Richard Yong WANG, Partner, Lawyer and Patent Attorney

 

"Patentable subject matter" refers to the invention-creations that can be protected by patent, and are those the Patent Law aims to protect.

 

The premise for an invention-creation to be protected by a patent, is that it is a patentable subject matter as stipulated in the Patent Law, otherwise it will lack patentability,  and shall not enter subsequent examination procedures or get patented. Only if an invention-creation that has passed the patentability examination, could it be subsequently examined as to the prescribed "novelty, inventiveness and applicability" to further determine whether the other conditions for patenting are met.

 

In China, the subject matter patentable under the Patent Law is defined in two ways: a positive conceptual definition and a negative exclusionary provision.

 

Article 2 of the Patent Law defines the three categories of patentable subject matter, namely, inventions, utility models, and designs, as follows:

 

An invention refers to a new technical solution of a product, a process, or an improvement thereof.

 

A utility model refers to a new technical solution suitable for practical use of the shape, structure or combination thereof of a product.

 

A design refers to a new design that is aesthetically appealing and suitable for industrial application made on the whole or part of the shape, pattern or combination thereof, as well as the combination of color, shape and pattern.

 

On the other hand, for the national and public interests, the Patent Law also makes restrictive provisions on the scope of patent protection, i.e. exclusionary provisions. Article 5 of the Patent Law stipulates that no patent right shall be granted for any invention-creation that violates the law, social morality, or obstructs the public interest, and no patent right shall be granted for any invention-creation that has been obtained or utilized in violation of laws and administrative regulations, and have been completed by relying on such genetic resources; and Article 25 of the Patent Law stipulates six specific circumstances under which subject matter is not patentable.

 

Additionally, Article 20 of the Patent Law as amended in 2021 introduces the principle of good faith, that is, "the principle of good faith shall be followed in applying for, and enforcing, a patent. One shall not abuse the patent right to harm the public interests or the legitimate rights and interests of others", and, accordingly, Rule 11 of the Implementing Regulations of the Patent Law as amended in 2023 stipulates that inventions-creations that violate the principle of good faith shall be excluded from patentability as non-patentable.

 

Therefore, based on the Patent Law amended in 2021 and its Implementing Regulations amended in 2023, the Guidelines for Patent Examination (or the new Guidelines) released at the end of 2023 have further amended the provisions of the 2021 Guidelines for Patent Examination (or the old Guidelines) on how to apply the preceding provisions relevant to the subject matter protectable under the Patent Law. The following is an explanation of how the provisions of the new Guidelines on the patentable subject matter are understood and applied for your reference.

 

I. Paragraph 2 of Article 2 of the Patent Law

 

In the old Guidelines, the technical solutions provided for in Paragraph 2 of Article 2 of the Patent Law (or Article 2.2) were defined as a collection of technical means that make use of the laws of nature adopted to solve the technical problems to be solved, and that are usually embodied by technical features. A solution that does not use technical means to solve technical problems to obtain a technical effect that conforms to the laws of nature is not the subject matter provided for in Article 2.2. Moreover, according to the old Guidelines, smell, or signals or energy, such as sound, light, electricity, magnetism, waves, etc., are not subject matter as provided for in Article 2.2, but inventions-creations that use their properties to solve technical problems are excluded.

 

The provisions on technical solutions in the new and old Guidelines are essentially identical.

 

II. Paragraph 1 of Article 5 of the Patent Law

 

Article 5.1 of the Patent Law stipulates that no patent right shall be granted for inventions-creations that violate the law or social morality, or impede the public interests.

 

In the new and old Guidelines, laws are further defined as those enacted and promulgated by the National Congress or the Standing Committee of the National Congress in accordance with the legislative procedures, and do not include administrative rules and regulations. Inventions-creations that are contrary to the laws shall not be patentable.

 

The old Guidelines gave specific examples of inventions-creations that were contrary to the law, such as "equipment, machines or tools used for gambling", without specifying the specific legal basis. To further standardize the examination under Article 5 of the Patent Law, the new Guidelines clarify the specific laws violated by the relevant acts in the examples, including the Criminal Law, Public Security Administration Punishment Law, Bank Law, and Negotiable Instruments Law of China.

