1、RECOVERY THROUGH INGENUITY|2021 NINTH EDITIONINTERNATIONAL2021 Ninth Edition|2U.S.CHAMBER INTERNATIONAL IP INDEX 2021The 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 glo

2、bal economic growth,and generating breakthrough 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 associat

3、ions.This report was conducted 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,Managin

4、g Director and Founder|Prof.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

5、the University of Maastricht in the Netherlands;as well as a Professor at the School of Pub-lic 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,intellectu

6、al property management,pharmacoeconomics,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.Torstenss

7、on specializes in innovation,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 advoc

8、acy plans.He is the author of a number of academic and commissioned reports and publications and is the co-author of all nine editions of the U.S.Chamber International IP Index.Copyright 2021 by the U.S.Chamber of Commerce.All rights reserved.No part of this work,covered by the copyrights herein,may

9、 be reproduced or copied in any form or by any meansgraphic,electronic,or mechan-ical,including photocopying,recording,taping,or information and retrieval systemswithout the permission of the C THROUGH INGENUITYCONTENTS 1.FOREWORD2.EXECUTIVE SUMMARY 3.OVERVIEW OF THE NINTH EDITION4.THE GLOBAL IP ENV

10、IRONMENT IN 20205.OVERALL RESULTS AND CATEGORY-BY-CATEGORY SCORES6.ECONOMY OVERVIEWSAPPENDIX:METHODOLOGY,SOURCES,AND INDICATORS EXPLAINEDTABLES AND FIGURES Table 1:Ninth edition Index economies by World Bank regionTable 2:Ninth edition Index economies by World Bank income groupTable 3:Change in over

11、all score,eighth edition versus ninth editionFigure 1:Association between the Index scores and the Global Competitiveness Report 2019,Innovation Capability Pillar scoresFigure 2:Association between Index scores and the Global Innovation Index 2018,Innovation Output sub-index scoresFigure 3:Associati

12、on between the Index life sciences-related indicators scores and clinical trial activity Figure 4:Association between the Index life sciences-related indicators scores and early-phase clinical trial activityFigure 5:Association between the Index life sciences-related indicators scores and biological

13、 clinical research intensity?American WorldView scores?Figure 9:Category 1:Patents,Related Rights,and Limitations,percentage available scoreFigure 10:Category 2:Copyrights,Related Rights,and Limitations,percentage available scoreFigure 11:Category 3:Trademarks,Related Rights,and Limitations,percenta

14、ge available scoreFigure 12:Category 4:Design Rights,Related Rights,and Limitations,percentage available score?available scoreFigure 14:Category 6:Commercialization of IP Assets,percentage available scoreFigure 15:Category 7:Enforcement,percentage available score?2021 Ninth Edition|4U.S.CHAMBER INTE

15、RNATIONAL IP INDEX 20212021 OVERALL SCORESTurkeyColombiaChileRussiaPeruJordanBrazilUAEBruneiSaudi ArabiaPhilippinesUkraineIndiaVietnamKenyaArgentinaSouth AfricaThailandEgyptEcuadorIndonesiaKuwaitNigeriaAlgeriaPakistanVenezuela100.00%90.00%80.00%70.00%60.00%50.00%40.00%30.00%20.00%10.00%0%26.4527.432

16、6.4327.8630.1630.6014.1032.5935.5636.6136.7737.2537.4938.4039.5439.8140.3841.1341.9842.3244.5346,56 THROUGH INGENUITYUnited StatesUnited KingdomGermanyFranceJapanSwedenNetherlandsIrelandSwitzerlandSpainSingaporeSouth KoreaItalyAustraliaHungaryCanadaIsraelGreecePolandNew ZealandTaiwanMoroccoMexicoChi

17、naCosta RicaDominican RepublicMalaysia51.6154.3254.4654.8658.2559.6266,1869.1070.5070.6772.5774.7178.2380.5583.1583.7384.3884.6885.8288.8690.0290.9291.12 91.4392.2793.9095.312021 Ninth Edition|6U.S.CHAMBER INTERNATIONAL IP INDEX 20211FOREWORD Every day,innovators and creators wake up ready to de-liv

18、er the next big thing;They go to bed thinking about what challenge theyre going to tackle next.They chan-nel their passion and their talent in a million different ways all so we can live healthier,more productive,?Last year,COVID-19 effectively condensed every avenue for innovation into one:Defeat t

19、he COVID-19 pandemic.Innovators didnt panic,they pivoted,and poured every resource into our global emergency response.?-tive diagnostic tests,therapeutics,and vaccines:all the tools our doctors and nurses need to serve patients and their families.The wireless technology community fast tracked implem

20、entation of 5G to keep us connected and protected as we learned to work and learn from home.The entertainment,publishing,and arts com-munity produced new content to enrich our lives as we adjusted to our new normal.DAVID HIRSCHMANNNone of it was easy all of it was important.The human impact of intel

21、lectual property-intensive industries is truly immeasurable.That doesnt mean its not tangible.Through our global intellectual property(IP)system we value innovators contributions to society and assure them that their investments are worthy of the risk required to make them.The Index describes this f

22、unction of the global IP system?-tion ecosystem even further.The Index recognizes that with a robust global IP system in place,we can harness innovation for good to control COVID-19 and restore our world to health.Recovery through ingenuity is within our grasp if we just enable innova-tors and creat

23、ors to keep THROUGH INGENUITY2EXECUTIVE SUMMARY The COVID-19 pandemic upended life as we knew it.As global citizens adjusted to living through a global pandemic,intellectual property played an essentialif oftentimes underappreciatedrole in the creation and development of technological and creative s

24、olutions.Treatments and vaccines for coronavirus were devel-?-nitys ability to make high-risk,high-capital investments in R&D.As we adjusted to the way we work,teach,and connect with others,IP-enabled digital technologies allowed us to remain connected to one another,even if in isolation.And while m

25、any of us spent much of the year in quarantine,the development of new stream-ing services and creative content provided both a wel-come escape and brought us together.Throughout GEOGRAPHIC COVERAGE AlgeriaIndonesiaRussiaArgentinaIrelandSaudi ArabiaAustraliaIsraelSingaporeBrazilItalySouth AfricaBrune

26、iJapanSouth KoreaCanadaJordanSpainChileKenyaSwedenChinaKuwaitSwitzerlandColombiaMalaysiaTaiwanCosta RicaMexicoThailandDominican RepublicMoroccoTurkeyEcuadorNetherlandsUnited StatesEgyptNew ZealandUAEFranceNigeriaUnited KingdomGermanyPakistanUkraineGreecePeruVenezuelaHungaryPhilippinesVietnamIndiaPol

27、andthe pandemic,transparent and predictable IP rights have also provided the legal and economic basis for an unprecedented level of highly successful collabo-rations between government,industry,academia,and non-governmental organizations.In this context,being able to measure how equipped economies a

28、re to generate and safeguard innovation and creativity is more important than ever before.Now in its ninth edition,the International IP Index bench-marks the IP framework in 53 global economies across 50 unique indicators.An effective IP system,as outlined by the criteria evaluated in the Index,will

29、 be critical to rebuilding healthy communities,getting citizens back to work,and reinvigorating the global economy.2021 Ninth Edition|8U.S.CHAMBER INTERNATIONAL IP INDEX 2021IP enabled the development of a pipeline of thera-peutics solutions to combat COVID-19.While the vaccines currently authorized

30、 for use against COVID-19 use novel technologies,they?made possible by effective IP that has now been successfully applied during the pandemic.Of the over 1,600 active COVID-19 clinical trials,almost two-thirds tested existing medicines regis-tered for a different indication,illustrating the ways IP

31、 enables follow-on innovation.Vaccines and therapeutics were developed at un-precedented speed because of the unprecedented scale of public-private partnership.As governments pivot their focus to the distribution of the vaccine,IP will be critical to facilitating licensing and technolo-gy transfer w

32、hile also expediting the manufacturing and delivery of vaccines and therapeutics.While IP was critical to the global response to COVID-19,economies took steps to undermine the framework that successfully enabled coronavirus-re-lated innovation.In Israel,Hungary,and Russia,governments issued compulso

33、ry licenses for COVID-19 therapeutics.Other economies,including Chile,Colombia,and Indonesia called for or enacted new laws that ex-pand the criteria for compulsory licensing.At the World Trade Organization(WTO),India and South Africa issued a proposal to waive IP rights on all COVID-19 related medi

34、cines,devices,and technologies through the TRIPS Council waiver KEY FINDINGSOver recent years,the international IP environment has continued to strengthen,despite some negative developments resulting from certain governments responses to COVID-19.In the 2021 report,32 of the 53 economies bench-marke

35、d had positive improvements in their scores.Since the second edition of the Index in 2014,the aggregated score of the economies benchmarked has improved 6.24%.Of the BRICS economies included since the in-augural edition of the Index in 2012,China and India have improved the framework for IP-driv-en

36、innovation and creativity.In that time,Chinas score has increased 18.34%while Indias improved 13.44%.However,despite this positive progress,?in both markets.Trade agreements continue to substantively improve national IP frameworks.These changes,if implemented effectively,should improve Chinas domest

37、ic IP framework.Howev-er,ongoing market access barriers,uneven en-forcement,measures requiring forced technology?continue to make the business environment in Chi-na highly challenging for rightsholders.As a result of the implementation of some com-mitments in the U.S.-Mexico-Canada Agreement(USMCA),

38、Mexico had the second largest overall increase in score at 3.87%due to legislative changes to improve copyright and trademark protection and the commercialization of IP assets.However,Mexico forfeited more substantive gains for life sciences IP protection when critical protec-? THROUGH INGENUITYCATE

39、GORY-BY-CATEGORY RESULTS Patents,Related Rights,and LimitationsTwenty-one economies achieve a score of 70%or more of the available score and 31 economies in total achieve a score of over 50%.?Alice-related technologies.Additionally,USPTO proposed changes to the inter partes review process on patent

40、validity challenges.In China,the government passed amendments to the Patent Law which outline Chinas new patent linkage regime and introduce patent term restoration for biopharmaceuticals.?In India,the government streamlined reporting requirements for patent holders under the Form 27 scheme.0.00%10.

