Scholar's Award: Crisis at the Patent Office: Rethinking the Patentability of Biotechnology in Comparative Perspective

该项目的目的是通过比较美国和欧洲关于生物技术专利的争议，更深入地了解关于专利制度在当代社会中的作用的日益增长的全球政治。近年来，由于专利已成为创新过程的核心，而创新过程被认为是国家和地区经济健康的组成部分，专利制度也已成为在许多紧迫的全球公共政策问题上发生冲突的主要论坛。在反对世界贸易组织的街头抗议活动中，在欧洲专利局的会议室中，以及在两者之间的许多地方，批评人士要求知识产权制度必须改变，以考虑到其决定的伦理和社会影响，包括贸易自由化对发展中世界的影响、公民获得负担得起的保健的权利、生活商品化和市场的伦理界限。以及自由科学探究的局限性。与此同时，为现状辩护的人辩称，专利局不是解决此类问题的合适场所；在这个空间里，发明者有权排除他人制造一项发明，并且无法控制一项发明是否或如何实际使用。本项目探讨政治背景是否以及如何影响这些挑战的形式和实质，这些挑战对专利局的地位和合法性的影响，以及专利局是否以及如何构建以解决这些问题。研究者提出了以下问题：1)这些辩论的形式在美国和欧洲之间有何不同？它们在主题、参与者、赢家和输家方面是否有所不同？2)如果这些争论不同，那么为什么？这些差异是否可以从政治结构或文化的角度来解释，或者在两种情况下都发生的生物技术和知识产权的更广泛斗争的背景下解释？3)这些辩论的参与者如何设想专利局在知识生产、其管辖权（国家、地区或全球）、科学与市场之间的关系以及社会和道德秩序的配置方面的作用？4)批评者提出了哪些替代方法来将伦理和社会考虑纳入专利局的审议？这些在政治上、经济上和社会上可行吗？5)在其他情况下，我们是否以及如何将伦理或社会问题纳入科技政策制定中，这一领域的政治能否教会我们任何东西？研究者通过使用定性研究方法来解决这些问题，包括访谈、人种学观察和文献分析。除了从广义上描述过去30年来发生的生物技术专利辩论之外，研究者还通过关注四种类型的生物技术专利的争议来组织分析，这些争议涵盖了该领域正在讨论的广泛问题。研究者将在包括人类胚胎干细胞、疾病基因、包括动物在内的高等生命形式、本土知识和转基因生物在内的专利中进行选择。这项研究与科学技术研究、生命伦理学和公共政策领域的学术研究有关。它有助于对生物技术的比较政治研究的增长，它也有助于我们对科学和技术政策世界中运作的组织的形态、政治和稳定性的理解。此外，该项目还提供了关于在其他情况下是否以及如何将伦理和社会问题纳入专利政策和科技政策的见解。

The objective of this project is to gain a deeper understanding of the growing global politics about the role of the patent system in contemporary societies, by comparing the controversies over patenting biotechnology in the United States and Europe. In recent years, as patents have become central to innovation processes that are considered integral to the health of national and regional economies, the patent system has also become a major forum for clashes over many pressing global public policy issues. At street protests against the World Trade Organization, in meeting rooms at the European Patent Office, and many places in between, critics are demanding that intellectual property regimes must change to take into account the ethical and social implications of their decisions, including the consequences of trade liberalization for the developing world, the rights of citizens to affordable health care, the commodification of life and ethical boundaries of markets, and the limits of free scientific inquiry. Defenders of the status quo, meanwhile, argue that the patent office is not an appropriate venue for such questions; it is a space where inventors are given a right to exclude others from manufacturing an invention, and has no control over whether or how an invention is actually used. This project addresses whether and how political context influences the shape and substance of these challenges, the implications of these challenges for the status and legitimacy of patent offices, and whether and how patent offices can be structured to address these concerns. The investigator poses the following questions: 1) How do the shapes of these debates vary between the United States and Europe? Do they vary in terms of their themes, their participants, and the winners and losers? 2) If these debates vary, then why? Can these differences be explained in terms of political structures or cultures, or in the context of the broader battles over biotechnology and intellectual property rights that are occurring in both contexts?3) How do the participants in these debates envision the patent office''s role, in terms of knowledge production, its jurisdiction (national, regional, or global), the relationship between science and markets, and the configuration of social and moral orders?4) What alternative methods are critics proposing to incorporate ethical and social considerations into patent office deliberations? Are any of these politically, economically, and socially feasible?5) Can the politics in this domain teach us anything about whether and how we can incorporate ethical or social concerns into science and technology policymaking in other contexts?The investigator addresses these questions by using qualitative research methods, including interviews, ethnographic observation, and document analysis. In addition to characterizing, in a broad sense, the biotechnology patenting debates that have occurred over the past 30 years, the investigator organizes the analysis by focusing on controversies over four types of biotechnology patents that cover the breadth of issues that are being debated in this arena. The investigator will choose among patents covering human embryonic stem cells, disease genes, higher life forms including animals, indigenous knowledge, and genetically modified organisms. This study is relevant to scholarship in the fields of science and technology studies, bioethics, and public policy. It contributes to the growing body of research on the comparative politics of biotechnology, and it also facilitates our understanding of the shape, politics, and stability of organizations that operate in the world of science and technology policy. Furthermore, the project provides insight into whether and how ethical and social concerns can be incorporated into both patent policy and science and technology policy in other contexts.