chapter 1 Inventions-creations for which No Patent Right shall be Granted
1. Introduction
Granting patent right for an invention-creation shall be favorable to advance the application of the invention-creation, enhance innova- tion capability, and promote the progress of science and technology, and the development of economy and society. Thus, Article2 provides for subject matters for which patent right may be granted. considering the interests of the state and the society, certain restrictions are also made in the patent Law to the extent of patent protection. on one hand, Article5 provides that no patent rightshall be granted for any invention-creation that is contrary to the laws or social morality or that is detrimental to public interest;no patent rightshall be granted for any invention-creation where acquisition or use of the genetic re- sources, on which the development of the invention-creation relies, is not consistent with the provisions of the laws and administrative regu- lations. on the other hand, Article25 provides for a list of subject mat- ters for which no patent rightshall be granted.
2. subject Matters Not complying with Article2.2
“Invention”in the patent Law refers to any new technical solu- tion concerning a product,a processor improvement thereof. This is a general definition to the subject matters for which patent protection may besought, rather than a specific examination criterion for the de- termination of novelty or inventive step.
Atechnical solution is an aggregation of technical means applying the laws of nature to solve a technical problem. usually, technical means are embodied as technical features.
Asolution that does not adopt technical means to solve a technical problem and thereby does not achieve any technical effect in com- pliance with the laws of nature does not constitute a subject matter as defined in Article2 . 2 .
smell, signal such as sound, light, electricity, magnetism, and wave, or energy does not constitute a subject matter as provided in Article 2 . 2 . However, patent applications in which its nature is utilized to solve a technical problem cannot be excluded as above.
3. Inventions-creations Excluded from patent protection under Article5
According to Article5 . 1, no patent rightshall be granted for any invention-creation if its disclosure, use or manufacture is contrary to the laws or social morality or detrimental to public interest.
According to Article5 . 2, no patent rightshall be granted for any invention-creation where acquisition or use of the genetic resources, on which the development of the invention-creation relies, is not consist- ent with the provisions of the laws and administrative regulations.
The connotation of the laws, administrative regulations, social morality and public interest is quite broad, which may vary with time and from region to region. sometimes certain restrictions may be add- ed or removed because of enactment and implementation of a new law or administrative regulation or amendment to or abolishment of a pre- ceding law or administrative regulation. Therefore, the examinershall pay special attention to this point in conducting examination according to Article5 .
3. 1 Inventions-creations Excluded from patent protection under Article5. 1
3. 1. 1 Inventions-creations contravening the Laws
The laws refer to the laws formulated and promulgated by theNa- tional people,s congress or its standing committee following the leg- islative procedure. They do not include administrative regulations made by the state councilor its departments or local governments.
where an invention-creation is contrary to the laws, it cannot be granted for a patent right. For example, gambling facilities, devices or instruments, drug-taking appliances, apparatus for counterfeiting ban- knotes, bills,official documents, certificates, seals, and historic relics are all inventions-creations contravening the laws and no patent rights shall be granted for them.
where an invention-creation is not contrary to the laws but its a-
buse may be contrary to the laws, it shall not be excluded from patent protection as above. Examples of such include the various toxicants, anesthetics,sedatives, and analeptics used for medical treatment, and playing cards and chesses used for entertainment.
Rule 10 provides that inventions-creations that are contrary to the laws referred to in Article5 shall not include an invention-creation merely because the exploitation of which is prohibited by the laws. It means that, where the laws merely restrict or limit the manufacture, sale or use of the product of an invention-creation, the product perse and the processes of its manufacture do not belong to the inventions- creations that are contrary to the laws. For example, although the man- ufacture, sale or use of the various weapons used for national defense are restricted by the laws, these weapons perse and its processes of manufacture are still patentable subject matters.
