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Guiding Case No. 84: Eli Lilly and Company v. Changzhou Watson Pharmaceuticals Co., Ltd. (Case about dispute over infringement upon patent for invention)

Guiding Case No. 84: Eli Lilly and Company v. Changzhou Watson Pharmaceuticals Co., Ltd. 


(Issued on March 6, 2017 as deliberated and adopted by the Judicial Committee of the Supreme People's Court) (最高人民法院审判委员会讨论通过 2017年3月6日发布)

Keywords: civil; infringement upon patent for invention; patent for invention of drug preparation methods; scope of protection; technical investigator; identification of techniques for preparation of the alleged infringing drug 关键词 民事/侵害发明专利权/药品制备方法发明专利/保护范围/技术调查官/被诉侵权药品制备工艺查明
Key Points of Judgment 【裁判要点】
1. In dispute over infringement upon a patented drug preparation process, without any evidence to the contrary, it shall be presumed that the technique of the alleged infringing drug recorded with the drug supervision department is the preparation technique it actually uses; if there is any evidence proving that the recorded technique of the alleged infringing drug is inauthentic, such evidence as the technology source, production procedure, batch production records, and recordation document of the alleged infringing drug shall be fully examined and the actual preparation technique of the alleged infringing drug shall be determined according to the law. 1.药品制备方法专利侵权纠纷中,在无其他相反证据情形下,应当推定被诉侵权药品在药监部门的备案工艺为其实际制备工艺;有证据证明被诉侵权药品备案工艺不真实的,应当充分审查被诉侵权药品的技术来源、生产规程、批生产记录、备案文件等证据,依法确定被诉侵权药品的实际制备工艺。
2. For the technical fact that the preparation techniques for the alleged infringing drug are complicated, it may be ascertained by comprehensively using such approaches as technical investigators, expert assistants, judicial identification, and consultancy with science and technology experts. 2.对于被诉侵权药品制备工艺等复杂的技术事实,可以综合运用技术调查官、专家辅助人、司法鉴定以及科技专家咨询等多种途径进行查明。
Legal Provisions 【相关法条】
1. Paragraph 1 of Article 59, Article 61, and paragraph 1 of Article 68 of the Patent Law of the People's Republic of China (2008 Amendment) (Paragraph 1 of Article 56, paragraph 2 of Article 57, and paragraph 1 of Article 62 of the Patent Law of the People's Republic of China (2000 Amendment) are applied in this case) 1.《中华人民共和国专利法》(2008年修正)第59条第1款、第61条、第68条第1款(本案适用的是2000年修正的《中华人民共和国专利法》第56条第1款、第57条第2款、第62条第1款)
2. Articles 78 and 79 of the Civil Procedure Law of the People's Republic of China 2.《中华人民共和国民事诉讼法》第78条79条
Basic Facts 【基本案情】
On July 25, 2013, Eli Lilly and Company (hereinafter referred to “Eli Lilly”) filed a lawsuit with the Higher People's Court of Jiangsu Province (hereinafter referred to as the “HPC of Jiangsu”) and alleged that it owned the patent for invention of the process involved (No. 91103346.7) and the drug olanzapine prepared by using the patented process involved was a new product. Changzhou Watson Pharmaceuticals Co., Ltd. (hereinafter referred to as “Watson Company”) produced olanzapine by using a preparation process falling into the protection scope of the patent involved and sold it in the market, which infringed upon Eli Lilly's patent for invention of the process involved. Therefore, Eli Lilly filed this lawsuit and requested the HPC of Jiangsu to order that: (1) Watson Company should pay Eli Lilly CNY151,060,000 as compensation for its economic loss and CNY28,800 for the investigation and evidence-taking fees paid by Eli Lilly for stopping the infringement and other reasonable expenses paid by Eli Lilly; (2) Watson Company should publish a statement on its website and the Medicine Economic Reporter to eliminate the adverse impact of its infringing act on Eli Lilly; (3) Watson Company should bear the lawyer's fees of CNY1,500,000 incurred from this case and paid by Eli Lilly; and (4) Watson Company should assume all litigation fees of this case. 2013年7月25日,礼来公司(又称伊莱利利公司)向江苏省高级人民法院(以下简称江苏高院)诉称,礼来公司拥有涉案91103346.7号方法发明专利权,涉案专利方法制备的药物奥氮平为新产品。