 

It should be noted that in the new Guidelines, the example of equipment for counterfeiting cultural relics is an invention that violates the law has been deleted, because with regard to "equipment for counterfeiting cultural relics", the relevant law does not explicitly stipulate the act of "falsifying cultural relics" itself. The act of reproducing or imitating cultural relics is not expressly prohibited by law, and only when there is improper act, such as using copied or imitated cultural relics to commit fraud, might violate the provisions of the Criminal Law, the Public Security Administration Punishment Law, and other laws. Moreover, in the examination practice, it is essentially difficult to distinguish between equipment for counterfeiting cultural relics and that for reproducing or imitating cultural relics. As a result, the example of "counterfeiting cultural relics" has been removed from the new Guidelines to make the wording more rigorous.

 

With regard to inventions-creations contrary to social morality, the phrase "e.g., designs with pictures or photographs of violent murder or obscenity" in the old Guidelines has been revised into "e.g., products or methods with violent murder or obscene contents", so that the subject matter excluded from patentability is not limited to designs and pictures, and also extends to all technical solutions of the kind.

 

With regard to inventions-creations that harm the public interests, the new Guidelines give further detailed relevant provisions and explanation with examples. For instance, if an invention involves "symbols and signs of political parties", the new Guidelines make it clear that it is harmful to the public interests, and shall not be patentable. However, inventions-creations involving "major national economic and cultural events" are not excluded in a broad term, and it is required to consider whether the degree of harm or impact of the execution or use of the invention-creation on society has reached the level of harming the public interests, and if it does, it is not patentable.

 

However, it should be noted that if an invention-creation does not violate the law, but it does because it is abused, it does not fall into this category. Such examples include, among other things, various poisons, narcotics, sedatives, stimulants, and chess and cards used for entertainment. The term "invention-creation in violation of the law" as mentioned in Article 5 of the Patent Law does not include inventions-creations whose execution is merely prohibited by law. In other words, if the production, sale, or use of a mere invention is restricted or constrained by law, the product itself and its manufacturing methods or processes are not inventions that violate the law. In addition, if an invention could be harmful to the public interests due to abuse of it, or if the invention has some defects while producing positive effects, such as drugs with certain side effects on the human body, it should not be excluded from patentability on the grounds of "harming the public interests". In this regard, the provisions of the new Guidelines are largely the same as those of the old Guidelines.

 

III. Paragraph 2 of Article 5 of the Patent Law

 

Article 5.2 of the Patent Law stipulates that no patent shall be granted for inventions-creations that have been obtained in violation of laws and administrative regulations or by using genetic resources, and have been developed by relying on such genetic resources.

 

Rule 29.1 of the newly amended Implementing Regulations expands the concept of "genetic resources" from "materials derived from human, animal, plant or microbial functional units containing genetic functional units and of actual or potential value" to also include "genetic information generated from use of such materials". Correspondingly, the new Guidelines have made the following adaptive amendments: the definition of "genetic resources" has been revised to "materials of actual or potential value that contain genetic functional units, such as humans, animals, plants or microorganisms, and genetic information generated from use of such materials"; and "the invention makes use of the genetic function of genetic resources" has been added the wording "analysis and utilization of the genetic information generated by the genetic function unit", with the corresponding provisions and examples also added, that is, "the genetic function of the invention-creation using the genetic resources refers to separation, analysis and processing of the genetic function unit, or the analysis and utilization of the genetic information generated by the genetic function unit, etc., to make the invention-creation and realize the value of the genetic resources".

 

In addition, to implement the provisions of the Biosecurity Law and the Regulations on the Administration of Human Genetic Resources, the new Guidelines stipulate that "the acquisition or use of genetic resources in violation of the provisions of laws and administrative regulations refers to the acquisition or use of genetic resources in violation of the prohibitive provisions of the law and administrative regulations, or without prior approval from the relevant administrative agencies or departments or permission from relevant rights holders under the provisions of the relevant Chinese laws and administrative regulations". For example, under the provisions of the Animal Husbandry Law and the Measures for the Examination and Approval of Import, Export, and Foreign Cooperation in Research and Utilization of Livestock and Poultry Genetic Resources, the export of livestock and poultry genetic resources included in the Conservation List of China's Livestock and Poultry Genetic Resources shall go through the relevant approval procedures. If the development of an invention-creation depends on the export, abroad, of a livestock and poultry genetic resources that are included in the list of livestock and poultry genetic resources protected in China, and the invention-creation has not gone through the examination and approval procedures, the invention-creation shall not be granted a patent. For another example, the new Guidelines have added that "under the provisions of the Biosecurity Law and the Regulations on the Administration of Human Genetic Resources, where information on the nation's human genetic resources is provided or open for use to foreign organizations, it shall be reported to the administrative agency or department for science and technology under the State Council in advance, and a backup of the information shall be submitted, and where it might impact the nation's public health, national security, or social and public interest, it shall also pass a security review, and if the development of an invention-creation depends on the provision of information on the nation's human genetic resources to foreign organizations, if the relevant formalities are not completed, the invention shall not be patented".

