In order to ensure the effective implementation of the newly revised Patent Law, further improve China’s patent protection system, and align with relevant international rules, the State Council issued the “Decision on Amending the Implementing Regulations of the Patent Law of the People’s Republic of China” on December 11, 2023. The revised “Implementing Regulations” has come into effect as from January 20, 2024. This revision involves significant changes and adjustments to the system, overall representing an important response to the needs of innovation entities and an optimization of the patent legal system.

The “Implementing Regulations of the Patent Law of the People’s Republic of China” was promulgated by Decree No. 306 of the State Council of the People’s Republic of China on June 15, 2001. It underwent its first revision based on the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People’s Republic of China issued on December 28, 2002, and its second revision based on the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People’s Republic of China issued on January 9, 2010. The current third revision is in accordance with the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People’s Republic of China issued on December 11, 2023.

To assist you in better understanding the significant changes in the revised “Implementing Regulations of the Patent Law” and to better serve your needs regarding patent prosecution and protection, we have summarized and explained the relevant contents and procedures. We hereby introduce the new regulations concerning substantive examination, in conjunction with the related content from the newly revised “Guidelines for Patent Examination.”

  • Non-patentable applications or subject matters

I. Provisions on the Principle of Good Faith

Article 20 of the Patent Law of People’s Republic of China (PRC) (revised in 2020) for the first time clearly stipulates the principle of Good Faith:

The principle of good faith shall be followed in applying for patents and exercising patent rights. The patent rights shall not be abused to harm public interests or the legitimate rights and interests of others.

The revised Implementing Regulations of the Patent Law stipulates:

The principle of good faith shall be followed in applying for patents. All types of patent applications shall be based on real invention and creation activities, and no fraudulent or deceptive practices shall be tolerated.

In Chapter 1, Part II of the Patent Examination Guidelines, it is stipulated that: Paragraph 1 of Article 20 of the Patent Law stipulates that the principle of good faith shall be followed in applying for patent applications and exercising patent rights, and Rule 11 of the Implementing Regulations of the Patent Law further stipulates that all types of patent applications shall be based on real invention and creation activities and no fraudulent or deceptive practices shall be tolerated.

Regarding “Circumstances of Rejection”, the Patent Examination stipulates: “Various circumstances where an invention application shall be rejected as provided for in Rule 59 are as follows.

(4) the principle of good faith are violated in the process of applying for a patent, i.e. the patent application is not based on real invention and creation activities, but based on fraudulent or deceptive practices”.

Therefore, if it is found in the examination procedure that the contents involved in the application are not real, the application may be rejected on this basis.

II. Provisions on “Detrimental to Public Interest”

Article 5 of the Patent Law of People’s Republic of China (PRC) (revised in 2020) stipulates that no patent right shall be granted for any invention-creation that violates laws or social morality or that is detrimental to public interest.

In the Patent Examination Guidelines, more specific circumstances have been added in the provision that an invention-creation that is detrimental to public interest cannot be granted a patent right for invention. For example, the revised Patent Examination Guidelines stipulates:

“Invention-creations involving symbols and signs of political parties, major national political events, hurting people’s feelings or national feelings, and propagating feudalism and superstition cannot be granted patent rights; invention-creations that involve major national economic events, cultural events or religious beliefs, which are consequently detrimental to public interest, cannot be granted patent rights.”

  • Relevant regulations on genetic resources

I. Provisions on Genetic Resources in the Patent Law and Implementing Regulations

Article 5 of the Patent Law (revised in 2020) also stipulates that no patent right shall be granted for any invention-creation where acquisition or use of the genetic resources, on which the development of the invention-creation relies, violates the provisions of laws or administrative regulations.

In the revised Implementing Regulations of the Patent Law, the definition of genetic resources has been revised by adding “and genetic information generated by using such material”, that is, the genetic resources referred to in the Patent Law mean the material obtained from human body, animal, plant, or microorganism, etc. which contains genetic functional units and is of actual or potential value, and genetic information generated by using such material. The invention-creation developed relying on the genetic resources referred to in the Patent Law means that the invention-creation is developed relying on the use of the genetic function of the genetic resources.

II. Examination of “Genetic Resources”

In the above-mentioned provisions, genetic 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.

Genetic functional unit refers to a gene, or a DNA, or an RNA fragment having genetic function of an organism.

Material obtained from human body, animal, plant, or microorganism, etc. which contains genetic functional units refer to carrier of genetic functional units, which includes not only a whole organism, but also a part of it, such as organ, tissue, blood, body fluid, cell, genome, gene, DNA or RNA fragment, etc.

With regard to an invention-creation, using the genetic function of the genetic resources refers to, for example, isolating, analyzing, and/or processing genetic functional units, or analyzing and utilizing genetic information generated by genetic functional units, to develop the invention-creation and to realize the value of the genetic resources.

Chapter 1, Part II of the Patent Examination Guidelines specifically stipulates as follows:

“Acquisition or use of the genetic resources that violates the provisions of laws and administrative regulations” means that the acquisition or use of the genetic resources violates the prohibitive provisions of laws and administrative regulations or is not beforehand approved by relevant administrative departments or licensed by relevant right holder in accordance with the provisions of relevant laws and administrative regulations of China.”

