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1、 2024 Special 301 Report Office of the United States Trade Representative ACKNOWLEDGEMENTS The Office of the United States Trade Representative(USTR)is responsible for the preparation of this Report.United States Trade Representative Katherine Tai gratefully acknowledges the contributions of staff t

2、o the writing and production of this Report and extends her thanks to partner agencies,including the following Departments and agencies:State;Treasury;Justice;Agriculture;Commerce,including the International Trade Administration and the Patent and Trademark Office;Health and Human Services;and Homel

3、and Security,including the United States Customs and Border Protection,Homeland Security Investigations,and the National Intellectual Property Rights Coordination Center.USTR also recognizes the contributions of the Office of the Intellectual Property Enforcement Coordinator,as well as those of the

4、United States Copyright Office.In preparing the Report,substantial information was solicited from U.S.embassies around the world,from U.S.Government agencies,and from interested stakeholders.The draft of this Report was developed through the Special 301 Subcommittee of the interagency Trade Policy S

5、taff Committee.3 TABLE OF CONTENTS EXECUTIVE SUMMARY.4 SECTION I:Developments in Intellectual Property Rights Protection,Enforcement,and Related Market Access.9 SECTION II:Country Reports.40 UKRAINE REVIEW SUSPENDED.40 PRIORITY WATCH LIST.40 ARGENTINA.40 CHILE.42 CHINA.44 INDIA.54 INDONESIA.57 RUSSI

6、A.59 VENEZUELA.62 WATCH LIST.63 ALGERIA.63 BARBADOS.64 BELARUS.65 BOLIVIA.66 BRAZIL.67 BULGARIA.69 CANADA.70 COLOMBIA.71 ECUADOR.72 EGYPT.73 GUATEMALA.74 MEXICO.75 PAKISTAN.77 PARAGUAY.78 PERU.79 THAILAND.80 TRINIDAD AND TOBAGO.82 TRKIYE.83 TURKMENISTAN.84 VIETNAM.85 ANNEX 1:Special 301 Statutory Ba

7、sis.86 ANNEX 2:U.S.Government-Sponsored Technical Assistance and Capacity Building.88 4 EXECUTIVE SUMMARY The Special 301 Report(Report)is the result of an annual review of the state of intellectual property(IP)protection and enforcement in U.S.trading partners around the world,which the Office of t

8、he United States Trade Representative(USTR)conducts pursuant to Section 182 of the Trade Act of 1974,as amended(the Trade Act,19 U.S.C.2242).Congress amended the Trade Act in 1988 specifically“to provide for the development of an overall strategy to ensure adequate and effective protection of intell

9、ectual property rights and fair and equitable market access for United States persons that rely on protection of intellectual property rights.”1 In particular,Congress expressed its concern that“the absence of adequate and effective protection of United States intellectual property rights,and the de

10、nial of equitable market access,seriously impede the ability of the United States persons that rely on protection of intellectual property rights to export and operate overseas,thereby harming the economic interests of the United States.”2 This Report provides an opportunity to put a spotlight on fo

11、reign countries and the laws,policies,and practices that fail to provide adequate and effective IP protection and enforcement for U.S.inventors,creators,brands,manufacturers,and service providers,which,in turn,harm American workers whose livelihoods are tied to Americas innovation-and creativity-dri

12、ven sectors.The Report identifies a wide range of concerns,including:(a)challenges with border and criminal enforcement against counterfeits,including in the online environment;(b)high levels of online and broadcast piracy,including through illicit streaming devices;(c)inadequacies in trade secret p

13、rotection and enforcement in China,Russia,and elsewhere;(d)troubling“indigenous innovation”and forced or pressured technology transfer policies that may unfairly disadvantage U.S.right holders in markets abroad;and(e)other ongoing,systemic issues regarding IP protection and enforcement,as well as ma

14、rket access,in many trading partners around the world.Combating such unfair trade policies can foster American innovation and creativity and increase economic security for American workers and families.A priority of this Administration is to craft trade policy in service of Americas workers,includin

15、g those in innovation-and creativity-driven export industries.The Report serves a critical function by identifying opportunities and challenges facing U.S.innovative and creative industries in foreign markets and by promoting job creation,economic development,and many other benefits that effective I

16、P protection and enforcement support.The Report informs the public and our trading partners and seeks to be a positive catalyst for change.USTR looks forward to working closely with the governments of the trading partners that are identified in this years Report to address both emerging and continui

17、ng concerns and to build on the positive results that many of these governments have achieved.1 Omnibus Trade and Competitiveness Act of 1988,1303(a)(2),102 Stat.1179.2 Id.1303(a)(1)(B);see also S.Rep.100-71 at 75(1987)(“Improved protection and market access for U.S.intellectual property goes to the

18、 very essence of economic competitiveness for the United States.The problems of piracy,counterfeiting,and market access for U.S.intellectual property affect the U.S.economy as a whole.Effective action against these problems is important to sectors ranging from high technology to basic industries,and

19、 from manufacturers of goods to U.S.service businesses.”).5 This Administration also recognizes that counterfeit products in particular,including counterfeit medicines,may harm the citizens of the trading partners where those counterfeit products are sold.In that regard,appropriate enforcement can a

20、lso serve the interests of foreign governments.Counterfeit products are more likely to be made of substandard materials or contain toxic or harmful chemicals.They also are more likely to be manufactured in workplaces that are not subject to the same regulations and safety standards as legitimate com

21、merce.As such,these products can pose serious potential health and safety risks to consumers.The production and sale of counterfeit goods also harms local businesses and governments by undermining fair market values and disincentivizing investment.The Report calls for adequate and effective enforcem

22、ent against trademark counterfeiting,which plays a key role in reducing the potential health and safety risks due to counterfeit products.THE 2024 SPECIAL 301 LIST The Special 301 Subcommittee received stakeholder input on more than 100 trading partners but focused its review on those submissions th

23、at responded to the request set forth in the notice published in the Federal Register to identify whether a particular trading partner should be named as a Priority Foreign Country,placed on the Priority Watch List or Watch List,or not listed in the Report.Following extensive research and analysis,U

24、STR has identified 27 trading partners as follows:Priority Watch List Watch List Argentina Chile China India Indonesia Russia Venezuela Algeria Barbados Belarus Bolivia Brazil Bulgaria Canada Colombia Ecuador Egypt Guatemala Mexico Pakistan Paraguay Peru Thailand Trinidad and Tobago Trkiye Turkmenis

25、tan Vietnam The Special 301 review of Ukraine has been suspended due to Russias full-scale invasion of Ukraine in February 2022.OUT-OF-CYCLE REVIEWS An Out-of-Cycle Review is a tool that USTR uses to encourage progress on IP issues of concern.Out-of-Cycle Reviews provide an opportunity to address an

26、d remedy such issues through heightened engagement and cooperation with trading partners and other stakeholders.Out-of-Cycle Reviews focus on identified IP challenges in specific trading partner markets.Successful resolution of specific IP issues of concern can lead to a positive change in a trading

27、 partners Special 301 status outside of the typical period for the annual review.Conversely,failure to address identified IP concerns,or further deterioration as to an IP-related concern within the specified Out-of-Cycle Review period,can lead to an adverse change in status.6 USTR may conduct additi

28、onal Out-of-Cycle Reviews of other trading partners as circumstances warrant or as requested by a trading partner.REVIEW OF NOTORIOUS MARKETS FOR COUNTERFEITING AND PIRACY In 2010,USTR began publishing annually the Review of Notorious Markets for Counterfeiting and Piracy(Notorious Markets List)sepa

29、rately from the annual Special 301 Report.The Notorious Markets List identifies illustrative examples of online and physical markets that reportedly engage in,facilitate,turn a blind eye to,or benefit from substantial copyright piracy and trademark counterfeiting,according to information submitted t

30、o USTR in response to a notice published in the Federal Register requesting public comments.In 2023,USTR requested such comments on August 24,2023,and published the 2023 Notorious Markets List on January 30,2024.USTR plans to conduct its next Review of Notorious Markets for Counterfeiting and Piracy

31、 in the fall of 2024.THE SPECIAL 301 PROCESS The Congressionally mandated annual Special 301 Report is the result of an extensive multi-stakeholder process.Pursuant to the statute mandating the Report,the United States Trade Representative is charged with designating as Priority Foreign Countries th

32、ose countries that have the most onerous or egregious acts,policies,or practices and whose acts,policies,or practices have the greatest adverse impact(actual or potential)on relevant U.S.products.(See ANNEX 1.)To facilitate administration of the statute,USTR has created a Priority Watch List and a W

33、atch List within this Report.Placement of a trading partner on the Priority Watch List or Watch List indicates that particular problems exist in that country with respect to IP protection,enforcement,or market access for U.S.persons relying on IP.Provisions of the Special 301 statute,as amended,dire

34、ct the United States Trade Representative to develop action plans for each country identified as a Priority Watch List country that has also been on the Priority Watch List for at least one year.Public Engagement USTR solicited broad public participation in the 2024 Special 301 review process to fac

35、ilitate sound,well-balanced assessments of trading partners IP protection and enforcement and related market access issues affecting IP-intensive industries and to help ensure that the Special 301 review would be based on comprehensive information regarding IP issues in trading partner markets.USTR

36、requested written submissions from the public through a notice published in the Federal Register on December 6,2023(Federal Register notice).In addition,on February 21,2024,USTR conducted a public hearing that provided the opportunity for interested persons to testify before the interagency Special

37、301 Subcommittee of the Trade Policy Staff Committee(TPSC)about issues relevant to the review.The hearing featured testimony from witnesses,including representatives of foreign governments,industry,and non-governmental organizations.USTR posted on its public website the testimony received at the Spe

38、cial 301 hearing and offered a post-hearing comment period during which hearing participants could submit additional information in 7 support of,or in response to,hearing testimony.3 The Federal Register notice drew submissions from 45 non-government stakeholders and 16 foreign governments.The submi

39、ssions filed in response to the Federal Register notice are available to the public online at www.regulations.gov,docket number USTR-2023-0014.Country Placement The Special 301 listings and actions announced in this Report are the result of intensive deliberations among all relevant agencies within

40、the U.S.Government,informed by extensive consultations with participating stakeholders,foreign governments,the U.S.Congress,and other interested parties.USTR,together with the Special 301 Subcommittee,conducts a broad and balanced assessment of U.S.trading partners IP protection and enforcement,as w

