Letter of Recommendation No. 8016 of the State Information Bureau: On the development of examination criteria that meet the characteristics of traditional Chinese medicine-Industry News-Shenzhen deep trust patent Agency Co., LTD

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Letter of Recommendation No. 8016 of the State Information Bureau: On the development of examination criteria that meet the characteristics of traditional Chinese medicine

Release Time：

2022-08-17

Representative Zhu Zhaoyun: I have received your proposal on Strengthening and Improving the Protection of Intellectual Property Rights of Traditional Chinese Medicine, and my reply is as follows. The bureau attaches great importance to the protection of intellectual property rights of traditional Chinese medicine, combines the characteristics of the field of traditional Chinese medicine, continuously improves the examination standards, improves the quality of examination, and strengthens the guidance and protection of traditional Chinese medicine innovation. Your suggestions on formulating review standards and strengthening team building are highly consistent with the work being carried out by our bureau, and have been carefully studied and absorbed in combination with actual conditions. I. On the formulation of examination standards that meet the characteristics of traditional Chinese medicine, to improve the quality and efficiency of traditional Chinese medicine patent examination

Zhu Zhaoyun Representative:

Your proposed Suggestions on Strengthening and Improving the Protection of Intellectual Property Rights of Traditional Chinese Medicine I have received your reply as follows.

The bureau attaches great importance to the protection of intellectual property rights of traditional Chinese medicine, combines the characteristics of the field of traditional Chinese medicine, continuously improves the examination standards, improves the quality of examination, and strengthens the guidance and protection of traditional Chinese medicine innovation. Your suggestions on formulating review standards and strengthening team building are highly consistent with the work being carried out by our bureau, and have been carefully studied and absorbed in combination with actual conditions.

I. On the formulation of examination standards that meet the characteristics of traditional Chinese medicine, to improve the quality and efficiency of traditional Chinese medicine patent examination

In order to cooperate with the implementation of the newly revised Patent Law, in 2020, the Bureau launched a comprehensive revision of the Patent Examination Guide (hereinafter referred to as the "Guide"), and solicited public opinions from November 10 to December 10 of the year. Among them, the special chapter adds "Several provisions on the examination of invention patent applications in the field of Chinese medicine" and other contents, and makes detailed and clear provisions on the examination standards of the authorized object of Chinese medicine invention patents, the writing of specifications and claims, novelty, creativity and practicality. The new content fully considers the characteristics of traditional Chinese medicine innovation, for example, standardizing the rules for writing the names of traditional Chinese medicine, clarifying that clinical effect data includes clinical medical records or clinical cases, and providing clear writing guidelines. In the judgment of the novelty of the invention of pharmaceutical use of traditional Chinese medicine, it is emphasized that we should pay attention to the relationship between the disease and syndrome of traditional Chinese medicine and the disease or drug action mechanism of Western medicine. In view of the invention of TCM compositions with a relatively high number of applications in the field of TCM, it is emphasized that the creative judgment should grasp the characteristics of TCM invention and innovation, and fully consider the "principle, method, prescription and medicine" of the invention and prior art. According to the formation law and conception process of TCM compositions in clinical practice, the invention of TCM compositions is divided into two categories: "addition or subtraction prescription invention" and "self-organizing prescription invention". Typical cases of creativity and non-creativity are given.

Second, on increasing the construction and training of talents in the field of traditional Chinese medicine, clarify the review time limit and optimize the process

(1). Strengthen the training of examiners in the field of traditional Chinese medicine and publicize examination standards. Attention is paid to the recruitment of examiners with professional backgrounds, and the current patent examiners in the field of traditional Chinese medicine are usually master's or doctoral students graduated from traditional Chinese medicine. Continuously improve the training system for examiners, and carry out centralized training for new examiners on basic legal knowledge, grasp of examination standards, retrieval skills, etc. To build a multi-level business guidance system for post inspectors, provide a variety of platforms such as social services, research and learning, and promote the improvement of comprehensive quality. At the same time, according to the development of the technical field of traditional Chinese medicine, multiple measures were taken to improve the technical understanding ability of examiners and the application ability of examination standards by building a database of technical experts, holding technical update lectures, and carrying out professional technical practice training. After the official release of the revised content of the Guide, the Bureau will also use public lectures and other channels to widely publicize the special chapter of Chinese medicine for innovative subjects and improve the quality of patent writing.

(2). Strengthen the application of intelligent review technology. Actively promote the construction of intelligent upgrading of patent examination and retrieval systems, of which the intelligent retrieval part has been put into operation, and the intelligent examination part is expected to be online by the end of 2022. The system relies on new technologies such as cloud platform data centers and big data to provide functional processes, data collection and analysis capabilities for fine management of the review cycle, and can realize the visualization, intelligent management and monitoring of the review process. At the same time, big data and artificial intelligence processing technologies such as text recognition and semantic clustering are used to build semantic search engines to provide technical support for abnormal patent application screening and processing.

(3). Strengthen communication and exchanges during the review process. In order to promote the communication between patent examiners and applicants, help examiners understand the content of inventions and prior art, and improve the quality and efficiency of examination, when the Guide was revised in 2019, the Bureau relaxed the time limit for examiners to meet with applicants, and added discussion methods such as video conferencing and email. It is convenient for the examiner and the applicant to initiate communication requests or requests by telephone and other means at any stage of the patent substantive examination procedure. The future online intelligent review system will also provide technical support and system guarantee for this.

In the next step, the bureau will accelerate the release and implementation of the Guidelines, continue to deepen the review capacity building, launch the intelligent review system as soon as possible, further strengthen the guidance and protection of traditional Chinese medicine innovation, promote the inheritance of traditional Chinese medicine science and technology essence and adhere to the innovation, and accelerate the revitalization and development of traditional Chinese medicine.

We sincerely thank you for your concern and support for intellectual property work, and hope to continue to pay attention to the development of intellectual property cause and put forward more valuable suggestions and suggestions for intellectual property work.

State Intellectual Property Office

August 10, 2022

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