With the deepening process of reform and the continuous growth of the market economy, there is a gradual increase in the IPR protection in China. During the past more than a decade, many large international medical enterprises have come to China to invest and build factories
The condition of the IPR protection in China should be looked upon in a reformative and progressive perspective in order to carry out the economic and technological cooperation with China in an active manner.
Comparatively perfect IPR protection systems
From 1980s' China started its process of establishing the IPR protection systems. Since the approval of Trademark Law in 1982 and promulgation of Patent Law in 1984, China has made hundreds of laws and regulations concerning the IPR. In 1992, in order to act on the international practices. China amended Patent Law by expanding the protected subjects from the mere protection of methods to the protection of products (prescription). All these IPR laws, together with other civil and criminal laws have constituted China's IPR protection systems, which have effectively defended the IPR of obligees. Almost at the same time, nearly a hundred laws and regulations such as Drug Law and New Drug Regulation Rules were issued. In effect, the legal systems of medicine took initial shape.
So far, China has signed almost all the international IPR treaties and agreements such as the Paris Convention on Protection of Industrial Property Right. China has also signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of WTO and bears its corresponding obligations. To do its duty, China has revised Patent Law, and Copyright Law, to make Chinese Legal system meet basically the requirements of Trips. China has acceded to WTO formally in 2001, and it can be said that the Chinese Legal system of intellectual property has approached the international level.
Awareness on IPR protection is strengthened
With the unceasing perfection of the IPR protection systems in China are increasingly strengthening their awareness and capability in the IPR protection. As the market competition intensifies, many enterprises cannot content themselves by just putting out other's products or using others' brands. They are keen on obtaining their own IPR and creating their own brands. In other words, quite a few of enterprises and science & technology research bodies have been the pioneer in safeguarding the IPR and striking piracy. This ever-expanding enterprise group is the very basis of the IPR protection and the under their efforts, the IPR protection in China is improved day by day.
Piracy is still serious
One cannot deny that piracy is still very serious across China. And the most serious area is the infringement of copyright by software and CDs. Piracy of patents and feigned products are commonly seen in the medical circles. The Chinese government has carried out strike against all sorts of piracy acts, including acts directed at every link of products including producing and marketing.
IPR in biological medical area
The IPR protection in biological medical area has its own specialty, which is decided by the biological medicine itself as a special consumer product. Every kind of drug must go through the animal experiments before being put into clinical use and special examination and approval before going into the markets. Since the former Patent Law issued in 1984 does not protect the patent of the medical product, the Chinese government therefore amended it and granted the administrative protective right to these patents which had lost the right to apply for patent priority in China.
The administrative protection of new drug
From 1992, the drug regulation departments in China began to grant some new medicine producers qualified with some conditions a certain period of administrative protection, which can last seven and a half years at maximum. The applicants should provide the related testimonial, pass certain application procedures and get approval of the State Drug Administration, then they can obtain the administrative protection for new drug.
Yet after the amended Patent Law could grant patent to medicine, such kind of administrative protection lost its original meaning, since the producers pays more and more attention to using patent to protect their own rights.
Dug registration & patent protection
It should be emphasized that drug registration and patent protection are two different conception systems. The former means a sort of administrative examination and qualification authorization, while the latter refers to some rights vested by laws. Therefore, the two systems cannot go in parallel. For instance, some drugs, which have passed medical registration, may be not granted patent; on the contrary, some drugs or their production technologies, which have got patent, cannot go through drug registration. In this connection, the right way for the biological medicine researchers and developers is to focus on the two systems at the same time in order to get complete protection and enough market profits.
The certificate of the drug clinical tests, and later be chosen by the drug development units to carry out clinical tests.
Protection of the human genetic resources
In view of the serious situation of the continuous bio-piracy of the human genetic resources in China, such as theft of the gene resources of some epidemic disease, by some foreign research bodies in name of scientific or cooperative research, the Ministry of Science and Technology and the Ministry of Health co-issued the Interim Procedures of Regulation over China's Human Genetic Resources in September 1998, which has stipulations regarding protection of China's human genetic resources and related international cooperation and IPR issues.
Medicine technology innovation
New drugs development is characterized by long research period, big investment, and high risk, which make enterprises dare not to attempt. China's medicine enterprises which have difficulties in researching new medicine independently and eliminating risk is supported by the government. For instance, Ministry of Science and Technology, with the support of State High-tech Research and Development Project, has completed:
-- Finished one per cent of human genetic group measuring order working outline drawing, and on the basis of it, measured the accurate order drawing
-- Put 18 kinds of medicine and biology technology products
-- Built up the medium test scale production base for the man-made blood substitute
The success of the R & D projects, has raised the level of research in medicine, and pushed forward production and industrialization of new drugs.
For the intellectual property of the research objects the principle of agreement preference has been adopted, that is, except the prior agreement, the ownership and other rights (mainly IPRs) of the research objects supported by the Chinese government, belong to the units who carry out the research, and if there is an agreement, it should be complied. It requires that the government must make an agreement with the research units in advance if it wants to use or popularize the objects; at the same time, the policy encourages the research units to push forward the industrialization and commercialization of the objects actively.
Many issues have propped up after China's entry into WTO in relations to IPR protection. These problems are ones of, for instance, IPR protection regarding trade, administrative measures involved in IPR and protection of local or traditional culture etc.
The safety of gene medicine
With regard to the specialty of gene medicine and gene therapy, their safety in use has become the concern of the scientists and common people. It is the full expectation of the circles of science, law and bio-ethics, environment protectionists and general public that the impact of gene medicine and gene therapy on the safety of human body and environment should be assessed objectively with a fair standard. Obviously, more efforts should be made in this case.
Public order and public morality
The priority for the existence and development of the IPR laws is to guard the public interests against being infringed while protecting the patent and other rights of the inventors, which is also what every nation lays great emphasis on in their legislative and judiciary practice, that is, the protection of the interests of scientists and commercial enterprises should not menace the public order and public morality.
Protection of the IPR
It refers to the protection that should be identified by both parties concerned through the pre-concluded contract, and in some cases the stipulations in China's laws should be abided by. It mainly includes the protection of human gene resources and other biology resources in China. The rational share of costs, the reasonable use of resources and the just share of achievements are the guarantee for the broad, sustained and fruitful international cooperation.
- (The author is General Director of Intellectual Property Affairs Center of Ministry of Science and Technology of China)