中药饮片处方知识产权保护的意义及思路

文章对中药饮片处方知识产权的保护现状和保护难点进行了分析,初步阐明了中药饮片处方知识产权保护的重要性和意义.同时提出了在产品开发前期针对中药饮片处方进行专利保护、中药品种保护、处方备案保护、著作权保护、商业秘密保护等多种思路.特别是基于我国中药饮片处方发展现状和中医药管理体制,提出了较为可行的处方备案保护制度,为最终进行科学有效的中药知识产权保护奠定基础.     

试论科研课题实施过程中的知识产权保护

衡量一个单位的创新能力和竞争实力,很大程度上取决于拥有自主知识产权的质和量.本文探讨了科研课题申请、立项、执行、结题等各阶段可能出现的知识产权问题,包括申请阶段的论文与专利文献的查新检索、执行过程中产生的知识产权成果的保护、专利的申请与论文发表的关系等.并以我国《合同法》为依据论述在科研合作中的知识产权归属.从机制、制度、人员素质等角度提出知识产权保护策略.期望能够给科研工作者及管理人员有益的提示.     

我国医药卫生领域知识产权保护的现状与可持续发展

为了促进我国医药卫生领域知识产权保护和可持续发展,该文对目前的状况进行分析,总结了成功经验,探讨了存在的主要问题和阻碍发展的关键问题,为今后我国医药卫生领域知识产权的保护和可持续发展工作提出了建设性的意见。     

关于中药知识产权保护的思考

中医药是我们的国粹，是21世纪最令人关注的研究领域之一，也是被公认的产生中国知识产权的优势领域。为此，做好该领域的知识产权工作，对推动我国中药科技进步、提高我国中药的国际地位，均有着极其重要的意义。经过20多年的努力，我国知识产权保护机制基本形成，并逐渐完善。在专利申请制度不断完善的过程中，或许人们对申请知识产权保护尚缺乏正确认识和了解，或许发生在管理层面的不足，特别是中药专利申请方面所反映或暴露出的一些问题，如职务发明少、创新发明少、申请国际专利少等应该引起人们的思考。对此，笔者在分析原因的基础上，提出以下认识和建议供参考。     

知识产权保护中的社会伦理学问题初探

知识产权是当代社会国际关注的焦点问题之一 ,保护知识产权逐渐成为国际社会的共同要求。但是 ,知识产权保护不是绝对的。随着社会的变化及科技的发展 ,特别是在某些特定的社会条件下 (重大疾病爆发流行、国家安全受到严重威胁 )、在某些特定的领域中 (遗传学、基因治疗研究 ) ,知识产权保护是有条件的。一、知识产权保护及其意义知识产权也一直是我国加入世界贸易组织的焦点问题。我国政府近年积极参加与知识产权保护有关的国际组织的活动 ,已几乎是所有与知识产权有关的国际公约和条约的成员国。随着加入世贸组织的成功 ,我国还将在知识产…     

医药卫生科研管理应注意知识产权保护

“知识经济”的生命和源泉在于创新，在知识经济占主导地位的时代，不创新就难以在激烈的市场竞争中立足。同样，如何不注意对创新成果的保护，也不能在激烈的市场竞争中立于不败之地。因而科研管理要适应科技创新体系，应注意知识产权的保护。医药卫生科研管理中，计划管理、成果管理和科技开发管理与专利保护有着密切的关系。本文就有关医药卫生领域的专利保护和策略以及科研管理中注意专利保护的几个环节谈谈粗浅看法。     

医院缺乏知识产权保护意识

京津沪渝医院管理高级论坛日前在北京举行。论坛提出，我国医疗行业应注重保护知识产权。目前，医疗机构对知识产权重要性认识不足，缺乏有效的管理系统，特别是在医院的科研活动中，对专利信息有效利用严重不足。     

冷静审视药品知识产权保护法规

为了鼓励药品领域加快研发和创新，保障人们用药安全，我国近年已先后出台多项有关知识产权的法律和法规，但“入世”后，我们必须遵守与贸易有关的知识产权协议(TRIPS)的所有规定，所以有必要以协议规定的专利保护为基础，对现有法律、法规及它们之间的相互关系，进行一下清理，并在必要时对某些法规作出适当调整。     

关于高校科技管理中知识产权保护的若干思考

针对我国高校科技及管理人员的知识产权保护意识与水平不相适应，高校科学技术成果、论文与专利的比例不平衡，普通高校知识产权保护制度的建立基本上处于初级阶段等现象，指出我国加入WTO后面对日益激烈的科技、经济形势，必须加强科技管理中的知识产权保护，并提出若干对策建议。     