41、ell as related market access issues affecting IP-intensive industries,in accordance with the statutory criteria.(See ANNEX 1.)The Special 301 Subcommittee,through the TPSC,provides advice on country placement to USTR based on this assessment.This assessment is conducted on a case-by-case basis,takin

42、g into account diverse factors such as a trading partners level of development,its international obligations and commitments,the concerns of right holders and other interested parties,and the trade and investment policies of the United States.It is informed by the various cross-cutting issues and tr

43、ends identified in Section I.Each assessment is based upon the specific facts and circumstances that shape IP protection and enforcement in a particular trading partner.In the year ahead,USTR will continue to engage trading partners on the issues discussed in this Report.In preparation for,and in th

44、e course of,those interactions,USTR will:Engage with the U.S.Congress and U.S.Government agencies,as well as U.S.stakeholders and other interested parties to ensure that USTRs position is informed by the full range of views on the pertinent issues;Conduct extensive discussions with individual tradin

45、g partners regarding their respective IP regimes;Encourage trading partners to engage fully,and with the greatest degree of transparency,with the full range of stakeholders on IP matters;Develop an action plan with benchmarks for each country that has been on the Priority Watch List for at least one

46、 year to encourage progress on high-priority IP concerns;and Identify,where possible,appropriate ways in which the U.S.Government can be of assistance.(See ANNEX 2.)USTR will conduct these discussions in a manner that both advances the policy goals of the United States and respects the importance of

47、 meaningful policy dialogue with U.S.trading partners.In 3 Available at https:/ustr.gov/issue-areas/intellectual-property/special-301/2024-special-301-report.8 addition,USTR will continue to work closely with other U.S.Government agencies to ensure consistency of U.S.trade policy objectives.STRUCTUR

48、E OF THE SPECIAL 301 REPORT The 2024 Report contains the following Sections and Annexes:SECTION I:Developments in Intellectual Property Rights Protection,Enforcement,and Related Market Access discusses global trends and issues in IP protection and enforcement and related market access that the U.S.G

49、overnment works to address on a daily basis;SECTION II:Country Reports includes descriptions of issues of concern with respect to particular trading partners;ANNEX 1:Special 301 Statutory Basis describes the statutory basis of the Special 301 Report;and ANNEX 2:U.S.Government-Sponsored Technical Ass

50、istance and Capacity Building highlights U.S.Government-sponsored technical assistance and capacity building efforts.April 2024 9 SECTION I:Developments in Intellectual Property Rights Protection,Enforcement,and Related Market Access An important part of the mission of the Office of the United State

51、s Trade Representative(USTR)is to support and implement the Administrations commitment to protect American jobs and workers and to advance the economic interests of the United States.USTR works to protect American innovation and creativity in foreign markets employing all the tools of U.S.trade poli

52、cy,including the annual Special 301 Report(Report).Intellectual property(IP)infringement,including patent infringement,trademark counterfeiting,copyright piracy,4 and trade secret theft,causes significant financial losses for right holders and legitimate businesses.IP infringement can undermine U.S.

53、competitive advantages in innovation and creativity,to the detriment of American workers and businesses.5 In its most pernicious forms,IP infringement endangers the public,including through exposure to health and safety risks from counterfeit products,such as semiconductors,automobile parts,apparel,

54、footwear,toys,and medicines.In addition,trade in counterfeit and pirated products often fuels cross-border organized criminal networks,increases the vulnerability of workers to exploitative labor practices,and hinders sustainable economic development in many countries.This Section highlights develop

55、ments in 2023 and early 2024 in IP protection,enforcement,and related market access in foreign markets,including:examples of initiatives to strengthen IP protection and enforcement;illustrative best practices demonstrated by the United States and our trading partners;U.S.-led initiatives in multilat

56、eral organizations;and bilateral and regional developments.This Section identifies outstanding challenges and trends,including as they relate to enforcement against counterfeit goods,online and broadcast piracy,protection of trade secrets,forced or pressured technology transfer and preferences for i

57、ndigenous IP,6 geographical indications(GIs),innovative pharmaceutical products and medical devices,trademark protection issues,copyright administration and royalty payment,and government use of unlicensed software.This Section also highlights the importance of IP to innovation in the environmental

58、sector and considerations at the intersection of IP and health.Finally,this Section discusses the importance of full implementation of the World Trade Organization(WTO)Agreement on Trade-Related Aspects of Intellectual Property Rights(TRIPS)and developments on the use of WTO dispute settlement proce

59、dures by the United States to resolve IP concerns.4 The terms“trademark counterfeiting”and“copyright piracy”may appear below also as“counterfeiting”and“piracy,”respectively.5 The Issue Focus of the 2022 Review of Notorious Markets for Counterfeiting and Piracy examines the impact of online piracy on

60、 U.S.workers.Workers,such as content creators and the creative professionals who support the production of creative works,rely more than ever on adequate and effective copyright protection and enforcement to secure their livelihoods in todays digital era.Online piracy is not only highly detrimental

61、to the U.S.economy as a whole,but it also has a strong impact on the everyday lives of individual workers.6 In certain countries,preferences or policies on“indigenous IP”or“indigenous innovation”refer to a top-down,state-directed approach to technology development,which can include explicit market s

62、hare targets that are to be filled by producers using domestically owned or developed IP.10 A.Initiatives to Strengthen Intellectual Property Protection and Enforcement in Foreign Markets The Office of the United States Trade Representative(USTR)notes the following important developments in 2023 and

63、 early 2024:The Dominican Republic is removed from the Watch List this year for making significant progress on addressing concerns with intellectual property(IP)enforcement and transparency.Through the leadership of and coordination by the Interministerial Council on Intellectual Property,Dominican

64、Republic agencies increased enforcement actions and interagency cooperation on combating signal piracy,improved resource allocation for agencies,made publicly available enforcement-related statistics,increased the number of specialized IP prosecutors,and worked with various U.S.agencies to receive t

65、raining and technical assistance.In 2023,the Dominican Republic also increased enforcement actions against counterfeit medicines,including the opening of 8 cases by the Office of the Special Prosecutor for Crimes and Offenses Against Health targeting counterfeits sold at pharmacies and illicit marke

66、ts,seizing more than 4 million units of counterfeit medicines.The Dominican Republic has committed to continue taking enforcement actions to combat copyright infringement,including signal piracy,and to increase capacity through training and engagement with the United States.Uzbekistan is removed fro

67、m the Watch List this year due to sustained progress on long-standing issues pertaining to IP protection and enforcement.Uzbekistan enacted new Customs Code amendments in February 2024 that introduce ex officio authority to suspend and seize counterfeit imports and exports,announced plans in the 202

68、2 National Strategy for the Development of Intellectual Property to combat counterfeit goods and online piracy,acceded in 2019 to the World Intellectual Property Organization(WIPO)Performances and Phonograms Treaty(WPPT)and WIPO Copyright Treaty(WCT),collectively known as the WIPO Internet Treaties,

69、and has made continuous efforts since 2021 to move government agencies to licensed software.The United States also recognizes the continued high-level political attention to IP,including Uzbekistans support for and participation in the Intellectual Property Working Group under the United States-Cent

70、ral Asia Trade and Investment Framework Agreement(TIFA).The United States will continue working with Uzbekistan and will closely monitor implementation of the new Customs Code amendments and the continued transition to licensed software across the government.The United States also encourages Uzbekis

71、tan to address reported increases in the availability of counterfeit goods within the county.Bulgaria passed the Act Amending and Supplementing the Criminal Code,which provides for the criminal prosecution of persons who create conditions for online piracy.The amendments entered into force in August

72、 2023.Bulgaria has been a safe haven for online piracy,and the United States will monitor the use and impact of the amendments.In Peru,Congress passed an amendment to its Law Against Organized Crime to expand its application to intellectual property crimes.This amendment enables the Peruvian 11 Nati

73、onal Police and the Prosecutors Office to use Perus Law Against Organized Crime procedures when investigating potential organized crimes related to intellectual property infringement.Moreover,the amendment will permit the imposition of harsher prison sentences(ranging from 8 to 15 years)for members

74、of criminal organizations involved in customs offenses and crimes against intellectual property.India finalized the Patents(Amendments)Rules,2024,which include amendments to the procedures for pre-grant oppositions,an update to the reporting form for patent working,and decreased reporting time for r

75、eporting foreign applications.The amendments have the potential to reduce long-standing burdens on patent applicants.In March 2023,China acceded to the Convention of 5 October 1961 Abolishing the Requirement of Legalisation for Foreign Public Documents(Apostille Convention),which entered into force

76、with respect to China in November 2023.For certain documents from Contracting States of the Apostille Convention,China will reportedly replace its current system for consularization procedures with a new authentication procedure based on Apostille certificates,which may reduce the authentication pro

77、cess from 20 working days to a few working days.In October 2023,Indonesias Directorate General for Intellectual Property and Indonesian enforcement authorities collaborated with the International Criminal Police Organization(INTERPOL),the U.S.Department of Justice International Computer Hacking and

78、Intellectual Property Attorney Advisor for Asia,and Korean enforcement authorities to arrest operators of an illicit Internet Protocol television(IPTV)service and seize servers and streaming equipment.As of March 2024,there are 62 members of the 1991 Act of the International Union for the Protection

79、 of New Varieties of Plants Convention(UPOV 1991).The treaty requires member countries to grant IP protection to breeders of new plant varieties,known as breeders rights.An effective plant variety protection system incentivizes plant-breeding activities,which leads to increased numbers of new plant

80、varieties with improved characteristics such as high-yield,tolerance to adverse environmental conditions,and better food quality.In addition,promoting strong plant variety protection and enforcement globally helps improve industry competitiveness in foreign markets,encourages the importation of fore

81、ign plant varieties,and enhances domestic breeding programs.Since the publication of the 2023 Special 301 Report,Armenia has acceded to UPOV 1991.As of March 2024,there are 112 parties to the World Intellectual Property Organization(WIPO)Performances and Phonograms Treaty and 116 parties to the WIPO

82、 Copyright Treaty(WCT),collectively known as the WIPO Internet Treaties.These treaties,which were completed in 1996 and entered into force in 2002,have raised the standard of copyright protection around the world,particularly with regard to online delivery of copyrighted content.The treaties,which p

