[Jian Xu] Bolar exception and genetic resources protection in China

Bolar exception

Of particular relevance to pharmaceutical companies, China patent law also recognises the exception to infringement similar to the Bolar exception in the United States, as it is not regarded as infringement by "producing, using or importing patented medicine or patented medicinal equipment for the purpose of providing the information as required for administrative examination and approval, and producing and importing the patented medicine or patented medicinal equipment exclusively for the said purpose". This clause is favourable to generic drug manufacturers as it will allow them to put their products on the market right after a pharmaceutical patent expires.

Genetic resources

China has realised its rich genetic resources and is seeking to protect them. China patent law states that "For an invention based on genetic resources, the applicant shall state the direct source and the original source of the genetic resources in the application documents. If the applicant is not able to state the original source, it or he shall state the reasons." Disclosure is compulsory for inventions relying on genetic resources. This clause is thus important to pharmaceutical companies which exploit genetic resources for drug discovery. Failure to comply with the disclosure rule can result in the patent being invalid.