41、00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%SingaporeJapanSouth KoreaSwitzerlandUnited StatesFranceGermanyIrelandNetherlandsSpainSwedenTaiwanUnited KingdomItalyHungaryAustraliaIsraelChinaGreeceCanadaPolandNew ZealandMoroccoJordanCosta RicaDominican RepublicBruneiRussiaColombiaKenyaSaud

42、i ArabiaMexicoPeruPhilippinesUAETurkeyChileMalaysiaEgyptUkraineBrazilIndonesiaKuwaitVietnamEcuadorIndiaArgentinaThailandPakistanAlgeriaNigeriaSouth AfricaVenezuela97.2294.4494.4494.4494.4491.6791.6791.6791.6791.6791.6791.6791.6788.8986.1183.3383.3380.8380.5678.3375.0071.7870.8363.8963.6163.3361.1155

43、.5650.0050.0050.0049.8347.2247.2247.2244.4443.7241.6736.1136.1135.9433.3333.3333.3333.1733.1732.2230.2227.7822.2222.2222.228.332021 Ninth Edition|10U.S.CHAMBER INTERNATIONAL IP INDEX 2021Copyrights,Related Rights,and LimitationsThe global environment for creators and copyright holders continues to b

44、e challenging,with 32 of the 53 econo-mies failing to reach 50%of the total available score.However,there were a number of positive copyright reforms in Index economies over the last year.As a result of the USMCA,both Mexico and Canada introduced copyright reforms.While the Canadian gov-ernment exte

45、nded the term of protection for some copyrighted works,the Mexican government introduced more substantive reforms to the Federal Law on Copyright.New amendments to the Chinese Copyright Law strengthened the legal framework for sound and broad-casting,improved provisions on technological protection m

46、easures(TPMs)and digital rights management(DRM)and increased statutory damages for copyright infringement.In Costa Rica,the government developed a new software asset management platform to ensure that all central government ministries use fully licensed software.0.00%10.00%20.00%30.00%40.00%50.00%60

47、.00%70.00%80.00%90.00%100.00%United StatesUnited KingdomSingaporeGermanySwedenFranceSouth KoreaAustraliaNetherlandsJapanIrelandNew ZealandItalyIsraelSpainMalaysiaGreeceHungaryCanadaMexicoMoroccoCosta RicaSwitzerlandPolandChinaKenyaIndonesiaRussiaDominican RepublicIndiaSaudi ArabiaSouth AfricaTaiwanK

48、uwaitTurkeyThailandUAEPeruChileColombiaJordanBrazilUkrainePhilippinesEcuadorArgentinaVenezuelaAlgeriaBruneiNigeriaEgyptPakistanV THROUGH INGENUITY0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%United KingdomUnited StatesSouth KoreaFranceGermanyIrelandJapanNetherlandsNew ZealandSwe

49、denSwitzerlandAustraliaChinaItalySingaporeSpainCanadaHungaryIsraelMalaysiaMexicoTaiwanThailandTurkeyUAEBrazilChileColombiaCosta RicaDominican RepublicGreeceIndiaPhilippinesPolandSouth AfricaVietnamArgentinaBruneiKenyaMoroccoNigeriaPeruSaudi ArabiaEcuadorEgyptIndonesiaJordanKuwaitUkraineAlgeriaPakist

50、anRussiaVenezuela100.00100.0093.7587.5087.5087.5087.5087.5087.5087.5087.5081.2575.0075.0075.0075.0068.7568.7568.7562.5062.5062.5062.5062.5062.5056.2556.2556.2556.2556.2556.2556.2556.2556.2556.2556.2550.0050.0050.0050.0050.0050.0050.0043.7543.7543.7543.7543.7543.7537.5037.5037.5037.50Trademarks,Relat

51、ed Rights,and LimitationsOnline shopping increased dramatically during the COVID-19 pandemic,leading to a corresponding increase in the online sale of counterfeit goods.While many economies lack the appropriate resources to combat the increase sale of counterfeit goods online,there were a series of

52、positive developments in 2020.In Thailand,the government applied an injunctive-style relief mechanism to disable access to websites with trademark-infringing content.In Mexico,the revised Industrial Property Law included a mechanism whereby injunctive-style relief can be?In Malaysia,the Parliament p

53、assed the Trademarks Act which expands the type of marks that can be registered,improves enforcement provisions against trademark-infringing goods,and makes Malaysia a contracting party to the Madrid Protocol.2021 Ninth Edition|12U.S.CHAMBER INTERNATIONAL IP INDEX 2021Design Rights,Related Rights,an

54、d Limitations Many of the Index economies have some form of design rights protection in place,with an average score of 64.95%in this category.In 2020,China,Japan and the Ukraine all increased the available term of protection for design rights.?all Member States specifying both registered and unregis

55、tered design rights be protected.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%FranceGermanyIrelandJapanNetherlandsSwedenSwitzerlandUnited KingdomSouth KoreaGreeceHungaryIsraelItalySpainTurkeyUnited StatesBrazilMalaysiaMexicoPolandRussiaNew ZealandSingaporeTaiwanMoroccoPakistanUk

56、raineCanadaArgentinaBruneiDominican RepublicIndiaKenyaVietnamAustraliaChileColombiaCosta RicaEcuadorIndonesiaPeruThailandUAEChinaEgyptJordanKuwaitNigeriaPhilippinesSouth AfricaAlgeriaSaudi ArabiaV THROUGH INGENUITYTrade Secrets,Related Rights,and Limitations?in this category.In Canada,Parliament pas

57、sed new criminal provisions,including a 14-year prison term,for the theft and misappropriation of trade secrets as part of its USMCA implementation.In Taiwan,the Legislative Yuan passed a new trade secrets law that provides stronger safeguards for foreign?While the UAE introduced an 8-year term of r

58、egulatory data protection(RDP)for pre-clinical and clinical data,new draft implementing regulations in Saudi Arabia will limited the availability of RDP in the market.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%GermanyNetherlandsSpainSwedenSwitzerlandJapanItalyUnited StatesCana

59、daFranceIrelandGreeceNew ZealandPolandUnited KingdomSouth KoreaAustraliaHungaryTaiwanUAESingaporeColombiaChinaIsraelCosta RicaDominican RepublicJordanMalaysiaMexicoMoroccoSaudi ArabiaVietnamRussiaBrazilChileEcuadorTurkeyPeruSouth AfricaUkraineAlgeriaArgentinaEgyptIndiaIndonesiaKenyaKuwaitPakistanPhi

60、lippinesThailandBruneiNigeriaVenezuela100.00100.00100.00100.00100.0093.3391.6791.6785.0083.3383.3375.0075.0075.0075.0070.0066.6766.6766.6760.0058.3350.0045.0043.3341.6741.6741.6741.6741.6741.6741.6741.6736.6733.3333.3333.3326.6725.0025.0025.0016.6716.6716.6716.6716.6716.6716.6716.6716.6716.678.338.3

61、38.332021 Ninth Edition|14U.S.CHAMBER INTERNATIONAL IP INDEX 2021Commercialization of IP AssetsMany of the economies benchmarked in the Index have introduced policies that limit market access or commer-cialization of IP assets,with an average score of 59.42%in this category.While Algeria has histori

62、cally had a poor environment for commercialization,the 2020 Finance Law removed the 51-49%ownership requirement for non-strategic industries.In Turkey,the Parliament passed amendments introducing new local data storage requirements for social media services.In Nigeria,the government introduced new g

63、uidelines and amendments that strengthen existing localization requirements for multinational software companies and the oil and gas industry.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%Australia Israel United StatesSingaporeSwitzerlandUnited KingdomGermanyFranceHungaryIrelandN

64、etherlandsCanada JapanNew Zealand Italy Spain PolandSwedenTaiwanBrunei Greece Mexico Dominican RepublicMorocco Chile Malaysia JordanArgentina Costa RicaSouth Korea Turkey South Africa Saudi Arabia UAE EgyptPeru Brazil India China Philippines Pakistan Kuwait Nigeria Russia Algeria Ukraine Colombia Th

65、ailand VietnamKenya Venezuela Ecuador Indonesia THROUGH INGENUITYEnforcementEnforcement against IP theft continues to be a challenge for rights holders operating in global markets.Twen-ty-one economies(39.62%)achieve a score of 50%or more on this category,and only 10 economies achieve a score of 75%

66、or more.Only 16 of the 53 economies sampled in the Index regularly publish data on customs actions taken against suspected counterfeit goods.However,in 2020,Algeria,Chile and South Korea issued new reports issued or transparency measures on counterfeit goods seizures.As part of its implementation of

67、 the USMCA in 2020,Canada passed new provisions providing?authority to detain all suspected counterfeit goods,including those in-transit.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%United StatesUnited KingdomFrance Sweden Germany IrelandJapan South Korea Switzerland Netherlands

68、 Spain Singapore New ZealandAustralia Italy Israel Hungary Poland Canada Greece ColombiaMexicoDominican RepublicTaiwan BrazilSaudi ArabiaChile Thailand Morocco South AfricaMalaysia Russia Turkey Peru China UAE Costa RicaKuwait Ecuador Jordan Brunei Algeria Vietnam India Philippines Argentina Kenya P

69、akistan NigeriaUkraine Indonesia Egypt Venezuela 94.8093.8192.4990.3590.4989.9887.1386.4782.5682.3974.4672.8772.0271.3370.1969.3667.6762.0055.6154.9352.4848.9448.1447.1145.8642.9742.3142.2942.0340.8240.7839.6839.2138.8337.0035.8633.7332.8531.0228.2026.5125.6425.4923.4122.9422.6421.3419.3717.2116.981

70、6.6015.237.422021 Ninth Edition|16U.S.CHAMBER INTERNATIONAL IP INDEX 2021?a score of 50%or above and an average category score of 63.11%.?In Saudi Arabia and Ecuador,the national IP authorities launched new initiatives to help SMEs register and commercialize their IP assets.?the Australian economy.?

71、countrys IP policy for the next 10 yearsand kicked off a National Innovation Strategy.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%FranceIrelandItalyJapanSouth KoreaSwedenUnited KingdomUnited StatesGermanyNetherlandsSpainBrazilChinaSingaporeSwitzerlandAustraliaHungaryTaiwanCanad

72、aMexicoColombiaIndiaMalaysiaPhilippinesPolandGreeceNew ZealandThailandChileCosta RicaIsraelArgentinaIndonesiaMoroccoPakistanPeruSouth AfricaTurkeyVietnamEcuadorSaudi ArabiaUAEDominican RepublicNigeriaEgyptKenyaRussiaJordanAlgeriaBruneiUkraineKuwaitV THROUGH INGENUITY?While the numbers of treaties be

73、nchmarked in the Index has expanded over the nine editions of the report,many economies are not contracting parties to the majority of the treaties included.Twenty-one economies fail to achieve a score of 50%or more in this category.New trade agreements in China,Mexico,and Vietnam resulted in score

74、increases for each of those three economies.In Egypt,the government acceded to the International Convention for the Protection of New Varieties of Plants,act of 1991.?now in force.0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%CanadaFranceJapanNetherlandsSpainSwitzerlandUkraineUni

75、ted KingdomUnited StatesGermanyHungaryItalyPolandIrelandSwedenGreeceAustraliaSingaporeMoroccoSouth KoreaTurkeyPeruRussiaTaiwanCosta RicaDominican RepublicIsraelMexicoColombiaVietnamChileJordanBruneiEgyptKenyaPhilippinesChinaNew ZealandAlgeriaArgentinaEcuadorIndiaIndonesiaMalaysiaNigeriaSouth AfricaU

76、AEBrazilSaudi ArabiaThailandKuwaitVenezuelaPakistan100.00100.00100.00100.00100.00100.00100.00100.00100.0096.4396.4396.4396.4392.8692.8689.2985.7178.5778.5778.5771.4371.4368.1867.8667.8667.8660.7157.1457.1450.0050.0042.8642.8642.8642.8639.2935.7132.1432.1428.5728.5728.5728.5728.5721.4321.4317.8614.29

77、0.007.147.1414.2985.712021 Ninth Edition|18U.S.CHAMBER INTERNATIONAL IP INDEX 2021ECONOMIES WITHEFFECTIVE IP SYSTEMSHave 2X MORE innovation outputHave OVER 550 MORE high-value inventions patented per million populationAlmost 5X MORE knowledge output in?Host over 10X MORE clinical trials2X THE ACCESS

78、 to new music through legitimate and secure platformsAre 38%MORE LIKELY to attract venture capital and private THROUGH INGENUITYpetitors to improve their own performance and better compete at the highest levels for global investment,talent,and growth.ECONOMIES INCLUDEDThe Index today covers 53 econo

