生物技术对专利制度的挑战与中国专利法修改探讨

蓬勃发展的现代生物技术已对传统专利制度形成了挑战。美国率先对基因、转基因技术授予专利 ,欧盟随之对生物技术发明出台法律保护指令 ,中国虽早有水稻等基因技术产品的发明与大面积种植 ,却在 2 0 0 1年修订的专利法中回避了生物技术发明的可专利性 ,使生物技术陷入努力开发但得不到充分法律保护的窘境。因此 ,阐明生物技术对专利制度的挑战 ,比较欧盟立法 ,探讨中国生物技术专利保护对生物技术发展的影响 ,及生物技术专利的国际合法性 ,对中国专利法修改提出意见 ,当前亟具意义     

The patentability of human beings: the effect of a proposed exclusion in the Patents Act 1953

The author critically examines the debate over whether "human beings" ought to be patentable. The article outlines the choices between excluding just the patenting of whole organisms or parts of organisms. After considering New Zealand, Canadian, and European Union Patent law, the author concludes that at very least New Zealand must statutorily prevent the patenting of whole organisms.     

Patenting human beings: do sub-human creatures deserve constitutional protection?

The availability of patents for genetically altered animals raises questions about the patentability of human beings. Genetic research will produce beings who fall halfway between what we currently think of as "animal" and "human." It is unclear on which side of the legal line these creatures will fall. In April 1988, Congress revised the Patent Act with a statement that human beings are not to be considered patentable subject matter. Congress, however, failed to supply a definition of the term "human being." A definition will clarify the legal status of sub-human creatures. The author addresses this problem and proposes a definition of "human being" as an amendment to the Patent Act.     

WTO规则与中国知识产权刑事立法——以美国诉中国知识产权执法措施案为背景

2007年,美国就中国知识产权执法措施向WTO提起申诉,美国三项指控中最重要的指控即中国知识产权刑事立法门槛过高,导致对知识产权保护不利,其主要法律依据为WTO的TRIPS协议第61条。本文使用WTO争端解决机构在解决争端时惯用的"条约法解释规则方法"和"综合审查原则方法",模拟站在WTO争端解决机构的角度,详细考查TRIPS第61条的上下文、TRIPS协议的目的和宗旨、中外知识产权刑事立法的历史区别、中外知识产权刑事立法体系的区别,以及中外对"构成商业规模的蓄意假冒商标和盗版"刑法规定的区别,得出如下结论:中国知识产权刑事立法虽然有待进一步完善,但并没有违反TRIPS协议第61条的规定。     

Recent developments in the patentability of software in the UK

Over the past few months there has been renewed debate at the UK Intellectual Property Office (“UK IPO”) and in the UK courts over whether computer programs can be considered patentable inventions. In particular, concern persists that the UK authorities and the European Patent Office (“EPO”) are applying different tests for the patentability of computer software, even though they are applying the same legislation. This article reviews the positions taken by the UK and the EPO tribunals, and how these impact upon businesses wishing to patent inventions encompassed in software.     

中美知识产权“刑事门槛”争端的法律问题

2007年4月美国就中国知识产权刑事保护机制问题提交WTO争端解决机构(DSB)以寻求解决。这是DSB受理的第一起就知识产权刑事保护机制问题所引发的争端。本案的争议核心是如何解释作为"刑事门槛"的《TRIPS协定》第61条所规定的"商业规模"。通过DSB解释实践,可以看出,"商业规模"的解释主权应属各成员所有,但解释边界受《TRIPS协定》第61条相关条件的限制,中国知识产权刑事保护立法机制符合《TRIPS协定》,没有必要继续下降"刑事门槛"。美国对中国知识产权的施压应由单纯要求"降低刑事门槛"转变为"如何在降低正版产品的价格情况下加大对盗版的刑事打击力度"。     

The Effects of University Patenting and Licensing on Downstream R&D Investment and Social Welfare

A central argument behind the Bayh-Dole Act presumed that firms had no incentives to invest in downstream R&D aimed at developing university inventions committed to the public domain. The empirical evidence on university patenting and licensing is partly at odds with the premises of this argument. Non-exclusive licensing of university patents has been common and lucrative, and in the area of biomedical technologies university patents and licensing restrictions may be a hindrance to downstream R&D, rather than a stimulus. The paper presents a model of R&D competition based on a university invention where appropriability conditions are defined by the patentability of downstream innovations and imitation opportunities. A comparison of equilibria under “open access” to university inventions and under “university patenting” shows that only under restrictive conditions the latter regime results in increased R&D investment and social welfare. In general, university licensing royalties are therefore a poor gauge of social welfare gains from university patenting. This is an extensive revision of the paper “University Patents, R&D Competition, and Social Welfare” presented at the conference on University Spin-Offs at the Université du Québec à Montréal on February 27th, 2004. I would like to thank the conference participants and a referee from the journal for useful comments and suggestions.     