3.1.2 Inventions-creations contrary to social Morality
“social morality”refers to ethical or moral norms and rules gen- erally recognized as justifiable and accepted by the public. Its connota- tion is based on certain cultural background, continuously changes with time and social progress, and varies from region to region. social mo- rality referred to in the chinese patent Law indicates that within the territory of china.
where an invention-creation is contrary to social morality, it shall not be granted apatent right. For example, inventions-creations such as a design with drawings or photographs of violence, murder orobsceni- ty, an artificial sexual organ or its substitute not for medical use, or a method of mating a human-being with an animal,a process for modif- ying the germ line genetic identity of human beingsora human being thus modified,a process for cloning human beingsora cloned human being, use of human embryos for industrial or commercial purposes,
and a process for modifying the genetic identity of animals which is likely to cause them suffering without any substantial medical benefit to human-beings or animals, are contrary to social morality and thus shall not be granted patent rights.
3. 1.3 Inventions-creations Detrimental to Public Interest
The expression “detrimental to public interest”means that the ex- ploitation or use of an invention-creation may cause detriment to the public or the society or may disrupt the normal order of the state and the society.
[Examples]
where an invention-creation employs the means of disabling or injuring a person or damaging property, such as an anti-theft device or process by causing blindness to the thief, it shall not be granted apa- tent right.
where the exploitation or use of an invention-creation may seri- ously pollute the environment, seriously waste energy or resources,dis- rupt ecological balance, or impair the health of the public, the inven- tion-creation shall not be granted a patent right.
where a patent application has words or pictures concerning an important political event of the state or a religious belief, hurting the sentiments of the people or of an ethnic group, or advocating supersti- tion, it shall not be granted a parent right.
However, if an invention-creation is possibly detrimental to public interest in its abuse, or has certain defects despite positive effects, such as a pharmaceutical product with side effects on human body, it shall not be refused to grant a patent right on the ground that it is detrimen- tal to public interest.
3. 1.4 Inventions-creations partially contravening Article5. 1
A patent application is considered partially contravening Article
5 . 1 if apart of the application contains certain content that is contrary to the laws or social morality or that is detrimental to public interest and the rest part of the application is not. In respect of such an applica- tion, the examiner during examination shall notify the applicant to a- mend his application and delete the part contravening Article5 . 1 . If the applicant refuses to delete the part that is contrary to the laws, it cannot be granted a patent right.
For example, concerning an invention-creation of“aslot marbles game machine”, which will ejecta certain amount of money when the player achieves a certain amount of points, the examinershall notify the applicant to delete or amend the part involving ejection of money and make it a mereslot marbles game machine. otherwise, even if it is a new technical solution involving an inventive step, it cannot be gran- ted a patent right.
3. 2 Inventions-creations Excluded from patent protection under Article5.2
According to Article5 . 2, no patent rightshall be granted for any invention-creation where acquisition or use of the genetic resources, on which the development of the invention-creation relies, is not consist- ent with the provisions of the laws and administrative regulations.
According to Rule26 . 1, the genetic resources referred to in the patent Law mean the material obtained from such as human body, ani- mal, plant, or microorganism which contains functional units of heredi- ty and is of actual or potential value. The invention-creation is devel- oped relying on the genetic resources referred to in the patent Law means that the invention-creation is developed relying on the use of the heredity function of the genetic resources.
In the above-mentioned provisions, heredity function refers to the ability of organism to pass on traits or characteristics from an ancestor to a descendent through reproduction, or allow the entire organism to be reproduced.
Functional unit of heredity refers to a gene, or a DNA or RNA fragment having heredity function of an organism.
“Material obtained from such as human body, animal, plant or mi- croorganism which contains functional units of heredity”refers to car- rier of functional units of heredity, which includes not only a whole or- ganism, but also apart of it, such as organ, tissue, blood, body fluid, cell, genome, gene, DNAor RNAfragment, etc.
with regard to an invention-creation, using the heredity function of the genetic resources refers to, for example, isolating, analyzing and/or processing the functional units of heredity to develop the in- vention-creation and to realize the value of the genetic resources.
