China Releases Typical Cases of Intellectual Property Protection by China Customs in 2024 – China Facing Imported Counterfeits Due to Manufacturing Moving to Other Countries
On April 23, 2025, China’s General Administration of Customs releases their Typical Cases of Intellectual Property Protection by China Customs in 2024 (2024年中国海关知识产权保护典型案例). In contrast to prior years, Customs, in explaining the cases, mentioned two new trends. The first is the export of high-tech products infringing Chinese-owned IP due to the “gradual shift of China’s export momentum from Made in China to Created in China.” The second is that China now needs to block imports of counterfeits due to the “industrial transfer of some labor-intensive commodities.”
A translation follows. The original text is available here (Chinese only).
Case 1: Shenzhen Customs introduced technical investigators to investigate and handle a case of photovoltaic equipment infringement
In September 2024, a new energy equipment company in Shenzhen discovered that a batch of photovoltaic production equipment suspected of infringing its patent right of “a lateral upper and lower boat device” was about to be exported, with a value of RMB 10.79 million, and submitted an application for intellectual property protection to Shenzhen Customs. After reviewing, Shenzhen Customs immediately initiated the protection procedure based on the application, implemented control on the batch of goods and suspended customs clearance. In view of the complex characteristics of the patented technology involved in the goods, the high social attention of the case, and the parties’ disputes over the facts of infringement, Dapeng Customs under Shenzhen Customs contacted the China (Shenzhen) Intellectual Property Protection Center and innovatively introduced technical investigators to assist in law enforcement. Relying on its professional assistance, customs inspection personnel accurately locked the physical goods inspection target, scientifically formulated field inspection plans, and rigorously implemented inspection, evidence collection and detention procedures. This innovative measure not only effectively safeguarded the legitimate rights and interests of the right holder, but also minimized the losses that may be caused to the parties by risks such as damage to cargo loading and unloading and delayed delivery. At present, the right holder has filed a lawsuit with the court based on the evidence obtained by the customs inspection.
This case is a typical example of the first successful introduction of technical investigators to implement patent customs protection in the national customs system. The technical investigators, based on the claims and instructions of the patents involved, assisted the customs in inspecting and collecting evidence on the structural components in the equipment related to the patent technology involved. While protecting the rights of the right holder to view the goods, it also further shortened the inspection time and protected the interests of the consignor. It fully demonstrated the professional support role of the technical investigation mechanism for customs protection measures, accumulated valuable experience for the customs system to carry out in-depth patent protection work, and has important demonstration significance for further improving the level of customs protection of intellectual property rights.
Case 2: Shanghai Customs seized a series of infringing foreign trade “new three items” products
In March 2024, the Waigaoqiao Port Customs under Shanghai Customs found 737 solar panels declared as “unbranded” during an inspection of a batch of exported solar panels, suspected of infringing the trademark SUNTECH and graphics, with a value of RMB 243,800. Subsequently, Shanghai Customs further sorted out the export information of photovoltaic products such as solar panels, and seized a total of 2,480 solar panels suspected of infringing the trademark right of “JINKO”, with a value of RMB 1.09 million. After confirmation by the right holder, the above-mentioned goods are all infringing goods. The customs detained the goods in accordance with the law, and made an administrative penalty decision to confiscate the infringing goods and impose a fine after filing an investigation.
In June 2024, Yangshan Customs under Shanghai Customs issued a control order based on the application of the right holder, and carried out precise interception of four batches of exported solar cell modules suspected of infringing its patent rights. 13,730 solar cell modules suspected of infringing its patent rights were seized, with a value of RMB 6.28 million. The customs detained the goods in accordance with the law.
The “new three” of foreign trade, represented by new energy vehicles, lithium batteries, and photovoltaic products, have gained new export advantages with new technologies and new products, reflecting the gradual shift of China’s export momentum from Made in China to Created in China. Photovoltaic products, as the new energy application power supply for the green and low-carbon transformation of energy, have gradually become a “new business card” for stabilizing foreign trade. Customs cracks down on photovoltaic products that infringe trademark rights based on factors such as “high brand awareness, serious infringement status, and relatively clear infringement clues” to maintain corporate brand reputation; comprehensively uses the linkage processing mechanism of “risk control + comprehensive + on-site” to crack down on photovoltaic products that infringe patent rights, protect corporate scientific and technological innovation achievements and transformation and upgrading momentum, and contribute customs strength to the high-quality export of the “new three” products of foreign trade.
Case 3: Hangzhou Customs launched a rapid response mechanism for major cases to coordinate enforcement and seize infringing drill bits
In July 2024, Yiwu Customs under Hangzhou Customs found590,600 drill bits with the SKF and graphic trademark and 59,300 drill bits with the “DORMER” trademark when inspecting a batch of export goods. Due to the large number and high valuation of this batch of drill bits, the customs immediately activated the rapid response mechanism for major cases. After confirmation by the right holder, the batch of drill bits were all infringing goods. The customs detained the goods and filed a case for investigation in accordance with the law. The case handlers keenly noticed that the purchase transaction list and transfer records of the drill bits involved in the case submitted by the consignor were only 80,000 RMB, which was a big gap from the general market situation. They judged that 80,000 RMB was only a deposit, not the actual transaction price of the goods. The customs promptly fixed the key evidence involved in the case, such as the sales contract and freight entrustment agreement, assisted the public security organs in carrying out infringement identification and price identification, and actively promoted the public security organs to conduct criminal investigations. In October 2024, the public security organs formally filed a case for investigation. After the relevant departments determined that the batch of drill bits was worth RMB 955,700. The case is still under further investigation, and the public security organs have taken criminal coercive measures against the suspect.
The rapid response mechanism for major cases is an effective means for customs to deal with cases with large numbers or case values, strong public response, public opinion attention, and involving major or sensitive commodities. In this case, the customs case officers, relying on their rich experience in handling cases, promptly activated the rapid response mechanism for major cases and smoothly promoted the public security organs to file a case. This is a typical case in which customs and public security organs deepened the “enforcement connection” of intellectual property protection and jointly cracked down on infringement and illegal criminal activities throughout the chain.
