On April 29th, Ambassador Jamieson Greer, U.S. Trade Representative (USTR), issued the 2025 Special 301 Report. In a press release (being quite different in tone from many over the past decade), the USTR stated that "[o]ur trading partners must address the concerns identified in the Special 301 Report and stop those stealing the intellectual property of hard-working businesses and individuals." She credited the President with "ha[ving] a track record of empowering our innovators and workers," and in this vein in a somewhat threatening tone states that the Report provided "a basis for the United States to take trade enforcement action against those not playing fairly."
The press release accompanying the Report notes that its review of Ukraine (which has been the subject of criticism in prior versions of the Report's "Watch List"; see below) continues to be suspended due to "full-scale invasion of Ukraine in February 2022." It mentions removal of Turkmenistan from the Watch List due to a lack of "significant concerns" from stakeholder over IP protection of enforcement in that country. On the other hand, Mexico was raised from the Watch List to the Priority Watch List (wherein a heightened level of scrutiny is applied) due to "long-standing and significant IP concerns that have not been resolved," ironically citing complaints regarding "Mexico's implementation of the United States-Mexico-Canada Agreement (USMCA)" (now having been abrogated by imposition of the Trump tariffs), followed by a litany of categories including "trademark counterfeiting and copyright piracy, protection of pharmaceutical-related IP, pre-established damages for copyright infringement and trademark counterfeiting, and plant variety protection."
Also included in the press release are a number of "cross-cutting issues" highlighted in this year's Special 301 Report, that include online piracy, insufficient enforcement against counterfeiting, particularly from China, forced technology transfer amounting to "state-sponsored theft of trade secrets to the transfer under pressure from state actors," again citing China, aggressive promotion of the EU's exclusionary geographical indication policies, and concerns over protection of pharmaceuticals and medical devices. (To be fair, these more general complaints echo similar concerns expressed for more than a decade in Special 301 Reports promulgated by prior administrations.)
The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994). The 1988 amendments were directed particularly "to provide for the development of an overall strategy to ensure adequate and effective protection of intellectual property rights and fair and equitable market access for United States persons that rely on protection of intellectual property rights" because "the absence of adequate and effective protection of United States intellectual property rights, and the denial 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." The Report "provides an opportunity to put a spotlight on foreign 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 America's innovation- and creativity-driven sectors."
According to the Executive Summary of the Report itself, "[a] top trade priority for the Administration is to use all possible sources of leverage to encourage other countries to open their markets to U.S. exports of goods and services and to provide adequate and effective protection and enforcement of intellectual property (IP) rights," the emphasis on "leverage" being new to this year's Report. The Executive Summary further contains the exhortation that:
This Report provides an opportunity to put a spotlight on foreign 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 America's innovation- and creativity-driven sectors.
Further contained in this portion of the Report is the warning that "this Administration continues to closely monitor developments in, and to engage with, those countries that have been on the Priority Watch List for multiple years," and that "[f]or countries failing to address U.S. concerns, USTR will take appropriate actions, which may include enforcement actions under Section 301 of the Trade Act or pursuant to World Trade Organization (WTO) or other trade agreement dispute settlement procedures."
Specific concerns motivating the Report include:
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 protection and enforcement in China, Russia, and elsewhere; (d) troubling policies on "indigenous innovation" and forced technology transfer (which can range from state-sponsored theft of trade secrets to transfer under pressure from state actors) 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 market access, in many trading partners around the world.
This litany seems to have been taken word-for-word from last year's Report, as was the assertion that "[c]ombating such unfair trade policies can foster American innovation and creativity and increase economic security for American workers and families."
The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for [intellectual property rights] (IPR) or deny fair and equitable market access for persons that rely on intellectual property protection." The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."m Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property." These Watch Lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."
Pursuant to the Act, the USTR reviewed "more than 100" of this country's trading partners and identified eight countries on a "Priority Watch List" (increased by one from last year) and another 18 countries on the "Watch List" (decreased from last year by transfer of Mexico to the Priority Watch List and removal of Turkmenistan from the Watch List), all relating to deficiencies in intellectual property protection in these countries. The Priority Watch List in the 2025 Report includes Argentina, Chile, China, India, Indonesia, Mexico (newly added this year), Russia, and Venezuela. On the Watch List this year are Algeria, Barbados, Belarus, Bolivia, Brazil, Bulgaria, Canada, Colombia, Ecuador, Egypt, Guatemala, Pakistan, Paraguay, Peru, Thailand, Trinidad & Tobago, Turkey, and Vietnam.