The following contents were added to this part of the new Guidelines: “Another example is that, pursuant to the Biosafety Law of People’s Republic of China (PRC) and the Regulations of People’s Republic of China (PRC) on the Management of Human Genetic Resources, if the information of China’s human genetic resources is provided or made available to foreign organizations, it shall be reported to the administrative department of science and technology of the State Council in advance and a copy of the information shall be submitted. If it may affect China’s public health, national security and social public interests, it shall also pass the safety examination. If the completion of an invention-creation depends on the information of China’s human genetic resources provided to foreign organizations and the relevant procedures are not fulfilled, the invention-creation cannot be granted a patent right. ”

Regarding “Circumstances of Rejection”, the Patent Examination stipulates: “Various circumstances where an invention application shall be rejected as provided for in Rule 59 are as follows:

(1) the subject matter of the application violates laws or social morality or is detrimental to public interest, or it is developed relying on genetic resources, the acquisition or use of which violates the provisions of laws and administrative regulations, or it is one of the objects mentioned in Article 25 for which no patent right shall be granted;

…

(7) the patent application is for an invention-creation developed relying on genetic resources, however, the applicant fails to indicate the direct or original source of such genetic resources in the patent application documents; where the original source cannot be indicated, the reasons thereof is not stated either;”

  • Grace period concerning novelty

I. Revision of Implementing Regulations

In the revised Implementing Regulations of the Patent Law, the circumstance of “academic meetings or technical meetings held by international organizations and recognized by relevant competent authorities in the State Council” is added to “academic meetings or technical meetings” stipulated in the provisions of the grace period concerning novelty.

Moreover, in the previous Implementing Regulations, it was stipulated that “Where any invention-creation for which a patent is applied falls under the circumstance (2) or (3) of Article 24 of the Patent Law, the applicant shall, when filing the application, make a declaration and, within a time limit of two months from the date of filing, submit certifying documents issued by the entity which organized the international exhibition or academic or technological meeting, stating the fact that the invention-creation had been exhibited or published and indicating the date of its exhibition or publication”.

However, in the revised Implementing Regulations, the above-underlined requirement has been deleted. That is to say, the certifying documents do not need to be issued by the entity which organized the international exhibition or academic or technological meeting.

II. Regarding the material submission deadlines for various circumstances of “grace period concerning novelty”

In the “Preliminary Examination” Part, the Patent Examination Guidelines stipulates material submission deadlines in the preliminary examination for various circumstances:

  1. For the circumstance where an invention-creation was first made public for the purpose of public interest when an emergency or an extraordinary situation occurred in the country.

For the circumstance where the invention-creation for which a patent is applied for was first made public for the purpose of public interest within six months before the filing date, when an emergency or extraordinary situation occurred in the country, if the applicant had been informed before the filing date, the applicant should declare it in the request form when filing the patent application, and submit supporting materials within two months from the filing date. If the applicant knows about the matter on their own after the filing date, they shall make a statement requesting a grace period concerning novelty within two months after knowing about it, and attach supporting materials. The examiner may, when necessary, require the applicant to submit supporting materials within a specified time limit. If the applicant learns of it only after receiving a notification from the Patent Office, the applicant shall, within the responding period specified in the notification, submit observations regarding the grace period concerning novelty and attach supporting documents.

Supporting materials for the circumstance that an invention-creation was first made public for the purpose of public interest when an emergency or an extraordinary situation occurred in the country shall be issued by the relevant departments of the people’s governments at or above the provincial level. The supporting materials shall indicate the reasons and date of disclosure for the purpose of public interest, as well as the date, form and content of disclosure of the invention, and be affixed with the official seal.

  1. For the circumstance where an invention-creation was first exhibited at an international exhibition sponsored or recognized by the Chinese Government.

Where an invention-creation for which a patent is applied for was first exhibited at an international exhibition sponsored or recognized by the Chinese Government within six months before the date of filing, if the applicant requests the grace period concerning novelty, the applicant shall make a declaration in the request form when filing the application, and submit supporting materials within two months from the filing date.

  1. For the circumstance where an invention-creation was first made public at a prescribed academic or technological meeting within six months before the date of filing.

Where an invention-creation for which a patent is applied for was first made public at a prescribed academic or technological meeting within six months before the date of filing, if the applicant requests the grace period concerning novelty, the applicant shall make a declaration in the request form when filing the application, and submit supporting materials within two months from the filing date.

  1. For the circumstance where an invention-creation was disclosed by another person without the consent of the applicant

Where an invention-creation for which a patent is applied for is disclosed by another person without the consent of the applicant within six months before the date of filing, if the applicant knows about it before the date of filing, the applicant shall make a declaration in the request form when filing the application, and submit supporting materials within two months from the filing date. If the applicant knows about the matter after the date of filing, the applicant shall submit a declaration to request the grace period concerning novelty with supporting materials within two months after knowing about it. The examiner may, when necessary, require the applicant to submit the relevant supporting materials within the specified time limit. If the applicant learns of it only after receiving a notification from the Patent Office, the applicant shall, within the responding period specified in the notice, submit observations regarding the grace period concerning novelty and attach supporting documents.

In the Substantive Examination Part of the Patent Examination Guidelines, it is further stipulated that “where an application for a patent falls under the circumstances mentioned in Item (1) or Item (4) of Article 24 of the Patent Law, and the applicant only knows about it after receiving a notification from the Patent Office, the applicant shall, within the responding period specified in the notification, submit observations regarding the grace period concerning novelty and attach supporting documents. When necessary, the Patent Office may also require the applicant to submit supporting documents to confirm the date and substantive contents of the said circumstance”.

 

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