Case 4: Xiamen Customs builds a strong “entry” protection network to seize a series of infringing condiments
In April 2024, Quanzhou Customs under Xiamen Customs found 139,100 bags of sour soup powder, monosodium glutamate, fried chicken powder and other condiments using the “KNORR” and “AJINOMOTO” trademarks when inspecting a batch of export goods. After confirmation by the right holder, the above-mentioned goods were infringing goods. The customs detained the goods in accordance with the law, and made an administrative penalty decision to confiscate the infringing goods and impose a fine after filing an investigation. While investigating the case, Xiamen Customs focused on “imported” infringing goods, formed an expert team to carry out special infringement risk assessment, screened customs clearance data and case information, conducted a comprehensive analysis of route characteristics and logistics trends, extracted high-risk infringement characteristics, and strengthened control and analysis of key commodities. In June and November of the same year, a total of 213,600 bags of chicken essence that infringed the exclusive rights of the “AJINOMOTO” and “Maggi” trademarks were seized again.
”Food is the first necessity of the people, and food safety is the first priority.” Food safety is always the top priority in the field of people’s livelihood. In this series of cases, the customs started with one infringement case that was discovered, screened high-risk commodities through big data analysis, and conducted special control. Two batches of similar infringing condiments were discovered one after another, effectively blocking the infringing goods from entering the international market, which reflects the customs’ implementation of the “no strictest, only stricter” law enforcement standard in the field of food safety. This series of cases effectively safeguards the health and safety of consumers and the international reputation of Chinese products, and is a typical example of the customs’ heavy blow to “imported” infringing commodities.
Case 5: Beijing Customs and other customs promote integrated protection to escort cultural and creative products to go overseas
In December 2024, Beijing Customs carried out precise training for Beijing Pop Mart Cultural and Creative Co., Ltd. (hereinafter referred to as Pop Mart), and analyzed the industry and regional infringement trends in detail for the infringement of cultural and creative enterprises in the jurisdiction, extracted the characteristics of the categories, channels and trading countries of infringing goods, and carried out cross-customs information sharing with the help of the intellectual property customs protection working group mechanism, and assisted relevant customs in strengthening the analysis and control of infringement risks. In the same month, customs in many places successively seized 9 batches and 140,000 pieces of cultural and creative products suspected of infringing the copyright of “Labubu” and other copyrights, with a value of RMB 170,000.
In July 2024, the General Administration of Customs established a working group mechanism for customs protection of intellectual property rights, and local customs shared information, studied clues, and established an integrated intellectual property protection pattern. As a representative enterprise of China’s trendy culture “going overseas”, Pop Mart has been in short supply in Southeast Asian countries as China’s cultural and creative IP has increased its global influence. In this case, the customs encouraged cultural and creative enterprises to carry out customs filing, improve the effectiveness of rights protection, and form a strong joint force to combat infringement and protect innovation through cross-customs coordinated law enforcement. This case is a typical example of customs deepening the integrated protection of intellectual property rights and escorting cultural and creative products “going overseas”.
Case 6: Guangzhou Customs seized a series of cases involving imported infringing sporting goods
In 2024, there will be a large number of international sports events, and the risk of infringement of sports goods will increase. In January 2024, Nansha Customs under Guangzhou Customs found 13,000 footballs with trademarks such as “MOLTEN”, “ERREA” and “KIPSTA” with a value of RMB 415,000 when inspecting the goods declared for import by a trading company. After investigating the case, Guangzhou Customs sorted out and controlled similar goods imported from the same country. In July of the same year, Panyu Customs under Guangzhou Customs found 3,079 footballs with the “MOLTEN” trademark when inspecting goods imported from the same country by another trading company. The goods were worth RMB 101,000. After confirmation by the right holder, the above-mentioned goods were all infringing goods. The customs detained the goods in accordance with the law, and made an administrative penalty decision to confiscate the infringing goods and impose a fine after filing an investigation.
With the industrial transfer of some labor-intensive commodities, the role of intellectual property protection in the import link has become increasingly important. Customs across the country adheres to the working concept of “strict protection, large-scale protection, fast protection, and common protection”. By refining the characteristics of infringement, analyzing the manifest information, locking the logistics routes, and implementing precise control, it effectively blocks the infringing sports goods from entering the domestic market, effectively maintains the normal trade order of the domestic market, and supports the development of China’s sports industry. This series of cases reflects the customs officers’ profound understanding and professionalism of protecting intellectual property rights, and is a typical case of customs actively combating infringement and illegal acts in the import link.
Case 7: Huangpu Customs and other customs agencies cooperated efficiently to seize the case of transshipping infringing sports shoes
In November 2024, Huangpu Customs received a report from the right holder that a batch of infringing sports shoes were about to be declared for export from the customs. Huangpu Customs gave full play to the two core advantages of data resources and data models, and used the customs’ intelligent risk control shipping trajectory monitoring and analysis function to track the container trajectory in real time. After discovering that the batch of goods had been shipped and left the port for Hong Kong, Huangpu Customs contacted Hong Kong Customs through the Guangdong Branch of the General Administration of Customs to monitor and intercept the container. Hong Kong Customs found out that the container had been transferred to Shenzhen for export, and immediately notified Shenzhen Customs of the information. Shenzhen Customs further found out that after the container changed ships midway, it successfully seized more than 13,000 pairs of infringing sports shoes using trademarks such as “TIMBERLAND”, with a value of RMB 235,800.
The Decision of the CPC Central Committee on Further Comprehensively Deepening Reform and Promoting Chinese-style Modernization, which was reviewed and approved at the Third Plenary Session of the 20th CPC Central Committee, proposed to “deepen cooperation in the Guangdong-Hong Kong-Macao Greater Bay Area and strengthen the connection of rules and mechanisms”. In response to the new trend of drifting infringing goods, the customs of Guangdong and Hong Kong quickly shared risk information in cross-customs and cross-regional joint law enforcement, implemented control and interception at all levels, and cooperated in case investigations, forming a relatively mature customs protection and law enforcement cooperation mechanism for intellectual property rights. This case is a typical example of close cooperation between the customs of Guangdong and Hong Kong to protect intellectual property rights, reflecting the responsibility of customs to serve the high-quality development of the Guangdong-Hong Kong-Macao Greater Bay Area.
