At the end of 2020, China National Intellectual Property Administration (CNIPA) published the latest version of revision of the Guidelines for Patent Examination, all of which were aimed at Chapter X of Part II (“Some Provisions on Examination of Invention Applications in the Field of Chemistry”). The revision came into force on January 15, 2021. The revision involves many aspects, mainly including supplementary experimental data, as well as judgement of novelty and inventiveness of patent applications for inventions for compounds and inventions in biological field. The revision of supplementary experimental data may mainly be intended to meet China’s commitments in the Sino-US trade agreement；therevision of compound inventions is intended to eliminate the discord between Chapter IV (Inventive Step) and Chapter X (Chemical Inventions) of the Guidelines for Patent Examination；and the revision of inventions in biological field clarifies examination practices in the past several years on the grounds that the old Guidelines for Patent Examination could not keep pace with development of science and technology. There is no doubt that the revision will have a great impact on future prosecution of patent applications. The revision will be described in detail below.
1. Regarding supplementary experimental data
After the revision in 2017, the provision on supplementary experimental data is now revised again. The comparison between these two versions is shown as follows:
3.5 Regarding supplementary experimental data
Whether the description is sufficiently disclosed is judged based on the content recorded in the initial description and claims.
3.5 Regarding supplementary experimental data
3.5.1 Examination principles
Whether the description is sufficiently disclosed is judged based on the content recorded in the initial description and claims.
|An examiner shall examine the experimental data supplemented by an applicant after the filing date. The technical effects proved by the supplementary experimental data shall be obtained by those skilled in the art from the disclosure of the patent application.||An examiner shall examine the experimental data supplemented by an applicant after the filing date to satisfy the requirements of paragraph 3 of Article 22, and paragraph 3 of Article 26 etc. of the Patent Law. The technical effects proved by the supplementary experimental data shall be obtained by those skilled in the art from the disclosure of the patent application..|
3.5.2 Supplementary experimental data for patent applications for drugs
Under the examination principles in Section 3.5.1 of this Chapter, examples of examination of patent applications for drugs are presented. Example 1 and Example 2 (omitted).
As known from the above comparison, the written record of the examination principles for supplementary experimental data has not changed, i.e. the technical effects proved by the supplementary experimental data shall be obtained by those skilled in the art from the disclosure of the patent application. However, two examples are provided in the added Section 3.5.2, which shows that the CNIPA tends to accept supplemented data.
(1) Example 1
For the case where “the specification has recorded the preparation examples of compound A, the blood pressure lowering effect and the experimental method for measuring the blood pressure lowering activity, but has not recorded the experimental result data”, Example 1 explicitly stipulates that the technical effects to be proved by the supplementary experimental data on the blood pressure lowering effect “can be obtained from the specification” and the supplementary experimental data shall also be examined in the examination of inventiveness.
In the past examination practices, when specification only contain qualitative records of effects without quantitative data, the effects was generally not to be considered as “can be obtained from the specification”. However, the revision this time stipulates “that there is written record means the effects can be obtained “, therefore the case that the disclosure is insufficient due to the absence of the experimental data will almost completely disappear.
However, it should be noted that “the supplementary experimental data shall also be examined in the examination of inventiveness” does not mean that “inventiveness is bound to be recognized based on the supplementary data”. In Example 1, “blood pressure lowering effect” can be obtained from the specification while “superior blood pressure lowering effect over the prior art” is not recorded therein. In other words, although the supplementary experimental data can be used to support the claim that “the claimed compound has blood pressure lowering effect”, it may not support the claim that “the blood pressure lowering effect of the claimed compound is superior to that of the prior art”.
Under the condition that “the blood pressure lowering effect” of the claimed compound is recognized, according to past examination practices, if there is no compound with blood pressure lowering effect that has similar structure disclosed in the prior art, the inventiveness of the claimed compound is generally recognized. At this time, the supplementary data is effective for inventiveness.
However, if there are compounds having similar structure with blood pressure lowering effect which had been disclosed in the prior art, a mere proof of “the compound of the present invention has a blood pressure lowering effect” is generally insufficient to establish inventiveness. At this time, even if the supplementary experimental data quantitatively shows that the compound’s blood pressure lowering effect in the present invention is superior to that of the prior art, the CNIPA may opine that since the conclusion drawn from this data is only “the claimed compound has an blood pressure lowering effect”, the inventiveness of the present invention may still not be recognized. This is also evident from the fact that the Guidelines for Patent Examination did not give a clear conclusion for Example 2 involving inventiveness.
