我国仿制药专利挑战制度研究

李健

doi:10.20060/j.cnki.ISSN1009-3222.2023.0045

我国仿制药专利挑战制度研究

doi: 10.20060/j.cnki.ISSN1009-3222.2023.0045

李健

南京大学法学院, 江苏南京 210093

详细信息

作者简介:
李健, 男, 博士研究生。E-mail: 2465416599@qq.com

中图分类号: D923.42
计量
- 文章访问数: 204
- HTML全文浏览量: 159
- PDF下载量: 10
- 被引次数: 0
出版历程
- 收稿日期: 2022-10-21
- 网络出版日期: 2023-02-01
- 发布日期: 2023-01-18

Research on the Patent Challenge System of Generic Drug in China

LI Jian

School of Law, Nanjing University, Nanjing 210093, China

摘要

摘要: 我国现行专利法律体系初创了仿制药专利挑战制度，成为仿制药企与原研药企专利纠纷早期解决制度的核心组成部分。我国的专利挑战制度包含无效宣告激励制度和行政、司法“双轨”救济机制等内容。该制度既体现创新激励与尊重人权相统一的设计理念，也具有矫正正义与优化效率的价值意蕴。但作为其组成部分的通知制度和滥诉赔偿制度存在缺乏督促机制、适用条件不明等问题，使得该制度仍存在较大运行风险。在未来相关法律修改上，建议完竣专利挑战通知制度，限缩滥诉赔偿中的“主观恶意”认定标准，以实现仿制药企、原研药企与社会公众的多元利益平衡。
- 原研药 /
- 仿制药 /
- 专利挑战 /
- 制度构造 /
- 价值整合
Abstract: China's current patent legal system has initiated the patent challenge system of generic drug, which has become the core component of the early resolution system of patent disputes between generic drug companies and original drug companies. China's patent challenge system includes the invalidation announcement incentive system and the administrative and judicial "dual track" relief mechanism. This system not only embodies the design concept of the unity of innovation incentive and respect for human rights, but also has the value implication of correcting justice and optimizing efficiency. However, as for the notification system and compensation system for indiscriminate litigation, there are some problems such as lack of supervision mechanism and unclear application conditions, which make the system remain greater operational risks. In terms of future amendments to relevant laws, it is suggested to complete the patent challenge notification system and limit the identification standard of "subjective malice" in indiscriminate litigation compensation, so as to achieve the balance of multiple interests among generic drug enterprises, original drug research enterprises and the public.
- original drug /
- generic drug /
- patent challenge /
- system construction /
- value integration

HTML全文

参考文献(41)