79、mies that together represent both a geographical cross-section of the world and most of global economic output,together contributing over 90%of global GDP.As Table 1 shows,the Index includes economies from all major regions of the world and is truly a global measure.1 3OVERVIEW OF THE NINTH EDITIONN

80、ow in its ninth edition,the U.S.Chamber of Com-merces International IP Index continues to provide an important industry perspective on the IP standards?investment decisions.The Index is a unique and con-tinuously evolving instrument.Not only does it assess the state of the international IP environme

81、nt,it also provides a clear roadmap for any economy that wishes to be competitive in the 21st century knowledge-based global economy.Large or small,developing or devel-oped,economies from around the world can utilize the insights about their own national IP environments as well as that of their neig

82、hbors and international com-ASIALATIN AMERICA&THE CARIBBEANAFRICA&MIDDLE EASTEUROPE&CENTRAL ASIANORTH AMERICAAustraliaArgentinaAlgeriaFranceCanadaBruneiBrazilEgyptGermanyUnited StatesChinaChileIsraelGreece IndiaColombiaJordanHungary IndonesiaCosta RicaKenyaIreland JapanDominican RepublicKuwaitItaly

83、MalaysiaEcuadorMoroccoNetherlands New ZealandMexicoNigeriaPoland PakistanPeruSaudi ArabiaRussia PhilippinesVenezuelaSouth AfricaSpain Singapore UAESweden South Korea Switzerland Taiwan Turkey ThailandUnited KingdomVietnam Ukraine Table 1:Ninth edition Index economies by World Bank regionSource:World

84、 Bank(2020)2021 Ninth Edition|20U.S.CHAMBER INTERNATIONAL IP INDEX 2021In addition to geographic diversity,the Index also includes economies from a broad spectrum of income groups?Table 2:Ninth edition Index economies by World Bank income groupSource:World Bank(2020)LOWER-MIDDLE-INCOME ECONOMIESUPPE

85、R-MIDDLE-INCOME ECONOMIESHIGH-INCOME ECONOMIESHIGH-INCOME OECD MEMBERSAlgeriaArgentinaBruneiAustraliaEgyptBrazilKuwaitCanadaIndiaChinaSaudi Arabia ChileKenyaColombiaSingaporeFranceMoroccoCosta RicaTaiwanGermanyNigeriaDominican RepublicUAEGreecePakistanEcuadorHungaryPhilippinesIndonesiaIrelandUkraine

86、JordanIsraelVietnamMalaysiaItalyMexicoJapanPeruNetherlandsRussiaNew ZealandSouth AfricaPolandThailandSouth KoreaTurkeySpainVenezuelaSwedenSwitzerlandUnited KingdomUnited S THROUGH INGENUITYREGIONAL RANKINGS REGIONAVERAGE OVERALL%INDEX SCORENorth America85.01%Europe and Central Asia77.18%Asia55.37%La

87、tin America43.28%Africa and Middle East40.66%NORTH AMERICAOVERALL SCOREREGIONAL RANKINGUnited States95.31%1Canada74.71%2EUROPE AND CENTRAL ASIAOVERALL SCOREREGIONAL RANKINGUnited Kingdom93.90%1Germany92.27%2France91.43%3Sweden90.92%4Netherlands90.02%5Ireland88.86%6Switzerland85.82%7Spain84.68%8Italy

88、83.15%9Hungary78.23%10Greece70.67%11Poland70.50%12Turkey51.07%13Russia46.58%14Ukraine39.54%15ASIAOVERALL SCOREREGIONAL RANKINGJapan91.12%1Singapore84.38%2South Korea83.73%3Australia80.55%4New Zealand69.10%5Taiwan66.18%62021 Ninth Edition|22U.S.CHAMBER INTERNATIONAL IP INDEX 2021LATIN AMERICAOVERALL

89、SCOREREGIONAL RANKINGMexico58.25%1Costa Rica54.46%2Dominican Republic54.32%3Colombia48.17%4Chile47.20%5Peru46.56%6Brazil42.32%7Argentina36.77%8Ecuador30.60%9Venezuela14.10%10AFRICA AND MIDDLE EASTOVERALL SCOREREGIONAL RANKINGIsrael72.57%1Morocco59.62%2Jordan44.53%3UAE41.98%4Saudi Arabia40.38%5Kenya3

90、7.25%6South Africa36.61%7Egypt32.59%8Kuwait27.86%9Nigeria27.43%10Algeria26.45%11ASIAOVERALL SCOREREGIONAL RANKINGChina54.86%7Malaysia51.61%8Brunei41.13%9Philippines39.81%10India38.40%11Vietnam37.49%12Thailand35.56%13Indonesia30.16%14Pakistan26.43% THROUGH INGENUITY4THE GLOBAL IP ENVIRONMENT IN 2020T

91、HE BROADER CONTEXT:THE COVID-19 PANDEMIC Over the past 15 months,the COVID-19 pandemic has dominated world affairs.At the time of research,over 100 million persons had tested positive for the virus globally and more than 2 million deaths were record-ed.2 While the outbreak was initially concentrated

92、 in China and high-income economies in Southeast Asia,Western Europe,and the United States,new cases are growing daily all over the world,including in lower-in-come emerging and developing world markets.The pandemic is having a dramatic and deep impact on health systems and the global economy.Year-e

93、nd estimates by the Organisation for Economic Co-op-eration and Development(OECD)in its December 2020 Economic Outlook found that real global gross domestic product(GDP)shrank by 4.2%in 2020.3 The negative economic impact has been particular-ly pronounced in the United Kingdom,Latin Amer-ica,the Eur

94、ozone,Russia,and the Middle East,with estimated national economic contractions of 5%or more.Global trade has also seen a sharp drop.The second quarter of 2020 saw a quarter-on-quar-ter decline of almost 15%,the highest on record.4 World Trade Organization(WTO)estimates suggest that,while not as bad

95、as the second quarter,the overall drop in merchandise trade volume is likely to be just under 10%,at 9.2%,in 2020.While economic activity is currently recovering in many economies,it is likely that there will be an extended period of time before the global economy will return to pre-pandemic levels.

96、INNOVATION AT THE SPEED OF LIGHT:COVID-19 AND THE BIOPHARMACEUTICAL INDUSTRYWhile so many technology-based companies and IP-in-tensive industries have allowed consumers,business-es,and societies to keep functioning in the face of the unprecedented pressure of the COVID-19 pandemic,no other industry

97、or sector can match the incredible accomplishments of the research-based biopharma-ceutical industry.For the industry,the pandemic has been a cause for full-scale mobilization.Individual com-panies and industry associations are actively working with governments around the world to help alleviate the

98、 pressures on national health systems,develop new treatments and vaccines,and ensure manufacturing capacity can meet all demand.Since the onset of the pandemic,research-based companies have dedicated?companies pledges to donate millions of doses of potential medical treatments to affected economies;

99、initiate new clinical trials and research for use of exist-ing treatments in COVID-19 patients;create partner-ships with other life sciences companies,the public?-nancial donations to affected communities.According to data from the Biotechnology Innovation Organiza-tion(BIO),it took roughly three mo

100、nths from the pub-lication of genetic sequencing data of COVID-19 until?5 This compares to 20 months during the Severe Acute Respiratory Syndrome(SARS)outbreak in 2003.At the time of research,data published by the Pharmaceutical Research and Manufacturers of America(PhRMA)at the end of 2020 showed t

101、hat almost 1,600 active clinical trials were taking place globally to test treatments and potential vaccines for COVID-19.Of these trials,almost two-thirds(994 trials)were testing existing medicines registered for a different indication.Almost 600 unique COVID-19 treatments were being tested,and a t

102、otal of 145 vaccines were in clinical trials with a further 162 in preclinical testing.Most important,in December 2020,2021 Ninth Edition|24U.S.CHAMBER INTERNATIONAL IP INDEX 2021?-oNTech and Moderna Therapeutics,respectivelywere approved for emergency use in North America,Europe,and parts of Asia.A

103、t the time of research,millions of patients around the world had begun to receive the inoculations.It is impossible to overstate the enormity of these ac-complishments.The speed at which this research has taken place is unprecedented and shows the extensive?industry and the biotech community and the

104、 ability to scale up quickly and decisively to understand and devel-op a treatment for a novel virus that was not prevalent in?distribution,and organizational level,the innovative?remarkable.As many politicians,policymakers,and?-proved for emergency use by the U.S.Food and Drug Administration(FDA),t

105、his achievement truly amounts to a modern-day miracle.Similarly,the innovation and creativity of other IP-inten-sive industries and sectors have been absolutely central to allowing societies,workplaces,and economies to function as the pandemic has raged across the world through remote working,the us

106、e of telehealth medi-cal services,and online shopping.And while all these products and technologies existed before the pandemic struck,all areas of activity have,by and large,exploded in conjunction with the pandemic.But what has enabled the creation and commercializa-tion of these technologies?The

107、simple fact is that the innovation,science,and tech-nological progress that has allowed societies to func-tion during the COVID-19 pandemic did not emerge overnight.Instead,these technologies and products are the fruit of a pre-existing innovation ecosystem that is centered on and built around IP ri

108、ghts and incentives.Without strong and clear IP rights it is unlikely that any of those products and technologiesor the underlying R&Dthat have been so essential to keeping societies functioning?As the Index and its accompanying Statistical Annex have shown over the past nine years,the link between

109、IP rights,innovation,and the commercialization of new products and technologies is clear and statistically sig-?A SYMBIOTIC RELATIONSHIP:IP RIGHTS AND INNOVATIONThe concept of innovation enjoys wide-ranging,if not universal,support.Both developed and developing economies alike recognize the importan

110、ce and impact of innovation on their national economic performance,global competitiveness,and overall well-being.As part of their wider strategies for economic growth,they aim to put in place frameworks under which innovation can?takes place in various shapes and forms.Peter Drucker,one of the gurus

111、 of innovation and entrepreneurship in the 20th century,considered innovation to be a social and economic phenomenon as much as it is a techno-logical one.He found that innovation can be generated both from the supply side,via“the consistent manner of changing the yield(or maximizing the output)of e

112、xisting resources,”from the demand side,by“chang-ing the value and satisfaction obtained from resources by the consumers,”or through a combination of the two.6?according to its technological features(be it a prod-uct,a process,or a service)but also according to other characteristics,such as administ

113、rative or organizational structures(including the strategy,structure,system,and human capital of an organization),as well as the mar-ket itself(including pricing and marketing practices).7 The bottom line is that innovation is highly complex,dynamic,and time sensitive.The composition,charac-teristic

114、s,pace,and direction of innovationregardless THROUGH INGENUITY?myriad of factors,external as well as internal,technolog-ical as well as social.Consequently,just as the manner in which innovation takes place is not subject to black or white patterns,neither can it be divided into good or bad categori

115、es.On the contrary,one can identify differ-ent forms of innovationincremental,radical,modular,and architecturalall of which have a role to play in the overall life cycle of innovation and its interaction with societys progress.Unfortunately,the complexity of and variety in how innovation takes place

116、 have shrouded one of its most fundamental driving principles:namely,that any attempt to dictate a certain direction of innovation(or when dealing with absolutes such as which innovations are desirable and which are not)using special“top-down instruments”will most likely end in failure.Rather,it is?

