1、CoverInternationalIP Index 2024 Twelfth Edition2|International IP IndexThe 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.Copyright 2023 by the U.S.Chamber of Comme

3、rce.All rights reserved.No part of this work,covered by the copyrights herein,may be reproduced or copied in any form or by any meansgraphic,electronic,or mechanical,including photocopying,recording,taping,or information and retrieval systemswithout the permission of the Chamber.This report was cond

4、ucted by Pugatch Consilum,(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 Pr

5、of.Pugatch is the Managing 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 Maastri

6、cht in the Netherlands;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,pha

7、rmacoeconomics,pricing 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 innovati

8、on,tax and intellectual 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

9、 of a number of academic and commissioned reports and publications and is the co-author of all 12 editions of the U.S.Chamber International IP Index.3|International IP IndexContents Foreword.6Executive Summary.7Overview of the Twelfth Edition.20The Global IP Environment in 2023 Major Developments,Ov

10、erall Index Scores,and Category-by-Category Results.26Economy Overviews.78Appendix:Methodology,Sources,and Indicators Explained.405Tables and FiguresTable 1:Twelfth Edition Index Economies by World Bank Region.21Table 2:Twelfth Edition Index Economies by World Bank Income Group.22Table 3:European Un

11、ion Member States Included in the Twelfth Edition of the Index.36Table 4:Change in Overall Score,Twelfth Edition versus Eleventh Edition .414|International IP IndexTable 5:Top 25 Provenance Economies in Terms of Their Propensity to Export Counterfeit Products,GTRIC-e Average 2017-2019.69Figure 1:Cur

12、rent Scores,Indicators 5 and 25,Select Index Economies and EU Member States versus Estimated Score Reduction,EU Member States .37Figure 2:Current Scores;Indicators 5,6,7,and 25;Select Index Economies and EU Member States versus Estimated Score Reduction;EU Member States.38Figure 3:Category 1:Patents

13、,Related Rights,and Limitations,%Available Score.45Figure 4:Category 2:Copyrights,Related Rights,and Limitations,%Available Score.49Figure 5:Category 3:Trademarks,Related Rights,and Limitations,%Available Score.54Figure 6:Category 4:Design Rights,Related Rights,and Limitations,%Available Score.56Fig

14、ure 7:Category 5:Trade Secrets and the Protection of Confidential Information,%Available Score.58Figure 8:Category 6:Commercialization of IP Assets,%Available Score.61Figure 9:Category 7:Enforcement,%Available Score.67Figure 10:Category 8:Systemic Efficiency,%Available Score.72Figure 11:Category 9:M

15、embership and Ratification of International Treaties,%Available Score.755|International IP IndexVenezuelaRussiaAlgeriaPakistanKuwaitIndonesiaEcuadorEgyptNigeriaArgentinaSouth AfricaKenyaThailandIndiaUkraineVietnamGhanaBruneiPhilippinesBrazilHondurasSaudi ArabiaJordanUAEColombiaChilePeruTrkiyeMalaysi

16、aDominican RepublicCosta RicaChinaMexicoMoroccoTaiwanNew ZealandPolandGreeceIsraelCanadaHungaryAustraliaItalySouth KoreaSingaporeSwitzerlandSpainIrelandNetherlandsJapanSwedenGermanyFranceUKU.S.95.4894.1293.1292.4692.1291.2691.2489.3886.4485.9884.9484.9283.9080.7076.9076.2272.7471.4270.7469.3667.3462

17、.7659.9857.8655.3055.0453.4451.0449.8249.7248.8448.4246.5246.0044.7042.1641.5841.0840.8840.7640.3038.6438.2837.8837.2837.0036.3433.8630.4029.5828.4227.4226.3625.0014.10U.S.Chamber International IP Index 2024,Overall Scores,%Available Score 6|International IP IndexForewordAs Charles Dickens wrote in

18、the opening of A Tale of Two Cities,“it was the best of times,it was the worst of times.”That is certainly the state of intellectual property(IP”)policy around the globe.The transformative power of innovation has never been more evident.People everywhere have more choice than ever before,with an arr

19、ay of technologies at their fingertips to enhance productivity,simplify everyday challenges,and improve the quality of life.We have more medical solutions than any time in history,both to everyday ailments and devasting medical diagnoses.And the rapid growth of new creative content has enriched our

20、lives and expanded our cultural horizons.Solutions abound to everyday hardships and existential crises,alike,with each new challenge an invitation to innovation that will be critical to advancing human progress.Day in and day out,society reaps the outsized benefit of these invaluable innovations.Eco

21、nomists quantify these benefits as a“social surplus.”While 98%of the value of a new technology benefits the billions of users,the innovator responsible for that technology receives only 2%.Thats a value ratio of 50:1.Intellectual property(IP)is critical to sustaining the innovation ecosystem that pr

22、opels ongoing progress.IP rights create the legal conditions required for the investment,collaboration,and commercialization needed to improve the human condition.The U.S.Chambers International IP Index helps global policymakers assess the strengths and weaknesses of their national ecosystem relativ

23、e to neighbors and economic competitors.The Index measures how economies empower innovators and creators and whether individual nations and the global marketplace are on the path to shape a brighter future.While nations like Saudi Arabia,Brazil,and Nigeria have made strides in advancing their IP fra

24、meworks,major economies such as the United States and the European Union have remained stagnant,which endangers their continued IP leadership.On the global stage,we continue to see heated debates around IP waivers through discussions at the World Trade Organization and World Health Organization.Ther

25、e are also continued efforts by India and the Africa Group to undermine IP protections through proposals for mandatory technology transfer of green technology and climate change-related solutions.Ironically,those efforts will undercut the business communitys efforts to address emerging challenges,fr

26、om climate change to future pandemics.IP has helped drive unprecedented global advances over the past fifty years,be it stamping out poverty or improving health.Continued strong IP policies will allow this progress to continue.However,maintaining the status quo or a retreat from IP will cause the in

27、novation engine to sputter,with global consumers suffering the consequences.7|International IP Index76-100%51-75%26-50%1-25%Overall Economy ScoresExecutive SummaryThe 12th edition of the International IP Index benchmarks the IP framework in 55 global economies across 50 unique indicators.The Index n

28、ot only provides a roadmap for economies seeking to enhance IP-driven innovation and creativity but also sheds light on trends in global IP protection in the last year.8|International IP Index Geographic CoverageAlgeriaArgentinaAustraliaBrazilBruneiCanadaChileChinaColombiaCosta RicaDominican Republi

29、cEcuadorEgyptFranceGermanyGhanaGreeceHondurasHungaryIndiaIndonesiaIrelandIsraelItalyJapanJordanKenyaKuwaitMalaysiaMexicoMoroccoThe NetherlandsNew ZealandNigeriaPakistanPeruPhilippinesPolandRussiaSaudi ArabiaSingaporeSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTrkiye United ArabEmirate

30、sUkraineUnited KingdomUnited StatesVenezuelaVietnam9|International IP IndexKey Findings20The overall score improved in 20 economies,creating renewed optimism about the future of global IP policy.Multilateral organizations have an opportunity to correct course and reaffirm the global commitment to IP

31、,rather than continue to further tolerate counterproductive measures such as IP waivers.Saudi Arabia,Brazil,and Nigeria earned the largest improvements in overall score at 6.04%,4.50%,and 3.00%respectively.These advancements illustrate how economies can make a conscious,policy choice to invest in in

32、novative capacity to help deliver solutions to global challenges.Twenty-seven economies scores remained unchanged.While eight economies overall scores dropped,only Ecuador had a decrease of over 1%reflecting the absence of effective measures to allow border officials to effectively take action again

33、st IP-infringing goods.There was almost no positive movement among top-ranked economies that have traditionally been global leaders on advancing IP protection,making it incumbent upon the U.S.,the EU and others to reassert their global leadership on IP policy.While the global public health emergency

34、 on covid-19 ended in May 2023,the World Trade Organization(WTO)continues to tirelessly debate the waiver of IP rights for therapeutics and diagnostics.The ongoing waiver debate only ensures that its proponents will be on the sidelines,forced to wait to be recipients of technological solutions,rathe

35、r than part of the successful ecosystem that creates them.Should WTO members agree to an expansion of the waiver,economies scores will be negatively impacted in the next edition of the Index.The World Health Organizations(WHO)draft Pandemic Accord includes calls for further time-bound IP waivers and

36、 forced technology transfer while the International Health Regulations likewise propose coercive technology transfer.As feared,the effort to undermine IP protections have expanded beyond the life sciences industry,with economies like India and the Africa Group calling for IP waivers and mandatory te

37、chnology transfer of green technology and climate change solutions.10|International IP IndexWhile developed economies have traditionally had world-class IP systems critical to advancing innovation,many high-income economies continue to consider policy and regulatory proposals which threatens to cede

38、 this leadership to foreign competitors.Economies of all levels of development continue to take steps to combat online piracy,building on positive momentum in recent years.In the United States,the Administration released a proposal to expand the use of march-in rights on the basis of price.Coupled w

39、ith the drug pricing provisions of the Inflation Reduction Act and ongoing uncertainty around patentability,the U.S.continues to undermine the framework needed to sustain the life sciences ecosystem.In Europe,the General Pharmaceutical Legislation,Patent Package,and European Health Data Space propos

40、als will limit the availability of regulatory data protection,needlessly expand the ability to grant compulsory licenses,undermine the system for Standard Essential Patent(SEP)licensing and negotiations,and jeopardize trade secrets protection.Emerging artificial intelligence policies at the national

41、 level must be evaluated in light of pre-existing commitments at the WTO,World Intellectual Property Organization(WIPO)and in free trade agreements,as well as against the important principles articulated by G-7 members.The introduction or extended application of dynamic injunctions for protecting co

42、pyrighted works online increased in 2023,with Argentina and Brazil joining countries like Canada,India,and Singapore in utilizing some form of dynamic injunctions.Additional economies,such as the Philippines,are considering introducing injunctive relief that would include a dynamic element.Economies

43、 introduced or extended criminal causes of action for copyright infringement.Notably,India enacted criminal sanctions for copyright infringement.11|International IP IndexCategory-by Category ResultsPatents,Related Rights,and LimitationsTwenty-three economies achieve a score of 70%or more of the avai

44、lable score and 31 economies in total achieve a score of 50%or more.Draft patent amendments in India will enhance the framework for patent protection by improving existing patent opposition mechanisms and introducing positive changes to the Form 27 requirements to declare a working patent.In Pakista

45、n,draft amendments will eliminate the pre-grant opposition in Pakistan,bringing improve certainty to patent rights.However,the proposed legislation also further limits or eliminates the potential patentability of computer-implemented inventions(CIIs)and biopharmaceutical innovation.IP holders face c

