New clauses on the protection of genetic resources were added to the amended Chinese Patent Law four years ago. So far, it appears that the new filing requirements – in particular, the genetic source form – are not placing an undue burden on applicants
Efforts have been made in recent years to combat the growing threat of bio-piracy. However, no international agreement has yet been reached between developing and developed countries on this subject. Although China is a developing country, it also has a wealth of genetic resources; therefore, reinforcing protection in this area is in its best interests. When ratification of an international convention reached a deadlock, the Chinese legislature decided to amend its domestic legislation to introduce clauses on protection for genetic resources in the third amendment to the Patent Law. China’s current patent law system includes three statutes: • the Patent Law; • the Implementing Regulations of the Patent Law; and • the Guidelines for Patent Examination, established by the Patent Law and its Implementing Regulations. The Patent Law The Patent Law includes two clauses on protection for genetic resources and indication of the source of genetic resources – Article 5.2 and Article 26.5. New clauses on the protection of genetic resources were added to the amended Chinese Patent Law four years ago. So far, it appears that the new filing requirements – in particular, the genetic source form – are not placing an undue burden on applicants Article 5.2 – the so-called ‘protection clause’ for genetic resources – states that: “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 or administrative regulations.” Article 26.5 – the so-called ‘source indication clause’ – states that: “Where an invention-creation is developed relying on genetic resources, the applicant shall indicate, in the application documents, the direct and original sources of such genetic resources; where the applicant fails to indicate the original source, he or it shall state the reasons thereof.” The protection clause is largely substantive, reflecting the three key principles of the Convention on Biodiversity. It has great legal significance and effect. The source indication clause, on the other hand, is procedural – an operational measure introduced to implement the protection clause. The Implementing Regulations In order to allow these two clauses to be properly implemented into the Patent Law, the Implementing Regulations set out the following detailed provisions. Defining ‘genetic resources’ The first sentence of Rule 26(1) of the Implementing Regulations defines the scope of ‘genetic resources’ as follows: “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 Patent Law thus combines the definitions of ‘genetic material’ and ‘genetic resource’ set out in the Convention on Biodiversity, extending them to include genetic resources obtained from a human body. Therefore, the definition in the Patent Law is broader than that found in the convention. Defining ‘invention-creation developed relying on genetic resources’ The second sentence of Rule 26(1) defines ‘invention-creations developed relying on genetic resources’ as follows: “the invention-creation developed relying on 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.” This definition greatly narrows the scope of this type of invention-creation. In other words, not all invention-creations involving the acquisition or use of genetic resources are governed by these clauses, but only those developed by “using the heredity function of the genetic resources”. This lessens the burden placed on patent applicants in the field of biotechnology. How to indicate the source of genetic resources Rule 26(2) of the Implementing Regulations sets out how to indicate the source of genetic resources: “Where an application for a patent 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 form provided by the patent administration department under the State Council.” Therefore, applicants for patents for invention-creations that rely on genetic resources must fill in an additional form – provided by the State Council’s Patent Administration Department – indicating the source of the genetic resources. The form may be submitted voluntarily by the applicant or may be requested by the examiner during examination. Consequences of breach of these provisions Rules 44, 53 and 65 of the Implementing Regulations set out the grounds for rejecting patent applications and invalidating granted patents. Article 5.2 of the Patent Law can be used both to reject an application and to invalidate a patent. However, Article 26.5 can be used only to reject a patent application under examination. In other words, the Patent Law metes out punishments based on the severity of breach of these provisions. Bio-piracy contravenes Article 5 of the Patent Law and violates substantive law, and is therefore punished severely. However, behaviour that does not conform to Article 26.5 of the Patent Law fails only to meet the requirements in operational procedures and is a relatively minor issue. Such behaviour can be dealt with leniently and will not be subjected to any post-grant punishments, provided that the applicant fulfils the examiner’s requirements during examination. Guidelines for Patent Examination The Guidelines for Patent Examination issued by the State Intellectual Property Office of China (SIPO) provide detailed guidelines for examinations, as well as detailed criteria to be applied in patent examinations – the major points of which are summarised below.