117、public,and the environment as a whole that directs the manner in which innovation and the creation and commercialization of new products and technologies is conducted,as well as the nature and direction it takes.Within this context,the existence of clear and strong IP rights is crucial both in theor

118、y and in practice.FROM THE PROBLEM OF FREE-RIDING TO THE REAL WORLD OF INNOVATING,R&D AND CREATING NEW PRODUCTS AND TECHNOLOGIES:HOW IP RIGHTS ENABLE INNOVATION“He who has no hope that he shall reap will not take the trouble to sow.”Jeremy Bentham,18008?-ing scarce resources to unlimited wants,econo

119、mists?Knowledge and other forms of intellectual creation,however,are a unique resource,given that they are not inherently scarce(at least not in the way econo-mists understand the word).Theoretically speaking,the potential use of existing knowledge or any other form of intellectual creation is unlim

120、ited and may be diminished only when they become obsolete or irrel-evant to society.In fact,the use of any intellectual cre-ation or knowledge-based product by one individual does not reduce its accessibility to others but is more likely to increase it.Economically speaking,innova-tive products that

121、 are based on knowledge and other expressions of artistic and intellectual creations(be they a new piece of software,a medical technology,a pharmaceutical drug,or an innovative telecommu-nications product,to name just a few modern exam-ples)have the characteristics of a“public good.”They are“non-riv

122、al,”in the sense that the use of such a product by one individual does not reduce its quan-tity or availability for others(i.e.,there is not less of that creation to use).They are also“non excludable,”in that the use of that creation by one individual does not prevent other people from using it at t

123、he same time.9 For example,consider a case in which an author has introduced a brilliant masterpiece or the case of an innovator who was able to come up with?these creations are introduced to the market,there is no physical limitation on the ability of others to freely?makes knowledge-based products

124、 so specialthe fact that they are not inherently scarce.However,this is what also makes such products so vul-nerable.In the absence of necessary protection mech-anisms,there is an intrinsic temptation to use these products at the expense of the efforts and investment of their creators.The developmen

125、t of knowledge-based products is a very expensive,risky,and time-consum-?creating a knowledge product,the cost of copying or downloading this product is negligible.As such,knowledge-based products are highly susceptible to the 2021 Ninth Edition|26U.S.CHAMBER INTERNATIONAL IP INDEX 2021so-called fre

126、e-rider problema philosophical and eco-nomic dilemma referring to the act of using or deriving?without paying or contributing toward the cost or effort required to create it.Thus,economic theory suggests that,in the absence of any institutional provisions that establish property rights in knowledge-

127、based products,the tendency to free-ride will increase.Consequently,?-ly decrease.This problem was recognized and noted in the 1800s by British philosopher Jeremy Bentham,who argued that“without the assistance of the law,the inventor would almost always be driven out the market?possession of a disco

128、very which has cost the inventor much time and expense.”10In order to prevent the problem of free-riding,society has designed various systems of IP rights and incen-tives.This includes everything from general,cross-sec-toral rights such as patents,copyrights,trademarks,?incentives such as regulatory

129、 data protection for bio-pharmaceutical test data.IP rights may be thought of as social contracts between society and the individual innovator(be it a person or company)who develops the new knowledge product or intellectual creation.This contract stipulates that,in exchange for societys ability to e

130、njoy and use this new product or creation(which is a result of the time,money,and efforts invested by the individual),the innovator will be granted ownership,albeit for a limited period of time,of that product or creation.In this sense,IP rights have two major functions with regard to knowledge crea

131、tion(and its uses)and innovation:?-all process of knowledge creation and innovation.IP rights also provide for the commercial platform on which knowledge is created,exchanged,and used for the purpose of advancing technological innovation.Critically,the empirical evidence on the effects of IP rights

132、on rates of innovation,high-tech output,and R&D largely bears out our theoretical understanding of how IP rights work:economies with strong national IP envi-ronments tend also to see higher levels of innovation,high-tech output,R&D,and commercialization activities.LAYING THE FOUNDATION FOR FIGHTING

133、THE NEXT PANDEMIC:MEASURING THE IMPACT OF IP RIGHTS ON INNOVATION AND ECONOMIC ACTIVITY Since 2015,the Index has included a Statistical An-nex that investigates the relationship between the strength of economies national IP environments and different types of economic activity,including rates of R&D

134、 spending,innovation,technology creation,and?IP protection reveal that IP rights are,in fact,a critical instrument for economies seeking to enhance access to innovation,grow domestic innovative output,and?economy.Conversely,weak IP protection stymies long-term strategic aspirations related to innova

135、tion and development.This years Annex has been updated with new data to?years from 50 to 53 economies.The evidence from these statistical correlations shows,again,the strong,di-?protection and innovationranging from attractiveness to venture capital and R&D investments,to high-tech employment,to the

136、 magnitude of innovative activities,outputs,and early adoption of technologies.?capacity and output,the empirical evidence is quite?-ments have higher levels of innovation capacity and?and THROUGH INGENUITYBelow,Figures 1 and 2 show the relationship between“Innovation Capability”(as measured by the

137、World Eco-nomic Forum in the Global Competitiveness Report),“Innovation Output”(as measured by WIPO and INSEAD in the Global Innovation Index),and strength of the national IP environment(as measured by the Index).Figure 1:Association between the Index scores and the Global Competitiveness Report 201

138、9,Innovation Capa-bility Pillar scores11 Global Competitiveness Report 2019,Innovation Capability Pillar scores9080706050403010 20 30 40 50 60 70 80 90 100Index ninth edition overall scores,standardized to 100GBDEUSTWCHKRSGJPSEFRILCACNNZAUIEESITHUGRPLMYRUTRMXCRAEBRSAINBNDOMAPECOJOCLZATHARDEVNKEPHECE

139、GIDPKDZNGKWVENLCorrelation:0.87 Source:World Economic Forum(2019);Global Innovation Policy Center,U.S.Chamber of Commerce(2021)2021 Ninth Edition|28U.S.CHAMBER INTERNATIONAL IP INDEX 2021Figure 2:Association between Index scores and the Global Innovation Index 2018,Innovation Output subindex scores1

140、2 As Figure 1 shows,economies with fair to strong IP re-gimes are much more likely to maintain an environment capable of producing innovative outputs compared with weaker economies.There is a very strong relation-ship(a correlation of 0.87)between the Index scores and the Global Competitiveness Repo

141、rts“Innovation Capability”pillar scores.Similar results can be seen in Figure 2.The Global Innovation Indexs“Innovation Output”sub-index is an aggregate measure that looks?creation and development,including intangible assets,research publications,and high-tech production.When compared with the Index

142、,there is also a very strong correlation of 0.85 to the Index scores.Economies with robust IP regimes experience more knowledge-based,technological,and creative outputs than do economies whose IP regimes trail behind.Index ninth edition overall scores,standardized to 060504030201006055504

143、540353025201510Economies in bottom third of the IndexEconomies in middle third of the IndexEconomies in top third of the IndexIndex ninth edition overall scores,standardized to 100Global Innovation Index 2020,Innovation Output sub-index score19.6624.9745.93Global Innovation Index 2020,Innovation Out

144、put sub-index scoreCorrelation:0.85Finally,it is worth examining the evidence on biophar-maceutical innovation and strength of a national IP envi-ronment.As mentioned,the speed at which COVID-19 vaccines and treatments have been developed over the past year has been truly breathtaking.Yet the scienc

145、e and technological capacity that has allowed industry,public research organizations,and academic research-ers to carry out this development are based on decades of R&D experience and innovation.Just as for other forms of technological innovation,it is highly unlike-ly that this biopharmaceutical R&

146、D would have taken place without strong and clear IP incentives.Developing new medicines is a long-term,high-risk,resource-in-?research facilities,and researchers are high.Compared with many other high-tech industriesfor example,com-puter softwaredeveloping the next ground-breaking THROUGH INGENUITY

147、treatment for cancer or Alzheimers disease requires more than just a laptop and a great idea.As medicines become more targeted and technically sophisticated,the cost of development rises dramatically.In 1979,the total cost of developing and approving a new drug stood at USD138 million.Almost 25 year

148、s later,in 2003,?13 A 2012 estimate points to the total cost of drug development being approximately USD1.5 billion.14 The latest,2016,research from Tufts University suggests that it costs USD 2.6 billion,on average cost,to develop a new drug.15 International experience and the basic economics of th

149、e biopharmaceutical industry show how critical IP rights are to incentivise and support this research and development of new medical technologies and products.16 In particular,patents and other forms of exclusivity for biopharmaceuticals,such as regulatory data protection(RDP)and special exclusivity

150、 incentives for the protection and production of orphan drugs,enable research-based companies to invest vast sums in R&D and the discovery of new drugs,products,and therapies.On average,only one to two of every 10,000 synthesized,examined,and screened compounds in basic research will successfully pa

151、ss through all stages of R&D and go on to become a marketable drug.IP rights provide a limited-term market exclusivity that gives?ahead of competition from additional market entrants who bore none of the costs of early-stage investment,R&D,and product commercialization.Many drugs and therapies may n

152、ot have been discovered without the legal rights provided to innovators through IP laws.Indeed,the available evidence on clinical research and rates of innovative clinical trials bears this out.Clinical trials represent one of the most important activities carried out by biopharmaceutical companies

153、in differ-ent countries.Clinical research is a cornerstone of the drug development process.Conducting clinical trials is part of an extensive process for determining which compounds out of hundreds under investigation may be further developed and eventually brought to market,and in what manner.The m

154、ain purpose of clinical trials is to test and provide proof of the safety,quality,and?of existing drugs.Clinical trials are conducted within a highly controlled and studied environment where all aspects of a drug candidate are monitored,recorded,and subjected to high levels of scrutiny and evaluatio

155、n.The clinical research process includes complying with a wide range of regulations governing international best?drugs,for instance,good laboratory practice guidelines on conducting toxicity studies,good manufacturing practice,and protecting the rights of patients through good clinical practice.17 W

156、ithout clinical trials,it would?sense,while the nature of clinical research has changed over the past few decades with new development tech-nologies emerging,clinical research is still a funda-mental cornerstone of modern medical development.Clinical trials also provide patients with early access to

157、 innovative drugs,which may literally revolutionize existing treatments available domestically for prevalent diseases.18 In fact,clinical trials enable advance access to treatments that may continue beyond the duration of the trial.19 In this sense,the availability of a trial in a host country can b

158、e the difference between a patient gaining access to a given novel treatment in research or waiting for a number of years until the product has been fully developed and globally launched.For pa-?the availability of local trials can be a question of life or death.Clinical trials also enable local phy

159、sicians to participate in cutting-edge research as well as become members of multicenter research networks.Such ex-perience helps build R&D expertise and prestige,and expands the ability of local researchers to publish their?They often involve improvements to infrastructurehos-pitals,clinics,and hea

160、lth technologiesin local com-munities.20 Participation in multinational,cutting-edge research helps ensure that clinical trials and sites meet international standards of good clinical practice and expose clinicians to new techniques and treatment 2021 Ninth Edition|30U.S.CHAMBER INTERNATIONAL IP IND

161、EX 2021strategies.In this sense,the growth and conduct of clinical trials improve the overall medical research infra-structure and experience in a given country and region.?-resents the largest portion of biopharmaceutical R&D spending.In 2019,global life sciences R&D spending was estimated by Deloi

162、tte to be around$177 billion.A substantial proportion of this expenditure comes from members of the PhRMA trade association.In its annual 2019 membership survey,PhRMA estimated that R&D expenditure by member companies in 2018 totaled over USD78 billion.The level and complexity of clinical research a