46、ontinued uncertainty over patents in Brazil.While a Federal Court ruled in favor of a patent term adjustment following an undue delay to the patent grant,the Supreme Court separately ruled that patent rights cannot apply beyond 20 years from initial application,regardless of the time of grant.Catego

47、ry 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%8.3316.6722.2222.2227.7830.2232.2233.1733.1733.3333.3333.3333.3335.9436.1136.1136.1138.8943.7244.4447.2247.2247.2247.2250.0050.0055.3955.5661.1163.3363.6163.8970.8372.2275.00

48、75.0078.3380.5680.8383.3383.3388.8991.6791.6791.6791.6791.6791.6791.6791.6794.4494.4494.4494.4497.22VenezuelaRussiaAlgeriaSouth AfricaParkistanThailandArgentinaEcuadorIndiaIndonesiaKuwaitNigeriaVietnamEgyptBrazilHondurasUkraineGhanaChileTrkiyeMalaysiaPeruPhilippinesUAEColombiaKenyaSaudi ArabiaMexico

49、BruneiDominican RepublicCosta RicaJordanMoroccoNew ZealandHungaryPolandCanadaGreeceChinaAustraliaIsraelItalyFranceGermanyIrelandNetherlandsSpainSwedenTaiwanUKU.S.SwitzerlandSouth KoreaJapanSingapore12|International IP IndexCopyrights,Related Rights,and LimitationsWhile many Index economies struggle

50、to provide effective copyright protection,the average score on this category improved marginally from 49.70%last year to 50.61%this year in 2023.In Brazil,Anatel launched new efforts to locate and disable illegal set-top boxes,which have resulted in the seizure of nearly 1.5 million illegal units.Sa

51、udi Arabi and Egypt both continued to disable access to copyright-infringement websites,building upon positive momentum in both economies to enhance copyright enforcement.Greeces implementation of the EUs Digital Single Market Directive clarified the definition of what constitutes secondary liabilit

52、y for communication to the public of a protected work.While Nigerias new Copyright Act includes new mechanisms to address devices or online platforms with copyright-infringing content,the legislation also creates a new basis to issue compulsory licenses and expands existing educational use exception

53、s.Category 2:Copyrights,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%0.0018.2921.8621.8623.2923.2923.2924.8625.4326.1427.7130.4332.5732.5733.4335.5735.9036.1436.1437.5738.8639.1039.5739.6639.7142.6742.7143.2943.2945.1446.2946.8648.2

54、949.8653.4354.1462.5764.1064.7166.1468.4370.1471.8076.8680.4381.9584.0085.5785.5790.7191.1492.7194.7196.2996.43U.S.SingaporeUKFranceGermanySwedenSouth KoreaNetherlandsAustraliaJapanIrelandSpainNew ZealandItalyCanadaIsraelMalaysiaGreeceHungaryMexicoMoroccoCosta RicaSwitzerlandSaudi ArabiaPeruPolandKe

55、nyaChinaNigeriaGhanaThailandKuwaitIndonesiaDominican RepublicIndiaBrazilTaiwanSouth AfricaHondurasTrkiyeColombiaUAEPhilippinesChileJordanUkraineVietnamEcuadorVenezuelaEgyptArgentinaBruneiAlgeriaPakistanRussia13|International IP IndexTrademarks,Related Rights,and LimitationsMost economies sampled in

56、the Index offer basic forms of trademark protection,with only 10 of 55 sampled economies failing to score 50%or more on this category.The overall average score in this category increased from 62.39%in the eleventh edition to 62.84%in the twelfth edition.The Saudi IP Authority seized more than 12 mil

57、lion trademark and design infringing items and worked with online merchants and intermediaries to take down close to 60,000 e-commerce-related ads or infringing content.Taiwans Supreme Administrative Court issued a potentially precedent setting ruling on what constitutes a well-known mark,marking a

58、potential turning point in Taiwanese jurisprudence and the manner in which administrative law assesses trademark infringement of well-known marks.Category 3:Trademarks,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%0.0037.5037.5037.50

59、43.7543.7543.7543.7543.7543.7550.0050.0050.0050.0050.0050.0050.0056.2556.2556.2556.2556.2556.2556.2556.2556.2556.2562.5062.5062.5062.5062.5062.5062.5068.7568.7568.7568.7575.0075.0075.0075.0075.0081.2587.5087.5087.5087.5087.5087.5087.5093.7593.75100.00100.00U.S.UKSouth KoreaFranceSwitzerlandSwedenNew

60、 ZealandNetherlandsJapanIrelandGermanyAustraliaSpainSingaporeSaudi ArabiaItalyChinaUAEIsraelHungaryCanadaTrkiyeThailandTaiwanPhilippinesMexicoMalaysiaGhanaVietnamSouth AfricaPolandIndiaGreeceDominican RepublicCosta RicaColombiaChileBrazilPeruNigeriaMoroccoKenyaHondurasBruneiArgentinaUkraineKuwaitJor

61、danIndonesiaEgyptEcuadorVenezuelaPakistanAlgeriaRussia14|International IP IndexDesign Rights,Related Rights,and LimitationsMost economies 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 t

62、his category this year was 64%;up marginally from 63.77%last year.Indonesia proposed new amendments to the Design Law to increase of the total term of protection available up to fifteen years.The EU proposed changes to the existing legal framework for community designs which updates legal definition

63、s and registration requirements,improves the scope of protection for design rights,and expands the potential exceptions to industrial design protection under a so-called repair clause.Category 4:Design Rights,Related Rights,and Limitations,%Available Score0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.

64、00%80.00%90.00%100.00%0.0032.5032.5037.5042.5042.5042.5042.5042.5042.5045.0045.0045.0045.0045.0045.0045.0045.0055.0055.0055.0055.0055.0055.0055.0055.0055.0057.5062.5062.5062.5065.0067.5067.5067.5075.0075.0075.0075.0080.0087.5087.5087.5087.5087.5087.5090.00100.00100.00100.00100.00100.00100.00100.0010

65、0.00UKSwitzerlandSwedenNetherlandsJapanIrelandGermanyFranceSouth KoreaTrkiyeSpainItalyIsraelHungaryGreeceU.S.PolandMexicoMalaysiaBrazilTaiwanSingaporeNew ZealandUAEUkrainePakistanMoroccoCanadaVietnamKenyaIndiaHondurasGhanaDominican RepublicChileBruneiArgentinaThailandSaudi ArabiaPeruIndonesiaEcuador

66、Costa RicaColombiaAustraliaPhilippinesNigeriaKuwaitJordanEgyptChinaSouth AfricaVenezuelaAlgeriaRussia15|International IP IndexTrade Secrets and the Protection of Confidential InformationOnly 23 of the 55 economies included in the Index achieved a score of 50%or more on this category,and 22 economies

67、 achieved a score of 33.33%or less.The average score on this category remained the weakest on the Index at 48.97%,unchanged from last year.The EU introduced legislation that will reduce the term of regulatory data protection(RDP)and condition the extension of the term of exclusivity on external fact

68、ors,such as market access.The EU also published proposals to create a European Health Data Space(EHDS)that would alter the way confidential and proprietary health data is disseminated and make protected IP and trade secrets subject to secondary use.Category 5:Trade Secrets and the Protection of Conf

69、idential Information,%Available Score0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%BruneiNigeriaVenezuelaAlgeriaArgentinaEgyptIndiaIndonesiaKenyaKuwaitPakistanPhilippinesThailandGhanaPeruUkraineTrkiyeRussiaBrazilChileEcuadorSouth AfricaCosta RicaDominican RepublicJordanMalaysiaMe

70、xicoMoroccoSaudi ArabiaVietnamIsraelChinaColombiaHondurasSingaporeUAEAustraliaHungaryTaiwanSouth KoreaGreeceNew ZealandPolandUKFranceIrelandCanadaItalyU.S.JapanGermanyNetherlandsSpainSwedenSwitzerland8.338.338.3316.6716.6716.6716.6716.6716.6716.6716.6716.6716.6725.0025.0025.0026.6728.3333.3333.3333.

71、3333.3341.6741.6741.6741.6741.6741.6741.6741.6743.3345.0050.0050.0058.3360.0066.6766.6766.6770.0075.0075.0075.0075.0083.3383.3385.0091.6791.6793.33100.00100.00100.00100.00100.0016|International IP IndexCommercialization of IP AssetsOf the 55 economies sampled,20 fail to achieve a score of 50%or more

72、 with a full thirteen scoring 33.33%or less on the category.The average score on this category was 58.78%.In China,new rules that accompany the Anti-Monopoly Law contain broad language and vest considerable discretion with the government to identify and define what constitutes anti-competitive behav

73、ior.The Turkish Government took steps to address issues with Trkiyes localization policies highlighted in the WTO panel ruling,including the development of new Drug Reimbursement regulations,the termination of relevant import substitution programs,and the opening of reimbursement lists to previously

74、 excluded foreign companies.Morocco launched a new IP Marketplace to share information on registered IP assets and help facilitate licensing and commercialization activity.Figure 8:Category 6:Commercialization of IP Assets,%Available Score 0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%1

75、00.00%4.178.3312.5016.6720.8323.6726.3327.8329.1729.1732.0032.0033.3334.6736.1738.8341.6743.0044.5045.8350.0052.8354.1754.1758.3358.3361.1761.1762.5065.3365.3366.6769.5070.8370.8372.1773.6779.1779.1783.3383.3386.1786.1786.1787.5087.5087.5087.5090.3391.6791.6791.6795.8394.5095.83IndonesiaEcuadorVenez

76、uelaGhanaKenyaRussiaVietnamColombiaAlgeriaUkraineNigeriaThailandKuwaitPakistanPhilippinesChinaIndiaBrazilPeruEgyptSaudi ArabiaSouth AfricaTrkiyeUAECosta RicaHondurasArgentinaJordanSouth KoreaChileMalaysiaDominican RepublicMexicoGreeceMoroccoBruneiTaiwanPolandSwedenItalySpainCanadaJapanNew ZealandFra

77、nceHungaryIrelandNetherlandsGermanySingaporeSwitzerlandUKU.S.AustraliaIsrael17|International IP IndexEnforcementMany Index economies struggle to provide adequate enforcement measures,with only 23 Index economies achieving a score of 50%or more and only 11 economies achieving a score of 75%or more.Th

78、e average score on this category remains one of the weakest on the Index at 50.24%.Dutch law enforcement took decisive action against one of Europes largest providers of set-top boxes and disabled access to illegal content in hundreds of thousands of set-top boxes across the continent.The Dominican

79、Republic established and operationalized a new Inter Ministerial Council on IP that will coordinate IP enforcement across the government.Algeria launched a new commercial court which will provide legal expertise on complex areas of commercial law,including IP.Category 7:Enforcement,%Available Score

