On 23 September 2019, China’s National Intellectual Property Administration (CNIPA) launched the 2019 amended Patent Examination Guidelines (Chinese), which became effective on 1 November 2019. In comparison to the draft amendments of 4 April 2019, things have not much changed. An example are the rules on human embryonic stem cells (hESCs).
An exclusion to the “use of Embryo for industrial or commercial purposes” is added into
Section 3.1.2, Chapter 1 of Part II of the Patent Examination Guidelines 2010 (English), clarifies that inventions-creations that are contrary to social morality shall be excluded from patent registration.
“Social morality” refers to ethical or moral norms and rules generally recognized as justifiable and accepted by the public.”
Examples were given in the Patent Examination Guidelines 2010:
- a design with drawings or photographs of violence, murder or obscenity;
- an artificial sexual organ or its substitute not for medical use;
- or a method of mating a human-being with an animal;
- a process for modifying the germ line genetic identity of human beings or a human being thus modified [this is where He Jiankui went too far. He was sentenced to three years in prison and fined RMB 3 million for illegally carrying out the human embryo gene-editing experiments, in which three genetically edited babies were born, thus modifying their genetic identity (see article by Zhang Yangfei for China Daily on 30 December 2019, here)];
- a process for cloning human beings or a cloned human being;
- use of human embryos for industrial or commercial purposes;
- and a process for modifying the genetic identity of animals which is likely to cause them suffering without any substantial medical benefit to human-beings or animals.
The 2019 draft amendments (Chinese) and the 2019 final amendments (Chinese) provide an exception to the prohibition to grant patent rights to the use of human embryos for industrial or commercual purposes. If a stem cell is isolated or obtained from a human embryo within 14 days of fertilization that has not undergone in vivo development, an invention made by using such a stem cell will be excluded from being an unpatentable subject matter.
Where the 2010 guidelines state in Section 9.1.1.1 of Chapter 10 Part II that embryonic stem cell of human beings and a preparing method thereof shall not be granted the patent right in accordance with the provisions of Article 5.1 Patent Law 2008 (English) the 2019 amended guidelines clarify that human embryonic stem cells (hESCs) do not belong to human bodies at various stages of formation and development, and are therefore eligible for patent registration.