83、rovide for certain exclusive rights,require parties to provide adequate legal protection and effective legal remedies against the circumvention of technological protection measures(TPMs),as well as certain acts 12 affecting rights management information(RMI).Since the publication of the 2023 Special

84、 301 Report,Saint Vincent and the Grenadines has acceded to the WCT.The United States will continue to work with its trading partners to further enhance IP protection and enforcement during the coming year.B.Illustrative Best Intellectual Property Practices by Trading Partners The Office of the Unit

85、ed States Trade Representative(USTR)highlights the following illustrative best practices by trading partners in the area of intellectual property(IP)protection and enforcement:Cooperation and coordination among national government agencies involved in IP issues are examples of effective IP enforceme

86、nt.Several countries,including the United States,have introduced IP enforcement coordination mechanisms or agreements to enhance interagency cooperation.In Saudi Arabia,the Saudi Authority for Intellectual Property(SAIP)created the permanent National Committee for the Enforcement of Intellectual Pro

87、perty to coordinate IP enforcement,issue reports and case studies,and develop IP legislation and regulations.Brazils National Council on Combating Piracy and Intellectual Property Crimes comprises representatives from executive branch ministries and the private sector,and works to discuss ongoing IP

88、 enforcement issues,propose public policy initiatives,and organize public awareness workshops.Indonesia expanded the Intellectual Property Enforcement Task Force to include coordination on IP enforcement with the Attorney Generals Office,for a total of ten member agencies.Indonesias Directorate Gene

89、ral for Intellectual Property(DGIP)has encouraged its investigators to take a proactive role in IP-related complaints and used an online system for complaints to facilitate better coordination with the Indonesian National Police.South Africas Companies and Intellectual Property Commission,South Afri

90、can Revenue Service,and South African Police Service share responsibility for IP enforcement and coordinate on enforcement raids led by the new national IP enforcement unit called the South African Police Service National Counterfeit Unit.In 2023,the Dominican Republic Interministerial Council of In

91、tellectual Property,led by the Ministry of Industry,Commerce,and Micro,Small,and Medium Enterprises,coordinated the agencies involved in IP protection and enforcement to better advance cooperation and information sharing.Specialized IP enforcement units and specialized IP courts also have proven to

92、be important catalysts in the fight against counterfeiting and piracy.For example,in March 2024,the Philippines launched a new E-Commerce Bureau under the Department of Trade and Industry,which is intended to focus on protecting consumers and merchants engaged in e-commerce transactions,including to

93、 protect against the sale of counterfeit goods online.In India,the Intellectual Property Rights Divisions provide specialist courts for hearing IP disputes in the Delhi High Court and Madras High Court,with a forthcoming new Intellectual Property Rights Division announced at the end of last year for

94、 the Calcutta High Court.13 Many trading partners conducted IP awareness and educational campaigns,including jointly with stakeholders,to develop support for domestic IP initiatives.In Spain,the Ministry of Industry,Trade,and Tourisms Patent and Trademark Office carried out campaigns against IP thef

95、t.In Algeria,the Office of Copyright and Neighboring Rights(ONDA)hosts counterparts from other North and West African countries for regional training on protecting IP rights.The United Arab Emirates(UAE)launched an IP Ecosystem program to advance IP protections in key economic and creative sectors o

96、f the UAE,including support for new technologies and student awareness programs.In Indonesia,DGIP dispatched around 350 trainers to educate over 5,000 elementary school students on IP awareness.In Thailand,the Department of Intellectual Property conducted outreach via podcasts,a singing contest in c

97、ollaboration with the popular JOOX music app,and IP awareness campaigns at physical markets.In the Philippines,the Intellectual Property Office of the Philippines organized an“IP and Citizen Journalism for Schools”program for youths,launched a“Pirated Inferno”comic,and collaborated with stakeholders

98、 on an anti-piracy campaign.Uzbekistan conducted a“counterfeit prevention month”with awareness-building events around the country,and the Ministry of Justice has developed a catalogue of counterfeit products to help educate consumers to differentiate between counterfeit and legitimate goods.In Kazak

99、hstan,the Ministry of Justice established 20 regional IP branches to conduct public outreach and education throughout the country.In Peru,the Ministry of Production organized a course for 1,930 undergraduate students from ten universities on IP taxation and customs issues.Brazils National Council to

100、 Combat Piracy(CNCP)received funding for the first time in the agencys history,which it plans to use in part to develop a campaign to raise awareness of the damage caused by IP crimes.Another best practice is the active participation of government officials in technical assistance and capacity build

101、ing.In 2023,U.S.Embassy Jakarta hosted the Intellectual Property Rights Investigative Methods Workshop in Indonesia for investigators,prosecutors,regulators,and customs officials from DGIP,Ministry of Law and Human Rights,Indonesian Food and Drug Authority(BPOM),Attorney General Office,Ministry of H

102、ealth(Kemenkes),and Ministry of Trade.The training was developed as a collaboration of the U.S.National Intellectual Property Rights Coordination Center;U.S.Homeland Security Investigations;the U.S.Department of Homeland Security Attaches for Jakarta,Singapore,and Thailand;the U.S.Department of Just

103、ice(DOJ),the U.S.International Computer Hacking and Intellectual Property Attorney Advisor(ICHIP)for Asia;the U.S.Federal Bureau of Investigation;the U.S.Customs and Border Protection;the U.S.Patent and Trademark Office(USPTO);the Royal Thai Police;and the Pharmaceutical Security Institute.Indonesia

104、s judges participated in an Indo-Pacific Judicial Colloquium on Intellectual Property,Innovation,and Technology,which was organized by the USPTO.Judicial and customs officials in Morocco participated in a series of IP border enforcement workshops hosted by the USPTO to strengthen networks between in

105、dustry officials and bolster enforcement of intellectual property.Saudi Arabia hosted a patent examiner training program led by USPTO experts for officials from Saudi Arabia,Oman,and Qatar.In collaboration with the World Intellectual Property Organization(WIPO),IP Key Latin America,USPTO,and the Jap

106、an Patent Office,Paraguay hosted its first Subregional Seminar on the Enforcement of Intellectual Property 14 Rights with participation from special agents,experts from the private sector,prosecutors,judges,customs officials,and police officers in charge of combating counterfeiting and piracy from t

107、he United States and countries across Latin America.The Intellectual Property Office of the Philippines conducted a National Judicial Colloquium on Intellectual Property Adjudication,which included participation from judges from Australia and Singapore to share best practices.In Thailand,the Departm

108、ent of Intellectual Property organized workshops for law enforcement officers on“Prevention of Intellectual Property Violations,”trainings on how to examine counterfeit goods,and a workshop with the Economic Crime Department officers and local law enforcement in Bangkok.Copyright officials from Keny

109、a and Nigeria participated in a USPTO training on broadcasting,communication to the public,making available,and equitable remuneration rights.Representatives from the Dominican Republics National Copyright Office,Institute of Telecommunications,Attorney Generals Office,judiciary,and police forces pa

110、rticipated in a September 2023 Digital Piracy Working Group meeting led by the DOJ and a January 2024 USPTO workshop on digital piracy crimes.In Peru,the Ministry of Production organized 64 workshops in 2023 for 1,959 officials from various Peruvian ministries engaged in IP and customs work on ident

111、ifying,controlling,and seizing illicit goods.Separately,the Superior Court of Justice of Lima hosted its first specialized course in November 2023 on crimes against IP,which included presentations from representatives of the DOJ and the USPTO.Approximately 100 participants from a variety of ministri

112、es and law enforcement agencies participated in the course,learning about the harmful impacts of a wide range of IP crimes,including the sale of adulterated medicines,counterfeit clothing,and pirated books,and the streaming of pirated digital content.In Bulgaria,the Prosecutor Generals Office provid

113、ed a course on investigating IP and computer crimes at the National Institute of Justice for 15 investigators.Micro,small,and medium-sized enterprises(MSMEs)play a positive role in the global economy as they contribute widely to innovation,trade,growth,investment,and competition.According to a study

114、 by the European Patent Office(EPO)and the European Union Intellectual Property Office(EUIPO)in 2019,small and medium-sized enterprises(SMEs)that have at least one IP right are 21%more likely to experience a growth period.7 Many trading partners provide capacity building,technical assistance,or othe

115、r resources to help MSMEs better understand IP and how to protect and enforce their IP.For example,the United Kingdom provides IP audits to help potential high growth,innovative MSMEs with a tailored assessment of the IP within their business to help them develop IP management strategies,and India p

116、rovides administrative and financial incentives for the creation and use of IP by SMEs and startups.In Liberia,the Intellectual Property Office established IP Management Clinics for SMEs.In 2023,the Dominican Republic Ministry of Industry,Commerce,and Micro,Small,and Medium Enterprises provided trai

117、nings to 926 MSMEs enterprises through the Ruta Program raising awareness about the importance of registering intellectual property assets.7 See EPO/EUIPO,High-growth Firms and Intellectual Property Rights:IPR Profile of High-potential SMEs in Europe(May 2019),https:/link.epo.org/web/high_growth_fir

118、ms_study_en.pdf.15 C.Multilateral Initiatives The United States works to promote adequate and effective intellectual property(IP)protection and enforcement through various multilateral institutions,notably the World Trade Organization(WTO).In 2023,the United States advanced its Intellectual Property

119、 and Innovation agenda in the WTO Council for Trade-Related Aspects of Intellectual Property Rights(TRIPS Council)through a series of different initiatives that cover often unexplored areas connected to IP and innovation.Over the course of three meetings,the United States and co-sponsors presented o

120、n cross-border cooperation among IP offices,research collaboration across borders,and incubators and accelerators support of startups operating in a cross-border environment.The discussions were wide-ranging and spurred Members to consider the links between these areas.Throughout 2023,the United Sta

121、tes,together with other Members of the WTO,worked to orient Members efforts toward a pandemic response and greater preparedness,and sought to identify priority steps that could be taken,including in the area of trade facilitation and IP protections.In the TRIPS Council,discussions were held with res

122、pect to lessons learned,including best practices and shortcomings,on issues such as domestic COVID-related IP measures that WTO Members have taken during the pandemic,licensing and technology transfer partnerships that were formed during the pandemic,and access to COVID-19 therapeutics for certain u

123、pper-middle income countries.These issues are complex,which is why the U.S.Trade Representative requested that the U.S.International Trade Commission conduct an investigation and prepare a report regarding access to COVID-19 diagnostics and therapeutics.This report,published in October 2023,has help

