Diseases endemic in developing countries: how to incentivize innovation

This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.     

药品专利权的功能异化与修正

高投入、高风险的制药业需要依赖药品专利权激励药品创新并促进药品获得。然而,TRIPs协定下高水平的药品专利保护体系使得药品专利权发生了一系列功能异化,具体表现为减缓药品创新速度、药品获得困难以及国际社会的财富分配不公。因此,有必要反思并重构现有的药品专利国际保护制度,借鉴并创新国际社会诸如公私合作伙伴关系模式与药物研发财税金融支持机制等已有的经验与实践,从而更好地兼顾药品创新与药品持续获得。     

中美药品上市审批过程中的专利链接问题研究

目的：为我国药品专利链接制度的发展与完善提供启示与借鉴。方法：运用案例分析、法条分析、经济分析及国内外法律制度比较分析等论证方法,剖析我国专利链接制度。结果与结论：根据我国医药产业发展水平和国民对药品可及性的实际需求,分阶段推行我国药品专利链接制度。     

FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002)

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.     

The generic drug market in Japan: will it finally take off?

Historically, brand-name pharmaceuticals have enjoyed long periods of market exclusivity in Japan, given the limited use of generics after patent expiration. To improve the efficiency of the health-care system, however, the government has recently implemented various policies aimed at increasing generic substitution. Although this has created expectations that the Japanese generic drug market may finally take off, to date, generic usage has increased only modestly. After reviewing the incentives of key market participants to choose generics, we argue that previous government policies did not provide proper incentives for pharmacies to boost generic substitution. We offer some recommendations that may help to increase generic usage.     

体育动作可专利性法律问题研究

体育产业化要求利用知识产权保护体育运动参与者的经济利益。体育动作的不断革新要求对引入专利保护进行研究。通过分析专利制度法律规定和体育动作的特性发现,体育动作具有受到专利保护的可能性。但是,通过专利保护体育动作仍然需要克服许多困难,只有体育产业和法律制度能够良好的协调和互动,才能通过体育动作的专利保护促进体育运动的进步和体育产业的健康发展。     

Prizes for innovation of new medicines and vaccines

This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research in favor of prizes. The authors conclude that a system of prizes to reward drug development would break the link between R&D incentives and product prices, and that such a reform is needed to improve innovation and access to new medicines and vaccines.     

The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe and Japan

Legal context: Pharmaceutical patent litigation is on the rise. The focal pointof this increasingly contentious area of litigation is the surgein pharmaceutical patent challenges mounted by generic drugmanufacturers. Pharmaceutical companies need to identify viableenforcement strategies that can survive these challenges andeffectively manage the life cycle of their pharmaceutical productsaround the world. Key points: The degree to which pharmaceutical companies can capitalizeupon the value of their second generation patents to extendthe protection given to existing drug products depends in parton the patent landscape, country by country, and also on theregulatory landscape for generic drug products and their entryinto the marketplace.This paper will examine the patent laws,drug approval regulations, and court decisions on the validityand enforceability of later stage or second generation patentsdirected to combination compounds, selection inventions, andnew indications, in three major jurisdictions: The United States,Europe/UK, and Japan. Practical significance: Successful pharmaceutical companies can maintain a competitiveadvantage in the global pharmaceutical industry by evaluatingand strengthening the way existing drug products are protectedand, in many cases, changing the nature of protection underthe patent laws by improving upon the pharmaceutical productitself.     

Exploring the flexibilities in TRIPS: lessons from India's pharmaceutical patent law

This article examines the extent to which the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) permits countries to utilize two key flexibilities, i.e. the exclusion of new forms of known drugs from patent protection and local working requirements to facilitate access to affordable medicines and foster domestic pharmaceutical innovation. It examines how India has implemented and recently utilized these two key flexibilities and concludes with the view that other developing countries can equally follow the Indian model.     

Patents for critical pharmaceuticals: the AZT case

Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems. This Note traces the evolution of these incentive programs--the patent system, and, to a lesser extent, the orphan drug program--and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.     