Examining the genetic source form The guidelines explain that the direct source of genetic resources referred to in the Patent Law refers to the direct channel to obtaining genetic resources. When indicating the direct source of the genetic resources, the applicant must provide information such as the time, place, means and provider. The ‘original source of genetic resources’ referred to in the law means the place and in situ conditions where the organism to which the genetic resources belong was collected. When indicating the original source of the genetic resources, the applicant must provide information such as the time and place of collection, and the identity of the person who collected the organism to which the genetic resources belong. During preliminary examination and substantive examination, examiners should focus on whether the indication of the direct and original sources provided by the applicant meets the requirements of the genetic source form (ie, whether the indication is clear and complete). If these requirements are not fulfilled, the examiner shall issue a notification for correction, ordering the applicant to fix the problem. If no correction is made within the time limit, the examiner shall issue a notification that the application is deemed to have been withdrawn. If these requirements still remain unfulfilled, the patent application shall be rejected. Examining indication of source of genetic resources The guidelines further provide that, after reading the description and claims carefully, the examiner shall determine whether the development of the invention-creation relies on genetic resources and, if so, specify which genetic resources. If the applicant fails to submit a genetic source form, the examiner shall issue an office action requesting that it make a supplementary submission. The office action shall also specify which genetic resources shall be indicated regarding its source and explain the reasons thereof. Examination of sufficient disclosure The guidelines explicitly state that the contents of the genetic source form do not belong to the disclosure contained in the original description and claims. For this reason, they can be used neither as the basis to judge whether the description has sufficiently disclosed the claimed inventions nor as the basis to amend the description and claims. Therefore, if exploitation of an invention-creation relies on the acquisition and use of relevant genetic resources, the source of the genetic resources must be disclosed in the description in order for the inventioncreation to meet the requirements set out in Article 26.3 of the Patent Law regarding sufficient disclosure. On the other hand, if the acquisition and use of genetic resources relate only to the completion of an invention-creation, the genetic source form may be submitted later during examination, which does not go beyond the scope of the original description and claims provided in Article 33 of the Patent Law.
Applications related to genetic resources and examination practice Pattern of applications According to internal SIPO statistics (the following is based on citations taken from a research report on the general subject research project of the Academic Committee of SIPO entitled “Protection for Genetic Resources and Indications of the Source of Genetic Resources”, research for which was started in July 2013 and completed in December 2013 by the Department of Medicinal/Biological Patent Examination), between October 1 2009 and June 30 2013, 7,149 of the patent applications filed in China included a genetic source form. Of these, 7,111 applications were from Chinese domestic applicants (including five from Taiwan and one from Hong Kong), while 38 applications were from outside China. Among the 38 applications from abroad, nine were from South Korea, six each were from the United States, Japan and Indonesia, three each from France and Denmark, and one each from India, Canada, Switzerland, Germany and Finland. In 2013 alone SIPO received 825,136 patent applications – yet in in the last four years only 7,149 applications included a genetic source form. Analysing the current situation of patent examination According to internal SIPO statistics, where genetic source forms were filed, these were requested by examiners in 75.7% of cases; such forms were filed voluntarily in only 24.3% of cases. Therefore, it can be seen that the majority of applicants choose to file a genetic source form only after receiving an office action, preferring to leave it for the examiner to decide whether the form is needed. If the examiner fails to request a genetic source form, this lack is not considered to be grounds for invalidation once a patent is granted – meaning that there is little risk for applicants in waiting for an office action before filing a genetic resource form. According to a sample survey, among those applicants that did file a genetic source form, 83.8% were granted a patent and only 1.96% were rejected – with the rest either withdrawing voluntarily or being deemed to have withdrawn. Further, for those that were rejected, the grounds for the rejection were mainly Article 22 (which deals with novelty and inventiveness) and Article 26.3 (which deals with sufficient disclosure of the description) of the Patent Law. To date, no patent application has yet been rejected on the grounds that it does not conform to Article 5.2 or 26.5 – which relate to genetic resources. Current laws and regulations and trends in patent examination There are currently quite a few laws and administrative regulations concerning protection for genetic resources obtained from humans, plants and animals in China – including over 10 laws and administrative regulations which are extremely specialised (eg, the Interim Procedures for Human Genetic Resources Management and the Animal Husbandry of China). Since patent examiners are generally unfamiliar with these laws and regulations, and find it difficult to judge correctly whether an application conforms to them, it is envisaged that patent examination, re-examination and invalidation regarding protection for genetic resources will be relatively lax. That is, potentially illegal conduct will be ruled illegal and rejection or invalidation decisions issued accordingly on related patent applications or patents only if the court or relevant authorities provide evidence that the conduct is in fact illegal.