药品专利审查和新药注册制度的链接与完善

在医药知识产权保护体系内,目前我国十分突出的一个问题就是药品专利审查和注册管理制度的不匹配,不完善.提出要将药品专利审查和注册管理进行制度链接,必须同时在专利立法中进行防范有关注册时出现专利纠纷问题的制度设计和在药品注册立法中进行有关专利链接制度的设计.     

从社会价值角度看药品专利保护与公共健康利益的冲突

TRIPS协议将医药产品纳入专利保护范围以后，引发了国际社会对药品专利和公共健康二者利益如何平衡的争执。本文在浅述药品专利保护与公共健康双方争端由来的基础上，浅谈了争执双方的利益所在，然后从社会价值、知识产权制度的利益衡平目标等方面分析后，笔者认为，在当前公共健康不断受到AIDS、SARS、禽流感等高发传染性疾病的挑战的情况下，应在保护药品知识产权的同时，不断加强对公共健康的保护。     

Semiconductor chips, genes, and stem cells: new wine for new bottles?

This Article analogizes early semiconductor technology and its surrounding economics with isolated genes, stem cells, and related bioproducts, and their surrounding economics, to make the case for sui generis (of its own class) intellectual property protection for isolated bioproducts. Just as early semiconductors failed to meet the patent social bargain requiring novelty and non-obviousness in the 1980s, isolated genes and stem cells currently fail to meet the patent bargain requirements of non-obviousness and eligible subject matter that entitle them to traditional intellectual property protection. Like early semiconductor chip designs, nevertheless, the high cost of upstream bioproduct research and development, coupled with the need to sustain continued economic growth of the biotechnology industry, mandates that Congress provide some level of exclusive rights to ensure continued funding for this research. Sui generis intellectual property protection for isolated bioproducts would preserve the incentive to continue innovation in the field. As illustrated by the semiconductor industry, however, such sui generis protection for this technology must include limitations that address the need to provide an appropriate level of public access to facilitate downstream product development and enrich the public domain.     

论专利壁垒的剥削性

专利壁垒有两点区别于传统的非关税贸易壁垒:一是它不仅出现在跨国贸易的流通领域,而且存在于一国的产业领域;二是专利壁垒表面上是为阻止竞争产品进入专利保护地域,而实质上是为保护专利产品市场,拉动专利产品生产规模,使专利权尽可能实现价值增量,从而获得超额剩余价值,因此,专利壁垒具有剥削性。通过创新型劳动的价值计算、创新型劳动与剩余价值的形成、专利壁垒与剩余价值的实现等方面对专利壁垒的剥削性加以剖析,提出专利壁垒的应对方略不仅要从国家和企业两个层面着手,更应当从构建和谐共赢的国际知识产权法律制度和建立国际经济新秩序大视角着眼。     

中医药技术秘密保护的价值审视和风险规制

现代医药的知识产权保护是建立在以西方科技为发展基点、西医药为主要保护对象、专利保护为核心手段基础之上的产权保护制度.在应对中医药的知识产权保护时,一味遵循西药的专利保护制度无法适应中医药理论体系,依靠专利制度进行中医药知识产权保护往往捉襟见肘.相比之下,长期处于专利制度云翳背后的技术秘密保护手段,能够有效弥补传统以专利为核心的知识产权保护制度不足,成为了中医药产权保护的新常态.同时,技术秘密保护也存在着固有的缺陷,并与涉及社会公共利益的信息公开制度存在冲突.本文致力于主动审视技术秘密保护手段在中医药产权保护领域的独特价值,积极找寻破解中医药技术秘密保护困境的方法,从法律视角提供构建和完善中医药技术秘密保护的思路.     

新技术对专利实质条件制度的影响及其评价

专利实质条件为发明创造获取专利保护的准入条件。受新技术的影响 ,专利实质条件趋向宽松 ,可专利保护主题范围不断扩大。考虑到我国目前的技术发展水平 ,在知识产权国际条约的框架内 ,我国应对新技术领域内的专利申请 ,严格各项专利实质条件的标准 ,防止专利保护门槛的降低 ,并积极参加有关国际条约的制订 ,维护发展中国家的利益     

Patenting medical devices: the economic implications of ethically motivated reform

This article explores whether the current patent system strikes the optimal balance between providing incentives to inventors to bring new medical devices to the marketplace and promoting public health by ensuring that these medical devices are widely available at a reasonable price. After providing an overview of the relationship of patent law to medical devices, the author explains how ethical and economic considerations suggest the need for an alternative patent system for medical devices and notes the difficulties with this proposal. The author concludes that a combination of alternatives to the current system most equitably account for the interests and needs of both healthcare device consumers and producers.     