Public engagement noted in the Report includes there having been received written submissions from 45 non-governmental organizations (NGOs) and 19 foreign governments. In addition, the USTR held a public hearing on February 19, 2025, with witnesses including representatives of "foreign governments, industry, and non-governmental organizations." Submissions are available at www.regulations.gov, docket number USTR-2024-0023.
The Report contains two Sections (on "Developments in Intellectual Property Rights Protection and Enforcement" and "Country Reports") and two Annexes on particular issues (the statutory bases of the Report, and government technical assistance and capacity building efforts). Prefatory remarks to Section I include a discussion of the purpose and justifications (practical and statutory) of the Report. These include its context in the USTR's mission, which includes "support[ing] and implement[ing] the Administration's commitment to protect American jobs and workers and to advance the economic interests of the United States." These efforts are directed to "[f]ostering innovation and creativity," which is "essential to U.S. economic growth, competitiveness, and the estimated 63 million American jobs that directly or indirectly rely on intellectual property (IP)-intensive industries," citing USPTO, Intellectual Property and the U.S. Economy: Third Edition at 4 (Mar. 2022). This sector represents "41% of the U.S. gross domestic product (GDP)" and "47.2 million workers that are directly employed in IP-intensive industries" who "also enjoy pay that is, on average, 60% higher than workers in non-IP-intensive industries." These statistics support the Report's further assertions that "IP infringement, including patent infringement, trademark counterfeiting, copyright piracy, and trade secret theft, causes significant financial losses for right holders and legitimate businesses" and also "U.S. competitive advantages in innovation and creativity, to the detriment of American workers and businesses." Specific topics set forth in this Section of the Report include: "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 multilateral organizations; and bilateral and regional developments."
The Report cites (and emphasizes) significant progress in several U.S. trading partners, including:
• Peru, specifically enactment of measures to "criminalize the unauthorized camcording or reproduction of motion picture audiovisual works in cinemas or similar venues without requiring proof of commercial intent."
• India, which finalized changes to its Patent Rules involving "amendments to the procedures for pre-grant oppositions, an update to the reporting form for patent working, and decreased reporting time for reporting foreign applications." Also mentioned are withdrawal of portions of the Indian Copyright Act that would have had "severe implications for right holders who make their content available online."
• Vietnam, where there was a first -- a criminal conviction for online copyright infringement. Also, local police partnered with the U.S. Department of Justice's International Computer Hacking and Intellectual Property (ICHIP) program and the Alliance for Creativity and Entertainment (ACE) to shut down movie piracy sites.
• Chile, which approved a "side letter" under its bilateral free trade agreement with the U.S. permitting market access for U.S. meat and cheese products.
The Report also notes that there are now 62 members of the 1991 Act of the International Union for the Protection of New Varieties of Plants Convention (UPOV 1991), which requires member countries to grant IP protection to new plant variety breeders. Consequently, according to the Report, there should be "increased numbers of new plant varieties with improved characteristics, such as high-yield, tolerance to adverse environmental conditions, and better food quality" which helps "improve industry competitiveness in foreign markets, encourages the importation of foreign plant varieties, and enhances domestic breeding programs." There are also now 114 signatories to the World Intellectual Property Organization (WIPO) Performances and Phonograms Treaty and 118 parties to the WIPO Copyright Treaty (WCT). These treaties have "raised the standard of copyright protection around the world, particularly with regard to online delivery of copyrighted content." In addition, the Report states that "Cameroon and Saint Kitts and Nevis have acceded to both of the WIPO Internet Treaties" since the 2024 Special 301 Report was published.
Continuing on a positive note, the Report identifies "illustrative best IP practices" by U.S. trading partners. These include "cooperation and coordination among national government agencies involved in IP issues is an example of effective IP enforcement," citing Brazil (citing its National Council on Combating Piracy and Intellectual Property Crimes), the Dominican Republic (citing its Interministerial Council of Intellectual Property), Ecuador (citing a digital manual from its National Service of Intellectual Rights for increasing custom enforcement efficiencies), Paraguay (citing its Intellectual Property Rights Interagency Coordination Center), and Thailand (citing a joint effort involving 16 governmental agencies to combat counterfeit goods).