124、ed to inform a thoughtful and constructive policy discussion and deliberative process at the WTO and in other fora.8 D.Bilateral and Regional Initiatives The United States works with many trading partners on IP protection and enforcement through the provisions of bilateral instruments,including trad

125、e agreements and memoranda of cooperation,and through regional initiatives.The following are examples of bilateral coordination and cooperation:Trade and Investment Framework Agreements(TIFAs)between the United States and more than 50 trading partners and regions around the world and other similar f

126、rameworks for bilateral engagement have facilitated discussions on IP protection and enforcement.In February 2023,the United States and Peru,through its Trade Promotion Agreement,held the sixth meeting of the Free Trade Commission to discuss the implementation of the agreement.In July 2023,the Intel

127、lectual Property Working Group under the United States-Central Asia TIFA met to discuss and share ideas about customs enforcement in each country.In August 2023,the United States and Thailand held a technical meeting to discuss issues raised under the United States-Thailand TIFA,followed by a TIFA m

128、eeting in September.In September 2023,the United States and Paraguay met for the second time under the United States-Paraguay TIFA and reviewed implementation of the 2022 8 U.S.International Trade Commission,COVID-19 Diagnostics and Therapeutics:Supply,Demand,and TRIPS Agreement Flexibilities(Octobe

129、r 2023),https:/www.usitc.gov/publications/332/pub5469.pdf.16 Intellectual Property Work Plan.The twelfth meeting of the United States and Ukraine Trade and Investment Council was held in November 2023 to discuss Ukraines ongoing efforts to develop a strong IP environment despite Russias full-scale i

130、nvasion in 2022.In December 2023,the United States and Vietnam held a TIFA Intellectual Property Working Group meeting to discuss issues such as IP enforcement,which were reported in the TIFA meeting.The fourteenth Ministerial-level meeting of the India-United States Trade Policy Forum(TPF)held in J

131、anuary 2024,and several meetings of the Intellectual Property Working Group under the TPF throughout the year,discussed Indias efforts to modernize its patent system and exchanged ideas on other patent,copyright,and trademark issues.In February 2024,the United States and Armenia met under the United

132、 States-Armenia TIFA and discussed efforts to update Armenias IP environment.Regional coordination and cooperation also increase the effectiveness of engagement on IP protection and enforcement challenges that extend beyond individual jurisdictions:In 2023,the United States hosted the Asia-Pacific E

133、conomic Cooperation(APEC)with a host year theme of“Creating a Resilient and Sustainable Future for All.”The United States continued to use the Intellectual Property Experts Group and other APEC sub-fora to build capacity and raise standards in the Asia-Pacific region.This included continued discussi

134、ons with APEC economies on effective practices for enforcement against illicit streaming in a United States-led initiative on illicit streaming,which previously included the joint publication of the Report on Results of Survey Questionnaire on Domestic Treatment of Illicit Streaming Devices(ISDs)by

135、APEC Economies and a virtual workshop.The United States also organized workshops on the margins of the Intellectual Property Experts Group Meeting.The“Roundtable on Copyright and Creativity in the Digital Economy”provided diverse perspectives from independent creators,producers,and union workers on

136、the importance of copyright protection and enforcement for promoting inclusive growth for individuals and small and medium-sized enterprises(SMEs)in the creative industries.The“Workshop on Geographical Indications and Preservation of Common Names”fostered a dialogue on inclusive trade by featuring S

137、ME producers and other stakeholders who spoke about the economic benefits of preserving the use of common names and the problems they encounter when common names are not preserved.The United States organized a workshop on“Leveraging Industrial Design Protections for Small-and-Medium Sized Enterprise

138、s,”as the United States continues to lead an initiative on industrial design protection.This workshop highlighted industrial design protection as a critical component of any IP portfolio for competitive businesses in the modern innovation economy,particularly for small and medium-sized businesses in

139、 the APEC region.The United States also organized a“Green Technology One Day Program,”bringing together policymakers and individuals involved in the research,development,and commercialization of green technologies.Together with Intellectual Property Experts Group delegates,they discussed the importa

140、nce of IP protection and enforcement as essential tools for their work and outlined issues associated with fostering a green economy.Under its trade preference program reviews,the Office of the United States Trade Representative(USTR),in coordination with other U.S.Government agencies,examines 17 IP

141、 practices in connection with the implementation of Congressionally authorized trade preference programs,including the Generalized System of Preferences(GSP)program,the African Growth and Opportunity Act,the Caribbean Basin Economic Recovery Act,and the Caribbean Basin Trade Partnership Act.USTR has

142、 pending GSP reviews of IP practices in Indonesia and South Africa but is not making any determinations about ongoing reviews while duty-free benefits under GSP remain lapsed.USTR continues to work with trading partners to address policies and practices that may adversely affect their eligibility un

143、der the IP criteria of preference programs.In addition to the work described above,the United States anticipates engaging with its trading partners on IP-related initiatives in fora such as the Group of Seven(G7),WIPO,the Organisation for Economic Co-operation and Development(OECD),and the World Cus

144、toms Organization.USTR,in coordination with other U.S.Government agencies,looks forward to continuing engagement with trading partners to improve the global IP environment.E.Intellectual Property Protection,Enforcement,and Related Market Access Challenges Border,Criminal,and Online Enforcement Again

145、st Counterfeiting Trademark counterfeiting harms consumers,legitimate producers,and governments.Consumers may be harmed by fraudulent and potentially dangerous counterfeit products,9 particularly medicines,automotive and airplane parts,and food and beverages that may not be subject to the rigorous g

146、ood manufacturing practices used for legitimate products.Infringers often disregard product quality and performance for higher profit margins.Legitimate producers and their employees face diminished revenue and investment incentives,adverse employment impacts,and reputational damage when consumers p

147、urchase fake products.Counterfeiting may also increase costs for firms to enforce their intellectual property(IP)rights.Governments lose the tax revenues generated by legitimate businesses and may find it more difficult to attract investment when illegal competitors undermine the market.For a furthe

148、r discussion on the potential health and safety risks posed by counterfeit goods,please see the Issue Focus section of the 2023 Review of Notorious Markets for Counterfeiting and Piracy.The problem of trademark counterfeiting continues on a global scale and involves the production,transshipment,and

149、sale of a vast array of fake goods.Counterfeit goods,including semiconductors and other electronics,chemicals,medicines,automotive and aircraft parts,food and beverages,household consumer products,personal care products,apparel and footwear,toys,and sporting 9 See Organisation for Economic Co-operat

150、ion and Development and European Union Intellectual Property Office,Dangerous Fakes:Trade in Counterfeit Goods that Pose Health,Safety and Environmental Risks(March 2022),https:/www.oecd.org/publications/dangerous-fakes-117e352b-en.htm(identifying types of potentially dangerous counterfeit products,

151、associated health and safety risks,and global trade statistics from 2017 to 2019 for these products).18 goods,make their way from China10 and other source countries,such as India and Trkiye,directly to purchasers around the world.The counterfeits are shipped either directly to purchasers or indirect

152、ly through transit hubs,including in Hong Kong,Kyrgyzstan,Singapore,and Trkiye,to third-country markets such as Brazil,Kenya,Mauritius,Mexico,Nigeria,Paraguay,and Russia,that are reported to have ineffective or inadequate IP enforcement systems.According to an Organisation for Economic Co-operation

153、and Development(OECD)and European Union Intellectual Property Office(EUIPO)study released in June 2021,titled Global Trade in Fakes:A Worrying Threat,the global trade in counterfeit and pirated goods reached$464 billion in 2019,accounting for 2.5%of the global trade in goods for that year.11 China(t

154、ogether with Hong Kong)continues to be the largest origin economy for counterfeit and pirated goods,accounting for more than 85%of global seizures of counterfeit goods from 2017 to 2019.12 The report identified Bangladesh as one of the top five source economies for counterfeit clothing globally,whic

155、h stakeholders have also identified as a concern this year.13 Stakeholders also continue to report dissatisfaction with border enforcement in Singapore,including concerns about the lack of coordination between Singapores Customs authorities and the Singapore Police Forces Intellectual Property Right

156、s Branch.The manufacture and distribution of pharmaceutical products and active pharmaceutical ingredients bearing counterfeit trademarks is a growing problem that has important consequences for consumer health and safety and is exacerbated by the rapid growth of illegitimate online sales.Counterfei

157、ting contributes to the proliferation of substandard,unsafe medicines that do not conform to established quality standards.The United States is particularly concerned with the proliferation of counterfeit pharmaceuticals that are manufactured,sold,and distributed by numerous trading partners.The top

158、 countries of origin for counterfeit pharmaceuticals seized at the U.S.border in Fiscal Year 2023 were India,Singapore,and China(together with Hong Kong).14 A recent study by OECD and EUIPO found that China,India,Indonesia,Pakistan,the Philippines,and Vietnam are the leading sources of counterfeit m

159、edicines distributed globally.15 U.S.brands are the most popular targets for counterfeiters of medical products,and counterfeit U.S.-brand medicines account for 38%of global counterfeit medicine seizures.16 While it may not be possible to determine an exact figure,the World Health Organization(WHO)1

160、0 In fiscal year 2023,China(together with Hong Kong)accounted for over 83%of the value(measured by manufacturers suggested retail sale price)of counterfeit and pirated goods seized by U.S.Customs and Border Protection.U.S.Customs and Border Protection,Intellectual Property Rights(IPR)Seizures Dashbo

161、ard,(April 1,2024),https:/www.cbp.gov/newsroom/stats/intellectual-property-rights-ipr-seizures.11 OECD/EUIPO,Global Trade in Fakes:A Worrying Threat at 9(Jun.2021),https:/www.oecd-ilibrary.org/sites/74c81154-en/index.html?itemId=/content/publication/74c81154-en.12 Id.at 27.13 Id.at 48.14 U.S.Customs

162、 and Border Protection,Intellectual Property Rights(IPR)Seizures Dashboard,(April 1,2024),https:/www.cbp.gov/newsroom/stats/intellectual-property-rights-ipr-seizures.15 OECD/EUIPO,Trade in Counterfeit Pharmaceutical Products at 35(Mar.2020),http:/www.oecd.org/gov/trade-in-counterfeit-pharmaceutical-

