Abstract：The patent linkage system was introduced into the China-US Economic and Trade Agreement signed in 2020.However,based on the observation of institutional transplantation in many countries,the article finds that this early dispute resolution mechanism,which can link generics’ marketing approval and branded drugs’ patent protection,has the effect of delaying the market entry of generics.Nevertheless,sufficient and timely generics competition can stabilize drug prices,ensure drug availability and produce huge consumer surplus.As a country that relies heavily on generics,China must be alert to the competitive risks in patent linkage.China should learn from other countries’ anti-monopoly system transplantation practice,and achieve a balance between drug competition and innovation policies by supervising drug patents registration,canceling the automatic suspension of generic drug approval,adding damage compensation clauses,and rigorously inspecting anti-competitive settlement agreements.
孙瑜晨. 专利链接制度的竞争风险及法律因应研究—基于美、加、欧、印、澳、韩经验的比较[J]. 中国科技论坛, 2021(9): 163-172.
Sun Yuchen. Research on the Competitive Risk of Patent Linkage System and Legal Response —Comparison Based on the Case Study of the USA and Other Countries. , 2021(9): 163-172.
[1]MARTIN J A,RANDALL R R,JOHN R T.Cases and materials on patent law[M].Saint Paul:West Academic Publishing,2009.
[2]ALEXANDER D,ERIK V.Can regenerative medicine save big pharma's business model from the patent cliff[J].Regenerative medicine,2010,5 (5):687.
[3]ASHUTOSH K.Patent or patient,link them properly:patent linkage and competition (a comparative study)[EB/OL]. (2012-01-02)[2020-03-10].https://works.bepress.com/ashutosh_kumar/1/.
[4]RON A B,RICHARD W H,ROBERT C,et al.Empirical analysis of drug approval-drug patenting linkage for high value pharmaceuticals[J].Northwestern journal of technology and intellectual property,2010,8 (2):174.
[5]RON A B.I'm still your baby:Canada's continuing support of U.S.linkage regulations for pharmaceuticals[J].Marquette intellectual property law review,2010,15 (1):104-105.
[6]KYUNG-BOK S,RUTH L,DEBORAH G,et al.Moderating the impact of patent linkage on access to medicines:lessons from variations in South Korea,Australia,Canada,and the United States[J].Globalization and health,2018,14 (1):101.
[7]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.
[8]EU-DGC.Pharmaceutical sector enquiry:final report[EB/OL]. (2009-07-08)[2020-04-11].https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.
[9]FTC.Generic drug entry prior to patent expiration:an FTC study[EB/OL]. (2002-07-01)[2020-09-05].https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-expiration-ftc-study/genericdrugstudy_0.pdf.
[10]邱福恩.美国药品专利链接制度实践情况及其启示[J].知识产权,2018 (12):87-93.
[11]HENRY G,CARLOS B,ANNA T,et al.Pharmaceutical patent challenges:company strategies and litigation outcomes[J].American journal of health economics,2017,3 (1):33-59.
[12]JOSHUA P D.Applying litigation economics to patent settlements:why reverse payments should be per se illegal[J].Rutgers law journal,2009,41 (1&2):255.
[13]ERNST R B,RICHARD M,ASHOKE B,et al.Authorized generic drugs,price competition,and consumers' welfare[J].Health affairs,2007,26 (3):790-799.
[14]FTC.Authorized generic drugs:short-term effects and long-term impact:a report of the Federal Trade Commission[EB/OL]. (2011-08)[2020-04-10].http://www.ftc.gov/opa/2011/08/genericdrugs.shtm.
[15]USTR.2017 special 301 report[EB/OL]. (2018-04-04)[2020-06-22].https://ustr.gov/sites/default/files/301/2017%20Special%20301%20Report%20FINAL.PDF.
[16]THOMAS A F,JOEL L. ‘Linkage’ pharmaceutical evergreening in Canada and Australia,Australia and New Zealand[J].Health policy,2007,4 (1):1-11.
[17]袁锋.我国移植和构建专利链接制度的正当性研究—对现行主流观点之质疑[J].科技与法律,2019 (6):1-12.
[18]DAVID A F,JOANNA T B.What the patent dance of the biosimilars act means for biosimilars[J].Journal of commercial biotechnology,2014,20 (4):31.
[19]BRYAN M,DARIA K.Contemporary issues in pharmaceutical patent law[M].London;New York:Routledge,2017.
[20]JOEL L.After compulsory licensing:coming issues in Canadian pharmaceutical policy and politics[J].Health policy,1997,40 (1):70-71.
[21]RON A B,DAN C,BENGT D,et al.Structure-function analysis of global pharmaceutical linkage regulations[J].Minnesota journal of law,science & technology,2011,12 (2):392-393.
[22]AIDAN H.The anti-competitive effects of brand-controlled ‘pseudo-generics’ in the Canadian pharmaceutical market[J].Canadian public policy,2003,29 (1):21-32.
[23]邰红,郭煜,韦嵥,等.各国专利链接制度比较研究以及在我国建立专利链接制度探讨[EB/OL]. (2020-04-08)[2020-09-20].https://www.kwm.com/zh/cn/knowledge/downloads/kwm-intellectual-property-protection-blue-book-202-00408.
[24]CATHERINE D.EU unlikely to follow US with “patent linkage”system,says expert[EB/OL]. (2017-07-11)[2020-04-12].https://www.out-law.com/en/articles/2017/july/eu-unlikely-to-follow-us-with-patent-linkage-system-says-expert/.
[25]KRISTOF R,JULIA P,ANDREW B,et al.Patent-related barriers to market entry for generic medicines in the European Union:a review of weaknesses in the current European patent system and their impact on market access of generic medicines[J].Journal of generic medicines,2008,5 (4):255-280.
[26]张浩然.竞争视野下中国药品专利链接制度的继受与调适[J].知识产权,2019 (4):50-70.
[27]SHAMNAD B.Drug patent linkage controversy:a middle path solution[EB/OL]. (2008-07-09)[2020-05-10].https://spicyip.com/2008/07/drug-patent-linkage-controversy-middle.html.
[28]SANDEEP K R.Patent linkage and data exclusivity:a look at some developments in India[J].Journal of generic medicines,2011,8 (3):140-149.
[29]ROBERT Z.USTR,a letter to Mark Vaile,Australian Minister for Trade[EB/OL]. (2004-11-17)[2020-05-05].https://ustr.gov/archive/assets/Trade_Agreements/Bilateral/Australia_FTA/Implementation/asset_upload_file393_6951.pdf.
[30]程永顺,吴莉娟.韩国药品专利链接制度评述[EB/OL]. (2020-08-27)[2020-10-07].http://www.zhichanli.com/article/9345.html.
[31]LARA J G.Stretching the limits of intellectual property rights:has the pharmaceutical industry gone too far[J].IDEA-journal of law and technology,2001,41 (2):233-236.
[32]JOEL L.Canada's patented medicine notice of compliance regulations:balancing the scales or tipping them[J].BMC health services research,2011,11 (1):64-69.
[33]SCOTT H,MARK A L.Earning exclusivity:generic drug incentives and the Hatch-Waxman act[J].Antitrust law journal,2011,77 (3):947.
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