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1、CoverInternationalIP Index 2023 Eleventh Edition2|2023 International IP I U.S.Chamber of Commerces Global Innovation Policy Center()is working around the world to champion intellectual property rights as vital to creating jobs,saving lives,advancing global economic growth,and generating breakthrough
2、 solutions to global challenges.The U.S.Chamber of Commerce is the worlds largest business federation representing the interests of more than 3 million businesses of all sizes,sectors,and regions,as well as state and local chambers and industry associations.This report was conducted by Pugatch Consi
3、lum,(www.pugatch-)a boutique consultancy that provides evidence-based research,analysis,and intelligence on the fastest growing sectors of the knowledge economy.Authors of this report are Meir Pugatch and David Torstensson.Professor Meir Pugatch,Managing Director and Founder|Prof.Pugatch is the Mana
4、ging Director of Pugatch Consilium a boutique consultancy that provides evidence-based research,analysis and intelligence on the fastest growing sectors of the knowledge economy.He is an IPKM Professor of Valorisation,Entrepreneurship and Management at the University of Maastricht in the Netherlands
5、;as well as a Professor at the School of Public Health,University of Haifa in Israel,in which he acts as the Chair of the Health Management Division since 2019.Prof.Pugatch specializes in innovation strategies,organizational entrepreneurship,intellectual property management,pharmacoeconomics,pricing
6、 and reimbursement,and the management of public health systems.He is the author and editor of an extensive number of publications and serves as a referee and editorial board member of numerous peer review journals.David Torstensson,Partner|Dr.Torstensson specializes in innovation,tax and intellectua
7、l property policy,with a particular focus on the health care,information and communication technology and content industries.He has wide experience in policy and economic analysis,as well as data sampling and creation of strategic operational and advocacy plans.He is the author of a number of academ
8、ic and commissioned reports and publications and is the co-author of all ten editions of the U.S.Chamber International IP Index.Copyright 2023 by the U.S.Chamber of Commerce.All rights reserved.No part of this work,covered by the copyrights herein,may be reproduced or copied in any form or by any me
9、ansgraphic,electronic,or mechanical,including photocopying,recording,taping,or information and retrieval systemswithout the permission of the Chamber.4|2023 International IP I Foreword.8Executive Summary.10Overview of the Eleventh Edition.32The Global IP Environment in 2022Major Developments,Overall
10、 Index Scores,and Category-by-Category Results.36The Future Is Calling(and Its Mobile!):How IP Rights Enable Innovation and the Development of Telecommunications Technology,5G,and International Technology Transfer.85Economy Overviews.107Appendix:Methodology,Sources,and Indicators Explained.xxTables
11、and FiguresTable 1:Eleventh Edition Index Economies by World Bank Region.33Table 2:Eleventh Edition Index Economies by World Bank Income Group.34Table 3:Change in Overall Score,Tenth Edition Versus Eleventh Edition.53Table 4:Economic Benefits of Improving IP Protection for Mobile and ICT Communicati
12、ons Infrastructure and Related Technologies,Strength of Correlation 20192022.92Table 5:World Bank Digital Adoption Index 2016 and Index Eleventh Edition Overall Scores.94Table 6:Economist Intelligence Unit(EIU)5G Readiness Guide and Index Eleventh Edition Overall Score.96Figure 1:Category 1:Patents,
13、Related Rights,and Limitations,%Available Score.55Figure 2:Category 2:Copyrights,Related Rights,and Limitations,%Available Score.61Figure 3:Category 3:Trademarks,Related Rights,and Limitations,%Available Score.65Figure 4:Category 4:Design Rights,Related Rights,and Limitations,%Available Score.68Figu
14、re 5:Category 5:Trade Secrets and the Protection of Confidential Information,%Available Score.71Figure 6:Category 6:Commercialization of IP Assets,%Available Score.75Figure 7:Category 7:Enforcement,%Available Score.78Figure 8:Category 8:Systemic Efficiency,%Available Score.81Figure 9:Category 9:Memb
15、ership and Ratification of International Treaties,%Available Score.83Figure 10:Mobile Cellular Subscriptions(per 100 People),19802021,World Bank,World Development Indicators.86Figure 11:Individuals Using the Internet(%of Population)19802020,World Bank,World Development Indicators.87Figure 12:Estimat
16、ed Positive Economic Impact of Deployment of 5G Standard to U.S.and European GDP,USD,20212025.89Figure 13:Estimated Number of Jobs Created and/or Transformed Through 5G Deployment,U.S.and Europe,20212025.90Figure 14:Overall Score,Indicators 26,27,28,and 29 Isolated.101Figure 15:Chinas Overall Score,
17、Indicators 26,27,28,and 29 Isolated,Seventh Edition Versus Eleventh Edition.103Figure 16:Charges for the Use of IP,Payments(Balance of Payments,Billion USD),Total Payments,2021 or Latest Available Year,50 Index Economies,World Bank,and Overall Score,Indicators 26,27,28,and 29 Isolated,Top Half Versu
18、s Lower Half.1066|2023 International IP I International IP Index 2023,Overall Scores,%Available ScoreVenezuelaRussiaAlgeriaPakistanKuwaitIndonesiaEcuadorEgyptNigeriaArgentinaSouth AfricaKenyaThailandIndiaUkraineVietnamGhanaBruneiPhilippinesBrazilHondurasSaudi ArabiaJordanUAEColombiaChilePeruTurkeyMa
19、laysiaDominican RepublicCosta RicaChinaMexicoMoroccoTaiwanNew ZealandPolandGreeceIsraelCanadaHungaryAustraliaItalySouth KoreaSingaporeSwitzerlandSpainIrelandThe NetherlandsJapanSwedenGermanyFranceUKU.S.95.4894.1493.1292.4692.1491.2690.7089.3686.4486.0084.9484.4483.9080.6876.9075.7272.7270.9270.7469.
20、2866.3162.2658.9857.8654.5654.2853.4451.0749.8249.7248.8446.0044.7042.3842.1642.0241.5841.0840.8840.7439.7438.6438.2837.3637.2837.0033.3432.8230.6830.4228.4227.4226.3625.0214.108|2023 International IP I property(IP)was critical to how nations,businesses,and individuals managed through and emerged fr
21、om the COVID pandemic.Through therapeutics,vaccines,and technology that helped us remain connected,protected,entertained,and informed,IP was pivotal to our ability to work together and for the global economy to recover.Despite these achievements,policies like the World Trade Organizations move to el
22、iminate IP protection for vaccines incentivize political scapegoating over investing in solutions.This threatens the global framework for IP protections and jeopardizes the future of innovation.Its important for decision-makers to remember the innovation and creativity ecosystem is not inevitable.Fr
23、om small startups to major corporations,innovators and creators of all stripes depend on a framework of laws that provides a pathway for investments in the exciting,cutting-edge products and services of tomorrow.The hope of a brighter future is only possible through the rule of law.The International
24、 IP Index(Index),created by the U.S.Chamber of Commerce,is a powerful tool for assessing the strength and effectiveness of IP frameworks established by policymakers worldwide.It provides invaluable data that can be used to not only support arguments,but to inspire real policy changes to drive innova
25、tion forward and shape a more promising future.The 2023 Index highlights a crucial turning point in the global IP landscape.As multilateral organizations continue to debate the future of IP and some of the worlds major economiesincluding the United Statespropose unsettling policy changes,the decisio
26、ns to be made by policy makers will carry unprecedented weight.Policymakers have a choice:they can help spur innovation and creativity or stop it altogether.Those choices can help create jobs and growth or mix the cement of stagnation.The Index illustrates that the choice is clear:we can harness IP
27、to help deliver the economy of tomorrow.But we must work together to do it.The Chamber is proud to stand alongside innovators and creators from around the globe urging decision makers to step up and take a leadership role to protect IP rights.The Index serves as a valuable tool to help guide them,wi
28、th everyone standing to benefit from the fruits of our shared labor.10|2023 International IP I Economy ScoresExecutive SummaryNow in the eleventh edition,the International IP Index benchmarks the IP framework in 55 global economies across 50 unique indicators.The Index creates a roadmap for economie
29、s seeking to strengthen the ecosystem for innovation and creativity through more effective IP standards.Geographic CoverageAlgeria Argentina Australia Brazil Brunei Canada Chile China Colombia Costa Rica Dominican Republic Ecuador Egypt France Germany GhanaGreece Honduras Hungary India Indonesia Ire
30、land Israel Italy Japan Jordan Kenya Kuwait Malaysia Mexico Morocco The Netherlands New ZealandNigeria Pakistan Peru Philippines PolandRussia Saudi Arabia Singapore South Africa South Korea Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates Ukraine United Kingdom United States Vene
31、zuela Vietnam12|2023 International IP I However,there was still modest progress to strengthen IP protection in some global markets,with scores improving in 18 economies,while nine took steps backwards.Morocco,Thailand,and Vietnam had the largest improvements in their overall score at 2.5%,2.5%,and 2
32、.02%respectively.Asia had the greatest improvement in the regional average score as a result of score improvements in Malaysia and Singapore,in addition to Thailand and Vietnam.Russias score dropped 21.62%as a result of a series of measures taken by Russia targeting international rightsholders.IP wa
33、s critical to the research&development of innovative vaccines,therapeutics,and diagnostics that underpinned the global response to COVID-19.IP rights facilitated 143 licensing agreements in 31 different countries for COVID-19 therapeutics alone,in turn ensuring that global supply well exceeds demand
34、.Yet,ongoing negotiations within the World Trade Organization(WTO)and World Health Organization(WHO)to waive IP rights will undermine the innovation ecosystem that was pivotal to combatting COVID-19 and threaten the ability to respond effectively to the next major global public health threat.Followi
35、ng the 2021 Executive Order on Promoting Competition in the American Economy and the passage of the Inflation Reduction Act,policymakers in the United States are considering changes to the patent framework to address concerns with drug prices that will undermine the U.S.life sciences ecosystem and t
36、he many U.S.jobs supported by IP-driven innovation.Likewise,policy proposals under consideration in the European Union that condition IP protection,reduce the term of regulatory data protection,and undermine investment in rare disease treatments will jeopardize the EUs long-standing leadership on IP