Case 8: Qingdao and Ningbo Customs seized a series of cases involving infringing goods exported to African countries
In October 2024, Huangdao Customs under Qingdao Customs seized 68 infringing refrigerators in two batches exported to Libya, with a value of RMB 204,600, and refrigerators with the Pepsi graphic trademark logo. The customs quickly launched the “execution connection” mechanism and transferred the case to the public security organs. At present, the public security organs have merged the two cases for investigation.
In October 2024, Beilun Customs under Ningbo Customs found 1.19 million welding rods with the ” ” (graphic) trademark logo, with a value of RMB 178,500, when inspecting a batch of goods for export to Ghana. After confirmation by the right holder that the above goods were infringing goods, the customs quickly secured evidence and transferred the case to the public security department.
In September 2024, the Forum on China-Africa Cooperation Summit was successfully held in Beijing. The Forum on China-Africa Cooperation-Beijing Action Plan (2025-2027) proposed to “expand cooperation with African customs in areas such as customs clearance facilitation, law enforcement and capacity building, and jointly combat infringement and counterfeiting” and other illegal and criminal acts. In September of the same year, the General Administration of Customs deployed the “Special Action for Customs Protection of Intellectual Property Rights in Africa (2024)” in customs across the country. The above cases fully demonstrated the law enforcement results of the special action, strengthened the intellectual property protection awareness of export enterprises, and maintained the good image of Chinese brands and “Made in China” in African countries. It is a concentrated reflection of the customs’ implementation of the national intellectual property power strategy and service to major power diplomacy.
Case 9: Chengdu, Urumqi and Gongbei Customs seized infringing goods from cross-border e-commerce channels
In January 2024, Chengdu Shuangliu Airport Customs under Chengdu Customs discovered suspected infringing boots using trademark logos such as “UGG” during an inspection of a batch of exported cross-border e-commerce goods. Subsequently, it strengthened control over the same enterprise and seized 473 pieces of shoes and bags using the same trademark logo, which were confirmed as infringing goods by the right holder.
In July 2024, Alashankou Customs under Urumqi Customs discovered 1,050 handbags using the “PINK” trademark logo during an inspection of a batch of exported cross-border e-commerce goods, which were confirmed as infringing goods by the right holder.
In December 2024, the Hong Kong-Zhuhai-Macao Bridge Customs under the Gongbei Customs discovered 4,054 cigarettes with trademarks such as “Yunyan” and “MARLBORO” hidden in lamps during an inspection of a batch of exported cross-border e-commerce goods. They were confirmed as infringing goods by the right holder.
China’s cross-border e-commerce has grown from small to large in scale, and its quality has become stronger and better, and has become a new highlight in China’s foreign trade and global trade. Customs has strengthened its crackdown on infringing goods in cross-border e-commerce, effectively safeguarded the legitimate interests of right holders and consumers, and escorted the healthy and orderly development of the new cross-border e-commerce business. This series of cases is a typical example of customs strengthening intellectual property protection in the new cross-border e-commerce business.
Case 10: Nanjing, Tianjin and Dalian Customs accurately applied the “Criteria for Administrative Penalty Discretion of the Customs of the People’s Republic of China (III)” series of cases
In December 2023, Xinshengwei Customs under Nanjing Customs found that 141 jerseys and other goods used the MANCHESTER CITY 1894 and graphics trademark logo when inspecting a batch of exported goods, with a value of RMB 4,240.85. After confirmation by the right holder, the batch of goods was infringing goods, and the customs detained the goods and filed a case for investigation in accordance with the law. During the investigation of the case, the “Discretion Benchmarks for Administrative Penalties of the Customs of the People’s Republic of China (III)” (hereinafter referred to as “Discretion Benchmarks (III)”) were promulgated and implemented. The customs investigation determined that the party met the provisions of Article 7, paragraph 1, item 4 of the “Discretion Benchmarks (III)” that “the number of imported and exported goods that infringe intellectual property rights is less than 200 pieces and the value is less than 5,000 yuan, the party acknowledges in writing that the goods are infringing goods, voluntarily abandons the infringing goods and hands them over to the customs for handling in accordance with the law”, and made a decision not to impose administrative penalties in January 2024, ordering the party to immediately fulfill the obligation not to import and export infringing goods and educate them.
In December 2023, Xingang Customs under Tianjin Customs found 72 bicycles with the “FOREVER” trademark logo when inspecting a batch of export goods, with a value of RMB 9,299.06. After confirmation by the right holder, the above-mentioned goods were infringing goods, and the customs detained the goods and filed a case for investigation in accordance with the law. During the investigation of the case, the “Discretion Criteria (III)” was promulgated and implemented. The customs investigation determined that the party was a first-time offender, and met the provisions of Article 8 of the “Discretion Criteria (III)” that “the number of infringing goods imported and exported is less than 500 pieces and the value is less than 10,000 yuan, the party acknowledges in writing that the goods are infringing goods, voluntarily abandons the infringing goods and hands them over to the customs for handling in accordance with the law”. The first violation can be exempted from punishment. In January 2024, a decision was made not to impose administrative penalties, ordering the party to immediately fulfill the obligation not to import and export infringing goods and educate them.
In April 2024, Dayaowan Customs under Dalian Customs found that 10 sets of bearings used the “NTN” trademark when inspecting a batch of exported bearings, with a value of RMB 1,444. The right holder confirmed that the above-mentioned goods were infringing goods. The customs detained the goods and filed a case for investigation in accordance with the law. It was found that the party had been punished by the customs twice for exporting infringing goods within one year before the incident. It met the provisions of Article 12 of the Discretion Criteria (III) that “after being administratively punished by the customs for violating Article 25 of the “Regulations on the Implementation of Customs Administrative Penalties”, the same act of violating customs supervision regulations was committed within one year”. In June 2024, an administrative penalty of confiscating the infringing goods and imposing a fine of 25% of the value of the goods was imposed.