“Acquisition or use of the genetic resources is not consistent with the provisions of the laws and administrative regulations”means that the acquisition or use of the genetic resources is not beforehand ap- proved by relevant administrative departments or licensed by relevant right holder in accordance with the provisions of relevant laws and ad- ministrative regulations of china. For example, in accordance with the provisions of“Animal Husbandry Law of the people,s Republic of china”and “Measures for Examination and Approval in respect of the Entry and Exit of Genetic Resources of Livestock and poultry and in respect of Research in Their utilization in cooperation with Foreign Entities”, in the case of exporting abroad the genetic resources that have been included in the directory for protection of the genetic re- sources of livestock and poultry in china, relevant formalities for ex- amination and approval shall begone through. where certain genetic resources that have been included in the directory for protection of livestock and poultry are exported abroad from china, but no formality for examination and approval has been gone through, no patent right shall be granted for any invention-creation developed relying on such genetic resources.
4. subject Matters Excluded from Patent Protection under Article25
where a patent application claims a subject matter belonging to the subject matters excluded from patent protection under Article 25.1, it shall not be granted a patent right.
4. 1 scientific Discoveries
“scientific discoveries”refer to the revelations of substances, phe- nomena, transformation processes and their features and laws, which objectively exist in the nature. scientific theories are the generalization of understandings of the nature, and are discoveries in a broader sense. All of these are the extension of the cognition of human beings. Be- cause these discovered substances, phenomena, processes, features and laws are different from the technical solutions of reforming the objec- tive world, they are not inventions-creations as referred to in the patent Law and therefore cannot be granted patent rights. For example,dis- covery of the photosensitive property of a silver halide under illumina- tion cannot be granted a patent right. However, patent right may be granted for the photographic film and the process to produce the film in accordance with this discovery. For another example, finding in the nature a previously unknown substance existing in its natural state is merely a discovery, and cannot be granted a patent right(for examina- tion of patent applications concerning substance separated or extracted from the nature for the first time, chapter10, section 2 . 1 of this part shall apply).
It should be noted that, although invention and discovery aredif- ferent in substance, they are closely interrelated. usually, many inven- tions are made on the basis of discoveries. In turn, inventions promote discoveries. such close relationship between invention and discovery is especially prominent in “use invention”of chemical substances. when a special property of a certain substance is discovered, usually a use in- vention utilizing this property will be made accordingly.
4.2 Rules and Methods for Mental Activities
“Mental activities”refer to human,s thinking movements. They originate from human,s thinking, and produce abstract results through inference, analysis and judgment, or, via human,s thinking movement,produce results by indirectly acting on the nature. Rules and methods
for mental activities are rules and methods governing people,s think- ing, expression, judgment, and memorization. Because they do not use technical means or apply the laws of nature, nor do they solve any technical problem or produce any technical effect, they do not consti- tute technical solutions. Rules and methods for mental activities not only fail to comply with Article2 . 2, but also fall to be the circum- stance as provided in Article25 . 1 (2 ) . Therefore, rules and methods instructing people on how to perform this kind of activities cannot be granted patent rights.
In determining whether or not a claimed subject matter in a patent application involving rules and methods for mental activities is apa- tentable subject matter, the following principles shall be followed.
(1)If a claim concerns only rules and methods for mental activi- ties, it shall not be granted a patent right.
If a claim, except for the title of the subject matter, is defined by rules and methods for mental activities in the whole contents, in sub- stance it concerns only rules and methods for mental activities, and it
shall neither be granted a patent right.