80、0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%7.4216.5718.2919.2920.7122.2922.4323.7124.0024.2924.8625.0025.1426.1427.4328.2929.4333.2934.2937.0038.8639.0040.7142.0043.0043.8644.5746.7146.8647.2948.0048.0050.2950.5753.7155.7156.7163.7168.8670.5772.0072.4373.1473.2976.2983.7187.57

81、88.0088.1490.1491.8692.2993.8695.4396.00VenezuelaNigeriaEgyptIndonesiaUkrainePakistanKenyaGhanaArgentinaPhilippinesAlgeriaIndiaBruneiVietnamRussiaJordanEcuadorKuwaitCosta RicaChinaHondurasTrkiyePeruSouth AfricaSaudi ArabiaMoroccoThailandUAEMalaysiaBrazilDominican RepublicTaiwanChileMexicoColombiaCan

82、adaGreecePolandHungaryIsraelItalyAustraliaSpainSwitzerlandNetherlandsJapanIrelandGermanySwedenFranceUKU.S.SingaporeNew ZealandSouth Korea18|International IP IndexSystemic EfficiencyOnly 14 economies failed to achieve a score of 50%or above in this category.Overall,the average score is one of the str

83、ongest on the Index,at 63.55%;up from 62.73%last year.The Saudi IP Authority continued IP awareness raising activities and improved stakeholder engagement on IP policy through public consultations on a new draft IP Law,the Madrid Protocol,and the WIPO Internet Treaties.Kenya joined the World Intelle

84、ctual Property Organization(WIPO)and the World Economic Forum(WEF)s“Inventor Assistance Program”(IAP)which provides pro-bono IP legal advice for innovators.Costa Rica launched a dedicated IP training and outreach effort focusing exclusively on the needs of entrepreneurs and SMEs.Category 8:Systemic

85、Efficiency,%Available Score 0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%10.0010.0020.0020.0025.0025.0030.0035.0035.0040.0040.0040.0045.0045.0050.0050.0050.0050.0055.0055.0055.0060.0060.0060.0065.0065.0065.0065.0065.0065.0070.0070.0070.0070.0070.0075.0080.0080.0080.0085.0085.008

86、5.0090.0090.0090.0090.0090.0095.0095.0095.0095.0095.0095.0095.00100.00KuwaitVenezuelaBruneiUkraineAlgeriaGhanaJordanEgyptHondurasRussiaNigeriaKenyaSouth AfricaDominican RepublicUAEEcuadorTrkiyeVietnamArgentinaIndonesiaPakistanChileMoroccoIsraelCosta RicaGreeceNew ZealandPeruThailandColombiaIndiaMala

87、ysiaAustraliaCanadaSaudi ArabiaPolandPhilippinesHungaryMexicoChinaSingaporeSwitzerlandGermanyBrazilNetherlandsSpainFranceTaiwanIrelandItalyJapanSwedenUKU.S.South Korea19|International IP IndexMembership and Ratification of International TreatiesThis Index category remains one of the strongest overal

88、l with twenty-two economies achieving a score of 75%or more with 14 economies with a score of over 96%.The average score in this category was 62.86%;marginally up from last years 62.70%average.Brazil acceded to the full Hague Agreement including the Geneva Act.Thailand is considering new amendments

89、to the Copyright Act to prepare to accede to parts of the WIPO Internet Treaty.Many new free trade agreements fail to include comprehensive IP chapters.The New Zealand-European Union Free Trade Agreement does not include any reference to patent rights.Moreover,while the UAE recently concluded four C

90、omprehensive Economic Partnership Agreements which include IP chapters,the substance of the individual IP chapters are limited to rights already defined and specified in TRIPS.Category 9:Membership and Ratification of International Treaties,%Available Score 0.00%10.00%20.00%30.00%40.00%50.00%60.00%7

91、0.00%80.00%90.00%100.00%7.147.147.1414.2921.4321.4328.5728.5728.5728.5728.5732.1432.1432.1435.7135.7142.8642.8642.8642.8650.0057.1457.1457.1460.7160.7167.8667.8667.8668.1871.4371.4371.4378.5778.5778.5785.7185.7189.2992.8692.8696.4396.4396.4396.43100.00100.00100.00100.00100.00100.00100.00100.00100.00

92、100.00KuwaitPakistanVenezuelaSaudi ArabiaSouth AfricaThailandIndiaEcuadorIndonesiaMalaysiaUAEAlgeriaArgentinaBrazilHondurasNew ZealandBruneiEgyptKenyaPhilippinesJordanChileColombiaNigeriaChinaMexicoCosta RicaDominican RepublicIsraelTaiwanPeruRussiaVietnamGhanaSouth KoreaTrkiyeAustraliaSingaporeGreec

93、eIrelandMoroccoGermanyHungaryItalyPolandUkraineU.S.UKSwitzerlandSwedenJapanNetherlandsSpainFranceCanada20|International IP IndexOverview of the Twelfth EditionNow in its twelfth edition,the U.S.Chamber of Commerces International Intellectual Property(IP)Index continues to provide an important indust

94、ry perspective on the IP standards that influence both long-and short-term business and investment decisions.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 road map for any economy that wants to

95、be competitive in the 21st centurys knowledge-based global economy.Large or small,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 a

96、nd better compete at the highest levels for global investment,talent,and growth.21|International IP IndexEconomies IncludedThe Index today covers 55 economies.Together,these 55 economies represent both a geographical cross-section of the world and most of global economic output,together contributing

97、 over 90%of global gross domestic product(GDP).As Table 1 shows,the Index includes economies from all major regions of the world and is truly a global measure.1 Table 1:Twelfth Edition Index Economies by World Bank Region AsiaLatin America and the CaribbeanAfrica and Middle EastEurope and Central As

98、iaNorth AmericaAustraliaArgentinaAlgeriaFranceCanadaBruneiBrazilEgyptGermanyU.S.ChinaChileGhanaGreece IndiaCosta RicaIsraelHungary IndonesiaColombiaJordanIreland JapanDominican RepublicKenyaItaly MalaysiaEcuadorKuwaitThe Netherlands New ZealandHondurasMoroccoPoland PakistanMexicoNigeriaRussia Philip

99、pinesPeruSaudi ArabiaSpain SingaporeVenezuelaSouth AfricaSweden South Korea UAESwitzerland Taiwan Trkiye ThailandUKVietnam Ukraine Source:World Bank(2023)22|International IP IndexIn addition to geographic diversity,the Index includes economies from a broad spectrum of income groups as defined by the

100、 World Bank.Table 2 provides an overview of all 55 economies sampled according to income group as defined by the World Bank.Table 2:Twelfth Edition Index Economies by World Bank Income GroupLower-Middle-Income EconomiesUpper-Middle-Income EconomiesHigh-Income EconomiesHigh-Income OECD MembersAlgeria

101、ArgentinaBruneiAustraliaEgyptBrazilKuwaitCanadaGhanaChinaSaudi Arabia ChileHondurasColombiaSingaporeFranceIndiaCosta RicaTaiwanGermanyIndonesiaDominican RepublicUAEGreeceKenyaEcuadorHungaryMoroccoJordanIrelandNigeriaMalaysiaIsraelPakistanMexicoItalyPhilippinesPeruJapanUkraineRussiaThe NetherlandsVie

102、tnamSouth AfricaNew ZealandThailandPolandTrkiyeSouth KoreaVenezuela(2020)SpainSwedenSwitzerlandUKU.S.Source:World Bank(2023).The World Bank has temporarily unclassified Venezuela pending the release of national accounts statistics.Consequently,the Index classifies Venezuela per its 2020 classificati

103、on.23|International IP IndexRegional Rankings RegionAverage overall%Index ScoreNorth America85.85%Europe and Central Asia76.28%Asia56.53%Latin America44.37%Africa and Middle East42.97%Europe and Central AsiaOverall ScoreRegional RankingUnited Kingdom94.12%1France93.12%2Germany92.46%3Sweden92.12%4The

104、 Netherlands91.24%5Ireland89.38%6Spain86.44%7Switzerland85.98%8Italy83.90%9Hungary76.90%10Greece71.42%11Poland70.74%12Trkiye51.04%13Ukraine40.30%14Russia25.00%1524|International IP IndexNorth AmericaOverall ScoreRegional RankingUnited States95.48%1Canada76.22%2AsiaOverall ScoreRegional RankingJapan9

105、1.26%1South Korea84.94%2Singapore84.92%3Australia80.70%4New Zealand69.36%5Taiwan67.34%6China57.86%7Malaysia53.44%8Phillippines41.58%9Brunei41.08%10Vietnam40.76%11India38.64%12Thailand38.28%13Indonesia30.40%14Pakistan27.42%1525|International IP IndexLatin AmericaOverall ScoreRegional RankingMexico59.

106、98%1Dominican Republic55.30%2Costa Rica55.04%3Peru49.82%4Chile49.72%5Colombia48.84%6Brazil46.52%7Honduras42.16%8Argentina37.00%9Ecuador29.58%10Venezuela14.10%11Africa and Middle EastOverall ScoreRegional RankingIsrael72.74%1Morocco62.76%2Saudi Arabia48.42%3UAE46.00%4Jordan44.70%5Ghana40.88%6Kenya37.