The Discretion Benchmark (III) is a specific measure for the customs to implement the decision-making arrangements of the CPC Central Committee and the State Council on regulating administrative discretion, and provides a guiding and normative discretion benchmark for the customs to strictly, standardize and fairly handle intellectual property cases. Since the implementation of the Discretion Benchmark (III), the national customs have accurately applied different levels of discretion according to the facts, nature, circumstances and degree of social harm of the illegal acts, reflecting the legislative spirit of proportionate punishment and leniency and severity, which is of great significance to improving the fairness and transparency of administrative penalties, protecting the legitimate rights and interests of the parties, and promoting the standardization and professionalization of customs law enforcement.
Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves
This week, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of foreign facilities. But they also raise questions about implementation, industry impact, and long-term effects. This is another step from the Department of Commerce Bureau of Industry and Security’s (BIS) Section 232 investigation into pharmaceuticals initiated on April 1, 2025. These developments, while unsurprising, should be viewed within the constellation of broader administration policy, and could make real progress on furthering the manufacturing onshoring agenda for the critical life sciences industry.
The Executive Order: Streamlining Domestic Manufacturing
Signed on May 5, 2025, the Executive Order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” aims to reduce barriers to building and expanding pharmaceutical manufacturing capacity in the United States.[1] The White House frames this as a national security imperative, citing estimates that new facilities can take 5 to 10 years to construct due to regulatory hurdles—a timeline deemed “unacceptable.” The order directs the FDA and the Environmental Protection Agency (EPA) to review and streamline regulations related to the approval of new and expanded manufacturing sites, eliminate “duplicative or unnecessary requirements,” and maximize “timeliness and predictability” in reviews.
The order also emphasizes early collaboration between the FDA and domestic manufacturers to support facilities before they come online. This could mean more pre-approval guidance or technical assistance, potentially reducing delays in licensure inspections. Additionally, the order calls for increased fees and inspections for foreign manufacturing plants, alongside stricter enforcement of active pharmaceutical ingredient (API) source reporting. The FDA is tasked with publicly disclosing the number of foreign inspections conducted, broken down by country and manufacturer, and considering a public list of non-compliant facilities.
This push for domestic production builds on Trump’s first-term efforts, such as Executive Order 13944 (August 6, 2020), which aimed to reshore essential medicines. The current order reflects a broader “America First” agenda, with the administration arguing that domestic facilities face more frequent and rigorous inspections than their foreign counterparts—a disparity they seek to address.
FDA’s Expanded Unannounced Inspections: Leveling the Playing Field?
On May 6, 2025, the FDA announced plans to expand unannounced inspections at foreign manufacturing facilities producing drugs, food, and medical products for the U.S. market. This builds on a pilot program launched under the Biden administration in India and China, which had stalled due to recent staff cuts. The agency’s goal is to ensure foreign facilities face the same level of scrutiny as domestic ones, addressing long-standing concerns about inconsistent oversight. The FDA emphasized that it can take enforcement actions—such as warning letters or import bans—against facilities that delay, block, or refuse these inspections.
FDA Commissioner Marty Makary, appointed under the Trump administration, underscored that these surprise inspections aim to align foreign oversight with domestic standards. The agency also plans to optimize inspector resources by reducing time spent in-country, allowing for more inspections without additional staffing. This is particularly significant given recent reports of layoffs and budget constraints at the FDA, which have strained its inspection capacity.
Context and Analysis: Opportunities and Challenges
These actions don’t exist in a vacuum. Since the inauguration, the FDA has undergone significant changes, reflecting the administration’s broader push to reduce bureaucracy, roll back regulations, and prioritize domestic interests. The appointment of Marty Makary as FDA Commissioner and Robert F. Kennedy Jr. as Health and Human Services Secretary has set a tone of aggressive reform. These changes suggest a dual focus: easing regulatory burdens for U.S. manufacturers while intensifying scrutiny of foreign ones. However, the FDA’s ability to execute these policies amidst staffing shortages and budget cuts remains a critical question.
Opportunities naturally reveal themselves. First, the Executive Order’s emphasis on streamlining regulations could significantly reduce the time and cost of building or expanding U.S. manufacturing facilities. The news cycle has been full of recent announcements—totaling in the multiple billions—by both large and small pharma companies making commitments to invest in U.S. manufacturing and research and development. Second, expanded unannounced inspections may deter foreign manufacturers from cutting corners, potentially reducing the competitive advantage of lower-cost production in countries like India and China. This could benefit U.S. contract manufacturing and development companies by narrowing the cost gap, but to be sure, could result in at least a short-term cost increase for manufacturers looking to move operations back home. Finally, the promise of pre-approval collaboration could help companies navigate complex—and sometimes confusing—regulatory requirements, reducing the risk of delays or rejections during licensure inspections.
But challenges are also plentiful. First, the FDA’s recent layoffs and budget constraints raise concerns about its capacity to conduct more foreign inspections or provide robust support for domestic manufacturers. The agency’s Office of Inspections and Investigations was already struggling with a 16% vacancy rate among investigators before these changes. It was reported that, as of September 2024, 42% of the 4,700 plants that manufacture drugs for the U.S. were overdue for inspection.[2] Second, higher inspection fees and stricter API source reporting could raise operating costs for foreign facilities, potentially leading to supply chain disruptions or price increases for U.S. consumers. Companies reliant on foreign APIs may need to reassess their sourcing strategies. Third, the White House’s foreshadowed tariffs on imported drugs could complicate the economics of foreign manufacturing, forcing companies to weigh the costs of relocating production to the U.S. against potential trade barriers. Finally, while streamlining domestic approvals is appealing, eliminating “duplicative or unnecessary” requirements risks weakening oversight. The opioid crisis, partly fueled by lax FDA standards in the past, serves as a cautionary tale.
Tariffs: Potential Impact and Twists
Further, tariffs continue to place economic pressure on foreign manufacturing. Large U.S. manufacturers have estimated tariff impacts of “a few hundred million dollars,” primarily due to tariffs on Chinese products (e.g., the International Emergency Economic Powers Act (IEEPA) 20% fentanyl tariff, the IEEPA 125% reciprocal tariff, Section 301 tariffs) as well as China’s retaliatory tariffs. As a result, manufacturers have begun to implement mitigation strategies. For example, companies are now beginning to invest more heavily in domestic R&D and manufacturing in order to meet U.S. product demand, while maintaining manufacturing facilities abroad to serve global demand.