The Report also points out "specialized IP enforcement units" in Algeria (which instituted an IP academy in conjunction with WIPO), India (for further progress in specialty courts in IP matters), the Philippines (for launching a new e-Commerce Bureau for oversight of e-commerce activities) and Saudi Arabia (for establishing an IP Public Prosecution Department for training IP lawyers in criminal proceedings involving trademark, copyright, patent, and industrial design infringement).
IP awareness and educational campaigns were also discussed, including those in Peru (where a series of 41 virtual and in-person training sessions were put on by the Copyright Directorate of the National Institute for the Defense of Free Competition and the Protection of Intellectual Property), the Philippines (where their IP office published and distributed a comic entitled the "Pirated Inferno), Spain (for campaigns against IP theft), Thailand (for establishing a "Business Class" program on cable and social media and a television quiz show), and the United Arab Emirates (for establishing a "centralized IP and intangible assets hub" for "innovators, artists, entrepreneurs, academics, and startups").
Further noted were instances of "active participation of government officials in technical assistance and capacity building" in Algeria (involving members of their judiciary attending a workshop in Paris put on by the U.S. Patent and Trademark Office and the French national patent office); Bulgaria (for a workshop from Department of Justice's International Computer Hacking and Intellectual Property (ICHIP) program); Brazil (for participation of patent examiners from National Institute for Industrial Property in a USPTO-based workshop, joined by examiners from Argentina, Chile, Colombia, Ecuador, Mexico, Paraguay, and Peru for advanced biotechnology patent examination); India (for hosting a South Asia Judicial Conclave on IP, joined by representatives from Bangladesh, Bhutan, the Maldives, Nepal, and Sri Lanka); Pakistan (for participating in a "best practices" roundtable on digital piracy with members of the USPTO, FBI, FCC and DHS); the Philippines (for conducting National Judicial Colloquium on Intellectual Property Adjudication); and Türkiye (for specialized police training for custom officials).
The important role of micro, small, and medium-sized enterprises (MSMEs) in the global economy, and efforts by U.S. trading partners (India, Liberia, and the United Kingdom) to provide technical and other assistance, to these entities was also mentioned.
Multilateral and bilateral initiatives are discussed in the Report. This section of this year's Report focuses on initiatives under the World Trade Organizations, which the Report states "are critical, as stakeholders have raised concerns regarding the use of multilateral institutions to undermine IP rights by some member countries." Specifically, the Report describes the U.S. Intellectual Property and Innovation agenda before the TRIPS Council, and in particular work done by the Friends of Intellectual Property and Innovation (FOII) group which in 2024 "focused on how protecting and enforcing copyright can benefit creators and other workers in the creative industries." Bilateral efforts cited in the 301 Report include Trade and Investment Framework Agreements (TIFAs) with more than 50 U.S. trading partners, which include Argentina (citing its eighth Innovation and Creativity for Economic Development (ICED) Forum), Bangladesh (which held an Investment Cooperation Forum Agreement (TICFA) Council and "discussed issues such as high levels of counterfeiting in Bangladesh and efforts to update IP laws in Bangladesh"), Egypt (which discussed "developments in Egypt's IP framework and the country's future-looking National IP Strategy"), India (regarding several meetings "discussing India's efforts to modernize its patent system and exchanging ideas on other patent, copyright, and trademark issues"), Nepal (which held a meeting on "updates to draft IP legislation in Nepal, technical assistance and trademark issues"), Paraguay (which reviewed implementation of the 2022 Intellectual Property Work Plan), the Philippines (which held a technical meeting in June to discuss IP issues raised under the United States-Philippines TIFA), and Saudi Arabia (citing a meeting to discuss "opportunities for cooperation on IP enforcement").