 

IV. Article 25 of the Patent Law

 

Article 25 of the Patent Law specifically lists the following inventions-creations that are expressly not protectable subject matter: (1) scientific discoveries; (2) rules and methods of mental activity; (3) methods of diagnosis and treatment of diseases; (4) animal and plant varieties; (5) nuclear transformation methods and substances obtained by nuclear transformation methods; (6) designs of the pattern, color or combination of the two used mainly for identification. However, methods for producing the products listed in the aforesaid item (4) are excluded.

 

Although the specific application of Article 25 of the Patent Law is not changed in the new Guidelines, most of the inventions-creations relating to rules and methods of mental activities are implemented using computer equipment and computer programs, and there is a very small number of applications that obviously do not use technical means, or do not make use of the laws of nature. Therefore, in the examination practice, inventions-creations relating to rules and methods of mental activities usually involve computers and computer programs, including not only technical features, but also rules and methods of mental activities or commercial activities, and the examination of such patentable subject matter has certain particularities. As the China National Intellectual Property Administration (CNIPA) has made special provisions in Chapter 9 of Part II of the new Guidelines entitled "Several Provisions on the Examination of Invention Patent Applications Relating to Computer Programs", we will not elaborate here.

 

Moreover, to adapt to the development of new technologies and respond to the calls of the industry, some important changes have been made to the provisions of the new Guidelines on diagnostic methods related to diseases, mainly including:

 

1) In the old Guidelines, among the non-patentable examples, the following methods were listed: blood pressure measurement, pulse diagnosis, podiatry, X-ray diagnosis, ultrasound diagnosis, gastrointestinal angiography diagnosis, endoscopic diagnosis, isotope tracer image diagnosis, infrared non-destructive diagnosis, disease risk assessment method, disease treatment effect prediction method, and genetic screening diagnosis method. However, in the new Guidelines, the blood pressure measurement method has been removed from the list. In other words, according to the new Guidelines, inventions-creations relating to blood pressure measurement methods are patentable subject matters now.

 

The reason for the above amendments is that with the development of intelligent monitoring devices, the purpose of blood pressure measurement is becoming more and more diversified, and the direct purpose of more and more patent applications relating to blood pressure measurement is not to obtain disease diagnosis results or health conditions, but only to obtain intermediate result information, and no longer meet the purpose of diagnosing diseases, but to provide safety protection, improve fitness programs or sleep quality, etc., so this type of patent applications do not meet the condition of "obtaining disease diagnosis results or health status as the direct purposes", blood pressure measurement is no longer a typical method of diagnosing the disease. However, it should be noted that for other examples, it is still necessary to meet the following two conditions when determining whether it is a disease diagnosis method: (1) taking a living human or animal body as the object; (2) taking obtaining disease diagnosis or health condition as the direct purpose.

 

2) It is clarified that "information processing methods performed by computers and other devices in all steps" are not diagnostic methods.

 

The provisions of the new Guidelines on inventions that are not diagnostic methods also explicitly include "information processing methods implemented by devices, such as computers, in all steps". This is because, with the development of big data, AI, gene technology and the like, computers and other devices with information processing capabilities have been widely used in the medical field to execute information processing methods involving diagnosis, with a purpose generally to use the high-speed computing power, storage capacity, and network communication capability of the computer to improve the accuracy and efficiency of information processing, and to identify, store, and transmit information. It is usually only used to inform doctors to accurately diagnose diseases and develop treatment plans. The amendment clearly does not directly identify "information processing methods executed by computers and other devices in all steps" as disease diagnosis methods, with a view to meeting the needs of technological progress and economic and social development, to respond to the demands of innovating entities in recent years, and to strengthen the protection of such innovations.