For the health of the economy and patent system: rationale and scope of patent attorney privilege

Legal context: There exists, in some countries, a patent attorney privilege.This privilege allows an actual or potential holder of patentrights to withhold from a court communications that it has hadwith its patent attorney. The privilege is not recognized inall jurisdictions and there is variation in the extent of theprivilege in those countries where it does exist. Key points: This article explores the rationale for the privilege in orderto see if there is a sound basis upon which to found it. Througha consideration of the justifications for other legal privileges,the article finds that patent attorney privilege is a justifiableprotection for communications between clients and their patentattorneys. If there was a possibility that the communicationswould have to be revealed in court, this may impact the fulland frank nature of the communications. Such communicationsassist patent attorneys, as professionals with expertise ina specialized field, to provide clients with appropriate andeffective advice. That advice goes directly to the maintenanceand benefit of the patent system and the overall economy. Practical significance: As a result of the variation in the extent of the privilegearound the world, there are moves afoot to reform its operation.This article reveals strong public policy reasons for the recognitionof a patent attorney privilege. These grounds also reinforcethe need to ensure that privilege is not unduly limited in itsoperation in any jurisdiction.     

Big genetic data and its big data protection challenges

The use of various forms of big data have revolutionised scientific research. This includes research in the field of genetics in areas ranging from medical research to anthropology. Developments in this area have inter alia been characterised by the ability to sequence genome wide sequences (GWS) cheaply, the ability to share and combine with other forms of complimentary data and ever more powerful processing techniques that have become possible given tremendous increases in computing power. Given that many if not most of these techniques will make use of personal data it is necessary to take into account data protection law. This article looks at challenges for researchers that will be presented by the EU's General Data Protection Regulation, which will be in effect from May 2018. The very nature of research with big data in general and genetic data in particular means that in many instances compliance will be onerous, whilst in others it may even be difficult to envisage how compliance may be possible. Compliance concerns include issues relating to ‘purpose limitation’, ‘data minimisation’ and ‘storage limitation’. Other requirements, including the need to facilitate data subject rights and potentially conduct a Data Protection Impact Assessment (DPIA) may provide further complications for researchers. Further critical issues to consider include the choice of legal base: whether to opt for what is often seen as the ‘default option’ (i.e. consent) or to process under the so called ‘scientific research exception’. Each presents its own challenges (including the likely need to gain ethical approval) and opportunities that will have to be considered according to the particular context in question.     

The attack of the clones: patent law and stem cell research

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called "Edinburgh patent", and the inquiry of the European Group on Ethics in Science and New Technologies into "The Ethical Aspects of Patenting Involving Human Stem Cells".     

农民健康权理论下我国农村合作医疗法律制度构建——以农民利益保障为研究视角

我国农村合作医疗是一项关系到8亿农民切身健康利益的重要制度，但在目前的实施过程中，仍存在医疗保障不到位、农民医疗利益被侵犯等各种问题，致使农民的生命健康权得不到应有的保障。鉴于此，以农民利益保障为研究视角，提出了我国农村合作医疗法律制度构建中的责任制度、资金制度、监管制度和纠纷解决制度以使我国农村合作医疗切实保障农民健康权的落实和农民利益的实现。     

Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

国防专利的特殊性研究——兼谈知识产权保护制度之创新

关于国防专利的特殊性主要围绕权利归属和保密性两个问题展开。在权利归属问题上,有观点认为国防专利的所有权主体只能是国家,这种观点是错误的,依据有关法条和法理基础,国防专利权归属是多元化的。在保密性问题上,确实存在着与一般专利的公开性之间的冲突,这也是采取国防专利这种特殊保护模式的根本原因所在。国防专利是专利制度的一个例外。整个知识产权保护制度也在不断发展和创新,国防专利保护对其他特殊类型的知识产权保护具有一定的借鉴意义。     

Fundamental principles of the international protection system of intellectual property rights and the applications