(1) Example 2
Example 2 involves the case where “claim 1 relates to a compound of general formula, the specification has recorded the anti-tumor effect of the compound of general formula, as well as its preparation method, and the preparation examples of a number of specific compounds. However, the result data is only generally described that the IC50 value of the specific compounds is in the range of 1-100nM”. The applicant supplemented the experimental data to prove that the IC50 value of the compound A in the present invention is 15nM, and the compound of the comparative document is 87nM.
For this case, the revised Guidelines for Patent Examination did not give an explicit conclusion on inventiveness, and instead only stipulated that “According to the original application documents, compound A and its anti-tumor effect have been disclosed, the technical effects proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It shall be noted that at this time, an examiner shall also combine the supplementary experimental data to further analyze whether the protection extent of the technical solution claimed meets the requirements of inventiveness.”
This leaves room for the following different understandings:
i) Based on the fact that the IC50 value of compound A is significantly lower than that of the compound in the comparative document, the inventiveness of compound A shall be recognized, but the inventiveness of the compound of general formula (IC50 value = 1-100nM, equivalent to the compound in the comparative document) shall not be recognized;
ii)Based on the fact that the IC50 value of compound A is significantly lower than that of the compound in the comparative document, it shall be recognized that the structural difference between compound A and the compound in comparative document is a feature contributing to inventiveness, and the compound of general formula with this feature shall be recognized as a whole;
iii) It can be only recognized based on the disclosure of the specification that the supplemented data proved that “the IC50 value of compound A is in the range of 1-100nM”, which is equivalent to that of the compound in the comparative document. Therefore, the inventiveness of compound A cannot be recognized, let alone the inventiveness of the compound of general formula.
In the case of the above understanding i) and ii), it is believed the CNIPA shows a rather degree of acceptance of the supplemented data. However, in the case of the above understanding iii), the degree of acceptance is limited. In general, the revision shows significantly better acceptance of the supplemented data for the case that “only qualitative description is included in the specification”, but the degree of acceptance of the supplemented data will be further observed.
In addition, there are the following two major questions in this revision:
(1) For non-pharmaceutical patent applications, shall the supplementary data of the invention be allowed?
In our standpoint, the first sentence of Section 3.5.2 is “In accordance with the Examination Principles in Section 3.5.1 of this chapter, examples of examination involving pharmaceutical patent applications are provided here” which means that the treatments of examples 1 and 2 described in the section are in compliance with the “Examination Principles in Section 3.5.1”. Section 3.5.1 is a general clause, so reference may be made to the two examples in Section 3.5.2 to handle non-pharmaceutical patent applications.
(2) Can experimental data be supplemented to overcome support problems?
The record before the revision is “An examiner shall examine the experimental data supplemented by an applicant after the filing date.”, while the revision states “An examiner shall examine the experimental data supplemented by an applicant after the filing date to satisfy the requirements of paragraph 3 of Article 22, and paragraph 3 of Article 26 etc. of the Patent Law ”
Does this change mean that “the experimental data supplemented to meet the requirements of Article 26, paragraph 4 of the Patent Law (find support from the specification) shall not be examined”?
In this regard, we believe that the main purpose of the legislation regarding the supplementary experimental data is to satisfy China’s commitments in the Sino-US trade agreement. The Sino-US Trade Agreement explicitly stipulates that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements including sufficiency of disclosure and inventive step.” The revision of the Patent Law and the Guidelines for Patent Examination shall explicitly reflect the fulfillment of this commitment. Therefore, the two provisions of Article 22, paragraph 3 and Article 26, paragraph 3 of the Patent Law are particularly emphasized. Similarly, the separate Section 3.5.2 may also be set up for this reason.
As mentioned earlier, Section 3.5.2 is a refinement of Section 3.5.1, rather than a special preferential treatment. Similarly, the “etc.” in “To meet the requirements of Article 22, paragraph 3, Article 26, paragraph 3, etc. of the Patent Law” also means that this is not an exclusive clause.
However, it should be noted that for inventions in chemical field, the reason for not being supported by the specification is generally “the claims can be supported by the records of the specification, but not be substantially supported by the embodiments.” As for the interpretation of the foregoing Examples 1 and 2, the revision essentially means that “the effect supported by written records is considered to be obtained from the specification and can be supported by the supplementary experimental data.” According to this logic, almost all support problems will be resolved by providing supplementary experimental data. This is unrealistic according to examination practices. This may be one of the reasons why support issues are not explicitly included within the reviseded Guidelines for Patent Examination.