Regional initiatives discussed in the Report include the Asia-Pacific Economic Cooperation (APEC) Intellectual Property Experts Group discussing ways "to build capacity and raise standards for the protection of IP rights in the Asia-Pacific region." In particular, topics discussed included increasing effectiveness of enforcing IP rights against illicit streaming. Workshops by this group in August 2024 and February 2025 were held that "highlighted the benefits of leveraging the work products of other offices, such as to reduce patent application backlogs, increase patent quality, reduce costs, and reduce time to obtaining patents."
Regarding what the Report terms "trade preference programs" are 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. The Report mentions pending reviews under these programs of IP practices in South Africa and Indonesia.
Finally, in this subsection was discussed anticipated engagement with trading partners including the Group of Seven (G7), the World Intellectual Property Organization (WIPO), the Organisation for Economic Co-operation and Development (OECD), and the World Customs Organization.
Turning to specific issues of concern*, trademark counterfeiting is said to harm "consumers, legitimate producers, and governments . . . particularly [with regard to] medicines, automotive and airplane parts, and food and beverages that may not be subject to the rigorous good manufacturing practices used for legitimate products." The Report accuses infringers, motivated by higher profit margins, of disregarding product quality and performance. The Report recites a litany of negative consequences to legitimate producers and their employees (including diminished revenue and investment incentives), adverse employment impacts, and reputational damage when consumers purchase fake products, as well as increased costs for firms to enforce their intellectual property rights and loss of tax revenues generated by legitimate businesses to governments. The potential for health and safety risks associated with counterfeiting are further discussed in the 2023 Review of Notorious Markets for Counterfeiting and Piracy according to the Report.
Countries particularly called out in the Report in this regard include China, India, and Türkiye, from whom counterfeit "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 goods" enter the global stream of commerce. Vietnam is also mentioned as a manufacturer of such counterfeit goods.
Also involved are "transit hubs" in countries including Chile, Hong Kong, Kyrgyz Republic, Singapore, Türkiye, and the United Arab Emirates that distribute counterfeit goods to third-country markets that include Brazil, Kenya, Mexico, Nigeria, Paraguay, and Russia. Citing a 2021 Organisation for Economic Co-operation and Development (OECD) and European Union Intellectual Property Office (EUIPO) study entitled Global Trade in Fakes: A Worrying Threat, the Report states that 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," with China (and Hong Kong) being the largest country of origin for counterfeit and fake goods. Also of concern in the Report is Singapore border enforcement for weakness and "lack of coordination between Singapore's Customs authorities and the Singapore Police Force's Intellectual Property Rights Branch" (concerns voiced last year and earlier) and Bangladesh as "one of the top five source economies for counterfeit clothing globally."
Counterfeit pharmaceuticals remain a particular concern as a growing problem with "important consequences for consumer health and safety [that are] exacerbated by the rapid growth of illegitimate online sales . . . [and] contributes to the proliferation of substandard, unsafe medicines that do not conform to established quality standards." Most of these goods confiscated by the U.S. were sourced from India, China, including Hong Kong, the United Arab Emirates, and Singapore, the Report alleges, and transshipped through China, India, Indonesia, Pakistan, the Philippines, and Vietnam. The Report also states that counterfeit U.S. brand-name medicines amount to 38% of global counterfeit medicine seizures and that "substandard or falsified medical products comprise 10% of total medical products in low- and middle-income countries" (although the Report qualifies this statement with the caveat that "it may not be possible to determine an exact figure" for the latter statistic). These trends are increasingly exacerbated by use of on-line pharmacies, with illicit providers comprising "between 67% to 75% of web-based drug merchants" according to a 2020 study. And these counterfeit items are being distributed by "legitimate express mail, international courier, and postal services to ship counterfeit goods in small consignments" rather than large cargo ships, amounting to 90% of counterfeit goods seized at the U.S. border and making detection and enforcement more difficult. The Report cites the Issue Focus section of the 2024 Review of Notorious Markets for Counterfeiting and Piracy (Notorious Markets List) for further information in this regard. The Report also asserts that "[c]ounterfeiters also increasingly sell counterfeit goods on online marketplaces, particularly through platforms that permit consumer-to-consumer sales" and urge e-commerce platforms to take "proactive and effective steps to reduce piracy and counterfeiting," with suggestions on how to do so.
