Abstract

The amended Patent Law provides that no patent right shall be granted for an invention-creation in violation of the provisions in the laws and administrative regulations and completed relying on genetic resources. The Patent Law also provides that, for an invention-creation completed relying on genetic resources, the applicant shall indicate the direct source and the original source of the genetic resources in the application documents; if the applicant cannot indicate the original source, he or it shall state the reasons.

Relevant Provisions

According to Article 5 paragraph 2 of the Patent Law, no patent right shall be granted for an invention-creation completed relying on genetic resources, if the acquisition or utilization of the said genetic resources is in violation of laws or administrative regulations.

According to Article 26 paragraph 5 of the Patent Law, for an invention-creation completed relying on genetic resources, the applicant shall indicate the direct source and the original source of the genetic resources in the application documents; if the applicant cannot indicate the original source, he or it shall state the reasons.

The terminologies in the above articles of the law are interpreted as follows:

1. Definition for “invention-creation completed relying on genetic resources” in Article 5 paragraph 2 of the Patent Law

Rule 26 paragraph 1 of the Implementation Regulations of the Patent Law provides that an invention-creation completed relying on genetic resource in the Patent Law refers to an invention-creation the completion of which utilizes the genetic functions of genetic resources.

The content that “the completion of an invention-creation utilizes the genetic functions of genetic resources” means that functional units of heredity are isolated, analyzed, treated and so on, so as to complete the invention-creation and realize the value of the genetic sources.

2. Definition for “genetic resources”

Rule 26 paragraph 1 of the Implementation Regulations of the Patent Law provides that “genetic resources” in the Patent Law refers to materials obtained from a human body, an animal, a plant or a microorganism etc. which contain functional units of heredity and have actual or potential values.

“Materials obtained from a human body, an animal, a plant or a microorganism etc. which contain functional units of heredity” refers to carriers of functional units of heredity, which include not only the whole organism but also some parts of an organism, such as organs, tissues, blood, humor, cells, genomes, genes, DNA or RNA fragments, etc.

3. “Genetic function”

“Genetic function” refers to the capability of an organism to pass down a trait or characteristic generation by generation through propagation or to replicate the whole organism.

4. “Functional units of heredity”

“Functional units of heredity” refers to a gene or DNA or RNA fragments having genetic functions of organisms.

The meaning of the content that the acquisition or utilization of genetic resources shall not violate laws or administrative regulations

The acquisition or utilization of genetic resources in violation of laws or administrative regulations means that the acquisition or utilization of genetic resources has not been approved by relevant administrative authorities or has not been permitted by relevant property owner beforehand according to relevant laws and administrative regulations of China. For example, according to the provisions of “Animal Husbandry Law of the People's Republic of China” and “Measures of the People’s Republic of China for the Examination and Approval of Entry & Exit and the Foreign Cooperative Research on the Application of Genetic Resources of Livestock and Poultry”, applicants who export genetic resources of livestock and poultry listed in the catalogue of the genetic resources of livestock and poultry under protection of China, should go through relevant examination and approval procedures. An invention-creation completed relying on the genetic resources of livestock and poultry that are exported from China and listed in the catalogue of the genetic resources of livestock and poultry under protection of China, shall not be granted a patent right if the relevant examination and approval procedures have not been gone through.

The circumstance where an application falls under the provisions of Article 5 paragraph 2 of the Patent Law, i.e. the completion of an invention-creation relies on genetic resources the acquisition or utilization of which is in violation of laws, is not only the ground for rejection in Preliminary Examination and Substantive Examination before granting a patent right, but also the ground for requesting an invalidation of a patent after granting a patent right.

5. The scope of patent for disclosure of genetic resources

All the patent applications filed in China apply, including the patent application firstly filed in China and foreign patent application entering China by means of Paris treaty or PCT.

6. Definition for the term “direct source of genetic resources”

The term “direct source of genetic resources” in the Patent Law refers to the direct channel access to genetic resources. When the applicant indicates the direct source of genetic resources, he or it shall provide information such as time, location and way of getting the genetic resources, and supplier. 

7. Definition for the term “original source of genetic resources”.

The term “original source of genetic resources” in the Patent Law refers to collection sites of the organism, to which the genetic resources belong, in a primary environment. When the organism, to which the genetic resources belong, is a naturally growing organism, the primary environment refers to an environment where the organism naturally grows; when the organism, to which the genetic resources belong, is a cultivated or domesticated organism, the primary environment refers to an environment where the organism forms its particular traits or characteristics. When the applicant indicates the original source of genetic resources, he or it shall provide information such as time and location of collecting the organism to which the genetic resources belong, and the collector.