Written by:Tina TAI, Yu GUO, Bin WU（Intellectual Property）[1]
Part Five About Supplementary Test Data
I.The review criteria for supplementary experimental data in the past two years
There have been positive changes in the review criteria for supplementary experimental data in 2020:
On January 15, 2020, Article 1.10 of the “China-US Economic and Trade Agreement” officially signed by the US and China on drug-related intellectual property rights mentioned the supplementary data rule and mentioned that “China should allow drug patent applicants to use supplementary data in examination procedures, patent reexamination procedures, and judicial procedures to meet relevant requirements for patentability, including requirements for sufficient disclosure and inventiveness.”
On August 24, 2020, at the 1810th meeting of the Judicial Committee of the Supreme People’s Court, the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Laws in the Trial of Administrative Cases for Patent Authorization and Confirmation (1) were passed. The judicial interpretation which was effective on September 12, 2020, stipulates in Article 10 that: “The drug patent applicant shall submit supplementary experimental data after the filing date, claiming to rely on the data to prove that the patent application complies with Article 22, paragraph 3 and Article 26, paragraph 3 of the Patent Law ,the people’s court shall review such provisions.”
In addition, the newly revised “Patent Examination Guidelines”, which was implemented on January 15, 2021, describes in Part Two, Chapter 10, Section 3.5 that on the basis of the principle of examination of supplementary experimental data, further two specific examples of supplementary experimental data for pharmaceutical patent applications are given in the section 3.5.2. In particular, in Example 1, it is clearly pointed out: “The claim claims compound A. The specification describes the preparation example, hypotensive effect and experimental methods for determining the hypotensive activity of compound A, but does not record the experimental results data. To prove the specification fully disclosed, the applicant submitted the data on the blood pressure lowering effect 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 contents disclosed in the patent application documents. It should be noted that the supplementary experimental data should also be examined when judging inventiveness.”
Based on the above-mentioned series of amendments to laws and regulations, the Supreme People’s Court and CNIPA began to show a relatively loose trend in the review of supplementary test data.
For example, the administrative litigation for invalidation of ticagrelor crystal patent[2], the second-instance judgment issued by the Supreme People’s Court on October 26, 2020 ((2019) Supreme Law Zhi Xing Zhong No. 33) set clear standards for the acceptance of supplementary experimental data. In this judgment, the Supreme People’s Court first clarified that “based on the difference in cognition of the existing technology, the different understanding of the invention of the technical solution, and the inconsistency of the understanding of the technical personnel in the field, etc., it is inevitable that the applicant did not record the specific experimental data in the original application documents.” Based on this consideration, the Supreme People’s Court has established positive and negative conditions for the acceptance of supplementary experimental data:
First of all, the original patent application documents should clearly record or implicitly disclose the facts to be verified that the supplementary experimental data intends to directly prove, which is a positive condition. If the facts to be verified that the supplementary experimental data intend to directly prove are clearly recorded or implicitly disclosed in the original patent application documents, it can be deemed that the applicant has completed the relevant research and the acceptance of the supplementary experimental data does not violate the principle of prior application rule. In details, the relevant supplementary experimental data cannot be refused to accept for a reason that the original patent application documents record the facts to be verified while the relevant experimental was not be recorded, assuming that the applicant constitutes a false record for the purpose of obtaining improper benefits; nor can require the supplementary experimental data submitted by the applicant be formed before the filing date or the priority date because there is a possibility that the applicant may make false records.
Secondly, the applicant cannot make up for the inherent defects of the original patent application documents by supplementing experimental data, which is a negative condition. The so-called supplementary experimental data cannot be used to make up for the inherent defects of the original patent application documents, is intended to emphasize that the supplementary experimental data should usually prove the authenticity of the facts to be verified that are clearly recorded or implicitly disclosed in the original patent application documents, and serve as supplementary proofs of the legal essential facts that the applicant or the patent right holder ultimately needs to prove ,instead of independently proving the undisclosed contents of the original patent application documents, thereby overcoming the inherent shortcomings such as insufficient disclosure in the original patent application documents.