37、-driven innovation.While the deployment of 5G has already contributed over$100 billion to U.S.GDP,studies estimate that the 5G standard will contribute$1.5 trillion to U.S.GDP and create or transform 16 million U.S.jobs by 2025.The continued deployment of 5G and other information and communications
38、technologies(ICT)is dependent upon economies creating an enabling environment through strong IP standards.The Index illustrates how economies with the most effective IP frameworks are more likely to have increased availability of ICT technologies,a stronger digital environment,and greater ability to
39、 deploy 5G.However,economies that utilize localization policies,onerous licensing requirements,and forced technology transfer will stymie the development of new ICT and mobile technologies,including 5G.In Latin America,Perus national IP Office(INDECOPI)and Brazils“Operation 404 against piracy”disabl
40、ed access to hundreds of websites hosting pirated content.In Canada,the Federal Court issued a dynamic injunction order requiring Canadian ISPs to disable access to illegal live streaming of National Hockey League matches online.In the United States,a U.S.District Court issued injunctions ordering U
41、.S.ISPs to disable access to copyright-infringing content online.However,the U.S.still lacks a comprehensive,modern statutory framework to combat online commercial piracy.Key Findings28Twenty-eight economies scores remained unchanged,illustrating that progress to improve global IP protection may be
42、stagnating.Economies are threatening to weaken the framework for IP-driven innovation through discussions at the multilateral organizations and in capitals.Mobile technologies like 5G,which helped consumers remain connected during the global pandemic,also generate a significant,positive economic imp
43、act.Building upon the positive momentum on copyright enforcement in the tenth edition of the Index,many economies continued to take steps to address copyright-infringing content online in 2022.*The Chambers Patient Access Report will examine the specific impact price controls and market access barri
44、ers have access to innovation in the U.S.and foreign markets.The report will be released in March 2023.14|2023 International IP I economies achieve a score of 70%or more and 30 economies achieve a score of 50%or more in the patent indicators.The average score on the category is 59.31%,which is the f
45、ifth highest scoring category on the Index.While Brazils Supreme court declared that a 10-year term of patent exclusivity was unconstitutional in 2021,in a positive development in 2022,a member of the Brazilian Chamber of Deputies introduced draft legislation to provide a period of patent term resto
46、ration.Chinas Supreme Court issued the first judgement related to its early resolution mechanism,which provided clarification on the mechanics of the notification process and the responsibilities of follow-on applicants.In Malaysia,amendments to the Patent Act created a defined pathway for post-gran
47、t opposition proceedings.Category-by-CategoryPatents,Related Rights,and Limitations0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%8.3316.6722.2222.2227.7830.2230.3932.2233.1733.1733.3333.3333.3333.3336.1136.1136.1138.8943.7244.4447.2247.2247.2247.2249.8350.0050.0050.0061.1163.3363
48、.6163.8970.8371.7875.0075.0078.3380.5680.8383.3383.3388.8991.6791.6791.6791.6791.6791.6791.6791.6794.4494.4494.4494.4497.22VenezuelaRussiaAlgeriaSouth AfricaParkistanThailandBrazilArgentinaEcuadorIndiaIndonesiaKuwaitNigeriaVietnamEgyptHondurasUkraineGhanaChileTurkeyMalaysiaPeruPhilippinesUAEMexicoCo
49、lombiaKenyaSaudi ArabiaBruneiDominican RepublicCosta RicaJordanMoroccoNew ZealandHungaryPolandCanadaGreeceChinaAustraliaIsraelItalyFranceGermanyIrelandThe NetherlandsSpainSwedenTaiwanUKU.S.SwitzerlandSouth KoreaJapanSingaporeCategory 1:Patents,Related Rights,and Limitations,%Available Score16|2023 I
50、nternational IP I economies achieve a score of 50%or more on the copyright indicators.The average score on the category is 49.70%.In Brazil,the National Telecommunications Agency and the national Film Agency signed a cooperation agreement to create a new administrative injunctive relief mechanism ta
51、rgeting online piracy.Thailand enacted a new Copyright Act that creates a notice-and-takedown system,defines liability for service providers,and creates additional remedies for the circumvention of technological protection measures(TPMs).Vietnam amended the Copyright Law to promote cooperative actio
52、n against online piracy and provide intermediaries with defined responsibilities related to copyright infringement.Category-by-CategoryCopyrights,Related Rights,and Limitations0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%0.0018.2919.7121.2921.8621.8623.2923.2924.8625.4326.1426.8
53、627.7130.4332.5732.5733.4335.5735.9036.1436.1438.8639.1039.5739.6639.7139.7142.6743.2943.2945.1446.2948.2949.8653.4354.1460.5362.5764.7164.8666.1470.1471.8076.8680.4381.9584.0085.5785.5790.7191.1492.7194.7196.2996.43U.S.SingaporeUKFranceGermanySwedenSouth KoreaThe NetherlandsAustraliaJapanIrelandSpa
54、inNew ZealandItalyIsraelCanadaMalaysiaHungaryGreeceMexicoMoroccoCosta RicaSwitzerlandPeruPolandKenyaChinaGhanaThailandSaudi ArabiaKuwaitIndonesiaDominican RepublicIndiaTaiwanSouth AfricaHondurasTurkeyColombiaUAEPhilippinesChileJordanBrazilUkraineVietnamEcuadorVenezuelaArgentinaBruneiAlgeriaNigeriaEg
55、yptPakistanRussiaCategory 2:Copyrights,Related Rights,and Limitations,%Available Score18|2023 International IP I ten of the 55 sampled economies fail to score 50%or more on this category.Overall,the average score on this category was 62.39%.The Saudi Authority for Intellectual Property(SAIP)continue
56、d to improve its enforcement efforts by disabling access to over 3,000 websites hosting infringing content and conducted over 5,000 physical in-person visits to investigate the sale of IP-infringing goods.In France,a 22-month special operation conducted against the online sale of counterfeit toys an
57、d childrens articles resulted in the seizure or take down of over 16 million counterfeit goods.In Thailand,the Memorandum of Understanding(MOU)between rightsholders,online retailers,and the Thai Government has resulted in increased enforcement efforts against counterfeit goods available online.Categ
58、ory-by-CategoryTrademarks,Related Rights,and Limitations0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%0.0037.5037.5037.5043.7543.7543.7543.7543.7543.7550.0050.0050.0050.0050.0050.0050.0056.2556.2556.2556.2556.2556.2556.2556.2556.2556.2556.2562.5062.5062.5062.5062.5062.5062.5068.7
59、568.7568.7568.7575.0075.0075.0075.0081.2587.5087.5087.5087.5087.5087.5087.5093.7593.75100.00100.00U.S.UKSouth KoreaFranceSwitzerlandSwedenNew ZealandThe NetherlandsJapanIrelandGermanyAustraliaSpainSingaporeItalyChinaUAEIsraelHungaryCanadaTurkeyThailandTaiwanPhilippinesMexicoMalaysiaGhanaVietnamSouth
60、 AfricaSaudi ArabiaPolandIndiaGreeceDominican RepublicCosta RicaColombiaChileBrazilPeruNigeriaMoroccoKenyaHondurasBruneiArgentinaUkraineKuwaitJordanIndonesiaEgyptEcuadorVenezuelaPakistanAlgeriaRussiaCategory 3:Trademarks,Related Rights,and Limitations,%Available Score20|2023 International IP I econo
61、mies included in the Index have in place some form of statutory law defining design rights and a term of protection for registered design rights.The average score on this category this year was 63.77%.China and Morocco both became full contracting parties to the Hague Agreement.Brazils Senate and Ch
62、amber of Deputies also approved accession to the Hague Agreement,though the accession has not yet been formalized.Category-by-CategoryDesign Rights,Related Rights,and Limitations0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%0.0032.5032.5032.5037.5042.5042.5042.5042.5042.5042.5045
63、.0045.0045.0045.0045.0045.0045.0055.0055.0055.0055.0055.0055.0055.0055.0055.0057.5062.5062.5062.5065.0067.5067.5067.5075.0075.0075.0075.0080.0087.5087.5087.5087.5087.5087.5090.00100.00100.00100.00100.00100.00100.00100.00100.00UKSwitzerlandSwedenThe NetherlandsJapanIrelandGermanyFranceSouth KoreaTurk
64、eySpainItalyIsraelHungaryGreeceU.S.PolandMexicoMalaysiaBrazilTaiwanSingaporeNew ZealandUAEUkrainePakistanMoroccoCanadaVietnamKenyaIndiaHondurasGhanaDominican RepublicChileBruneiArgentinaThailandPeruIndonesiaEcuadorCosta RicaColombiaAustraliaPhilippinesNigeriaKuwaitJordanEgyptChinaSouth AfricaVenezue
65、laSaudi ArabiaAlgeriaRussiaCategory 4:Design Rights,Related Rights,and Limitations,%Available Score22|2023 International IP I 23 of the 55 economies included in the Index achieved a score of 50%or more on this category while 22 economies achieved a score of 33.33%or less.The average score on this ca
66、tegory is the weakest on the Index at 48.97%.While Vietnam passed amendments to its Law on Intellectual Property,the amendments did not resolve the lack of clarity on availability of regulatory data protection(RDP).The U.S.State Departments 2022 Investment Climate Statement stated that the Saudi Foo
67、d and Drug Authority and SAIP reaffirmed their support for the availability of RDP in the Kingdom.While the UAE published new Executive Regulations in 2022,the regulations did not clarify existing uncertainty around the availability of an eight-year RDP term.Category-by-CategoryTrade Secrets and the
68、 Protection of Confidential Information0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%BruneiNigeriaVenezuelaAlgeriaArgentinaEgyptIndiaIndonesiaKenyaKuwaitPakistanPhilippinesThailandGhanaPeruUkraineTurkeyRussiaBrazilChileEcuadorSouth AfricaCosta RicaDominican RepublicJordanMalaysia
69、MexicoMoroccoSaudi ArabiaVietnamIsraelChinaColombiaHondurasSingaporeUAEAustraliaHungaryTaiwanSouth KoreaGreeceNew ZealandPolandUKFranceIrelandCanadaItalyU.S.JapanGermanyThe NetherlandsSpainSwedenSwitzerland8.338.338.3316.6716.6716.6716.6716.6716.6716.6716.6716.6716.6725.0025.0025.0026.6728.3333.3333
70、.3333.3333.3341.6741.6741.6741.6741.6741.6741.6741.6743.3345.0050.0050.0058.3360.0066.6766.6766.6770.0075.0075.0075.0075.0083.3383.3385.0091.6791.6793.33100.00100.00100.00100.00100.00Category 5:Trade Secrets and the Protection of Confidential Information,%Available Score24|2023 International IP I ec
71、onomies fail to achieve a score of 50%or more,with a 13 scoring 33.33%or less on the category.The average score on this category was 58.62%.Chinas new Anti-Monopoly Law expands the governments basis for action against anti-competitive behavior and substantially increases fines and penalties includin
72、g with respect to IP rights.Following the WTO ruling on Turkeys discriminatory biopharmaceutical market access and localization policies,the Turkish government committed to implementing the panels recommendation in a matter consistent with their WTO obligations.New legislation in Thailand improved t
73、he technology transfer environment by providing IP-based incentives for the commercialization of academic and publicly funded research.Category-by-CategoryCommercialization of IP Assets0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%4.178.3312.5016.6720.8323.6726.3327.8329.1729.173
