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Analysis of Supplemented Experimental Data in Patent Examination — Reflections on Reexamination of a Patent Application of XX Pharmaceutical
Yan WANG
Chinese Patent Attorney
Chemistry & Biotechnology Department
Linda Liu & Partners
In the practice of Chinese patent examination, it has been controversial concerning whether or not supplemented experimental data can be accepted and whether or not such data can be used to eliminate substantive defects such as insufficient disclosure and lack of inventiveness of a patent application. In this article, we briefly analyze whether or not supplemented experimental data can be accepted in the present practice of Chinese patent examination based on the reexamination of a patent application of XX Pharmaceutical Company Limited.
During the substantive examination of the Chinese patent application, the examiner asserted that the disclosure of the description was not sufficient and this did not comply with Article 26.3 of the Chinese Patent Law, thus rejected the application accordingly. The specific grounds for rejection are as follows:
The present application claims compounds useful for inhibiting dipeptidyl peptidases. The description discloses the preparation method and biological assessment experiments of the compounds of the present invention, but only generally explains in the tryptase assay that “compounds of the invention were found to inhibit DPP-IV activity at concentrations that are at least 50 fold less than those concentrations required to produce an equiactive inhibition of protease activity for FAP alpha. The apparent inhibition constants (Ki) for compounds of the invention, against DPP-IV, were in the range from about 10-9M to about 10-5M”. However, “compounds of the invention” are compounds of a general formula and contain numerous compounds, so a person skilled in the art cannot know the types of compounds from which the result of effect experiment is achieved. Therefore, a person skilled in the art cannot confirm based on the description that the compounds claimed by the present application have the use and/or using effect as asserted by the applicant, moreover, a person skilled in the art can neither predict according to the prior art that the present invention can realize the use and/or using effect as it claims; therefore, the disclosure of the compounds is insufficient.
We can see from the above grounds raised by the examiner that although the present application provides experimental data, yet it does not disclose specific types of compounds which are measured to obtain the above experimental data; instead, it only generally describes that the compounds used are compounds of a general formula of the present application. As the general formula of the present application covers numerous types of compounds, the examiner asserts that the specific types of compounds that the experimental data described by the description is based on cannot be determined, and whether or not the compounds shown by the general formula of the present application can achieve the same technical effect cannot be further confirmed either.
In conclusion, the main problem of the present application is that instead of providing specific compounds, it only simply describes that the experimental subject is “compounds of the present invention” in describing experimental data. The writer believes that seen from the surface, the above problem is arose from small errors in drafting of the patent application, but the root cause may be that with such drafting manner, XX Pharmaceutical expects to not only obtain protection for the patent, but also keep secret of the structure of its specific compounds with the best technical effect so as to form technical barrier and increase the difficulty of imitation of generic drugs.
However, during the substantive examination of the present application, the Chinese Patent Office holds a very strict standard for such drafting manner of compounds; thus the present application was rejected. The applicant XX Pharmaceutical Company Limited filed a request for reexamination and submitted supplemented experimental data after the rejection.
The Patent Reexamination Board then set up a collegial panel, examined the present application, and eventually made a Decision of Reexamination to revoke the Decision of Rejection of the present application. According to the above Decision of Reexamination, it seems that the supplemented experimental evidence submitted by the applicant along with the request for reexamination was accepted by the collegial panel, and that the defect of insufficient disclosure of the description of the present application has been eliminated thereby. But whether or not this is the case, we will make further analysis based on the specific grounds provided in the Decision of Reexamination as follows.
The collegial panel asserts that in determining whether or not a claimed technical solution is sufficiently disclosed, in addition to the disclosure of the description of the present application, one shall also investigate the prior art of the present application from the viewpoint of a person skilled in the art. If a person skilled in the art can predict that the compounds can achieve its use and/or using effect by combining the disclosure of the description with the prior art, then the disclosure of said use and/or using effect in the description meets the requirement of sufficient disclosure.