专利联营之反垄断规制分析

由于“专利灌丛”问题,产业发展越来越受控于很多分散的、独立的专利权。专利联营解决了这一问题,它整合了互补技术,降低了交易成本,排除了专利间实施的交互限制,避免了昂贵的法律诉讼。但由于专利联营固有的“联合”特点,使其必然对联合体之外的市场主体构成限制竞争,具有“垄断”的先天嫌疑,而由于专利联营政策越来越被拥有较多专利权的跨国企业控制,特别是信息领域技术标准制定中诞生的专利联营,已经凸现出滥用市场支配力、防碍技术创新的趋势。因此,有必要制定专利联营的反垄断规则。     

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.     

中国制造业走出国门的知识产权保护问题

入世后,中国产业尤其是制造业面临着专利技术侵权的严峻考验,在国际大企业不断的侵权诉讼中,寻找问题的关键和突破重围成为国内企业走出国门的当务之急。本文结合2003年里发生的中国制造业在国内外所受的专利侵权案件,分析其产生的原因,以江苏省制造业为例,试对我国制造业在WTO大背景下出口的知识产权保护问题提出相应的解决方案。     

知识产权制度的未来

知识经济的发展和数字网络的兴起使知识的创新与传播日益多样化，深刻地改变了知识产权制度的生态环境。生态环境的巨大变化进一步暴露了知识产权制度的先天缺陷，使知识产权制度面临前所未有的危机和挑战，改革现有知识产权制度与探索知识产权制度的补充或替代成为必然。知识创新激励制度的多样性、可替换性与环境适应性表明，单一制度无法提供所有知识领域的最佳激励，多元化成为未来知识产权制度的必然选择。     

专利创造性的经济学分析

专利创造性的主要经济学理论包括选择价值理论、连续发明理论、错误成本理论和互补发明理论.这些经济学理论对深入认识专利创造性提供了有益的视角,并能够对专利政策的制定以及专利创造性判断的司法实践提供帮助.分析表明,专利实践中的很多做法都暗含了这些理论分析所隐含的经济理性,但是由于经济学理论难以提供可操作性的工具,经济分析要为政策制定和创造性判断提供具体指导还需要进一步研究.     

重大突发公共卫生危机下的药品专利强制许可——现实需要、伦理因应与法律安排

新型冠状病毒肺炎于2019年底在我国爆发并迅速扩散,引发了全国性的重大突发公共卫生危机。为实现特效专利药品的充分供给,实施药品专利强制许可是最为高效的选择,不仅可以消解药品专利市场运营中所固有的“反公有地”悲剧,同时也可以有效规避药品专利国际合作中技术劫持与贸易倾轧。对于以人为本的主体性原则和与人为善的有益性原则两项伦理准则的遵循,保证了药品专利强制许可实施的伦理正义;而对于药品专利强制许可申请主体扩展和药品专利强制许可补偿标准细化两项法律完善举措的采取,则使我国药品专利强制许可机制克服了自身缺陷,能够在实践中有序运行,为重大突发公共卫生危机的化解提供制度支撑。     

Creating value through external intellectual property commercialization: a desorptive capacity view

In open innovation systems, capturing value through external intellectual property (IP) commercialization is an increasingly important strategy for firms to keep pace with competitive changes. However, many firms have major difficulties in creating value through external patent exploitation. To understand these challenges, this paper explores how firms manage their external patent exploitation based on a multiple case study research design with fourteen firms from the pharmaceutical and chemical industry. Adopting a desorptive capacity perspective we find four main factors influencing the firms’ management of external patent exploitation: the type of value creation, the organizational structure, the locus of initiative, and the extent of know-how transfer along with the patent. Based on these factors, three archetypes of external patent exploitation with different levels of desorptive capacity are identified. The article extends the concept of desorptive capacity and existing literature on intellectual property management in the context of open innovation. Managerial implications helping firms to implement external IP commercialization structures are discussed.