干细胞专利技术现状研究

目的了解国内、外干细胞相关专利的情况，为更好地应用知识产权对我国干细胞技术领域的研究成果进行保护提供合理化建议。方法根据干细胞研究专业术语确定相关主题词，以德文特（Derwent）数据库为背景，对多个专利数据库进行检索、筛查和分类，建立干细胞专利数据库。从专利的角度人手，对数据库中的2571篇国际及228篇国内干细胞专利文献进行分类分析。结果干细胞研究领域的专利申请情况总体呈上升趋势；早期专利申请主要涉及遗传工程中的DNA或RNA、载体、宿主等方面，随着研究的发展，涉及人或动物细胞或组织的专利申请逐渐增多，1998年后涉及人类细胞或组织的专利申请数量有了大幅增加，但目前仍以动物源性的细胞或组织为主（15．9％）；国内2001年以后申请的专利集中在人或动物来源的细胞或组织方面，以涉及人源细胞或组织的占首位（28．1％）。结论国内外干细胞相关专利现状的分析表明，国内在干细胞研究方面存在一定优势，应从多角度应用知识产权对研究成果进行保护。     

Access to generic antiretrovirals: inequality, intellectual property law, and international trade agreements

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-à-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.     

Evolution of the international intellectual property rights system: patent protection for the pharmaceutical industry and access to medicines

This article discusses the evolution of the international intellectual property rights system in three phases and the implications for public health, especially for the implementation of policies for access to medicines. During the first phase, characterized by the Paris and Berne Convention, signatory countries defined which technological fields should be protected (or not). Under the second phase, with the enforcement of the WTO TRIPS Agreement, countries are obliged to grant patent protection for all technological fields, including for the pharmaceutical industry. Within their national legislations, countries also have the opportunity to implement access to TRIPS flexibilities for medicines. With the third phase, characterized by the negotiation and signing of bilateral and regional free trade agreements, countries will have to implement TRIPS-plus provisions which may have negative implications for the TRIPS flexibilities as well as for policies for access to medicines. The authors conclude that the currently proposed international intellectual property rights system favors patent-holder rights and that a balance is needed between patent holders' and health rights.     

Has the implementation of the TRIPS Agreement in Latin America and the Caribbean produced intellectual property legislation that favours public health?

OBJECTIVE: The World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. METHODS: Legislation in 11 Latin American and Caribbean countries was analysed. The variables considered in the analysis were: the term of patents issued, patentable subject matter, transition periods (that is, time until legislation was enacted), reversal of the burden of proof of patent infringement, exhaustion of rights, compulsory licensing and the early working exception (which allows a country to complete all procedures necessary to register a generic product before the original patent expires). FINDINGS: By 2000, all of the countries studied had reformed their legislation to conform to the agreement. Brazil and Argentina used the transition period until 2005 to grant patents in the pharmaceutical industry. All countries, except Panama, made use of the safeguards and flexibilities available through the agreement by including mechanisms for compulsory licensing in their legislation. Argentina; Bolivia, Colombia, Ecuador, Peru and Venezuela (countries that represented the Andean community); the Dominican Republic; and Panama included mechanisms to allow parallel importation. Mexico did not. Brazil only permits parallel importation after a compulsory licence has been issued. The early working exception is included in legislation in Brazil and the Dominican Republic. CONCLUSION: The countries in this study did not incorporate all of the mechanisms allowed for by the Agreement and are not adequately using the provisions that enable World Trade Organization (WTO) members to obtain better health for the public, particularly in regard to gaining access to medicines. This situation may deteriorate in future if other agreements establish more restrictive rules for intellectual property rights.     

全国三级公立医院2010—2019年专利现状分析

目的 分析全国三级公立医院2010—2019年专利申请和授权情况,为提高公立医院知识产权保护意识,促进医疗卫生领域专利申报和转化提供参考依据.方法 通过佰腾网专利数据库进行专利文献检索,使用SPSS 19.0进行统计分析.结果 2010—2019年,全国1497家三级公立医院专利申请数共计94321件,其中实用新型专利...     

Separating online piracy from counterfeit medicines: The need for policy reform and a call to action

The recent public backlash against proposed federal anti-piracy legislation provides important lessons regarding promoting public policy for public health and patient safety online. Anti-piracy legislation contained many novel regulatory strategies that may have had an impact on combating counterfeit medicines sold by online pharmacies, but was derailed due to non-health related considerations and concerns about intellectual property rights protection. Instead, effective policy to regulate online pharmacies needs to focus on health and patient safety issues separate from intellectual property considerations to combat this online crime.     

