Abstract
BackgroundThe patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars’ perspectives on patent protection for human genes.MethodsA content analysis of academic literature was conducted to identify Chinese scholars’ concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and any legal and policy recommendations offered for the gene patent regime in China.Results57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles (n = 41) that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable.ConclusionChinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China.
Highlights
The patenting of human genes has been the subject of debate for decades
The finding of this study indicates that debates about human gene patents have captured the attention of Chinese scholars, and that discussions have explored important issues associated with the patenting of human genes, e.g., benefits and potential risks, patent-eligibility of human genes, as well as challenges for the Chinese patent regime and the proposed improvements
This paper explores the background of the author(s), benefits and risks associated with gene patents, reasons for and against the gene patent regime and the patentability of human genes, as well as the suggestions for improving Chinese IP system for the patenting of genes
Summary
The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars’ perspectives on patent protection for human genes. The rapid progress of genetic diagnostic technology, along with the advent of inexpensive gene sequencing, has increased the availability and affordability of DNArelated tests and genome-based treatment for patients [1]. A recent study estimated that the gene-sequencing market in China will reach nearly $2.5 billion USD by 2021 [2]. Similar to the business model of other pharmaceutical innovations, intellectual property law has played a key role in securing a path forward to the commercialization of genetic diagnostics based on mutated segments of DNA. In 2013, the Supreme Court of the US denied the patent-eligibility for isolated genetic sequences in Association for Molecular Pathology v
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