国外生物技术药品在我国的知识产权保护情况介绍

国外生物技术药品在我国的知识产权保护情况介绍１９９２年１月１７日,中美知识产权谅解备忘录正式签署,我国对美国符合条件的生物技术药品给予行政保护。１９９３年１月１日我国实行了新的专利法,对生物技术药品品种给予专利保护。这样,在双重制度下,我国科研界和制...     

FDA着手进行非专利生物技术药品等同_陛判断

欧洲有3种非专利生物技术药品[人生长激素、促红细胞生成素（EPO）、粒细胞巨噬细胞集落刺激因子（GM—CSF）]、日本有2种（人生长激素、促红细胞生成素）已经上市销售。但是,美国虽然已经确立了关于非专利生物技术药品批准制度的方针,但必要的法律制度和指南等尚不完备。围绕生物技术药品的这种环境差异源于美国食品与药物管理局（FDA）在判断专利生物技术药品和非专利生物技术药品之间的等同性上踌躇不决。     

欧洲专利局批准第一例植物技术专利

欧洲专利局(西德、慕尼黑)批准了一项有关植物的专利,这在欧洲看来还是第一例。这项专利将批给高级农业遗传科学公司(Agrigenetic Advanced Science Co.)。这项专利是使一个联接在一个植物启动子后面的植物基因在一种 T-DNA 转化系统中表达,专利包括了有关的载体、转化方法和植物材料。至今,欧洲专利协定(European Patent Convention)是否许可关于动植物的专利还未确定。但这项专利的批准为其它一些通过基因工程创造的新型动植物的专利许可开辟了道路。决定批准这项专利的关键论据是“由一种可以取得专利的技术产生的产品亦受该项专     

专利(即将)到期生物医药产品的博弈策略

1　通用名生物医药产品大有可为到期或即将到期的专利生物医药产品的投入 -产出比十分可观 ,因此是在位者 (专利药品的生产产家和所有权人 )和市场欲进入者 (通用名药品的生产者 )博弈的焦点。通用名药品对于化学制药行业已经是家常便饭 ,随着一种专利药品的保护到期 ,其他产家就可以不受其原有专利权制约而进行生产和销售 ,市场上立即涌现大批的、相对便宜的通用名药品 ,在位者的合法市场垄断地位优势几乎消失殆尽 ,但对于生物....     

抗感染药物专利到期品种筛选案例分析

无论在国际市场还是在国内市场,抗感染药物始终是品种繁多、市场份额最大的一类药物。对抗感染药物的追逐是各家医药企业聚焦的重点之一。从专利战略的角度出发,对专利即将到期药品的开发又是众多医药企业的主要选择。本文以抗感染药为例,对专利到期药物的初步筛选进行分析,探讨如何利用药品专利信息监测进行品种的筛选。     

农业生物技术领域专利态势分析

专利是技术的有效载体,通过专利态势分析可以在一定程度上有效掌握技术发展脉络及发展趋势。基于专利信息,采用定量数据、定性调研与专家智慧有机结合的方法,从申请趋势、保护市场、领域分布、重要专利权人等多维度分析视角进行农业生物技术领域专利技术态势分析。通过专利态势分析掌握全球农业生物技术专利保护概貌,指出重点方向。在此基础上结合中国农业生物技术领域专利法律状态和专利转让许可状况探讨中国农业生物技术专利保护现状及存在问题,以期支撑中国农业生物技术领域的创新决策。     

2011～2020年我国生物医学领域科技成果转化分析

基于国内转让/许可专利库数据,全面系统地对我国生物医学领域专利成果转化进行梳理分析.研究表明,虽然目前我国生物医学专利转化率偏低,且部分领域转化明显滞后,但在2015年国家修订《促进科技成果转化法》后,各方积极探索成果转化新模式,转化成绩显著,转化的技术趋势也与生物医学产业发展趋势基本符合,表明政策有效驱动转化工作开展...     

引发DNA芯片产业剧震的专利登陆日本

日本国内各公司该如何应对专利许可的要求？声称赢了Affymetrix公司的英国公司的基本专利已经登陆日本。如果不签订合同则有可能因专利侵权被起诉。考虑进军DNA芯片领域的符公司是如何应对的，我们对此进行了采访。[编者按]     

仿制药市场——中国药企的机遇在哪里？

全球仿制药市场近年来增长迅速,至2013年化学仿制药市场容量预期将高达2500亿美元,发达国家仍为最大的市场。此外在2020年前预计约有450-500亿美元的生物制药的专利也将到期,这对于生物仿制药意味着重要发展机遇。“对仿制药市场影响最大的因素主要包括专利到期,法律法规与政府政策、新兴市场发展、降价趋势以及药品采购代理和药品费用支付方的影响。”     

2005年SFDA的新规定和批准的新生物技术药物

2005年国家食品药品监督管理局（SFDA）对药品监管工作采取了一系列新举措,及时启动了对已通过GMP认证企业的飞行检查,逐步强制施行GLP规范,大力推动《疫苗流通和预防管理条例》,施行疫苗批签发管理制度.进一步完善新药审评机制,于2005年11月制定发布了《药品特别审批程序》,加快了突发事件的新药评审速度等。     

Models for facilitating access to patents on genetic inventions

The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.     