163、nd the number of active clinical trials is a good proxy for levels of biopharmaceutical innovation and R&D capacity.This is particularly true for the most complex and cut-ting-edge biopharmaceutical innovation represented by early-phase trials(phases I and II),and for trials involving large-molecule

164、 biologics and novel biotechnologies.The presence of high levels of per capita early phase trials suggests cutting-edge,innovative research is tak-ing place,in the sense that these represent initial hu-?therefore typically require very controlled environments and high-quality human resources and inf

165、rastructure that can ensure such an environment.Similarly,biologic and biotechnology-based medicines and technologies are increasingly being used in the treatment of some?as in cutting-edge medical research.For example,the majority of the vaccines and therapeutics developed to be used against COVID-

166、19 are based on new,complex biotech research.The vaccines developed by both Mod-?biotechnology.Unlike traditional vaccines,which inject a weakened or inactive pathogen,mRNA technology contains instructions on how the human body should?immune system response.21 Although scientists and bio-pharmaceuti

167、cal researchers have been studying mRNA technologies for decades,the COVID-19 vaccines are?technology.Given the size,complexity,and inherent instability of a biologic,the R&D process requires a considerable level of stability and technical capacity.?within a clinical trial necessitates a highly cont

168、rolled environment in which transportation and storage of the drug are controlled,the trial protocols are strictly adhered to,and patients are monitored carefully.Looking at biopharmaceutical R&D and IP incentives,there is a strong and direct relationship between levels of clinical research and IP p

169、rotection.Economies with higher levels of biopharmaceutical IP protectionthat allow for the patenting of biopharmaceutical innovation,that provide RDP and full patent term restorationtend also to host substantially higher levels of biopharma-ceutical innovation as represented by clinical research.Th

170、is years Statistical Annex includes four relevant cor-relations relating to biopharmaceutical innovation:1.Clinical trials2.Early-phase clinical research3.Development of biologic therapies4.Biotechnological innovationThese correlations measure the relationship between?rates of the above-described in

171、dicators for biophar-maceutical innovation and R&D for the 53 economies include in the Index.Overall,the results are quite clear:There is a strong correlation between the availability of biopharmaceutical IP rights and levels of biophar-maceutical innovation as measured through levels of?Scorecard.A

172、ll correlations achieved a score of between 0.74 and 0.81,suggesting a strong relationship be-tween the availability of relevant biopharmaceutical IP rights and the biopharmaceutical innovation variables THROUGH INGENUITYFigure 3:Association between the Index life sciences-related indicators scores

173、and clinical trial activity22The availability of IP rights acts as a powerful incentive for attracting clinical research,which accounts for approx-imately 60%of biomedical foreign direct investment on R&D.On average,economies scoring in the upper half of the Index host as many as 15 times more clini

174、cal trials compared with economies in the lower half of the Index.50403020007006005004003002001000Index ninth edition,life sciences-related indicators scores,standardized to 100Number of clinical trials registered to date in clinicaltrials.gov per million population6.034.202.34

175、1.043.09 2.218.1749.3066.1628.7649.109.3540.789.7647.4726.5171.0737.3136.2723.6433.0044.8589.7027.9238.0413.7730.2717.233.15839.9049.365.5811.7829.14392.92427.74304.84239.71223.36457.78310.28356.98399.90247.93289.88308.65290.49187.33571.52633.03418.90882.11605.55VenezuelaPakistanIndonesiaNigeriaIndi

176、aAlgeriaEcuadorEgyptArgentinaKuwaitSouth AfricaPhilippinesThailandKenyaUkraineVietnamUAETurkeyBrazilBruneiRussiaSaudi ArabiaPeruColumbiaMalaysiaChileJordanCosta RicaChinaMexicoDominican RepublicMoroccoTaiwanGreeceIsraelPolandNew ZealandCanadaHungaryAustraliaItalySouth KoreaSingaporeSpainNetherlandsI

177、relandFranceSwitzerlandGermanyJapanUnited KingdomSwedenUnited States2021 Ninth Edition|32U.S.CHAMBER INTERNATIONAL IP INDEX 2021Figure 4:Association between the Index life sciences-related indicators scores and early-phase clinical trial activityEconomies that maintain robust IP environments tend to

178、 see more than 20 times more early-phase clinical trials on average compared with economies whose life sciences-related IP environments trail behind.Number of early-phase clinical trials registered to date in clinicaltrials.gov per million population2000010 20 30 40 50 60 70 80

179、 90 100Index ninth edition overall scores,standardized to 100GBDEUSCHKRSGJPSEFRILCACNNZAUIEESITHUGRPLMYRUTRMXCRAEBRSAINBNDOMAPECOJOCLZATHARTWVNKEPHECEGIDPKDZNGUNVENLKW THROUGH INGENUITYFigure 5:Association between the Index life sciences-related indicators scores and biological clinical research int

180、ensityLooking at clinical trials on biologics is a similar story.When looking just at life sciences-related protection,on average,economies within the upper half of the Index host substantially more clinical trials on innovative biologic drugs compared with economies falling within the lower half of

181、 the Index.Number of biologic clinical trials registered to date in clinicaltrials.gov per million population5045403530252015105010 20 30 40 50 60 70 80 90 100Index ninth edition,life sciences-related indicators scores,standardized to 100GBDEUSKRSGJPSEFRCACNNZAUIEESITHUGRPLMYRUTRMXCRAEBRSAINBNDOMAPE

182、COJOCLZATHARTWKEPHECEGIDPKDZNGVNUAVENLKW2021 Ninth Edition|34U.S.CHAMBER INTERNATIONAL IP INDEX 2021?WorldView scores23Economies scoring in the top half of the Index are much more likely to provide environments that are conducive to biotech innovation than are economies scoring in the bottom half of

183、 the Index.?DEUSCHKRSGJPSEFRNZ?IEESITHUILPL?CN?MYINCLMXGRRU?BRTR?THPH?NL?ID THROUGH INGENUITYACCENTUATING TRADITIONAL CHALLENGES FOR THE RESEARCH-BASED BIOPHARMACEUTICAL INDUSTRY:COVID-19,COMPULSORY LICENSING,AND LIMITATIONS ON IP RIGHTSDespite the critical role that IP rights and incentives play in

184、 enabling biopharmaceutical innovation,in 2020,several economies restricted or overrode existing pro-?pandemic,many policymakers and governments have called for or enacted new laws that expand relevant pro-visions relating to the use of compulsory licenses and the overriding of IP rights.In March 20

185、20,the govern-ment of Israel authorized the issuing of a compulsory license for the antiviral drug lopinavir/ritonavir(AbbVies Kaletra).The issuing of the license was based on existing emergency use powers under the Patent Law.Sections 104-105 grant the Israeli government broad powers,essentially al

186、lowing it to override any existing patent in the event of a national emergency or national security crisis.Under these provisions,a rights-holder has no ability to challenge the decision or access a recourse mechanism.Any royalties to be paid are ultimately set by a government-appointed body.While A

187、rticle 31 of the Agreement on the Trade-Related Aspects of Intel-lectual Property Rights(TRIPS)and the Doha Declaration are clear that compulsory licensing represents a“mea-sure of last resort”intended primarily for public health and humanitarian emergencies such as the COVID-19 pandemic,it is regre

188、ttable that the Israeli government was unable to reach an alternative solution that did not involve the overriding of IP rights.Israel has made sub-stantive progress over the past decade in strengthening its national IP environment for biopharmaceuticals and become a model for other economies seekin

189、g to build their research-based industries.It remains to be seen whether the use of compulsory licensing during the COVID-19 pandemic was a one-off or a new,negative policy departure.On December 31,2020,the Russian government issued a compulsory license under Order 3718.The order authorizes a local

190、manufacturer to produce a generic version of remdesivir,an antiviral drug used in the treat-ment of COVID-19,and overrides the existing Eurasian patents for the drug.The order is based on Article 1360 of the Civil Code Part IV,which grants the government broad powers to act“in the interest of nation

191、al secu-rity”and override any existing granted rights relating to patents,utility models,and industrial designs.News reports suggest that the order follows a request by the local manufacturer made to the government in Novem-ber 2020.Article 1360 states that rights-holders shall be awarded“reasonable

192、 remuneration.”The issuing of this license comes on the heels of two other licenses issued over the past three years.In 2018,the Moscow Arbitration Court granted a compulsory license to local manufacturer Nativa for Celgenes Revlimid.The com-pulsory license was for Celgene to license one of its gran

193、ted patents for the production of a product in which a dependent patent was to be used by Nativa.Without a license,the use of this patent would constitute infringe-ment of Celgenes patent.Critically,the lower cost of the product by Nativa was considered by the court as being economically advantageou

194、s and a deciding factor in granting the license.In 2019,another compulsory license was issued to Nativa on largely similar grounds.Finally,in November 2019,a bill was sent to the Duma that would amend existing laws on compulsory licensing(Article 1360 of Part IV of the Civil Code).The proposed amend

195、ments would provide a fairly broad ground for a compulsory license to be issued in the event of a na-tional emergency and to protect the health and safety of the public.Compulsory licensing as an actively used tool in Russian industrial and health policy not only is outside international norms but i

196、s self-defeating.Over time it will hollow out Russias national IP environment and incentives for future innovation,biopharmaceutical and otherwise.Critically,the negative effect will be the same on Russian as on foreign innovators.While other economies have not issued involuntary licenses,many gover

197、nments have called for or enacted new laws that expand relevant provisions relating to the use of compulsory licenses and the overriding of IP 2021 Ninth Edition|36U.S.CHAMBER INTERNATIONAL IP INDEX 2021rights.For example,in March 2020,again in response?the Chilean lower house,the Chamber of Deputie

198、s,passed a unanimous resolution endorsing the use of compulsory license for any and all products,diagnos-tics,medical devices,and other medical paraphernalia related to COVID-19.This was followed in June with a legislative proposal and set of amendments published by a group of senators.This proposal

199、,Bulletin 13,572-11,would introduce sweeping changes to Chiles com-pulsory licensing regime,including an expedited and abbreviated process for the hearing and granting of?applicable royalties to a maximum of 5%of the sales price of the licensed product;and a broad elimination of liability for manufa

200、cturers,individuals,and legal entities that violate existing IP rights(including patent rights and trade secrets)for the production or distribution of any medicines,vaccines,and other technologies related to the pandemic.Similarly,in March 2020,an emergency law(Decree 476)was issued by the Colombian

201、 government in response to the COVID-19 pandemic.While the decree does not explicitly amend existing legislation relating to compul-sory licensing,Article 1,sub-section 1.7 of the Decree grants the Minister of Health broad and full authority to make a Declaration of Public Interest relating to any a

202、nd all“medicines,medical devices,vaccines and other health technologies that are used for the diagnosis,pre-vention and treatment of COVID19.”While not legally a compulsory license,such declarations essentially nullify any existing IP protection and carry the same practical impact of eliminating a r

203、ights-holders ability to freely use a granted exclusivity.On a parallel track,another group of legislators proposed a wide-reaching Sen-ate Bill in December 2020 that would drastically mod-ify Colombias Pharmaceutical Policy.The Chambers chief concern is the creation of so-called“automatic”compulsor

204、y licenses by the Colombian Commerce Ministry,Food&Drug regulatory agency,and Justice Ministry.The bill includes a troubling provision(Article 57,Paragraph 3)calling for the removal of governmen-?speed.Finally,the bill contains numerous unfortunate references to the belief that IP rights are a barri

