| The pharmaceutical patent system can ensure the innovation and development of the pharmaceutical industry.However,due to the low predictability of the research results in the pharmaceutical field,in terms of the application for a patent,the patent examiner cannot get the technical effect of the invention merely through deduction,but needs the support of corresponding experimental data as well.The 2017 Guidelines For Patent Examination adds a provision on the supplementary submission of experimental data,which conditionally allows the submission of experimental data after the date of application to prove that the specification is fully disclosed or that the invention is creative.The original intention of the addition of this regulation by the State Intellectual Property Office is to correct the previous erroneous practice of our patent examiners,namely directly ignoring or not reviewing the supplementary experimental data.While the supplementary experimental data on the application date that eliminate the doubt on the full disclosure of the specification or the invention creativity is acceptable,it is rarely adopted in the current patent examination practice.As a result,the provision did not play its real role.Based on the practice of drug patent examination,this paper discusses the problems existing in the examination standard of supplementary experimental data in the practice of patent examination in our country and puts forward the corresponding solutions,combined with the judgment standard of full disclosure of specification and the creative judgment standard of invention.First of all,the invalid Entresto patent case and the first bio-genetic technology drug case in China are introduced,the focus of controversy in which is summarized as follows:The criteria for judging the full disclosure of specifications and the one for judging invention and creativity differ.Besides,the provisions on supplementary experimental data in China’s Guidelines For Patent Examination are relatively general,vague and lackof pertinence.There are some difficulties when the patent applicant/the right holder wants to eliminate the doubt of the full disclosure of the specification or invention creativity by handing in the experimental data.Secondly,factors considered for the full disclosure of the specification in the practice of patent examination in our country are analyzed: the subject of judgment,"clear,complete","achievable",the object,the subject and the method of creative judgment.By the comparison with the corresponding provisions in the practice of foreign patent examination,it is clear that there are differences in the consideration factors of the patent applicant/the right holder in the two dissimilar stages of full disclosure of the specification and creativity of the invention.Finally,combined with the above analysis,we improve the examination standard of supplementary experimental data in our country.That is to say,we are aimed to distinguish between the examination standards for eliminating the doubt of the full disclosure of specification and creative invention.Meanwhile,the corresponding judicial interpretation should be issued as soon as possible to ensure the unity of patent examination and judicial trial standards. |
