Examination Changes on Patents Relating to Biological and Chemical fields in Amendments to Guidelines for Patent Examination in 2025

CHANG TSI
Insights

November21
2025

On November 13, 2025, the China National Intellectual Property Administration (CNIPA) issued the "Decision of the CNIPA on Amendments to the Guidelines for Patent Examination," making significant revisions to the guidelines. The revised guidelines will officially take effect on January 1, 2026. The relevant amendments regarding examination on patents in the biological and chemical fields are as follows:


1. Regarding "plant varieties" and "plant sought to be protected by patent"

These amendments further clarify that plant varieties mentioned in the Patent Law refers to “a plant population that has been artificially bred or discovered and improved, exhibits consistent morphological characteristics and biological properties, and has relatively stable genetic traits.” According to Article 25.1 (4) of the Patent Law, no patent rights shall be granted for plant varieties. New plant varieties can get protection under the Regulations on the Protection of New Varieties of Plants. 

Meantime, the amended Guidelines for Patent Examination further indicates plant refers to the organism which maintains its life by synthesizing carbohydrate and protein from the inorganics, such as water, carbon dioxide, and inorganic salt, through photosynthesis, and usually is immovable; wild plants found in nature that have not undergone technical treatment and exist naturally belong to scientific discoveries and cannot be granted patent rights; however, when wild plants are artificially bred or improved and have industrial value, the plant itself does not fall under the category of scientific discoveries; plants and their propagation materials obtained through artificial breeding or improvement of discovered wild plants, if they do not have consistent morphological characteristics and biological properties or relatively stable genetic traits in their population, cannot be considered as "plant varieties" and thus can be sought for protection by patent.

In summary, by clarifying the connotation of plant varieties, the scope of patentable objects has been actually expanded, forming an effective connection with the plant new variety system.

2. Regarding sequence listing

The calculation rules for additional fee involving sequence listings are amended, clarifying that "the number of pages of a sequence listing in a computer-readable form submitted in accordance with the prescribed format shall not be counted", and deleting the previous provisions “where the description contains a nucleotide and/or amino acid sequence listing with more than 400 pages and the applicant only submits the sequence listing in computer-readable form at the time of entering the national phase, the additional fee for the description of the said nucleotide and/or amino acid sequence listing shall be charged as that of 400 pages.” This amendment will significantly reduce the additional fees for biological patent applications that include sequence listings.

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