The CNIPA has made a decision on amending the Guidelines for Patent Examination, which takes into effect on January 15, 2021. It is made for Chapter 10, Part Ⅱ of the Guidelines for Patent Examination, mainly involving the examination standards for supplementary experimental data, compound novelty and inventive step in the field of compound and biology.
- Examination Standard of Supplementary Experimental Data
This part of modifications includes two parts, one is for revising the examination principles of the original supplementary experimental data, and the other is adding the examination examples of the supplementary experimental data relating to pharmaceutical patent applications.
The requirements for supplementary experimental data are further clarified in its general examination principle, which means it is must meet the requirements for novelty and inventive step of the patent application or the full disclosure. In the current practice, the examiners have already implemented the examination in accordance with such requirements. Therefore, this revision is also the clarification of the standards already abided in practice into the guidelines.
Second, two examples of supplementary experimental data for pharmaceutical patent applications have been added. Example 1 relates to the case proving that the supplementary experimental data of the specification is fully disclosed. The necessary requirement to be achieved is that the technical effects or functions explained by the supplementary experimental data can be obtained from the disclosure of the patent application document. Example 2 involves the case proving that the claims have inventive step and the subsequent supplementary filing of experimental data, and the requirement to be met is that the technical effects to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents.
According to the above two examples, it is clear that the examination principle of supplementary experimental data for new pharmaceutical patent applications must meet the general examination one of supplementary experimental data. The content to be proved by the supplementary experimental data must have been recorded in the disclosure of the patent application documents, and then the experimental data can be used to analyze whether the claimed technical solution meets the inventive requirements.
- Claims for Function-defining or Use-defining Type
" If there is only one function or use of the composition disclosed in the description, the composition shall be drafted as the function-defining or use-defining type" is revised as " If there is only one function or use of the composition disclosed in the description, the composition usually need to be drafted as the function-defining or use-defining type ". It can be understood that such revision provides the examiners with flexibility based on specific cases during the examination, which can be more beneficial to protect the legitimate rights and interests of patent applicants.
- Examination Standard of Compound Novelty
In this revision, the concept of “mentioned is disclosed” is first clarified, which indicates that as long as the chemical name, molecular formula (or structural formula) and other structural information of the compound is recorded in the reference document, it has complied with the concept of "disclosed" compound by those skilled in the art, so the compound does not involve novelty.
Secondly, in the case of "be presumed without novelty", it is clear that the structure information recorded in the citations is insufficient to identify the similarities and differences between the claimed compound and the compound disclosed in the citations, that is under the circumstance of excluding "mentioned is disclosed", the physicochemical parameters, method of preparation and effect experimental data recorded in the citations are all taken into consideration comprehensively. First, it is more conforming to the overall evaluation concept of compounds in the chemical field to add the effect experimental data on the basis of the original physical and chemical parameters and preparation method, making the concept of "presumption" more reasonable and rigorous. Second, asking the examiners to presume that the two are substantially the same after comprehensive consideration means higher examination requirements on them with sufficient and reasonable examination objections. In addition, "unless the applicant can provide evidence to prove that there has been a real structural difference." also provides patent applicants with a more beneficial opportunity to fight for their rights and interests.
- Examination Standard of Inventive step for Compound
First, unify the examination standards of inventive step for compound and inventive step for invention, that is, make judgments according to the "three-step method". This part is already implemented by examiners and judges whether in the process of substantive examination of patent applications or in the practice of patent applications or patent administrative litigation procedures.
When judging the inventive step of a compound, follow the three steps: 1) determine whether it is the closest to existing technology; 2) determine the structural difference of the compound and the technical issues to be solved based on the difference; 3) determine whether it is obvious, which is usually showed by changes in usage and/or improvements in effects.
Therefore, this revision makes the standards of examiner’s office action more uniform. It not only provides the examiner with a clearer judgment idea and standard examination criteria in the examination process, but also guides the applicant to understand the examiner’s analysis logic and reasoning process of the conclusion more clearly.
At the same time, there are five examples in the Guidelines for Patent Examination to further emphasize the idea of the "three-step method" in judging the inventive step of a compound. Examples 1 to 3 are reorganized on the original cases, and example 4 is used for comparison with example 3. Example 1 is intended to explain that under the premise that the parent cores are inconsistent, there is no technical enlightenment in the prior art even if the uses and/or effects are the same. Example 2 is aimed at illustrating that in the case of the same main structure but different groups, the use and/or effect is completely different, there is no technical enlightenment in the prior art. Example 3 is to state that when the main structure are the same, but the groups are different, the uses and/or effects are the same, and the prior art has technical enlightenment. Example 4 aims to show that when the parent cores are the same, even if different groups have similar properties, unexpected technical effects are obtained, and there is still no technical enlightenment in the prior art. Example 5 is a new example, which aims to describe the different review conclusions brought about by the structural differences between the general formula compound and the specific compound in the inventive judgment combined with unexpected technical effects.
- Increasing of Biological Materials Deposit Unit
On the basis of the two original collection centers, the Guangdong Provincial Microbial Culture Collection (GDMCC) in Guangzhou has been newly added, which has also become an international collection of microorganisms under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
- Drafting of Claims for Monoclonal Antibody
Based on the original sequence structure to characterize the monoclonal antibody, the hybridoma that produced it can also be used to define it, and the corresponding example description has been added.
- Examination Standard of Inventive step in the Biological Field
As with the above-mentioned revision of the examination standard for the inventive step of compounds, the inventive standard in the biological field is also unified with the one of invention, which means the judgment is made according to the "three-step method". Considering that inventions in the field of biotechnology involve different levels of protection topics such as biological macromolecules, cells, and individual microorganisms. Except for common ways such as structure and composition, there are also special ways like the deposit number of biological materials in the ways to characterize these protection themes. The structural difference between the invention and the prior art, the distance of the kinship, and the predictability of technical effects are needed to consider in the judgment of inventive step.
On this basis, supplementary explanations for inventive judgments of "genes", "recombinant vectors", "transformants" and "monoclonal monomers" are provided, and explanations for creativity and non-creativity enable the logic of judging inventive step to be more rigorous and clear. In addition, a description of the standard for determining the inventive step of "polypeptide or protein" was supplemented with circumstances of involving inventiveness.
The amendments to Chapter 10 of Part II of the Guidelines for Patent Examination are timely and powerful for both the examiner's practice of examination and the protection of patent applicants' rights and interests in the field of chemistry. On the one hand, it is more rigorous and logical to sort out the examination standard for inventive step of compounds or in the field of biology and fit it into the "three-step method" of invention. On the other hand, the detailed specification of supplementary experimental data is also more favorable to the innovative development of biomedicine and the pharmaceutical linkage system in China.