The third amendment to the Chinese Patent Law was passed by the Standing Committee of the National People's Congress on December 27 2008. The new Patent Law will enter into force on October 1 2009. In accordance with the amendment to the Chinese Patent Law, the Implementing Regulations and the Guidelines for Patent Examination are under amendment. The draft version of the Implementing Regulations was submitted on February 27 2009 to the State Council for review. The draft version of the Guidelines for Patent Examination was open to the public for comment on July 10 2009. Among the various amendments in the new Patent Law, the protection of genetic resources has been recognised for the first time in the Chinese Patent Law, which will have a significant impact on the patenting of inventions involving genetic resources. Thus, it may be worthwhile to look at recent developments for patenting inventions concerning genetic resources.
Legal provisions on genetic resources
Two paragraphs concerning genetic resources have been added into article 5 and article 26, respectively in the new Patent Law. They are article 5, paragraph 2 and article 26, paragraph 5.
Article 5, paragraph 2 provides that "No patent right shall be granted for an invention-creation of which the acquisition or exploitation of genetic resources violates the relevant laws and administrative regulations, and whose completion depends on said genetic resources."
Article 26, paragraph 5 provides that "For an invention-creation whose completion depends on genetic resources, the applicant shall describe the direct source and original source of said genetic resources in the application documents; the applicant shall state reasons if the original source of said genetic resources can not be described."
No definitions have been given in the new Patent Law for the terms "genetic resources" and "an invention-creation whose completion depends on genetic resources" recited in the two articles.
The definitions for "genetic resources" and "the invention-creation whose completion relies on genetic resources" could be found in Rule 26, paragraph 1 of the draft version of the Implementing Regulations.
According to the draft version of the Implementing Regulations, genetic resources is defined as "any material taken from human beings, animals, plants or microorganisms that contains genetic function units and has practical or potential values", whereas "the invention-creation whose completion relies on genetic resources" is defined as "the invention-creation whose completion uses the genetic functions of the genetic resources". The draft version of the Guidelines for Patent Examination provides a further interpretation for "the invention-creation whose completion uses the genetic functions of the genetic resources", which is interpreted as "isolating, analysing and treating the genetic function units to complete the invention-creation and realise the value of the genetic resources".
The draft version of the Guidelines for Patent Examination provides further interpretations for the terms "genetic functions" and "genetic function units", wherein "genetic functions" means "the ability of transition of the traits and characteristics to next generations of an organism by propagation, or the ability of reproducing the whole organism," and "genetic function unit" means "a gene or DNA or RNA fragments with genetic function of an organism".