| | |
| Announcement of the China National Intellectual Property Administration for Amending the Guidelines for Patent Examination | | 国家知识产权局关于修改《专利审查指南》的公告 |
| (Announcement No. 391 of the China National Intellectual Property Administration) | | （国家知识产权局公告第三九一号） |
| For the purposes of comprehensively implementing the spirit of General Secretary Xi Jinping's important instructions on strengthening the protection of intellectual property rights, deepening the implementation of the decision and deployment of the reform of “simplifying procedures, decentralizing powers, combining decentralization with appropriate control, and optimizing services,” actively responding to the requirements of the rapid economic and technological development for examination rules, and improving the quality and efficiency of patent examination, the China National Intellectual Property Administration has decided to amend the Guidelines for Patent Examination, which are hereby issued and shall come into force on January 15, 2021. | | 为全面贯彻习近平总书记关于加强知识产权保护的重要指示精神，深化落实“放管服”改革决策部署，积极回应经济科技快速发展对审查规则的诉求，提高专利审查质量和审查效率，国家知识产权局决定对《专利审查指南》作出修改，现予发布，自2021年1月15日起施行。 |
| | 特此公告。 |
| China National Intellectual Property Administration | | 国家知识产权局 |
| December 11, 2020 | | 2020年12月11日 |
| Decision of the China National Intellectual Property Administration for Amending the Guidelines for Patent Examination | | 国家知识产权局关于修改《专利审查指南》的决定 |
| The China National Intellectual Property Administration has decided to make the following amendments to the Guidelines for Patent Examination: | | 国家知识产权局决定对《专利审查指南》作如下修改： |
| I. Amendment to Section 3.5, Chapter X of Part II | | 一、第二部分第十章第3.5节的修改 |
| Section 3.5, Chapter X of Part II of the Guidelines for Patent Examination is amended to read: | | 将《专利审查指南》第二部分第十章第3.5节修改为： |
| 3.5 Supplementary experimental data | | 3.5关于补交的实验数据 |
| 3.5.1 Examination principles | | 3.5.1 审查原则 |
| Whether or not the description is sufficiently disclosed is judged based on the content recorded in the initial description and claims. | | 判断说明书是否充分公开，以原说明书和权利要求书记载的内容为准。 |
| An examiner shall examine the experimental data supplemented by an applicant after the filing date for satisfying the requirements of paragraph 3 of Article 22, and paragraph 3 of Article 26 of the Patent Law. The technical effects proved by the supplementary experimental data shall be obtained by those skilled in the art from the patent application disclosed. | | 对于申请日之后申请人为满足专利法第二十二条第三款、第二十六条第三款等要求补交的实验数据，审查员应当予以审查。补交实验数据所证明的技术效果应当是所属技术领域的技术人员能够从专利申请公开的内容中得到的。 |
| 3.5.2 Supplementary experimental data for applications for drug patents | | 3.5.2 药品专利申请的补交实验数据 |
| Under the examination principles in Section 3.5.1 of this Chapter, examples of examination involving applications for drug patents are given. | | 按照本章第3.5.1节的审查原则，给出涉及药品专利申请的审查示例。 |
| [Example 1] | | 【例1】 |
| The protection claimed is compound A. The description has recorded the preparation examples of compound A, the blood pressure lowering effect and the experimental method for measuring the blood pressure lowering activity, but has not recorded the experimental result data. In order to prove that the description is fully disclosed, the applicant has supplemented 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 effects to be proved by the supplementary experimental data can be obtained from the patent application documents disclosed. It shall be noted that the supplementary experimental data shall also be examined in the examination of inventiveness. | | 权利要求请求保护化合物A，说明书记载了化合物A的制备实施例、降血压作用及测定降血压活性的实验方法，但未记载实验结果数据。为证明说明书充分公开，申请人补交了化合物A的降血压效果数据。对于所属技术领域的技术人员来说，根据原始申请文件的记载，化合物A的降血压作用已经公开，补交实验数据所要证明的技术效果能够从专利申请文件公开的内容中得到。应该注意的是，该补交实验数据在审查创造性时也应当予以审查。 |
| [Example 2] | | 【例2】 |
| The protection claimed is compound of general formula I. The description has recorded general formula I and its preparation method, the preparation examples of a number of specific compounds A and B, among others, in general formula I, as well as the anti-tumor effect of general formula I, and the experimental method and experimental result data for the measurement of anti-tumor activity. The experimental result data are recorded that the IC50 value of the compound of the example on tumor cells is in the range of 10-100 nM. In order to prove the inventiveness of the claims, the applicant supplemented the comparative experimental data, which showed that the IC50 value of compound A was 15nM, while the compound of comparative document 1 was 87nM. For those skilled in the art, according to the original application documents, the compound A and its anti-tumor effect has been disclosed, and the technical effects to be proved by the supplementary experimental data can be obtained from the patent application documents disclosed. It shall be noted that, at this time, the examiner needs to further analyze whether the technical solution requested by the claim satisfies with the requirements for inventiveness in consideration of the supplementary experimental data. | | 权利要求请求保护通式I化合物，说明书记载了通式I及其制备方法，通式I中多个具体化合物A、B等的制备实施例，也记载了通式I的抗肿瘤作用、测定抗肿瘤活性的实验方法和实验结果数据，实验结果数据记载为实施例化合物对肿瘤细胞IC50值在10-100nM范围内。为证明权利要求具备创造性，申请人补交了对比实验数据，显示化合物A的IC50值为15nM，而对比文件1化合物为87nM。对于所属技术领域的技术人员来说，根据原始申请文件的记载，化合物A及其抗肿瘤作用已经公开，补交实验数据所要证明的技术效果能够从专利申请文件公开的内容中得到。应该注意的是，此时，审查员还需要结合补交实验数据进一步分析权利要求请求保护的技术方案是否满足创造性的要求。 |
