The amendments to Guidelines for Patent Examination for invention involving embryonic stem cell – Lexology

1. Background of the Amendments

According to some relevant explanations of the China National Intellectual Property Administration 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 much 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