The above-mentioned judgment of the Supreme People’s Court clarified for the first time the criteria for accepting supplementary experimental data, that is, the relevant technical effects should be clearly recorded or implicitly disclosed in thespecification, which is a positive condition. That is to say, as long as the description clearly records or even implicitly discloses the relevant technical effects, even if there is no specific effect data, experimental data that proves the effect by submitting relevant experimental data after the application date or after the priority date can also be introduced. In addition, the inherent shortcomings in the application documents cannot be overcomed by supplementing experimental data, which is a negative condition for receiving supplementary experimental data. Regarding the newly introduced expression “inherent shortcomings” in the judgment, the judgment did not specifically explain its meaning.
In addition, the administrative litigation case for invalidation of Nuoxinto composition patent[3], the Supreme People’s Court issued the second-instance judgment on June 30, 2021 ((2019) Supreme Law Zhixing Zhong No. 235), reiterating the standard of acceptance of supplementary experimental data set by the aforementioned second-instance judgment in the administrative litigation case for invalidation of the Grilo crystal patent. In this judgment, regarding the necessity and possibility of receiving supplementary experimental data, the Supreme People’s Court further pointed out that “due to the deviation in the understanding of the existing technology, the difference in the understanding of the invention of the technical solution, the knowledge level of those skilled in the art, it may be inevitable that the applicant did not record specific experimental data in the original application documents for different reasons. For example, in terms of inventiveness, as far as the inventive step of compound drugs is concerned, it can be based on the structure or morphology of the compound itself, or the efficacy of compound drugs. Among them, the drug effect can be either the drug use, that is, the indication; or the drug effect, that is, the drug’s activity, toxicity, stability, route of administration, and so on. Non-obvious technical contributions in any of the above aspects can enable the technical solution to meet the inventiveness requirements of the patent authorization. It is difficult for the applicant to accurately predict the point of invention on the filing date or priority date. Even if the applicant has made an accurate prediction on the point of invention, for the same technical problem, the different understandings of the prior art and different choices of the closest prior art lead to different facts and data required to prove inventiveness. . In addition, in terms of full disclosure, the examiner or invalidation petitioner may have a different understanding of the patent application documents from that of the patent applicant, and therefore question whether the patent application meets the requirements for full disclosure. In the above cases, patent applicants need to rely on supplementary experimental data submitted after the filing date or priority date to prove that their patent application meets the conditions for patentability. Therefore, the supplementary experimental data submitted by the patent applicant after the filing date should be reviewed instead of rejected all.”
The judgment positively responded to “If the experimental data submitted by the patentee after the application date is accepted, it can be used to prove the claimed technical effect that cannot be obtained from the specification, which will undoubtedly impact the issue of the prior application rule in China’s patent law and the basic legal principle of “publicity for protection” ” mentioned in the first-instance judgment of this case[4]”. The Supreme People’s Court held that when compared with different reference documents, the technical problems solved by the present invention may be different, while the patent applicant or patentee cannot predict the specific reference documents to be cited in the subsequent substantive examination and/or invalidation examination process when filing the patent application. Therefore, patent applicants or patentees should be allowed to submit supplementary experimental data based on the effects simply recorded in the specification, and then conduct an examination.
Furthermore, in the case of cariprazine monohydrochloride crystal invalidation case[5] (Invalidation Decision No. 47087), although the specification only implicitly mentions the purity of the crystal, it was decided to consider the experimental data related to purity submitted after the application date, and then recognized the inventiveness of the crystal based on the above-mentioned content in the specification in the invalidation decision made by the Patent Reexamination and Invalidation Examination Department of the CNIPA made the invalidation decision on January 5, 2021. Specifically, the invalidation decision is based on the content of paragraph 0014 of the patent specification involved, “Hydrochloride is particularly preferred because it can be prepared with the highest yield and highest purity. Another advantage of monohydrochloride is that it can be easily prepared using standard solvents and reaction conditions.” It is deemed that the “purity” in this paragraph refers to the purity of “cariprazine monohydrochloride”. Based on this, it is judged that cariprazine monohydrochloride with higher purity than other salts is a technical effect that the patentee has paid attention to and should have conducted research before the application date. According to this, based on the supplementary test data submitted by the patentee (counter-evidence 1 and 2), it is determined that the total impurity content and the maximum characteristic impurity content of monohydrochloride are significantly lower than other salt types, and the present invention realizes the unexpected technical effect.