An examination of Article 27 of the TRIPS Agreement in relation to the provisions on patentable subject matter under the PDA in Nigeria

Article 27 of the TRIPS Agreement remains the most controversial provision of the TRIPS Agreement. This provision on patentable subject matter stipulates what is permissible under patent law. This article evaluates the Patent and Designs Act by considering the extent of compliance of the Act as provided by the TRIPS Agreement. To this end, the paper proceeds in four parts excluding the introduction. In the first section, it situates the discussion within the general framework of Patent and Designs Act. The next section, turns to an examination of the compliancy of the law. Finally, in the fourth and fifth sections, it analyses the modifications necessary against the backdrop of the examination carried out in the previous section. In the concluding section, a summary of the compliance of the law in relation to the TRIPS Agreement is provided.     

Human Rights, Development, and the WTO: The Cases of Intellectual Property and Competition Policy

The World Trade Organization (WTO) has sometimes been portrayedas being at odds with the protection of human rights. This articletakes issue with this perception, both generally and with specificreference to WTO agreements/activities in the areas of intellectualproperty (IP) and competition policy. The rules and proceduresof the WTO are directly supportive of civil rights in the senseof freedom to participate in markets and freedom from arbitrarygovernmental procedures. In addition, the system contributesto development and to the realization of broader economic, social,and cultural rights, by stimulating economic growth and therebyhelping to generate the resources that are needed for the fulfilmentof such rights. The article examines various human rights andpublic interest rationales for the protection of intellectualproperty rights (IPRs). The recent amendment to the Agreementon Trade-Related Aspects of Intellectual Property Rights (TRIPS)to facilitate access to medicines in the event of public healthemergencies is outlined. With respect to competition policy,such policy constitutes an important aspect of governance insuccessful market-based economies. There is a clear need forcooperative approaches to the implementation of national competitionpolicies. The appropriate scope and venue for such cooperationare a matter for further deliberation.     

Disentangling effort and performance: a renewed look at gender differences in commercializing medical school research

Recently, questions about gender gaps in science have extended to academic technology transfer. Using systematic data on US medical school faculty, we capture both behavior and performance, examining the hypothesis that women are less likely than men to commercialize their research findings. We pooled faculty invention data from ten departments in three Academic Health Centers from 1991 to 1998??a period when patenting had become prevalent and other researchers note that a gender gap was pronounced. Rather than focusing on patenting, we capture the first step in the commercialization process, as well as the subsequent successful licensing of faculty inventions to a company. We find no significant gender differences in the likelihood of reporting inventions or successfully commercializing them. We do find differences in the number of inventions reported, however, with women disclosing fewer inventions than their male counterparts. Our results demonstrate that gender effects are highly conditioned by employment context and resources. We attribute differences in our findings with regards to gender to the use of outcome measures that capture both behavior and performance, and the inclusion of a more extensive set of control variables.     

美国对人类克隆技术的专利保护

美国专利制度中关于人类克隆技术的专利保护有三个问题 :(1)人类克隆技术是否是可享专利性的主题。 (2 )人类克隆技术能否满足可享专利性的实质条件。 (3)人类克隆技术上之专利权能否得到执行。中国应对人类克隆技术提供专利保护。     

TR IPS 协定下为公众健康限制商标使用的合法性评析

对于澳大利亚为公众健康限制商标使用权而出台的烟草通用包装法案是否违反了TRIPS协定,众说纷纭。支持和反对该法案者的三个争议焦点是:限制烟草商标的使用是否违反TRIPS协定中有关商标注册条款、TRIPS协定赋予商标权人肯定性权利还是否定性权利,以及为保护公众健康限制烟草商标使用能否构成妨碍商标使用的合理措施。结合TRIPS相关条款解释及WTO类似案例的专家组和上诉机构裁决,并对上述争议焦点逐一展开论述,确定为公众健康限制商标使用权的成员国没有违反TRIPS协定下的义务。     

TRIPS协议第13条“三步检验法”对著作权限制制度的影响——兼评欧共体诉美国“版权法110(5)节”案

从《伯尔尼公约》到TRIPS协议,三步检验法经历着从复制权限制的反限制到所有权利限制的反限制的扩大过程,其助推力则为美国版权法第110条款争端案和随后WTO专家组对TRIPS协议第13条的解释。对于三步检验法的三步优先适用顺序这一问题,WTO专家组以"等级命题"的方式给予回答。由此,三步检验法成为著作权限制制度适用的一个大前提,凸出了背后著作权人权利扩张的趋向,中国著作权法中三步检验法其实质为二步检验法,未来如何进行调整尚有待立法者和学界进一步思索。     