Examples include the following:
methods of examining patent applications;
methods and systems of managing organization, production, com- mercialactivities, or economy, etc.;
traffic rules, schedules, competition rules;
methods of deduction, inference, or operations;
rules of classifying books, methods of editing dictionary, methods of searching information, methods of classifying patents;
rules and methods of editing calendar;
operating instructions of an instrument or an apparatus;
grammar of various languages, rules of coding chinese charac- ters;
computer languages, computing rules;
short-cut arithmetic methods and relevant pithy formulae;
mathematical theories and methods of conversion; methods of psychological test;
methods of teaching, lecturing, training, and beast training; rules and methods of various games or entertainment;
methods of statistics, accounting, or bookkeeping; music books, food recipes, or chess manuals;
methods of keeping fitness;
methods of disease survey and methods of population census;
methods of presenting information;and computer programs perse.
(2)Except the cases described above in point(1), if aclaim in its whole contents contains not only matter of rule or method for mental activities but also technical features, then the claim, viewed as a whole, is not a rule or method for mental activities, and shall not be excluded from patentability under Article25 .
4.3 Methods for Diagnosis or for Treatment of Diseases
“Methods for diagnosis or for treatment of diseases”refer to the processes of identifying, determining, or eliminating the cause or focus of diseases which are practiced directly on living human or animal bodies.
For humanity and ethical reasons, it is acknowledged that a doctor shall be given the freedom to choose any means in the course of diag- nosis or treatment of diseases. Moreover, this kind of methods are not susceptible of industrial application because they are practiced directly on living human or animal bodies, and are not inventions-creations in the context of the patent Law. Therefore, methods for diagnosis or for treatment of diseases shall not be granted patent rights.
However, instruments or apparatus for implementing these meth- ods of diagnosis or treatment, or substances or materials for use in such methods are subject matters for which patent right may be granted.
4.3. 1 Diagnostic Methods
Diagnostic methods refer to the processes of identifying, stud- ying, and determining the cause or focus of diseases on living human or animal bodies.
4.3. 1. 1 Inventions Belonging to Diagnostic Methods
where a method involving diagnosis of a disease complies with the following two requirements, it is a diagnostic method and cannot be granted a patent right:
(1)it is practiced on a living human or animal body;and
(2)its immediate purpose is to obtain the diagnostic result of a disease or health condition.
If an invention, as viewed from its description, is practiced on samples in vitro, but its immediate purpose is to obtain the diagnostic result of a disease or health condition for the same subject, it shall not be granted a patent right.
If a method claimed in a patent application includes diagnostic steps, or includes testing steps if no diagnostic steps, and the diagnostic result of adisease or health condition can be reached immediately based on the diagnostic or test information thus obtained according to the medical knowledge in the prior art and the disclosure of the appli- cation, then the method can be regarded as satisfying the above re- quirement(2) .
The following are examples of diagnostic methods for which no patent rightshall be granted:
method of measuring blood pressure, method of taking pulse, feet diagnostic method,X-ray diagnostic method, ultrasonic diagnostic method, gastrointestinal radiography diagnostic method, endoscopy di- agnostic method, isotope tracing diagnostic method, infrared noninva- sive diagnostic method, method of evaluating the risk of suffering diseases, method of predicting the therapeutic efficacy for diseases, and gene screening diagnostic method.
4.3.1.2 Inventions Not Belonging to Diagnostic Methods
The following are examples which do not belong to diagnostic methods:
(1)method of pathological anatomy practiced on a dead human or animal body;
(2)method the immediate purpose of which is only to obtain in- formation from the living human or animal body as an intermediate re- sultrather than to obtain the diagnostic result or health condition, or method of processing such information (e.g. , physique and body pa- rameters, physiological parameters, or other parameters);and
(3)method the immediate purpose of which is only to treat or test the body tissues, body fluids, or excrements that have been removed from the human or animal body in order to obtain information as an intermediate result rather than to obtain the diagnostic result or health condition, or method of processing such information.
As for the above items(2)and (3), it should be noted that only if the diagnostic result of a disease and health condition cannot be reached immediately based on the obtained information persein ac- cordance with the medical knowledge in the prior art and the disclosure of the application, can the information be regarded as an interme- diate result.