This invalidation decision has caused quite a stir in the industry. Its biggest breakthrough is that although the patent specification implicitly discloses the excellent purity of cariprazine monohydrochloride and does not record experimental data record concerning the purity of cariprazine monohydrochloride. Supplementary experimental data including the purity of cariprazine monohydrochloride were approved at the level of the administrative authority for patent examination. Furthermore, through the supplementary experimental data, it is believed that the monohydrochloride has better purity than other salts, and it is finally determined that the monohydrochloride has achieved unexpected effects.
In addition, in the invalidation case of Lucapari camphorate crystals[6](Invalidation Decision No. 49639), the patentee tried to introduce 5 technical effects through supplementary experimental data. The specific information is shown in the table below.
In the end, the collegiate panel only accepted the supplementary experimental data related to the effects of “hygroscopicity” and “crystal stability” (comparative data with the existing technology), and refused to accept the supplementary experimental data of the other three effects (compared with the existing technology).Regarding “chemical stability”, the collegiate panel believed that the specification only disclosed “thermal stability”, and “chemical stability” and “thermal stability” were different. Therefore, the supplementary effect experimental data involving “chemical stability” was unacceptable. Regarding “dissolution”, the collegiate panel believed that the properties of “suitable for preparing solid dosage forms” in the field cover many different characteristics. Unless the specification clearly stated, it cannot be considered that the specification discloses the effects of “dissolution”.
Towards the end of this article, the review examiner of CNIPA published “Considerations of Supplementary Experimental Data in Invalidation Cases”[7] in the “China Intellectual Property News” on October 24, 2021. In this article, for the review of supplementary experimental data, the author once again reiterated that it should comply with the basic principle of “prior application rule”. On this basis, the author believes that the examination example “[Example 1]” given in “3.5.2 Supplementary Experimental Data for Pharmaceutical Patent Applications” in Chapter 10 of Part Two of the “Patent Examination Guidelines” must meet the following two conditions: (1) Compound A is a specifically disclosed compound and has been prepared in the application file, which excludes the condition of the general formula containing multiple compounds, and also the preferred compounds that are further screened out through experiments on the application date among the many listed compounds.
(2) Another condition is that a certain specific activity of compound A has been disclosed, and it is not among the many activities that may be pursued to select a specific activity through experiments after the application date, or from the vague description of the activity, Choosing a specific preferred activity eliminates the possibility of listing of possible activities or mechanisms for staking and screening for specific activities or uses in the future.
In summary, judging from the judgments and invalidation decisions made by the Supreme People’s Court and CNIPA in the past two years, in the context of Article 10 of the Supreme People’s Court Judicial Interpretation and Section 3.5 of Chapter 10 of Part Two of the “Patent Examination Guidelines” clearly stated “supplementary experimental data should be reviewed “, the Supreme People’s Court and CNIPA began to try to lessen the review standards for supplementary experimental data, and gradually accept supplementary experimental data with written records but no specific data in the specification.
II.Examination of supplementary test data in compound patent invalidation examination
After carefully reading all invalid decisions and court judgments retrieved in the part one of the foregoing search, we found that 4 invalid decisions and 4 court judgments involved supplementary test data. However, whether the supplementary test data submitted by the patentee was acceptable was not commented in the three invalid decisions of the invalidation case rivaroxaban (No. 45997), Maxitentan (No. 48183) and Carfilzomib (No. 51835) on, while all of the decisions ultimately maintained the validity of the patent right based on the non-obviousness of the compound structure. Therefore, a total of 5 invalid decisions and judgments indeed were reviewed on whether the supplementary test data is acceptable. Among the 5 invalidation cases, none of them was accepted the supplementary test data submitted by the patentee during the defense process.
Among the 5 cases that were not accepted supplementary test data, 3 of them were the first-instance judgments on the invalidation of a series of empagliflozin compounds (Trial numbers: (2018) Jing 73 Xingchu No. 1097, 1098 and 1099). In the administrative litigation of the aforementioned cases, the patentee claimed that the patent specification in question implicitly disclosed that the compound in question had “high selectivity for SGLT-1”[8], and that the effect had been discovered before the filing date. However, the court (Beijing Intellectual Property Court) held that the patent specification involved did not implicitly disclose the “SGLT-1 high selectivity”, and then refused to accept the supplementary experimental data submitted by the patentee based on the “prior application rule”.
