Abstract
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Establishment of China's Biotechnology Patent Protection
China's biotechnology patent protection started with the Patent Law of the People's Republic of China, enacted on April 1, 1985, which has been amended three times to date.1 Article 25 of the original version settled the rule that medicine, chemical compounds, and animal and plant varieties are unpatentable subject matter. According to the patent classifications of China, biotechnology falls within “chemical art,” so biotechnology materials cannot be patented. But inventions—creations by methods of biotechnology, genetic engineering, or microbiology—are patentable subject matter.
There were no objections to this scheme at the time the Patent Law was enacted, partly because of lack of experience in intellectual property law. However, in the three years since the Patent Law came into effect, issues relating to plant varieties emerged.2 Researchers in some breeding organizations applied to patent agricultural breeding methods, with the obvious purpose of protecting new varieties. Although it was clear that plant varieties were unpatentable subject matter, there was debate on whether breeding methods could be patented. Some experts pointed out that it was inappropriate to grant patent rights for the breeding methods, because breeding materials were kept confidential during Patent Office review of the application. That is to say, the public normally could not access those materials, and thus, there is the “inadequate disclosure” problem.
The Regulation on Seeds, enacted March 13, 1989, by the State Council (China's cabinet), provides that the public should be encouraged to cultivate new varieties of crops and plants and that patenting of seeds and transfer of possession is consistent with the Patent Law and its related regulations. All these rules show the legislators' awareness of the need for protecting the cultivator's creation, but they unfortunately do not clarify the cultivator's rights and interests.
Before the draft proposal for the first revision of the Patent Law was published in early 1990s, SIPO (State Intellectual Property Office of the People's Republic of China) negotiated an agreement with the Ministry of Agriculture that plant varieties are excluded from the protection of the Patent Law according to conventional rules. Accordingly, Article 25 of the Patent Law, amended on January 1, 1993, clarifies that it does not protect plant varieties, but that processes for making new plant varieties are patentable. Although Article 11 extends process patent rights to the making, using, selling, or offering for sale of processes for making new plant varieties, the rules are so strict for process patents (for a patent to issue, the process must possess the characteristics of novelty, usefulness, and inventiveness—especially novelty) that many such processes are not granted patent rights. Thus, the Patent Law has only a limited influence on the protection of plant varieties.
However, this revision removed two categories of unpatentable subject matter: (1) food, drink, and condiments; and (2) medicine (substances obtained by chemical methods). In fact, this solved the problem of whether genes could be patented under the Patent Law of China. Moreover, this extends the scope of biotechnology patents to include microorganisms, inventions involving heredity, and biological inventions. Up to 1993, biotechnology patent protection under the Patent Law had included microorganisms, biological inventions, biological methods to obtain substances, inventions from genetic engineering, and inventions from microbiology.
In 1994, China joined the Patent Cooperation Treaty. In 1995, China joined the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. Meanwhile, the China General Microbiological Culture Collection Center (CGMCC) and China Center for Type Culture Collection (CCTCC) became international depository organizations for microorganisms.
Regulations of the People's Republic of China on the Protection of New Varieties of Plants were published in March 20, 1997, which for the first time provided for patent protection for new varieties of plants. After this, the Ministry of Agriculture and State Forestry Administration promulgated related regulations. China started to grant patent rights for new plant varieties on April 23, 1999. In March 1993, China joined the International Convention for the Protection of New Varieties of Plants (1978) and officially became the 39th member of the International Union for the Protection of New Varieties of Plants (UPOV).
On December 1, 2000, the Seed Law of the People's Republic of China, which describes the rules for the protection of new plant varieties, came into force. What's more, China has established many related regulations on this topic, such as the Rules of Implementation of the Regulations of the People's Republic of China on the Protection of New Varieties of Plants, Rules for the Reexamination Board for New Plant Varieties of Ministry of Agriculture, the Guidelines for Agricultural New Varieties of Plant, etc.
Concerned about the potential loss of genetic resources to other developed countries, and recognizing the rising importance of genes and biotechnology inventions, in 1998, the Ministry of Health and the Ministry of Science and Technology jointly promulgated the Interim Measures for the Administration of Human Genetic Resources, which was the start of protecting human genetic resources. The promulgation showed that the Chinese government realized the importance of genetic resources and was taking action to preserve them.
The 2000 amendment of the Patent Law brought in a new concept called “biological materials,” which assimilated genetic materials into the scope covered by the Patent Law. Biological materials are those containing hereditary information that are capable of self-reproducing or which can be copied in the biosystem. Biological materials include genes, plasmids, microorganisms, plant and animal cells, etc. After this, SIPO enlarged the rules for reviewing biotechnology patents, which are not limited in the area of microorganisms, in the Guideline for Patent Examination. This edition of the Patent Law and Guideline for Patent Examination strengthens the protection afforded by patents and simplifies the patenting process.