The collegial panel further cites Reference 1: JP2003-300977A, Publication Date of which is October 21, 2003, and Reference 2: WO02/02560A, Publication Date of which is January 10, 2002 (both belong to the prior art of the present application). The collegial panel points out that the compounds of a general formula defined in claim 1 of the present application have similar structure with the specific compounds in References 1 and 2, and a person skilled in the art, on the basis of References 1 and 2, can predict that the compounds of the present application after change of skeletons also have corresponding DPP-IV inhibitory activity based on the analysis of acting mechanism of DPP-IV inhibitor compounds. Moreover, according to the description of the present application, the present application intends to provide a compound as a dipeptidyl peptidases IV (DPP-IV) inhibitor, so a person skilled in the art can predict that the compound of the present application has the technical effect it claims. To sum up, a person skilled in the art can predict that the compounds claimed by claims 1-3 of the present application have the use and/or using effect as disclosed by the description by combining the disclosure of the description with the prior art, and the present application complies with Article 26.3 of the Chinese Patent Law.
We can see from the specific grounds provided by the collegial panel in the Decision of Reexamination that the collegial panel did not provide a specific or explicit conclusion concerning whether or not the supplemented experimental data was accepted. The collegial panel evaded this problem during the reexamination, and determined with combination of the prior art that the technical effect of the compounds of general formula in the present application can be predicted by a person skilled in the art. Although according to the above grounds of the collegial panel in the Decision of Reexamination, the present application temporarily overcame the defect of insufficient disclosure of the description, yet as the collegial panel believed that the structure and technical effects of the compounds of general formula of the present application can be conceived and predicted by a person skilled in the art based on the prior art, the present application then had the defect that the compounds of general formula did not possess inventiveness, and the applicant was thus caught in a dilemma.
Out of dissatisfaction with the grounds provided in the Decision of Reexamination, the applicant of the present application further filed administration litigation to the Beijing Intellectual Property Court. At present, the case is under further inquisition.
In combination with the present application, the writer thinks that in the present practice of Chinese patent examination, with the adjustment of examination standard and strategy, examiners mainly focus on examining whether or not a patent application possesses inventiveness, and hold a looser examination standard on whether or not the disclosure of the description of a patent application is sufficient. However, the examination standard on whether or not the experimental data disclosed in the description has a probative force does not change significantly. In the present application, for instance, the examiner asserted during the substantive examination that experiments disclosed in the description of the present application did not have a probative force, neither did the collegial panel confirm the probative force of the experimental data disclosed in the description during the reexamination procedure.
Moreover, in the present practice of Chinese patent examination, examiners would take the experimental data supplemented after the filing data into consideration, but they would consider very prudently the relationship between such evidence and the fact disclosed in application documents. Generally, evidences submitted after the filing date would not change the fact that examiners affirm based on application documents; that is, evidences submitted after the filing date can only be used to verify the objective fact that exists in the application documents, can be predicted by a person skilled in the art or has already been proved, but cannot prove facts that a person skilled in the art cannot confirm based on the application documents, nor can it prove facts that the application documents do not disclose. In the specific examination procedure, the examiner would analyze whether or not the submitted evidence is relevant to the claimed technical solution, and if the relevance cannot be confirmed, the examiner would not accept it to prove factum probandum. For the technical effect that has been disclosed in the application documents but cannot be predicted nor have already been proved, examiners always regard the additional experimental data submitted after the filing date as not having a probative force; for the additional experimental data submitted to prove unexpected technical effect, examiners would firstly consider whether or not said technical effect can be affirmed of existence by a person skilled in the art based on the disclosure of the description, then determine whether or not the technical effect of the invention goes beyond the expectation of a person skilled in the art; generally, if the technical effect merely overmatches the most related prior art, it does not mean that such effect cannot be expected.
In conclusion, in the present practice of Chinese patent examination, it is still very difficult to eliminate substantive defects of insufficient disclosure and lack of inventiveness of a patent application with supplemented experimental data. It remains an important task for every enterprise and patent agency to comprehensively consider various factors including market environment, strategy for application and policy of examination, accurately seek for balance between technical disclosure and confidentiality and strive for a more stable and more efficient patent right from the beginning of a patent application.