74、2.0032.0033.3334.6736.1738.8341.6743.0044.5045.8350.0052.8354.1754.1757.0058.3358.3361.1762.5065.3365.3366.6766.6769.5070.8372.1773.6779.1779.1783.3383.3386.1786.1786.1787.5087.5087.5087.5090.3391.6791.6791.6794.5095.8395.83IndonesiaEcuadorVenezuelaGhanaKenyaRussiaVietnamColombiaAlgeriaUkraineNigeri
75、aThailandKuwaitPakistanPhilippinesChinaIndiaBrazilPeruEgyptSaudi ArabiaSouth AfricaTurkeyUAESouth KoreaCosta RicaHondurasArgentinaJordanChileMalaysiaDominican RepublicMoroccoMexicoGreeceBruneiTaiwanPolandSwedenItalySpainCanadaJapanNew ZealandFranceHungaryIrelandThe NetherlandsGermanySingaporeSwitzer
76、landUKU.S.AustraliaIsraelCategory 6:Commercialization of IP Assets,%Available Score26|2023 International IP I majority of the sampled economies in the Index strugle on this category with only 23 Index economies achieving a score of 50%or more.Only 11 economies achieve a score of 75%or more.The avera
77、ge score on this category is 50.10%.In Malaysia,the government has taken action in 500 cases of physical sales of set-top boxes and disabled access to over 2,000 websites.A new law in Chile,which entered in to force in January 2022,introduced statutory damages for trademark infringement.In Indonesia
78、,the government increased inspections of shopping malls and created a program to certify legitimate physical and online places of commerce.Category-by-CategoryEnforcement0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%7.4216.5716.8618.4318.4319.2922.1424.0024.2924.8625.0025.1426.14
79、27.2928.4329.4331.5733.2934.4337.0038.8639.2140.7142.0042.9743.0043.8644.5746.7147.2947.8648.0050.2950.5753.7155.7156.7163.7168.8670.4372.0072.2973.2973.2976.2983.7183.8688.0088.1490.0091.8692.4393.8695.5796.00VenezuelaNigeriaEgyptIndonesiaUkrainePakistanKenyaGhanaArgentinaPhilippinesAlgeriaIndiaBru
80、neiVietnamRussiaJordanEcuadorKuwaitCosta RicaChinaHondurasTurkeyPeruSouth AfricaSaudi ArabiaMoroccoThailandUAEMalaysiaBrazilDominican RepublicTaiwanChileMexicoColombiaCanadaGreecePolandHungaryIsraelItalyAustraliaNew ZealandSingaporeSpainThe NetherlandsSwitzerlandSouth KoreaJapanIrelandGermanySwedenF
81、ranceUKU.S.Category 7:Enforcement,%Available Score28|2023 International IP I economies outperform their overall Index scores on this category,with countries such as Brazil,Colombia,India,and the Philippines achieving a score 70%or more.Overall,the average score on this category is one of the stronge
82、st on the Index,at 62.73%.Morocco launched new technical assistance programs for academic researchers,research institutes,and small and medium-sized enterprises(SMEs)on the commercialization of IP assets.The Korean Intellectual Property Office provides SMEs with educational and technology assistance
83、 programs that has resulted in an increase in patent applications by SMEs.The UKs new IP Counter-Infringement Strategy 2022-2027 seeks to strengthen the UKs already world-class enforcement environment by improving coordination of activities related to IP infringement.Category-by-CategorySystemic Eff
84、iciency0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%10.0010.0020.0020.0025.0025.0030.0035.0035.0035.0040.0040.0040.0045.0045.0050.0050.0050.0055.0055.0055.0055.0060.0060.0060.0060.0065.0065.0065.0065.0070.0070.0070.0070.0070.0075.0080.0080.0080.0080.0085.0085.0085.0090.0090.0090
85、.0090.0095.0095.0095.0095.0095.0095.0095.00100.00KuwaitVenezuelaBruneiUkraineAlgeriaGhanaJordanEgyptKenyaRussiaDominican RepublicHondurasNigeriaEcuadorUAESouth AfricaTurkeyVietnamArgentinaIndonesiaPakistanSaudi ArabiaChileCosta RicaIsraelMoroccoGreeceNew ZealandPeruThailandColombiaIndiaMalaysiaPhili
86、ppinesPolandCanadaAustraliaHungaryMexicoTaiwanChinaSingaporeSwitzerlandBrazilGermanyThe NetherlandsSpainFranceIrelandItalyJapanSwedenUKU.S.South KoreaCategory 8:Systemic Efficiency,%Available Score30|2023 International IP I economies achieve a high score on this category with 22 economies achieving
87、score of 75%or more and 14 economies achieving a score of over 96%.This category remains one of the stronger overall categories on the Index achieving an average score of 62.70%.Vietnam and Thailand both acceded to parts of the WIPO Internet Treaties in 2022.Morocco acceded to the Singapore Treaty a
88、nd is now a full member of each of the two trademark-related treaties included in the Index.Chile acceded to the Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks.Nigeria became a full contracting party to the Convention on Cybercrime with the treaty enteri
89、ng into force in November 2022.Category-by-CategoryMembership and Ratification of International Treaties0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%7.147.147.1414.2917.8621.4321.4328.5728.5728.5728.5728.5732.1432.1435.7135.7142.8642.8642.8642.8650.0057.1457.1457.1460.7160.7167.
90、8667.8667.8668.1871.4371.4371.4378.5778.5778.5785.7185.7189.2992.8692.8696.4396.4396.4396.43100.00100.00100.00100.00100.00100.00100.00100.00100.00100.00KuwaitPakistanVenezuelaSaudi ArabiaBrazilSouth AfricaThailandEcuadorIndiaIndonesiaMalaysiaUAEAlgeriaArgentinaHondurasNew ZealandBruneiEgyptKenyaPhil
91、ippinesJordanChileColombiaNigeriaChinaMexicoCosta RicaDominican RepublicIsraelTaiwanPeruRussiaVietnamGhanaSouth KoreaTurkeyAustraliaSingaporeGreeceIrelandMoroccoGermanyHungaryItalyPolandCanadaFranceJapanThe NetherlandsSpainSwedenSwitzerlandUKUkraineU.S.Category 9:Membership and Ratification of Inter
92、national Treaties,%Available S International IP IndexOverview of the Eleventh EditionNow in its eleventh edition,the U.S.Chamber of Commerces International IP Index continues to provide a critical industry perspective on the IP standards that influence both long-and short-term business and investmen
93、t decisions worldwide.The Index is a unique and continuously evolving instrument.Not only does it assess the state of the international IP environment,but it also provides a clear roadmap for any economy that wishes to be competitive in the 21st centurys knowledge-based global economy.Large or small
94、,developing or developed,economies from around the world can use the insights about their own national IP environments as well as those of their neighbors and international competitors to improve their own performance and better compete at the highest levels for global investment,talent,and growth.E
95、conomies IncludedThe Index today covers 55 economies.Together,these 55 economies represent both a geographical cross-section of the world and most of the global economic output,together contributing over 90%of global GDP.As Table 1 shows,the Index includes economies from all major regions of the wor
96、ld and is truly a global measure.1 Table 1:Eleventh Edition Index Economies by World Bank Region AsiaLatin America and the CaribbeanAfrica and Middle EastEurope and Central AsiaNorth AmericaAustraliaArgentinaAlgeriaFranceCanadaBruneiBrazilEgyptGermanyU.S.ChinaChileGhanaGreece IndiaCosta RicaIsraelHu
97、ngary IndonesiaColombiaJordanIreland JapanDominican RepublicKenyaItaly MalaysiaEcuadorKuwaitThe Netherlands New ZealandHondurasMoroccoPoland PakistanMexicoNigeriaRussia PhilippinesPeruSaudi ArabiaSpain SingaporeVenezuelaSouth AfricaSweden South Korea UAESwitzerland Taiwan Turkey ThailandUKVietnam Uk
98、raine Source:World Bank(2022)In addition to geographic diversity,the Index includes economies from a broad spectrum of income groups as defined by the World Bank.Table 2 provides an overview of all 55 economies sampled according to income group as defined by the World Bank.34|2023 International IP I
99、 2:Eleventh Edition Index Economies by World Bank Income Group Lower-Middle-Income EconomiesUpper-Middle-Income EconomiesHigh-Income EconomiesHigh-Income OECD MembersAlgeriaArgentinaBruneiAustraliaEgyptBrazilKuwaitCanadaGhanaChinaSaudi Arabia ChileHondurasColombiaSingaporeFranceIndiaCosta RicaTaiwan
100、GermanyIndonesiaDominican RepublicUAEGreeceKenyaEcuadorHungaryMoroccoJordanIrelandNigeriaMalaysiaIsraelPakistanMexicoItalyPhilippinesPeruJapanUkraineRussiaThe NetherlandsVietnamSouth AfricaNew ZealandThailandPolandTurkeySouth KoreaVenezuela(2020)SpainSwedenSwitzerlandUKU.S.Source:World Bank(2022).Th
101、e World Bank has temporarily unclassified Venezuela pending the release of national accounts statistics.Consequently,the Index classifies Venezuela per its 2020 classification.Regional Rankings RegionAverage overall%Index ScoreNorth America85.60%Europe and Central Asia76.14%Asia56.42%Latin America43
102、.83%Africa and Middle East42.04%Africa and Middle EastOverall ScoreRegional RankingIsrael72.72%1Morocco62.26%2UAE46.00%3Jordan44.70%4Saudi Arabia42.38%5Ghana40.88%6Kenya37.36%7South Africa37.28%8Nigeria33.34%9Egypt32.82%10Kuwait28.42%11Algeria26.36%12AsiaOverall ScoreRegional RankingJapan91.26%1Sing
103、apore84.94%2South Korea84.44%3Australia80.68%4New Zealand69.28%5Taiwan66.31%6China57.86%7Malaysia53.44%8Philippines41.58%9Brunei41.08%10Vietnam40.74%11India38.64%12Thailand38.28%13Indonesia30.42%14Pakistan27.42%15Europe and Central AsiaOverall ScoreRegional RankingUK94.14%1France93.12%2Germany92.46%
104、3Sweden92.14%4The Netherlands90.70%5Ireland89.36%6Spain86.44%7Switzerland86.00%8Italy83.90%9Hungary76.90%10Greece70.92%11Poland70.74%12Turkey51.07%13Ukraine39.74%14Russia25.02%15 Latin AmericaOverall ScoreRegional RankingMexico58.98%1Costa Rica54.56%2Dominican Republic54.28%3Peru49.82%4Chile49.72%5C
105、olombia48.84%6Honduras42.16%7Brazil42.02%8Argentina37.00%9Ecuador30.68%10Venezuela14.10%11North AmericaOverall ScoreRegional RankingU.S.95.48%1Canada75.72% International IP IndexThe Global IP Environment in 2022Major Developments,Overall Index Scores and Category-by-Category ResultsInternational Dev
106、elopmentsAs noted last year,since the onset of the COVID-19 pandemic,the global IP rights architecture contributed to the rapid availability of lifesaving vaccines and therapies.Decades in development,the existing IP ecosystem stimulated investment in a host of other technological solutions that hav
107、e kept humans safe,connected,and productive to a degree unimaginable in previous pandemics.However,over the past two years,the global IP rights system has faced serious challenges from governmental and nongovernmental activists who misrepresent the role that IP rights and IP assets play in driving i
108、nnovation and supporting the economy and who also blame IP rights for unrelated access challenges.Instead of recognizing how decades of research and development facilitated a response to the pandemic,governmental and nongovernmental activists have used the pandemic to assert their longstanding views
109、 and strategies to weaken the protection of IP.The broader context:The COVID-19 pandemic and the global economyEven as COVID-19 continued to dominate world affairs in 2022,the global community has availed itself of new and better tools to mitigate the health and socioeconomic impact of the pandemic.
