Jacqueline Lui
 

Jacqueline Lui is a United States registered patent agent at Deacons, Alexandra House 3rd–7th & 18th Floors, Central, Hong Kong, China (e-mail: jacqueline.lui@deacons.com.hk).

China's imminent entry into the World Trade Organization and the opening of its vast markets necessitate a basic understanding of Chinese patent law.

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.

Subject matter
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. Table 1 is 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 standard for applying Article 25(1) of the Chinese Patent Law is consistent with international standards, that is, a material that is a mere discovery of nature is not patentable but may be given patent protection if it has been isolated or purified from its natural environment and has been definitively characterized. In the United States, a mere description of a discovery from nature without stating its usefulness would also be rejected by the US Patent and Trademark Office for lack of utility.

Article 25(3) of the Chinese Patent Law has many similarities to Article 52(4) of the European Patent Convention in that both jurisdictions exclude methods of surgery, therapy, and diagnosis practiced on the human or animal body, all of which are generally allowed in the United States. Specific examples of excluded subject matter in China include methods of treatment such as acupuncture, radiotherapy, and immunization. Also excluded are methods of disease diagnosis such as endoscopic and ultrasonic methods. Furthermore, prophylactic treatment methods of diseases, methods of treating wounds, methods of contraception, artificial insemination, and embryo transfer are also expressly excluded from patent protection in China. These exclusions, however, do not apply to methods not directly applied on the body. Thus, methods of treatment and diagnosis applied to tissue and other biological materials isolated and separated from the body are patentable subject matter. Methods of analysis, treatment, and data collection as applied to the body for purposes that are not disease related are also allowed, as are products and compounds used for treatment and diagnosis of diseases.

Further examples of patentable subject matter in China include (1) nontherapeutic cosmetic hair treatment methods such as giving permanent waves or dyeing; (2) methods of sterilization that are not directly practiced on the animal or human body; (3) methods of treatment and preservation of corpses; and (4) methods of measuring physiological parameters solely for the purpose of perfecting a medical instrument¹.

Article 25(4) of the Chinese Patent Law excludes animal and plant varieties from patent protection. This exclusion is mainly directed toward organisms per se, so methods of breeding and products derived from these organisms remain patentable. However, for the methods of breeding to be patentable, they must not be "essentially biological" in nature; that is, human intervention should play a key role in the success of the process in order to meet Chinese requirements. Currently, the Chinese Patent Office gives a broad interpretation to Article 25(4) to cover all plant and animal varieties including transgenic ones². Thus, the only form of protection for plants in China is under the Regulations for the Protection of New Varieties of Plants, which covers certain types of vines, forest trees, fruit trees, and ornamental plants. China is a member of the International Union for the Protection of New Varieties of Plants (UPOV)³, and priority may be claimed if a prior new plant variety rights application has been filed in a UPOV state.

Claims
The types of acceptable claim language and format are provided in Rules 20–23 of the Implementing Regulations of the Chinese Patent Law. The preferred format for an independent claim is the European two-part style that contains a preamble portion and a characterizing portion. The general requirement for claim language is that of clarity and definiteness.

Products may generally be claimed as a compound, a composition, or a product defined by process. A compound should be clearly defined according to its chemical name and structure using internationally recognized nomenclature. Genetic materials are considered chemical substances. Thus genes, DNA, RNA, and chromosomes are patentable like any other chemical substances. Compounds that cannot be readily defined by their chemical or molecular structures may be claimed using their physical and chemical parameters as determined by methods well known and accepted in the art. If the product cannot be sufficiently characterized even using these parameters, it is possible for the product to be claimed by its process of manufacture if the product is rendered distinct in characteristics and utility using the process cited in the claim.

Composition of matter may be claimed in an open-ended or closed-ended manner, with or without numerical ranges and amounts limitations. The scope of the claim allowed is dependent on the subject matter, the description, and what is known in the art. Closed-ended language (such as "consisting of"), intermediate language (such as "consisting essentially of"), and open-ended language (such as "comprising") all have equivalent Chinese counterparts that are understood and accepted by the Chinese Patent Office. Functional limitations and use limitations may also be acceptable if they are clear and definite, and supported by the disclosure. Method claims may be recited as a series of steps, or as a method of use. The equivalent of "Swiss-type" claims for pharmaceuticals may be recited to avoid rejection under Article 25(3), such as the "use of a compound X for the preparation of a pharmaceutical composition for the treatment of disease Y".

