In China, DNA fragments, genes, and proteins are also considered to be chemical substances. Because it has been possible to protect chemical substance under Chinese patent law since 1993, DNA fragments, genes, and proteins can be protected under the Chinese Patent Law.

China is the most populous country in the world, with over 1.2 billion people—a staggering consumer market for pharmaceutical and biotechnology products. With a fast-growing economy based on the government's drive for economic reform and modernization, China has in recent years twice revised her patent laws to promote science and technology. The first revision was adopted in 1992 and allowed, for the first time, the patenting of pharmaceuticals. However, enforcement remained problematic, partly because of certain loopholes in the definition of infringement in the 1992 Patent Law. The second amendment, passed recently and scheduled to come into force in July 2001, will significantly improve enforceability of certain patented products.

With the imminent accession of China into the World Trade Organization, it is important to familiarize ourselves with the basics of Chinese patent law, and to discover how biotechnology patents can be obtained. This article gives an overview of the main requirements for obtaining a patent in China, with particular focus on the aspects unique to biotechnology inventions. It includes examples of patentable and nonpatentable biotechnology subject matter, as well as novelty and inventiveness standards of the Chinese Patent Office.

Article 25 of the Chinese Patent Law provides a list of subject matter excluded from patent protection. This list is similar to that found in Articles 52 and 53 of the European Patent Convention. A comparison of the relevant excluded matter in the two jurisdictions. In contrast, the patent statute in the United States does not expressly bar any specific subject matter from patent protection, but rather defines positively patentable inventions under 35 USC Section 101 as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."

The Chinese Patent Law provides that no patent right shall be granted for animal and plant varieties. According to the interpretation of the Examination Guidelines of Chinese Patent Office (CPO), plant variety means plant and animal variety means animal. So it seems that it is impossible to protect plant and animal under patent law by interpreting the meanings of plant variety and animal variety in the same way as EPO.

Inventions of transgenic plants and animals are an important part of biotechnological inventions and more and more products relating to genes will be produced through transgenic plants and animals. Biotechnology industry is playing an increasingly important role in the new century. If China wants to progress in the field of biotechnology, technology innovation in the field must be encouraged. It is crucial to protect biotechnology inventions, including transgenic plants and animals, under patent law. So, this article suggests deleting the provisions set out in patent law and providing patent protection for plants and animals.

As in Japan and the United States, the regulation to protect new plant varieties in China was drawn up mainly according to UPOV Convention and China has already joined the UPOVC. Following the experiences of Japan and the United States, this article suggests that both the patent law and plant variety law can protect the same new plant variety in China.

Although animal and plant varieties cannot be protected under Chinese patent law at present, the processes used in creating animal and plant varieties can be protected under Chinese patent law. So the processes to be used to create animals and plants including genetic engineering processes can be protected under Chinese patent law, if the processes are not essentially biological.

In 1992, the first time the patent law was amended, protection of a process patent was extended to the product directly obtained by the patented process. Does the protection scope of a patented process for producing animal or plant extend to the animal or plant per se directly obtained by the patented process?

In China, there is no relevant court decision to interpret the issue. The purpose of extending the protection of the process patent is to protect the process invention sufficiently. The process invention in every technical field must be treated equally. Before deleting the provision that prohibits protecting animal and plant varieties in Chinese patent law, it is important to protect animals and plants indirectly through the processes that directly produce the animals and plants.

In China, at the beginning of patent law implementation, the processes relating to use of micro-organisms could be protected under patent law. From 1993, micro-organisms per se could also be protected under patent law.

Regarding the patent application of gene invention in China, up to the end of 1999, the Chinese Patent Office had received 1,754 patent applications, of which 475 were Chinese applications, and 1,279 applications were foreign applications, coming mainly from the United States, Japan, Germany and Great Britain.

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