4.3.2 Methods of Treatment for Diseases
Methods of treatment for diseases refer to the processes of inter- cepting, relieving, or eliminating the cause or focus of diseases so that the living human or animal bodies may recover or gain health or re- lieve pain.
Methods of treatment for diseases include the various methods which serve treatment purpose or which are of treatment nature. proph- ylactic methods and methods of immunization are regarded as methods of treatment for diseases.
For a method both possibly serving treatment purpose and possi- bly serving non-treatment purpose, unless it is clearly stated that the method serves non-treatment purpose, it cannot be granted a patent right.
4.3.2.1 Inventions Belonging to Methods of Treatment for Disea- ses
The following are examples that belong to or shall be regarded as methods of treatment for diseases and thus shall not be granted patent rights:
(1 )methods of treatment by surgery, methods of treatment by pharmaceutical therapy, or psychotherapeutics;
(2 )methods of acupuncture, anesthesia, manipulation, massage,
Gua sha(scraping therapy), qigong,hypnosis, medicated bath, air bath, sunbath, forest bath, and nursing care for the purpose of treat- ment;
(3)methods of stimulating or irradiating a human or animal body by radiation of electricity, magnetism, sound, light, or heat etc. for the purpose of treatment;
(4)methods of coating, freezing, or diathermy etc. for the purpose of treatment;
(5)various immunization methods for prevention of diseases;
(6)methods auxiliary to a surgery treatment and/orpharmaceuti- cal therapy, such as method of processing cells, tissues, or organs that will be returned to the same subject, method of hemodialysis, method of monitoring the depth of anesthesia, method of taking medicines, method of injecting medicines, or method of applying medicinesexternally;
(7)methods of fertilization, contraception, increasing the number of sperm,adosculation, or embryonic transfer etc. for the purpose of treatment;
(8)methods of cosmetic surgery, stretching limbs, losing weight, or increasing height for the purpose of treatment;
(9)methods of treating human or animal wounds, such as method of disinfecting or bandaging a wound;and
(10 )other methods such as method of artificial respiration and method of oxygen supply for the purpose of treatment.
It shall be noted that although methods of treatment for diseases by using medicines are not patentable, medicines perse can be granted patent rights. For examination of patent applications concerning medi- cal use of substances, chapter10, sections2 . 2 and 4 . 5 . 2 of this part shall apply.
4. 3. 2. 2 Inventions Not Belonging to Methods of Treatment for Diseases
The following methods are examples which do not belong to methods of treatment for diseases, and shall not be excluded from pat- entability under Article25 . 1(3):
(1 )methods of making artificial limbs or other prostheses, and methods of measurement in making such artificial limbs or prostheses. Take for example a method of making dental prosthesis, including the step of making tooth mould in the oral cavity of the patient and the step of making dental prosthesis outside the oral cavity. Although the ultimate aim is for treatment, the purpose of the method in itself is to make suitable dental prosthesis;
(2)methods of stockbreeding by treating animal bodies by anon- surgery means to change their growing trait, such as methods of apply- ing certain electromagnetic stimulation to live lambs in order to accel- erate their growth speed, improve the quality of mutton, or increase the output of wool;
(3)methods of butchering animals;
(4 )methods of treating dead human or animal bodies, such as methods of anatomy, beautification, antisepsis, or making specimen;
(5)methods of purely cosmetic nature,i.e. , methods of cosmetic nature which are not invasive to human body or do not produce wounds, including methods of deodorization, protection, decoration, or beautification for non-treatment purpose practiced partially on such di- rectly visible parts as skin, hair, nail, and teeth externals;
(6)methods for making a human or animal not in a diseased state feel comfortable or pleased, or methods for supplying oxygen, negative oxygen ions,or moisture under a special condition such as for diving or for shielding from toxic gas;and
(7)methods of killing bacteria, viruses, lice, or fleas on a human or animal body (on the skin or in the hair, excluding wounds and in- fected sites).