 

V. Application of Good-Faith Principle

 

To fundamentally address the long-standing issue involving a large number of irregular or abnormal applications, to Article 20 of the Patent Law as amended in 2021 has been added a new provision that "the principle of good faith shall be followed in applying for and enforcing the patent rights". Therefore, Section 5 "Examination under Rule 11 of the Implementing Regulations of the Patent Law" has been added to Chapter 1 of Part II of the new Guidelines, which requires examining whether or not an invention patent application complies with Rule 11 of the Implementing Regulations, and to apply, in the examination, the Provisions on Regulating the Patent Application promulgated by Decree No. 77 of the CNIPA on December 21, 2023 and entering into effect on January 20, 2024. In the Provisions, eight types of irregular or abnormal patent applications are listed, including:  (1) the invention-creation content of multiple patent applications is obviously the same, or the invention-creation is substantially formed by a simple combination of different invention-creation features and elements; (2) the patent application is fabricated, forged, or altered in the content of the invention-creation, experimental data or technical effects, or plagiarized, simply replaced, pieced together the prior art or prior design, or other similar circumstances; (3) the content of the invention-creation of the patent application is mainly randomly generated by use of computer technology; (4) the invention-creation of the patent application is clearly inconsistent with technological improvement or common sense of design, or is inferior, piled up, or unnecessarily narrows the scope of protection; (5) the applicant submits multiple patent applications without carrying out actual R&D, without reasonable explanations; (6) filing multiple patent applications that are substantially related to a specific organization, individual, or address in a malicious dispersion, succession, or other places; (7) transferring or receiving the right to apply for a patent for an improper purpose, or falsely changing the inventor or designer; and (8) other abnormal patent application acts that violate the principle of good faith, and disrupt the normal order of patenting.

 

In other words, pursuant to the provisions of the new Guidelines, in the substantive examination procedure, whether an invention patent application complies with the provisions of Rule 11 of the Implementing Regulations of the Patent Law shall be examined, and the Provisions on Regulating Patent Application shall apply. If, after examination, an application does not comply with the provisions of Rule 11 of the Implementing Regulations, it shall be rejected. Section 4.7 of Chapter Eight in Part II of the new Guideline emphasizes that "there should be evidence or sufficient grounds" in the application of the provision in the examination, and the principle of prioritizing proof is reflected in placing "with evidence" on top of "sufficient grounds" to avoid abuse of the provision.

 

It should be noted that, in addition to the provisions on patentable subject matter that excludes irregular or abnormal applications from patentability under the good-faith principle, in the new Guidelines, the examination requirements pursuant to Rule 11 of the Implementing Regulations have been added to the relevant provisions on the scope of preliminary examination, reexamination and invalidation procedures with respect to inventions, utility models, designs, and patent evaluation report preparation for purpose to develop a comprehensive and systematic regulatory system, and ensure that the legislative purpose of the law provisions on good faith is effectively delivered, with guaranteed enforcement in all aspects of patent examination.

 

 

Author:

Mr. Richard Yong WANG

 

Mr. Wang received his bachelor's degree in 1991 from the department of computer science of East China Normal University and his master's degree rom the Institute of Computing Technology of the Chinese Academy of Sciences in 1994. In 2005, he received degree of master of laws from Renmin University of China. From 1994 to 2006, Mr. Wang worked with China Patent Agent (HK) Ltd, as a patent attorney and director of Electrical and Electronic Department. Mr. Wang joined Panawell in January 2007.

 

Mr. Wang is a member of the All-China Patent Attorneys Association (ACPAA), Sub-Committee of Electronic and Information Technology of ACPAA, LES China and AIPPI China, and FICPI China.

 

In the past years, Mr. Wang has handled thousands of patent applications for both domestic and foreign clients, and he has extensive experiences in application drafting, responding to office actions, patent reexamination and invalidation proceeding, patent administrative litigation, infringement litigation, software registration and integrated circuit layout design registration. As a very experienced patent attorney and attorney-at-law, Mr. Wang also participated in many patent litigation cases on behalf of a number of multinational companies as leading attorney. Mr. Wang's practices include computer hardware, computer software, communication technology, semiconductor devices and manufacturing process, automatic control, household electrical appliances, and etc.