In addition to the tariffs imposed by the statutory authorities listed above, on April 1, 2025, BIS initiated a Section 232 investigation under the Trade Expansion Act of 1962 into pharmaceuticals. This investigation focuses on the national security implications of importing pharmaceuticals and pharmaceutical ingredients, including finished generic and non-generic drug products, medical countermeasures, critical inputs like active pharmaceutical ingredients and key starting materials, and derivative products of these items. The investigation must conclude within 270 days. Following the investigation, the President has the authority to impose various trade restrictions, including tariffs on the investigated products.
Generally, these tariffs are typically additive. However, in a twist, the relationship between Section 232 tariffs and the 125% reciprocal tariff are exclusive of each other. For example, if a Chinese product is subject to a Section 232 tariff, it will not be subject to the 125% reciprocal tariff. This exclusivity might offer some relief to the pharmaceutical industry if Section 232 tariffs are imposed on certain Chinese pharmaceutical products and are set at a rate lower than 125%.
These developments may demand strategic adjustments, including but not limited to:
Reevaluate Supply Chains: this one is debatable, but it is as good a time as ever to assess reliance on foreign manufacturing and consider investing in U.S. facilities to capitalize on regulatory relief and mitigate tariff risks.
Strengthen Compliance Programs: prepare for unannounced inspections by enhancing quality control systems and ensuring accurate API source reporting. Non-compliance of course could lead to public shaming or import restrictions.
Engage with FDA Early: leverage the FDA’s offer of pre-approval support to streamline facility approvals. This could involve early consultations on emerging technologies or production line modifications. The FDA is not always the easiest to correspond with—especially recently—but the administration’s commitment to domestic manufacturing could yield a critical advantage over foreign entities when it comes to dealing with FDA.
Monitor Tariff Developments: With the administration promising more details on tariffs within weeks, companies should model the financial impact of potential trade policies and explore diversification strategies.
Looking Ahead: Balancing Speed, Safety, and Security
The administration’s FDA is charting a course that prioritizes domestic manufacturing and robust foreign oversight, but the path is fraught with challenges. Streamlining regulations could unleash innovation and strengthen the U.S. drug supply chain, but only if the FDA retains the expertise and resources to maintain safety standards. Expanded unannounced inspections are a step toward domestic parity, but their success hinges on adequate staffing and international cooperation. Meanwhile, the specter of tariffs looms large, potentially reshaping the economics of the global pharmaceutical industry.
As with everything recently, it is too early to say whether and to what extent these actions will have a meaningful impact, but the number of policy moves is growing to a critical mass. The coming months will reveal whether the FDA can deliver on these ambitious goals or if resource constraints and policy trade-offs undermine their impact. For now, manufacturers should stay proactive, aligning their strategies to the extent possible with the administration’s priorities while safeguarding compliance in an increasingly complex and uncertain regulatory environment.
FOOTNOTES
[1] Executive Order available here: Regulatory Relief to Promote Domestic Production of Critical Medicines – The White House
[2] Nearly 2,000 drug plants are overdue for FDA checks after COVID delays, AP finds | The Associated Press
Julian Klein also contributed to this article.
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DHS Announces the Rescission of Romania’s Designation into the Visa Waiver Program
The Visa Waiver Program (VWP) permits citizens of designated countries to travel to the United States for business or tourism for stays of up to 90 days without a visa. In return, those countries must permit U.S. citizens and nationals to travel to their countries for a similar length of time without a visa for business or tourism purposes. The VWP utilizes a risk-based, multi-layered approach to detect and prevent terrorists, serious criminals, and other mala fide actors from traveling to the United States.
On May 2, 2025, the Department of Homeland Security (DHS), in consultation with the Department of State, rescinded Romania’s VWP designation.
DHS had paused implementation of the VWP in order to conduct a review of Romania’s designation on March 25, 2025. The review has concluded, and given the Trump administration’s focus on increased border and immigration security, DHS decided that Romania’s designation should be rescinded to protect the integrity of the VWP and to enhance border and immigration security.
However, Romania may be reconsidered for VWP designation in the future should they meet the statutory eligibility criteria. The eligibility requirements are defined in Section 217 of the Immigration and Nationality Act as amended by the Secure Travel and Counterterrorism Partnership Act of 2007 and the Visa Waiver Program Improvement and Terrorist Travel Prevention Act of 2015. Pursuant to the statute, a country may be designated into the VWP if the following requirements are met:
Has an annual temporary visitor visa (i.e., B visa) refusal rate of less than 3%;
Accepts the repatriation of its citizens, former citizens, and nationals ordered removed from the United States within three weeks of the final order of removal;
Enters into an agreement to report lost and stolen passport information to the United States via INTERPOL or other means designated by the secretary of Homeland Security;
Enters into an agreement with the United States to share terrorism and serious criminal information;
Issues electronic, machine-readable passports with biometric identifiers;
Undergoes a DHS-led evaluation of the effects of the country’s VWP designation on the security, law enforcement, and immigration enforcement interests of the United States; and
Undergoes, in conjunction with the DHS-led evaluation, an independent intelligence assessment produced by the DHS Office of Intelligence and Analysis (on behalf of the director of National Intelligence).
WhatsApp? A Legally Binding Contract….
In the recent case of Jaevee Homes Limited v. Mr Steven Fincham, the English High Court has handed down judgment that an exchange of WhatsApp messages between the parties formed a basic and legally binding contract, providing a reminder to parties involved in pre-contract discussions to exercise caution.
Background facts
The case centred around a contractual dispute between a property developer, Jaevee Homes Limited (“Claimant”) and a demolition contractor, Steve Fincham, trading as Fincham Demolition (“Defendant”) who the Claimant had hired to undertake demolition works. The parties exchanged WhatsApp messages in April-May 2023 regarding the work with the Claimant confirming the job via WhatsApp on 17 May 2023. On 26 May 2023, a formal subcontract and purchase order was emailed on the behalf of the Claimant to the Defendant however, it was never signed or acknowledged.
