific procedures or models is often lacking or not specific enough. The latter is especially the case in disease models where the level of pain, suffering, distress and lasting harm depends on the duration of the study (for progressive disease models) or the dosage given (for infectious or chemically induced disease models). This, in turn, may lead to inconsistencies in severity classification between countries, within countries and even within institutions. To overcome this, two Belgian academic institutions with a focus on biomedical research collaborated to develop a severity classification for all the procedures performed. This work started with listing all in-house procedures and assigning them to 16 (sub)categories. First, we determined which parameters, such as clinical signs, dosage or duration, were crucial for severity classification within a specific (sub)category. Next, a severity classification was assigned to the different procedures, which was based on professional judgment by the designated veterinarians, members of the animal welfare body (AWB) and institutional animal ethics committee (AEC), integrating the available literature and guidelines. During the classification process, the use of vague terminology, such as 'minor impact', was avoided as much as possible. Instead, well-defined cut-offs between severity levels were used. Furthermore, we sought to define common denominators to group procedures and to be able to classify new procedures more easily. Although the primary aim is to address prospective severity, this can also be used to assess actual severity. In summary, we developed a severity classification for all procedures performed in two academic, biomedical institutions. These include many procedures and disease models in a variety of animal species for which a severity classification was not reported so far, or the terms that assign them to a different severity were too vague.
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