Patentable subject matter refers to inventions and creations that are eligible for patent protection and fall within the scope intended by the patent law.
For any invention to obtain patent protection, it must first qualify as patentable subject matter as defined by the patent law. Inventions that do not meet this criterion are not patentable, cannot proceed to further examination, and will not be granted patent rights. Only inventions that pass the examination for patentable subject matter can proceed to further examinations for “novelty, inventiveness, and industrial applicability” to determine if they meet other conditions for patentability.
China defines the scope of patentable subject matter through two methods: positive conceptual definitions and negative exclusions.
Article 2 of the Patent Law of the People’s Republic of China (hereinafter referred to as the Patent Law) defines the three categories of patentable subject matter eligible for patent rights, namely inventions, utility models, and designs:
- Inventions: New technical solutions proposed for a product, method, or their improvements.
- Utility Models: New technical solutions proposed for the shape, structure, or combination of a product, suitable for practical use.
- Designs: New designs made for the overall or partial shape, pattern, or their combination of a product, as well as the combination of color with shape or pattern, which are aesthetically pleasing and suitable for industrial application.
Additionally, considering the interests of the nation and the public, the Chinese Patent Law imposes restrictive provisions, known as exclusions, on the scope of patent protection.
Article 5 of the Patent Law stipulates that no patent rights shall be granted for inventions that violate laws, social morality, or public interests. Inventions completed by violating laws or administrative regulations to obtain or use genetic resources, and inventions relying on such genetic resources, shall also not be granted patent rights. Article 25 of the Patent Law specifies six specific categories of non-patentable subject matter.
Furthermore, the 2021 amendment to the Patent Law introduced the principle of good faith, stating that patent applications and the exercise of patent rights should adhere to this principle. They should not harm public interests or the legitimate rights and interests of others. Consequently, the Implementing Regulations of the Patent Law, revised in 2023, stipulate that inventions violating the principle of good faith are excluded from patent protection.
Therefore, based on the 2021 amended Patent Law and the 2023 revised Implementing Regulations, the Examination Guidelines issued at the end of 2023 (hereinafter referred to as the New Guidelines) further modify the 2021 Examination Guidelines (hereinafter referred to as the Old Guidelines) on how to apply the Patent Law’s provisions regarding patentable subject matter.
The following sections will explain how the New Guidelines interpret and apply the provisions on patentable subject matter for reference.
1. Article 2, Paragraph 2 of the Patent Law
In the Old Guidelines, a technical solution as defined in Article 2, Paragraph 2 of the Patent Law was described as “a collection of technical means utilizing natural laws to solve a technical problem, usually manifested by technical features.” Solutions that do not use technical means to solve technical problems to achieve effects conforming to natural laws are not considered patentable subject matter under this provision. Examples include smells or signals such as sound, light, electricity, magnetism, and waves, unless their properties are used to solve technical problems.
The provisions regarding technical solutions in the New Guidelines are essentially identical to those in the Old Guidelines.
2. Article 5, Paragraph 1 of the Patent Law
Article 5, Paragraph 1 of the Patent Law states that no patent rights shall be granted for inventions that violate laws, social morality, or public interests.
Both the Old and New Guidelines clarify that “laws” refer to laws enacted and promulgated by the National People’s Congress or its Standing Committee, excluding administrative regulations and rules. Inventions that violate such laws cannot be granted patent rights.
The Old Guidelines provided examples of inventions violating laws, such as gambling devices, but did not specify the legal basis. To further standardize the examination of Article 5, the New Guidelines specify the relevant laws for such examples, including the Criminal Law, the Law on Penalties for Administration of Public Security, the People’s Bank of China Law, and the Negotiable Instruments Law.
The New Guidelines also remove the example of “forged relics equipment” as an invention violating the law because related laws do not explicitly prohibit the act of forging relics. Only improper conduct involving the use of forged or copied relics, such as fraud, might violate the Criminal Law or the Law on Penalties for Administration of Public Security. Hence, the example was removed for greater precision.
Regarding inventions violating social morality, the Old Guidelines listed examples like designs featuring violent or obscene images or photos. The New Guidelines expand this to include all products or methods containing violent or obscene content, not just designs or images.
For inventions harming public interests, the New Guidelines provide further details and examples. For instance, inventions involving symbols and emblems of political parties are deemed harmful to public interest and are non-patentable. However, inventions related to significant national economic or cultural events are not categorically excluded but require consideration of the invention’s potential harm or impact on society.
If an invention is not illegal but can be misused to violate the law, such as various poisons, narcotics, sedatives, stimulants, or recreational games, they do not fall under this provision. Article 5 of the Patent Law does not include inventions solely because their manufacture, sale, or use is legally restricted or regulated. Similarly, inventions with certain drawbacks, like medicines with side effects, cannot be denied patentability on the grounds of harming public interest. The provisions on this aspect in the New and Old Guidelines remain consistent.
3. Article 5, Paragraph 2 of the Patent Law
Article 5, Paragraph 2 of the Patent Law stipulates that no patent rights shall be granted for inventions completed based on genetic resources obtained or used in violation of legal or regulatory provisions.
The newly revised Implementing Regulations expand the definition of “genetic resources” to include genetic information derived from such materials. The New Guidelines adapt to this by redefining genetic resources as “materials containing functional units of heredity, taken from humans, animals, plants, or microorganisms, and having actual or potential value, including genetic information derived from such materials.”
