State Council, Implementing Rules for the PRC Patent Law (2nd Revision)

Promulgated: January 9 2010
Effective: February 1 2010

Main contents: The Rules clarify terms and phrases of the PRC Patent Law. Article 8 of the Rules defines the term “invention or utility model completed in China” as an invention or utility model the substantive contents of whose technical solution were completed in China. Also according to the Rules, the term “genetic resource” means a material containing functional units of heredity derived from the human body, an animal, plant or micro-organism and that has actual or potential value. The term “invention or creation completed based on genetic resources” means an invention or creation completed using the genetic function of a genetic resource (Article 26).

In terms of compulsory licences, the phrase “has failed to fully exploit its/his/her patent” means that the method or scale of exploitation of the patent by the patentee and/or its/his/her licencee(s) fails to satisfy domestic demand for the patented product or patented process. The term “patented pharmaceutical” means any patented product or product directly derived from a patented process in the medical field, including the patented active ingredient required to manufacture such product as well as the diagnostic aids required to use such product, required to solve a public health issue (Article 73).