Declaration of patent applications as financial interests: a survey of practice among authors of papers on molecular biology in Nature.
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OBJECTIVES: To determine whether authors of scientific publications in molecular biology declare patents and other potential financial interests. DESIGN: Survey of a 6-month sample of papers related to molecular biology in Nature. METHODS: The esp@cenet worldwide patent search engine was used to search for patents applied for by the authors of scientific papers in Nature that were related to molecular biology and genetics, between January and June 2005. RESULTS: Of the 79 papers considered, four had declared that certain authors had competing financial interests. Seven papers in which no financial interests were declared had authors with patent applications that were based on the research in the paper or were closely related to it. Another paper had two authors with connections to biotechnology companies that were not disclosed. CONCLUSION: Two thirds of the papers in which authors had patent applications or company affiliations that might be considered to be competing financial interests did not disclose them. Failure to disclose such information may have negative implications on the perception of science in society and on its quality if the possible bias is hidden. Journals should make greater efforts to ensure full disclosure, and scientific institutions should consider failure to disclose financial interests as an example of scientific malpractice. Establishing a register of interests for scientists is one way to increase transparency and openness. (+info)
Patome: a database server for biological sequence annotation and analysis in issued patents and published patent applications.
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With the advent of automated and high-throughput techniques, the number of patent applications containing biological sequences has been increasing rapidly. However, they have attracted relatively little attention compared to other sequence resources. We have built a database server called Patome, which contains biological sequence data disclosed in patents and published applications, as well as their analysis information. The analysis is divided into two steps. The first is an annotation step in which the disclosed sequences were annotated with RefSeq database. The second is an association step where the sequences were linked to Entrez Gene, OMIM and GO databases, and their results were saved as a gene-patent table. From the analysis, we found that 55% of human genes were associated with patenting. The gene-patent table can be used to identify whether a particular gene or disease is related to patenting. Patome is available at http://www.patome.org/; the information is updated bimonthly. (+info)
Stimulation programs for pediatric drug research--do children really benefit?
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Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children. Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations. (+info)
A proposal for measuring the degree of public health-sensitivity of patent legislation in the context of the WTO TRIPS Agreement.
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OBJECTIVE: This study aims to propose a framework for measuring the degree of public health-sensitivity of patent legislation reformed after the World Trade Organization's TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement entered into force. METHODS: The methodology for establishing and testing the proposed framework involved three main steps:(1) a literature review on TRIPS flexibilities related to the protection of public health and provisions considered "TRIPS-plus"; (2) content validation through consensus techniques (an adaptation of Delphi method); and (3) an analysis of patent legislation from nineteen Latin American and Caribbean countries. FINDINGS: The results show that the framework detected relevant differences in countries' patent legislation, allowing for country comparisons. CONCLUSION: The framework's potential usefulness in monitoring patent legislation changes arises from its clear parameters for measuring patent legislation's degree of health sensitivity. Nevertheless, it can be improved by including indicators related to government and organized society initiatives that minimize free-trade agreements' negative effects on access to medicines. (+info)
Access to generic antiretrovirals: inequality, intellectual property law, and international trade agreements.
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The governments of numerous low- and middle-income countries are currently instituting rules that strengthen changes in domestic intellectual property legislation, often made to conform to the mandates of "free" trade agreements signed with the United States. These measures frequently include intellectual property provisions that extend beyond the patent law standards agreed upon in recent World Trade Organization negotiations, which promised to balance the exigencies of public health and patent holders. In this paper, we analyze the concern that this augmentation of patent law standards will curtail access to essential medicines, particularly as they relate to the AIDS pandemic. We critically examine the potential threats posed by trade agreements vis-a-vis efforts to provide universal access to antiretroviral medications and contend that the conditioning of economic development upon the strengthening of intellectual property law demands careful attention when public health is at stake. Finally, we examine advocacy successes in challenging patent law and conclude that greater advocacy and policy strategies are needed to ensure the protection of global health in trade negotiations. (+info)
Commentary: isolated stem cells--patentable as cultural artifacts?
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This article argues that an isolated embryonic stem cell basically represents a cultural artifact that has no equivalent to cells of the embryo, and that it is likely that the isolation of adult stem cells has a similar consequence. An isolated stem cell could thus be distinguished as something other than the stem cell existing as part of a human body. Since isolation of stem cells implies modification, product patents should, where the results carry enough novelty, inventive step, and potential for industrial application, as a matter of principle be a viable option for patent authorities. Questions of morality, which may affect the patentability, should also be viewed in light of the distinction between isolated result and body part. At the same time, it is essential that patent authorities do not accept broad patent claims that will be detrimental to research. Disclosure of potential conflicts of interest is found at the end of this article. (+info)
The increasing dominance of teams in production of knowledge.
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We have used 19.9 million papers over 5 decades and 2.1 million patents to demonstrate that teams increasingly dominate solo authors in the production of knowledge. Research is increasingly done in teams across nearly all fields. Teams typically produce more frequently cited research than individuals do, and this advantage has been increasing over time. Teams now also produce the exceptionally high-impact research, even where that distinction was once the domain of solo authors. These results are detailed for sciences and engineering, social sciences, arts and humanities, and patents, suggesting that the process of knowledge creation has fundamentally changed. (+info)
Meta-analysis of traditional Chinese patent medicine for ischemic stroke.
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BACKGROUND AND PURPOSE: A large number of traditional Chinese patent medicine (TCPM) are widely used for ischemic stroke in China. The aim of this study was to systematically review the existing clinical evidence on TCPM for ischemic stroke. METHODS: We identified all TCPM that were listed in the Chinese National Essential Drug list of 2004 and those commonly used TCPM in current clinical practice for ischemic stroke. Fifty-nine TCPM were identified for further evaluation. We applied Cochrane systematic review methods. We searched for reports of randomized controlled trials and controlled clinical trials on any of the 59 TCPM for ischemic stroke comparing one TCPM with control. PRIMARY OUTCOMES included death or dependency at the end of follow-up (at least 3 months) and adverse events. Effects on neurological impairments were a secondary outcome. RESULTS: One-hundred ninety-one trials (19,338 patients) on 22 TCPM were available and included, of which 120 were definite or possible randomized controlled trials and 71 were controlled clinical trials. The methodological quality of included trials was generally "poor." Few trials reported methods of randomization. Three trials were randomized, double blind, and placebo-controlled. PRIMARY OUTCOMES: one trial on Puerarin and one trial on Shenmai injection assessed death or dependency at the end of long-term follow-up (at least 3 months) and found no statistically significant difference between 2 groups. The reported adverse events including allergic reaction, headache, nausea, diarrhea, bellyache, blood pressure change, and subcutaneous ecchymosis. Most of the adverse events were not severe. SECONDARY OUTCOMES: analysis of the secondary outcome, "marked improvement in neurological deficit," showed apparent benefits of about the same magnitude for all the TCPM studied. Of the 22 TCPM, 8 drugs (Milk vetch, Mailuoning, Ginkgo biloba, Ligustrazine, Danshen agents, Xuesetong, Puerarin, and Acanthopanax) had relatively more studies and patient numbers. CONCLUSIONS: There was insufficient good quality evidence on the effects of TCPM in ischemic stroke on the primary outcome (death or dependency). We considered the apparent benefit on neurological impairment was as likely to be attributable to bias from poor methodology as to a real treatment effect. However, because the agents assessed appeared potentially beneficial and nontoxic, further randomized controlled trials are justified. Eight drugs could be further research priorities. (+info)