China: Rules On Genetic Resources Tightened

China's Patent Law, which was revised in 2008, introduces a new stipulation that "no patent right shall be granted for any invention-creation which is completed on the basis of genetic resources of which the acquisition or use breaches the stipulations of related laws and regulations" (Article 5 paragraph 2). The purpose of the new stipulation is to regulate the act of acquiring and using genetic resources by way of violating the Convention on Biological Diversity and the related stipulations of China's laws, making inventions by employing genetic resources and filing applications for patent rights on those inventions. That is, no patent right shall be granted for such inventions. In order to ensure the implementation of this stipulation, the revised Patent Law introduces a further stipulation that "an applicant who files a patent application for an invention-creation completed on the basis of genetic resources shall in the patent application document indicate the direct and original source of the genetic resources; the applicant unable to indicate the original source of the genetic resources must provide an explanation" (Article 26 paragraph 5). How to comprehend and practise these stipulations of the new Patent Law is becoming a concern for patent applicants at home and abroad in the field of biotechnology and pharmaceuticals.

Applicable laws

In order to avoid application of the above legal provisions, what laws must inventors obey when making invention-creations in which acquisition or use of genetic resources is involved?

The new Implementing Regulations of the Patent have no particular stipulations. However, the Implementing Regulations define genetic resources: "The term genetic resources in the Patent Law means any material of human, animal, plant, microbial or other origin containing functional units of heredity and having actual or potential value" (Rule 26). The Implementing Regulations also define an "invention-creation which is completed on the basis of genetic resources" as follows: "An invention-creation which is completed on the basis of genetic resources in the Patent Law refers to an invention-creation which is completed by using the hereditary function of the genetic resources." It should be pointed out that the definition of the genetic resources given by the Implementing Regulations is substantially the same as that given by the Convention on Biological Diversity, and is about equal to the understanding of this term by researchers in this field. The explanation of "an invention-creation which is completed on the basis of genetic resources" by the Implementing Regulations emphasises that it must be an invention-creation that is completed by using the "hereditary function" of the genetic resources. In other words, an invention does not belong to an invention-creation that is completed on the basis of genetic resources if it is made by using merely functions of some material other than the hereditary function, although the material satisfies the definition of the genetic resources.

Obviously, these stipulations in the Implementing Regulations further delimit the application of the stipulations of the Patent Law related to the protection of genetic resources, and provide more specific guidelines for patent examining practices in this field.

Article 5 paragraph 2

What are the laws and regulations referred to in Article 5 paragraph 2 of the Patent Law?

The latest version of the Guidelines for Patent Examination (revised by the State Intellectual Property Office in 2010) has the following stipulations:

That the acquisition or use of the genetic resources breaches the stipulations of related laws and regulations means that the acquisition or use of the genetic resources does not get approval by related administrative authorities or obtain a licence by related right owners beforehand in conformity with the provisions of related laws and regulations of China. For example, in accordance with the provisions of Animal Husbandry Law of the People's Republic of China (referred to as Animal Husbandry Law hereinafter) and Measures of the People's Republic of China for the Examination and Approval of the Entry and Exit As Well As Foreign-Related Cooperative Research and Utilization of Livestock and Poultry Genetic Resources (referred to as Measures for the Examination and Approval hereinafter), where any livestock or poultry genetic resource included in the protection list is to be exported to abroad, the examination and approval formalities shall be required; thus, where an invention-creation is completed on the basis of livestock or poultry genetic resource included in the protection list which is exported to abroad, and no examination and approval formalities have been gone through, no patent right shall be granted for the invention-creation" (see Section 3.2, Chapter 1, Part II of the Guidelines for Examination)

From these Guidelines, it can be inferred that, when examining patent applications related to genetic resources, the State Intellectual Property Office will examine whether or not the acquisition or use of the genetic resources breaches the provisions of the Animal Husbandry Law and the Measures for the Examination and Approval. It should be noted, however, that further laws and regulations which aim at protecting genetic resources are expected to come up in the future. After these new laws and regulations come into force, the State Intellectual Property Office will also examine whether or not patent applications conform to their provisions.