Genes and patent policy: rethinking intellectual property rights

Concerns about human gene patents go beyond moral disquiet about creating a commodity from a part of the human body and also beyond legal questions about whether genes are unpatentable products of nature. New concerns are being raised about harm to public health and to research. In response to these concerns, various policy options, such as litigation, legislation, patent pools and compulsory licensing, are being explored to ensure that gene patents do not impede the practice of medicine and scientific progress.     

Gene patents, health care policy and licensing schemes

Human gene patents continue to stir social controversy, including the possibility that they might adversely affect public access to useful technologies. It has been suggested that a compulsory licensing policy might be used to alleviate the adverse effect of patents in this context. We suggest, however, that it is unclear whether existing international policies and licensing practices will permit compulsory licensing to be used in a way that would address common concerns. Indeed, given the minor role that genetic technologies have in most health care systems, it would be difficult to justify compulsory licensing. At a minimum, policy makers need to be more realistic about the potential effects of international trade agreements on the development of biotechnology policies.     

Evaluating the Usefulness of Compulsory Licensing in Developing Countries: A Comparative Study of Thai and Brazilian Experiences Regarding Access to Aids Treatments

While compulsory licensing (CL) is described in the TRIPS agreement as flexibility to protect public health by improving access to medicines in developing countries, a recent literature contends adversely that CL may harm public health. Therefore, this article intends to evaluate the usefulness of CL in the South through the prism of obligations and goals entrusted to patent holders (the effective and non‐abusive exploitation of patents in order to achieve industrial and health developments) and in light of experiences in Thailand and Brazil regarding access to antiretroviral drugs. In this way, it shows that the obligations assigned to patent holders were better served by the recipients of CL and brought significant health and industrial benefits in the two high middle‐income countries. In particular, CL allowed the scaling‐up of free and universal access to antiretroviral drugs by assuring the financial sustainability of these public health programs endangered by monopolistic practices from patent holders.     

Burning bridges

A Wisconsin foundation's aggressive approach to patent licensing is damaging its reputation, compromising its own university's research collaborations and stymieing stem cell research.     

Recent Supreme Court decisions and licensing power

The recently decided eBay and MedImmune cases interject both reassurance and uncertainty into the present patent licensing landscape, affecting the strategic decisions to be considered during negotiations.     

Patent pools and clearinghouses in the life sciences

The biopharmaceutical industry is slowly absorbing the idea of collaborative patent licensing models. Recently, two patent pools for developing countries have been launched: the Pool for Open Innovation against Neglected Tropical Diseases initiated by GlaxoSmithKline (GSK), which is referred to as the BIO Ventures for Global Health (BVGH) pool, and the Medicines Patent Pool (MPP) initiated by UNITAID. Various organizations have recommended using pools or clearinghouses beyond the humanitarian dimension where many patents are owned by many different actors. As a first attempt, MPEG LA, which administers patent pools in various technology fields, is now setting up a clearinghouse for patents related to molecular diagnostics. These examples as well as the results from an empirical study provide useful insights for the design and administration of future pools and clearinghouses in the life sciences.     

The (political) economics of antiretroviral treatment in developing countries

Despite unprecedented international mobilisation to support universal provision of highly active antiretroviral therapy (HAART), national governments continue to play the key role in determining access to treatment. Whereas some AIDS-affected countries have performed as well as or better than expected given their level of development, institutional characteristics and demographic challenges (e.g. Thailand and Brazil), others (notably South Africa) have not. This article argues that the 'economics' of antiretroviral drug delivery is at heart a political-economy of access to treatment. It depends on commitment on the part of national governments to negotiate with pharmaceutical companies over patented antiretroviral drug prices, on their policy towards compulsory licensing, and on the approach they adopt to delivering HAART. Civil society has an important role to play in encouraging governments to become, and remain, committed to taking action to ensure sustainable and widespread access to HAART.     

Access to essential medicines: a Hobbesian social contract approach

Medicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases (such as HIV/AIDS and tuberculosis) these essential medicines are protected by patents that permit the patent-holder to operate a monopoly on their manufacture and supply, and to price these medicines well above marginal cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states' sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters.     

战略性微生物资源知识产权现状研究及发展对策

微生物作为全世界分布最广且拥有量最多的生物资源,其应用已涉及到诸多领域并展现出了巨大的经济价值和社会价值。因此研究微生物及其知识产权(intellectual property rights,IPR)全产业链的现状和发展,对于我们如何全新地认知微生物,如何挖掘微生物资源以及发挥微生物作为产业最重要部分的作用具有重要的意义。我国已形成了较为完备的微生物相关专利保护体系,已形成了基于微生物的全产业链生态发展闭环格局。本文通过以微生物专利构成实质技术转移、许可和质押相关大数据分析,通过挖掘利用各种微生物资源,从战略高度探索国家开放遗传资源的大数据,围绕微生物功能性活性成分、菌株(群)基因大数据,基于微生物功能代谢产物、基因组进行数据分析、预警和专利布局,做好微生物资源IPR现状研究及发展对策。最终形成以产业为依托,战略性资源作为引导,IPR助推微生物全产业链中核心技术引擎的格局,进而实现微生物战略资源产业集群发展。