The latest amendment to the Patent Law is the 2008 one. Its highlights are as follows:
1. Encourage creativity and emphasize the law's function of putting inventions into practice use; 2. Enhance the protection offered by patents; that is, enlarge the Patent Law's scope of validity, improve the protection of patentees' rights, and strengthen the administrative punishment for infringement.
Status of Biotechnology Patent Protection in China
Today, SIPO follows these rules in reviewing biotechnology patent applications and granting patents.
No Patent Rights Granted for Plant and Animal Varieties
Article 25 of Patent Law settled this rule: neither new plant and animal varieties cultivated by traditional ways, nor animals or plants obtained by recombinant DNA technology or modern hybridization techniques, can be patented. However, the techniques used to obtain organisms and the methods of producing genetically modified plants and animals can be patented.
Cultivators can ask for protection if the new plant variety(ies) meet the requirements of the Regulations of the People's Republic of China on the Protection of New Varieties of Plants. The regulation provides: “New plant varieties are species cultivated by human[s] or developed on the basis of wild plants, with novelty, stability and specificity as well as a proper name.” The entity or person who has accomplished the breeding enjoys an exclusive right to his or its protected variety, except when used by farmers for propagation or exploited by scientists for research purposes.
Microorganisms and Genetic Materials can be Patented
According to the classification of modern biology, microorganisms belong to neither plants nor animals. But, according to Rules of Implementation of Patent Law of the People's Republic of China and Guidelines for Patent Examination, microorganisms can be patented. Microorganisms include bacteria, actinomycetes, fungi, viruses, algae, etc.
If invention-creations of this kind involve cultures not available to the public, the applicants should follow Article 24 of Rules for the Implementation of Patent Law of the People's Republic of China and deposit a sample of the microorganism with CGMCC and CCTCC, which are authenticated by the Budapest Treaty.
Biological Manufactures are Patentable
Biological manufactures are preparations, such as vaccines, antitoxins, antibiotics, etc., which are made from microorganisms, animal toxins, human or animal blood, and so on and used for preventing, diagnosing, or treating diseases. The amended Patent Law allows medicines and chemical-process-obtained materials to be patented. Biological manufactures related to cultures that are not available to the public must be deposited, as per Article 24 of the Rules of Implementation of Patent Law of the People's Republic of China (discussed above).
Patentable Process to Obtain Organism Should be Repeatable and Non-Biological
There are many processes useful to obtain organisms; however, not all processes are patentable. The requirement of utility means that the invention-creation should be repeatable and not rely on random factors. As a practical matter of fact, however, many biological processes depend on random factors, leading to tremendous individual difference(s). This is why many processes are not patentable. In addition, the process for inducing mutations with chemical or physical methods, or processes of filtering by nature, cannot be patented either.
No Patent Rights Will be Granted for Methods for the Diagnosis or Treatment of Diseases
Article 25 of Patent Law settled this rule: all methods for diagnosis or treatment of diseases, such as acupuncture, moxibustion,3 embryo transfer, operations, etc. and including genetic techniques, cannot enjoy the protections granted by patent law. However, none of the following is considered, for this purpose, a method for the diagnosis or treatment of diseases:
1. Medicine and medical apparatus for diagnosis and treatment of diseases; 2. Laboratory testing processes conducted outside of human or animal bodies; 3. Post-mortem testing; 4. Physical index testing not used for diagnostic or treatment purposes.
The Patenting Process
Biotechnology Patent Application Process
First, relevant documents must be submitted, especially the claims. Specifications must indicate the technical field to which the invention-creation belongs, the technical problem(s) it solves, and its main characteristics.
After receiving a patent application, the patent administration department will conduct a preliminary examination to confirm whether patent-related fees have been charged, whether all forms are correctly filled out, and so on. After that, the application will be published promptly after the expiration of 18 months from the date of filing. After publication, these files will be sent to the appropriate office; for example, most biotechnology invention-creations are reviewed by examiners from the biotechnology office, which is a branch of the Chemistry Department. The review will take months—even years—to finish, as the application will be examined thoroughly.
China's plant variety protection is in the charge of the Ministry of Agriculture and State Forestry Administration. The State Forestry Administration's duty is to protect new varieties of forest, bamboo, woody climber, fruit trees, herb, woody oil producers, and so on, while the Ministry of Agriculture protects the remaining plants.
Deposit of Biological Materials During Patenting
When an invention concerns a new biological material not available to the public and which cannot be described in the application in such a manner as to enable the invention to be carried out by a person skilled in the art, the applicant shall, in addition to the other requirements provided for in the Patent Law and these Rules, go through the following formalities:
1. Deposit a sample of the material with a depositary institution designated by the patent administration department under the State Council before, or at the latest, on the date of filing (or by the priority date, where priority is claimed), and submit at the time of filing (or at the latest, within four months from the filing date) a receipt of deposit and the viability proof from the depository institution. When the materials are not submitted within the specified time limits, the sample of the biological material shall be deemed not to have been deposited; 2. Provide in the application relevant information on the characteristics of the biological material; 3. Indicate, where the application relates to the deposit of the biological material, in the request and the description the scientific name (with its Latin name) and the name and address of the depositary institution, the date on which the sample of the material was deposited, and the accession number of the deposit. If, at the time of filing, this information is not indicated, it shall be supplied within four months from the date of filing and if, after the expiration of the time limit, it has not been supplied, the sample of the biological material shall be deemed not to have been deposited.
