This part mainly compares the examination standards for supplementary experimental data in the United States, Europe and China, and on this basis, gives some suggestions on examination practices in China.
1.Comparative Study of Current Examination Practices in the United States, Europe and China
In the evaluation of inventiveness (non-obviousness) in the United States, technical effects are not a core element in the analysis of lead compounds. On the one hand, if the compound indicated by the invalidation petitioner cannot be used as a suitable lead compound, or those skilled in the art have no motivation to modify the lead compound to obtain the compound of the present invention, then the compound of the present invention should be deemed non-obvious even if the compound does not have exceptionally excellent technical effects. On the other hand, if the lead compound is selected correctly, and those skilled in the art have the motivation to modify the structure to obtain the compound of the present invention, even if the compound of the present invention has certain advantages, it may not be non-obvious. When dealing with supplementary experimental data, the US courts are more inclined to discover technical facts and verify the correctness of the lead compound analysis on this basis. Therefore, the U.S. courts are open to accept supplementary experimental data. Supplementary experimental data can be used to prove the effect of quantitative data mentioned in the description but not explicitly recorded, or they can be used to illustrate the comparative conclusion of the explicit or implicit technical effects of the patent with the prior art.
The European Patent Office applies the “credibility standard” in inventiveness evaluation. That is, if the effect described in the description is at least credible to those skilled in the art, regardless of whether the effect is explicitly mentioned in the description or whether quantitative data are clearly recorded, supplement experimental data are allowed to support the effect of the quantitative data mentioned but not clearly recorded in the description, or to support the relevant technical effect that is explicitly or implicitly indicated in the patent. On the other hand, if those skilled in the art have sufficient reasons and evidence to show that the claimed technical effect is highly suspicious, and supplementary experimental evidence is used to exclude such suspicion, it is not allowed to rely on supplementary experimental data to claim the effect. According to the “credibility standard”, the absence of an explicit description of the technical effect or the absence of quantitative data in the patent description does not necessarily lead to a highly suspicious claimed technical effect. The conclusion depends on whether or not the opposite conclusion is recorded in the prior art and patent description, or whether or not the technical effect is unreasonable from the perspective of general technical knowledge.
In Chinese examination practice, the determination of the technical effect in examination of inventiveness or full disclosure is often an important basis for determining whether or not the corresponding technical solution is inventive or whether or not it is fully disclosed in the description. On this basis, for the case where the corresponding technical effect is clearly recorded in the original application document but the data are not disclosed, then the applicant or patentee will consider supporting the objective existence of the effect via supplementary experimental data. However, whether or not the supplementary experimental data should be accepted in China has always been the focus of disputes in various fields.
The 2010 edition of the Guidelines for Patent Examination, Chapter 10, Section 3.4 provides the following: “Determination on whether or not the description fully discloses shall be based on the content recorded in the original description and the claim. Examples and experimental data supplemented after the filing date shall not considered.” Although the 2010 edition of the “Guidelines for Patent Examination” does not consider the experimental data supplemented after the filing date, in actual examination practice, some examiners will allow patent applicants to submit data providing comparison with the closest prior art for demonstrating the excellent technical effect of the present invention compared with the prior art in circumstance where the effect data are already recorded in the description of the present application.
Regarding this, the provision was amended in the “Decision on Amending the Guidelines for Patent Examination” in 2017 to the following: “Determination on whether or not the description fully discloses shall be based on the content recorded in the original description and the claim. Examiners shall examine examples and experimental data supplemented after the filing date. The technical effects proved by the supplementary experimental data should obtainable by those skilled in the art from the disclosure of the patent application.” The 2017 amended Guidelines increases the degree of acceptance of supplementary data, and in fact fixes the above practice.
However, in practice, the CNIPA sets a higher standard for the following element: “The technical effects proved by the supplementary experimental data should be obtainable by those skilled in the art from the disclosure of the patent application”. That is, if the data are explicitly stated in the description, it is considered that the technical effect can be obtained from the content disclosed in the patent application; while for the case where the data are not explicitly stated, then the data are considered as “assertive disclosure”, and the technical effect is not recognized as obtainable from the disclosure of the patent application, and thus cannot be used as a basis for supplementing the experimental data. This practice is also reflected in the invalidation examination in the compound field. Among all the 35 invalidation decisions analyzed, there are nine decisions involving the patentees submitting supplementary experimental data (counter-exhibits) in the hope of overcoming the issues of inventiveness or insufficient disclosure. However, among the above nine decisions, only one decision (Decision No. 37539) accepted the supplementary experimental data submitted by the patentee (said supplementary experimental data are the experimental data already recorded in the priority patent). The other eight decisions (Decision Nos. 20147, 22284, 33101, 33102, 33103, 33591, 36902, 39131) all rejected the supplementary experimental data submitted by the patentees.