The Report addresses these concerns by summarizing U.S. efforts to combat these counterfeits:
The United States continues to urge trading partners to undertake 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, such as significant monetary fines and meaningful sentences of imprisonment, are available and applied to deter counterfeiting. In addition, trading partners should ensure that competent 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 action wastes resources and compromises the global enforcement effort.
The Report identifies countries such as Canada, Columbia, Ecuador, Indonesia, Pakistan, Türkiye, and Turkmenistan as having practices that fall short of adequate efforts to stem the flow of counterfeit goods across borders. Additionally, the emergence of more complicated supply chains and increase segmentation provides more opportunities for counterfeit goods to enter into the stream of commerce at multiple points according to the USTR.
Online and broadcast piracy are also discussed, the Report noting that "[t]he increased availability of broadband Internet connections around the world, combined with increasingly accessible and sophisticated mobile technology, has led to the development of legitimate digital platforms for distribution of copyrighted content." But such "technological developments have also made the Internet an extremely efficient vehicle for disseminating pirated content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content." Sources of online piracy mentioned in the Report include Argentina, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Guatemala, India, Mexico, the Netherlands, Pakistan, Poland, Romania, Russia, Switzerland, Thailand, and Vietnam, estimated as costing the U.S. economy "at least $29.2 billion and as much as $71 billion in lost revenue each year."
A particular form of copyright piracy (particularly of music), termed "stream-ripping," is practiced (or ineffectively prevented) in Canada, Chile, India, Mexico, Nigeria, Russia, and Switzerland, the Report asserts. Illicit streaming devices (ISDs) "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" while illicit Internet Protocol Television (IPTV) services "unlawfully retransmit telecommunications signals and channels containing copyrighted content through dedicated web portals and third-party applications that run on ISDs or legitimate devices." These technologies contribute "notable levels of piracy" in high levels in Algeria, Argentina, Brazil, Canada, Chile, China, Guatemala, Hong Kong, India, Indonesia, Jordan, Mexico, Morocco, Singapore, Switzerland, Taiwan, Thailand, the United Arab Emirates, and Vietnam, with China being identified as a "manufacturing hub" for these devices and Iraq as a source of satellite receivers "pre-loaded with pirate IPTV apps." Signal theft remains a problem in Brazil, Argentina, and Honduras.
Also noted were the use of camcorders to produce expropriated contend, in Russia, India, and China, with ineffective impediments to counteracting such illicit activities found in Argentina, Brazil, Ecuador, and Russia (which don't effectively criminalize such activities), in contrast to laws now in effect in Canada, Japan, Peru, the Philippines, and Ukraine (which the Report "urges countries to adopt laws and enforcement practices designed to prevent unauthorized camcording" similar to those adopted in these latter countries). The Report cites approvingly a report from the Asia-Pacific Economic Cooperation (APEC) on effective practices for addressing these problems.
The significance of the problem was synopsized in the Report as follows:
In addition to the distribution of copies of newly released movies resulting from unauthorized camcording, other examples of online piracy that damage legitimate trade are found in virtually every country listed in the Special 301 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 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 presents 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.
Difficulties in trade secret protection have its own subsection of the Report. The problems of adequately protecting trade secrets have arisen "in a wide variety of industry sectors, including information and communications technology, services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing sectors, [that] rely on the ability to protect and enforce their trade secrets and rights in proprietary information" and include theft of "business plans, internal market analyses, manufacturing methods, customer lists, and recipes" that "are often among a company's core business assets," according to the Report. Trade secret protection is particularly important for small businesses, according to the Report, which "often rely on trade secret protection to preserve the secrecy and value of their technology" because "[s]mall 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 of trade secrets for their proprietary technology." The Report states that trade secret protection (or lack of it) is a particular problem in Russia, China, and India, and "effective remedies appear to be difficult to obtain" in these countries (including an absence of criminal penalties). "Lack of legal certainty regarding trade secrets also dissuades companies from entering into partnerships or expanding their business activities in these and other countries" the Report states. While "[t]he United States uses all trade tools available to ensure that its trading partners provide robust protection for trade secrets and enforce trade secrets laws," according to the Report, only Taiwan was mentioned as having made successful efforts in protecting trade secrets since the last Special 301 Report.
