PATENTING OF BIOTECH INVENTIONS IN VIETNAM

Patenting facts

From the outset of the protection system of the Intellectual Property (IP) Rights, biotechnological inventions in Vietnam, which are commonly concerning (i) living organisms (e.g., plant/animal varieties; plants/animals; microorganisms) and elements derived therefrom (e.g., cell lines, DNA sequence), and (ii) methods using living organisms and non-living products thereof, had been protected by authors' certificates. This form of protection later on has been found inappropriate because the exclusive right to use the invention was vested in the State and the authors were just entitled to moral rights and limited remuneration. It accordingly discouraged creative activities of inventors and therefore was subsequently replaced by patent. In brief, the patenting of biotechnological inventions in Vietnam may be broken into three stages, corresponding to statutory documents.

During 1980s, biotechnological inventions, involving methods using living organisms and non-living products thereof, had been awarded protection in accordance with the Regulations on innovations, rationalization and inventions pursuant to the Decree 31-CP in 1981, by authors' certificates. Among living organisms, only new plant/animal varieties had found protection.

In the following stage, the protection of said biotech products and methods has been carried out in accordance with the Ordinance on Protection of Industrial Property Rights in 1989 by conferring the exclusive rights on the patent holder. Although the exception from patentability had been applied to plant/animal varieties and microorganisms, the former had still been protected under the 1981 Regulations, i.e., authors' certificates simultaneously did exist for said subject matters.

With the dramatic pace of the biotech development, the third period of the patenting of the biotechnological inventions in Vietnam has been marked by the will and determination of the Vietnamese Government to bring the IP system up with the international standards, especially the Agreement on Trade Related Aspects of Intellectual Property (TRIPs) under the World Trade Organization (WTO), with the introduction of the 1995 Civil Code, most noted improvement of the IP system in Vietnam. The Civil Code and its guiding regulations neither deal specifically with the question whether or not living organism (particularly microorganism) is itself patentable, nor exclude the possibility. Thus, in this patenting period, patentability has been extending to all the biotechnological subject matters mentioned above with the exception of new plant/animal varieties which are protected under the sui generis protection regime (Decree 13/2001/ND-CP). Article 2(1a) Decree 13 defines a plant variety as a plant grouping within a single botanical taxon of the lowest known rank, which grouping can be defined by the expression of the characteristics resulting from a given genotype. It is, therefore, obvious that this sui generis system has not been applied to transgenic plants/animals which are characterized by a single gene.

The patenting practice of the biotechnological inventions in Vietnam can be illustrated by the numbers of inventions relating to biotechnology filed with the Vietnamese National Office of Industrial Property (NOIP) which are presented in the following table (source: Research on the theoretical framework and practice of the examination and deposit of biological material for biotech inventions, 1/2003, NOIP).

(*the number of prosecuted applications including both granted and refused ones.)

It can be seen from the table that the number of inventions involving living things and elements derived therefrom in more currently patenting stage has considerably increased in comparison to the corresponding number in the previous stage. This increase can probably be explained by the extension of the Vietnamese IP regulations on patenting to the living organisms and also be an evidence to demonstrate that the change in the IP regime has brought it in line with the international standards.

Current situation

In Vietnam, although the number of applications in the biotechnology has markedly climbed, there is no specific law relating to the patenting of the biotechnological inventions. Though the patent law (Article 4 of Decree 63/CP of 1996 on Industrial Property, amended by Decree 06/CP of 2001) has been addressing the exclusion from patentability of the following:

• plant/animal varieties;
• preventive, therapeutic and diagnostic methods for the treatment of humans or animals;
• essentially biological processes for the production of plants or animals except for microbiological processes,

there is a lack of detailed guiding rules, particularly on the form of patent application (by which applicant would be able to provide an enabling specification of the biotechnological inventions), the examination procedure as well as deposit procedure for microorganism and biological material in general. This might be one of the reasons for the low proportion of biotech applications been prosecuted (about 25%). Even more, wherever the claimed invention is new microorganism itself or a new product obtained from it, the examination of the relevant characteristics of the microorganism is beyond the control of the examiners during prosecution.

In addition, the biotechnology is of great speculativeness and may create many ethical arguments, for example, human cloning, processes for modifying the germ line genetic identity of human beings or uses of human embryos for industrial or commercial purposes as well as "terminator technology". Although Article 787 of the 1995 Civil Code provides that inventions "contrary to ordre public or morality" are not patentable, there is no list of the biotechnological items considered to be contrary to ordre public or morality, providing the Patent Office and competent court with a legal framework to explicitly define the conceptions.

Conclusion

Summarizing it must be noted that patent protection is now possibly available for microorganisms, transgenic plants/animals, protein, DNA sequences, genes, cell line and vectors in Vietnam as long as they meet the statutory requirements. Although there is a lack of the specific legal provisions and relevant guiding rules on the biotechnological inventions as specified above, so that the uncertainties still exist at present, however, the biotech inventors may hope for more sufficient legal framework to permit them to effectively guarantee their investment in near future.