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本文梳理分析了自1995年—2020年10月我国国内的药品专利侵权案件,分别从案件受理年份、诉讼主体、涉案药品类别、案件审理级别、案件结论等维度进行实证分析。由上述统计分析可知,我国化学药的专利侵权案件数量最多,占比53.3%,其次为中药专利侵权案件,数量占比30.7%,生物药专利侵权诉讼案件占比16%。在我国国内药品专利中,药品的“基础专利”多掌握在国外原研制药企业手中,原研制药企业通过围绕“基础专利”进行专利布局,积极利用专利诉讼策略。本文结合实证研究,探讨了我国制药企业专利工作具体策略。 相似文献
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从药品基本专利和从属专利看我国医药企业专利战略 总被引:7,自引:1,他引:6
药品专利是药品知识产权的一项最主要组成部分,在药品知识产权保护中发挥着极其重要的作用。目前,我国医药企业已经逐渐对专利引起重视,但是在专利工作中仍存在着很多不足,尤其是大多数企业缺乏必要的、整体的、宏观的专利战略,有时进行盲目投资,从而造成巨大损失,同时也导致药品专利纠纷案件不断出现。本文介绍了药品基本专利及从属专利,提出我国医药企业专利工作中存在的问题,并提出解决问题的对策,以期对我国医药企业药品专利工作有一定借鉴。 相似文献
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专利保护期延长制度、Bolar例外和专利链接制度是美国《药品价格竞争与专利期补偿法案》中规定的3种基本制度,三者一起平衡了仿制药企业和原研药企业的利益,既促进了原研药的创新,也促进了仿制药的加速上市。药品等一些特殊商品在进入市场之前,出于公共安全的考虑,往往需要经过严格的行政审批程序,而这样的行政审批程序通常耗时较长,会导致药品在相关专利被授权后的一段时间内,因需要履行行政审批的要求而无法上市销售,专利权保护能够覆盖的市场独占期实际上被削减了。为了补偿专利权人的利益,很多国家制定了专利保护期延长制度,以弥补专利权持续期间内,由于行政审批程序导致的专利保护期的损失。我国于2008年在《专利法》中引入Bolar例外,在第四次修改专利法草案中拟引入药品专利保护期延长制度(又称作药品专利期限补偿制度)。本文详细介绍了美国药品专利保护期延长制度的实体要求和申请程序,研究了专利保护期延长期间专利权的效力,讨论了专利保护期延长与专利期限调整及Bolar例外等制度之间的关系,并对我国专利法修改提出建议。 相似文献
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申报专利是保证药品在市场上独占性销售的重要手段,本文旨在利用国际专利数据库,分析外国制药企业在中国的药品专利布局.取1985年至2012年,注册为中国的全部药品专利,从专利申请数量的发展趋势、专利权人的分布、公司分布、治疗领域以及专利类型等五个方面,分析外国制药企业在我国申请药品专利的特点及发展趋势,为我国制药公司专利保护及研发技术创新提供参考. 相似文献
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也谈医药企业的专利战略 总被引:1,自引:0,他引:1
论述专利战略是企业经营发展不可或缺的组成部分,针对医药企业实施专利战略过程中存在的问题加以分析,指出医药企业实施专利战略应采取加强医药企业科技人员的专利意识、建立科研院校和企业的合作伙伴关系、培养一批复合型人才、发展从属专利、在仿制中获得专利、进攻型和防御型专利战略的合理选择等有效措施。 相似文献
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Fleuranceau-Morel P 《Pharmacoepidemiology and drug safety》2002,11(1):37-44
It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters. 相似文献
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医药高等专科学校的教育 ,必须与现代化医药企业的生产实践相结合 ,为发展医药经济服务。学校应加强与企业的联系沟通 ,及时了解现代化医药企业的生产现状和医药经济发展对人才的需求 ,在教育教学的实践中采取一系列相应的、有效的措施。只有坚持学校与企业紧密联系 ,教育与生产劳动相结合 ,探索教学改革新路子 ,学校才能办出特色 ,受到社会、企业的欢迎。 相似文献
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实施纠正预防行动 持续改进药品质量 总被引:2,自引:0,他引:2
目的为我国药品生产企业实施纠正预防行动提供借鉴。方法综合现有有关纠正预防行动的指南,结合生产实际,采用内容分析方法。结果与结论纠正预防行动对于制药企业来讲已经变得越来越重要,我国企业应认真研究纠正预防行动在企业生产中的应用,持续改进企业的药品质量。 相似文献
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In order to survey the involvement of pharmacists in clinical drug trials (CDTs) in Norway, a questionnaire was submitted to all community pharmacies (288), pharmacy departments in hospitals (98), and pharmaceutical companies (52). The response rate was 81, 73, and 64 percent, respectively. Community pharmacies had minimal involvement, while 34 percent of the pharmacy departments had taken part in one or more CDTs annually 1980-1982. During the same three-year period, 393 trials had been started by the responding companies. Within the pharmaceutical industry 41 percent of the CDT staff were pharmacists. Pharmacists in 48 percent of community pharmacies and 96 percent of pharmacy departments in hospitals considered CDTs a pharmaceutical task. However, none of the community pharmacists and less than half of the hospital pharmacists said they had knowledge of CDT methodology. We recommend that pharmacists should be more extensively engaged in CDTs. Their participation should not be limited to traditional pharmaceutical work, but should include CDT planning and monitoring. This in turn requires education in CDT methodology, which should be included in the compulsary pharmaceutical curriculum. 相似文献
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《Clinical Research and Regulatory Affairs》2013,30(2):77-82
AbstractInternal Revenue Code and procedures concerning research expenditures in the pharmaceutical industry have very substantial effects on both the costs of drug products and the competitive position of US pharmaceutical companies which export drug products. The advantages to the community of tax credits for pharmaceutical research are reviewed in this paper and some of the practical difficulties in delineating how such credits should be qualified are discussed. 相似文献