| II. Amendment to Section 4.2.3, Chapter X of Part II | | 二、第二部分第十章第4.2.3节的修改 |
| In the last paragraph of Section 4.2.3, Chapter X of Part II of the Guidelines for Patent Examination, “it shall be written as performance-limited or use-limited” is replaced with “usually it needs to be written as performance-limited or use-limited,” and “in certain fields, such as alloys, the inherent property and/or use of the invented alloy shall usually be stated.” Is amended to read “In certain fields, such as alloys, the inherent performance and/or use of the invented alloy shall usually be stated.” | | 将《专利审查指南》第二部分第十章第4.2.3节最后一段中的“则应写成性能限定型或者用途限定型”修改为“通常需要写成性能限定型或者用途限定型”，将“在某些领域中，例如合金，通常应当写明发明合金所固有的性质和/或用途。”修改为“在某些领域中，例如合金，通常应当写明发明合金所固有的性能和/或用途。” |
| The rest of this section is not amended. | | 本节其他内容无修改。 |
| III. Amendment to Section 5.1, Chapter X of Part II | | 三、第二部分第十章第5.1节的修改 |
| Item (1), Section 5.1., Chapter X of Part II of the Guidelines for Patent Examination is amended to read: | | 将《专利审查指南》第二部分第十章第5.1节中的第（1）项修改为： |
| (1) Where the protection extent claimed in an application or a patent is a compound, if the chemical name, molecular formula (or structural formula) and other structural information on the compound are recorded in a comparative document, those skilled in the art believe that the claimed compound has been disclosed, the compound is not novel, unless the applicant can provide evidence to prove that the compound cannot be obtained before the date of filing an application. | | （1）专利申请要求保护一种化合物的，如果在一份对比文件中记载了化合物的化学名称、分子式（或结构式）等结构信息，使所属技术领域的技术人员认为要求保护的化合物已经被公开，则该化合物不具备新颖性，但申请人能提供证据证明在申请日之前无法获得该化合物的除外。 |
| If the structural information recorded in a comparative document is insufficient to determine the structural similarities and differences between the claimed compound and the compound disclosed in the comparative document, but after making comprehensive consideration in consideration of other information recorded in the comparative document, including physical and chemical parameters, preparation methods and experimental data on effects, among others, those skilled in the art have reasons to assume that they are substantially the same, and the claimed compound is not novel, unless the applicant can provide evidence to prove that the structure is indeed different. | | 如果依据一份对比文件中记载的结构信息不足以认定要求保护的化合物与对比文件公开的化合物之间的结构异同，但在结合该对比文件记载的其他信息，包括物理化学参数、制备方法和效果实验数据等进行综合考量后，所属技术领域的技术人员有理由推定二者实质相同，则要求保护的化合物不具备新颖性，除非申请人能提供证据证明结构确有差异。 |
| The rest of this section is not amended. | | 本节其他内容无修改。 |
| IV. Amendment to Section 6.1, Chapter X of Part II | | 四、第二部分第十章第6.1节的修改 |
| Section 6.1, Chapter X of Part II of the Guidelines for Patent Examination is amended to read: | | 将《专利审查指南》第二部分第十章第6.1节修改为： |
| 6.1 Inventiveness of the compound | | 6.1化合物的创造性 |
| (1) To judge the inventiveness of a compound invention, it is necessary to determine the structural difference between the claimed compound and the compound closest to the prior art, and determine whether the prior art as a whole has offered technical enlightenment for solving the technical problem through this structural transformation on the basis of the technical problem actually solved by the invention based on the use and/or effect obtained by such structural modification. | | （1）判断化合物发明的创造性，需要确定要求保护的化合物与最接近现有技术化合物之间的结构差异，并基于进行这种结构改造所获得的用途和/或效果确定发明实际解决的技术问题，在此基础上，判断现有技术整体上是否给出了通过这种结构改造以解决所述技术问题的技术启示。 |
| ．．．．．． | | 需要注意的是，如果所属技术领域的技术人员在现有技术的基础上仅仅通过合乎逻辑的分析、推理或者有限的试验就可以进行这种结构改造以解决所述技术问题，得到要求保护的化合物，则认为现有技术存在技术启示。 |
| | ．．．．．． |
Dear visitor,you are attempting to view a subscription-based section of lawinfochina.com. If you are already a subscriber, please login to enjoy access to our databases . If you are not a subscriber, please subscribe . Should you have any questions, please contact us at:
+86 (10) 8268-9699 or +86 (10) 8266-8266 (ext. 153)
Mobile: +86 133-1157-0713
Fax: +86 (10) 8266-8268
database@chinalawinfo.com
| |
您好：您现在要进入的是北大法律英文网会员专区，如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户，请注册并交纳相应费用成为我们的英文会员 。如有问题请来电咨询；
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail: database@chinalawinfo.com
|
| | | |
| | | |