205、er to public access of IP-intensive goods.No doubt,these ex-ceptional mechanisms may undermine bilateral norms for IP as established in the U.S.-Colombia FTA.Outside of Latin America,there were similar devel-opments in Asia.For example,in Indonesia,a new Presidential Regulation(No.77 2020)on compuls

206、ory licensing was issued in July.The new regulation de-scribes the circumstances under which government?relates to government use of patented technologies and the overriding of any granted patent exclusivity in the event of a public emergency(including,but not limited to,a public health crisis)and f

207、or purposes of defense and national security.With respect to the government use and overriding of patents for medicines and bio-pharmaceutical products,the regulation states that this?such as the current COVID-19 pandemic,but based on?/or biotechnology that are priced expensivesic.”Under this regula

208、tion,the Indonesian government is consid-ering government-use licensing for COVID-19 thera-pies already available locally under voluntary licensing,potentially reversing some of the recent positive steps taken by the Indonesian government to protect intel-lectual property.More broadly,at the level o

209、f international institutions,there have also been efforts to undermine and weaken international standards of IP protection for COVID-19-re-lated treatments and vaccines.Most notably,in October 2020,India and South Africa requested that the TRIPS Council and wider WTO General Council approve a TRIPS

210、waiver for COVID-19-related products,including any approved vaccines.As mentioned,the severe and sudden impact the COVID-19 pandemic is having on public health around the world means that,in effect,the conditions of the THROUGH INGENUITYpotential issuing of a compulsory license are being met in many

211、 economies.However,it is squarely outside the scope of international law and applicable standards?all mechanism that can be used to sanction the viola-tion and overriding of granted property rights for any product,diagnostic,medical device,and other medical paraphernalia related to COVID-19.Unlike o

212、ther pan-demic-related emergency measures that have been introduced around the world,including,for example,in Canada and Germany,the proposed legislative amend-ments and changes introduced in Chile,Colombia,?or suitable sunset clause.TO SPC OR NOT TO SPC?EU INSTITUTIONS CONTINUE TO UNDERMINE BIOPHAR

213、MACEUTICAL IP INCENTIVESAs noted over the course of the Index,there contin-ues to be a high degree of uncertainty regarding the availability of patent term restoration in the EU and the United Kingdom.In 2015,under the overarching initiative to reform and deepen the single market with the purpose of

214、 spurring economic growth in the EU,the European Commission announced its intentions to explore options for recalibrating certain elements of patent term restoration for biopharmaceuticals,so-?One option for change put forth by the commission was to provide European manufacturers of generic drugs an

215、d biosimilars with an SPC manufacturing and export exemption(“SPC exemption”).The overriding purpose of the proposal was to provide European manufacturers of generic drugs and biosimilars a competitive advan-tage by weakening IP protection for innovators.As the Index and others have pointed out,ther

216、e were many troubling assumptions underlying the commissions proposal.Indeed,this was recognized even by several key EU Member States.Most basically,the proposal assumed that there is an actual market and demand for European generic manufacturers.Yet it is not at all clear what this market is or whe

217、re the demand for ge-neric medicines produced in Europe would come from.More broadly,instead of allowing European generic manufacturers to gain a competitive advantage,it is much more likely that,over time,other economies will emulate the EU and also introduce policies that under-mine biopharmaceuti

218、cal IP protection.In fact,events in 2020 suggest that this is exactly what is happening.In a wide-ranging set of amendments to the Law on Protection of Rights to Inventions and Utility Models,the Ukraine has notably weakened its patenting envi-ronment as it relates to biopharmaceuticals.While these

219、legislative changes are meant to better align Ukraines national IP environment with that of the EU as part of the 2017 Ukraine-European Union Association Agree-ment,they will have the opposite effect.Not only do these changes substantially weaken the eligibility for biopharmaceutical patentable subj

220、ect matter,new pro-cedural barriers to obtaining patent term restoration as well as an export and stockpiling exemption have also been introduced.The latter exemption is modeled on the EUs Regulation 2019/933.As the Index has re-peatedly pointed out,the most obvious side effect of the overriding of

221、IP rights in the EU is that the policy will be emulated by other economies.As the Ukraine?generics industry,the introduction of an SPC exemption will simply end up hurting Europes research-based industry and lead to a global race toward the bottom in weakening IP standards.Further developments in 20

222、20 add to the uncertainty over the EUs SPC regime.In July,the Court of Jus-tice of the European Union(CJEU)handed down a verdict in the case Santen SAS v Directeur gnral de lInstitut national de la proprit industrielle,C-673/18.Originating in France and referred to the CJEU by the Paris Court of App

223、eal in 2018,the case is about the extent to which it is possible to obtain an SPC for new innovations relating to approved biopharmaceutical products and treatments.In earlier rulingssee,for ex-ample,the 2012 Neurim Pharmaceuticals(1991)Ltd 2021 Ninth Edition|38U.S.CHAMBER INTERNATIONAL IP INDEX 202

224、1v Comptroller-General of Patentsthe CJEU had held that it was possible to obtain an SPC for the new use of a product for which a market authorization(MA)for the same active ingredient had already been granted.This decision has now,effectively,been overturned.In its 2020 ruling,the CJEU emphatically

225、 stated“that an?it covers a new therapeutic application of an active in-gredient,or of a combination of active ingredients,and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.”The court argued that on this point the Neurim precedent

226、 had erred and not fully taken into account the intentions of the lawmakers when originally developing the underlying IP incentive and EU Regu-lation:“the EU legislature intended,in establishing the SPC regime,to protect not all pharmaceutical research giving rise to the grant of a patent and the ma

227、rketing of a new medicinal product,but to protect research?ingredient or a combination of active ingredients as a medicinal product.”From a legal perspective,the courts verdict may set an unfortunate precedent and further limit the availability of European incentives for biopharmaceutical innovation

228、.More broadly,from a public policy perspective,the courts verdict fails to understand the basics of biopharmaceutical innovation.Technological innovation is frequently thought of as consisting of two distinguishable modes or models:radical innovation and incremental innovation.Radical innovation,as

229、the name suggests,is the introduction of completely new or revolutionary ideas or products.Frequently,such innovations wholly alter the way an industry or even an economy functions,fundamentally changing economic and social behavior.In contrast to radical innovation,incremental innovation is a proce

230、ss of piecemeal improvement of existing technologies or techniques.Usually,incremental innovations follow on from revolutionary or radical innovations.Does this mean that radical innovation is the proverbial“good”form of innovation and nonrevolutionary incremental innovation is“bad”and,from a societ

231、al perspective,largely useless?That is the underlying policy rationale behind the courts reasoning.In its verdict and assump-tions about the intentions of European lawmakers,the court has implied that incremental biopharmaceutical innovations are less meaningful and therefore should not be eligible

232、for the SPC incentive.But most biophar-maceutical innovation is in large part incremental.In fact,incremental innovation is an essential part of the biopharmaceutical R&D process.Follow-on medications and incrementally improved or altered therapies fre-quently reduce side effects,improve on existing

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

234、cines and medical de-vices.This includes insulin,beta-blockers,Angioten-sin-converting-enzyme(ACE)inhibitors,contraceptives,insulin pumps,statins,zoledronic acid,and countless other commonly used biopharmaceutical products and devices.The development of HIV/AIDS treatment is a concrete example of ho

235、w incremental improvements to existing technologies over time amount to what in effect becomes a radical innovation whereby the latest technology is barely recognizable compared with its?HIV/AIDS antiretrovirals had serious side effects and were combination therapies requiring the consumption of lar

236、ge volumes of medication several times per day.Side effects included diarrhea,severe nausea,loss of sense of taste,skin problems,and painful nerve injury.The development of the second generation of drugs,centering on the concept of highly active antiretroviral therapy,saw improved treatment options

237、and reduced side effects.Still,treatment centered on the adminis-tration and consumption of several medicines per day.It is only in recent years that new therapies have been introduced based on incremental innovations that al-low for combination pills.Instead of an array of pills taken every few hou

238、rs,these products require that the patient take only a single pill once daily.This new ease of medication has led to increased adherence,which? THROUGH INGENUITYno major change in lifestyle.This allows patients to live socio-economically productive lives with what had once been a debilitating and of

239、ten fatal disease.In the long?for treating side effects,thus reducing the cost burden on a given health system.It is hard to see how this type of innovation should not be eligible for IP incentives such as SPC protection.More broadly,since 2018,the European Commission has been conducting a regulator

240、y review of the Or-phan Regulation and the Paediatric Regulation,which provide special incentives(including market exclusivity)for products developed for rare diseases and children.In November 2020,the commission published an“In-ception Impact Assessment”with the view of proposing some legislative c

241、hanges to both regulations.Orphan drugs are niche treatments for diseases with small pa-tient populations and commercial markets.Since the?in the United States(1983),Japan(1993),and the EU(2000)have managed to bring about a sea-change in R&D,clinical research,and the development of new products for

242、rare diseases.For example,in the decade prior to the introduction of special incentives in the United States,1973-83,only 10 products were approved for marketi.e.,only one drug per year on average.24 Since then,more than 575 drugs and biologic products have been developed and approved.A key driver o

243、f this success has been a clear and strong market exclusivity incentive.In the EU,the Orphan Regulation provides a 10-year term of marketing exclusivity(orphan status can be withdrawn after six years if designation criteria?by two years if a pediatric investigation plan has been completed when reque

244、sting approval.)On the back of these schemes,as well as key pharmaco-genomics discoveries that fueled interest in development of niche products,25 the number of orphan drugs developed and authorized for rare diseases has increased expo-nentially.Since its introduction in 2000,the EU Orphan Regulatio

245、n had,as of 2017,resulted in:nearly 2,000 orphan designations approved;over 150 orphan medicinal products approved by the EMA for over 90 rare diseases(up from only eight orphan products available in 2000);an increase of 85%in the number of rare diseases for which an orphan designation exists in the

246、 EU;and an increase of 88%in clinical research activity on?largest EU countries experiencing an even bigger increase of 104%during that period.It is critical that the Commission bear this positive impact in mind when reviewing how and what aspects of the regulation it proposes to change.2021 Ninth E

247、dition|40U.S.CHAMBER INTERNATIONAL IP INDEX 2021COUNTRYNINTH EDITIONEIGHTH EDITIONCHANGE IN OVERALL SCOREUnited States95.31%95.28%0.03%United Kingdom93.90%93.92%-0.02%Germany92.27%91.08%1.19%France91.43%91.50%-0.07%Japan91.12%90.40%0.72%Sweden90.92%90.56%0.36%Netherlands90.02%89.64%0.38%Ireland88.86

248、%88.98%-0.12%Switzerland85.82%85.34%0.48%Spain84.68%84.64%0.04%Singapore84.38%84.42%-0.04%South Korea83.73%82.20%1.53%Italy83.15%83.18%-0.03%Australia80.55%79.62%0.93%Hungary78.23%78.38%-0.15%Canada74.71%72.86%1.85%Israel72.57%72.76%-0.19%Greece70.67%70.10%0.57%Poland70.50%70.56%-0.06%New Zealand69.