It should be pointed out that, according to the Patent Law, in order to meet the requirement for granting a patent right, the acquisition or use of the genetic resources shall conform to general laws (formulated by the National People's Congress and its Standing Committee) and administrative rules (formulated by the Central People's Government – the Sate Council). In the Chinese legal system, laws in broad sense further comprise local rules formulated by the People's Congress and its Standing Committee at the provincial level (provinces, autonomous regions and municipalities directly under the central government) and departmental rules formulated by the ministries and commissions under the State Council and departments directly under the State Council with administrative functions. The local rules and the departmental rules have lower legal hierarchy than the general laws and administrative rules. If the acquisition or use of genetic resources conforms to laws and administrative rules but merely does not conform to local rules or departmental rules, these legal stipulations of the Patent Law are not applicable.

Examples of inventions affected

What inventions belong to "invention-creations which are completed on the basis of genetic resources"?

This is a most important question in the patent prosecution practice; it concerns whether an invention claimed in a patent application meets the requirement for granting a patent right as prescribed in the Patent Law, and it also concerns whether it is necessary to go through the formalities of disclosing the source of genetic resources in the patent application according to the related procedural provisions of the Patent Law. As described above, the Implementing Regulations explain what are "genetic resources" and what is "an invention-creation which is completed on the basis of genetic resources"; furthermore, the Guidelines for Examination make more detailed explanations of some terms involved in these stipulations of the Implementing Regulations (see Section 3.2, Chapter 1, Part II of the Guidelines for Examination). For example, the Guidelines for Examination stipulate that "using the hereditary function of genetic resources in an invention-creation refers to subjecting the functional units of heredity to processes of separation, analysis, treatment and the like in order to complete the invention-creation and achieve the value of the genetic resources".

In practice, patent applicants should note that, in the determination of whether an invention belongs to "invention-creations which are completed on the basis of genetic resources", what should be taken into consideration is not merely the content of claims in the patent application, but also, more importantly, whether any genetic resources are utilized during the process of making the claimed invention. In some cases, it cannot be determined from the content of claims per se whether any genetic resources are utilized during the process of making the claimed invention. Some illustrative examples will be described below.

Example 1: A patent application relates to a method for extracting xylitol from a wild soybean, wherein the wild soybean has a particular gene responsible for producing xylitol. The material used in the invention is a wild soybean having a particular gene, that is a kind of genetic resource. During the process of making the invention, however, what has been done is merely the extraction of a particular gene product (xylitol) without separation, analysis or treatment of the gene per se. Thus, the invention does not use the hereditary function of the material and does not belong to "invention-creations which are completed on the basis of genetic resources".

Example 2: A patent application relates to an oral nucleic acid solution made from a nucleic acid derived from a mung bean. The material used in the invention is a mung bean, that is a kind of genetic resource, from which the genetic material (a nucleic acid) is separated and extracted. During the process of making the invention, however, the hereditary function of the material has not been used to achieve the value of the genetic resource, but only the medicinal function or nutritional function of the nucleic acid has been used. Thus, the invention does not belong to "invention-creations which are completed on the basis of genetic resources".

Example 3: A patent application relates to a novel protein drug extracted from a blood sample of a patient with liver can- cer having a particular gene. Although the blood material used in the invention is taken from a patient with liver cancer having a particular gene, during the process of making the invention, what has been done is merely the extraction of a particular protein without separation, analysis or treatment of the gene per se. Thus, the invention does not use the hereditary function of the material and does not belong to "invention-creations which are completed on the basis of genetic resources".

Example 4: A patent application relates to a novel gene X, obtained through chemical synthesis based on the known genome information of E. coli. The invention produces a product which itself can be regarded as genetic resources. During the process of making the invention, however, chemical synthesis is carried out merely based on the known genome information of E. coli without use of any existing genetic resource. Thus, the invention does not belong to "invention-creations which are completed on the basis of genetic resources".

Example 5: A patent application relates to a novel antibiotic drug obtained by transforming a particular antibiotic gene derived from a human into a microorganism and expressing the gene. During the process of being made, the invention includes the separation and transformation of a particular gene, and uses the hereditary function of the gene to achieve the value of the genetic resources, therefore belonging to "invention-creations which are completed on the basis of genetic resources".

Questions remain

It should be pointed out that the Patent Law revised in 2008 is the first time that China has introduced stipulations concerning the protection of genetic resources. Therefore, the comprehension and application of these stipulations remain to be tested by the patent examining practice and even judicial practice in the future.

Previously published on WWW.MANAGINGIP.COM

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