110、This has been most notable with respect to the development of new biopharmaceuticals,including vaccines,antiviral medicines,and other therapeutics.Global estimates from the Johns Hopkins Coronavirus Resource Center sugest that at the end of 2022,over 13 billion total doses of COVID-19 vaccines had b
111、een administered.2 In September,the IMF and WHO stopped updating the global“Vaccine Tracker”website.However,the latest available data archived in this website sugest that of the 196 economies included in the database,74%(145 economies)had secured enough vaccine doses to fully vaccinate 70%of their r
112、espective populations.3(The 70%figure is the baseline used by the IMF and WHO.At the time data were compiled in September 2022,many economies had achieved a far greater supply of vaccine and had exceeded the 70%figure.)As the global community moves forward in 2023,the COVID-19 pandemic will continue
113、 to have a profound impact on the worldwide economy and on how we interact and live as a globalized society.Individual economies will experience the pandemics health and economic impact differently,with varying levels of severity experienced depending on the individual socioeconomic circumstances of
114、 that economy.However,three years into this pandemic,the critical takeaway is clear:the global community today is in a far better position to manage the health and socioeconomic impact of the pandemic than it was at the beginning of this crisis.This is in large measure due to the extraordinary effor
115、ts of IP-intensive industries and,in particular,the research-based biopharmaceutical industry.38|2023 International IP I new paradigm for biopharmaceutical innovation and R&D:The research-based biopharmaceutical industry and the COVID-19 pandemicAt the time of this research,data published by the Pha
116、rmaceutical Research and Manufacturers of America(PhRMA)in 2022 showed that 2,142 active clinical trials were taking place globally to test treatments and potential vaccines for COVID-19.4 Data from the Biotechnology Innovation Organization housed in their“COVID-19 Therapeutic Development Tracker”sh
117、ow that 710 unique active compounds were in development.5 As of December 2022,four vaccines were authorized by the U.S.Food and Drug Administration(FDA)for emergency use or were fully approved.6 Inpatient and outpatient treatments and therapies are also available to COVID-19 patients today that were
118、 not on the market at the beginning of the outbreak or were originally intended for the treatment of other indications.It is impossible to overstate the enormity of these accomplishments.The speed at which this research has taken place is unprecedented.It shows the extensive scientific capacity deve
119、loped by the biopharmaceutical and biotech communities and their ability to understand and develop a treatment for a novel virus that was not present in human beings 36 months ago and to scale up manufacturing quickly and decisively.At a scientific,manufacturing,distribution,and organizational level
120、,what the industry together with its partners in academia and the public sector has been able to achieve is remarkable.As many politicians,policymakers,and scientists pointed out when the first vaccine was authorized for emergency use by the FDA,this achievement truly amounts to a modern-day miracle
121、.The scientific and technological capacity that has allowed industry,public research organizations,and academic researchers to achieve this technological miracle is based on decades of scientific study,R&D investment,and innovation predicated to a large degree on a system of strong,clear,and reliabl
122、e IP rights.Developing new medicines is a long-term,high-risk,resource-intensive process that includes a high rate of sunken costs such as laboratories,equipment,and researchers.As medicines have become more targeted,technically sophisticated,and effective,the cost of development has risen dramatica
123、lly.In 1979,the total cost of developing and approving a new drug stood at USD 138 million.Almost 25 years later,in 2003,this figure was estimated at USD 802 million.A 2012 estimate puts the total cost of drug development at approximately USD 1.5 billion.By 2016,research from Tufts University sugest
124、s it cost USD 2.6 billion,on average,to develop a new drug.7International experience and the basic economics of the biopharmaceutical industry show how critical IP rights are to enable this massive investment in the research and development of new medical technologies and products.Patents and other
125、forms of exclusivity for biopharmaceuticals,such as regulatory data protection(RDP)and special incentives for the protection and production of orphan and pediatric drugs,enable research-based companies to make otherwise unsustainable investments in R&D toward the discovery of new medicines,medical d
126、evices,and therapies.Although public sector funding of early-stage scientific research is critically important,the private sector,without any guarantee of a return on investment,funds and performs the lions share of the applied science that turns advances in knowledge into usable products that save
127、lives.For example,a 2021 report commissioned by PhRMA shows that,in 2018,the research-based biopharmaceutical industry invested USD 102 billion R&D.8 This compares to a total budget for the National Institutes of Health of USD 35.4 billion,of which only an estimated 8%was invested in research direct
128、ly related to drug development.Biopharmaceutical innovation is an extremely high-risk investment.On average,only one to two of every 10,000 synthesized,examined,and screened compounds in basic research will successfully pass through all stages of R&D and will go on to become a marketable medication.
129、IP rights provide a limited-term market exclusivity that gives firms sufficient time to recoup R&D investments.Generic competition from additional market entrants follows later,by design,precisely because these follow-on manufacturers bear none of the costs of early-stage investment,R&D,and product
130、commercialization carried by the innovator.The resulting system effectively allows generic manufacturers to benefit from the research and investment of the innovating company and offers the innovating company time to recoup its significant investment.The innovative,scientific,and technological progr
131、ess that has allowed the global community to function during the COVID-19 pandemic did not emerge overnight.Instead,these technologies and products are the fruit of a preexisting innovation ecosystem that relies on IP rights to enable allocation of resources,formation of partnerships,and transfer of
132、 technology on commercial terms.Without strong and clear IP rights,it is unlikely that any of the products and technologiesor the underlying sciencethat have been essential to keep societies functioning and fighting the COVID-19 pandemic would exist.As the Index and its accompanying Statistical Anne
133、x have sought to show over the past decade,the relationship among IP rights,innovation,and the commercialization of new products and technologies is clear and statistically significant.40|2023 International IP I a wrong turn:The World Trade Organization(WTO)TRIPS waiverAfter almost two years of disc
134、ussion,the WTO approved a waiver of patent rights under the Trade-Related Aspects of Intellectual Property Rights(TRIPS)Agreement at the Ministerial Conference in Geneva in June 2022.The final Ministerial Decision allows eligible WTO members“to limit the rights provided for under Article 28.1 of the
135、 TRIPS Agreementby authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder.”9 The waiver gives members extraordinarily broad latitude to override any relevant patent rights through“any instrument availa
136、ble in the law of the Member such as executive orders,emergency decrees,government use authorizations,and judicial or administrative orders.”Under Paragraph 6,the waiver will remain in effect for at least five years with the possibility of further extension depending on the“exceptional circumstances
137、 of the COVID-19 pandemic.”As the Index stated clearly and unequivocally when the idea for a waiver was first broached in 2020,waiving IP rights will undermine the existing framework that has been critical to the global response to the COVID-19 pandemic.Instead,the waiver will lead to highly negativ
138、e long-term policy and practical outcomes without meaningfully helping those population groups and economies in need of assistance.Indeed,the way the waiver proposal was framed from the outset and how it has now been executed bears this out.In October 2020,before a single vaccine was fully tested,re
139、viewed,and authorized as safe and effective by competent scientific and regulatory bodies,a group of WTO members led by India and South Africa put forth a proposal to waive the greater part of the international IP rights commitments that form the TRIPS Agreement.10 This first proposal would waive ne
140、arly the entirety of the TRIPS Agreement for an undefined period.Specifically,the proposal requested,“In these exceptional circumstances,we request that the Council for TRIPS recommends,as early as possible,to the General Council a waiver from the implementation,application,and enforcement of Sectio
141、ns 1,4,5,and 7 of Part II of the TRIPS Agreement in relation to prevention,containment or treatment of COVID-19.”These sections of TRIPS relate to the following IP rights:Section 1:Copyright and Related Rights;Section 4:Industrial Designs;Section 5:Patents;and Section 7:Protection of Undisclosed Inf
142、ormation.The only parts of the TRIPS agreement and IP rights that would be unaffected by this proposal were trademarks,geographical indications,and semiconductors(layout designs).When the initial waiver was agreed to in June 2022,the Ministerial Decision specified,“No later than six months from the
143、date of this Decision,Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.”In December 2022,the General Council agreed to extend the deadline for discussions,following six months of intense,but deadlocked,negotiations in Geneva.As the Inde
144、x and stakeholders pointed out over the past two years,the waivers proponents have offered no evidence that IP rights were or would become a barrier to an effective global response to the pandemic.They have merely asserted that virtually all IP rights were inconsistent with their vision of global eq
145、uity.It remains unclear to this day how the waiving of IP rights related to patents,copyright protection,industrial designs,and trade secrets would in any way,shape,or form have led to a more successful international response to the COVID-19 pandemic.Waiver proponents continue to assert that waiving
146、 IP rights will accelerate global production or will increase local capacity to manufacture vaccines,therapeutics,and diagnostics.However,in practice,a waiver of IP rights will impede ongoing and successful efforts to voluntarily license and scale global production of safe and effective therapeutics
147、 and diagnostics.Voluntary agreements have allowed innovative industry to share its technical expertise with local partners.These agreements,in turn,empower manufacturing partners with the tools to ensure the innovative treatments and medicines are safe and effective for global consumers.There are c
148、urrently 143 COVID-19 licensing agreements for therapeutics with manufacturers in 31 economies,all supported by the contractual licensing of IP rights,whether on commercial or not-for-profit terms.Moving forward with an expansion of the waiver will undermine existing voluntary licensing agreements,w
149、hich have been critical to rapidly meeting global demand.Transferring technical expertise is cultivated through sustained education,investment,and collaboration between innovative industry and local partners,which is made possible by the preexisting system of IP rights.Access to all medicinesnot jus
150、t COVID-19 vaccines and therapeuticsis a complex subject that does not lend itself to generalizing.Access involves many factors such as health system infrastructure,skilled human resources,health financing,logistics,transportation networks,proper storage and distribution,and a technical drug regulat
151、ory capacity.Within this context,the protection of IP plays a relatively small role.For example,most of the medicines viewed as essential(as compiled on essential drugs lists by WHO and numerous individual economies)are off patent and not subject to any form of exclusivity.Yet patients in many econo
152、miesnot just least developed economies but richer middle-income economies,toostrugle to access these products.Given these are generic,follow-on medicines,IP rights are not an influencing or limiting factor.With respect specifically to the COVID-19 vaccines,many economies lack the basic health infras
153、tructure and level of development to safely transport,store,and administer these vaccines.Underdeveloped health systems,a lack of trained health care professionals,and the lack of access to basic health services(including many essential medicines)mean that many economies face significant systemic ch
154、allenges in successfully vaccinating or treating their entire populations.These challenges have nothing to do with the protection of IP or availability of IP rights.The International Federation of Pharmaceutical Manufacturers&Associations has noted many of these challenges and how they relate to equ
155、itable access to COVID-19 therapeutics.11These include health system challenges related to financing and procurement,trade and supply chain,limited health care workforce,sanitary and drug regulations,and quality and safety assurance of the biopharmaceutical supply chain.42|2023 International IP I im
156、plementation of a national or regional vaccination campaign and the management of the pharmaceutical and medical supply chain shed light on nonIP-related barriers,which may impede timely access to medicines.The medical distribution and storage system in place in any given economy directly affects th