Regarding the case that data are supplemented to assert that claims can be supported by the specification, we suggest following the previous approach, that is, explain the rationality of the protection extent of the claims based on the theory , and use the supplementary data as auxiliary evidence to strengthen the evidence. In practice, different examination departments and different examiners may have different understandings of the Guidelines for Patent Examination, and countermeasures shall be considered comprehensively with reference to the attitude reflected in the office action.
2. Criteria for judgement of novelty and inventiveness of the compound
(1) Principle of judgement for novelty
The revision of the judgment principle of novelty is almost a reflection of past examination practices. Regarding a case where a certain compound is presumed not to possess novelty according to physical and chemical parameters, and preparation methods disclosed in the comparison document, the revision here makes it explicit that sufficient reasoning is required, rather than only assertion presumption.
This can correct wrong practices of a few examiners who have misunderstood the legislative intent of the pre-amended Guidelines for Patent Examination.
(2) Principle of judgement for inventiveness
Regarding the principle of judgement for inventiveness, the revision of this time is relatively extensive, while from the aspect of specific content, we believe that it does not have substantive changes, with its essence still being a clarification of misunderstandings in examination practices during judging inventiveness of compound inventions based on the three-step method and unexpected technical effects.
Specifically, Chapter IV of the Guidelines for Patent Examination stipulates that the three-step method shall be the principle of judgement for inventiveness of inventions. For compound inventions, i) determine the structural difference between the claimed compound and the closest compound in the prior art, ii) determine the technical problem solved through this structural transformation in the present invention, and iii) investigate whether there is any motivation in the prior art to solve the technical problem through this structural transformation. In addition, if the claimed compound achieves unexpected technical effects, it shall be recognized that the invention is non-obvious with inventiveness.
On the other hand, in Chapter X of the Guidelines for Patent Examination before revision of this time, for compound inventions, the criterion of “similar structure” was introduced. It stipulates that when there is no known compound with similar structure in the prior art, the claimed compound is creative as long as it has a certain effect. On the contrary, when there are known compounds with similar structures in the prior art, the inventiveness of the claimed compound shall be determined based on unexpected technical effects.
We always believe that Chapter X is the refinement of Chapter IV, and the definition of “similar structure” should be “structures that are considered to be able to achieve the same effect based on the structure-activity relationship”. The provisions of these two chapters are inherently unified without contradiction. However, in the Guidelines for Patent Examination before the revision of this time, the description of “similar structure” may be misunderstood as determining whether the structure is close based on the similarities and differences of the ring structure or based on the number of different substituents which sometimes leads to different conclusions based on judgment of inventiveness obtained from Chapter IV or Chapter X.
In the invalidation request case represented by Daiichi Sankyo VS Beijing Wansheng, this issue was studied in detail from the Review Committee to the Supreme People’s Court, which made it clear that the judgement for inventiveness of compound should also follow the three-step method. Probably just taking this into consideration, the record of “similar structure” is deleted in the revision of this time, and the revision states judgment is made as to whether the compound invention possesses inventiveness based on “whether there is an instruction of structure-activity relationship in the prior art”. This will help unify the principles of judgement for inventiveness of compound inventions.
It is worth noting that the concept of electronic isosteres is explicitly introduced in this revision, that is, when the structural difference between the claimed compound and the compound of the prior art belongs to the commonly recognized electronic isosteres, unexpected technical effects are required to prove inventiveness. Although this is already a routine practice of many examiners, it is clarified for the first time, it is expected that more examination opinions involving electronic isosteres will be seen in the future, and applicants may rely more on supplementary experimental data for comparative examples.
3. Criteria for judgement of novelty and inventiveness in biological field
In the Guidelines for Patent Examination after the amendments, provisions on inventions in biological field mainly include:
(1) The same with compound inventions, the three-step method is explicitly used as the principle of examinations and is judged on the basis of “whether there is a motivation in the prior art to apply distinguishing technical features to the closest prior art in order to solve the technical problems in the present invention”;
(2) Clarify conventional practices in current examination practices, for example:
i) For monoclonal antibodies, it shall be allowed to be defined by comprising 6 CDRs at the same time;
ii) For monoclonal antibodies with known antigens, it clarifies that judgment of inventiveness may be on the basis of its structural features and effects.
In general, we believe that the revision of provisions on inventions in biological field have not exceeded expectations which is basically made in response to the rapid development of biological technology. Regarding the real focus issues, such as “whether antigen-binding fragments can be supported by the specifications” and “whether sequences defined by homology requirements can be supported by specifications”, etc., the examination standards for these focus issues may not change to a large extent in the short term.