常州华生制药有限公司(以下简称华生公司)使用落入涉案专利权保护范围的制备方法生产药物奥氮平并面向市场销售,侵害了礼来公司的涉案方法发明专利权。为此,礼来公司提起本案诉讼,请求法院判令:1、华生公司赔偿礼来公司经济损失人民币151060000元、礼来公司为制止侵权所支付的调查取证费和其他合理开支人民币28800元;2、华生公司在其网站及《医药经济报》刊登声明,消除因其侵权行为给礼来公司造成的不良影响;3、华生公司承担礼来公司因本案发生的律师费人民币1500000元;4、华生公司承担本案的全部诉讼费用。
In the trial of first instance, the HPC of Jiangsu found that: 江苏高院一审查明:
The patent involved was a Chinese application for patent for invention of the “process for preparing a compound of thiophene benzodiazepine” (No. 91103346.7) filed by Lilly Industrial Company (U.K.) on April 24, 1991 and the date of announcement of the patent grant was February 19, 1995. On April 24, 2011, the patent involved was expired. On March 17, 1998, the patentee of the patent involved was changed to Eli Lilly Co., Ltd. (U.K.); and on February 28, 2002, the patentee was changed to Eli Lilly. 涉案专利为英国利利工业公司1991年4月24日申请的名称为“制备一种噻吩并苯二氮杂化合物的方法”的第91103346.7号中国发明专利申请,授权公告日为1995年2月19日。2011年4月24日涉案专利权期满终止。1998年3月17日,涉案专利的专利权人变更为英国伊莱利利有限公司;2002年2月28日专利权人变更为伊莱利利公司。
The claims in the announcement of granting of the patent involved were described as follows: 涉案专利授权公告的权利要求为:
1. A process for preparing 2-methyl-10-(4-methyl-1-piperazine)-4H-thiophene and [2, 3, -b] [1, 5] benzodiazepine, or salt on the basis of its acid. 1.一种制备2-甲基-10-(4-甲基-1-哌嗪基)-4H-噻吩并[2,3,-b][1,5]苯并二氮杂,或其酸加成盐的方法,
The methods described include: 所述方法包括:
(a) making N-methyl piperazine react with the compound in the following formula, (a)使N-甲基哌嗪与下式化合物反应,
Where Q is a perssad that may be abscisic, or 式中Q是一个可以脱落的基团,或
(b) making the compound in the following formula have a ring-closed reaction (b)使下式的化合物进行闭环反应
In July 2001, the Institute of Materia Medica, Chinese Academy of Medical Sciences (hereinafter referred to as the “Institute of Materia Medica”) and Watson Company applied for a new drug certificate for olanzapine and its tablets to the China Food and Drug Administration (hereinafter referred to as the “CFDA”). On May 9, 2003, the Institute of Materia Medica and Watson Company were granted new drug certificates for the bulk pharmaceutical chemical (BPC), olanzapine, and olanzapine tablets issued by the CFDA and Watson Company was granted the Approved Documents of Drug Registration for olanzapine and olanzapine tablets. As recorded in the application materials of the new drug, Study Materials and Literature Materials for Production Techniques of the BPC, the preparation techniques were as follows: A crude product was obtained after adding and mixing 4-amino-2-methyl-10-benzyl-thiophene benzodiazepine, hydrochloride, methyl piperazine, and dimethyl formamide and the yield coefficient was 94.5%; a crude product was obtained after adding and mixing 2-methyl-10-benzyl-(4-methyl-1-piperazinyl)-4H-thiophene benzodiazepine, glacial acetic acid, and hydrochloric acid, which were then neutralized with sodium hydroxide, and the yield coefficient was 73.2%; and the total yield coefficient was 39.1% after two times of refining. On the basis of analysis of the reaction formula, type-5 compound was generated in the reaction of type-4 compound and methyl piperazine and then type-1 compound was obtained upon debenzylation of type-5 compound. In August 2003, Watson Company promoted sales of a new antipsychotic drug, “Watson-Olanzapine” (5 mg) it produced to the No. 7 People's Hospital of Qingdao City. As recorded in the product publicity materials, the main ingredient of olanzapine tablets was olanzapine and its chemical name was 2-methyl-10-(4-methyl-1-piperazine)-4H-thiophene and benzodiazepine. 