2.New Changes in the Standards for Supplementary Experimental Data in Chinese Examination Practice and Suggestions thereof
There have been positive changes in the examination standards for supplementary experimental data in 2020:
Article 1.10 “Regarding Drug-Related Intellectual Property” in the China-US Economic and Trade Agreement officially signed by China and the United States on January 15, 2020 mentions rules for supplementary data: “China should allow drug patent applicants to rely on supplementary data in the patent examination procedure, patent reexamination procedure and judicial procedure to meet relevant requirements for patentability, including the requirements for sufficient disclosure and inventiveness.”
On August 24, 2020, the 1810th Session of the Judicial Committee of the Supreme People’s Court passed the “Provisions (I) of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Administrative Cases Involving the Grant and Confirmation of Patents”. This judicial interpretation came into effect on September 12, 2020. Article 10 of the interpretation provides the following: “If a drug patent applicant submits supplementary experimental data after the filing date, claiming to rely on the data to prove that the patent application complies with Articles 22.3 and 26.3 of the Chinese Patent Law, the people’s court shall conduct examination on said submission.”
In addition, the newly amended “Guidelines for Patent Examination”, which came into effect on January 15, 2021, in Section 3.5 of Chapter 10 of Part II, further provides two specific examples regarding supplementary experimental data of drug patent applications on the basis of the examination principles for supplementary experimental data. In particular, Example 1 explicitly points out the following: “The claims are directed to compound A, and the description records the preparation examples of compound A, the blood pressure lowering effect and the experimental methods for measuring the blood pressure lowering activity, but the experimental result data are not recorded. To prove sufficient disclosure of the description, the applicant has supplemented the blood pressure lowering effect data of compound A. For those skilled in the art, according to the original application documents, the blood pressure lowering effect of compound A has been disclosed, and the technical effect to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It should be noted that the supplementary experimental data should also be examined in inventiveness examination.”
In response to the above-mentioned positive changes, we hope that these policies can be truly implemented to bring more benefits to patent applicants, and will give more specific guidance in individual cases. The 2020 Supreme People’s Court Judicial Interpretation and the 2021 Edition of the Guidelines for Examination undoubtedly reflect a positive change to the early examination standards of supplementary experimental data in China by policy makers, and the firm determination of the country to protect innovation and encourage invention and creation. On this basis, we propose to provide flexible explanation of the following element provided in the new Guidelines: “The technical effects proved by the supplementary experimental data should obtainable by those skilled in the art from the disclosure of the patent application.” In determination of the technical effects of compounds, reasonable consideration should be given to related technical effects that are explicitly recorded in the description or that can be inferred from the description. If the relevant quantitative experimental data are not recorded in the description, the applicant or the patentee should have the opportunity to submit relevant experimental data to support the technical effects so as to provide an objective technical factual basis for the examination. In actual examination of individual cases, the “credibility standard” of the European Patent Office can be used as a reference in determining whether or not the supplementary experimental data are acceptable. That is, as long as the prior art or the content of the description does not give those skilled in the art sufficient reasons to believe that the effects are highly suspicious, the experimental data supplemented after the filing date to prove these effects shall be accepted.
As the most essential and the most fundamental patents and intellectual property in the field of medicine, compound patents have an extremely important position in the entire industry of medicine. However, at the same time, it should be recognized that compound patents are a difficult examination point in the fields of chemistry and medicine. The technology is complex and involves many unexplored scientific fields. We hope that through this series of articles, we can sort out the statistics regarding past examination results, current examination practices, and examination practice standards of various countries regarding compound patents for readers, and provide some suggestions and references for future examination standards of compound patents during the Fourth Amendment of the Chinese Patent Law.
This article is a research project supported by Beijing Adi Paike International Consulting Co., Ltd.
 The authors are all patent agents at King & Wood Mallesons (Beijing).
Contact Person: Tina TAI, email@example.com, 010- 58785132