Policy dilemmas in providing antiretroviral treatment in Brazil

This paper addresses institutional constraints that have affected Brazilian politics regarding provision of anti-retroviral treatment (ART) to HIV/Aids patients. We analyzed the normative conflict resulting from international agreements on intellectual property rights, especially patent protection, and the constitutional rights of Brazilian patients to universal and free access to ART. These constraints have not substantially changed the Brazilian public policy yet, but they may impact the future sustainability of this policy. As the main barrier to the production of patented drugs is not technological but institutional, Brazilian government faces a dilemma. It may either abide by existing monopolistic restrictions or it may incite competitiveness of domestic industries and developing countries in the pharmaceutical market.     

International investment agreements and public health: neutralizing a threat through treaty drafting

The high profile investment claims filed by Philip Morris challenging Uruguayan and Australian measures that restrict advertising and logos on tobacco packaging awakened the public health community to the existence and potential detrimental impact of international investment agreements (IIAs). More recently, Eli Lilly challenged Canada’s invalidation of a pharmaceutical patent under an IIA. All of the cases claim that the intellectual property rights of the investor were infringed. As a result of these cases, many commentators and activists view IIAs as a threat to public health and have lobbied against their inclusion in ongoing trade negotiations. This article does not argue against IIAs. Instead, it seeks to demonstrate how more sophisticated treaty drafting can neutralize the threat to public health. In this regard, the article seeks to engage members of the public health community as campaigners not against IIAs but as advocates of better treaty drafting to ensure that IIAs do not infringe upon the right of a nation to take non-discriminatory measures for the promotion and protection of the health of their populations.     

Patently obvious: a public health analysis of pharmaceutical industry statements on the Trans-Pacific Partnership international trade agreement

The Trans-Pacific Partnership Agreement (TPPA) is a regional trade agreement being negotiated by 12 countries, including New Zealand and the United States of America (USA). The patent-holding pharmaceutical industry (the Industry) has lobbied for enhanced intellectual property protections and rules affecting pharmaceutical pricing and reimbursement in the TPPA. These provisions would likely reduce access to affordable medicines. This paper reports on a study exploring how the Industry has used language to frame the TPPA in an effort to influence opinion and exert leverage. We undertook a thematic analysis of the language used in publicly available statements about the TPPA from the Industry’s national associations in the USA and New Zealand. Data included press releases, submissions and other statements dated 2008–2013. The Industry framed the TPPA as contributing to the public good. The TPPA was portrayed as redressing inequitable pharmaceutical policies, which limit people’s access to new medicines. Further, the TPPA was constructed as the route to economic growth for the USA and ultimately for all TPPA countries, through increased intellectual property protection for the pharmaceutical industry. This framing obscured tensions between Industry interests and public health goals. The Industry remained silent on the issue of affordability, a key dimension of equitable pharmaceutical access. The use of rhetoric, such as ‘win-win outcomes’ (for TPPA countries and the Industry), hid the vested economic interests of the Industry in the TPPA. Understanding the Industry’s framing of issues can assist public health advocates in challenging prevailing discourses and exposing vested interests.     

Intellectual property and access to medicines: an analysis of legislation in Central America

Globalization of intellectual property (IP) protection for medicines has been advancing during the past decade. Countries are obliged to adapt their legislation as a requirement of their membership to the World Trade Organization or as a condition of being part of international trade agreements. There is a growing recognition that, in low-income countries, stronger IP protection is a barrier to access to medicines. At the same time, the number of low-income countries writing national legislation to protect IP for pharmaceutical products is growing worldwide, but little research has been done on the ways in which this process is happening at the national level.This paper aims to contribute to the understanding of the implementation of IP legislation at the national level by providing a comparative analysis of the countries that are part of the United States–Dominican Republic–Central America Free Trade Agreement (DR-CAFTA). The analysis shows three trends. First, countries have often implemented stronger IP protection than required by trade agreements. Second, some countries have adopted IP protection before signing the trade agreements. Third, the process of ratification of DR-CAFTA increased public debate around these issues, which in some cases led to IP legislation that considers public health needs. These trends suggest that industrialized countries and the pharmaceutical industry are using more tactics than just trade agreements to push for increased IP protection and that the process of national legislation is a valid arena for confronting public health needs to those of the industry.