Novelty
China has an "absolute" novelty requirement, with no grace period provided for public disclosure before the filing date (priority date) except under extremely limited conditions. Public disclosure may be in the form of printed document, oral disclosure, or public use. Only public use and oral disclosure within China are considered novelty destroying. However, any publicly available printed document, whether available in China or overseas, may be considered prior art. Exceptions to this rule include disclosure at an exhibition sponsored or recognized by the Chinese government; disclosure at a prescribed academic or technological meeting; or disclosure by any person without the consent of the applicant, for which a six-month grace period is provided for filing the patent application. The interpretation of these exceptions is uncertain, and it is highly recommended that a priority date be established before any public disclosure.

Inventiveness
The approaches to determining inventiveness are set forth in detail in the Examination Guideline of the Chinese Patent Office. Besides the primary approach of comparing the level of technological innovation with what is known in the art based on the assessment of the examiner according to the standard of that notional "person skilled in the art," secondary indicia of inventiveness may also be considered. These are well-known tests such as providing solution to a long-felt problem, overcoming technical prejudice, unexpected results, and commercial success.

Sufficiency of disclosure
It is important to note that Rule 18(8) of the Implementing Regulations of the Chinese Patent Law requires that the description of a patent application describes in detail the best mode contemplated by the applicant for carrying out the invention. For pharmaceuticals, the Chinese Patent Examiner would also be looking for indications, animal and/or clinical test subsequent data, efficacy range, and methods of quantitative analysis. Although the Chinese Patent Office does allow some of this data to be submitted after the filing date, such post-filing submission cannot be added into the specification or be used to enlarge the scope of a claim.

If an application concerns a new microorganism or a microbiological process, the Chinese Patent Office may require that a specimen of the organism be deposited with an approved depositary institution on or before the date of filing if the microorganism is not available to the public. Because China is a contracting state of the Budapest Treaty, the microorganisms may be deposited in any International Depositary Authority recognized under this treaty. Microorganisms include not only bacteria, fungi, actinomyces, viruses, protozoa, and algae, but also cell lines and plasmids. Once deposited, any entity can request a sample of the microorganism after the publication of the application. The specimen will be released upon an undertaking by the entity not to make the specimen available to others, and to use it only for experimental purposes before the grant of a patent⁴.

Infringement procedures
Article 11 of the 1992 law states that "no entity or individual may, without the authorization of the patentee, make, use, or sell the patented product, or use the patented process and use or sell the product directly obtained by the patented process, for production or business purposes." Although infringement litigation remains relatively rare compared to the United States, there has been some success by patentees in enforcing their patent rights. In a recent decision by the Chongqing Municipal No. 1 Intermediate People's Court, the defendant, South-West Hecheng Pharmaceutical Factory, was found to have infringed on patent No. 85105643 granted to Glaxo Group Ltd. for a process for the manufacturing of ondansetron (a drug used for the prevention of chemotherapy and radiation-induced nausea) and related compounds⁵.

In the second amendment that will come into force in July 2001, "offer for sale" will be added to the list of infringing activities. The second amendment will further provide the means for calculating damages, including a maximum fine of up to three times the profits obtained for passing off activities.

Conclusion
The number of invention patent applications in China has been increasing steadily in recent years, reaching more than 35,000 in 1999. Among the more than 250,000 applications filed between 1985 and 1999, Chinese herbal medicines, foodstuffs, and pharmaceuticals were the art groups that had the highest number of applications⁶. Although these numbers appear very small compared to the United States, Europe, and Japan, the increasing number of patent cases in litigation indicates that awareness of the exploitation and enforcement of intellectual property is building, and that the Chinese economy is becoming more technology-intensive. With China being both an important manufacturing center and a consumer market of staggering proportions, the time has arrived to claim your intellectual real estate before it is turned into public property.

1. Examination Guideline of Chinese Patent Law, Part II, Chapter 1, Section 3.3.
2. Chan, C. China Patents and Trade Marks 1 (1998).
3. http://www.upov.int
4. Implementing Regulations of the Patent Law of PRC Rules 25 and 26.
5. Wu, Y. China Patents and Trade Marks 4, 61–65 (2000).
6. Wu X. China Patents and Trade Marks 4, 32–35 (2000).