From strict moral standards to ethical neutrality: a policy-guided shift in the patentability of human embryonic stem ce
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From strict moral standards to ethical neutrality: a policy-guided shift in the patentability of human embryonic stem cells in China Xuekai Xie1, Jiajv Chen2*
and Zhengyang Shu2
Abstract Attitudes towards human embryonic stem cells (hESCs) in China have witnessed a significant shift in 2020 that can be attributed to China’s policy guidance. For ethical reasons, stricter standards are adopted to curb related regulations and patent licensing. Through the introduction of policies, some research on hESCs has been recognized as legitimate and feasible to a certain standard and scope. In the subsequent practice of patent examination, the dual influence of policy support and public interest has led to a shift in the examination standards of China’s intellectual property authority from “strict morality” to “ethical neutrality”, implying limited recognition of hESCs’ patentability. In view of the promotion of policy incentives for the transformation and application of corresponding research, there is considerable social demand to provide patent protection for research results. In this context, an adjustment of related regulations is illustrated in this revision, manifesting a partial shift in regulations towards a supportive stance consistent with policy. Keywords: Human embryonic stem cells (hESCs), Ethics, Policy, Patentability
Introduction In terms of both resources and the quality of research on stem cells, China’s bank of human embryonic stem cells (hESCs) is at the forefront internationally. As of June 2019, 9292 patent applications for hESCs have been filed in China, ranking the country first in the world1. Nevertheless, due to China’s rigorous regulations, only 246 have been effectively licensed2. The patentability of hESCs is mainly covered by three progressive regulations, namely, 1
The data were retrieved from the European Patent Office website with patent names and abstracts including keywords “(stem or pluripotent or totipotent or precursor or progenitor) and cell” 2 The data were retrieved from CSIPO with keyword “human embryo” * Correspondence: [email protected] 2 School of Law, Zhejiang University of Finance & Economics, Hangzhou, 18 Xueyuan Street, Jianggan District, Hangzhou, Zhejiang, China Full list of author information is available at the end of the article
the Chinese Patent Law (CPL), Implementing Regulations of the Patent Law of the People’s Republic of China and the Guidelines for Patent Examination (GPE). As a specific standard for patent applications and requests in accordance with the other two regulations, the GPE are crucial in the practice of patent review. The patentability of an invention “contrary to social morality” is excluded in article 5 of the CPL3 despite the licensing of a human embryo not being explicitly provided for. In the early GPE (2006), it was further stipulated that “the application of human embryonics for industrial or commercial purposes” shall be deemed a violation of social morality, that “hESCs and 3
According to article 5 of the CPL, no
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