制药企业产品跳转行为的法律规制——基于产品创新与产品垄断的视角
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摘要
根据产品跳转的时机、方式以及后果,制药企业产品跳转行为或属于产品创新,或表现为产品垄断。我国与西方国家在规制制药企业产品跳转行为的路径上存在着优先顺序上的差异。在国家促进仿制药市场健康发展的背景下,我国规制制药企业产品跳转行为的合理路径应是优先适用专利法,严格遵守专利授予标准,并推进专利法与反垄断法、药品管理制度等法律规范的和谐共生。
According to the timing,method and consequence of product hopping, the product hopping behavior of the pharmaceutical enterprise either belongs to the product innovation or the product monopoly. There are different priorities between China and western countries in regulating pharmaceutical enterprises' product hopping.Under the background of promoting the sound development of China's generic drug industry, the reasonable way to regulate pharmaceutical enterprises' product hopping in China is to give priority to the patent law,strictlyapply the standard of patent grant and promote the harmonious symbiosis among patent law, anti-monopoly law, drug management system and other legal norms.
According to the timing,method and consequence of product hopping, the product hopping behavior of the pharmaceutical enterprise either belongs to the product innovation or the product monopoly. There are different priorities between China and western countries in regulating pharmaceutical enterprises' product hopping.Under the background of promoting the sound development of China's generic drug industry, the reasonable way to regulate pharmaceutical enterprises' product hopping in China is to give priority to the patent law,strictlyapply the standard of patent grant and promote the harmonious symbiosis among patent law, anti-monopoly law, drug management system and other legal norms.
引文
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[3]MICHAEL A C.Product hopping[J].Journal of Commercial Biotechnology, 2017,23(2):52-60.
[4]王艳,胡允银.制药行业产品跳跃:垄断还是创新[J].科技管理研究,2017(11):23-27.
[5]孙晋,钟原.美国药品行业“产品跳转”的反垄断规制:现状、争议及启示[J].学习与实践,2017(9):75-83.
[6]王晓晔,吴玉岭.与知识产权相关的限制竞争问题研究[M].北京:社会科学文献出版社,2010:542.
[7]杨继绳.知识必须通过法制渠道进入经济:二谈知识经济[N].经济参考报,1998-07-07(1).
[8]吕明瑜.知识产权垄断呼唤反垄断法制度创新:知识经济视角下的分析[J].中国法学,2009(4):16-33.
[9]黄龙.知识产权垄断及其法律规制[J].科技进步与对策,2001(1):147-148.
[10]王先林.我国反垄断法适用于知识产权领域的再思考[J].南京大学学报(哲学·人文科学·社会科学版),2013(1):34-43.
[11]张伟君.滥用知识产权在中国《反垄断法》中的含义:对欧盟在TRIPS理事会提出的质疑的回答[J].世界贸易组织动态与研究,2008(3):17-21.
[12]U.S.FOOD&DRUG ADMINISTRATION.Generic competition and drug prices[EB/OL].(2017-11-28)[2018-05-01].https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129385.htm.
[13]EUROPEAN COMMISSION.Pharmaceutical sector inquiry final report[EB/OL].(2009-07-08)[2018-05-01].http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.
[14]ROYALL M S, ASHLEY E J, JASON C M. Antitrust scrutiny of pharmaceutical product hopping[J].Fall,2013,28(1):71-77.
[15]NIKLAS F, SOREN B R. AstraZeneca:the first abuse case in the pharmaceutical sector[J].Competition Policy Newsletter,2005,103(3):54-56.
[16]WESTLAW. Walgreen Co.v. AstraZeneca pharmaceuticals[EB/OL].(2008-02-25)[2018-05-01].https://1.next.westlaw.com/.
[17]聚法案例网.吉联亚科学股份有限公司与国家知识产权局专利复审委员会其他二审行政判决书[EB/OL].(2016-03-01)[2018-05-01].https://www.jufaanli.com/.
[18]LEXOLOGY.European court of justice rejects Astrazeneca’s Losec appeal[EB/OL].(2018-04-14)[2018-05-01].https://www.lexology.com/library/detail.aspx?g=4707a6b5-abdf-446f-8750-612a9d3a96b6.
[19]WESTLAW. In re suboxone antitrust litigation[EB/OL].(2014-12-09)[2018-05-01].https://1.next.westlaw.com/.
[20]中国青年报.中国反垄断调查风暴再起[EB/OL].(2014-08-11)[2018-05-01].http://zqb.cyol.com/html/2014-08/11/nw.D110000zgqnb_20140811_1-10.htm.