107、88%7South Africa37.28%8Nigeria36.34%9Egypt33.86%10Kuwait28.42%11Algeria26.36%1226|International IP IndexThe Global IP Environment in 2023 Major Developments,Overall Index Scores,and Category-by-Category Results27|International IP IndexInternational Developments Yesterday,the#COVID19 Emergency Commit

108、tee met for the 15th time and recommended to me that I declare an end to the public health emergency of international concern.I have accepted that advice.With great hope I declare COVID-19 over as a global health emergency.Dr.Tedros Adhanom Ghebreyesus WHO Director General,May 5,2023Since the onset

109、of the COVID-19 pandemic,a global IP rights architecture developed over several decades has contributed to the rapid availability of lifesaving vaccines and therapies and to a host of other technological solutions that have kept humans safe,connected,and productive to a degree unimaginable in previo

110、us health crises.However,over the past three years,those same rights and architecture face serious challenges from governmental and nongovernmental activists who misrepresent the role of IP rights in innovation and the economy.Unfortunately,there is no clearer example of this misrepresentation and d

111、isconnection than the ongoing discussion at the World Trade Organization(WTO)on waiving IP rights.The Evolution of the WTO TRIPS Waiver in 2023After two years of discussion,the WTO at its Twelfth Ministerial Conference in Geneva in June 2022 approved a waiver of patent rights under the Trade-Related

112、 Aspects of Intellectual Property Rights(TRIPS)Agreement.The final Ministerial Decision allows eligible WTO Members“to limit the rights provided for under Article 28.1 of the TRIPS Agreementby authorizing the use of the subject matter of a patent required for the production and supply of COVID-19 va

113、ccines without the consent of the right holder.”2 The waiver gives members extraordinarily broad latitude in overriding any relevant patent rights through“any instrument available in the law of the Member such as executive orders,emergency decrees,government use authorizations,and judicial or admini

114、strative 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 of the COVID-19 pandemic.”As the Index stated clearly and unequivocally after the first proposal of a waiver,IP rights enab

115、led the development of vaccines,therapeutics,and diagnostics in record time.However,many real barriers inhibited access to these innovative medicines and technologies,including regulatory delays,trade barriers,export restrictions,and last-mile delivery issues.Waiving IP rights will lead to negative

116、long-term policy outcomes without meaningfully addressing these impediments to access and helping those population groups and economies in need of assistance.The way the waiver proposal was framed from the outset,how it has been executed,and the latest proposals for extending it all bear this out.In

117、 October 2020,before a single vaccine was fully tested,reviewed,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

118、the TRIPS Agreement.3 This first proposal would waive almost the entire 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 imple

119、mentation,application and enforcement of Sections 1,4,5,and 7 of Part II of the TRIPS Agreement in relation to prevention,containment or treatment of COVID-19.”28|International IP IndexThese sections of TRIPS relate to the following IP rights:Section 1:Copyright and Related Rights,Section 4:Industri

120、al Designs,Section 5:Patents,and Section 7:Protection of Undisclosed Information.The only parts of the TRIPS agreement and IP rights that would have been unaffected by this proposal were trademarks,geographical indications,and semiconductors(layout designs).As the Index and others pointed out at the

121、 time,these members offered no evidence that IP rights were or would become a barrier to an effective global response to the pandemic.They merely asserted that virtually all IP rights were inconsistent with their vision of global equity.It remains unclear to this day how the waiving of IP rights rel

122、ated to copyright protection,industrial designs,and trade secretsor patents for that matterwould have led in any way to a more successful international response to the COVID-19 pandemic.Although waiver proponents claim that undermining IP rights for complex,hard-to-manufacture medical technologiesin

123、cluding vaccines,treatments,diagnostics,and other related productswill enhance access,waiving IP will not accelerate global production or increase local technical know-how.Instead,such capabilities are cultivated through sustained education and investment over decades,which is precisely what the pre

124、existing system of IP rights has provided in those economies where they have been in place.Despite the failure of its proponents to demonstrate any benefit from an IP waiver in the first place,the WTO is currently considering an expansion of the waiver to therapeutics and diagnostics.The proposal to

125、 extend the 2022 Ministerial Decision and TRIPS waiver was formally introduced by a group of WTO member states in December 2022,many of which had supported the 2020 original waiver proposals.4 Not only would this proposal extend the existing Ministerial Decision and the waiver of patent rights to re

126、lated COVID-19 therapeutics and diagnostics,but it would do so for at least five years from the date of the extension and not from the original 2022 Ministerial Decision.Consequently,if approved as currently worded,this waiver extension would run for a longer period than the original Ministerial Dec

127、ision.At the time of research,the WTO had in 2023 hosted or organized discussions with members and stakeholders on three separate occasions in March,June,and September.Notably,two of these meetings were held after the World Health Organizations(WHO)May announcement that the COVID-19 global health em

128、ergency was over.Although both the initial waiver and its potential expansion aim to enhance the availability of medicines,access to medicines is a complex subject that does not lend itself to generalizing.Access involves many factors such as health system infrastructure,health financing,logistics,t

129、ransportation networks,proper storage,distribution,and a technical drug regulatory capacity.Within this context,the protection of IP plays a relatively small role.For example,most medicines in the world viewed as essential(as compiled on essential drugs lists by WHO and numerous individual economies

130、)are off patent and are not subject to any form of exclusivity.Yet patients in many economiesnot just least developed economies but richer middle-income economies toostruggle to access these products.Given these are generic follow-on medicines,IP rights are,per definition,not an influencing or limit

131、ing factor.In the context of therapeutics and diagnostics,the U.S.International Trade Commissions(USITC)report COVID-19 Diagnostics and Therapeutics:Supply,Demand,and TRIPS Agreement Flexibilities acknowledges the many real barriers that inhibit access,including slow regulatory approvals,limited gov

132、ernment budgets for healthcare expenditures,last-mile issues in lower-middle income countries(LMICs)and low-income countries(LICs),competing healthcare priorities,trade barriers,export restrictions,and issues with customs and border inspections.5 These challenges have nothing to do with the protecti

133、on of IP or availability of IP rights.29|International IP IndexFor diagnostics specifically,the report further notes nonprofit organizations and industry representatives generally agreed that patents did not act as a primary barrier limiting global access to two main types of COVID-19 diagnostic tes

134、ts.6As noted,the WHO director declared the global health emergency over in May 2023.The global manufacturing and supply of COVID-19 vaccineswith more than 15 billion doses producedhave outstripped global demand for the better part of two years.In fact,in 2022,the International Monetary Fund(IMF),WHO

135、,and WTO all suspended their respective monitoring of the global vaccine supply chain because there was no longer a need to monitor it.7 Indeed,data from September 2022 archived in the IMF-WHO Vaccine Tracker website suggest that of the 196 economies included in the database,145(or 74%)had secured e

136、nough vaccine doses to fully vaccinate 70%of their respective populations.8 As the WTO considers an expansion of the wavier to therapeutics and diagnostics,the USITC report cited rightly notes that“demand has also been impacted by the waning of the pandemic.”9Perhaps most tellingly,no WTO Member has

137、 made use of the TRIPS waiver to date.Paragraph 5 of the Ministerial Decision includes a requirement that members should 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

138、the Council for TRIPS any measure related to the implementation of this Decision,including the granting of an authorization.”Yet,as of late 2023,the TRIPS Councils online database reveals no notifications regarding use of the waiver in 2022 or 2023.This fact has been readily acknowledged by both the

139、 WTO and governments around the world.For example,in a March 2023 TRIPS Council meeting,the chair,Lansana Gberie,acknowledged that the council had received no paragraph 5 notifications.10 The USITC report noted the same fact:“Easing the use of CLs pertaining to COVID-19 vaccines was the primary focu

140、s of the 2022 Ministerial Decision;however,as of September 2023,CLs have not been used to access patents pertaining to COVID-19 vaccines.”11 Given that economies have not used the existing waiver,any expansion would only compound the error of the original waiver,which has set back international IP p

141、olicymaking for years.As WTO members,international policymakers,and domestic legislators around the world know,the architecture for building a global capacity for both innovation and local production of the products of biopharmaceutical innovation already exists.The ground floor of that architecture

142、 can be found in the WTO TRIPS Agreement,whereas many more critical elements are found in this Index.As the Index has documented over the past 12 years,too many economies have resisted the IP standards embodied in the TRIPS Agreement,which they have viewed as a cost rather than an investment.Consequ

143、ently,as this Index has quantified for more than a decade,the TRIPS Agreement has never been fully or faithfully implemented by most WTO members.Yet,for economies that want to be on the front lines in devising solutions to the next global health crisis that same IP architecture provides all the tool

144、s necessary for full and effective participation in the innovation ecosystem.This enables the allocation of scarce financial resources to risky innovative research&development(R&D),facilitates IP licensing for access to critical know-how,and fosters multidirectional technology transfer through contr

145、actual partnerships.Should WTO members move forward with extending the existing Ministerial Decision to any other products or technologies in 2024,including but not limited to COVID-19related therapeutics and diagnostics,this would constitute a further weakening of the international IP environment.A

146、s such,it would be considered in benchmarking individual economies scores in upcoming editions of the Index.30|International IP IndexReducing Competitiveness Through Bad Policy:How the EU Has and Continues to Undermine the European Research-Based Biopharmaceutical Industry and International IP Stand

147、ards As noted in the Index over the past decade,there continues to be growing uncertainty about the biopharmaceutical IP environment at both the EU level and among member states.Many European and national policymakers understand the industrys strategic value and importance.In its 2020 Pharmaceutical

148、 Strategy for Europe,the European Commission recognized the importance of the research-based industry:“There 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.”12

149、The commission is right.The research-based biopharmaceutical sector is one of Europes biggest success stories.European companies are some of the largest,most innovative,and most successful in the world.Moreover,non-European companies also invest billions of dollars and create thousands of job opport

150、unities in Europes research-based biopharmaceutical industry.This industry has a long track record of producing lifesaving medical innovations that have been or are currently used by millions of patients,and it is also an engine of economic growth in the EU.Figures from the European Federation of Ph

151、armaceutical Industries and Associations show that in 2021,the European research-based industry directly employed around 865,000 people(with 130,000 in high-skill R&D jobs),invested 44.5 billion in R&D activity,and generated 340 billion in production value.13 Unfortunately,the strategic value and ec

152、onomic contribution of this industry have,over the past nine years,seldom been recognized in the development of European IP policies.In 2015,under the overarching initiative to reform and deepen the single market with the purpose of spurring economic growth,the European Commission announced its inte

153、ntion to explore options for recalibrating certain elements of patent term restoration for biopharmaceuticals,or supplementary protection certificates(SPCs).One option for change was to provide European manufacturers of generic drugs and biosimilars with an SPC manufacturing and export exemption(SPC

154、 waiver).Although some member statesincluding Denmark,Sweden,and the United Kingdom(UK)voted against the measure in the European Council,Regulation 2019/933 has been in force since 2019,and the SPC export exemption is legal and operational in all EU member states.The decision to move ahead with the

155、SPC exemption was a significant blow to biopharmaceutical rightsholders and has weakened the IP environment across the EU.Because of this action,the score for this indicator was reduced by 0.25 for all EU member states in the eighth edition of the Index.In addition to weakening the SPC system,since

156、2018,the European Commission has been conducting a regulatory review of the Orphan Regulation and the Pediatric Regulation,which provide special incentives(including IP-based incentives and a defined period of market exclusivity)for products developed for rare diseases and children.In 2020,the commi

157、ssion published an“Inception Impact Assessment”with a view to proposing legislative changes to both regulations.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(19

158、83),Japan(1993),and the EU(2000)have brought about a sea change in R&D,clinical research,and the development of new products for rare diseases.In the decade before the introduction of special incentives in the United States,only 10 orphan products were approved for market.14 Since then,more than 575

159、 drugs and biologic products have been developed and approved for treatment of rare diseases.31|International IP IndexA clear and strong market exclusivity incentive has played a key role here.In the EU,the 2000 Orphan Regulation provides a 10-year term of marketing exclusivity(potentially expanded

