1. Background of the Amendments According to some relevant explanations of the China National Intellectual Property Administration (CNIPA) and our understanding, due to the development of science and technology, especially the development and in-depth research on human embryonic stem cells, the requirements for patent protection of human embryonic stem cell technology have gradually increased. The original regulations tend to be too strict, and they are not synchronized and unified with some present research ethics regulations.
The ethical regulations of human embryology research in China “Human Embryonic Stem Cell Research Ethics Guiding Principles” have a 14-day time limit for the study of human embryonic stem cells, that is, The period of in vitro culture of the blastocysts obtained by using in vitro fertilization, somatic cell nuclear transfer, unisex replication technology or genetic modification shall not exceed 14 days from the start of fertilization or nuclear transfer. In other words, according to the relevant regulations, a certain level of research on embryonic stem cells can be done. According to the original “Guidelines for Patent Examination”, Human embryonic stem cells and their preparation methods are all inventions that cannot be granted a patent right according to the first paragraph of Article 5 of the Patent Law, to a certain extent, some research results cannot be granted a patent right.
2. Comparison of before and after the Amendments
According to the “Guidelines for Patent Examination”, the human body at all stages of formation and development, including human germ cells, fertilized eggs, embryos and individuals, are inventions that cannot be granted a patent right as defined in Article 5, paragraph 1, of the Patent Law. The first paragraph of Article 5 of the Patent Law stipulates that patent rights shall not be granted for inventions and creations that violate the law, social ethics or hinder public interests, and thus it is a violation of social morality to use the human body at the stage of formation and development for industrial or commercial purposes, so a patent to protect it should not be granted. Prior to the amendment, the invention of embryonic stem cells would be deemed to belong to the category of inventions that cannot be granted patent rights as stipulated in Article 5, paragraph 1, of the Patent Law because they belong to the human body at the stage of formation and development.
The amendments to the “Guidelines for Patent Examination” mentioned that “embryonic stem cells do not belong to the human body at each stage of formation and development”, and deleted the content that “human embryonic stem cells and their preparation methods, which are all included in Inventions that cannot be patented according to the first paragraph of Article 5 of the Patent Law”.
After the amendments, the invention patents related to embryonic stem cells at least will not be rejected on the grounds of belonging to the human body at the stage of formation and development, which releases a large part of the restrictions on embryonic stem cells from the subject.
3. Evaluation of patentability of embryonic stem cells
Not all kind of embryonic stem cells can be the subject of invention. According to the amended Guidelines for Patent Examination, the application of human embryos for industrial or commercial purposes is still considered to be a violation of social morality. Only for those using human embryos that have not been developed in vivo and been fertilized within 14 days to isolate or obtain stem cells, they cannot be rejected to grant patent rights on the grounds of violating social morality. For “application of human embryos for industrial or commercial purposes”, if it has been developed in vivo, or if it has been fertilized for more than 14 days, it is still in violation of social morality and belongs to the category of patent rights that cannot be granted.