WTO强制许可制度的再修正

条款的模糊性是《TRIPS协议修正案》最主要的缺陷。WTO成员方可以任意解释《TRIPS协议修正案》,从而造成各WTO成员方实施《修正案》的措施不一致,WTO成员方也可规定一些不利于《TRIPS协议修正案》实施的国内措施,给《TRIPS协议修正案》的实施带来了很大的困难。明确和完善有关条款,限制WTO成员方任意解释权力,推动《TRIPS协议修正案》的认可和实施确有必要。本文建议在TRIPS协议末尾增加第74条至第84条,以作为TRIPS协议的第八部分     

Legal protection of biotechnological inventions. The European Parliament's perspective]

In 1996, the European Commission put forward a proposal for a Parliament and Concil Directive on the legal protection of biotechnology inventions. The article looks at vicissitudes which characterised the progress of the proposal in the Council and the European Parliament. The future directive will regulate the patentability of biological material, which is a particularly sensitive issue when the material is of human origin. The article also seeks to set the proposed directive in a wider context by referring to forthcoming international Convention Law on biotechnology and to the legal situation in Spain at present.     

Patenting of medical methods--need of the hour

LEGAL CONTEXT: There are differences between the legal system of various jurisdictionson the issue of patenting of medical and surgical methods. Insome jurisdictions, methods of treatment of the human body areconsidered as patentable. The need to grant patent protectionto medical methods is also reflected in the TRIPs Agreement. KEY POINTS: The article attempts to highlight the importance of grantingpatent protection to medical methods. Patents relating to themedical field fall into several categories. Though all thesepatents raise ethical issues, they are accepted by the societyand the medical profession and patents are available in allfields other than medical methods that include diagnostic, surgical,and therapeutic procedures. PRACTICAL SIGNIFICANCE: With the technological developments, new medical methods requireextensive research. The main concern is that medical methodsincrease the cost of healthcare and also stifle research. Butthese arguments are taken care of by the patent system itselfthat provides for compulsory licensing. The reality in the pharmaceuticalindustry shows that medical field is as sensitive to economicfactors as any other. Decisions of the Courts in various jurisdictionsprovide a valuable insight into the need for protection of medicalmethods. The recent milestone decisions of the US Supreme Courtand the Enlarged Board of Appeals of the European Patent Officeare an eye opener.     

GATT第15条:汇率义务衡量需提防的陷阱——基于人民币汇率义务问题的探讨

国内外论著在涉及人民币汇率义务的衡量时,普遍指向了GATT第15条,认为应当以此来确定IMF与WTO在人民币汇率义务问题上的管辖归属和衡量依据.然而,GATT第15条仅规定了IMF与WTO在经常账户下的货币兑换和国际支付方面的关系,并没有规定二者在汇率安排问题上的关系,汇率安排属于IMF辖域.西方的指责属于汇率安排问题,人民币汇率义务应由IMF依IMF协定第4条进行监督,而不应由WTO争端解决机制解决.     

从体制转换到体制协调:TRIPS的矫正之路——以发展中国家的视角

TRIPS作为由发达国家主导、发展中国家被动接受的一种制度安排,体现了发达国家的秩序主张,忽视了发展中国家的正义要求和利益关切,从而给发展中国家带来了负面社会后果。发展中国家一直没有停止过改变TRIPS的努力:首先推动在人权、公共健康、生物多样性等国际体制中制订与TRIPS相左的知识产权规范,然后试图在WTO体制内通过对TRIPS的解释和修订消除TRIPS与其它国际体制知识产权规范之间的冲突。这是一条从体制转换到体制协调的国际知识产权制度变革之路,关乎WTO成员之间利益关系的重新调整,因而势必遭到TRIPS既有秩序的受益者———发达国家的抵制,使其充满着艰难、曲折。对此,包括中国在内的发展中国家必须要有清醒的认识,做好因应准备。     

Recent Developments in China's Intellectual Property Laws

As one of the conditions in its acceptance into the WTO, theChinese government is required to comply with TRIPS. Known forits poor IPR regulations and inadequate judicial enforcement,China has nonetheless done much in recent years to reverse itsreputation as an IPR-unfriendly country, especially with theemergence of domestic technological innovations. Yet many necessaryimprovements remain to be realized, and here we provide someadvice in navigating the difficult Chinese IP system.     

贸易与人权关系初探——兼论WTO与人权

2001年11月在卡塔尔首都多哈举行的WTO第四次部长级会议通过了《关于TRIPS协议和公共健康宣言》引起了在WTO范围内知识产权的保护和人权保护之间关系的讨论,进而扩展到WTO法与国际人权法之间的关系。贸易和人权二者之间虽然存在着一定的冲突,但是二者在发展历史和实践中的联系却是不可忽视的。在现有的WTO框架下,发达国家和发展中国家基于各自的利益,都在人权问题上向对方发难。人权迟早会被纳入WTO的考虑范围之内,关键是以何种方式将其纳入WTO的范围。《多哈TRIPS宣言》是一种比较实际的方式,即就具体问题所涉及的人权达成具有国际法拘束力的协议,采用逐个、渐进的方式将人权纳入到WTO范围之内。