The key issue in dispute was determining the exact terms of the contract between the parties, particularly in relation to the payment terms. The Claimant argued that the terms of the written subcontract which incorporated its standard terms and sent to the defendant on 26 May 2023 were binding. On the other hand, the Defendant believed that a basic contract had been formed as a result of WhatsApp messages exchanged on 17 May 2023.
Outcome
The basic criteria for concluding most types of legally binding contract under English is well established: one party makes an offer which the other accepts and some money (or something else of at least nominal value) must pass between the parties. Importantly though, in most cases there is no requirement for a contract to be reduced to writing and signed by the parties nor is there any requirement for acceptance to be formally communicated with acceptance by conduct or implication being very common.
In reaching a decision in this case, the Judge applied these principles, using a common sense and contextual approach when reviewing the WhatsApp messages which had passed between the parties. As a result the Judge confirmed that the messages “whilst informal, evidenced and constituted a concluded contract” as opposed to pre-contractual negotiations. Although the messages did not agree all aspects concerning payment, the messages did confirm the relevant fees, scope of work and final date of payment.
In particular, the Judge focused on a relatively informal exchange of messages between the parties on 17 May 2023 in which the Defendant asked “Are we saying it’s my job mate so I can start getting organised mate” to which the Claimant responded “Yes”, holding that meant a legally binding contract had come into force on that date.
The Judge went on to note that at this point “there was no express indication that the final terms of the agreement between the Parties depended upon agreement as to any other matter such as incorporation of the Claimant’s standard terms”. Therefore, the subcontract and purchase order issued to the Defendant on 26 May which had never been signed or acknowledged by the Defendant were irrelevant as a legally binding contract had already come into force nine days before.
Impact of the ruling
This judgment is a helpful reminder that under English contract law, it is easy to (inadvertently) create a legally binding contract and that caution should be exercised when engaging in informal pre-contract discussions. In particular, if a party’s position is that any award of work is made subject to its standard terms or the conclusion of a formal written contract, that should be clearly stated in discussions and work not allowed to commence until a formal written contract has been concluded. If a written contract is concluded, that should contain an “entire agreement” clause which seeks to exclude any pre-contract discussions to provide certainty that neither party will be able to rely on statements or representations made during discussions which are not reflected in the final written contract.
The BR Privacy & Security Download: May 2025
Welcome to this month’s issue of The BR Privacy & Security Download, the digital newsletter of Blank Rome’s Privacy, Security, & Data Protection practice.
STATE & LOCAL LAWS & REGULATIONS
State Regulators Form Bipartisan Consortium for Privacy Issues: The California Privacy Protection Agency and the Attorneys General of California, Colorado, Connecticut, Delaware, Indiana, New Jersey, and Oregon have created the Consortium of Privacy Regulators (the “Consortium”), a bipartisan consortium, to collaborate on various privacy issues. The seven states all have comprehensive privacy laws that are currently or will be in effect, and the Consortium will collaborate on the implementation and enforcement of their respective state laws. The Consortium will hold regular meetings not only to share expertise and resources, but also to coordinate efforts to investigate potential violations of applicable laws.
CPPA Issues Updated ADMT Proposed Rules and Opens Comment Period for Data Broker Deletion Mechanism Proposed Rules; California Governor Urges CPPA to Not Enact ADMT Proposed Rules: The California Privacy Protection Agency (“CPPA”), the regulatory authority charged with enforcing the California Consumer Privacy Act, as amended by the California Privacy Rights Act (“CCPA”), has released a revised version of its proposed regulations on cybersecurity audits, risk assessments, and automated decision-making technology (“ADMT”). Among the notable modifications offered by the CPPA were to narrow the definition of ADMT, remove behavioral advertising from ADMT and risk assessment requirements, and reduce the kinds of evaluations that businesses would have to undertake when using ADMT. California’s Governor, Gavin Newsom, sent a letter to the CPPA, urging the agency not to enact the proposed regulations on ADMT, stating that the regulations “could create significant unintended consequences and impose substantial costs that threaten California’s enduring dominance in technological innovation.” In addition to the proposed ADMT regulations, the CPPA has progressed its rulemaking under the California Delete Act. The CPPA has opened the formal public comment period on its proposed regulations for the Delete Request and Opt-Out Platform. The Delete Act requires the CPPA to establish an accessible deletion mechanism to allow consumers to request the deletion of personal information from all registered data brokers through a single deletion request to the CPPA. The comment period will remain open until June 10, 2025.
Bill Introduced to Stop California CIPA Claims: The California Senate introduced S.B. 690, which aims to stop lawsuits for violations of the California Invasion of Privacy Act (“CIPA”) based on the use of cookies and other online tracking technologies. There has been a recent trend of class actions under CIPA, where plaintiffs claim that the use of cookies and tracking technologies on websites violates CIPA because such technologies facilitate wiretapping and constitute illegal pen registers or trap and trace devices. Not even businesses compliant with the CCPA that provide consumers with the ability to opt out of the sharing of personal information with providers of tracking technologies are immune from CIPA class actions. S.B. 690 would exempt online technologies used for a “commercial business purpose” from wiretapping and pen register or trap-and-trace liability. “Commercial business purpose” is defined as the processing of personal information in a manner permitted by the CCPA.
Arkansas’ Social Media Safety Act Struck Down; Arkansas Legislature Passes Amendments in Response: The U.S. District Court for the Western District of Arkansas held that the Arkansas’ Social Media Safety Act (“SMSA”), a law limiting minors’ access to social media platforms, was unconstitutional and granted a permanent injunction blocking SMSA from taking effect. The District Court held that SMSA violated the First Amendment because it did not meet the requisite standard of strict scrutiny. The District Court held that SMSA’s age verification requirements blocking minors’ access to social media platforms were not narrowly tailored to prevent minors from interacting online with predators and other harmful content. The District Court also found that SMSA was unconstitutionally vague, as it is not clear which of NetChoice’s members are subject to SMSA’s requirements, while SMSA regulates companies like Facebook and Instagram, it specifically exempts Google, WhatsApp, and Snapchat. In response to the District Court’s ruling, the Arkansas Legislature passed a new bill, S.B. 611, to amend SMSA to broaden the scope and applicability of SMSA to include additional online platforms, narrow the age of applicability to users under 16 (rather than 18), strengthen privacy protections for minor users, and add a private right of action for parents of minor users.