160、by two years or shortened by four years if certain circumstances are met).On the back of these schemes,as well as key pharmacogenomics discoveries that fuelled interest in the development of niche products,15 the number of orphan drugs developed and authorized for rare diseases has increased exponen

161、tially.As of 2017,the regulation has resulted in the following:Nearly 2,000 orphan designations approved More than 150 orphan medicinal products approved by the European Medicines Agency(EMA)for over 90 rare diseases (up from eight products available in 2000)85%increase in the number of rare disease

162、s for which an orphan designation exists in the EU 88%increase in clinical research activity on rare diseases between 2006 and 2016,with the EU-5 countries experiencing a 104%increase during that period.16The data are clear:the Orphan Regulation and its IP rightsbased,10-year market exclusivity ince

163、ntive have done exactly what they were intended to do:put more orphan medicines on the EU market.The real challenge facing European policymakers,both regionally and nationally,is to ensure that patients gain meaningful and effective access to these new medicines.Timely and equitable access to orphan

164、 medicines is not guaranteed in the EU,and substantial differences 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 repo

165、rt,the commission cited a survey conducted by the pan-European European Organisation for Rare Diseases(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

166、 less was available in the rest of the then-25 EU member states.17 The report 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 rapi

167、d access of patients to the new products throughout the entire Community and they need to be supplemented by incentives at Member States level.In this regard,the past experience was not entirely satisfactory.18 More recent evidence suggests that not much has changed since 2006.A 2017 study by the Of

168、fice of Health Economics(a British research institute)compared access to 143 orphan products that were approved for marketing in the EU between 2000 and 2016 across the then EU-5(including a division of England,Scotland,and Wales that comprises the UK).19 Overall,the study found the following:Access

169、 to authorized orphan products through public reimbursement varied substantially 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 the reimbursement decision by the national authority was 23.4

170、 months,nearly two years.20 That duration is also considerably longer for orphan medicines when compared to nonorphan medicines.For example,in the UK,the median number of months between the marketing authorization and the first National Institute for Health and Care Excellence appraisal was 20.2 mon

171、ths for orphan medicines compared with 12.7 months for nonorphan medicines.32|International IP IndexThe EU Orphan Regulation has succeeded in promoting research of rare diseases and incentivizing the development of orphan medicinal products,just as IP incentives in other economiessuch as the United

172、Stateshave produced similar positive outcomes.However,the last stepproviding patients with rare diseases with actual access to these medicinesis the member states responsibility.As the cited evidence suggests,access to orphan medicinal products is hampered by insufficient reimbursement and long dela

173、ys,resulting in unequal access to care for patients with rare diseases across the EU.Instead of questioning or reviewing the efficacy of the IP incentives enshrined in the Orphan Regulationwhich is what has produced this innovation in the first placethe commission and EU policymakers should put more

174、 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 all new and innovative biopharmaceutical products and technologies.The European Commission rightly pointed out in the Pharmaceutical Strategy for E

175、urope that“Innovative and promising therapies do not always reach the patient,so patients in the EU still have different levels of access to medicines.”21 However,just as with access to orphan drugs,substantial differences exist among member states with respect to both the number of products publicl

176、y reimbursed and the average time it takes for patients to gain effective access to them within a health system.Again,within this context,IP rights play no part.The design of a health systems biopharmaceutical market access policies takes place at the member state level.Each member state,through its

177、 broader health and biopharmaceutical policies,decides on market access policies and how to control the cost of medicines.Some EU member states and health systems seek to eliminate barriers to the introduction and use of new products and technologies.Others focus solely on cost and expenditure conta

178、inment and do not prioritize patient access to new products and innovation.Proposals for solving the access issue should recognize this fundamental fact.Existing IP incentives are not part of the problem.Finally,at both the member state EU levels,there has been a growing focus on exploring compulsor

179、y licensing for biopharmaceuticals.In 2017,health authorities in the Netherlands 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 SocietyDevelopment of New MedicinesBetter

180、,Faster and Cheaperwhich encouraged the use of compulsory licensing to strengthen the governments position in price negotiations.In 2020,the Hungarian government introduced an expedited compulsory licensing mechanism for biopharmaceuticals.In a separate development later that year,a Hungarian manufa

181、cturer began producing a local version of the drug remdesivir for use in a local 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.A compulsory licens

182、e was granted by the Hungarian authorities in late 2020.(In a positive development,this involuntary license was annulled by the Hungarian Constitutional Court in a ruling in October 2023.The ruling states that the compulsory licensing process was fundamentally flawed because it unfairly violated the

183、 patentees right to due process and a fair hearing.)In 2022,the European Commission issued a“Call for Evidence”on the current compulsory licensing regime across the EU.It is difficult to understand the rationale for this Call for Evidence.Each individual EU member state has national laws in place th

184、at address compulsory licensing in line with their WTO commitments.The commission posits in the Call for Evidence that a pressing need exists for“coordination and harmonization”at the EU level on compulsory licenses but provides no actual evidence that this is the case.TRIPS Article 31,the amendment

185、s introduced in the 2001 Doha Ministerial Declaration,and the subsequent General Council decision allowing the export of medicines produced under a compulsory license(outlined in Paragraph 6)form the international legal grounds for compulsory licensing for medicines.33|International IP IndexThe chai

186、rmans statement accompanying the General Council decision(concerning paragraph 6 of the Doha Declaration)underscores that these provisions are not in any way intended for industrial or commercial objectives and,if used,it is expected that they would be aimed solely at protecting public health.In add

187、ition,Article 31 and the Doha Declaration suggest that compulsory licensing represents a“measure of last resort”to be used only after all other options for negotiating pricing and supply have been exhausted.The commissions Call for Evidence asserts that the COVID-19 pandemic shows the need for clear

188、er and more“effective”compulsory licensing mechanisms.This was followed up with a proposal for new EU legislation in April 2023.Unfortunately,the proposed regulation is based on the same flawed logic as the Call for Evidence.For example,the preamble of the draft regulation explains the rationale and

189、 need for an EU-wide compulsory licensing regime:In the context of the Union crisis or emergency mechanisms,the Union should therefore have the possibility to rely on compulsory licensing.The activation of a crisis or an emergency mode or the declaration of a crisis or a state of emergency addresses

190、 obstacles to free movement of goods,services,and persons in crises and shortages of crisis-relevant goods and services.In cases where access to crisis-relevant products and processes protected by a patent cannot be achieved through voluntary cooperation,compulsory licensing can help in lifting any

191、patent-related barriers and thus ensure the supply of products or services needed to confront an ongoing crisis or emergency.It is therefore important that,in the context of said crisis mechanisms,the Union can rely on an efficient and effective compulsory licensing scheme at Union level,which is un

192、iformly applicable within the Union.This would guarantee a functioning internal market,ensuring the supply and the free movement of crisis-critical products subject to compulsory licencing in the internal market.If anything,the evidence and experience from the COVID-19 pandemic show the complete opp

193、osite.For example,as detailed previously,the much-discussed TRIPS waiver and subsequent 2022 WTO Ministerial Decision have proven to be completely unnecessary and ineffective.They address a problem of vaccine shortages that does not exist,and no WTO member has made use of it.Similarly,only one compu

194、lsory license was issued during the pandemic by the Israeli government to specifically address a perceived shortage of medicines,but the generic product was never distributed to Israeli patients with COVID-19.Much like the WTOs TRIPS waiver,the European Commissions fascination with expanding involun

195、tary mechanisms for sharing IP through a more“effective”compulsory licensing mechanism does not seem to be based on real-world data and need.More broadly,threats and the use of compulsory licensing of medicines as a basis for price negotiations are usually associated with low-income developing econo

196、mies with underdeveloped health systems and limited financial resources,not the European Commission or high-income EU member states with advanced and sophisticated health systems.The issuing of a compulsory license undermines the basic idea of the protection and sanctity of property rights,including

197、 IP rights in place to protect and incentivize biopharmaceutical innovation.Cost is not a relevant justification or basis for compulsory licensing or the overriding of any granted form of biopharmaceutical exclusivity.Moreover,the use of these types of licenses threatens the very foundation of the E

198、Us position as a global leader in innovation and high-tech industries,including biopharmaceuticals.34|International IP IndexFast-Forward to 2023the European Commission Proposes a New EU Pharmaceutical Legal FrameworkIn April 2023,the European Commission published a package of proposed legislative ch

199、anges to almost all facets of the biopharmaceutical market authorization process and related incentives,including for orphan and pediatric drugs.The proposed changes would fundamentally weaken the EUs legal framework as it relates to biopharmaceutical IP rights.Specifically,rights related to regulat

200、ory data protection(RDP),orphan drugs,and patent protectionthrough an expansion of existing Bolar exemptionswould be materially weakened.With respect to RDP,the proposed revised directive would replace the current RDP regime and 8+2+1 formula with a baseline formula of 6+2,which represents a defined

201、 data exclusivity term of protection of six years and a two-year market exclusivity window.Article 81(2)of the draft directive includes the possibility of extending this exclusivity to the existing 10-year period or even,under unique circumstances,12 years.However,the conditions that must be fulfill

202、ed to gain these additional periods of exclusivity are so complex that it is unlikely that any research-based entities will be able to access them.For example,under Article 82,the possibility of a 24-month extension of the term of data exclusivity is contingent on the relevant product being“released

203、 and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorization is valid.”Such“conditionality”of IP or regulatory protection establishes a counterproductive prece

204、dent as it makes the availability of such protection contingent on factors outside of rightsholders control.The commission has not taken into account that biopharmaceutical innovators are not responsible for the procurement,prescribing,and dispensation of medicines and health technologies.Individual

205、 EU member states and their respective health systems are in charge of all processes related to“the needs of the patients in the Member States,”that is,actual patient access,including pricing and reimbursement,procurement,and,more often than not,prescription and dispensation practices.The legislatio

206、n also reduces the market exclusivity period for orphan drugs.As mentioned,the current Orphan Regulation provides a 10-year term of marketing exclusivity.However,orphan status can be withdrawn after six years if designation criteria are no longer met,including if the drug is sufficiently profitable,

207、and exclusivity may be extended by two years if a pediatric investigation plan has been completed when requesting approval.Like the proposed RDP changes,Article 71 of the draft regulation provides a variable set of terms of protection for orphan medicinal products;in this case,the exclusivity period

208、s are 10,9,and 5 years.Eligibility for the maximum period of 10 years of protection is to be restricted and will be made available only for products that address what is described as a“high unmet medical need.”Under Article 70,products will need to provide an“exceptional therapeutic advancement,”and

209、 the use of the product should result“in a meaningful reduction in disease morbidity or mortality for the relevant patient population.”This reduction in eligibility for the maximum period of protection will,per definition,reduce the incentives to invest and develop new products and treatments for pa