157、e quality and safety of a pharmaceutical product.Storing medicines at either too high or too low temperatures may have a detrimental impact on the active ingredient,or the excipient compounds used.It is therefore essential that the distributors and dispensers of medicines ensure that the quality of
158、a medicine is not adversely affected under transportation,storage,or actual dispensation.This is of particular importance in economies with a tropical climate where,unless proper storage and transportation conditions are maintained,a medicines active ingredient will degrade and potentially render it
159、 useless.Many lower-and middle-income economies do not have the physical capacity to store and distribute general vaccines let alone the highly sophisticated mRNA-based COVID-19 vaccines,which,initially,required ultracold storage to retain their efficacy.Vaccines in general must be stored at either
160、refrigerated temperatures(28 degrees centigrade)or,if frozen,between 50 and 15 degrees centigrade.For the Pfizer-BioNTech COVID-19 vaccine,storage and handling requirements were initially set at ultracold temperatures between 80 and 60 degrees centigrade.One of the most important positive developmen
161、ts over the past two years has been the collection of data and medical experience showing that it is safe to store the Pfizer-BioNTech vaccine at higher temperatures.The most recent guidance from the U.S.Centers for Disease Control and Prevention states that the Pfizer-BioNTech vaccine can safely be
162、 stored in a standard refrigerator for up to 10 weeks.12 Similarly,the mRNA vaccine developed and manufactured by Moderna can safely be stored in a standard refrigerator for up to 30 days.Unlike the waiving of IP rights under the TRIPS Agreement,this development has had a meaningful impact on the ab
163、ility of patients around the world to access the Pfizer-BioNTech vaccine.Overall,it is unclear what positive impact the WTOs Ministerial Decision and waiver of IP rights have had.Although the initial waiver was agreed to as part of an effort to support extraordinary measures amid a global health cri
164、sis,the waivers realization came long after its ostensible purpose was mooted by a large and growing surplus of COVID-19 vaccine supplies.At over 15 billion doses produced,the global manufacturing and supply of COVID-19 vaccines today vastly outpace global demand.The same is true of the supply of th
165、erapeutics.Of the 80 million courses of COVID-19 treatment purchased by governments in 2022,only 18 million doses have been administered so far.Indeed,in some cases,individual economies have rejected additional deliveries of COVID-19 vaccines.For example,in November 2021,press reports and public sta
166、tements by White House officials sugested that the government of South Africa declined additional donations of COVID-19 vaccines.13In fact,the IMF,WHO,and WTO have all suspended their respective monitoring of the global vaccine supply chain because there is no longer a need to monitor it.In May 2022
167、,the“WTO-IMF Vaccine Trade Tracker”was suspended with the website simply stating,“We have stopped collecting the information and will no longer provide updates to the WTO-IMF COVID-19 Vaccine Trade Tracker.”14 Similarly,as mentioned,the“IMF-WHO Vaccine Tracker”was suspended on September 8,2022.Furth
168、ermore,to date,no country has used the waiver.Paragraph 5 of the Ministerial Decision includes a requirement that members notify the TRIPS Council when making use of the waiver:“For purposes of transparency,as soon as possible after the adoption of the measure,an eligible Member shall communicate to
169、 the Council for TRIPS any measure related to the implementation of this Decision,including the granting of an authorization.”Yet,as of December 2022,the TRIPS Councils online database reveals no notifications regarding use of the waiver.Of the 34 notifications filed after the adoption of the Minist
170、erial Decision and retrievable through the WTO TRIPS Councils online databasethe“e-TRIPS Gateway”and categorized under“TRIPS Article 63.2,Patents(including plant variety protection),”none relate to the waiver.Similarly,of the five notifications related to the issuing of compulsory licenses for publi
171、c health purposes and listed under“TRIPS and Public Health”or the“Paragraph 6 system”search categories,all predate the Ministerial Decision.Although three of these notifications relate to the COVID-19 pandemic,they all predate June 2022 and the issuing of the waiver.Finally,no notifications relate t
172、o the waiver categorized under“Other Notifications”in the database;all 88 notifications in this search category predate the Ministerial Decision with the latest being from 2012.Although it is possible that WTO members are using the waiver facility without notifying the WTO,it seems unlikely that zer
173、o notifications would be recorded six months after the Ministerial Decision was issued.More likely,as the ample international supply of COVID-19 vaccines and therapeutics sugests,the lack of notifications simply reflects the reality that the waiver is not needed.As WTO members,international policyma
174、kers,and domestic legislators are well aware,the existing IP framework created the architecture for building global capacity for innovation and local production of the products of biopharmaceutical innovation.The ground floors of that architecture can be found in the WTO TRIPS Agreement,whereas many
175、 more critical elements are found in this Index.As the Index has documented over the past 11 years,to date,too many economies have resisted the IP standards established by TRIPS,which they have erroneously viewed as a cost rather than as an investment.Consequently,and as this Index has quantified fo
176、r over a decade,the TRIPS Agreement has never been fully or faithfully implemented by most WTO members.Yet,for economies that wish to be on the front lines for solutions in the next pandemic or other health emergencies,that very same IP architecture,where supported by a rule of law environment,provi
177、des all the tools necessary for full and effective participation in the innovation ecosystem,thus enabling allocation of scarce financial resources to risky innovative R&D,facilitating IP licensing for access to critical know-how,and fostering multidirectional technology transfer through contractual
178、 partnerships.Continuing negotiations in Geneva to expand the waiver to therapeutics and diagnostics will only serve to further undermine the framework for IP-driven innovation and diminish the worlds ability to respond effectively to future pandemics.44|2023 International IP I signals:The EU and IP
179、 rightsExhibit 1:The research-based biopharmaceutical industryAs the Index has noted over the past decade,at both the European Union(EU)level and among individual Member States,there is growing uncertainty over the biopharmaceutical IP environment.On the one hand,many European and national policymak
180、ers understand the industrys strategic value and importance as illustrated by the immense contributions and accomplishments in fighting the COVID-19 pandemic.For example,the European Commission recognized the importance of the research-based industry in the 2020 Pharmaceutical Strategy for Europe:“T
181、here is a strong and competitive pharmaceutical industry in the EU.Together with other public and private actors,it serves public health and acts as a driver of job creation,trade,and science.”15 The commission is right.As an industry,the research-based biopharmaceutical sector is one of Europes big
182、est success stories.European companies are some of the largest,most innovative,and most successful in the world.Not only does this industry have a long track record of producing lifesaving medical innovations that have been,or are currently being,used by millions of patients,but the industry is also
183、 an engine of economic growth in the EU.Figures from the European Federation of Pharmaceutical Industries and Associations(EFPIA)show that in 2021,the European research-based industry directly employed around 840,000 people(with over 120,000 in high-skill R&D jobs),invested EUR 41.5 billion in R&D a
184、ctivity,and generated EUR 300 billion in production value.16Unfortunately,the strategic value and economic contribution of this industry are not always recognized in the development of IP policies.To begin with,a high degree of uncertainty continues to surround the availability of patent term restor
185、ation in both the EU and the UK.In July 2019,the supplementary protection certificate(SPC)export and stockpiling waiver entered into force.The waiver allows companies to manufacture generic and biosimilar products in Europe during the effective SPC period for export purposes to third(non-EU)countrie
186、s and to stockpile during the last six months of the validity of the SPC for the domestic market.The SPC manufacturing waiver weakens the scope of the exclusive rights conferred by an SPC and sends a negative signal to the world that the EU is weakening its commitment to IP incentives and innovation
187、.Following the entry into force of the SPC waiver,the score on this indicator was reduced by 0.25 for all EU Member States in the eighth edition of the Index.Under the terms of its withdrawal from the EU,the UK has maintained the SPC exemption in British law.In 2020,the UK Intellectual Property Offi
188、ce(IPO)held a public consultation on a draft Statutory Instrument that would amend the existing exemption,making it more compatible with UK statute.Unfortunately,despite rightsholders calling for the UK government to reconsider its decision to retain the exemption,in its public response to the consu
189、ltation,the government reiterated its position that the SPC exemption would be retained and would be operable going forward.Outside of the EU and UK,the regulation continues to damage international rightsholders.Instead of allowing European generic manufacturers to gain a competitive advantage,other
190、 economies are simply emulating the EU.In a wide-ranging set of amendments to the Law on Protection of Rights to Inventions and Utility Models,in 2020,Ukraine introduced an export and stockpiling exemption explicitly modeled on EU Regulation 2019/933.Similarly,in 2021,the Israeli Ministry of Justice
191、 published draft amendments to the Patent Law,“The Patents Law(Amendment No.14)(Increasing the Competitiveness of the Israeli Economy),5721-2021.”The proposed amendments seek to introduce a manufacturing,export,and stockpiling exemption to the current term restoration regime.Like the Ukraine example
192、,this law refers to and is explicitly modeled on Regulation 2019/933.As the Ukraine and Israel examples show,instead of benefiting the European generics industry,the introduction of the SPC exemption is hurting Europes research-based industry and has led to a global race toward the bottom in weakeni
193、ng global IP standards.Unlike Regulation 2019/933 and the SPC exemption,proposals for a new centralized process for granting and administering SPCs would be a positive addition to the IP environment in the EU.As part of the Unitary Patent system and Patent Court,the European Commission issued a“Call
194、 for Evidence”consultation in 2022.This document outlines several options for reforming the SPC system,including the potential for introducing a new centralized system of SPC protection and application.At the time of research,no final legislative proposal had been adopted or proposed by the commissi
195、on.The Index will continue to follow these developments in 2023.In addition to the SPC system,since 2018,the European Commission has been conducting a regulatory review of the Orphan Regulation and the Paediatric Regulation,which provide special incentives for products developed for rare diseases an
196、d children.The regulation includes IP-based incentives and a defined period of market exclusivity.Orphan drugs are niche treatments for diseases with small patient populations and commercial markets.Since the 1980s,a series of financial and regulatory incentives in the United States(1983),Japan(1993
197、),and the EU(2000)have managed to bring about a sea change in R&D,clinical research,and the development of new products globally for rare diseases.For example,in the decade before the introduction of special incentives in the United States,only 10 products were approved for market,that is,only one d
198、rug per year on average.17 Since then,more than 575 drugs and biologic products have been developed and approved.A key driver of this success has been a clear and strong market exclusivity incentive.In the EU,the Orphan Regulation provides a 10-year term of marketing exclusivity(orphan status can be
199、 withdrawn after six years if designation criteria are no longer met,including if the drug is sufficiently profitable,and,in addition,exclusivity may be extended by two years if a pediatric investigation plan has been completed when requesting approval).On the back of these schemes,as well as key ph
200、armaco-genomics discoveries that fueled interest in the development of niche products,18 the number of orphan drugs developed and authorized for rare diseases has increased exponentially.Since its introduction in 2000,the EU Orphan Regulation had,as of 2017,resulted in the following:46|2023 Internat
201、ional IP I Nearly 2,000 orphan designations approved Over 150 orphan medicinal products approved by the European Medicines Agency(EMA)for over 90 rare diseases(up from only 8 orphan products available in 2000)An increase of 85%in the number of rare diseases for which an orphan designation exists in
202、the EU An increase of 88%in clinical research activity on rare diseases between 2006 and 2016,with the EU-5 countries experiencing an even biger increase of 104%during that period19In 2020,the commission published an Inception Impact Assessment with the view of proposing some legislative changes to
203、both the Orphan and Paediatric Regulations.At the time of research,no draft law had been published by the European Commission.Public statements made by commission officials sugest that a final legislative proposal would be presented to the public and European Parliament in the first quarter of 2023.