To comply with the Biosafety Law and the Regulations on the Management of Human Genetic Resources, the New Guidelines specify that obtaining or using genetic resources in violation of legal or regulatory prohibitions, or without prior approval from relevant administrative authorities or rights holders, constitutes a violation.
For instance, under the Animal Husbandry Law and the Approval Measures for Import and Export and Cooperative Research Utilization of Livestock and Poultry Genetic Resources, exporting listed livestock and poultry genetic resources requires approval. If an invention relies on such resources exported without approval, it is non-patentable. Similarly, under the Biosafety Law and the Regulations on the Management of Human Genetic Resources, providing Chinese human genetic resources information to foreign organizations without reporting and submitting information to the State Council’s administrative department, or undergoing safety review for potentially impacting public health, national security, and social public interests, makes an invention completed based on such resources non-patentable.
4. Article 25 of the Patent Law
Article 25 of the Patent Law lists specific non-patentable subject matter:
- Scientific discoveries;
- Rules and methods for intellectual activities;
- Methods for diagnosing or treating diseases;
- Animal and plant varieties;
- Methods for nuclear transformations and substances obtained through such methods;
- Designs primarily serving identification purposes on printed matter, involving patterns, colors, or both.
Although the New Guidelines have not significantly modified the application of Article 25, most inventions related to intellectual activities involve computers and computer programs, making non-technical or non-natural law-utilizing applications rare. Therefore, the examination of inventions related to rules and methods for intellectual activities often involves both technical features and intellectual or commercial activity rules and methods. The New Guidelines have dedicated provisions for such cases in Chapter 9 of Part II (“Provisions on Examination of Inventions Involving Computer Programs”), which are not elaborated here.
Additionally, to adapt to technological advancements and industry demands, the New Guidelines make significant changes to the provisions on diagnostic methods for diseases:
- The Old Guidelines listed specific non-patentable diagnostic methods, such as blood pressure measurement, pulse diagnosis, foot diagnosis, X-ray diagnosis, ultrasound diagnosis, gastrointestinal contrast diagnosis, endoscopic diagnosis, isotope tracing imaging diagnosis, infrared non-destructive diagnosis, disease risk assessment methods, treatment effect prediction methods, and gene screening diagnosis. The New Guidelines remove “blood pressure measurement,” meaning inventions involving blood pressure measurement can now be considered patentable subject matter.
This change addresses the evolving purposes of blood pressure measurement due to the development of intelligent monitoring devices. Increasingly, inventions related to blood pressure measurement are aimed at providing safety protection, improving fitness routines, or enhancing sleep quality rather than diagnosing diseases.
However, for other examples, the criteria for determining whether they constitute diagnostic methods remain: (1) targeting living human or animal bodies; and (2) directly aiming at obtaining disease diagnosis results or health status.
- Clarifying that “information processing methods performed entirely by computers or other devices” do not constitute diagnostic methods.
The New Guidelines explicitly state that information processing methods performed entirely by computers or other devices are not considered diagnostic methods. This amendment addresses technological advancements in medical fields, where computers and devices are commonly used to process diagnostic information, enhancing accuracy and efficiency without directly diagnosing diseases.
5. Application of the Principle of Good Faith
To address the longstanding issue of numerous abnormal patent applications, the 2021 amendment to the Patent Law introduced the principle of good faith in Article 20, requiring patent applications and the exercise of patent rights to adhere to good faith. The new Implementing Regulations, in Article 11, further require that patent applications be based on genuine inventive activities and prohibit falsification.
Therefore, the New Guidelines add Section 5 in Chapter 1 of Part II, “Examination under Article 11 of the Implementing Regulations,” stipulating the examination of compliance with Article 11 and the application of the “Regulations on Standardizing Patent Application Behavior,” which list eight types of abnormal patent applications:
- Multiple applications with identical or essentially the same content, or formed by simple combinations of different inventive features or elements.
- Applications involving fabricated, falsified, altered inventive content, experimental data, or technical effects, or copying, simple substitution, or piecing together existing technologies or designs.
- Applications mainly generated using computer technology or other random generation methods.
- Applications proposing inventions obviously inconsistent with technological improvement or design logic, or degrading, piling, or unnecessarily limiting the scope of protection.
- Multiple applications submitted without actual R&D activities and without reasonable explanations.
- Maliciously dispersing, successively or remotely submitting multiple applications essentially related to specific units, individuals, or addresses.
- Transferring or receiving patent application rights for improper purposes, or falsely changing inventors or designers.
- Other abnormal patent applications violating the principle of good faith and disrupting normal patent work order.
The New Guidelines require substantive examination to verify compliance with Article 11 of the Implementing Regulations, applying the “Regulations on Standardizing Patent Application Behavior.” Applications failing to meet these requirements should be rejected. Section 4.7 of Chapter 8 in Part II emphasizes the principle of prioritizing evidence or sufficient reasons when applying this provision to avoid misuse.
In addition to excluding abnormal patent applications from patent protection based on the principle of good faith, the New Guidelines extend the examination of Article 11 compliance to the preliminary examination scope, reexamination, invalidation procedures, and patent evaluation report drafting for inventions, utility models, and designs. This comprehensive regulatory system ensures the effective implementation of the legislative intent of the good faith principle throughout all stages of patent examination.