249、10%68.64%0.46%Taiwan66.18%66.33%-0.15%Morocco59.62%59.66%-0.04%Mexico58.25%54.38%3.87%China54.86%50.96%3.90%Costa Rica54.46%52.60%1.86%5OVERALL RESULTS AND CATEGORY-BY-CATEGORY SCORESUp or down?How have economies fared in this edition of the Index?And what do the results of the 2021 Index tell us ab

250、out the state of the global IP environment?Below,Table 4 shows the overall results for the ninth edition of the Index and how it compares to last years edition.Table 4:Change in overall score,eighth edition versus ninth edition THROUGH INGENUITYCOUNTRYNINTH EDITIONEIGHTH EDITIONCHANGE IN OVERALL SCO

251、REDominican Republic54.32%53.96%0.36%Malaysia51.61%51.24%0.37%Turkey51.07%51.58%-0.51%Colombia48.17%46.40%1.77%Chile47.20%45.64%1.56%Russia46.58%45.92%0.66%Peru46.56%46.12%0.44%Jordan44.53%44.16%0.37%Brazil42.32%42.52%-0.20%UAE41.98%40.44%1.54%Brunei41.13%41.12%0.01%Saudi Arabia40.38%39.44%0.94%Phil

252、ippines39.81%39.94%-0.13%Ukraine39.54%39.66%-0.12%India38.40%38.46%-0.06%Vietnam37.49%36.62%0.87%Kenya37.25%36.82%0.43%Argentina36.77%35.74%1.03%South Africa36.61%36.62%-0.01%Thailand35.56%33.96%1.60%Egypt32.59%30.18%2.41%Ecuador30.60%30.18%0.42%Indonesia30.16%30.24%-0.08%Kuwait27.86%28.02%-0.16%Nig

253、eria27.43%27.62%-0.19%Algeria26.45%24.06%2.39%Pakistan26.43%26.50%-0.07%Venezuela14.10%14.22%-0.12%Overall,the vast majority of economies sampled in the Index have seen their IP environments improve in 2020.Out of the 53 economies included,32 saw a positive increase.This compares with 21 economies t

254、hat saw their scores drop.Furthermore,out of the 32 that saw an improvement to their national IP environments,almost two-thirds(19 economies)saw an increase of 0.5%or more.Two economiesChina and Mexicosaw improvements of over 3%,at 3.90%and 3.87%,respectively.Out of the 21 economies that saw a score

255、 decrease,only one,Turkey,experienced a drop of more than 0.5%,at 0.51%.2021 Ninth Edition|42U.S.CHAMBER INTERNATIONAL IP INDEX 2021To some extent,the improvement seen in 2020 builds on the preceding years,and in particular the last two editions of the Index.With Index scores now going?analyze and s

256、pot trends over time.Indeed,looking at the movement of the aggregated scores of the Index historically allows us to get a sense of how the global IP policy environment has evolved over time and what underlying factors are shaping this movement,positive or negative.MOVING AHEAD OR STANDING STILL?THE

257、GLOBAL IP ENVIRONMENT OVER NINE EDITIONS OF THE INDEXTo start,we can calculate the overall total score of all sampled economies vis-vis the maximum available total score in the Index.Although not controlling for changes in the composition of the Index with respect to the number of economies sampled

258、or the addition of new indicators,with these caveats in mind the total aggregated results provide a good starting point as a snapshot and point of comparison.Below,Figure 7 shows the composite score of the economies sampled as a percentage of the maximum score for each of the nine editions of the In

259、dex.58.00%57.00%56.00%55.00%54.00%53.00%53.00%51.00%50.00%49.00%48.00%47.00%FirsteditionSecondeditionThirdeditionFourtheditionFiftheditionSixtheditionSeventheditionEightheditionNinthedition57.29%56.57%54.85%54.93%53.06%53.62%54.27%55.72%51.05%? THROUGH INGENUITYComparing the starting point in 2012 w

260、ith the latest edi-tion,it is clear that there has been a positive movement?only 11 economies.A more meaningful comparison with a bigger sample of economies is from the second edition of the Index,when the number of economies more than doubled to 25.Here we can see a substantial improvement of the a

261、ggregated score of 6.24%.This is a considerable difference and improvement over time.Looking at the past few years,we can see that this positive movement has been sustained between the seventh and ninth edition.Not coincidentally,this is the only time period for which there have been two or more con

262、secutive positive increases over the life of the Index.So,on the face of it,the global IP environment today is quite a bit better than it was eight or nine years ago.Does this mean that every single economy in the Index today has a stronger national IP environment than it did in 2012?Not necessarily

263、.Given that the Index now?deal of variation in how these different economies have performed over time.Some economies have improved,others have deteriorated,and many have simply stood still.Still,it is possible to see some mega-trends and the impact of international policy decisions,particularly inte

264、rnational trade agreements.STILL A FORCE FOR GOOD?INTERNATIONAL TRADE AGREEMENTS AND THE INTERNATIONAL IP ENVIRONMENTHistorically,trade agreements have been fundamental in setting international standards for the protection and enforcement of IP rights.TRIPS,the North American Free Trade Agreement,an

265、d numerous U.S.-and EU-led bilateral agreements have helped improve the global IP?the world.It has been over a quarter of a century since the conclusion of the Uruguay Round.While the Doha Round had the potential to become a truly global trade agreement,it has effectively been shelved since 2015.Thu

266、s,it is new bi-and pluri-lateral agreements that have been the drivers in setting international IP standards.Over the course of the Index,several international trade agreements have been concluded that contain substan-tial IP provisions.These include:the EU-Canada Com-prehensive Economic and Trade A

267、greement(CETA);the Free Trade Agreement between the EU and Vietnam;the United States-Mexico-Canada Agreement(USMCA);the EU-Japan Economic Partnership Agreement;and the Economic and Trade Agreement between the Gov-ernment of the United States and the Government of the Peoples Republic of China.26 Non

268、e of these agree-?-dards through an FTA with the two largest U.S.trading partners.Despite some important gaps,overall,the IP standards in the original USMCA concluded in 2018 would have set a new,higher benchmark that would lead to more innovation,more job creation,and more economic growth across No

269、rth America.Unfortunately,this original agreement was substantively revised.In December 2019,Speaker of the House Nancy Pelosi announced that a revised USMCA had been agreed on with the White House,Canada,and Mexico.The text?of the original USMCA had been either completely re-moved or fundamentally

270、altered.This included critical provisions relating to biopharmaceutical IP protection and incentives.Nevertheless,these trade agreements have individually and cumulatively helped improve the global IP environment over the past decade.In fact,it is possible to see the direct positive impact these in-

271、ternational treaties can have on individual economies IP environment.This is particularly the case with the Agreement between the United States and China.2021 Ninth Edition|44U.S.CHAMBER INTERNATIONAL IP INDEX 2021ZOOMING IN ON THE BRICS To get a sense of what the score movement has looked like at a

272、n individual economy level and what some?is instructive to isolate and contrast the Index score movements of some of the largest emerging markets included in the Index,namely the BRICS economies:Brazil,Russia,India,China,and South Africa.?included in the Index from the beginning.Below,Fig-ure 8 show

273、s how the BRICS have performed over all editions of the Index.Isolating the results of the BRICS reveals the stark dif-ferences in performance over the course of the Index.Of note are China and India.Both economies started from a relatively low base,at 36.52%and 24.96%of the?Index in 2012.Yet,over t

274、ime,there has been a remark-able improvement in their national IP environments as measured by the Index.China steadily improved its?four editionsand especially the past twothis improve-ment has been extraordinary:over the past two editions of the Index,China has boosted its score by over 7%.Compared

275、 with 2012,China has improved its score by halfgoing from 36.52%of the total available score to 54.86%in this years editiona stunning growth of 18.34%.However,as has been detailed over the course?60.00%55.00%50.00%45.00%40.00%35.00%30.00%25.00%20.00%Eighth editionNinth editionSeventh editionSixth ed

276、itionFifth editionFourth editionThird editionSecond editionFirsteditionBrazil38.28%36.10%36.20%34.70%37.80%39.30%40.56%42.52%42.32%Russia44.68%44.27%45.13%43.53%44.37%43.23%43.24%45.92%46.58%India24.96%38.46%23.17%24.10%23.50%25.00%38.40%30.08%36.04%China36.52%38.73%41.33%42.13%42.37%47.70%47.67%50.

277、96%54.86%South Africa38.67%36.61%39.53%39.13%36.29%34.28%34.56%36.62% THROUGH INGENUITYof the Index,it is important to note that,in China espe-cially,while there have been improvements in terms of formal IP laws and regulations,the on-the-ground effects are harder to measure.The absence of predictab

278、le and transparent rule of law,and the use of industrial policies?corporations,in addition to various other policies that affect the landscape for companies doing business in China,all tend to make it harder for IP-intensive busi-nesses to operate and trade in the Chinese market.?there was little mo

279、vement in Indias score,but between?by over 12%.Like China,India has over the life of the Index seen the strength of its national IP environment grow by half,rising from a score of 24.96%of the total available score in 2012 to 38.40%in this years edition,an improvement of 13.44%.Although not as stron

280、g as China and India,Brazil,too,has seen some improvement in its score.Over the course of the nine editions of the Index,Brazils score improved by just over 4%.In contrast to Brazils,Chinas,and Indias level of improvement,Russia and South Af-rica have largely stood still.Russias score today is just

281、under 2%better than in 2012 but has hovered between 44%and 45%over the course of the Index.South Afri-cas score is actually worse today than in 2012,having dropped by just over 2%.What explains these differences in performance?While the number of indicators has grown substantially over the course of

282、 the Indexdoubling from the origi-nal 25 in 2012 to 50 in todays Indexand has naturally had an impact on individual economies Index scores,it is also clear that individual governments decisions and choices on IP policy have had a real and tangible impact on how different economies have performed on

283、the Index.For example,China has over the past two years essentially revamped its national IP environ-ment by amending and updating most major IP laws?that China is implementing key parts of the negotiat-ed trade agreement with the United States.Similarly,both the Brazilian and Indian governments hav

284、e made concerted efforts to improve their IP environments.In?-tional reforms,improving the licensing and technology transfer environment,and reducing a long-standing backlog of patent applications ranging from 10 to 13?over the past few years,the government of India has made concerted efforts to joi

285、n international IP initiatives and engage more fully in international IP fora.Most notably,India acceded to the WIPO Internet Treaties in September 2018,and in late 2018,Indian and Jap-anese authorities agreed to begin a Patent Prosecution?latter agreement is especially noteworthy,as up until this a

286、nnouncement,India did not have a functioning?IP environments in China,India,and Brazil are perfect?Of course not.While the improvements in all econo-mies have been real,challenges remain in all three.Of the three,only China achieves a score of 50%or more.This is considerably less than the average sc

287、ore for the top-performing economies on the Index.And as described above,the on-the-ground realities for IP-intensive companies are more complicated than the Index score suggests.This year,on the ninth edition,the average score for economies in the top 10 was 90.43%.Still,these three economies achie

288、vements are real and are the result of conscious efforts and policy choices made by their respective governments.In contrast to the generally positive reforms in China,India,and Brazil,in Russia the IP environment contin-ues to be shaped by the wider policy landscape and its focus on localization.As

289、 has been detailed over the course of the Index,Russian industrial and econom-ic policy over the past decade has increasingly been driven by an effort to localize industrial production and R&D.While there have been pockets of improvement 2021 Ninth Edition|46U.S.CHAMBER INTERNATIONAL IP INDEX 2021an

290、d IP reform including the copyright space where Russias score on the Index has almost doubled over the nine editionsthese positive efforts have largely been canceled out by these broader negative developments.Over the eight editions of the Index in which South Africa has been included,there have bee