The United States-Mexico-Canada Agreement (USMCA) has "the most robust protection for trade secrets of any prior U.S. trade agreement" according to the Report. The United States-China Economic and Trade Agreement (Phase One Agreement) has several trade secret commitments, the Report states, including "expanding the scope of civil liability, covering acts such as electronic intrusions as trade secret theft, shifting the burden of producing evidence, 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 business information by government personnel or third-party experts." Nevertheless, the Report also states that "USTR has been assessing China's lack of compliance with certain commitments in the Phase One Agreement, including with respect to trade secrets, and is considering potential responses."
The Report reiterates the U.S. government's support for continued work by international organizations (including the Organisation for Economic Co-operation and Development) to support trade secret protections ("[a]ction in international organizations is . . . crucial") and cites several studies on trade secret protection regimes.
Another subsection of the Report involves "forced" technology transfer, indigenous innovation, and preferences for indigenous IP. The Report sets forth examples of circumstances and government activities involved in such "forced" technology transfer and the deleterious consequences on IP, market access, and situations where reciprocal disclosure on U.S. industries. These examples include the following activities, many of which involved governmental action and all of which were mentioned in the 2022, 2023, and 2024 Special 301 Reports:
• Requiring the transfer of technology as a condition for 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, including with respect to the acquisition and use or licensing of IP;
• Providing national 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;
• Failing to take meaningful measures to prevent or to deter cyber intrusions and other unauthorized activities;
• Requiring use of, or providing preferences to, products or services that contain locally developed or owned IP, including with respect to government procurement;
• Manipulating the standards development process to create unfair advantages for national firms, including with respect to participation by foreign firms and the terms on which 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.
China and Indonesia are particularly recognized for such practices.
As in other years, geographical indications (i.e., country or region of origin limitations primarily for wine and foodstuffs) are discussed, specifically in the EU. This is particularly troubling for trademarks, the Report stating that "[t]he 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." These practices are particularly troublesome for medium-sized enterprises (MSMEs), according to the Report, because their trademarks are "among the most effective ways for producers and companies . . . to create value, to promote their goods and services, and to protect their brands." In addition, the Report asserts that "[t]rademark systems offer strong protections through procedures that are easy to use, cost-effective, transparent, and provide due process safeguards" and "[t]rademarks also deliver high levels of consumer awareness, significant contributions to gross domestic product and employment, and accepted international systems of protection," all of which are impeded by EU GI practices which "may result in consumer confusion to the extent that it permits the registration and protection of GIs that are confusingly similar to prior trademarks." The Report specifically calls out EU protections for cheese varieties (including feta, danbo, and Havarti) as instances where EU protections fly in the face of these names having been used extensively throughout the world (Argentina, South Africa, and Uruguay for danbo; Australia, New Zealand, the United States, among others, for havarti), which actions undermine the benefits of international standards under the Codex Alimentarius. The resulting trade deficits between the U.S. and EU caused by these restrictions are also mentioned, wherein the EU exported more than $1.4 billion of cheese to the United States last year while the United States exported only about $6.3 million of cheese to the EU.
The EU's efforts are expanding the reach of these GIs from agricultural products and foodstuffs to "apparel, ceramics, glass, handicrafts, manufactured goods, minerals, salts, stones, and textiles," according to the Report. The U.S. "continues to remain concerned about certain changes to the EU's 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 of an opposition to register a GI." The EU has also used instruments of international organizations (like WIPO) through the Lisbon Agreement for the Protection of Appellations of Origin and the Geneva Act thereof to expand the reach of GIs.
While having little luck dissuading the EU from continuing and expanding its GI practices, the Report cites several bilateral agreements (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, and others) that have a number of provisions aimed at curtailing some of the deleterious effects of GI protection as set forth in detail in the Report. The Report also sets forth several U.S. "goals" in this regard:
• Ensuring that the grant of GI protection 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;
• Ensuring that interested persons 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 spirits to other products.