204、20 When reviewing how and what aspects of the EU Orphan Regulation proposes to change,it is critical that the commission recognize the outlined empirical evidence and positive impact the Orphan Regulation has had over the past two decades.The Orphan Regulation has done exactly what it was intended t
205、o doplace more orphan medicines on the EU market.The real challenge facing European policymakers,both regionally and nationally,is to ensure that patients gain effective access to these new medicines.Timely and equitable access to orphan medicines is not guaranteed in the EU,and substantial differen
206、ces exist among Members States with respect to both the number of products publicly reimbursed and the average time it takes for patients to gain access to them.This should not be news to the European Commission.In a 2006 assessment report,the commission cited a survey conducted by the European Orga
207、nisation for Rare Disease(EURORDIS),which found that for a sample of 12 orphan products approved by the end of 2003,only one Member State demonstrated the availability of the entire sample,whereas only half of the sample or less was available in the rest of the then-25 EU Member States.21 The report
208、 concluded the following:The full benefits of the EU orphan regulations require optimal synergies between action on Community and on Members State level.Incentives at the European Union level need to be translated into rapid access of patients to the new products throughout the entire Community and
209、they need to be supplemented by incentives at Member States level.In this regard,the past experience was not entirely satisfactory.22More recent evidence sugests that not much has changed since 2006.A 2017 study by the Office of Health Economics(a British research institute)compared access to 143 or
210、phan products that were approved for marketing in the EU between 2000 and 2016 across the then EU-5(including a division among England,Scotland,and Wales that constitute the UK).23 Overall,the study found the following:Access to authorized orphan products through public reimbursement varied substant
211、ially among the sampled Member States,ranging from 93%in Germany to 33%in Wales.The average duration between the granting of marketing authorization by the EMA and reimbursement decision by the national authority was 23.4 monthsnearly two years.24 The duration is also considerably longer for orphan
212、medicines when compared to nonorphan medicines.For example,in the UK,the median number of months between the marketing authorization and the first NICE appraisal was 20.2 months for orphan medicines compared with 12.7 months for nonorphan medicines.The bottom line is that the EU Orphan Regulation ha
213、s been remarkably successful in promoting research into rare diseases and incentivizing the development of orphan medicinal products.IP incentives in other economiessuch as the United Stateshave produced similar positive outcomes.However,the last stepproviding patients with rare diseases with actual
214、 access to these medicinesis currently the sole responsibility of Member States.As this cited evidence sugests,access to orphan medicinal products is hampered by insufficient reimbursement and long delays,thus resulting in unequal access to care for patients with rare diseases across the EU.Instead
215、of questioning or reviewing the efficacy of the IP incentives enshrined in the Orphan Regulation,the commission and EU policymakers should put more effort and forward thinking into how to address this access barrier more effectively.This line of thought can also be applied more broadly to access to
216、all new and innovative biopharmaceutical products and technologies.The European Commission rightly pointed out in the Pharmaceutical Strategy for Europe that“Innovative and promising therapies do not always reach the patient,so patients in the EU still have different levels of access to medicines.”H
217、owever,just as with access to orphan drugs,substantial differences exist among Member States with respect to both the number of products publicly reimbursed and the average time it takes for patients to gain effective access to them within a given health system.Again,within this context,IP rights pl
218、ay no part.The design of a given health systems biopharmaceutical market access policies takes place at the Member State level.Each Member State,through its broader health and biopharmaceutical policies,decides on market access policies and how to control the cost of medicines.Some EU Member States
219、and health systems seek to eliminate barriers to the introduction and use of new products and technologies.Others focus solely on cost containment and do not prioritize patient access to new products and innovation.Proposals for solving the access issue should recognize this fundamental fact that ex
220、isting IP incentives are not part of the problem.Since the release of the 2020 Pharmaceutical Strategy for Europe,the European Commission conducted consultations on the strategy,including impact assessments on the Orphan and Paediatric Regulations and general pharmaceutical legislation.Following the
221、 consultations,the commission released a draft Directive and Regulation that includes proposed changes to the EU Pharmaceutical Legislation.Some of the proposed amendments to the EUs pharmaceutical regulatory framework could further endanger the EUs leadership position on global IP policy and biopha
222、rmaceutical innovation.Among the more troubling provisions are proposals to condition RDP on external factors beyond companies control,such as requiring simultaneous launch of new products in every member state,despite disparate approval and pricing timelines.Specifically,the proposals sugest reduci
223、ng the baseline term of RDP by two years(from eight to six),with restoration of these lost years of protection contingent upon a number of factors.A year of data protection can be restored if the medicine is launched in all 27 Member States within two years of marketing authorization or if the medic
224、ine meets an unmet medical need(which is narrowly defined),respectively.48|2023 International IP I months of data protection can be added if a relevant and evidence-based comparator is used during the pivotal clinical trials,but the cumulative total of these protection periods is capped at 8 years.S
225、uch“conditionality”of IP or regulatory protection establishes a counterproductive precedent as it makes the availability of such protection contingent upon external factors,including market access.This approach fails to consider factors that determine market access within individual European countri
226、es outside the control of companies,including different national regulatory requirements and the varying speed of pricing and reimbursement negotiations.Furthermore,the proposals include provisions to expand the Bolar Exemption to include health technology assessment(HTA)and pricing and reimbursemen
227、t processes.Such an expansion of the Bolar exemption is out-of-step with other OECD economies and would be a significant shift beyond allowing generic or biosimilar manufacturers to use a patented product only as needed to demonstrate the bioequivalence or biosimilarity of their product to the innov
228、ator product to secure marketing authorization.The expansion of the Bolar exemption to include HTA and pricing and reimbursement processes could further undermine patent enforcement in the EU and triger automatic price adjustments for innovative products due to the premature launch of patent-infring
229、ing generics or biosimilars.It is imperative that any revisions to the European legislation not undermine patent enforcement in the EU and are consistent with international trade commitments,including the WTO TRIPS agreement.Any changes to the Bolar Exemption must respect the underlying rationale,wh
230、ich was to ensure that generic or biosimilar manufacturers were not unduly delayed from launching their products due to the need to demonstrate the safety and efficacy of their medicines.The exemption also sought to create a balanced mechanism that includes measures to ensure that innovators are not
231、 prejudiced by such delays by SPCs.The proposed expansion of the exemption,coupled with the existing SPC manufacturing waiver,could further undermine the framework for biopharmaceutical innovation in the EU.The European Commission will formally introduce the Pharmaceutical Legislation in the spring
232、of 2023.The Index will closely monitor the proposed strategy for its impact on the innovation ecosystem in the EU.Finally,at both the Member State level and EU level,there has been a growing focus on exploring compulsory licensing for biopharmaceuticals.In 2017,health authorities in the Netherlands
233、promised to explore the use of compulsory licensing for medicines whose price was deemed excessive,acting on the advice included in a report by the Council for Public Health and Society(Development of New MedicinesBetter,Faster and Cheaper),which encouraged the use of compulsory licensing to strengt
234、hen the governments position in price negotiations.In Hungary,the government introduced an expedited compulsory licensing mechanism for biopharmaceuticals in 2020.In a separate development,a Hungarian manufacturer later that year began producing a local version of the drug remdesivir for use in a lo
235、cal clinical trial.Registration data in the European Union Clinical Trials Register show the trial was supported by the Hungarian government(the Ministry of Innovation and Technology through a consortium).Industry sources sugest that a compulsory license was granted by the Hungarian authorities in l
236、ate 2020.In 2022,the European Commission issued a“Call for Evidence”and public consultation on the current compulsory licensing regime across the EU,although the rationale is difficult to understand.Each individual EU Member State has national laws in place that address compulsory licensing in line
237、with their WTO commitments.The commission posits in the“Call for Evidence”that there is a pressing need for“coordination and harmonization”at the EU level on compulsory licenses but provides no actual evidence that this is the case.The document simply asserts that the COVID-19 pandemic shows the nee
238、d for clearer and more“effective”compulsory licensing mechanisms:The COVID-19 pandemic has underscored the importance of having a strong and balanced IP system(to provide the necessary incentives to develop new treatments and vaccines)and a suitable framework(for sharing technologies,know-how and da
239、ta).It has also trigered many debates,at national,EU and multilateral level,on the need for effective IP tools to ensure proper and global access to essential technologies in a crisis.Close public-private cooperation based on voluntary solutions for sharing the relevant IP and know-how,e.g.,licensin
240、g or manufacturing agreements,is the fastest and most effective way to develop and scale up the production of critical medicine and medical supplies.However,if voluntary arrangements between right holders,third parties(such as manufacturers)and public authorities fail or are unavailable,the use of l
241、ast-resort tools,namely compulsory licensing,might be needed.A compulsory license issued by a government authorises a party other than the patent holder to use a patented invention without the consent of the patent holder.In particular during a crisis,these tools must be effective to make an orderly
242、 EU response possible.25But,if anything,the actual evidence and experience from the COVID-19 pandemic show the complete opposite.As detailed here,the much-discussed proposed TRIPS waiver and subsequent 2022 WTO Ministerial Decision have proven to be completely unnecessary and wholly pointless.The wa
243、iver seeks to address a problem of vaccine shortages that does not exist,and no WTO Member appears to be making use of it.Similarly,with respect to compulsory licenses,only one was issued during the pandemic to specifically address a perceived shortage of medicines,and the generic product was never
244、used.However,other licenses were issued on the basis of addressing the cost of a given treatment as opposed to its availability.The Israeli government authorized a compulsory license for the antiviral drug lopinavir/ritonavir in 2020.As noted in previous editions of the Index,when the license was is
245、sued,limited clinical evidence showed that lopinavir/ritonavir would be an effective treatment against COVID-19.After the issuing of the license and importation of generic product from India,no information is publicly available that sugests the generic product was ever distributed to Israeli patient
246、s with COVID-19.Much like the WTO TRIPS waiver,the European Commissions fascination with expanding involuntary mechanisms for sharing IP through a more“effective”compulsory licensing mechanism is not based on real-world data and need.More broadly,threats and the use of compulsory licensing of medici