Legal principle, which underlies the value of the legal system, is supposed to be the origin and basis of concrete legal rules. It has also resulted from abstracting and summarizing the value and spirit of these legal rules. In light of the universality and hierarchy of legal principle, the principles of the international protection system of intellectual property rights (IPR) can be divided into the following two types: one is the fundamental principles applied to the what, why and how a legal system shall be constructed, such as principles of sovereignty, equality and mutual benefit, joint development, and international cooperation, which also can be expressed as the principles of sovereignty, international coordination and cooperation, fairness and justice. The other type includes those existing in the legal system and capable of being applied directly, such as the principle of national treatment, principle of minimum standard, principle of independence (for industrial property right), principle of independent protection (for copyright), principle of compulsory implementing patent (for patent right) and doctrine of priority (for industrial property right), etc. In my opinion, the principles of the international protection system of IPR shall follow the latter model, indicating that they shall be provided and written in the international conventions on the grounds that they can be applied directly, and that they can be universally applied to the whole international protection system of IPR instead of exclusive application to one certain system. Hereupon, the author believes that principles concerning the international protection system of IPR should include the principles of national treatment, minimum protection standard and public interest.     

从法律经济学的角度看专利制度的利弊——兼谈我国《专利法》的修订

现代专利法均毫无保留地肯定专利制度对经济发展的积极促进作用,但是,经济学家却对专利制度总体上的成本与效益众说纷纭。多数学者怀疑甚至否认专利制度的经济效益可能大于其经济成本。经济学研究成果表明专利制度会引起的巨大经济成本,该成本可能超出专利制度潜在的经济效益。因此,各国专利法应在保护专利权和公共利益之间达成一种平衡,从而减少专利制度的成本。我国的专利法过于强调专利制度的积极作用,对该制度的潜在消极影响估计不足,有待于进一步修订。     

我国药品专利司法保护制度立法与实践的宏观评析

专利司法保护之于激励创新药物研发的作用毋庸置疑,且得到了国内外研究和实践的印证。全面、宏观地梳理近年来我国药品专利案件总体情况,是评价和健全＂中国特色＂药品专利司法制度的基础。本文将在回顾我国创新药物专利保护立法现状的基础上,以＂中国知识产权裁判文书网＂登载的所有药品专利案件为样本,分析药品专利诉讼现状,并预测未来此类案件的发展趋势,以期为完善药品专利司法保护制度提供参考依据。     

论基因专利的法律限制

基因专利是特殊的专利制度。申请时应注重程序的公开性,本着专利的新颖性、实用性、创造性进行实质审查,其范围应包括基因成分专利和用途专利,在专利基因原材料的提供者和基因专利者的利益平衡中要注意原生权利和衍生权利的区别,注意保护基因提供者的利益。     

论临时保护请求权

专利法赋予了发明专利申请人一定限度的临时保护期请求权,但对该权利的规定归于模糊,其法律属性有待研究。实际上,临时保护期请求权不仅不是一个独立的权利,而且是一个极为孱弱的期待性权益,法律对其救济极为有限,不足以保护专利申请人的合法利益。赋予申请人完整的请求权利不会导致权利的滥用。法律有必要考虑做出适度的制度安排以确保专利申请人的利益,真正促进科技创新,实现知识产权法特别是专利法与民法制度的衔接。     

论基因的专利法律保护

对基因技术予以专利法律保护是必要而且急需的。世界各国对于如何设定基因保护的专利制度以及保护的程度、范围始终存有争议,但国际公约和各国的国内立法却在积极、稳妥、不间断地探索和发展着。我国正采取法律手段,不断强化基国知识产权的自我保护。     

人工智能技术对专利制度的挑战与应对

人工智能在专利发明创造领域参与程度逐渐深化,对现行的专利法带来诸多挑战。一是人工智能算法的可专利主题。因人工智能算法看似与传统的数学算法一致而被视为“智力活动的规则和方法”,尽管存有争议,但从专利法促进新技术发展和“与时俱进”的时代使命出发给予其专利保护是较为务实的做法。二是人工智能时代的专利审查标准。针对传统专利性判断标准已在人工智能时代失灵,适当调整“专利三性”,确立适合于人工智能专利的“新三性”标准。三是人工智能生成发明权利主体的界定。在人为因素仍作用的弱人工智能时代,可以基于专利法中“二元主体结构”,承认人工智能作为发明人的资格,同时将专利权赋予人工智能开发者或管理者。四是人工智能专利侵权认定。在人工智能专利侵权责任承担主体上采取动态区分规则:区分人工智能不同的发展阶段;区分不同阶段人类介入因素的作用;区分不同阶段不同主体对侵权结果的作用等。