With the growth of research in the biotechnology field in many countries, the issue of using genetic resources of one country to develop new pharmaceutical drugs or chemical compounds and commercializing such products is of concern to many countries, especially those with large biodiversity resources.
China is seeing an increasing number of patent applications involving gene-based technologies. It is fitting then, that it has revised its Patent Laws relating to genetic resources used in an invention patent.
Its amended patent law provides that if the acquisition or use of genetic resources violates relevant laws and regulations in China, any invention using such genetic resources will be barred from patenting. However, this does not mean the product cannot be marketed in the country, but then the product will not be protected by patent rights. The applicant must disclose the direct and original sources of such genetic resources and if the applicant cannot identify the source, it must specify the reason for failing to do so.
If the genetic resource is from China and a pharmaceutical product is produced using such genetic resource, it is not clear in what manner the benefit of commercialization if the drug using the genetic resource will be shared with the Chinese authorities.
If the genetic research is done in China, then the applicant must file a patent application in China first before filing a corresponding patent application overseas. The patent application must pass a confidentiality examination by the Chinese Patent Office (SIPO). The purpose of the examination is to prevent disclosure of information relating to national security or significant national interests. The recent amendments to the Chinese Patent Laws now extend this requirement (of passing the confidentiality tests) to foreign companies or individuals doing research in China, irrespective from where the genetic resource is obtained. The confidentiality examination is mandatory, regardless of whether an applicant intends to file its patent application in China first. If the applicant intends to file with a foreign patent office directly, it must submit its technical details to SIPO for a confidentiality examination beforehand. An applicant who files first with a foreign patent office without obtaining a confidentiality examination will be denied patent rights in China.
An International Application under the Patent Cooperation Treaty (PCT) system designating SIPO as the receiving office is deemed an application for the confidentiality examination.
Note that the Malaysian Patent Act also has similar provisions. For Malaysian residents, they are required to file a patent application in Malaysia first before filing overseas. Failure to do so is a severe criminal offence. Many multinational companies often overlook this provision. Although research may be done in Malaysia, the decision and action to file a patent is decided in the headquarters and often patents are first filed in the country where the head office is located.