163、products-a7c7e054-en.htm.16 Id.at 12.19 estimated that substandard or falsified medical products comprise 10%of total medical products in low-and middle-income countries.17 Furthermore,the increasing popularity of online pharmacies18 has aided the distribution of counterfeit medicines.A 2020 study b

164、y Pennsylvania State University found that illicit online pharmacies,which provide access to prescription drugs,controlled substances,and substandard or counterfeit drugs,represent between 67%to 75%of web-based drug merchants.19 The U.S.Government,through the U.S.Agency for International Development

165、 and other federal agencies,supports programs in sub-Saharan Africa,Asia,and elsewhere that assist trading partners in protecting the public against counterfeit and substandard medicines in their markets.Counterfeiters increasingly use legitimate express mail,international courier,and postal service

166、s to ship counterfeit goods in small consignments rather than ocean-going cargo to evade the efforts of enforcement officials to interdict these goods.Approximately 90%of U.S.seizures at the border are made in the express carrier and international mail environments.Counterfeiters also continue to sh

167、ip products separately from counterfeit labels and packaging to evade enforcement efforts that are limited by laws or practices that require counterfeit items to be“completed”and which may overlook the downstream application of counterfeit labels.20 Counterfeiters also increasingly sell counterfeit

168、goods on online marketplaces,particularly through platforms that permit consumer-to-consumer sales.The Office of the United States Trade Representative(USTR)urges e-commerce platforms to take proactive and effective steps to reduce piracy and counterfeiting,for example,by establishing and adhering t

169、o strong quality control procedures in both direct-to-consumer and consumer-to-consumer sales,vetting third-party sellers,engaging with right holders to quickly address complaints,and working with law enforcement to identify IP violators.21 The United States continues to urge trading partners to und

170、ertake more effective criminal and border enforcement against the manufacture,import,export,transit,and distribution of counterfeit goods.The United States engages with its trading partners through bilateral consultations,trade agreements,and international organizations to help ensure that penalties

171、,such as significant monetary fines and meaningful sentences of imprisonment,are available and applied to deter 17 WHO,Substandard and Falsified Medical Products(Jan.2018),https:/www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products.18 See Alliance for Safe Online Pharm

172、acies(ASOP Global)/Abacus Data,2020 National Survey on American Perceptions of Online Pharmacies(Oct.2020),https:/buysaferx.pharmacy/wp-content/uploads/2020/10/ASOP-Global-Survey-Key-Findings_October-2020-FINAL.pdf(based on a July 2020 poll of 1500 American consumers,“35%of Americans have now report

173、ed using an online pharmacy to buy medication for themselves or someone in their care”with“31%doing so for the first time this year because of the pandemic”).19 Journal of Medical Internet Research,Managing Illicit Online Pharmacies:Web Analytics and Predictive Models Study(Aug.2020),https:/www.jmir

174、.org/2020/8/e17239/;cf.ASOP Global/Abacus Data,infra(“At any given time,there are 35,000 active online pharmacies operating worldwide,96%of which are operating illegally in violation of state and/or federal law and relevant pharmacy practice standards.”);FDA,Internet Pharmacy Warning Letters(Mar.202

175、1),https:/www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters(listing illegally operating online pharmacies that have been sent warning letters by the FDA).20 For more information on these trends,see CBPs intellectual property rights seizure statistics at https:/www.cbp.g

176、ov/trade/priority-issues/ipr.21 For more examples,see DHS,Combating Trafficking in Counterfeit and Pirated Goods(January 2020),https:/www.dhs.gov/sites/default/files/publications/20_0124_plcy_counterfeit-pirated-goods-report_01.pdf.20 counterfeiting.In addition,trading partners should ensure that co

177、mpetent authorities seize and destroy counterfeit goods,as well as the materials and implements used for their production,thereby removing them from the channels of commerce.Permitting counterfeit goods,as well as materials and implements,to re-enter the channels of commerce after an enforcement act

178、ion wastes resources and compromises the global enforcement effort.In addition,trading partners should also provide enforcement officials with ex officio authority to seize suspect goods and destroy counterfeit goods in-country as part of their criminal procedures and at the border during import,exp

179、ort,or in-transit movement without the need for a formal complaint from a right holder.For example,regarding criminal enforcement,Trkiye provides its National Police with ex officio authority only in relation to copyright violations and not for trademark counterfeiting violations.Pakistan has not pr

180、ovided criminal enforcement authorities ex officio authority to take action against counterfeit goods.Regarding border enforcement,in Colombia,for example,the customs police reportedly do not have authority to enter primary inspection zones and lack ex officio authority to inspect,seize,and destroy

181、counterfeit goods in those zones.Similarly,in Ecuador,stakeholders have reported concerns with a lack of ex officio authority.Although Indonesia provides ex officio authority for its customs authorities and has a recordation system,right holders can only benefit from the system if they meet several

182、stringent requirements,including local permanent establishment requirements and large deposit requirements.Similarly,border authorities in Canada have ex officio authority to seize suspected counterfeit goods,but they do not consistently use this authority.Turkmenistan also lacks ex officio authorit

183、y for border enforcement.The United States coordinates with and supports trading partners through technical assistance and sharing of best practices on criminal and border enforcement,including with respect to the destruction of seized goods.(See ANNEX 2.)As supply chains have grown more complicated

184、,such increased segmentation has provided more opportunities for counterfeit goods to enter into the sourcing,production,manufacturing,packaging,and distribution process.This practice can taint the supply chain for goods in all countries,harm consumers,and create reputational risk for companies.Coun

185、tries must work together to detect and deter commerce in counterfeit goods.To this end,the United States strongly supports continued work in the OECD and elsewhere on countering illicit trade.For example,the OECD recently adopted recommendations for enhancing transparency and reducing opportunities

186、for illicit trade in free trade zones(also known as foreign-trade zones).22 The United States encourages the OECD and our trading partners to build off the Governance Frameworks to Counter Illicit Trade OECD report23 and the International Chamber of Commerce(ICC)Know Your Customer initiative24 aimed

187、 at tackling the problem of counterfeit goods transported by international shipping companies.The United States commends these efforts by the OECD and the ICC.22 OECD,Recommendation of the Council on Countering Illicit Trade:Enhancing Transparency in Free Trade Zones(Oct.2019),https:/legalinstrument

188、s.oecd.org/en/instruments/OECD-LEGAL-0454.23 OECD,Governance Frameworks to Counter Illicit Trade(Mar.2018),https:/www.oecd.org/corruption-integrity/reports/governance-frameworks-to-counter-illicit-trade-9789264291652-en.html.24 International Chamber of Commerce,Know Your Customer(Mar.2018),https:/cd

189、n.iccwbo.org/content/uploads/sites/3/2018/09/icc-2018-kyc-and-supply-chain-paper.pdf.21 Online Piracy and Broadcast Piracy The increased availability of broadband Internet connections around the world,combined with increasingly accessible and sophisticated mobile technology,has led to the developmen

190、t of legitimate digital platforms for distribution of copyrighted content.This development in turn has allowed consumers around the world to enjoy the latest movies,television,music,books,and other copyrighted content from the United States.However,technological developments have also made the Inter

191、net an extremely efficient vehicle for disseminating pirated content that competes unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content.Online piracy is the most challenging copyright enforcement issue in many forei

192、gn markets.For example,during the review period,countries such as Argentina,Bulgaria,Canada,Chile,China,Colombia,India,Mexico,the Netherlands,Pakistan,Poland,Romania,Russia,Switzerland,Thailand,and Vietnam had high levels of online piracy and lacked effective enforcement.A June 2019 report,titled Im

193、pacts of Digital Video Piracy on the U.S.Economy,estimated that global online video piracy costs the U.S.economy at least$29.2 billion and as much as$71 billion in lost revenue each year.25 Stream-ripping software can be used to create infringing copies of copyrighted works from licensed streaming s

194、ites,and stream-ripping is now a dominant method of music piracy,causing substantial economic harm to music creators and undermining legitimate online services.During the review period,stream-ripping was reportedly popular in countries such as Canada,Korea,Mexico,Nigeria,Russia,South Africa,and Swit

195、zerland.Furthermore,illicit streaming devices(ISDs),also referred to as piracy devices,continue to pose a direct threat to content creators,sports leagues,and live performances,as well as legitimate streaming,on-demand,and over-the-top media service providers.Similarly,illicit Internet Protocol tele

196、vision(IPTV)services unlawfully retransmit telecommunications signals and channels containing copyrighted content through dedicated web portals and third-party applications.Today,there are many illegal IPTV services worldwide,many of which are subscription-based,for-profit services with vast and com

197、plex technical infrastructures.Stakeholders continue to report notable levels of piracy through ISDs and illicit IPTV apps,including in Argentina,Brazil,Canada,Chile,China,Guatemala,Hong Kong,India,Indonesia,Iraq,Jordan,Mexico,Morocco,Singapore,Switzerland,Taiwan,Thailand,United Arab Emirates,and Vi

198、etnam.China,in particular,is a manufacturing hub for these devices,and Iraq is reportedly a source of satellite receivers pre-loaded with pirate IPTV apps.25 Blackburn,David et al,Impacts of Digital Video Piracy on the U.S.Economy at Foreword,ii(Jun.2019),https:/www.project-scope.org/wp-content/uplo

199、ads/2020/08/digital-video-piracy.pdf.See also Danaher,Brett et al,Piracy Landscape Study:Analysis of Existing and Emerging Research Relevant to Intellectual Property Rights(IPR)Enforcement of Commercial-Scale Piracy,USPTO Economic Working Paper No.2020-2(Apr.2020)(evaluating peer-reviewed studies ad

200、dressing the scope and magnitude of economic harm from piracy,particularly via digital channels,across music and books as well as movies and television),https:/ Signal theft by cable operators continues to be a problem.In most cases,infringers circumvent encryption systems or otherwise unlawfully ac

201、cess cable or satellite signals to access copyrighted content.For example,in Brazil,signal theft is used as a source of premium live content.Argentinas law enforcement authorities do not prioritize prosecuting theft of pay-tv signals.Honduras continues to have one of the highest rates of signal pira

202、cy in Latin America and the Caribbean,with lack of enforcement being an ongoing problem.There are also ongoing concerns that a major cable provider in the country is offering unlicensed programming,is using that pirated content to expand its market share,and is now moving to illegal streaming as wel

