Provisions on Supplementary Experimental Data in the Patent Examination Guidelines

As an experimental science, the technical effects of technical solutions in the field of medicine are often not intuitively confirmed, and need to rely on experimental data, but it is not easy for the right holder to accurately determine the scope of experimental data to be submitted. Therefore, the supplementary experimental data has been a concern in the trial of such patent cases.

Patent Examination Guidelines2010 Experimental Data on SupplementationThe regulations are very strict: the experimental data submitted after the application date will not be considered. Patent Examination Guidelines2017》First clearProvisions:The examiner shall review the experimental data submitted after the application date.LaterGuidelines for Patent Examination as of January 15, 2021Further relaxation of the review requirements for supplemental experimental data:To determine whether the specification is fully disclosed, the contents recorded in the original specification and claims shall prevail. The examiner shall examine the experimental data submitted by the applicant after the application date in order to meet the requirements of Article 22, paragraph 3, Article 26, paragraph 3, of the Patent Law. The technical effect proved by the supplementary experimental data should be obtained by the technical personnel in the technical field from the contents disclosed in the patent application.. At the same time, the new Review Guidelines also provide"Supplementary experimental data for drug patent applications" is included in two typical cases to illustrate which situation the supplementary experimental data can be accepted by the examiner.

Looking at the various versions of the "Patent Examination Guidelines", the first thing that can be determined is that the supplementary experimental data cannot be used as the basis for identifying patent rights. Regarding the acceptance of supplementary experimental data, the revised review guidelines further clarify that the review principle is applicable to Article 22, paragraph 3, and Article 26, paragraph 3, of the Patent Law. Although on the face of it, the above-mentioned modification seems to relax the requirements for full disclosure and inventiveness of the specification. However, in the examination practice, the examiner will still be extremely careful to consider whether the technical effect to be proved by the supplementary test data can be obtained from the contents disclosed in the patent application documents. The conditions and criteria under which supplementary submitted experimental data can be accepted will be discussed below based on some of the latest jurisprudence on the acceptance of supplementary data for reference in work practice.

Example1No.Invalid Decision No. 47428(ZL200680011591.6)

The patent in question claims to protect a crystal form of engagliflot, but there is no experimental data on the effect (medicinal effect, crystal form stability, solubility). The submitted prior art evidence documents experimental data on the pharmaceutical effects of compounds that are very similar in structure to this compound, and a person skilled in the art can expect the compounds of the present application in the form of crystals to have similar pharmaceutical effects. In addition, a person skilled in the art can expect stability and solubility effects based on ordinary technical knowledge. Therefore, the patent does not have the problem of insufficient disclosure. However, the applicant claims after the application."The crystalline form of the compound has a significant pharmaceutical effect" is not believed, although this part of the experimental data was obtained before the priority date of this case. The patent involved was found to be uncreative because it did not have unexpected technical effects.

Revelation: under normal circumstances, the evidence provided after the application will not change the facts determined by the examiner based on the application documents, that is, the evidence after the application can only be used to confirm the objective facts existing in the application documents that can be predicted or verified by the technicians in the field, but cannot prove the facts that the technicians in the field cannot be convinced according to the application documents, not to mention the fact that there is no record in the application documents. In other words, the effect to be certified must be the technical effect clearly recorded in the specification of the application document, and the technical effect can only be proved to the extent recorded in the specification.

Example2No.Invalid Decision No. 47087(ZL200880015627.7)

Patent requirements for protectionCariprazineMonohydrochloride AnhydrateType I crystal form, need to be based onThe technical effect of "it can be made with the highest purity" proves that the patent has achieved unexpected technical effects, but the patent only has a written description and does not record relevant experimental data. The invalidation decision maintained the validity of the patent by taking into account the purity experimental data made after the date of publication of the patent as supplemented by the applicant. In addition, the invalidation decision also took into account the experimental data provided by the counter-evidence to demonstrate the effect of solubility and stability. Solubility and stability effects alone are predictable by those skilled in the art, and thus cannot be used to prove that the patent achieves an unexpected technical effect.