2001年7月,中国医学科学院药物研究所(简称医科院药物所)和华生公司向国家药品监督管理局(简称国家药监局)申请奥氮平及其片剂的新药证书。2003年5月9日,医科院药物所和华生公司获得国家药监局颁发的奥氮平原料药和奥氮平片《新药证书》,华生公司获得奥氮平和奥氮平片《药品注册批件》。新药申请资料中《原料药生产工艺的研究资料及文献资料》记载了制备工艺,即加入4-氨基-2-甲基-10-苄基-噻吩并苯并二氮杂,盐酸盐,甲基哌嗪及二甲基甲酰胺搅拌,得粗品,收率94.5%;加入2-甲基-10-苄基-(4-甲基-1-哌嗪基)-4H-噻吩并苯并二氮杂、冰醋酸、盐酸搅拌,然后用氢氧化钠中和后得粗品,收率73.2%;再经过两次精制,总收率为39.1%。从反应式分析,该过程就是以式四化合物与甲基哌嗪反应生成式五化合物,再对式五化合物脱苄基,得式一化合物。2003年8月,华生公司向青岛市第七人民医院推销其生产的“华生-奥氮平”5mg-新型抗精神病药,其产品宣传资料记载,奥氮平片主要成份为奥氮平,其化学名称为2-甲基-10-(4-甲基-1-哌嗪)-4H-噻吩并苯并二氮杂。
In the trial of another case, authorized by the HPC of Jiangsu, the Shanghai Scientific and Technological Consulting Service Center issued a Technical Identification Report (No. 19 [2010], Identification, Shanghai) on August 25, 2011. According to the Report, in the experimental operation by following the techniques as recorded in the “Study Materials and Literature Materials for the Production Techniques of the BPC” in the recordation of Watson Company, the BPC, olanzapine, failed to be obtained. The identification conclusion was that the key reaction steps for production of the BPC, olanzapine, as recorded in the recordation materials of Watson Company lacked authenticity and the recorded production techniques were infeasible. 在另案审理中,根据江苏高院的委托,2011年8月25日,上海市科技咨询服务中心出具(2010)鉴字第19号《技术鉴定报告书》。该鉴定报告称,按华生公司备案的“原料药生产工艺的研究资料及文献资料”中记载的工艺进行实验操作,不能获得原料药奥氮平。鉴定结论为:华生公司备案资料中记载的生产原料药奥氮平的关键反应步骤缺乏真实性,该备案的生产工艺不可行。
Upon cross-examination, Eli Lilly recognized the Report and Watson Company raised no objection to the Report; however, Watson Company insisted that olanzapine may be produced by taking the two-step method; since some content involved trade secret, it was not included in the recordation materials. Therefore, experts failed to produce olanzapine according to such recordation materials. 经质证,伊莱利利公司认可该鉴定报告,华生公司对该鉴定报告亦不持异议,但是其坚持认为采取两步法是可以生产出奥氮平的,只是因为有些内容涉及商业秘密没有写入备案资料中,故专家依据备案资料生产不出来。
Watson Company claimed that it did not infringe upon the patent involved on the grounds that: From 2003 up to now, Watson Company has been using the recorded technique for production of olanzapine that was supplemented in 2008. The recordation document was approved by the CFDA on September 8, 2010 and it was feasible. Under the circumstance where Eli Lilly failed to submit any evidence to prove Watson Company's production techniques, Watson Company's recorded techniques for production of olanzapine in 2008 should serve as the comparison techniques for identifying whether there was an infringement. 华生公司认为其未侵害涉案专利权,理由是:2003年至今,华生公司一直使用2008年补充报批的奥氮平备案生产工艺,该备案文件已于2010年9月8日获国家药监局批准,具备可行性。在礼来公司未提供任何证据证明华生公司的生产工艺的情况下,应以华生公司2008年奥氮平备案工艺作为认定侵权与否的比对工艺。