4.3.2.3 Methods of surgery
Methods of surgery refer to the methods of traumatic or invasive treatment such as incision, resection, stitching, and tattooing practiced on living human or animal bodies with the aid of instruments. such methods cannot be granted patent rights. However,a method of treat- ment such as incision, resection, stitching, and tattooing practiced on a dead human or animal body may be patentable in so far as it does not violate Article5 . 1 .
Methods of surgery are divided into one kind for the purpose of treatment and the other kind for the purpose of non-treatment.
A method of surgery for the purpose of treatment belongs to methods of treatment for diseases, for which no patent rightshall be granted in accordance with Article25 . 1(3) .
For examination of methods of surgery for non-treatment purpo- ses, chapter5 , section 3 . 2 . 4 of this partshall apply.
4.4 Animal and Plant varieties
Animal and plant are living things. According to Article25 . 1 (4), no patent rights shall be granted for animal and plant varieties. Animal referred to in the patent Law does not include human being, and it refers to the lifeform which cannot synthesize carbohydrate and protein by itself but maintains its life only by absorbing natural carbo-
hydrate and protein. plant mentioned in the patent Law refers to the lifeform which maintains its life by synthesizing carbohydrate and protein from the inorganics, such as water, carbon dioxide, and inor- ganic salt, through photosynthesis, and usually is immovable. Animal and plant varieties can be protected under other laws and regulations other than the patent Law. For example, new plant varieties can get protection under the Regulations on the protection ofNew varieties of plants .
Moreover, according to Article25 . 2, patent right may be granted for processes used in producing animal and plant varieties. The proces- ses of production herein refer to non-biological processes, and do not include those for the production of animals or plants through essential- ly biological processes.
whether or not a process is an “essentially biological process” depends on the degree of human technical involvement in the process. If the human technical involvement is the controlling or decisive factor for achieving the result or effect of that process, the process is notes- sentially biological. For example, the method of raising high yield dair- y cattle through irradiation and the method of producing lean meat pigs by improving raising approach are patentable subject matters.
Microorganism inventions refer to those relating to producing a chemical substance(such as an antibiotics)or decomposing a sub- stance by means of microorganisms such as various bacteria, fungi, and viruses. Microorganisms and microbial processes are all patentable. For examination of patent applications for invention concerning microor- ganisms, the relevant provisions of chapter10 of this partshall apply.
4. 5 Methods of Nuclear Transformation and the substances ob- tained Therefrom
Methods of nuclear transformation and the substances obtained
therefrom are of much concern with national interests in economy, defense, scientific research, and public order, and shall not be monopo- lized by individuals or entities. Therefore they cannot be granted patent rights.
4.5. 1 Methods of Nuclear Transformation
Methods of nuclear transformation refer to the processes of one or more atomic nucleus forming one or more new atomic nucleus through fission or fusion, such as the method of magnetic mirror traps and the method of close traps for realizing nuclear fusion reaction and the vari- ous methods for realizing nuclear fission reaction. such methods can- not be granted patent rights. However, particle acceleration methods for increasing particle energy to realize nuclear transformation (such as e- lectron traveling wave acceleration method, electron standing wave ac- celeration method, electron collision method, electron circular accelera- tion method and so on)are not methods of nuclear transformation, and are thus patentable subject matters.
The various apparatus and devices used for realizing nuclear transformation, and the components thereof, are all patentable subject matters.
4.5.2 substances obtained by Means of Nuclear Transformation substances obtained by means of nuclear transformation mainly
refer to various radioisotopes manufactured or produced by accelera- tors, reactors, or other nuclear reaction apparatus. such radioisotopes cannot be granted patent rights.
However, use of those isotopes and the apparatus and devices used therefor are subject matters for which patent rights may be granted.