In the first-instance judgment of tofacitinib invalidation (Trial number: (2019) Jing 73 Xingchu No. 1460), the patentee submitted supplementary test data and requested to prove that the tofacitinib compound meets the full disclosure requirements stipulated in the Patent Law. In response to this, the court refused to accept the data based on the reason that the above supplementary test data is an article published after the priority date of the patent.
In one invalidation decision (No. 45381), CNIPA determined that “the experimental data submitted by the patentee in the statement of opinions is different from the effect recorded in this patent, and belongs to the follow-up research after the application date and thus is not considered by the collegiate panel”.
III.Scenarios s in which supplementary test data is accepted in the review of compound patent invalidation
Judging from the judgments and invalidation decisions made by the Supreme People’s Court and CNIPA in the past two years, in the context of Article 10 of the Supreme People’s Court Judicial Interpretation and Section 3.5 of Chapter 10 of Part Two of the “Patent Examination Guidelines” have clearly stated that “supplementary experiments data should be reviewed” , the Supreme People’s Court and CNIPA began to try to lessen the review standards on supplementary experimental data, and gradually accepted supplementary experimental data with written records but no specific data in the specification. However, judging from specific cases, there are some deviations between the Supreme People’s Court and the State Intellectual Property Office in terms of the degree of lessening.
Judging from the invalidation decision made by CNIPA and recent articles published in the “China Intellectual Property News”, we can see that from their perspective, currently only the following “Scenario 2” revised from the previous non-acceptance of supplementary experimental data to supplementary experimental data can be accepted. Regarding the following “Scenario 3” and “Scenario 4”, even according to the revised “Patent Examination Guidelines”, CNIPA still does not believe that the supplementary experimental data submitted by the patentee in the patent application or patent invalidation examination process can be adopted.
However, judging from the two judgments of the Supreme People’s Court, in addition to the patent specification “clearly recording” the technical effect to be proven, if the technical effect to be proven is “implicitly disclosed”, supplementary experimental data concerning the effect can also be accepted. “Scenario 2” in the above table can be considered as “clearly stated”, while “Scenario 3” and “Scenario 4” in the table above can be understood as “implicit disclosure”. Therefore, the specific circumstances and boundaries of “implicit disclosure” need to be further interpreted by other judgments.
In summary, we are cautiously optimistic about the review of supplementary experimental data, and predict that in the future, CNIPA and even the Beijing Intellectual Property Court will strictly follow the specific conditions of the two examples of the provisions of Section 3.5.2, Chapter 10, Part Two of the “Patent Examination Guidelines to examine the supplementary experimental data submitted by the patent applicant or the patentee. The supplementary experimental data beyond these two examples may be difficult to be accepted.
Part SIX Summary
In summary, on the basis of analyzing the specific scenarios s of compound patent invalidation from 2020 to 2021, and comparing it with the period from 2010 to 2019, we can see the following new trends and new changes in the recent invalidation review of compound patents.
1、The request frequency for invalidation of compound won‘t change drastically.
Starting from 2017, the number of invalidation cases for compound patents has reached about 10 cases per year. However, we have also noticed that in July 2021, after the State Drug Administration and CNIPA formally promulgated the implementation measures for the drug linkage system, almost all generic drug companies submitted type III of declaration for compound patents (That is, the generic drug applicant promises that the generic drug applied for will not be marketed temporarily before the expiration of the corresponding patent right expires). Based on this, we speculate that the number of patent invalidation cases involving pharmaceutical compounds will decline in the future.
2、The rate of compound patents being maintained has increased significantly
During the period from 2020 to 2021, the proportion of maintaining compound patent rights in invalidation procedures is as high as 100%, which is significantly higher than the data from 2010 to 2019 (approximately 55%). Especially for patents that only protect specific compounds, the possibility of being invalidated is significantly reduced.
3、It is difficult to invalidate a compound patent only on the basis of insufficient disclosure and/or unsupported issues
Judging from the results of invalidation decisions, as long as a reasonable explanation can be given based on the patent specification, it is difficult to invalidate a compound patent solely on the basis of insufficient disclosure and/or unsupported invalidation grounds.
