On October 30th, 2010, treaty parties of UN Convention on Biological Diversity passed the Nagoya Protocol on Access and Benefit Sharing (ABS). The key content of the protocol lies in Article 5 Fair and Equitable Benefit Sharing:

  1. In accordance with Article 15, paragraphs 3 and 7 of the Convention, benefits arising from the utilization of genetic resources as well as subsequent applications and commercialization shall be shared in a fair and equitable way with the Party providing such upon mutually agreed terms;
  2. To implement paragraph 1 above, each Party shall take legislative, administrative or policy measures, as appropriate;
  3. Benefits may include monetary and non­monetary benefits, including but not limited to those listed in the Annex.

In Chinese Patent Law, there are two clauses relating to genetic resources: paragraph 2, Article 5 and paragraph 5, Article 26.

Paragraph 2, Article 5: Patent rights shall not be granted for inventions that are accomplished by relying on genetic resources which are obtained or used in violation of the provisions of laws and administrative regulations.

This article could be used for both rejection and invalidation. The “genetic resources” mentioned above relates to Chinese genetic resources.

Paragraph 5, Article 26: With regard to an invention­creation accomplished by relying on genetic resources, the applicant shall, in the patent application documents, indicate the direct and original source of the genetic resources. If the applicant cannot indicate the original source, he shall state the reasons.

This article could be used for rejection, rather than invalidation. The “genetic resources” mentioned above refers to any genetic resources from any country.

In accordance with the above articles, when filing invention patents relying on genetic resources, applicant shall state it in a written request, and specify the direct and indirect origins of the genetic resources by filling out the Genetic Resource Disclosure Form designed by the Patent Office.

In practice, the following items normally need to be disclosed:

  1. separating functional units from genetic resources and analyzing and using of such;
  2. gene augmentation on functional units so as to alter genetic characters or to meet industrial production purposes;
  3. to produce new species, varieties and new lines of organisms with designed traits through sexual or asexual reproduction;
  4. separation of microorganisms with specified functions from natural world.

Whereas the following items need not to be disclosed:

  1. host cells normally used in gene engineering;
  2. DNA/RNA segments already disclosed in prior art.
  3. genetic resources used only in verifying the effects of inventions;
  4. genetic resources used as candidates and eliminated later on
  5. Genetic resources utilized in the process of an invention but whose genetic functions are not used.

However, it should be noted that the disclosure of the origins of genetic resources shall be based on full disclosure of the Description. This is because the content in the registration form is not regarded as part of the original Description and Claims, and therefore cannot be used to determine whether the Description is fully disclosed and also cannot be used as basis for amending Description and Claims.

In other words, applicant shall make sure the Description states and fully discloses the information on genetic resources used in the application, such as the origin, the biological characteristics and how to preserve them.

In actual practice of examination, for inventions relying on genetic resources, Examiner will examine whether an applicant has filed the registration form. For applicant who fails to file the registration form, Examiner will specify which genetic resources need to be disclosed and the reasons why, when informing the applicant to file the registration form. Normally, applicant could react by filing the registration form or the Observations.

Seen from above, Paragraph 5, Article 26 provides formal requirements for application documents. The registration form could either be submitted when filing the application or at any stage during the substantial examination by way of voluntary submission or submission upon Examiner’s request. Therefore, for efficiency purposes, applicant could only include genetic resources that clearly need to be disclosed in the registration form. When it is difficult to determine whether or not to disclose certain genetic resources, applicant could file the application without the registration lest its interests should be damaged.