247、nes as a basis for price negotiations are usually associated with low-income economies with underdeveloped health systems and limited financial resources,not high-income EU Member States with advanced sophisticated health systems.Issuing a compulsory license undermines the basic idea of the protecti
248、on and sanctity of property rights,including IP rights,in place to foster investment in biopharmaceutical innovation.Cost is not a relevant justification or basis for compulsory licensing or the overriding of any 50|2023 International IP I form of biopharmaceutical exclusivity.Moreover,the use of th
249、ese types of licenses threatens the very foundation of the EUs position as a global leader in innovation and high-tech industries,including biopharmaceuticals.As the cited data from EFPIA show,as an industry,the research-based biopharmaceutical sector is one of Europes bigest success stories and inc
250、ludes some of the largest,most innovative,and most successful research-based biopharmaceutical companies in the world.More broadly,the overriding of biopharmaceutical IP rights based on cost and price negotiations sets a wholly negative precedent that may be applied to other industries and sectors.I
251、f the EU or individual Member States wish to pay less,or nothing,for medicines using compulsory licenses,it is possible this could be applied next to the procurement of medical devices,software,trains,automobiles,or any other high-tech product that the public sector purchases.The Index will monitor
252、these developments in 2023.Exhibit 2:One step forward and two steps back?The EUs Digital Services Act Package and the digital economyOver the past two years,the European Commission has been working on a large legislative package regulating digital and internet-based commerce and the provision of rel
253、ated services.The package consists of two new pieces of legislation:the Digital Markets Act(DMA)and the Digital Services Act(DSA).At the time of this research,both acts had been approved by the European Parliament and the European Council.The laws will come into effect on a rolling basis during 2023
254、 and 2024.Both the DMA and DSA introduce substantive changes to the EUs internal market and how digital products and services are produced and traded.Like the General Data Protection Regulation(GDPR),the effect of both laws will stretch beyond the borders of the European Union.The DMA focuses primar
255、ily on regulating the activities of large online platforms and service providers,so-called digital gatekeepers.The law imposes significant compliance and reporting requirements on gatekeeper entities with most of the legislation being delegated to the entity level in the form of self-regulation.Rele
256、vant entitiesand future potential gatekeepersare expected to assess and monitor their own compliance under the law and to regularly report to the European Commission.The DMA gives the commission significant powers and the ability to,under Article 30,fine an entity found to be in noncompliance with t
257、he law of up to 10%of annual global turnover or as much as 20%in cases of repeat offenders.The DMAs focus on market size and power means that the legislation does not differentiate between the regulatory needs of different businesses and types of digital service providers.Instead,all identified digi
258、tal operators that match the relevant market power and size definitions under the law must comply with all provisions or risk potential fines and penalties.Like the DMA,the DSA fundamentally changes how the digital economy operates in the EU.It is also a sprawling piece of legislation granting vast
259、regulatory and monitoring powers to both the European Commission and national regulators.The law is full of definitions and categorizations of different providers of online“intermediary services,”including“caching,mere conduit,hosting,online platforms,very large online platforms,and very large onlin
260、e search engines.”Some of these categories are transplanted from preexisting definitions under the E-Commerce Directive,whereas others are new.Like the DMA,these categories impose various levels of compliance obligations and responsibilities.Generally,the larger the service provider,the more extensi
261、ve its responsibilities.However,as the regulations preamble itself acknowledges,these categories are fluid,and entities may,at different moments,be one or another or a combination of these categories with differing levels of accompanying compliance and reporting responsibilities:“Intermediary servic
262、es may be provided in isolation,as a part of another type of intermediary service,or simultaneously with other intermediary services.Whether a specific service constitutes a mere conduit,caching or hosting service depends solely on its technical functionalities,that might evolve in time,and should b
263、e assessed on a case-by-case basis.”Consequently,an entitys legal obligation and responsibilities may change rather significantly depending on what category of service provider the entity was at a given moment.From an IP rights perspective,one of the key features of the legislation is an updated def
264、inition of what an intermediary service providers responsibilities and liabilities are with regard to illegal and IP-infringing content.As noted over the course of the Index,historically,the EUs E-Commerce Directive combined with other relevant laws(such as the Copyright Directive 2001/29/EC)and the
265、ir national transposition have defined relevant safe harbors and under what circumstances intermediaries lose relevant protections across EU Member States.In principle,the concept of a safe harbor exemption was available to relevant intermediaries as long as they:1.did not actively participate in an
266、y infringing activity;and2.once made aware of the infringement,acted expeditiously to remove or disable access to the alleged infringement.Although the law is more than 20 years old,the rationale behind it remains sound:a desire to balance the need to effectively address potential illicit activity(i
267、ncluding the infringement of IP rights)without unduly overburdening intermediaries.However,the world in 2023 is very different from that of the early 2000s.Today,internet penetration and the use of mobile devices are almost ubiquitous across Europe and much of the developed world.For IP-intensive in
268、dustries,the shift from the physical to the digital has meant both a change in how IP infringement takes place and scale.Consequently,a growing proportion of IP infringement takes place online.Indeed,the explosion in copyright infringement over the past two decadeswhether through downloading,streami
269、ng,or some other technologyhas mirrored and followed the growth in internet and mobile connectivity.Similarly,the increasing popularity of online shopping has led to a marked growth in the sale of physical counterfeit goods through online marketplaces.The result is that rightsholders both in Europe
270、and globally face a reality where they have little practical recourse against the infringement of their rights.Unfortunately,the DSA does not take this new reality into account.Although the law includes some added responsibilities for intermediaries,particularly larger entities,and an important obli
271、gation of online marketplaces to enhance the“traceability of traders”using their platforms,the DSA does not fundamentally change the dynamics of IP enforcement online.It is also unclear how many of the new mechanisms introduced in the law will work in practice.For instance,although the law gives all
272、 individuals and entities the right under Article 14 to lodge notifications of illegal content to predefined categories of intermediaries,notifications filed by designated“trusted flagers”are to be“processed and decided upon with priority and without undue delay.”But given the sheer scale and volume
273、 of illegal and IP-infringing content on the internet,what will happen with notifications filed by non-trusted flagers?Will such notices be addressed in an expeditious fashion or deprioritized by intermediaries in favor of notices filed solely by trusted flagers?As currently drafted,that is a logica
274、l and not unlikely outcome.Furthermore,although the creation of the trusted flager concept may help standardize and professionalize the notification process,it may also prove to be largely ineffective and,in International IP Indexfact,act as a barrier to effective enforcement.The creation of what is
275、,in effect,an online enforcement gatekeeper adds a hurdle and layer of bureaucracy to an already elaborate enforcement process.There is also the question of the process of designating a trusted flager.Under Article 19 of the DSA,any entity can be designated as a trusted flager if it fulfills certain
276、 defined criteria.However,the authority for determining which entities qualify lies at the national level and the relevant regulatory authority in each EU Member State,a new body to be called a digital services coordinator.Because the DSA vests so much power and authority in the trusted flagers,the
277、practical result is that levels of online enforcement will indirectly depend on the effectiveness of each individual Member States digital services coordinator and their capacity to both expedite the trusted flager designation process and any investigations and/or disciplinary proceedings for truste
278、d flagers that have potentially misused or have failed to effectively use their powers.Under such a scenario,instead of harmonizing the digital market in the EU,as is the overarching goal of the DSA,the law will simply produce a postcode lottery across Member States whereby rightsholders abilities t
279、o enforce their IP rights online will rely not on harmonized EU standards but instead on the individual national capabilities of a new regulatory authority.Finally,it is unclear how the DSA will in practice interact with other EU statutes,specifically Directive 2019/790 on copyright and related righ
280、ts in the Directive on Copyright in the Digital Single Market(CDSM Directive).As noted in previous editions,the CDSM Directive strengthens protections for creators online by providing clear definitions of what constitutes secondary liability for communication to the public of a protected work.It als
281、o provides a clear definition and safe harbor mechanism for content-sharing platforms to avoid any direct liability.Although the DSA in its preamble states that the regulation“is without prejudice to the rules of Union law on copyright and related rightswhich establish specific rules and procedures
282、that should remain unaffected,”at the time of research,those“rules and procedures”had yet to be defined and transposed at the national level in all EU Member States.In conclusion,and like the GDPR,both the DMA and DSA greatly expand the authority and rule-making power of the European Commission over
283、 vast parts of the European and,per extension,the global economy.The sprawling nature of the legislation and the inclusion of such a high number of exceptions,carveouts,categorizations,definitions,and determinations to be made on a case-by-case basis will almost guarantee that once operational,the l
284、aw will have a whole host of unintended consequences both in Europe and beyond.Overall,it remains to be seen whether these new laws will materially improve IP rightsholders position and ability to protect and enforce their rights in the EU.The Index will continue to monitor these developments in 202
285、3.Overall Results and Category-by-Category ScoresUp or down?How have economies fared in this edition of the Index?Table 3 shows the overall results for the eleventh edition of the Index and how they compare to last years edition.54|2023 International IP I 3:Change in Overall Score,Tenth Edition Vers
286、us Eleventh edition CountryEleventh EditionTenth EditionChange in Overall ScoreUnited States95.48%95.48%0.00%UK94.14%94.14%0.00%France93.12%92.10%1.02%Germany92.46%92.46%0.00%Sweden92.14%92.14%0.00%Japan91.26%91.26%0.00%The Netherlands90.70%90.70%0.00%Ireland89.36%88.84%0.52%Spain86.44%85.94%0.50%Sw
287、itzerland86.00%86.00%0.00%Singapore84.94%84.44%0.50%South Korea84.44%83.94%0.50%Italy83.90%83.40%0.50%Australia80.68%80.70%0.02%Hungary76.90%76.90%0.00%Canada75.72%75.24%0.48%Israel72.72%72.74%0.02%Greece70.92%70.92%0.00%Poland70.74%70.74%0.00%New Zealand69.28%69.28%0.00%Taiwan66.31%66.29%0.02%Moroc
288、co62.26%59.76%2.50%Mexico58.98%58.98%0.00%China57.86%55.86%2.00%Costa Rica54.56%54.56%0.00%Dominican Republic54.28%54.28%0.00%Malaysia53.44%51.90%1.54%Turkey51.07%51.07%0.00%Peru49.82%49.32%0.50%Chile49.72%48.72%1.00%Colombia48.84%48.84%0.00%UAE46.00%46.02%0.02%Jordan44.70%44.70%0.00%Saudi Arabia42.