With regard to pharmaceuticals and medical devices and market access for U.S. products, the Report contends that the USTR has been "engaging with trading partners to ensure that U.S. owners of IP have a full and fair opportunity to use and profit from their IP, including by promoting transparent and fair pricing and reimbursement systems." (Gone from the Report is any mention of COVID-19 or the prior administration's acquiescence to international agreements foreswearing IP protection for vaccines or therapeutic products directed to the pandemic.) In its stead are efforts to support this sector and U.S. business's stake in it, specifically to "(1) ensure robust IP systems; (2) reduce market access barriers to pharmaceutical products and medical devices, including measures that discriminate against U.S. companies, are not adequately transparent, or do not offer sufficient opportunity for meaningful stakeholder engagement; and (3) enable trading partners to appropriately recognize the value of innovative medicines and medical devices so that trading partners contribute their fair share to research and development of new treatments and cures."
Specific countries whose practices regarding pharmaceuticals and medical devices fell under USTR's scrutiny include China (regarding (1) commitments for early resolution of patent disputes and (2) patent term extensions to compensate for "unreasonable patent office and marketing approval delays"); Canada and Mexico (with regard to compliance with relevant provisions of the USMCA); Japan (citing engagement regarding opportunities for private sector companies to provide public comments on medical pricing and reimbursement rules); and India (regarding market access barriers affecting U.S. companies that rely on IP protection). "Serious concerns" are raised by "trading partners to unfairly issue, threaten to issue, or encourage others to issue compulsory licenses" the Report asserts. Regarding compulsory licenses, the Report states that "governments should use compulsory licenses only in extremely limited circumstances and after making every effort to obtain authorization from the patent owner on reasonable commercial terms and conditions." Such licenses specifically should not be used "as a tool to implement industrial policy" (which includes "providing advantages to domestic companies") or "or as undue leverage in pricing negotiations between governments and right holders." The Report further states that the U.S. "will continue to monitor developments and to engage, as appropriate, with trading partners, including Colombia, India, Indonesia, Russia, and Türkiye. Also mentioned are statistics showing that "large developing countries" such as Brazil, India, and Indonesia have the highest tariffs for pharmaceutical products.
Exacerbating these problems are "unreasonable regulatory approval delays and non-transparent reimbursement policies" that "discourage the development and marketing of new drugs and other medical products" according to the Report. The U.S. in the past year has monitored, enforced, or engaged with trading partners (Australia (concerning delays in a notification product required under the U.S.- Australian Free Trade Agreement), Brazil, Canada, China, Colombia, Japan (regarding a lack of transparency on pricing and reimbursement policies), Korea (also regarding a lack of transparency on pricing and reimbursement policies), Mexico, Russia, and Türkiye) in efforts to remedy these impediments to efficient global access to medicines while protecting IP rights.
Trademark issues are also noted in the Report for China and Indonesia or a variety of impediments for protecting trademarks, and in Belize, Ecuador, Egypt, and Turkmenistan, which "frequently impose unnecessary administrative and financial burdens on trademark owners and create difficulty in the enforcement and maintenance of trademark rights." Formalities and "documentation requirements" (such as "obtaining traditional pen-and-ink signatures, notarized or legalized powers of attorney, and original documents") were noted for China, Indonesia, Iraq, and the United Arab Emirates. Other countries "do not provide the full range of internationally recognized trademark protections," including Argentina, Barbados, Belarus, and Indonesia, still others have "reportedly have slow opposition or cancellation proceedings" (India, Malaysia, Pakistan, and the Philippines) or no such proceedings at all (Belarus and Panama), and Iraq and South Africa have "extreme delays" in processing trademark applications. Finally, "absence of adequate means for searching trademark applications and registrations, such as by online databases, makes obtaining trademark protection more complicated and unpredictable" according to the Report.
In copyright matters, the Report cites "flawed or non-operational" copyright management organizations in several countries, naming India, Kenya, and Nigeria, despite efforts in countries including the United Arab Emirates to improve matters in this regard. The Report also notes that "it is important for right holders of a work or phonogram to be able to freely and separately transfer their economic rights by contract and to fully enjoy the benefits derived from those rights" and "unclear limitations" in this regard can diminish the effectiveness of these rights.
Software concerns included in the Report involve government use of unlicensed software (costing at least $46 billion globally in 2018 according to The Software Alliance). This issue is particularly noted in Argentina, China, Ecuador, Guatemala, Indonesia, Moldova, Pakistan, Paraguay, Romania, Turkmenistan, Uzbekistan, Venezuela, and Vietnam. The United States "urges trading partners to adopt and implement effective and transparent procedures to ensure legitimate governmental use of software." Under the heading of "Other Issues," the Report notes that the U.S. stakeholders have raised concerns regarding the EU's Copyright in the Digital Single Market and will continue to monitor copyright issues in the EU stemming from implementation thereof, without calling out any particular EU member.