291、n few sub-stantive IP reforms attempted,let alone passed.And while the other BRICS have engaged more fully in in-ternational IP fora or through participation in PPHs,South Africa has remined on the outside of these ef-forts.Out of the nine international IP treaties included in the Index,South Africa

292、 is only a full contracting party to one,the Patent Cooperation Treaty.It has signed,but?or the Convention on Cybercrime.Although South Africa has drafted legislation to accede to the WIPO Internet Treaties,questions remain about whether the Copyright Act Bill would include accession.The bill,?intro

293、duces sweeping exceptions and limitations to current law.Additionally,South Africa is not a member of either the Global Patent Prosecution Highway,the IP5 PPH,or any other bi-or multilateral PPH.In 2018,the South African government released the long-awaited document Intellectual Property Policy of t

294、he Republic of South Africa Phase I(the IP Policy).As recognized at the time,it was a positive step that the government of South Africa recognized the need to reform its na-tional IP environment and the value of consulting all stakeholders in that process.However,the IP Policy(as preceding draft pol

295、icies and related documents)focuses primarily on ways in which South Africa could better access existing and developed forms of IP,rather than on the manner in which IP can be created,be com-mercialized,and become an industrial asset in South Africa.For all economiesemerging and developed alikewhat

296、drives innovation,technological advances,and,ultimately,economic development and growth is the creation of new forms of intangible assets and IP.Yet both the IP Policy and South African IP policymaking over the past decade have largely been silent on this.Efforts to introduced substantive examinatio

297、n for pat-ents,pass a new Copyright Act,and modernize South?The direct link between policy choices and results on the Index is even clearer when examining the individual category-by-category scores,for both the BRICS and other economies.CATEGORY 1:PATENTS,RELATED RIGHTS,AND LIMITATIONSFigure 9 summa

298、rizes 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 maximum possible score of 9.As in past editions,the overall results for Category 1 are one of the strongest

299、of all the categories included in the Index.Twenty-one economies achieve a score of 70%or more of the available score and 31 economies in total achieve a score of over 50%.The average score on the category is 60.87%,which is the second-highest-scor-ing category on the Index.As in years past,Singapor

300、e is ranked number one,comfortably ahead of Japan,South Korea,Switzerland,and the United States.As noted in previous editions,the patenting environ-ment in the United States continues to be held back by uncertainty over what constitutes patentable subject matter and patent nullity proceedings throug

301、h the inter partes review(IPR),which occurs before the specialized Patent Trial and Appeals Board(PTAB)within the USPTO.Since the Supreme Court decisions in the Bilski,Myri-ad,Mayo,and Alice cases,there has been a high and sustained level of uncertainty as to which inventions are patentable in the U

302、nited States.Since 2014,the USPTO has issued and updated patent examination guidelines almost on an annual basis.Lower and cir-cuit court decisions in patent infringement proceed-ings have not always been consistent.The net result is that rights-holders are left without a clear sense of how decision

303、s on patent eligibility will be made and, THROUGH INGENUITYwhen granted patents are subsequently challenged or reviewed either through the courts or through the inter partes proceedings within the USPTO,which patent claims will be upheld.Under the leadership of former USPTO Director Andrei Iancu,the

304、 USPTO has recognized this dilemma and over the past three years sought to re-formulate its position 0.00%10.00%20.00%30.00%40.00%50.00%60.00%70.00%80.00%90.00%100.00%SingaporeJapanSouth KoreaSwitzerlandUnited StatesFranceGermanyIrelandNetherlandsSpainSwedenTaiwanUnited KingdomItalyHungaryAustraliaI

305、sraelChinaGreeceCanadaPolandNew ZealandMoroccoJordanCosta RicaDominican RepublicBruneiRussiaColombiaKenyaSaudi ArabiaMexicoPeruPhilippinesUAETurkeyChileMalaysiaEgyptUkraineBrazilIndonesiaKuwaitVietnamEcuadorIndiaArgentinaThailandPakistanAlgeriaNigeriaSouth AfricaVenezuela97.2294.4494.4494.4494.4491.

306、6791.6791.6791.6791.6791.6791.6791.6788.8986.1183.3383.3380.8380.5678.3375.0071.7870.8363.8963.6163.3361.1155.5650.0050.0050.0049.8347.2247.2247.2244.4443.7241.6736.1136.1135.9433.3333.3333.3333.1733.1732.2230.2227.7822.2222.2222.228.33Figure 9:Category 1:Patents,Related Rights,and Limitations,perce

307、ntage available scoreand the approach to be taken by its examiners.In Jan-?-ering section 101 patentability and section 112 claims relating to computer inventions,the“2019 Revised Pat-ent Subject Matter Eligibility Guidance”and“Examining Computer-Implemented Functional Claim Limitations for Complian

308、ce with 35 U.S.C.112.”With respect to section 101 patentability,the new guidance provides more of 2021 Ninth Edition|48U.S.CHAMBER INTERNATIONAL IP INDEX 2021a principle-based analysis of how patentability will be judged and describes the stepwise approach examiners should follow to understand and a

309、pply the Supreme Courts Alice/Mayo test.As the guidance rightly points out,the key challenge for USPTO examiners and courts has been to“consistently distinguish between patent-el-igible subject matter and subject matter falling within a judicial exception.”The new guidance recognizes this and seeks,

310、to the extent that is possible without further statutory changes,to clear this up with a revised proce-dure and process for examiners to follow.?published Adjusting to Alice USPTO Patent Examination Outcomes after Alice Corp.v CLS Bank International.This report examines the effect of the 2019 guidan

311、ce?Alice-related tech-nologiesthat is,technologies and applications that?-?that,overall,since the introduction of the guidance,?Al-ice?12 months following the introduction of the guidance.As the USPTO rightly notes,this is positive news.The Index commends the USPTO for taking this action and working

312、 together with all stakeholders to improve what is a challenging situation for rights-holders,applicants,and examiners alike.Similarly,over the past two years,the U.S.government?-tended effects of the PTAB system and publicly pledged to work with all stakeholders to address and remedy them.To begin

313、with,the USPTO introduced several important changes in 2018 and 2019.In 2018,former USPTO Director Iancu stated that the reform of IPR pro-ceedings was one of the agencys“highest priorities,”and that the agency was considering“how and when we institute proceedings,the standards we employ during the

314、proceedings,and how we conduct the overall pro-ceedings.The goal,with whatever action we take,is to increase predictability of appropriately-scoped claims.”Following these remarks,important reforms were an-nounced during the year,which included:(1)changing the patent claim construction standard used

315、,moving away from the broadest reasonable interpretation(BRI)standard to the so-called Phillips standard,the latter of which is the claim construction standard used in the judiciary since the mid-2000s;(2)a new Trial Practice Guide;and(3)Standard Operating Procedure(SOP)changes.Using the Phillips st

316、andard has aligned IPR proceedings with the same claim construction standards that are used in patent infringement proceedings at U.S.district courts.The revised Trial Practice Guide provides greater clarity on the grounds on which a review may be initiated.The changes to both SOP 1 and SOP 2 sought

317、 to streamline how judges are assigned,the composition of panels,and the way precedent-setting opinions are?Panel(POP),headed by the director.Since its introduc-tion,the POP has been active in shaping how the IPRs operate,with several of the panels decisions having been of high procedural importance

318、 addressing issues relating to the USPTO directors decisions to institute IPR proceedings(see,for example,Valve Corp.v Electronic Scripting Products Inc.)and procedural rules including the declaration of interested parties(ProppantExpress Investments LLC v Oren Techs.LLC).These efforts continued in

319、2020.Several new POP de-cisions were issued and the USPTO proposed import-ant potential changes to the IPR process.In May,the agency published a“Notice of Proposed Rulemaking”in the Federal Register.The notice includes proposed procedural changes incorporating the Supreme Court ruling in SAS Institu

320、te Inc.v Iancu on how patent validity challenges should be accepted and whether proceed-ings should be initiated on a select number of claims or all claims.The changes also included a question on whether the presumption in favor of a petitioner should be maintained or eliminated in pre-trial proceed

321、ings.Further changes were proposed in October,when the agency published a“Request for Comments on Discre- THROUGH INGENUITYtion to Institute Trials before the Patent Trial and Appeal Board”in the Federal Register.The proposed changes focus on how the PTAB should deal with serial and par-allel petiti

322、ons.These are instances when the same pat-ent and patent claims are petitioned to be challenged before the board in different petitions.In addition to the USPTOs actions,the Supreme Court was also active in 2020.In April,the Court held in Thryv Inc.v Click-to-Call Technologies LP,et al.that the time

323、line for submitting an IPR petition is not subject to judicial review and rests solely with the PTAB.The decision re-verses an earlier judgment by the U.S.Court of Appeals for the Federal Circuit,which held that the decision to hold an IPR proceeding in the case was an error.In October,the Supreme C

324、ourt also accepted petitions?Arthrex Inc.v Smith&Nephew Inc.and whether PTAB judges have been unconstitutionally appointed.While the key issue at hand concerns administrative law and the technical categorization of judges serving on the PTAB,legal?PTAB cases were vacated by the Federal Circuits earl

325、ier decision and have been held in abeyance.Overall,the high level of administrative and judicial activity illustrates how U.S.rights-holders continue to face great uncertain-ty over how patent disputes will be adjudicated and how decisions will be made and upheld within different fora.Uncertainty o

326、ver what constitutes patentable subject matter has crept into all facets of the patent systemfrom initial application and examination to standards of review and invalidity proceedings,whether admin-istratively through the PTAB or through the judiciary.In other economies,rights-holders continued to f

327、ace uncertainty and a challenging environment.As detailed in the preceding section,there continues to be a high degree of uncertainty regarding the availabil-ity of patent term restoration in the EU and the United Kingdom.Regulation 2019/933 remains in force and the SPC export exemption is,for all i

328、ntents and purpos-es,legal and operational in all EU Member States.In July,the CJEU reversed earlier precedent from 2012 by disallowing the issuing of an SPC for new innovations relating to approved biopharmaceutical products and treatments.In earlier rulings,the CJEU had held that it was possible t

329、o obtain an SPC for the new use of a product for which a market authorization for the same active ingredient had already been granted.This deci-sion has now,effectively,been overturned.The courts verdict sets an unfortunate precedent and will likely further limit the availability of European incenti

330、ves for biopharmaceutical innovation.It also stands in con-trast to thinking in other economies.Indeed,in other jurisdictions,authorities have found that equivalent mechanisms for term restoration should be made avail-able to rights-holders for new innovations relating to approved biopharmaceutical

331、products and treatments.For example,in South Korea an important decision was issued in 2020 by the Korean Intellectual Property Trial and Appeal Board(IPTAB).The IPTAB is a quasi-judicial?regards to patent rights.In July,the IPTAB issued what could become a precedent-setting ruling that any term res

332、toration granted should cover all uses under the existing patent and not be limited to just one primary or single use.This ruling clears up what has been a gray area for rights-holders in Korea and ensures that any term restoration granted provides a similar level of pro-tection for any and all uses

333、 as that of the original patent.With respect to the United Kingdom,although Brexit is technically in effect and the United Kingdom is no longer a member of the EU,under the terms of the Withdrawal Agreement,CJEU decisions made during the transition period will also apply in the United Kingdom.More broadly,while the U.K.government has the sovereignty and power to effectively shelve Regulation 2019/