210、tients with rare diseases.Ultimately,it will result in fewer products developed,commercialized,and available to these patient populations.Finally,the proposal expands existing Bolar exemptions to include health technology assessment and the pricing and reimbursement processes.A Bolar exemption(or ex

211、ception)allows follow-on applicants to begin the testing and regulatory approval processes for their follow-on products without acquiring consent from the rightsholder,in this case,the market authorization holder of the reference product.35|International IP IndexThis type of exception originates in

212、the United States and,specifically,the 1984 Drug Price Competition and Patent Term Restoration Act(Hatch-Waxman Act).The rationale behind these types of exceptions or exclusivity exemptions is to ensure that there is no undue delay in the market supply of follow-on products once the relevant exclusi

213、vity of the reference product expires.Bolar exceptions are not intended to be used to undermine rightsholders legitimately granted exclusivity periods.The expansion of the Bolar exemption to include health technology assessment and pricing and reimbursement processes would potentially weaken existin

214、g exclusivity periodsincluding duly granted patent protectionthrough the premature launch of patent-infringing generics or biosimilars.This would put rightsholders in a position whereby their IP rights are potentially infringed during the period of duly granted exclusivity whether through patent pro

215、tection or a different IP right.The Proposed Pharmaceutical Legislation and the Index:Quantifying the Negative Impact on Economies National IP EnvironmentThe support and adoption of the current proposals to weaken existing biopharmaceutical IP incentives in the EU will have a direct and tangible neg

216、ative impact on EU member states national IP environments and corresponding Index score.As currently constructed,the commissions proposals would primarily affect two Index indicators:Indicator 5.Pharmaceutical-related patent enforcement and resolution mechanism and Indicator 25.Regulatory data prote

217、ction(RDP)term.Indicator 5 measures the existence of primary and/or secondary legislation(such as a regulatory and/or administrative mechanism)that provides a transparent pathway for adjudication of patent validity and infringing issues before the marketing of a generic or biosimilar product.This sc

218、ore is evenly divided between the existence of a relevant mechanism and its application or enforcement.If no mechanism is in place,the maximum score that can be achieved is 0.5.Such a score is based on the extent to which de facto practices(such as expeditious preliminary injunctive relief)are in pl

219、ace that achieve a similar result.The European drug regulatory authority,the European Medicines Agency,does not evaluate or adjudicate patent validity or other IP rightsinfringing issues before the marketing of a generic or biosimilar product.Instead,rightsholders in all EU member states must seek i

220、njunctive relief through a national court of law once a potentially infringing product reaches the market.This is readily available in most EU member states.However,this is a limitation because it does not effectively address the issue of a potentially infringing product being approved for market be

221、fore sanitary registration and approval,and,consequently,the maximum score that all EU member states have achieved up until now for this indicator has been 0.5.Indicator 25 measures the term of RDP exclusivity granted to new biopharmaceutical products containing new active ingredients regardless of

222、molecular size and/or complexity.The baseline numerical term used is the existing EU term of 10 years(8+2)of marketing exclusivity.Half(0.5)of the available score is based on the term available for biologics or large molecule compounds.If an economys relevant RDP legislation or regulation either de

223、jure or de facto does not cover such compounds,then the maximum score that can be achieved for this indicator is 0.5.As mentioned,until now,RDP legislation in the EU is provided by Article 10 of Directive 2004/27/EC(amending 2001/83/EC).Before 2004,the EUs RDP regime was not harmonized among EU memb

224、ers,and the term of protection varied from 6 to 10 years.The 2004 amendments harmonized the term of protection according to the 8+2+1 formula.36|International IP IndexAccording to this formula,new pharmaceutical products are entitled to eight years of data exclusivity,two years of marketing exclusiv

225、ity(in which generic and follow-on applicants are allowed to submit bioequivalence studies),and an additional year of protection for new indications of existing products.This period of protection is not limited to chemical entities and also extends to biologics.Under this formula of data and market

226、exclusivity,the EUs practice has matched that of the Index benchmark,and all EU member states have achieved the maximum available score of 1.00 for this indicator.As Table 3 shows,the latest edition of the Index includes 10 EU member states.Table 3:EU Member States Included in the Twelfth Edition of

227、 the Index FranceGermanyGreeceHungaryIrelandItalyThe NetherlandsPolandSpainSwedenWhat would the impact of the commissions proposal be on these Index economies Index scores and specifically the scores for indicators 5 and 25?As discussed,under the current commission proposals,the effective term of RD

228、P would be reduced from 10 years to 8 years.This would result in a reduction of 0.20 for indicator 25.Similarly,the reduction in effective patent protection for pharmaceuticals due to the expansion of the Bolar exemption will result in a reduction of 0.25 to 0.50 for indicator 5 depending on the imp

229、lementation in each jurisdiction.As with all EU legislation,substantial differences can exist among EU member states in how the relevant statute is transposed and/or interpreted in national courts.How such implementation and interpretation take place will determine the total impact of these legislat

230、ive changes on the national IP environment and accompanying score for this indicator.The estimated score reduction is based on an average score of the midpoint score between a 0.5 reduction and a 0.25 reduction.Figure 1 shows the results of this reduction for all 10 EU member states included in the

231、Index.37|International IP IndexFigure 1:Current Scores,Indicators 5 and 25,Select Index Economies and EU Member States versus Estimated Score Reduction,EU Member States(Current Scores in Teal;Estimated Reduced Scores in Navy)Index maximum scoreUnited StatesSingaporeSwitzerlandUnited KingdomEU Member

232、 States current scoreJapanSwedenSpainPolandThe NetherlandsItaly IrelandHungaryGreeceGermanyFrance20%10%0%30%40%50%60%70%80%90%100%100%87.5%75%75%75%75%65%58.75%58.75%58.75%58.75%58.75%58.75%58.75%58.75%58.75%58.75%It is also possible to broaden this comparative analysis and to estimate the negative

233、impact of the commissions proposal on the total national IP environment as it relates to biopharmaceutical IP rights measured in the Index.This broadens the analysis to include two additional indicators:6.Legislative criteria and use of compulsory licensing of patented products and technologies and

234、7.Patent term restoration for pharmaceutical products.Figure 2 shows the results of this reduction for all 10 EU member states included in the Index.38|International IP IndexFigure 2:Current Scores;Indicators 5,6,7,and 25;Select Index Economies and EU Member States versus Estimated Score Reduction,E

235、U Member States(Current Scores in Navy;Estimated Reduced Scores in Teal)Index maximum scoreUnited StatesSwitzerlandSingaporeEU Member States current scoreJapanUnited KingdomSwedenSpainPolandThe NetherlandsItaly IrelandGermanyFranceHungaryGreece20%10%0%30%40%50%60%70%80%90%100%100%93.75%87.50%87.50%8

236、2.50%82.50%76.25%73.13%73.13%73.13%73.13%73.13%73.13%73.13%73.13%48.13%48.13%As Figure 1 shows,the adoption of the commissions proposals as currently drafted would result in a reduction of 16.25%for all EU member states for these two indicators from 75%of the maximum available Index score to 58.75%.

237、Compared with other Index economies,it would result in the national IP environment in all 10 EU member states for these two indicators becoming weaker than the United States,Singapore,Switzerland,the UK,and Japan.39|International IP IndexCurrently,all EU member states score is tied with or higher th

238、an all these comparator economies with the exception of the United States.Similarly,Figure 2 shows that broadening this analysis would result in a negative impact and reduction in all EU member states score.Currently,the average score for all 10 EU member states for these indicators is 82.50%;this s

239、core ranks higher than those for both Japan and the UK.Under the commissions proposals,this would drop to 73.13%,and all EU member states would rank in the bottom below other comparator economies.Although the General Pharmaceutical Legislation aims to create a 21st-century life sciences landscape th

240、at fosters innovation and enhances patient access,the proposed legislation will fundamentally weaken the ecosystem for biopharmaceutical innovation.Over time,such action will hollow out the national IP environment and framework for future biopharmaceutical innovation.With fewer resources,it stands t

241、o reason that biopharmaceutical manufacturers will have less to invest in R&D and will be less likely to develop new biopharmaceutical products and services at the same rate as in the past.The negative effect will be felt most keenly in the EU,which will continue to see rates of biopharmaceutical R&

242、D and clinical research drop.Before the commission moves forward with its reform efforts,it should pause and consider the full ramifications of its proposed policies.The Index will continue to monitor these developments in 2024.40|International IP Index Overall Results and Category-by-Category Score

243、sUp or down?How have economies fared in this edition of the Index?Table 4 shows the overall results for the twelfth edition of the Index and how they compare to last years edition.41|International IP IndexTable 4:Change in Overall Score,Twelfth Edition versus Eleventh EditionEconomyTwelfth editionEl

244、eventh editionChange in overall scoreUnited States95.48%95.48%0.00%UK94.12%94.14%0.02%France93.12%93.12%0.00%Germany92.46%92.46%0.00%Sweden92.12%92.14%0.02%Japan91.26%91.26%0.00%The Netherlands91.24%90.70%0.54%Ireland89.38%89.36%0.02%Spain86.44%86.44%0.00%Switzerland85.98%86.00%0.02%South Korea84.94

245、%84.44%0.50%Singapore84.92%84.94%0.02%Italy83.90%83.90%0.00%Australia80.70%80.68%0.02%Hungary76.90%76.90%0.00%Canada76.22%75.72%0.50%Israel72.74%72.72%0.02%Greece71.42%70.92%0.50%Poland70.74%70.74%0.00%New Zeland69.36%69.28%0.08%Taiwan67.34%66.31%1.03%Morocco62.76%62.26%0.50%42|International IP Inde

246、xEconomyTwelfth editionEleventh editionChange in overall scoreMexico59.98%58.98%1.00%China57.86%57.86%0.00%Dominican Republic55.30%54.28%1.02%Costa Rica55.04%54.56%0.48%Malaysia53.44%53.44%0.00%Trkiye51.04%51.07%0.03%Peru49.82%49.82%0.00%Chile49.72%49.72%0.00%Colombia48.84%48.84%0.00%Saudi Arabia48.