Key points of decision: for the technical effect recorded in the specification but without specific experimental data, if the technical personnel in this field can be sure that the patentee has paid attention to the technical effect before the application date and should have conducted research on the technical effect, and the technical effect can be obtained according to the contents disclosed in the specification, the patentee needs to supplement corresponding experimental evidence after the application date based on the examination, this experimental evidence can be taken into account as a basis for demonstrating the technical effects of the invention.

Example3：（2018) No. 2626 at the beginning of Beijing 73 line(CN201410098658.0)

Patent application for protectionA crystal line form of (2S,3R, 5S,6R)-2-(4-chloro-3-(4-(2-cyclopropoxyethoxy) benzyl) phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3, 4,5-triol · bis (L-proline) complex. It is necessary to analyze the mechanism of action and effect of the compound in crystal form in inventive judgment. However, the patent only describes the mechanism of action and effect of the crystal form compound and its parent compound, and there is no experimental data actually describing the effect. During the reexamination process, the applicant submitted a patent document whose application date was earlier than the application date of the patent in question and whose publication date was between the application date and the publication date of the patent in question. The patent document records the experimental data of the effect of the parent compound, and the applicant of the patent document is also the patent applicant involved in the case. The first-instance judgment accepted the experimental data and required the State Knowledge Bureau to re-identify creativity on this basis.

According to the present case, the patent document is sufficient to prove that the applicant has verified the effect through experiments before the filing date, and those skilled in the art can confirm the effect when the present application is disclosed. Therefore, the admission of the experimental data in this patent document would not be detrimental to the public interest, nor would it give the plaintiff protection beyond its technical contribution.

Combining the above cases, it can be concluded that:1) The admission of supplementary experimental data should not violate the two basic principles of the patent system, namely, the principle of first application and the principle of public exchange for protection. Even if the supplementary data is obtained before the application date, it cannot be accepted as long as the effect of the supporting evidence is not recorded in the original application;2) The formation time of the acceptable experimental data can be completed before the application date; It can be completed after the public date; It can also be completed before the application date and made public during the application date and the public day. Because supplementary experimental data often involves comparing the claimed invention with the comparative documents cited by the examiner in the authorization process, if such data must be formed before the application date, it is tantamount to requiring the applicant to foresee all the existing technologies that may be cited in the future before applying, which is obviously unreasonable and unfair. The key to whether supplementary data can be accepted depends onPersons skilled in the artCouldFrom the disclosure of the patent application.. Therefore, the data formed after the application in the above cases does not affect the nature of the application.The "first application principle" will not enable the applicant to obtain protection beyond his technical contribution, harm the public interest, and violate the principle of "publicity for protection;3) For providing additional experimental data to prove unexpected technical effects, the examiner will first consider whether the technical effects belong to those skilled in the art that can be believed to exist according to the description of the specification, and then further judge whether the technical effects of the invention exceed the expectations of those skilled in the art.

At the same time, the above cases also give some inspiration in the field of pharmaceutical patent writing:1) Attention should be paid to the excavation and description of technical effects; 2) In writingInstructionsAt the same time, we can try our best to explain what experimental methods and standards can support the technical effects recorded. Thus, if data needs to be supplemented in the future, it will be provided.The basis that "attention has been paid to the technical effect and should have been studied for the technical effect. Of course, the most secure way is still for the applicant to provide the original experimental data as detailed as possible when writing the original patent application specification (e. g., preparation of experimental data, characterization of experimental data, experimental data directly demonstrating the effect, experimental data demonstrating the effect on the side, comparative experimental data, etc.). After all, the provisions of the current patent examination guidelines on supplementary experimental data are not particularly clear at the operational level, and the acceptance of supplementary experimental data will still vary depending on the case and the examiner or judge's heart. For example, in the field of biomedicine, where the degree of predictability is lower than in other fields, it is necessary to provide sufficient experimental data to prove the creativity of the invention and to correctly handle the relationship between the technical secret and the full disclosure of the instructions.

Reference:

https://zhuanlan.zhihu.com/p/357817809

https://zhuanlan.zhihu.com/p/380790831

https://zhuanlan.zhihu.com/p/345932685#:~:text=纵观历来的各版《,利权有效的依据.