203、l.Unauthorized distributors may also steal“overspill”broadcast or satellite signals from neighboring countries,access broadcast signals,or otherwise hack set-top boxes to allow consumers unauthorized access to copyrighted content,including premium cable channels.Hotels remain common sites of this ty

204、pe of infringement as they may use their own on-site facilities to intercept programing services and retransmit them throughout the hotel without paying right holders.The proliferation of“camcords”continues to be a significant trade problem.Unauthorized camcording is the primary source of infringing

205、 copies found online of newly released movies.The recordings made in movie theaters today are very different from those by a single person sitting in a theater with a bulky videotape recorder.The results are not shaky,inaudible recordings.It is now easy for a surreptitious recording in a movie theat

206、er to result in a clean digital copy of a movie with perfect audio that can be quickly distributed online.The pirated version of the newly released movie may be available online while it is still showing in theaters.The economic damage is magnified because movies may be released in different markets

207、 at different times.Thus,a camcord of a movie released in one market can be made available unlawfully in another market before the movie hits the theaters there.In addition to theater owners who lose revenue,legitimate digital platforms,which often negotiate for a certain period of exclusivity after

208、 the theatrical run,cannot fairly compete in the market due to unauthorized camcording.Stakeholders continue to report serious concerns regarding unauthorized camcords.For example,in Russia,stakeholders continue to report significant levels of camcording.The withdrawal of major U.S.right holders fro

209、m the market following Russias full-scale invasion of Ukraine in 2022 has only exacerbated the issue.China remains a notable source of unauthorized camcords,including live streams of theatrical broadcasts online.China has taken some enforcement actions in recent years but still lacks a specific crim

210、inal law to address the issue.Additionally,stakeholders report that unauthorized camcords originating from India continue to be a concern.Countries also need to update legal frameworks to effectively deter unauthorized camcording and keep up with changing practices.For example,the requirement in som

211、e countries that a law enforcement officer must observe a person camcording and then prove that the person is circulating the unlawfully recorded movie before intervening often precludes effective enforcement.Countries like Argentina,Brazil,Ecuador,Peru,and Russia do not effectively criminalize unau

212、thorized camcording in theaters.The United States urges countries to adopt laws and enforcement practices designed to prevent unauthorized camcording,such as laws that have been adopted in Canada,Japan,the Philippines,and Ukraine.The Asia-Pacific Economic Cooperation(APEC)has also issued a report ti

213、tled Effective Practices for Addressing 23 Unauthorized Camcording.26 As the practice of camcording evolves,so too must methods for detecting and preventing camcording.One best practice to supplement,but not replace,such effective legal measures is building public awareness.Another important practic

214、e is for the private sector to work on capacity building to help theater managers and employees detect camcording and assist law enforcement.In addition to the distribution of copies of newly released movies resulting from unauthorized camcording,other examples of online piracy that damage legitimat

215、e trade are found in virtually every country listed in the Report and include:the unauthorized retransmission of live sports programming online;the unauthorized cloning of cloud-based entertainment software through reverse engineering or hacking onto servers that allow users to play pirated content

216、online,including pirated online games;and the online distribution of software and devices that allow for the circumvention of technological protection measures,including game copiers and mod chips that allow users to play pirated games on physical consoles.Piracy facilitated by online services prese

217、nts unique enforcement challenges for right holders in countries where copyright laws have not been able to adapt or keep pace with these innovations in piracy.The availability of recourse to right holders,enforcement procedures,and remedies are critical components of the online ecosystem.For all th

218、e above reasons,governments should avoid creating a domestic environment that offers a safe haven for online and broadcast piracy.Trade Secrets This years Report continues to reflect the growing need for trading partners to provide effective protection and enforcement of trade secrets.Companies in a

219、 wide variety of industry sectors,including information and communications technology,services,environmental technologies,and other manufacturing sectors,rely on the ability to protect and enforce their trade secrets and rights in proprietary information.Trade secrets are particularly important to s

220、mall businesses,which often rely on trade secret protection to preserve the secrecy and value of their technology.Small businesses may not have the resources to obtain and enforce patents,which require disclosure of the technology and risk infringement by others,and therefore rely on the protection

221、of trade secrets for their proprietary technology.Trade secrets,such as business plans,internal market analyses,manufacturing methods,customer lists,and recipes,are often among a companys core business assets.A companys competitiveness may depend on its capacity to protect such assets.Trade secret t

222、heft threatens to diminish U.S.competitiveness around the globe and puts U.S.jobs at risk.The reach of trade secret theft into critical commercial and defense technologies poses threats to U.S.national security interests as well.Various sources,including the National Counterintelligence and Security

223、 Center(NCSC),have reported specific gaps in trade secret protection and enforcement,particularly in China and Russia.27 Theft may arise in a variety of circumstances,including those involving departing employees taking portable storage devices containing trade secrets,failed joint ventures,cyber 26

224、 APEC,Effective Practices for Addressing Unauthorized Camcording(Nov.11,2011),https:/www.apec.org/docs/default-source/groups/ip/11_amm_014app05.doc.27 NCSC,Foreign Economic Espionage in Cyberspace at 5-9(2018),https:/www.dni.gov/files/NCSC/documents/news/20180724-economic-espionage-pub.pdf.24 intrus

225、ion and hacking,and misuse of information submitted by trade secret owners to government entities for purposes of complying with regulatory obligations.In practice,effective remedies appear to be difficult to obtain in a number of countries,including in China,India,and Russia.Lack of legal certainty

226、 regarding trade secrets also dissuades companies from entering into partnerships or expanding their business activities in these and other countries.Many countries do not provide criminal penalties for trade secret theft sufficient to deter such behavior.In some foreign countries,certain practices

227、and policies,including evidentiary requirements in trade secrets litigation and mandatory technology transfer,put valuable trade secrets at risk of exposure.Certain data governance regimes(whether proposed or implemented)also raise concerns for intellectual property protection in general and trade s

228、ecret protection of proprietary data in particular.The United States continues to monitor this trend and its impact on incentivizing innovation and market access.The United States uses all trade tools available to ensure that its trading partners provide robust protection for trade secrets and enfor

229、ce trade secrets laws.Given the global nature of trade secret theft,action by our trading partners is also essential.Several trading partners have recently strengthened or have been working toward strengthening their trade secret regimes,including Taiwan.The United States-Mexico-Canada Agreement(USM

230、CA),which entered into force in July 2020,has the most robust protection for trade secrets of any prior U.S.trade agreement.It includes a number of commitments addressing the misappropriation of trade secrets,including by state-owned enterprises:civil procedures and remedies,criminal procedures and

231、penalties,prohibitions against impeding licensing of trade secrets,judicial procedures to prevent disclosure of trade secrets during the litigation process,and penalties for government officials for the unauthorized disclosure of trade secrets.The United States-China Economic and Trade Agreement(Pha

232、se One Agreement),signed in January 2020,also includes several trade secret commitments to address a number of long-standing concerns in China,including on expanding the scope of civil liability,covering acts such as electronic intrusions as trade secret theft,shifting the burden of producing eviden

233、ce,making it easier to obtain preliminary injunctions to prevent use of stolen trade secrets,allowing criminal investigations without need to show actual losses,ensuring criminal enforcement for willful misappropriation,and prohibiting unauthorized disclosure of trade secrets and confidential busine

234、ss information by government personnel or third-party experts.Action in international organizations is also crucial.For instance,the United States strongly supports continued work in the Organisation for Economic Co-operation and Development(OECD)on trade secret protection,building off two studies r

235、eleased by the OECD in 2014.The first study,titled Approaches to Protection of Undisclosed Information(Trade Secrets),28 surveyed legal protection for trade secrets available in a sample of countries.The second study,titled Uncovering Trade Secrets-An Empirical Assessment of Economic Implications of

236、 Protection for Undisclosed Data,29 examined the protection of trade secrets for a sample of 37 countries,provided 28 Schultz,M.and D.Lippoldt,Approaches to Protection of Undisclosed Information(Trade Secrets):Background Paper(Jan.2014),https:/doi.org/10.1787/5jz9z43w0jnw-en.29 Lippoldt,D.and M.Schu

237、ltz,Uncovering Trade Secrets-An Empirical Assessment of Economic Implications of Protection for Undisclosed Data(Aug.2014),https:/doi.org/10.1787/5jxzl5w3j3s6-en.25 historical data for the period since 1985,and considered the relationship between the stringency of trade secret protection and relevan

238、t economic performance indicators.Also,in November 2016,the Asia-Pacific Economic Cooperation endorsed a set of Best Practices in Trade Secret Protection and Enforcement Against Misappropriation,30 which includes best practices such as:broad standing for claims for the protection of trade secrets an

239、d enforcement against trade secret theft;civil and criminal liability,as well as remedies and penalties,for trade secret theft;robust procedural measures in enforcement proceedings;and adoption of written measures that enhance protection against further disclosure when governments require the submis

240、sion of trade secrets.Forced or Pressured Technology Transfer,Indigenous Innovation,and Preferences for Indigenous Intellectual Property Right holders operating in other countries report an increasing variety of government measures,policies,and practices that require or pressure technology transfer

241、from U.S.companies.While these measures are sometimes styled as means to incentivize domestic“indigenous innovation,”in practice they disadvantage U.S.companies,conditioning market entry on surrendering their intellectual property(IP).These actions serve as market access barriers and deny U.S.compan

242、ies reciprocal opportunities to access foreign markets relative to market access provided to foreign companies operating in the United States.Such government-imposed conditions or incentives for technology transfer to domestically owned companies may also introduce non-market distortions into licens

243、ing and other private business arrangements,resulting in commercially suboptimal outcomes for the firms involved and for innovation in general.Furthermore,these measures discourage foreign investment in national economies;hurt local manufacturers,distributors,and retailers;and slow the pace of innov

244、ation and economic progress.This kind of government intervention in the commercial decisions that enterprises make regarding the ownership,development,registration,or licensing of IP is not consistent with international practice and may raise concerns regarding consistency with international obligat

245、ions as well.These government measures often have a distortive effect by forcing or pressuring U.S.companies to transfer their technology or other valuable commercial information to domestically owned entities.Examples of these policies include:Requiring the transfer of technology as a condition for

246、 obtaining investment and regulatory approvals or otherwise securing access to a market or as a condition for allowing a company to continue to do business in the market;Directing state-owned enterprises in innovative sectors to seek non-commercial terms from their foreign business partners,includin