4、The choice of lead compounds still cannot be a factor influencing inventiveness judgment
In the United States and Europe, when reviewing the inventive step of compound patents, it is first necessary to review the level of those skilled in the art and whether the closest prior art selected by the applicant is suitable as a lead compound for further technological improvement. However, in China, the introduction of this dispute reason by the patentee was neither accepted by CNIPA nor by the People’s Court.
5、The review on compound inventiveness begin to show emphasis on the non-obviousness step of the compound structure
After the second-instance verdict on the invalidity of the “ticagrelor compound” was made, when reviewing the inventiveness of the compound patent, CNIPA began to attach importance to the structure-activity relationship analysis between the prior art compound and the involved patent compound while abandoning the previous siample way of mechanical comparing whether the structure of the compound in prior art is close to the involved patent compound, making it clear that in the inventive judgment of compounds, the analysis of the structure-activity relationship is the key to determine the technical problems actually solved by the invention and to analyze whether the existing technology has corresponding technical enlightenment.
We hold that the important reason why the rate of compound patents is maintained as high as 100% from 2020 to 2021 is that CNIPA has indeed recognized the important influence of compound structure-activity relationship on the improvement of compound structure.
6、Supplementary test data may only be accepted under limited conditions
Regarding the supplementary test data, the judgment from Supreme People’s Court indicated that based on the consideration of “the difference in cognition of the existing technology, the different understanding of the invention of the technical solution, and the inconsistency of the understanding of the technical personnel in the field, etc., it is inevitable for that the applicant that has did not record stated the specific experimental data in the original application documents”, the Supreme People’s Court shows an attitude of relatively “relaxed”. It is believed that as long as the technical effect is “disclosed” or “implicitly disclosed” in the patent specification, relevant test data can be supplemented.
However, CNIPA takes a relatively “cautious” attitude and will strictly follow the specific conditions of the two examples specified in Section 3.5.2, Chapter 10, Part Two of the “Patent Examination Guidelines” to examine the supplementary experimental data submitted by the patent applicants or patentee, but supplementary experimental data beyond these two examples may be difficult to be accepted.
Obviously, there is a certain deviation between the Supreme People’s Court and CNIPA in the acceptance of supplementary test data. We will continue to pay attention to the final direction of this issue.
Thanks
This article is a research project supported by Beijing RDPAC International Consulting Co., Ltd.
[1] The authors are all patent attorneys of Beijing King & Wood Mallesons Law Firm.
Contact: Tina TAI,tinatai@cn.kwm.com，010- 58785132
[2] Because this case involves the compound crystal rather than the compound itself, the judgment is not counted in this article.
[3] Because this case involves the composition of two active ingredients rather than the compound itself, this judgment is not counted in this article.
[4] The first-instance court of this case refused to accept the supplementary experimental data. The specific reason is that “China’s patent law adopts the principle of prior application rule, and the precondition for patentees to obtain monopoly protection is that they require protection at the time of patent application. The technical solution has been fully disclosed. In the experimental field of medicine, the content of full disclosure usually should also include relevant technical effects and necessary experimental data. If it is only claimed in the specification that a certain technical effect has been achieved, but if the necessary experimental data information is not provided, and the effect is not directly and unambiguously obtained by those skilled in the art based on the existing technology after reading the specification, it cannot be considered that the relevant technical solution at the time of patent application can achieve the claimed technical effect. In this case, if the experimental data submitted by the patentee after the application date is accepted and can be used to prove the technical effect claimed by the patentee but cannot be obtained from the specification, it will undoubtedly impact the prior application rule of China’s patent law and the basic legal principle of“publication in exchange for protection”of patent rights.”
[5]Since this case involves the crystal of the compound rather than the compound itself, the judgment is not counted in this article.
[6] Because this case involves the compound crystals rather than the compound itself, the judgment is not counted in this article.
[7] https://finance.sina.com.cn/tech/2021-10-25/doc-iktzqtyu3360492.shtml
[8] The content of the specification is “The purpose of the present invention is to find new pyranosyl-substituted benzene derivatives, especially for sodium-dependent glucose cotransporter SGLT, especially SGLT2. Another purpose of the present invention is to show that the pyranosyl-substituted benzene derivative has an enhanced inhibitory effect on the sodium-dependent glucose cotransporter SGLT2 in vivo and/or in vitro compared with known compounds of similar structure, and/or has a better effect, and/or good pharmacological or pharmacokinetic properties”.