| PATENT RE-EXAMINATION BOARD V. BEIJING WINSUNNY HARMONY SCIENCE & TECHNOLOGY CO., LTD. AND DAIICHI SANKYO CO., LTD. (Administrative dispute over invalidation of patent rights in an invention) | | 专利复审委员会与北京万生药业有限责任公司、第一三共株式会社发明专利权无效行政纠纷案 |
| —Nature of the Markush claim, its amendment in invalidation proceedings and how to assess the “inventive step” | | ——马库什权利要求的性质、在无效程序中的修改方式和创造性判断方法 |
| [Abstract] | | 【裁判要旨】 |
| The compound patented under what is known as a Markush claim should be understood as the patent of a general technical solution rather than a patent of a collection of compounds. A claimant may amend a Markush claim as long as the amendment does not introduce into a claim a new class of compounds, or a single compound, with new properties and effects. However, exceptions to that rule will be considered on a case-by-case basis. | | 以马库什方式撰写的化合物权利要求应当被理解为一种概括性的技术方案，而不是众多化合物的集合。允许对马库什权利要求进行修改的原则，应当是不能因为修改而产生具有新性能和作用的一类或单个化合物，但是同时也要充分考量个案因素。 |
| The assessment of the “inventive step” necessary in patenting a compound under a Markush claim should follow the usual method – that is, the “three-step method” stipulated in the Guidelines for Patent Examination published by the National Intellectual Property Administration, PRC (hereinafter “NIPA”). It is to be noted that “unexpected technical effect” is nothing more than a contributing factor in establishing the inventive step. In usual circumstances, it will not be appropriate to skip the three-step method and determine whether or not a patent application involves an inventive step based only on whether it has unexpected technical effect. | | 对于以马库什方式撰写的化合物权利要求的创造性的判断，应当遵循创造性判断的基本方法，即专利审查指南所规定的“三步法”。意料不到的技术效果是创造性判断的辅助因素，通常不宜跨过“三步法”，直接适用具有意料不到的技术效果来判断专利申请是否具有创造性。 |
| [Case No.] | | 【案号】 |
| (2016) Administrative Retrial No. 41, SPC | | 最高人民法院（2016）最高法行再41号 |
| [Cause of action:] | | 【案由】 |
| Administrative dispute over invalidation of patent rights in an invention | | 发明专利权无效行政纠纷 |
| [Collegial panel members:] | | 【合议庭成员】 |
| Qin Yuanming | Li Rong | Ma Xiurong | | 秦元明|李嵘|马秀荣 |
| [Keywords:] | | 【关键词】 |
| amendment, invalidation proceeding, inventive step (non-obviousness), Markush claim | | 无效程序，马库什权利要求，修改方式，创造性 |
| [Relevant legal provisions:] | | 【相关法条】 |
| Patent Law of the People's Republic of China, article 31(1) | | 《中华人民共和国专利法》第三十一条第一款 |
| Rules for the Implementation of the Patent Law of the People's Republic of China, article 34 | | 《中华人民共和国专利法实施细则》第三十四条 |
| [Basic facts:] | | 【基本案情】 |
| In the retrial of an administrative dispute over the invalidation of an invention patent under a “Markush claim” between the Patent Re-examination Board of the National Intellectual Property Administration, PRC (hereinafter the “Patent Re-examination Board”) and Beijing Winsunny Harmony Science & Technology Co., Ltd. (hereinafter “Winsunny”), with Daiichi Sankyo Company Ltd. (hereinafter “Daiichi Sankyo”) joined as a third party in the first-instance proceedings, Daiichi Sankyo was the holder of an invention patent No. 97126347.7 entitled “The preparation method of the pharmaceutical composition for the treatment or prevention of hypertension”. The patent claims were written in the form of a Markush claim. Winsunny asked the Patent Re-examination Board to invalidate the patent on the basis that it involved no inventive step. | | 在再审申请人国家知识产权局专利复审委员会（以下简称专利复审委员会）与被申请人北京万生药业有限责任公司（以下简称万生公司）、一审第三人第一三共株式会社发明专利权无效行政纠纷案（简称“马库什权利要求”专利无效行政纠纷案）中，第一三共株式会社系名称为“用于治疗或预防高血压症的药物组合物的制备方法”、专利号为97126347.7的发明专利（即涉案专利）的权利人。涉案专利权利要求以马库什方式撰写。万生公司以涉案专利不具备创造性等为由向专利复审委员会提出无效宣告请求。 |
| On August 30, 2010, Daiichi Sankyo made the following amendments to the claim: | | 2010年8月30日，第一三共株式会社对权利要求进行了修改，其中包括： |
| (a) it deleted “or ester” in the phrase “or its salt or ester which can be used for medicinal purposes” in Claim 1; | | 1.删除了权利要求l中“或其可作药用的盐或酯”中的“或酯”两字； |
| (b) it deleted “alkyl with 1 to 6 carbon atoms” under the definition of R4 in Claim 1; and | | 2.删除权利要求1中R4定义下的“具有1至6个碳原子的烷基”； |
| (c) it deleted the other technical schemes except carboxyl and Formula COOR5a under the definition of R5 in Claim 1. | | 3.删除了权利要求l中R5定义下除羧基和式COOR5a外的其他技术方案。 |
| During the oral proceedings, the Patent Re-examination Board informed Daiichi Sankyo that the deletion of “or ester” in Claim 1 was approved, but that the other deletions were unacceptable since they did not conform to the relevant provisions under article 68 of the Rules for the Implementation of the Patent Law of the People's Republic of China. Daiichi Sankyo and Winsunny did not object to this. | | 专利复审委员会在口头审理过程中告知第一三共株式会社，对于删除权利要求l中“或酯”的修改予以认可，但其余修改不符合《中华人民共和国专利法实施细则》第六十八条的相关规定，该修改文本不予接受。第一三共株式会社和万生公司对此无异议。 |
On January 14, 2011, Daiichi Sankyo submitted a revised claim for replacement in which “or ester” in Claim 1 was deleted. The Patent Re- examination Board issued Examination Decision No. 16266 on the Request for Invalidation (hereinafter “Decision No. 16266”), in which it decided that Claim 1 of the patent involved in the case was non-obvious as compared to that in Evidence #1, had an inventive step and conformed to article 22(3) of the Patent Law of the People's Republic of China. Thus, on the basis of the revised version submitted by Daiichi Sankyo on January 14, 2011, the Patent Re- examination Board held that the patent right involved remained valid.
．．．．．． | | 2011年1月14日，第一三共株式会社提交了修改后的权利要求书替换页，其中删除权利要求1中的“或酯”。专利复审委员会作出第16266号无效宣告请求审查决定（简称第16266号决定），认为涉案专利权利要求l相比于证据1是非显而易见的，具有创造性，符合《中华人民共和国专利法》第二十二条第三款的规定。遂在第一三共株式会社于2011年1月14日提交的修改文本的基础上，维持涉案专利权有效。
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