[1]	药品专利纠纷早期解决机制实施办法(试行)[EB/OL]. [2021-11-21]. http://www.gov.cn/zhengce/zhengceku/2021-07/04/content_5622330.htm.
[2]	药品专利纠纷早期解决机制行政裁决办法[EB/OL]. [2021-11-23]. http://www.gov.cn/zhengce/zhengceku/2021-07/06/content_5622669.htm.
[3]	最高人民法院关于审理申请注册的药品相关的专利权纠纷民事案件适用法律若干问题的规定[EB/OL]. [2021-11-23]. http://www.court.gov.cn/fabu-xiangqing-311791.html.
[4]	BURK DL, LEMLEY MA. Policy levers in patent law[J]. Vi Law Rev, 2003, 89(7): 1575-1696.
[5]	《药品专利纠纷早期解决机制实施办法(试行)》政策解读[EB/OL]. [2021-11-22]. http://www.gov.cn/zhengce/zhengceku/2021-07/04/content_5622330.htm.
[6]	俞风雷. 知识产权保护中的利益平衡理论及其制度构建——以我国药品专利链接制度为例[J]. 求索, 2019(6): 82-87. https://www.cnki.com.cn/Article/CJFDTOTAL-QSZZ201906010.htm
[7]	苏冬冬. 药品专利链接制度建构的中国方案: 理论、原则与路径[J]. 科技进步与对策, 2022, 39(6): 121-129. https://www.cnki.com.cn/Article/CJFDTOTAL-KJJB202206013.htm
[8]	崔国斌. 专利法: 原理与案例[M]. 2版. 北京: 北京大学出版社, 2016: 421.
[9]	MATTHEW AVERY. Continuing Abuse of the Hatch-Waxman Act by Pharmaceutical Patent Holders and the Failure of the 2003 Amendments[J]. Hastings Law Journal, 2008, 60(1): 171 -200.
[10]	RON A. BOUCHARD, MONIKA SAWICKA. The Mud and the Blood and the Beer: Canada's New Progressive Licensing Framework for Drug Approval[J]. McGill Journal of Law and Health, 2009, 3(1): 49-84.
[11]	YOO EK. Effects of Patent-Approval Linkage System and Response Strategies Thereto[J]. IP Policy, 2015(24): 12-19.
[12]	何隽. "我不是药神"——印度药品专利的司法原则及其社会语境[J]. 清华法学, 2020, 14(1): 158-171. https://www.cnki.com.cn/Article/CJFDTOTAL-QHFX202001010.htm
[13]	科学技术部社会发展科技司, 中国生物技术发展中心. 2017中国生命科学与生物技术发展报告[M]. 北京: 科学出版社, 2017: 207-208.
[14]	The Korean drug Approval-Patent Linkage System: A Comparison with the US Hatch-Waxman Act[EB/OL]. [2021-11-21]. https://www.lexology.com/library/detail.aspx?g=5619213a-4714-4307-8bfd-8e12955841e1.
[15]	ANAND BN, KHANNA T. Do firms learn to create value? The case of alliances[J]. Strat Mgmt J, 2000, 21(3): 295-315. doi: 10.1002/(SICI)1097-0266(200003)21:3<295::AID-SMJ91>3.0.CO;2-O
[16]	GRINDLEY PC, TEECE DJ. Managing intellectual capital: Licensing and cross-licensing in semiconductors and electronics[J]. Calif Manag Rev, 1997, 39(2): 8-41. doi: 10.2307/41165885
[17]	中华人民共和国专利法(2020年修正)[EB/OL]. [2021-11-24]. http://www.cnipa.gov.cn/art/2020/11/23/art_97_155167.html.
[18]	程永顺, 吴莉娟. 探索药品专利链接制度[M]. 北京: 知识产权出版社, 2019: 26-27.
[19]	Patented Medicines (Notice of Compliance) Regulations, SOR 93-133, 6(1)[EB/OL]. [2021-11-24]. https://laws-lois.justice.gc.ca/eng/regulations/sor-93-133/FullText.html.
[20]	任虎. 韩国专利法研究[M]. 上海: 华东理工大学出版社, 2018: 109-110.
[21]	胡骁. 民事确认之诉的利益及其类型化研究[J]. 学海, 2020(2): 146-152. https://www.cnki.com.cn/Article/CJFDTOTAL-XHAI202002021.htm
[22]	曹志勋. 论我国法上确认之诉的认定[J]. 法学, 2018(11): 45-60. https://www.cnki.com.cn/Article/CJFDTOTAL-FXZZ201811005.htm
[23]	E. 博登海默. 法理学——法律哲学与法律方法[M]. 邓正来, 译. 北京: 中国政法大学出版社, 2017: 5-8.
[24]	吴柯苇. 仿制药专利挑战机制解释学分析与进路选择[J]. 科技进步与对策, 2021, 38(1): 79-86. https://www.cnki.com.cn/Article/CJFDTOTAL-KJJB202101011.htm
[25]	张文显. 法理学[M]. 北京: 高等教育出版社, 2018: 316-319.
[26]	崔国斌. 知识产权法官造法批判[J]. 中国法学, 2006(1): 144-164. https://www.cnki.com.cn/Article/CJFDTOTAL-ZGFX200601014.htm
[27]	程永顺, 吴莉娟. 探索药品专利链接制度[M]. 北京: 知识产权出版社, 2019: 4.
[28]	国家知识产权局专利局专利审查协作江苏中心组织. 药品专利链接与专利延长[M]. 北京: 知识产权出版社, 2021: 18-19.
[29]	BENJAMIN P. LIU. Fighting Poison with Poison-The Chinese Experience with Pharmaceutical Patent Linkage[J]. John Marshall Review of Intellectual Property Law, 2012, 11(3): 624-672.
[30]	原始创新发力国产新药从跟跑到并跑[EB/OL]. [2021-11-28]. https://baijiahao.baidu.com/s?id=1637902404977181184&wfr=spider&for=pc.
[31]	约翰·罗尔斯. 正义论[M]. 何怀宏, 译. 北京: 中国社会科学出版社, 2009: 27.
[32]	刘春田. 知识产权法[M]. 北京: 高等教育出版社, 2015: 152.
[33]	蒋启蒙, 朱雪忠. 专利侵权诉讼中无效宣告倾向的影响因素研究[J]. 科学学研究, 2022, 40(7): 1224-1233. https://www.cnki.com.cn/Article/CJFDTOTAL-KXYJ202207008.htm
[34]	RONALD COASE. The Problem of Social Cost[J]. The Journal of Law & Economic, 1960, 15(3): 837-877. doi: 10.1086/674872
[35]	威廉·M. 兰德斯, 理查德·A. 波斯纳. 知识产权法的经济结构[M]. 金海军, 译. 北京: 北京大学出版社, 2005: 381.
[36]	V. 奥斯特罗姆. 制度分析与发展的反思——问题与抉择[M]. 王诚, 译. 北京: 商务印书馆, 1992: 12.
[37]	彭情宝. 论司法审查行政裁决的强度——基于商标行政裁决"循环诉讼"的分析[J]. 学术论坛, 2014, 37(9): 93-96. https://www.cnki.com.cn/Article/CJFDTOTAL-XSLT201409021.htm
[38]	梅扬. 行政裁决制度的性质定位与困局破解[J]. 华中科技大学学报(社会科学版), 2021, 35(5): 93-101. https://www.cnki.com.cn/Article/CJFDTOTAL-HZLS202105012.htm
[39]	北京知识产权法院受理首例"药品专利链接"诉讼案件[EB/OL]. [2022-07-28]. https://mp.weixin.qq.com/s/d9aTSaxL8dV5sXWGMIZUbA.
[40]	Prioritizing Public Health: The FDA's Role in the Generic Drug Marketplace. [EB/OL]. [2022-07-28]. https://user.quickapp.cn/?packageName=com.google.android.googlequicksearchbox.11217978504.h5.generated&path=&shareUrl=¶ms=.
[41]	梁志文. 药品专利链接制度的移植与创制[J]. 政治与法律, 2017(8): 104-114. https://www.cnki.com.cn/Article/CJFDTOTAL-ZHEN201708010.htm