247、g with respect to the acquisition and use or licensing of IP;Providing domestically owned firms with an unfair competitive advantage by failing to effectively enforce,or discouraging the enforcement of,U.S.-owned IP,including patents,trademarks,trade secrets,and copyright;30 Best Practices in Trade

248、Secret Protection and Enforcement Against Misappropriation,https:/ustr.gov/sites/default/files/11202016-US-Best-Practices-Trade-Secrets.pdf.26 Failing to take meaningful measures to prevent or to deter cyber intrusions and other unauthorized activities;Requiring use of,or providing preferences to,pr

249、oducts or services that contain domestically developed or owned IP,including with respect to government procurement;Manipulating the standards development process to create unfair advantages for domestically owned firms,including with respect to participation by foreign firms and the terms on which

250、IP is licensed;and Requiring the submission of unnecessary or excessive confidential business information for regulatory approval purposes and failing to protect such information appropriately.In China,investment and regulatory approvals,market access,government procurement,and the receipt of certai

251、n preferences or benefits may be conditioned on a firms ability to demonstrate that IP is developed in or transferred to China,or is owned by or licensed to a Chinese party.China has made enforceable commitments to address forced or pressured technology transfer in the United States-China Economic a

252、nd Trade Agreement(Phase One Agreement).The United States urges that,in formulating policies to promote innovation,trading partners,including China,refrain from forced or pressured technology transfer and local preferences for indigenous IP and take account of the importance of voluntary and mutuall

253、y agreed commercial partnerships or arrangements.Geographical Indications The United States is working intensively through bilateral and multilateral channels to advance U.S.market access interests in foreign markets and to ensure that geographical indications(GI)-related trade initiatives of the Eu

254、ropean Union(EU),its Member States,like-minded countries,and international organizations do not undercut such market access.GIs typically include place names(or words associated with a place)and identify products as having a particular quality,reputation,or other characteristic essentially attributa

255、ble to the geographic origin of the product.The EU GI agenda remains highly concerning because it significantly undermines protection of trademarks held by U.S.producers and imposes barriers on market access for U.S.-made goods that rely on the use of common names,such as parmesan or feta.First,the

256、EU GI system raises concerns regarding the extent to which it impairs the scope of trademark protection,including exclusive rights in registered trademarks that pre-date the protection of a GI.Trademarks are among the most effective ways for producers and companies,including micro,small,and medium-s

257、ized enterprises,to create value,to promote their goods and services,and to protect their brands,even with respect to food and beverage products covered by the EU GI system.Many such products are already protected by trademarks in the United States,in the EU,and around the world.Trademark systems of

258、fer strong protections through procedures that are easy to use,cost-effective,transparent,and provide due process safeguards.Trademarks also deliver high levels of consumer awareness,significant contributions to gross domestic product and employment,and accepted international systems of protection.T

259、he EU GI system undermines 27 trademark protection and may result in consumer confusion to the extent that it permits the registration and protection of GIs that are confusingly similar to prior trademarks.Second,the EU GI system and strategy adversely impact access for U.S.and other producers in th

260、e EU market and other markets by granting protection to terms that are considered in those markets to be the common name for products.The EU has granted GI protection to thousands of terms that now only certain EU producers can use in the EU market,and many of these producers then block the use of a

261、ny term that even“evokes”a GI.However,many EU Member States,such as Denmark and France,still produce products that are claimed as GIs of other European countries,such as feta,and export these products outside of the EU using the protected GIs as the common name of the products.Furthermore,in 2017,th

262、e EU granted GI protection to the cheese name danbo,a widely traded type of cheese that is covered by an international standard under the Codex Alimentarius(Codex).Argentina,South Africa,Uruguay,and other countries produce danbo.Similarly,in 2019,the EU granted GI protection to havarti,notwithstandi

263、ng the long-standing and widespread use of this term by producers around the world.Australia,New Zealand,the United States,and other countries produce havarti.Like in the case of danbo,the Codex established an international standard for havarti in 2007,premised on the fact that havarti is produced a

264、nd marketed in many countries throughout the world under that name.The EUs approval of GIs for havarti and danbo undermine the Codex standards for these products,and World Trade Organization(WTO)Members have repeatedly challenged the EU to explain its treatment of Codex cheese standards at the WTO,i

265、ncluding in the Technical Barriers to Trade Committee.Moreover,havarti is included in the EUs most favored nation tariff rate quota,indicating that havarti was expected to be produced outside of and imported into the EU.Several countries,including the United States,opposed GI protection of these com

266、mon names,both during the EUs opposition period and at the WTO,but the European Commission granted the protection over that opposition and without sufficient explanation or notice to interested parties.As part of its trade agreement negotiations,the EU pressures trading partners to prevent any produ

267、cer,except from those in certain EU regions,from using certain product names,such as fontina,gorgonzola,parmesan,asiago,or feta.This is despite the fact that these terms are the common names for products produced in countries around the world,precisely because of Europes role in globalization over t

268、he past several centuries.In the EU and other markets that have protected EU GIs within their own GI systems,U.S.producers and traders either are effectively blocked from those markets or must adopt burdensome workarounds.They either cannot use the descriptors at all,or anything even evoking them,in

269、 the market or at best may sell their products only as“fontina-like,”“gorgonzola-kind,”“asiago-style,”or“imitation feta.”This is costly,unnecessary,and can reduce consumer demand for the non-EU products,as well as reduce consumer choice and cause consumer confusion.The United States runs a significa

270、nt deficit in food and agricultural trade with the EU.The EU GI system contributes to this asymmetry,which is acute in trade in agricultural products subject to the EU GI system.In the case of cheese,for example,where many EU products enjoy protection under the EU GI system,the EU exported more than

271、$1.3 billion of cheese to the United States last year.Conversely,the United States exported only about$6.1 million of cheese to the EU last year.Based on this evidence,EU agricultural producers exporting to the United States are doing quite well,benefiting considerably from the effective U.S.system

272、of trademark protection of GIs,28 despite the absence of an EU-style GI system.Unfortunately,U.S.producers,as evidenced by the deficit,are not afforded the same level of market access to the EU.Despite these troubling aspects of its GI system,the EU continues to seek to expand its harmful GI system

273、within its territory and beyond.Within its borders,the EU is enlarging its system beyond agricultural products and foodstuffs to encompass non-agricultural products,including apparel,ceramics,glass,handicrafts,manufactured goods,minerals,salts,stones,and textiles.The United States continues to remai

274、n concerned about certain changes to the EUs Common Agricultural Policy,adopted in November 2021 and entered into force on January 1,2023,which would transfer much of the GI application review process to interested EU Member States and sharply reduce the period for filing a reasoned basis in support

275、 of an opposition to register a GI.As noted above,the EU has also sought to advance its agenda through trade agreements,which impose the negative impacts of the EU GI system on market access and trademark protection in third countries,including through exchanges of lists of terms that receive automa

276、tic protection as GIs without sufficient transparency or due process.The EU has pursued its GI agenda in multilateral and plurilateral bodies as well.For example,in 2015,the EU,several EU Member States,and others expanded the World Intellectual Property Organization(WIPO)Lisbon Agreement for the Pro

277、tection of Appellations of Origin and their International Registration to include GIs,thereby enshrining several detrimental aspects of EU law in that Agreement.The Geneva Act of the Lisbon Agreement that emerged from these negotiations was the product of a decision led by the EU and certain Member

278、States to break with the long-standing WIPO practice of consensus-based decision-making and to deny the United States and 160 other WIPO countries meaningful participation rights in the negotiations.In 2020,the EU became party to the Geneva Act of the Lisbon Agreement.In other international organiza

279、tions,such as the United Nations Food and Agriculture Organization,the EU has attempted to pursue its agenda by alleging a connection between GIs and unrelated issues,such as biodiversity,sustainability,and food safety.In response to the EUs aggressive promotion of its exclusionary GI policies,the U

280、nited States continues its intensive engagement in promoting and protecting access to foreign markets for U.S.exporters of products that are identified by common names or otherwise marketed under previously registered trademarks.The United States is advancing these objectives through its trade agree

281、ments,as well as in international fora,including in the Asia-Pacific Economic Cooperation,WIPO,and the WTO.In addition to these negotiations,the United States is engaging bilaterally to address concerns resulting from the GI provisions in existing EU trade agreements,agreements under negotiation,and

282、 other initiatives,including with Argentina,Australia,Brazil,Canada,Chile,China,Ecuador,Indonesia,Japan,Kenya,Korea,Malaysia,Mexico,Moldova,New Zealand,Paraguay,the Philippines,Singapore,Taiwan,Thailand,Uruguay,and Vietnam,among others.U.S.goals in this regard include:Ensuring that the grant of GI p

283、rotection does not violate prior rights(for example,in cases in which a U.S.company has a trademark that includes a place name);Ensuring that the grant of GI protection does not deprive interested parties of the ability to use common names,such as parmesan or feta;29 Ensuring that interested persons

284、 have notice of,and opportunity to oppose or to seek cancellation of,any GI protection that is sought or granted;Ensuring that notices issued when granting a GI consisting of multiple terms identify its common name components;and Opposing efforts to extend the protection given to GIs for wines and s

285、pirits to other products.Pharmaceutical and Medical Device Innovation and Market Access The COVID-19 pandemic highlighted the importance of pharmaceutical,medical device,and other health-related innovations,as well as a lack of widespread,timely,and equitable global distribution of these innovations

286、.It also highlighted that extraordinary circumstances such as pandemics call for extraordinary measures.With that in mind,the Office of the United States Trade Representative(USTR)continues to seek adequate and effective protection for pharmaceutical and other health-related IP around the world to e

287、nsure robust American innovation in these critical industries to fight not only the current,but also future pandemics.USTR also recognizes that access to medicines in developing economies is important to development itself.USTR has also sought to level the playing field abroad by reducing market acc

288、ess barriers,including those that are not adequately transparent or do not offer sufficient opportunity for meaningful stakeholder engagement.As evidenced by the October 2023 U.S.International Trade Commission(USITC)report on“COVID-19 Diagnostics and Therapeutics:Supply,Demand,and TRIPS Agreement Fl

289、exibilities,”the price of medicines can be untenably high for some countries.At the same time,according to an October 2021 Geneva Network report titled How Tariffs Impact Access to Medicines,low and middle-income countries maintain the highest tariffs on medicines and pharmaceutical inputs among the

