China’s national patent law: means and experiences
Dr Zheng Yongfeng of the Patent Office of China presented this paper.
China promulgated its patent law in 1985. Since then, it has been amended twice, most recently in August 2000. The latest amendments will come into effect from 1 July 2001. There have been more than 10,000 patent applications in the past, the majority from within the country. However from 1992 onwards, about 1400 applications were received each year. With a view to joining WTO, China is providing more effective means to protect inventors in traditional medicine, consistent with the provisions of the TRIPS Agreement.
The objects of protection in traditional medicine
Chinese patent law usually protects products, methods and usage. However, for traditional medicine, products and usage were not protected, except that the method of preparation could be patented before 1 January 1993. After the first amendment, products, methods and usage can now be patented.
The pharmaceutical products which can be patented in the field of traditional medicine include traditional medical compositions, herbal preparations, extracts from herbal medicines or compositions, treated herbal materials and health foods with herbal medicines, etc.
The methods that can be patented in the field of traditional medicine include methods for the preparing the pharmaceutical preparations, methods for extracting special substances from natural medical materials and methods for treating natural medicine materials.
If a known drug is found to have any new indication, Chinese patent law protects the new indication.
The method used in drafting claims and descriptions for patent applications is critical to the success of the application. For example, if an application is described as a method of treating diseases, it will be rejected. On the other hand, if it is claimed as a method used in the preparation of drugs for the treatment of specific diseases (which is the new indication of a known drug), the application can be granted a patent.
Requirements for the granting of a patent in traditional medicine
Under Chinese patent law, invention-creation can be patented as three types i.e. inventions, utility models and designs. Inventions and utility models should possess novelty, inventiveness and practical application. In the context of traditional medicine, novelty means that before the date of filing no identical invention or utility model had been publicly disclosed in China or abroad, or had been publicly used or made known to the public by any other means in China, nor had any other person filed previously with the Patent Office an application which described the identical invention or utility model and was published after the said date of filing. Three types of inventiveness are recognized, namely inventiveness of pharmaceutical products, inventiveness of method and inventiveness of new use.
Inventiveness of pharmaceutical products means that the product composition is newly created and a new active ingredient (herbal medicine) is added, or a medicine is prepared by varying its existing composition resulting in it having new indications, or being more effective, or having fewer side effects than existing products. Such a preparation is considered to possess inventiveness and can be patented.
Inventiveness of method means a method of production that shows advantages, such as increased output or lower cost or increased purity of the extract separated from the raw material or decreased side effects of the product.
Inventiveness of new uses means any new indication for the known medicine for which data are provided to validate the claim.
In addition to the above requirements, applicants must provide a detailed description of the technology relating to the invention and disclose them clearly and completely so that a person skilled in traditional medicine can carry out the production.
Experience in the protection of traditional medicine
Over the past 15 years, China has promulgated the National Patent Law and amended it twice so as to be more consistent with the TRIPS Agreement. She has joined the Patent Cooperation Treaty (PCT) and her patent office has become an International Reception Bureau as well as an International Search and Primary Examining Bureau of the World Intellectual Property Office for PCT applications. In March 1999, China became a member state of the Union for the Protection of New Varieties of Plants (UPOV). A month later, China promulgated the Regulations of the People’s Republic of China on the Protection of New Varieties of Plants by which a new herbal medicine could be protected if it was first found to have curative effects.
The existing problems associated with the protection of intellectual property rights in traditional medicines in China can be summarized as follows:
• Patent rights are granted for a period of 20 years, but the time taken for research and development of the invention takes 2-5 years. This period of time is not deducted from the validity period of the patent, resulting in time lost for which no compensation is given.
• Inventors are reluctant to disclose their technology before patents are granted, but such disclosures are required for publication 18 months after the date of filing of the application.
• It is usually difficult for patent applicants to describe the constitution of a traditional medicine clearly, because most of the time traditional medicine is a mixture of many unknown substances, so it is also difficult for the judge to determine whether an infringement has taken place between the patented drugs and the products suspected.