Examination Practices on the Applications Concerning Genetic Resources


Examination Practices on the Applications Concerning Genetic Resources

 

The newly revised Patent Law provides that no patent shall be granted for an invention based on genetic resources, if the latter are obtained or utilized illegitimately (Article 5 Paragraph 2 Patent Law 2008). Where such resources are used, their initial/direct origin must be disclosed in the patent application; and reasons must be given if the disclosure cannot be provided (Article 26 Paragraph 6 Patent Law 2008).

The Implementing Regulations and Examination Guidelines further put forward the specific requirements and examination practices concerning these applications.

 

Rule 26.2 of the Implementing Regulations specifies that: Where an application is filed for an invention-creation the development of which relies on the use of genetic resources, the applicant shall state that fact in the request, and fill in the forms provided by the administration department under the State Council.

 

Besides, Section 5.3 of Part One of the Examination Guideline provides that: Where an application for patent is filed for an invention-creation which is developed on the basis of genetic resources, the applicant shall state the source of said genetic resources in the request, and fill in the Registration Form for Indicating Source of Genetic Resources, indicating the direct source and original source of such genetic resources. Where the applicant fails to state the original source, he or it shall state the reasons thereof. Where the application is not in conformity with the provisions, the examiner shall issue the Notification to Make Rectification, inviting the applicant to make rectification. Where no response is made within the time limit, the examiner shall issue the Notification that Application Deemed to be Withdrawn. Where the application is still not in conformity with the provisions after rectification, the application shall be rejected.

 

Furthermore, in Section 3.2 of Part Two of the Examination Guideline, it further points out that: According to Article 5.2, no patent right shall be granted for any invention-creation where acquisition or use of the genetic resources, on which the development of the invention-creation relies, is not consistent with the provisions of the laws and administrative regulations.

According to Rule 26.1, the genetic resources referred to in the Patent Law mean the material obtained from such as human body, animal, plant, or microorganism which contains functional units of heredity and is of actual or potential value. The invention-creation is developed relying on the genetic resources referred to in the Patent Law means that the invention-creation is developed relying on the use of the heredity function of the genetic resources.

In the above-mentioned provisions, heredity function refers to the ability of organism to pass on traits or characteristics from an ancestor to a descendent through reproduction, or allow the entire organism to be reproduced.

Functional unit of heredity refers to a gene, or a DNA or RNA fragment having heredity function of an organism.

"Material obtained from such as human body, animal, plant or microorganism which contains functional units of heredity" refers to carrier of functional units of heredity, which includes not only a whole organism, but also a part of it, such as organ, tissue, blood, body fluid, cell, genome, gene, DNA or RNA fragment, etc.

With regard to an invention-creation, using the heredity function of the genetic resources refers to, for example, isolating, analyzing and/or processing the functional units of heredity to develop the invention-creation and to realize the value of the genetic resources.

"Acquisition or use of the genetic resources is not consistent with the provisions of the laws and administrative regulations" means that the acquisition or use of the genetic resources is not beforehand approved by relevant administrative departments or licensed by relevant right holder in accordance with the provisions of relevant laws and administrative regulations of China. For example, in accordance with the provisions of "Animal Husbandry Law of the People¡¯s Republic of China" and "Measures for Examination and Approval in respect of the Entry and Exit of Genetic Resources of Livestock and Poultry and in respect of Research in Their Utilization in Cooperation with Foreign Entities", in the case of exporting abroad the genetic resources that have been included in the directory for protection of the genetic resources of livestock and poultry in China, relevant formalities for examination and approval shall be gone through. Where certain genetic resources that have been included in the directory for protection of livestock and poultry are exported abroad from China, but no formality for examination and approval has been gone through, no patent right shall be granted for any invention-creation developed relying on such genetic resources.

 

 

 

 

2011-08-08