In the Supplementary Approved Document for Drug Application issued by the CFDA on September 8, 2010 that was submitted by Watson Company, it was indicated in the column of “Application Items” that “(1) Changing the production techniques affecting the drug quality; and (2) Modifying the standards for drug registration”; and it was indicated in the column of “Approval Conclusions” that “Upon examination, it is hereby approved to change the production techniques of the drug and modify the quality standards. Without changing the original synthetic routes, the changed production techniques only adjust the solvents and reagents in the preparation techniques. The attached quality standards shall be implemented, effective for 24 months.” 华生公司提交的2010年9月8日国家药监局《药品补充申请批件》中“申请内容”栏为:“(1)改变影响药品质量的生产工艺;(2)修改药品注册标准。”“审批结论”栏为:“经审查,同意本品变更生产工艺并修订质量标准。变更后的生产工艺在不改变原合成路线的基础上,仅对其制备工艺中所用溶剂和试剂进行调整。质量标准所附执行,有效期24个月。”
In the Supplementary Application and Registration Materials for the Drug Olanzapine attached to the aforesaid Supplementary Approved Document for Drug Application issued in 2010, it was specified in 5.1.1 of Chapter 5.1 Study Materials and Literature Materials for Production Techniques of the BPC that “According to the actual production of the BPC, olanzapine, without changing the production technique routes originally applied, the preparation techniques for olanzapine are partially adjusted and the techniques are optimized, making the quality of intermediates of olanzapine further increased and guaranteed, and the related impurities in the process of preparation are under effective control. ……Since there is no change in the technique routes and the crystal solvent in the final step, the structure and crystal form of the compound are not changed.” 上述2010年《药品补充申请批件》所附《奥氮平药品补充申请注册资料》中5.1原料药生产工艺的研究资料及文献资料章节中5.1.1说明内容为:“根据我公司奥氮平原料药的实际生产情况,在不改变原来申报生产工艺路线的基础上,对奥氮平的制备工艺过程做了部分调整变更,对工艺进行优化,使奥氮平各中间体的质量得到进一步的提高和保证,其制备过程中的相关杂质得到有效控制。……由于工艺路线没有变更,并且最后一步的结晶溶剂亦没有变更,故化合物的结构及晶型不会改变。”
In the trial of second instance by the Supreme People's Court, in order to correctly find the technical facts involved in the case, in accordance with the provisions of Article 79 of the Civil Procedure Law and Article 122 of the Interpretation of the Supreme People's Court on the Application of the Civil Procedure Law of the People's Republic of China (hereinafter referred to as the “Interpretation on the Civil Procedure Law”), Eli Lilly's application for its expert assistants' appearing in court should be permitted; in accordance with the provisions of Article 117 of the Interpretation on the Civil Procedure Law, Watson Company's application for its witnesses' appearing in court should be permitted; in accordance with the provisions of Article 78 of the Civil Procedure Law and Article 227 of the Interpretation on the Civil Procedure Law, the personnel of the Jiangsu Scientific and Technological Consulting Center issuing the Technical Identification Report (No. 02 [2014], Judicial Identification, Jiangsu) should be notified of appearing in court; and in accordance with the provisions of Articles 2 and 10 of the Interim Provisions of the Supreme People's Court on Several Issues concerning Intellectual Property Courts' Technical Investigators' Participation in Litigation Activities, the technical investigators were initially designated to appear in court and all parties should separately inquire expert assistants, witnesses, and identifiers about the relevant technical issues. 最高人民法院二审审理过程中,为准确查明本案所涉技术事实,根据民事诉讼法七十九条、《最高人民法院关于适用〈中华人民共和国民事诉讼法〉的解释》(以下简称《民事诉讼法解释》》)第一百二十二条之规定,对礼来公司的专家辅助人出庭申请予以准许;根据《民事诉讼法解释》一百一十七条之规定,对华生公司的证人出庭申请予以准许;根据民事诉讼法七十八条《民事诉讼法解释》二百二十七条之规定,通知出具(2014)司鉴定第02号《技术鉴定报告》的江苏省科技咨询中心工作人员出庭;根据《最高人民法院关于知识产权法院技术调查官参与诉讼活动若干问题的暂行规定》第二条、第十条之规定,首次指派技术调查官出庭,就相关技术问题与各方当事人分别询问了专家辅助人、证人及鉴定人。
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