Connecticut Attorney General Issues Annual Report on Connecticut Data Privacy Act Enforcement: The Connecticut Attorney General released a new report detailing the actions it has taken to enforce the Connecticut Data Privacy Act (“CTDPA”). The report provides updates on: (1) the Connecticut Attorney General’s broader privacy and data security efforts; (2) consumer complaints received under the CTDPA to date; (3) several enforcement efforts highlighted in the Connecticut Attorney General’s initial report; (4) expanded enforcement priorities; and (5) recommendations for strengthening the CTDPA’s protections. While the Connecticut Attorney General seems to remain focused on enforcing the CTDPA’s transparency requirements (i.e., disclosures to be included in privacy notices) and requirements to obtain opt-in consent to process sensitive data, it seems to also have broadened its efforts to address opt-out practices and dark patterns. The Connecticut Attorney General’s priorities have further expanded as the CTDPA’s universal opt-out provisions became effective and new legislation related to minors’ privacy and consumer health data took effect.
Oregon Attorney General Reports Spike in Complaints on Use of Personal Data by Government Entities: The Oregon Department of Justice’s (“ODOJ”) Privacy Unit reported a big spike in the first three months of 2025 in complaints about the Department of Government Efficiency (“DOGE”). As of March 31, 2025, the Privacy Unit reports it received more than 250 complaints about DOGE. In addition to the DOGE complaints, the Privacy Unit received 47 complaints between January and March of this year relating to the Oregon Consumer Privacy Act (“OCPA”). In addition, ODOJ announced the publication of a 2025 Quarter 1 Enforcement Report, which addresses outreach and enforcement efforts of the OCPA from January 1 to March 31, 2025, and identifies broad privacy trends in Oregon. ODOJ previously issued a Six-Month Enforcement Report, which addressed enforcement efforts for the first six months of the OCPA. ODOJ plans to continue to issue these reports quarterly, with a longer report published every six months.
Ohio’s Age Verification Law Struck Down: The U.S. District Court for the Western District of Arkansas struck down Ohio’s Social Media Parental Notification Act, which required social media companies to verify user age and obtain parental consent for users under 16. NetChoice, a technology industry trade group that has challenged a number of recently enacted social media laws around the country on constitutional grounds, including Arkansas’ SMSA, alleged that the act violated the First Amendment. The District Court agreed and held that the law’s age verification requirement blocking minors’ access to social media is not narrowly tailored to protect children from the harms of social media. The District Court also held that the law’s definitions for which websites had to comply with the law were a content-based restriction because it favored some forms of engagement with certain topics to the exclusion of others.
California Attorney General Appeals Age-Appropriate Design Code Act Decision: As previously reported, NetChoice obtained a second preliminary injunction temporarily blocking the enforcement of the California Age-Appropriate Design Code Act (“AADC”). The California Attorney General has appealed this decision, stating that it is “deeply concerned about further delay in implementing protections for children online.” The AADC would place extensive new requirements on websites and online services that are “likely to be accessed by children” under the age of 18. NetChoice won its first preliminary injunction in September 2023 on the grounds that the AADC would likely violate the First Amendment. In April 2025, NetChoice’s motion for preliminary injunction was again granted on the grounds that the AADC regulates protected speech, triggering a strict scrutiny review, and while California has a compelling interest in protecting the privacy and well-being of children, this interest alone is not sufficient to satisfy a strict scrutiny standard.
FEDERAL LAWS & REGULATIONS
DOJ Issues Data Security Program Compliance Guide and FAQ; Provides 90 Day Limited Enforcement Policy: The National Security Division of the U.S. Department of Justice (“DOJ NSD”) released a compliance guide and FAQ as part of its implementation of its final rule on protecting Americans’ sensitive data from foreign adversaries (the “Final Rule”). The compliance guide is intended to provide general information to assist individuals and entities in complying with the Final Rule’s legal requirements and to facilitate an understanding of the scope and purposes of the Final Rule. The FAQ answers 108 questions regarding Final Rule topics such as the definition of sensitive personal data, prohibited and restricted transactions, and scope of the Final Rule’s application to certain corporate group transactions, among other topics. Concurrently, the DOJ NSD issued a limited enforcement policy through July 8, 2025. Under the limited enforcement policy, the DOJ NSD stated that it will not prioritize civil enforcement actions against any person for violations of the DSP that occur from April 8 through July 8, 2025, so long as the person is engaging in good faith efforts to comply with or come into compliance with the DSP during that time. NSD stated it will pursue penalties and other enforcement actions as appropriate for egregious, willful violations and is not limited in pursuit of civil enforcement if good faith compliance efforts, such as reviewing data flows, conducing data inventories, renegotiating vendor agreements, transferring services to new vendors, and conducting diligence on new vendors, are not undertaken.
FTC Sends Letter to Office of U.S. Trustee Regarding 23andMe Bankruptcy: Federal Trade Commission (“FTC”) Chairman Andrew N. Ferguson issued a letter to the U.S. Trustee regarding the 23andMe bankruptcy proceeding, expressing the concerns consumers have with the potential sale or transfer of their 23andMe data. The letter emphasizes the fact that the data 23andMe collects and processes is extremely sensitive, and highlights some of the public-facing privacy and data security-related representations the company has made. Chairman Ferguson urges the U.S. Trustee to ensure that any bankruptcy-related sale or transfer involving 23andMe users’ personal information and biological samples will be subject to the representations the company has made to users about both privacy and data security.