290、 World Trade Organization(WTO)Members identified in the report.31 The report notes that,in particular,large developing countries such as Brazil,India,and Indonesia have the highest tariffs for such products.Also,in Brazil,combined federal and state taxes account for 31%of the cost of medicines.32 A

291、holistic approach to promoting access to medicines is required.Moreover,unreasonable regulatory approval delays and non-transparent reimbursement policies can impede a companys ability to enter the market.The criteria,rationale,and operation of such measures are often non-transparent or not fully di

292、sclosed to patients or to pharmaceutical and medical device companies seeking to market their products.By contrast,various countries have implemented policies that significantly decrease regulatory timelines by“relying”on regulatory approvals by stringent health regulatory authorities in other count

293、ries,or relevant assessments by the World Health Organization.These policies are especially critical during health emergencies,where expediency is of the essence.USTR encourages trading partners to provide appropriate 31 Geneva Network,How Tariffs Impact Access to Medicines(Oct.2021),https:/geneva-

294、IQVIA,Market Prognosis Country Report:Brazil(2021).30 mechanisms for transparency,procedural and due process protections,and opportunities for public engagement in the context of their relevant health care systems.Among other examples,USTR engagement in the past year included:Monitored and enforced

295、Chinas commitments with respect to:(1)a mechanism for the early resolution of potential pharmaceutical patent disputes,including a cause of action to allow a patent holder to seek expeditious remedies before the marketing of an allegedly infringing product;and(2)patent term extensions to compensate

296、for unreasonable patent office and marketing approval delays that cut into the effective patent term;Monitored and enforced the implementation of Canada and Mexicos IP commitments in the United States-Mexico-Canada Agreement(USMCA),including the implementation of provisions to ensure that national-l

297、evel government processes for the listing and reimbursement of pharmaceutical products and medical devices are transparent,provide due process,are nondiscriminatory,and provide full market access for U.S.products;Engaged with Japan on the importance of providing regular and sufficient opportunities

298、for the private sector to provide public comments concerning Japans medical pricing and reimbursement rules;Engaged with India on the administration of its patent regime,including on disclosure requirements,treatment of confidential information,and patent application oppositions.The IP-intensive U.S

299、.pharmaceutical and medical device industries have expressed concerns regarding the policies of several trading partners,including,Australia,Brazil,Canada,China,Colombia,Japan,Korea,Mexico,New Zealand,Russia,Saudi Arabia,and Trkiye,on issues related to pharmaceutical innovation and market access.Exa

300、mples of these concerns include the following:Stakeholders have expressed concerns about delays by Australia in its implementation of the notification process as required,for example,under Article 17.10.4(b)of the United States-Australia Free Trade Agreement.While stakeholders welcomed the 2023 drug

301、 pricing reform package abolishing the price maintenance premium(PMP)and adding premiums to incentivize the early introduction of innovative drugs in Japan,they continue to express concerns about Japans shortcomings in terms of transparency,especially with regard to including meaningful stakeholder

302、input regarding pricing and reimbursement policies for advanced medical devices and innovative pharmaceuticals.Other concerns raised by stakeholders relate to a reported lack of meaningful stakeholder input in the development of a health technology assessment system,as well as a lack of transparency

303、 and predictability associated with Japans implementation in April 2021 of annual repricing for drug reimbursement,which applies to a larger-than-expected range of products.31 Stakeholders continue to report concerns regarding a lack of transparency in Koreas pricing and reimbursement policies for p

304、harmaceuticals and medical devices.Stakeholders continue to raise concerns regarding Trkiyes pharmaceutical manufacturing inspection process.The United States urges Trkiye to build upon its recent accession to the Pharmaceutical Inspection Convention and Co-operation Scheme(PIC/S)and to recognize Go

305、od Manufacturing Practices certificates issued by any of the PIC/S members to improve regulatory timelines.The United States seeks to establish or continue dialogues with trading partners to address these and other concerns and to encourage a common understanding on questions related to innovation a

306、nd pricing in the pharmaceutical and medical device sectors.The United States also looks forward to continuing its engagement with our trading partners to promote fair and transparent policies in these sectors.Trademark Protection Issues Trademarks help consumers distinguish providers of products an

307、d services from each other and thereby serve a critical source identification role.The goodwill represented in a companys trademark is often one of a companys most valuable business assets.However,in numerous countries,right holders consider bad faith trademarks to be a significant challenge,with an

308、 overwhelming number of bad faith applications filed and registrations granted.For example,while some progress occurred in 2023,the trademark system in China still largely lacks effective tools to combat widespread bad faith trademark applications,in part because it unnecessarily constrains examiner

309、s from considering marks for related goods or services in different classes when evaluating bad faith,likelihood of confusion,and other matters.While China published draft amendments to its Trademark Law in 2022 that appear to expand the definition of bad faith trademarks,which would allow for great

310、er enforcement,it remains to be seen whether the steps China has previously taken with respect to commitments in the United States-China Economic and Trade Agreement(Phase One Agreement)will address these issues.Stakeholders also raise concerns about the need for improved and reliable opposition pro

311、cedures in Indonesia,as well as decisions that provide reasoning and evidence,to help prevent counterfeiters from obtaining registrations for similar but not identical trademarks.Trademark holders also continue to face challenges in protecting their trademarks against unauthorized domain name regist

312、ration and trademark uses in some country code top-level domain names.Robust protection for well-known marks,another internationally recognized means of protecting marks outlined in the Paris Convention for Protection of Industrial Property,is also important for many U.S.producers and businesses who

313、 have built up the reputation of their brands.Stakeholders report that some countries that do have well-known mark provisions,such as China,nevertheless impose significant burdens on brand owners that attempt to establish their marks as well known.32 Another concern includes mandatory requirements t

314、o record trademark licenses,such as in Brazil,Ecuador,Egypt,Spain,Turkmenistan,and Uzbekistan,as they frequently impose unnecessary administrative and financial burdens on trademark owners and create difficulty in the enforcement and maintenance of trademark rights.Certain formalities and documentat

315、ion requirements,such as requirements for obtaining traditional pen-and-ink signatures,notarized or legalized powers of attorney,and original documents,can create trade barriers.Numerous countries including Algeria,China,Indonesia,Iraq,and the United Arab Emirates require formalities for filing docu

316、ments,such as intellectual property(IP)applications,registration maintenance,transfer of ownership submissions,and in opposition and cancellation proceedings,even though such formalities do not appear to advance any legitimate public policy goals.The absence of default judgments in opposition and in

317、validation proceedings in certain countries,such as China,incurs significant costs to U.S.companies.Companies are forced to submit detailed arguments and evidence in proceedings when the owners of the applications and registrations have no interest in or intention of defending their claims to exclus

318、ive rights in such marks,particularly in the case of bad faith trademark registrations and trademark squatters.One means of addressing this situation,according to some U.S.stakeholders,is to require owners of challenged trademarks to submit a written statement that they have an ongoing interest in t

319、heir trademark in order to continue with a full proceeding before the relevant authorities.A number of countries do not provide the full range of internationally recognized trademark protections.For example,many countries,such as Argentina,Barbados,Belarus,and Indonesia,do not provide protection for

320、 certification marks that are used to show consumers that particular goods or services,or their providers,come from a specific geographic region;meet standards with respect to quality,materials,or manufacturing methods such as with environmentally“green”products;or that labor was performed by a unio

321、n member or member of a specific organization.In other countries,the nature of the requirements imposed for registration of certification marks creates undue burdens on certifying entities.Direct-to-consumer global e-commerce flourished during the COVID-19 pandemic,and certified products have been v

322、alued by an ever-growing marketplace of purchasers.Providing for registration of and mechanisms to enforce rights in certification marks are essential to ensure safe,compliant,and reputable products and services.Companies use letters of consent to resolve potential disputes and overcome refusals bas

323、ed on a likelihood of confusion when multiple trademark owners agree that their marks may coexist in the marketplace without confusion as to the source of the identified goods or services.Some countries refuse to recognize letters of consent.Some countries accept the letters yet view them as informa

324、tional only.Other countries allow submission of the letters with the caveat that they may be ignored.When letters of consent are rejected,or given little or no effect,companies may be forced to employ alternative measures.Such measures could include the submission of detailed arguments and evidence,

325、and even litigation.This could be avoided through the recognition of and deference to letters of consent.Some countries such as Trkiye now accept letters of consent.33 Strict use of the Nice Classification or a countrys own sub-classification system to determine conflicts with prior marks does not r

326、eflect the realities of the relatedness of underlying goods or services in the current marketplace and introduces uncertainty into the registration process.Goods and services should be considered based on their commercial relationship and not solely in light of classification systems developed for a

327、dministrative convenience.Many countries,including India,Malaysia,Pakistan,and the Philippines,reportedly have slow opposition or cancellation proceedings,while Panama and Russia have no administrative opposition proceedings.Delays in obtaining registrations present a significant obstacle for protec

328、ting IP rights in foreign markets,with stakeholders identifying Bangladesh,Iraq,and South Africa as countries with extreme delays in processing trademark applications.A number of countries do not consider a likelihood of confusion with previously filed applications and registrations during examinati

329、on,otherwise known as“relative grounds”refusals.The failure to make these rejections costs U.S.companies millions of dollars a year in unnecessary opposition proceedings.Some countries that do consider relative grounds provide a pre-examination opposition period to allow third parties to submit obje

330、ctions before the national office conducts its own examination,thus resulting in unnecessary expenses to oppose marks the national office would likely refuse during examination.The absence of adequate means for searching trademark applications and registrations,such as by online databases,makes obta

331、ining trademark protection more complicated and unpredictable.The lack of such online systems leads to additional costs,both in terms of initial filing and in relation to docketing and maintenance of multiple registrations.Copyright Administration and Payment of Royalties Collective management organ

332、izations(CMOs)for copyright can play an important role in ensuring compensation for right holders when CMO practices are fair,efficient,transparent,and accountable.Also,the collection and distribution of royalties to U.S.and other right holders should be carried out on a national treatment basis.Unf

333、ortunately,CMO systems in several countries are reportedly flawed or non-operational.In some countries,like India,Kenya,and Nigeria,withdrawals of,or changes in,a CMOs authorization to operate leave right holders in defunct CMOs and music users confused over whom to pay.In the United Arab Emirates,the Ministry of Economy and the International Federation of the Phonographic Industry(IFPI)signed an