The Report spends less time than in other years on IP and the environment (under the heading of "Intellectual Property and Sustainability) and has a more extensive section on IP and health. In this subsection, the USTR says the U.S. "recognizes the important role of voluntary licensing in promoting greater access to health products" (in contrast with last year's discussion of the COVID IP waiver). Such voluntary acquiescence include voluntary licensing agreements with the Medicines Patent Pool (MPP) or directly with generic manufacturers. In an entirely different context from the 2024 Special 301 Report, what follows these broad policy assertions is a rather extensive discussion of how the WTO under the TRIPS regime has adapted to the dichotomy between international health concerns and IP protection, citing the Doha Declaration as an example (stating that "the United States respects a trading partner's right to protect public health and, in particular, to promote access to medicines for all"). However the Report further states with regard to the IP waiver under the Ministerial Decision on the TRIPS Agreement in June 2022 "[t]his five-year waiver has not increased access to COVID-19 vaccines but instead may actually negatively impact the development of new treatments and cures for the next pandemic by weakening the standard for IP protections and furthering a false narrative about the role of IP and access to medicines." This section also emphasizes that the United States "is firmly of the view" that agreements like TRIPS "have sufficient flexibility to allow trading partners to address the serious public health problems that they may face." And further, the Report asserts that "[t]he United States supports the WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration." Finally, the Report states that the U.S. "works to ensure" that trade agreements (bilateral and regional) and "engagement in international organizations" (including World Intellectual Property Organization (WIPO) and the World Health Organization (WHO)) "are consistent with U.S. policies concerning IP and health and do not impede its trading partners from taking measures necessary to protect public health."
This general portion of the Report concludes with a section on WTO implementation of the TRIPS agreement (emphasizing the "certain minimum standards" required of member countries) and one on dispute settlement and (IP) enforcement, wherein is announced that "[t]he United States will use all available means to resolve concerns, including bilateral dialogue and enforcement tools such as those provided under U.S. law, the World Trade Organization (WTO), and other dispute settlement procedures, as appropriate" (displaying the stick that is the alternative to the policy "carrots" extended in other portions of the Report). Specifically mentioned are efforts towards China and the EU for activities set forth in other sections of the Report that the U.S. considers contrary to TRIPS IP provisions.
Section II of the Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.
As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative's 2025 Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with other countries to increase protection for IP rights of U.S. IP rights holders. It also reflects in some places the differences in temperament and character of this Administration.
*Observant readers of earlier editions of the Special 301 Reports will recognize that the observations, arguments, examples, and topics in this Report echo (sometimes verbatim) analogous sections in earlier Reports, despite policy differences between different administrations.
For additional information regarding this and other related topics, please see:
• "U.S. Trade Representative Releases 2024 Special 301 Report," June 19, 2024
• "U.S. Trade Representative Releases 2023 Special 301 Report," May 29, 2023
• "U.S. Trade Representative Releases 2022 Special 301 Report," April 28, 2022
• "U.S. Trade Representative Releases 2021 Special 301 Report," May 23, 2021
• "U.S. Trade Representative Releases 2020 Special 301 Report," May 10, 2020
• "U.S. Trade Representative Releases 2019 Special 301 Report," April 29, 2019
• "U.S. Trade Representative Releases 2018 Special 301 Report," April 29, 2018
• "U.S. Trade Representative Issues 2017 Special 301 Report," May 4, 2017
• "U.S. Trade Representative Issues 2016 Special 301 Report," May 19, 2016
• "U.S. Trade Representative Issues 2015 Special 301 Report," April 30, 2015
• "U.S. Trade Representative Issues 2014 Special 301 Report," May 19, 2014
• "U.S. Trade Representative Issues 2013 Special 301 Report," May 30, 2013
• "U.S. Trade Representative Issues 2012 Special 301 Report," May 1, 2012
• "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 4, 2011
• "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 19, 2010
• "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
• "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
• "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008
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