How to promote the accessibility of technology in the era of hESC patents-A comparative analysis of the systems of the US and China.

We have entered the era of human embryonic stem cell (hESC) patents and the focus of discussion has shifted to how to rebalance interests. A potential way is to limit hESC patents and seek more effective utilization forms, such as ethical limitation, compulsory licensing, antimonopoly law regulation, experimental exception, and open licensing. This paper compares the restrictive measures in two major hESC markets, the United States and China, and explores the possibility of a balanced interests system.

Limiting hESC patents in China under a dual-value perspective: Chinese patent law has several tools available to avoid patent thickets and patent monopolization: Chinese patent law has several tools available to avoid patent thickets and patent monopolization.

Limited rights, open licenses, and compulsory licenses are measures to ensure that hESCs-related patents are optimally used to promote scientific research and economic and social development.

After He Jiankui's Case: Chinese Legislative Modifications in Human Embryo Gene Editing.

This article systematically discusses Chinese current legal status and rules for human embryo gene editing in both administrative law and criminal law after several legislative modifications, and further systematically evaluates the values and the defects of these modifications. After He Jiankui's case, Chinese legislators devoted themselves to improve human embryo gene editing legislation. As a result, human embryo gene editing's legal status becomes more determined. Rules for human embryo gene editing in Chinese administrative law have gradually become a complete system centering on "CBL-regulation," and the promulgation of Amendment (XI) to the Criminal Law reconciles the controversy existed in academic circles. Chinese rules for human embryo gene editing are moving from "doubtful development" to "complete legal system."

Realistic Dilemma and Solution of Stem Cell Application Supervision in China.

The regulatory system for the use of stem cells in China has experienced three stages of development. The internal reason for the constant changes is a lack of understanding of the legal nature of stem cells as a special object, and the external reason is the failure to reach a balance between encouraging and restricting the use of stem cells. With the introduction of China's first special regulations on stem cells in 2015, a dual-track application system for stem cell drugs and therapies has begun to take shape, but there still exists several problems such as gaps in the provisions of the upper law and unclear division of supervisory responsibilities. With respect to the regulatory system, a dual-track system with drug regulation as the mainstay and medical therapy as the supplement should be clarified. In terms of supervision design, stem cell medical therapy should be managed hierarchically according to the degree of risk, and a model should be formed in which the Ministry of Science and Technology conducts general supervision of the entire process, and the Health Commission and the Drug Administration conduct special supervision of clinical applications.

Rethink the patentability of human embryonic stem cell research findings: Relaxation based on benefit weighing.

Attitudes toward the patentability of the human embryonic stem cell (hESC) research findings are undergoing dynamic adjustment based on benefit weighing. In the early stage, ethical concerns prevailed: both the United States and China placed restrictions to some extent. As the science and technologies advance, the original balance has been broken. With a series of precedents and policies, the United States relaxes the conditions on hESCs. In this regard, China has established several rules mainly through patent examination practices. These rules are finally reflected in China's revised Guidelines for Patent Examination in 2020, which clearly defines the shift in China's stance.

Institutional Framework for the Management of Human Genetic Resources in China.

China has made efforts toward the preservation and utilization of human genetic resources (HGRs). In recent years, in the face of various issues that have become increasingly prominent in HGR research, China has continuously strengthened legislation and ethics, and has initially established a relatively complete legal system and ethical guidelines. In the design of regulatory responsibilities, a multisectoral linkage of the Ministry of Science and Technology (MOST), the National Health Commission (NHC), the National Medical Products Administration (NMPA), and the National Intellectual Property Administration (CNIPA) has been formed. In the supervision system, it includes a three-tier structure of Laws/Acts-Regulations-Guidance. In terms of management content, it mainly draws on the basic principles of international conventions such as the Convention on Biological Diversity (CBD), and implements examination and approval filing management and ethical supervision of HGR research in China.

From strict moral standards to ethical neutrality: a policy-guided shift in the patentability of human embryonic stem cells in China.

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.