289、38%41.38%1.00%Honduras42.16%42.18%0.02%Brazil42.02%42.02%0.00%Philippines41.58%41.58%0.00%Brunei41.08%41.08%0.00%Ghana40.88%40.88%0.00%CountryEleventh EditionTenth EditionChange in Overall ScoreVietnam40.74%38.72%2.02%Ukraine39.74%39.74%0.00%India38.64%38.64%0.00%Thailand38.28%35.78%2.50%Kenya37.36%
290、37.38%0.02%South Africa37.28%37.28%0.00%Argentina37.00%37.02%0.02%Nigeria33.34%31.34%2.00%Egypt32.82%32.82%0.00%Ecuador30.68%30.70%0.02%Indonesia30.42%30.42%0.00%Kuwait28.42%27.92%0.50%Pakistan27.42%27.43%0.01%Algeria26.36%26.36%0.00%Russia25.02%46.64%21.62%Venezuela14.10%14.10%0.00%Unlike the previ
291、ous two editions of the Index,where most economies saw their overall scores improve,most economies in 2022 saw no or only marginal changes to their national IP environments.Of the 55 economies included in the tenth and eleventh editions,this year,there was no score change in 28 economies,18 economie
292、s saw an improvement,and in 9 economies the overall Index score dropped.This compares to last year when an overwhelming majority of economies(85%)saw a net improvement in their overall scores.Two of those economies in the tenth edition of the IndexNigeria and the United Arab Emirates(UAE)saw sizeabl
293、e improvements of 3.94%and 4.04%in their overall scores,respectively.This year,the highest total percentage increase was 2.5%,achieved by the economies of Morocco and Thailand.Similarly,oof the nine economies whose scores dropped,only one,Russia,saw a drop of more than 2%.As detailed in its Economy
294、Overview,Russia saw a historic drop of 21.62%in its overall Index score.This is the largest single-year drop recorded in the 11 years of the Index.It comes as the result of Russian authorities largely suspending the protection of IP rights through a series of countersanctions targeting international
295、 rightsholders after the invasion of Ukraine and the imposition of international political and economic sanctions.However,the lack of large movements in overall scores does not mean that the global IP environment in 2022 stood still.As the following subsections and the individual Economy Overviews d
296、etail,many economies saw significant increases and,in many cases,decreases on individual Index category scores.Furthermore,a striking number of Index economies also put forward policy proposalsboth positive and negativethat,if implemented,would amount to substantial overall score changes in coming e
297、ditions of the Index.56|2023 International IP I 1:Patents,Related Rights,and LimitationsFigure 1 summarizes the total scores for Category 1.This category measures the strength of an economys environment for patents,related rights,and limitations.The category consists of nine indicators with a maximu
298、m possible score of 9.Figure 1:Category 1:Patents,Related Rights,and Limitations,%Available Score0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%8.3316.6722.2222.2227.7830.2230.3932.2233.1733.1733.3333.3333.3333.3336.1136.1136.1138.8943.7244.4447.2247.2247.2247.2249.8350.0050.0050.
299、0061.1163.3363.6163.8970.8371.7875.0075.0078.3380.5680.8383.3383.3388.8991.6791.6791.6791.6791.6791.6791.6791.6794.4494.4494.4494.4497.22VenezuelaRussiaAlgeriaSouth AfricaParkistanThailandBrazilArgentinaEcuadorIndiaIndonesiaKuwaitNigeriaVietnamEgyptHondurasUkraineGhanaChileTurkeyMalaysiaPeruPhilippi
300、nesUAEMexicoColombiaKenyaSaudi ArabiaBruneiDominican RepublicCosta RicaJordanMoroccoNew ZealandHungaryPolandCanadaGreeceChinaAustraliaIsraelItalyFranceGermanyIrelandThe NetherlandsSpainSwedenTaiwanUKU.S.SwitzerlandSouth KoreaJapanSingaporeAs in past editions,the overall results for Category 1 are st
301、ill one of the strongest of all the categories included in the Index.Twenty-three economies achieve a score of 70%or more of the available score,and 30 economies in total achieve a score of 50%or more.The average score in the category is 59.31%,which is the fifth highest scoring category in the Inde
302、x.As in years past,Singapore is ranked number 1,ahead of Japan,South Korea,Switzerland,and the United States.As noted in previous editions,the patenting environment in the United States continues to be held back by uncertainty over what constitutes patent-eligible subject matter and patent nullity p
303、roceedings through the inter partes review(IPR),which occurs before the specialized Patent Trial and Appeals Board(PTAB)within the U.S.Patent and Trademark Office(USPTO).Since the Supreme Court decisions in the Bilski,Myriad,Mayo,and Alice cases,there has been a high and sustained level of uncertain
304、ty about which inventions and discoveries are eligible for patent protection in the United States.Since 2014,the USPTO has issued and updated patent examination guidelines almost on an annual basis.Lower and circuit court decisions in patent infringement proceedings have not always been consistent.T
305、he net result is that rightsholders are left without a clear sense of how decisions on patent eligibility will be made or,when granted patents are subsequently challenged or reviewed either through the courts or through the inter partes proceedings within the USPTO,which patent claims will be upheld
306、.The USPTO has recognized this dilemma and has sought to reformulate its position and the approach to be taken by its examiners.In 2019,the office released new guidance covering Section 101(patent eligibility)and Section 112(functional claims)related to computer inventions,the“2019 Revised Patent Su
307、bject Matter Eligibility Guidance”(“The Guidance”)and“Examining Computer-Implemented Functional Claim Limitations for Compliance with 35 U.S.C.112.”With respect to Section 101(subject matter eligibility),the guidance provided more of a principle-based analysis of how eligibility would be judged and
308、described the stepwise approach examiners should follow to understand and apply the Supreme Courts Alice and Mayo test.As the Guidance rightly pointed out,the key challenge for USPTO examiners and courts has been to“consistently distinguish between patent-eligible subject matter and subject matter f
309、alling within a judicial exception.”The Guidance recognized this and sought to clear this up with a revised procedure and process for examiners to follow,to the extent possible without further statutory changes.The USPTO also introduced a“Deferred Subject Matter Eligibility Response pilot program”in
310、 response to requests from Congress.In 2020,the USPTOs Office of the Chief Economist published Adjusting to Alice USPTO Patent Examination Outcomes After Alice Corp.v.CLS Bank International.This report examined the effect of the 2019 Guidance on rates of first office rejections for Alice-related tec
311、hnologies,that is,technologies and applications that the USPTO and the U.S.Patent Classifications have defined as containing“abstract ideas.”The report found that,overall,since the introduction of the Guidance,there has been a statistically significant decrease in the number of first office rejectio
312、ns for Alice-related technologies.Specifically,the likelihood of receiving a first office rejection decreased by 25%in the 12 months after the introduction of the Guidance.As the USPTO rightly noted at the time of publication,this is positive news.Unfortunately,as noted by the Index,uncertainty over
313、 what constitutes patent-eligible subject matter has crept into all facets of the American patent systemfrom initial application and examination to standards of review and invalidity proceedings,whether administratively through the PTAB or through the judiciary.For example,with respect to 58|2023 In
314、ternational IP I influence and use of the USPTOs Guidance,the U.S.Court of Appeals for the Federal Circuit has expressly,and repeatedly,stated that the Guidance does not carry the force of statutory law or relevant case law and is therefore not a controlling factor in any patentability analysis carr
315、ied out by the court.Efforts to address this fundamental problem in the U.S.patent system continued within both the executive and legislative branches of the federal government in 2022.The USPTO,under the new leadership of Director Kathi Vidal,issued several requests for comments on issues pertainin
316、g to patentability,patent-eligible subject matter,and related UPSTO processes and procedures.In June,the agency published Patent-Eligible Subject Matter:Public Views on the Current Jurisprudence in the United States.This report,requested by a bipartisan group of senators,details the results of stake
317、holder feedback gathered in 2021 on the state of patent-eligible subject matter in the United States.After publication of this report,the agency announced that it will seek feedback on current examination practices as captured in the relevant sections of the patent manual(Manual of Patent Examining
318、Procedure 2106).In a separate development,the USPTO issued a request for comments on USPTO Initiatives to Ensure the Robustness and Reliability of Patent Rights in October 2022.This follows requests from both the White House and Congress.Specifically,in July 2021,President Joe Biden issued the Execu
319、tive Order on Promoting Competition in the American Economy.Alleging anticompetitive behavior in several sectors of the economy,the order asks the FDA and the USPTO to examine the extent to which the patent system“while incentivizing innovation,does not also unjustifiably delay generic drug and bios
320、imilar competition beyond that reasonably contemplated by applicable law.”As illustrated by the lifesaving innovation and product development witnessed during the COVID-19 pandemic,biopharmaceutical breakthroughs by American firms are improving health treatment for patients globally and are providin
321、g a steady stream of new drugs and health technologies.American research-based biopharmaceutical firms spent an estimated USD 72.4 billion in 2020 on R&D domestically in the United States.This leadership in global biopharmaceutical research and manufacturing also translates into large economic divid
322、ends for Americans.Revenues generated by a new blockbuster drug are comparable to the export of 1 million cars.The sector also accounts for and supports 4.5 million jobs.The basic economics of the biopharmaceutical industry show how critical IP rights are to incentivize and support the development o
323、f new medical technologies and products.Research from Tufts University published in 2016 sugests that it costs USD 2.6 billion,on average,to develop a new drug.On average,only one to two of every 10,000 synthesized,examined,and screened compounds in basic research will pass through all stages of R&D
324、 and will go on to become a marketable drug.Patents and other forms of exclusivity for biopharmaceuticals,such as RDP and special exclusivity incentives for the protection and production of orphan drugs,enable research-based companies to invest these vast sums in R&D and the discovery of new drugs,p
325、roducts,and therapies.It has been clear for many years that American taxpayers and patients are concerned with the cost of prescription medicines and have asked their elected representatives to take appropriate action.However,the cost of drugs is a complex subject that does not lend itself to genera
326、lizing.It involves many factors such as health system infrastructure;health financing;and how the American health system itself is organized,financed,and accessed by patients.Within this cost equation,the protection of IP plays a relatively small role.Instead of achieving the goal of lowering costs,
327、proposals that undermine the incentives that make biopharmaceutical R&D and investment possible risk the very model of innovation that since the mid-1980s have been providing Americans,and patients around the world,with new and better health technologies and medicines.Finally,in August 2022,Sen.Thom
328、 Tillis(R-NC)introduced the Patent Eligibility Restoration Act of 2022.Sen.Chris Coons(D-DE),the chair of the Senate Judiciary Committee Intellectual Property Subcommittee,cosponsored the legislation in September 2022.The proposed legislation marks a significant breakthrough on the legislative front
329、.As Sen.Tillis stated in conjunction with the release of the draft act,“Predictable patent rights are imperative to enable investments in the broad array of innovative technologies that are critical to the economic and global competitiveness of the United States,and to its national security.”At the
330、time of research,the proposed act had not been passed by Congress or signed into law by President Biden,but it was referred to the Senate Judiciary Committee for consideration that August.As noted,this level of uncertainty with respect to patentable subject matter is compounded by a sustained level
331、of unpredictability with respect to post-grant opposition and patent nullity proceedings.To provide a more cost-effective,efficient alternative to judicial proceedings,the 2011 America Invents Act(AIA)introduced new post-grant opposition and patent nullity proceedings.As noted in previous editions o
332、f the Index,despite the intentions of these new AIA mechanisms,the result has been a sustained level of uncertainty and unpredictability for many patent owners.This has been especially the case with the IPR,which occurs before the PTAB.As noted over the course of the Index,the U.S.government(chiefly
333、 through the USPTO)has recognized the unintended effects of the PTAB system and has publicly pledged to work with all stakeholders to address and remedy them.As a result,many important changes have since been introduced.Examples of these reforms include(1)changing the patent claim construction standard used,moving away from the broadest reasonable interpretation standard to the Phillips standard,w