The SIPO has entrusted these responsibilities to CGMCC and CCTCC.
Declaration of Patent Invalidity
Article 45 of Patent Law provides that: “where, starting from the date of the announcement of the grant of a patent right by the patent administration department under the State Council, any entity or individual considers that the grant of the said patent right is not in conformity with the relevant provisions of this law, it or he may request the Patent Reexamination Board to declare the patent right invalid. Where the patentee or the person who makes the request for invalidation is not satisfied with the decision of the Patent Reexamination Board either declaring the patent right invalid or upholding the patent right, such party may, within three months from receipt of the notification of the decision, institute legal proceedings in the people's court.”
Consider the case of Pfizer Ireland Pharmaceuticals vs. Patent Reexamination Board of the People's Republic of China. Twelve Chinese pharmaceutical companies requested that the Patent Reexamination Board declare Pfizer's patent rights in Viagra invalid on the grounds of inadequate disclosure of technical features in the claims. The Patent Reexamination Board ultimately declared the patent invalid. The Board believed that skilled artisans in the pharmaceutical industry would still need creative work to confirm that the compound (Viagra) had the second effect, as the claims provide. Pfizer's disclosure was considered inadequate.
Pfizer was, not surprisingly, dissatisfied with this result and resorted to legal proceedings in the people's court. At the conclusion of the trial of first instance, Pfizer won, and the court denied the Patent Reexamination Board's declaration.4 Pfizer's opponents—the twelve pharmaceuticals companies—immediately appealed to Beijing Higher People's Court, but to no avail: on October 27, 2007, Beijing Higher People's Court sustained the original judgment.5
Future Development of Legal Protection of China's Biotechnology Patents
Controversy over Whether a Human Gene Is a Scientific Find
On June 13, 2013, the U.S. Supreme Court handed down the AMP v. Myriad decision, holding that naturally occurring genes are unpatentable subject matter. Although there are academic debates in China about whether genes are patentable subject matter, the 2000 patent law amendment clearly provides for the patenting of isolated genes. Having said that, the U.S. clearly has gone down a different path, and it is not clear whether China will follow suit in the future.
The rule above is similar to the rule about natural materials, which is settled by the Patent Law. Finding some natural material is a scientific discovery and is not patentable; but separating it and changing its inner structure with technical methods in order to obtain some new value can render it a patentable invention, the way that ingredients of Chinese medicine leached from plants or animals can be patented.
Concept of Animal and Plant Variety
It is hard to establish the repeatability of plant and animal varieties by traditional modes of reproduction. As a result, many countries do not grant patent rights to animal and plant varieties. In order to encourage invention in the biological field, we can renew the concept of animal and plant variety. The best solution to the question of whether genetically modified plants and animals are patentable is to renew the concept of animal and plant variety as animal and plant varieties reproduced in traditional biological ways.
Patent Law and Morality
Article 25 of Patent Law states that: “no patent right shall be granted for any invention-creation that violates the laws of the State, goes against social morals or is detrimental to the public interest.” This is the only rule related to morality. It is therefore necessary to clarify the scope of invention-creations which cannot be patented:
1. Methods to clone a human being; 2. Methods to change the hereditary traits of a human being; 3. Commercial or industrial use of human embryos; 4. Methods to change animals' hereditary traits, causing or contributing to pain for the animals without any benefits to humans or animals.
But Article 5 of the Patent Law solves the problem of the abuse of cloning, genetic discrimination, unbalancing nature through biotechnology, and so on. What needs to be specified is that patent rights are more than use rights, but rather exclusive rights to forbid others to use the patent process or material. From this perspective, granting cloning technology patent rights does not mean to promote the abuse of cloning; on the contrary, there will be more limits on the patented inventions as, for example, patentees could apply for injunctive relief and seek compensation for infringement. It would be advantageous to promulgate regulations in order to prevent the abuse of biotechnology.
Protection of Genetic Resources
As we all know, China is a large country, full of genetic resources. Genetic resources are irreplaceable assets or precursors for biotechnology invention, without which much research could not succeed. It is therefore an urgent issue to protect China's genetic resources efficiently.
We propose that, on the one hand, the State Council and the People's Congress legislate and regulate to protect Chinese medicine, microorganisms, genetic information, etc; but on the other hand, encourage innovation and tap resources to create new intellectual property, and then turn that intellectual property into economic and technological gains.
Biotechnology is a rapidly developing field. With its growth, the legislation and biotechnology patent protection of China are developing accordingly.