247、42%42.38%6.04%Brazil46.52%42.02%4.50%UAE46.00%46.00%0.00%Jordan44.70%44.70%0.00%Honduras42.16%42.16%0.00%Philippines41.58%41.58%0.00%Brunei41.08%41.08%0.00%Ghana40.88%40.88%0.00%Vietnam40.76%40.74%0.02%Ukraine40.30%39.74%0.56%India38.64%38.64%0.00%Thailand38.28%38.28%0.00%Kenya37.88%37.36%0.52%South

248、 Africa37.28%37.28%0.00%Argentina37.00%37.00%0.00%43|International IP IndexEconomyTwelfth editionEleventh editionChange in overall scoreNigeria36.34%33.34%3.00%Egypt33.86%32.82%1.04%Indonesia30.40%30.42%0.02%Ecuador29.58%30.68%1.10%Kuwait28.42%28.42%0.00%Pakistan27.42%27.42%0.00%Algeria26.36%26.36%0

249、.00%Russia25.00%25.02%0.02%Venezuela14.10%14.10%0.00%Like last year,in this years Index,about half of all economies saw their overall scores change.Of the 55 economies included in the eleventh and twelfth editions,this year,there was no score change in 27 economies,20 economies saw an improvement,an

250、d in 8 economies the overall Index score dropped.Most of these changes were movements of less than 1%.This compares to the“big bangs”of recent preceding yearseditions 9 and 10when there was more substantial score movement.However,like last year and all preceding editions of the Index,this does not m

251、ean that no meaningful score developments occurred in 2023.On the contrary,three economiesBrazil,Nigeria,and Saudi Arabiasaw score improvements of 4.50%,6.04%and 3%,respectively.These are substantial and noteworthy improvements,especially for the latter two economies,which have over the course of th

252、e Index persisted with substantive reforms to their respective national IP environments.Since its inception in 2017-2018,the Saudi Authority for Intellectual Property(SAIP)has worked on improving the national IP environment.As detailed here,SAIPs reform efforts cut across the categories of the Index

253、,with improvements ranging from rightsholders ability to enforce their rights more effectively to expanding the institutional framework and systemic governance of IP rights and related industries.These improvements are reflected in the Kingdoms overall score increase over the past five years.Before

254、SAIPs reform efforts,Saudi Arabia achieved an overall Index score of 36.60%in the seventh edition of the Index.Today,that score has increased to an overall score of 48.42%.Although this does not mean that rightsholders face no challenges in Saudi Arabiathe overall score remains below 50%of the avail

255、able scorethese are nevertheless real and meaningful improvements to the Saudi national IP environment.The Saudi government and SAIP should be commended for their efforts.44|International IP IndexSimilarly,Nigeria has over the past five editions of the Index seen its overall Index score improve from

256、 27.62%in the eighth edition of the Index to 36.34%today.This follows targeted reform efforts related to Category 1:Patents,Related Rights,and Limitations;Category 2:Copyrights,Related Rights,and Limitations;and Category 9:Membership and Ratification of International Treaties.Of the eight economies

257、whose scores dropped,only one,Ecuador,saw a drop of more than 1%.As a result,Ecuador achieves an overall score of 29.58%in this years Index and is now roughly back to the same level of performance it had five years ago.However,the lack of large movements in overall scores does not mean that the glob

258、al IP environment in 2023 stood still.As the following subsections and the individual Economy Overviews in Section 5 detail,a striking number of Index economies put forth policy proposalsboth positive and negativethat,if implemented,would amount to substantial overall score changes in coming edition

259、s of the Index.45|International IP Index Category 1:Patents,Related Rights,and LimitationsFigure 3 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 maxi

260、mum possible score of 9.Figure 3: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%8.3316.6722.2222.2227.7830.2232.2233.1733.1733.3333.3333.3333.3335.9436.1136.1136.1138.8943.7244.4447.2247.2247.2247.2250.0050.0055.395

261、5.5661.1163.3363.6163.8970.8372.2275.0075.0078.3380.5680.8383.3383.3388.8991.6791.6791.6791.6791.6791.6791.6791.6794.4494.4494.4494.4497.22VenezuelaRussiaAlgeriaSouth AfricaParkistanThailandArgentinaEcuadorIndiaIndonesiaKuwaitNigeriaVietnamEgyptBrazilHondurasUkraineGhanaChileTrkiyeMalaysiaPeruPhilip

262、pinesUAEColombiaKenyaSaudi ArabiaMexicoBruneiDominican RepublicCosta RicaJordanMoroccoNew ZealandHungaryPolandCanadaGreeceChinaAustraliaIsraelItalyFranceGermanyIrelandNetherlandsSpainSwedenTaiwanUKU.S.SwitzerlandSouth KoreaJapanSingapore46|International IP IndexAs in past editions,the overall result

263、s for Category 1 are still one of the strongest of all the categories included in the Index.Twenty-three economies achieved a score of 70%or more of the available score,and 31 economies in total achieved a score of 50%or more.The average score in the category is 59.62%,which is the fifth highest-sco

264、ring category in the Index.As in years past,Singapore is ranked number one,ahead of Japan,South Korea,Switzerland,and the United States.As noted in previous editions and detailed in its Economy Overview,the patenting environment in the United States continues to be held back by uncertainty over what

265、 constitutes patent-eligible subject matter and patent nullity proceedings through the inter partes review,which occurs before the specialized Patent Trial and Appeals Board within the U.S.Patent and Trademark Office(USPTO).Since the Supreme Court decisions in the Bilski,Myriad,Mayo,and Alice cases,

266、there has been a high and sustained level of uncertainty about which inventions are patentable in the United States.Efforts to address this long-standing problem continued in 2023.Most promisingly,the Patent Eligibility Restoration Act(PERA)and Promoting and Respecting Economically Vital American In

267、novation Leadership Act(PREVAIL Act)were introduced into the Senate by Senators Tillis and Coons.As discussed with respect to previous iterations of the draft bills,the proposed legislation marks a significant breakthrough on the legislative front.Both drafts address many of the long-standing areas

268、of concern and uncertainty over what constitutes patentable subject matter in the United States as well as the uncertainty and unpredictability caused by the Patent Trial and Appeals Board.At the time of research,the proposed laws had not been passed by Congress or signed into law by President Biden

269、.In other economies,rightsholders also continued to face uncertainty and a challenging environment.As detailed over the course of the Index and in the preceding section,there continues to be a high degree of uncertainty regarding the availability of patent term restoration in the EU and the UK.Regul

270、ation 2019/933 remains in force,and the SPC export exemption is legal and operational in all EU member states.With respect to the UK,although the British government now has the sovereignty and power to effectively shelve Regulation 2019/933,it has instead chosen to maintain the EU SPC exemption.In B

271、razil,rightsholders continued to face many basic challenges in registering and protecting patent-eligible subject matter in 2023.Above all,there has been no resolution with respect to the provision of a TRIPS-compliant minimum term of patent protection.Given the Brazilian Patent and Trademark Office

272、,INPI,has historically had a long backlog of patent applications,Article 40 of the Industrial Property Law had up until 2021 provided innovators in Brazil with a guaranteed minimum term of exclusivity and protection of 10 years from grant for standard patents.In a series of decisions in the spring o

273、f 2021,the Brazilian Supreme Court removed this floor.Not only did the court declare that Article 40 was unconstitutional and would no longer be available or applicable,but the court also stated that the ruling should be retroactively applied but only to granted patents in the biopharmaceutical and

274、health-related fields.As noted in the Index since the ruling,the Supreme Courts judgment is a grave blow to Brazils national IP environment with thousands of biopharmaceutical rightsholders discriminated against and exclusivity periods cut short.Through this decision,the Brazilian Supreme Court has

275、further weakened Brazils standards of patent protection,and the selective retroactive application of the ruling to one field of technology and innovation is a violation of Article 27(1)of the TRIPS treaty and established international principles of nondiscrimination.In response to this situation,clo

276、se to 50 lawsuits have been filed across Brazil with rightsholders from the life sciences and health sector arguing for an extension of a granted patent term because of continued delays in patent prosecution.Unfortunately,these lawsuits have not led to any further clarity on the matter.47|Internatio

277、nal IP IndexIn a positive development,in April 2023,a federal court in Rio de Janeiro granted an adjustment of close to one year to the term of a granted patent,finding that there had been undue delay in the granting of the patent.In contrast,and although the facts of the case and legal issue at han

278、d were different,in January 2023,a Supreme Court panel ruling found that rightsholders did not have the right to extend a patent term of protection beyond 20 years from filing,irrespective of the time of grant.The bottom line is that rightsholders continue to face deep uncertainty about whether they

279、 will be able to effectively register and protect their innovations in Brazil.Discussions on restricting and curtailing patent rights also took place in Pakistan in 2023.In late 2022,the Intellectual Property Organization of Pakistan,IPO-Pakistan,published draft amendments to the Patent Ordinance.Th

280、ese proposed amendments make substantive changes to Pakistans legal regime for patents,including with respect to patentable subject matter.As noted over the course of the Index,patentability standards in Pakistan have for some time stood outside of international norms,especially with respect to high

281、-tech arts such as computer software and biopharmaceuticals.Unfortunately,under the draft amendments,a revised Section 7 proposes to further limit or eliminate the potential patentability of computer-implemented inventions(CIIs)and biopharmaceutical innovation.Under the existing Patent Ordinance,CII

282、s were not excluded as such,and the possibility remained to seek patent protection for CIIs.However,the new amendments explicitly exclude“computer programs”as inventions.Given that computer software and CIIs are at the heart of virtually all socioeconomic activity,including desktop PCs,smartphones,a

283、rtificial intelligence,and the Internet of Things,it is hard to see how eliminating patent eligibility for computer programs will help drive investment and resources into developing new digital and information and communication technology(ICT)-based technologies in Pakistan.Similarly,a new Subsectio

284、n(7(4)(f)related to biopharmaceutical inventions would eliminate the patentability of a“new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance.”This would appear to restrict the eligibility of incremental biopharmaceutical innov

285、ation,including changes to form and application of a known substance.This is a curious change because incremental innovation is an essential part of the biopharmaceutical R&D process.Follow-on medications and incrementally improved or altered therapies frequently reduce side effects,improve existing

286、 delivery systems or the administration of a medicine,increase effectiveness,and reduce dosages required.Without incremental innovationand the IP rights that drive investment and resources into developing themthe world would not have access to the latest generations of some of the most used medicine

287、s and medical devices.This includes,for example,insulin and insulin pumps,beta-blockers,ACE inhibitors,contraceptives,statins,zoledronic acid,and countless other commonly used biopharmaceutical products and devices.It is hard to see how this type of innovation should not be eligible for patent prote

288、ction.Should these amendments be enacted into law,Pakistans scores for indicators 2 and 3 will be reduced.In a positive move,the proposed amendments would eliminate Section 23 and the system of pregrant oppositions in Pakistan.Under existing patent statute,an inter partes opposition system is in pla

289、ce that can be triggered within four months after an application is published.If adopted in their current form,amendments to the Patent Ordinance would result in a score rise for indicator 9.Similarly,as has been detailed for over a decade in the Index,rightsholders in India face many basic challeng

290、es in registering and protecting patent-eligible subject matter.Most notably,Indian patent law has in place an additional requirement to patentability that goes beyond the required novelty,inventive step,and industrial applicability requirements.48|International IP IndexUnder Section 3(d)of the Indi

291、an Patent Act,there is an additional“fourth hurdle”regarding inventive step and enhanced efficacy that limits patentability for certain types of pharmaceutical inventions and chemical compounds.Several court cases have established an interpretation of Indian patent law whereby Section 3(d)can be ful

292、filled only if the patent applicant can show that the subject matter of the patent application has an improved therapeutic efficacy compared with the structurally closest compound as published before the patent application had been filed(regardless of whether a patent application for the earlier com

293、pound was filed in India).More broadly,this interpretation and case law also deny patentees with protection that goes substantially beyond what was specifically disclosed in the patent application.Compounds that fall within a chemical formula of a claimed group of compounds in a patent application,b

294、ut that are not specifically disclosed in the patent,could be regarded as not protected.Similarly,the environment for protecting CIIs in India has historically been marred by uncertainty.The Patent Act excludes“a mathematical or business method or a computer program per se or algorithms”as patentabl

295、e subject matter.Equally,old guidance documents,including the Indian patent manual,did not provide clarity on the extent to which CIIs were patentable.Over the past decade,new patent guidelines have been published.Unfortunately,these were not always consistent,with some more restrictive than others.

