A new amendment to China's patent law became effective on Oct 1. There are several significant changes to the country's patent law brought out by this third amendment to the original patent law of 1984.
For example, this new amendment includes tough disclosure rules for inventions relying on "genetic resources" in China.
China is rich in genetic resources, and the Chinese government supports and encourages research to lawfully develop intellectual property derived from these assets.
For inventions that rely on genetic resources, the amendment for the first time imposes a requirement that the patent applicant disclose in the application the direct source of the genetic resources.
In addition, the applicant must disclose the original source of the genetic resources or provide a reason explaining why he is unable to do so, if the original source cannot be identified.
The prospective patentee must also prove that access to such genetic resource was lawfully obtained.
The amendment also stipulates that no patent shall be granted to inventions that rely on genetic resources if the acquisition or use of the underlying genetic resources violated Chinese law or regulations.
These changes reflect discussions held at the Convention on Biological Diversity (CBD) and were adopted after consultation by the Chinese government with other biologically diverse countries, as well as discussions with the United States and other countries that were concerned about introduction of CBD-related concepts into patent examination.
The impact of these provisions will largely depend on how "reliance" on "genetic resources" is defined and what constitutes illegal acquisition and use.
The amendment does not provide a definition of "genetic resources," nor does it limit "genetic resources" to those in China only.
According to the CBD, "genetic resources" means genetic material of actual or potential value. And "genetic material" refers to any material of plant, animal, microbial, or other origin containing functional units of heredity.
China's interest in protecting genetic resources needs to be balanced with its interest in providing certainty in patent grants, encouraging development of a biotech R&D sector, and pursuing cooperative arrangements with other countries that reflect the risks involved in biotechnology research.
Until the scope of these provisions is clarified in the "implementing regulations" and examination guidelines, the revision of which is under way at the time of this writing, prudent companies will want to make sure that the genetic resource on which the completion of the invention relies is subject to proper access and benefit-sharing mechanisms.