296、The latest available document published in 2017,“Guidelines for Examination of Computer Related Inventions(CRIs),”significantly improved the patenting environment for CIIs in India.Unlike previous drafts of the guidelines,there was no requirement for hardware innovation.On this basis,the score for i

297、ndicator 3 increased by 0.50 in the sixth edition of the Index.Yet,the uncertainty over what CIIs and subject matter remain eligible for patent protection and what constitutes a technical effect within the context of computer software persists.The problem is highlighted by a 2023 court order by the

298、Delhi High Court(Microsoft Technology Licensing,LLC v.The Assistant Controller of Patents and Designs)finding that the Controller General had wholly misunderstood the meaning of Section 3(k)of the Patent Act and wrongly rejected the plaintiffs patent application.In a separate development,in August 2

299、023,the Controller General opened a public consultation on potential revisions to most of the offices manuals and guideline documents.This includes the existing Patent Manual and biopharmaceutical and CII guidelines.At the time of research,no formal draft proposal had been made available to the publ

300、ic.In an additional and positive development,in August,the Controller General published the“Draft Patents(Amendment),Rules,2023.”The proposed changes include some improvements to the existing opposition mechanisms,including introducing more defined timelines and vesting more discretion with the Cont

301、roller General as to the“maintainability of the representation”of the opposition.As noted over the course of the Index,the pregrant patent opposition mechanism in India has long been criticized for adding significantly to the already lengthy patent prosecution timelines,a fact acknowledged by the Pr

302、ime Ministers Economic Advisory Council(EAC-PM)2022 report Why India Needs to Urgently Invest in its Patent Ecosystem.The proposed“Draft Patents(Amendment),Rules”also make changes to Form 27.This requires that patent holders annually provide information on the extent to which a granted patent has be

303、en worked by patentees and licensees.As noted in the Index at the time,in 2020,a new Form 27 was introduced.Overall,this was a positive change.The new form removed questions pertaining to licenses and made it possible to file one form for several patents related to the same invention.Still,the form

304、retained questions about the approximate value as either manufactured or imported into India.In a positive move,the 2023 draft changes not only propose to remove any questions related to the approximate value of the patented technology but also clarify that the importation of an invention does not m

305、ean that it is“not worked”in India.Both the changes to Indias opposition proceedings and Form 27 are important and have the potential to improve Indias national IP environment.49|International IP IndexCategory 2:Copyrights,Related Rights,and LimitationsFigure 4 summarizes the total scores for Catego

306、ry 2.This category measures the strength of an economys environment for Copyrights,Related Rights,and Limitations.The category consists of seven indicators with a maximum possible score of 7.Figure 4:Category 2:Copyrights,Related Rights,and Limitations,%Available Score0.00%10.00%20.00%30.00%40.00%50

307、.00%60.00%70.00%80.00%90.00%100.00%0.0018.2921.8621.8623.2923.2923.2924.8625.4326.1427.7130.4332.5732.5733.4335.5735.9036.1436.1437.5738.8639.1039.5739.6639.7142.6742.7143.2943.2945.1446.2946.8648.2949.8653.4354.1462.5764.1064.7166.1468.4370.1471.8076.8680.4381.9584.0085.5785.5790.7191.1492.7194.719

308、6.2996.43U.S.SingaporeUKFranceGermanySwedenSouth KoreaNetherlandsAustraliaJapanIrelandSpainNew ZealandItalyCanadaIsraelMalaysiaGreeceHungaryMexicoMoroccoCosta RicaSwitzerlandSaudi ArabiaPeruPolandKenyaChinaNigeriaGhanaThailandKuwaitIndonesiaDominican RepublicIndiaBrazilTaiwanSouth AfricaHondurasTrki

309、yeColombiaUAEPhilippinesChileJordanUkraineVietnamEcuadorVenezuelaEgyptArgentinaBruneiAlgeriaPakistanRussia50|International IP IndexHistorically,Index economies have not performed well in Category 2.Although most Index economies continue to score poorly in this category,the average score in this cate

310、gory improved from 49.70%last year to 50.61%in 2023.As detailed here and in the individual Economy Overviews,many Index economies saw notable improvements to their copyright environments after legislative reforms and/or stronger enforcement measures.Although challenges remain,this is an important an

311、d positive achievement.As noted in past editions of the Index,one driver of this development is the increased use of injunctive-relief mechanisms.Ten years ago,rightsholders across the globe were struggling to effectively enforce their copyrights against online piracy.Beginning in the mid-to late 19

312、90s,advances in computer-based technology and the advent of the internet fundamentally changed how creative goods are consumed and accessed by consumers.In a growing number of the worlds economies,internet penetration and the use of mobile devices are almost ubiquitous.Even in developing economies t

313、hat often lack sophisticated technological infrastructure,consumers can access a growing range of digital services and content through mobile devices.The growth and scale of online piracy since the late 1990swhether through downloading,streaming,or some other technologyhave mirrored this growth in b

314、roadband and mobile device connectivity.The scale and volume of online infringement have resulted in a growing strain and burden on rightsholders to effectively protect their content and economic rights.Since the early 2010s,rightsholders have identified and successfully applied injunctive-style rel

315、ief to combat online infringement.Injunctive-style relief gives rightsholders the option of seeking redress for an infringement of copyright either through a court of law or,administratively,through a government authority.The mechanism can look and work differently depending on the legal jurisdictio

316、n,but the result is an order to disable access to the infringing content.The past decade has seen a sharp increase in the number of economies that use this type of mechanism to effectively disable access to infringing content.Today,many EU member states,the UK,India,Singapore,Canada,and a host of ot

317、her Index economies have introduced measures that allow rightsholders to seek and gain effective relief against copyright infringement online.These injunctions are often categorized as either static or dynamic.Static injunctions are the most common form.These actions are against a known copyright in

318、fringer and seek relief for a specified infringement action.However,many of these economies are also introducing dynamic injunctions.Such an injunction addresses the issue of mirror sites and disables infringing content that reenters the public domain by simply being moved to a different access poin

319、t online.Dynamic injunctive relief is an especially important tool for rightsholders of live-streamed content,such as sporting events,concerts,and televised specials.In welcome news,more Index economies introduced or extended the application of these types of injunctions in 2023.In May 2023,a federa

320、l court in Argentina not only ordered the disabling of access to several copyright infringing websites but also included a dynamic element in the order.The plaintiffsled by a coalition of international,regional,and domestic rightsholdersspecifically requested that the injunction include the ability

321、to update and apply the disabling of access to new websites and URLs as and when they appear.As noted over the course of the Index,rightsholders have historically faced significant challenges in protecting their copyrighted content in Argentina.The existing legal framework has major gaps,and enforce

322、ment remains inadequate.The granting of this court order is potentially of real significance because the judgment not only affirmed the right to injunctive relief online but also included the dynamic element and ability to quickly update the court order without having to restart legal proceedings.51

323、|International IP IndexIt is hoped that this enforcement route will now be available to rightsholders more broadly and will provide a clear and expeditious path for creators to enforce their rights in Argentina.Similarly,in Brazil,rightsholders also saw several positive developments with respect to

324、the availability of injunctive relief targeting online piracy.In late 2022,a court in So Paulo ordered the disabling of access to several websites that offered access to infringing materials.This order included a dynamic element.In addition,the Brazilian National Telecommunications Agency,Anatel,lau

325、nched a dedicated campaign against illicit IPTV set-top boxes.As in many other economies benchmarked in the Index,Brazil has seen an explosion in the growth and use of these physical boxes and the internet-based applications that provide users with copyright infringing content.In February 2023,Anate

326、l announced an“Action Plan to Combat the Use of Clandestine TV Boxes”that gives the agency a dedicated enforcement function to locate and disable these illegal set-top boxes.In September,Anatel announced that it had operationalized a dedicated laboratory and testing site to assist in these efforts.T

327、he agency is reportedly targeting both the physical devices and their streaming applications online and had at the time of research seized almost 1.5 million illegal set-top boxes and disabled access to hundreds of illicit access points.Additionally,in Canada,rightsholders continued to obtain injunc

328、tions against online providers of copyright infringing content.In late 2022,the federal court issued another order in relation to illegal streaming of the FIFA World Cup,and in July 2023,the court ordered the disabling of access to the illegal streaming of major league baseball games.Significantly,b

329、oth these orders included a dynamic element.Authorities in Saudi Arabia also maintained their commitment to supporting strong enforcement efforts against copyright infringement and online piracy.The national IP office SAIP works directly with rightsholders both as an intermediary,referring cases of

330、infringement to relevant Saudi enforcement authorities,and as an administrative enforcement authority in its own right.Specifically,SAIP has made the disabling of access to copyright infringing content online a major part of its enforcement remit.Historically,the disabling of access to web content,i

331、ncluding copyright infringing content,occurred sporadically through the Ministry of Culture and Information.Today,SAIP offers a portal through which rightsholders can directly communicate any suspected online infringement to the Authority,which will then investigate and take enforcement action.This

332、positive work continued in 2023,as the Authoritys latest Annual Report of Intellectual Property Enforcement for the Year 2022 shows both the scale and magnitude of the SAIPs enforcement efforts.With respect to copyright enforcement,in 2022,the Authority ordered the disabling of access to close to 1,

333、500 websites and online access points,almost double the number of orders issued in 2021 and five times the number in 2020.Some notable legislative and policy developments occurred in 2023,including criminal causes of action and greater sanctions for copyright infringement.As mentioned last year,the pirating of film and audiovisual content through illicit camcording has historically been a major ch