OMB Issues Memoranda on Federal Government Purchase and Use of AI: The U.S. Office of Management and Budget (“OMB”) issued memoranda providing guidance on federal agency use of AI and purchase of AI systems. The guidance in the memoranda builds on Executive Order 14179, Removing Barriers to American Leadership in Artificial Intelligence, signed by President Trump in January. The memorandum fact sheet states, “The Executive Branch is shifting to a forward-leaning, pro-innovation and pro competition mindset rather than pursuing the risk-averse approach of the previous administration.” Notwithstanding that characterization, the guidance does share many risk management and performance tracking concepts included in Biden administration directives. The guidance describes how to manage “high-impact” AI, which is defined as AI where the output serves as a principal basis for decisions or actions that have legal, material, binding, or significant effect on AI rights or safety. There are several examples of high-impact AI in the guidance, including enforcement of trade policies, safety functions for critical infrastructure, transporting chemical agents, certain law enforcement activities, and when protected speech is removed. Environmental impacts and algorithmic bias are not mentioned. However, the guidance directs agencies to use AI in a way that improves public services while maintaining strong safeguards for civil rights, civil liberties, and privacy.
States’ Attorneys General Challenge the Firing of FTC Commissioners: A coalition of 21 Attorneys General (the “Coalition”) supported two FTC Commissioners in challenging the decision by President Trump to fire them without cause. Led by the Colorado Attorney General, the Coalition filed an amicus brief in Slaughter v. Trump, emphasizing the important role the FTC has played in consumer protection and antitrust. The Coalition stated that the strong track record of the FTC is due in large part to the bipartisan structure of the FTC’s leadership and that “[a]llowing the president to have at-will removal authority would ruin the FTC’s independence by allowing the commission to become a partisan agency subject to the political whims of the president.”
NIST Releases Initial Draft of New Version of Incident Response Recommendations: The U.S. Department of Commerce National Institute of Standards and Technology (“NIST”) released the initial public draft of Special Publication 800-61 Rev. 3 (“SP 800-61”) for public comment. SP 800-61 is designed to assist organizations in incorporating cybersecurity incident response considerations throughout NIST Cybersecurity Framework 2.0 risk management activities to improve the efficiency and effectiveness of their incident detection, response, and recovery activities. The public comment period is open through May 20, 2025.
NIST Releases Initial Public Draft of Privacy Framework 1.1: NIST released a draft update to the NIST Privacy Framework (“PFW”). Updates include targeted changes to the content and structure of the NIST PFW to enable organizations to better use it in conjunction with the NIST Cybersecurity Framework, which was updated to version 2.0 in 2024 (“CSF 2.0”). The PFW’s draft update makes targeted changes to align with CSF 2.0, with a focus on the Govern Function (i.e., risk management strategy and policies) and the Protect Function (i.e., privacy and cybersecurity safeguards). The new draft also includes changes responsive to stakeholder feedback since the initial release of the PFW five years ago. The draft PFW also includes a new section on AI and privacy risk management and moves PFW use guidelines online. NIST is accepting comments on the draft through June 13, 2025.
FCC Delays Part of TCPA Rule Amendments: The Federal Communications Commission (“FCC”) announced that it was extending the effective date of one part of the amendments to the Telephone Consumer Protection Act (“TCPA”) rules the FCC released last year. The delayed amendments were initially set to become effective April 11, 2025, and relate to consumers’ revocation of consent. Amendments to C.F.R. § 64.1200(a)(10) were designed to make it easier for consumers to revoke consent under the TCPA by requiring callers to apply a revocation request received for one type of message to all future calls and texts. However, in response to industry comments, the FCC extended the effective date of C.F.R. § 64.1200(a)(10) until April 11, 2026, “to the extent that it requires callers to apply a request to revoke consent made in response to one type of message to all future robocalls and robotexts from that caller on unrelated matters.” The remaining portions of the amended rule went into effect on April 11, 2025.
U.S. LITIGATION
Fifth Circuit Vacates FCC Telecommunications Provider Fine: The Fifth Circuit vacated the $57 million fine imposed on AT&T by the FCC in 2024, which was part of a number of FCC enforcement actions issued concurrently by the FCC against major carriers related to the sale of geolocation data to third parties. All carriers have appealed the fines. AT&T argued that the penalty should be vacated in part because the FCC imposed sanctions without proving the allegations in court. Following the U.S. Supreme Court decision in U.S. Securities and Exchange Commission v. Jarkesy, in which the Supreme Court limited use of government agency courts and held that when the Securities Exchange Commission seeks civil penalties against a defendant for securities fraud, the Seventh Amendment entitles the defendant to a jury trial. The FCC argued that its enforcement action was rooted in Section 222 of the Telecommunications Act, which does not have roots in common law, and that, therefore, the Seventh Amendment right to a jury trial is inapplicable. However, the Fifth Circuit determined that Section 222’s requirement to use reasonable measures to protect consumer data is analogous to common law negligence. The Court stated that it was not denying the FCC’s right to enforce laws to protect customer data, but that the FCC must do so consistent with constitutional guarantees of a jury trial.
Illinois Federal Judge Reverses Prior Ruling on Retroactive Application of BIPA Amendments: In two cases before U.S. District Court Judge Elaine Bucklo, Judge Bucklo vacated her prior rulings that Illinois’ Biometric Information Privacy Act (“BIPA”) amendments passed by the Illinois legislature applied retroactively, stating that upon her reexamination of the issue she concluded that the “better interpretation of the amendment is that it changed the law” rather than clarified the initial intent of the legislature when it first passed BIPA. The Illinois Legislature amended BIPA in 2024 to provide that a company that collects a person’s biometric information multiple times in the same manner has committed only one violation of the law. Previously, the Illinois State Supreme Court held that each instance of collection constituted a violation supporting a claim for damages, resulting in potentially extreme liability for companies using biometric systems for business purposes such as timekeeping, where employees might clock in and out by scanning biometric identifiers multiple times per day. Judge Bucklo’s new ruling aligns with those of two other Illinois federal district courts. The plaintiffs will now be permitted to pursue their claims under the statute as it existed at the time of the alleged violations.
Pennsylvania District Court Holds Online Privacy Terms Sufficient for Implied Consent Under State Wiretapping Law: The U.S. District Court for the Western District of Pennsylvania held that disclosure of third-party data collection in online privacy statements that can be seen by a reasonably prudent person is sufficient to obtain implied consent to that disclosure. Pennsylvania’s wiretapping statute prohibits any person from intercepting a wire, electronic, or oral communication unless all parties have provided consent to interception. The website in question, operated by Harriet Carter Gifts, disclosed that the business tracked and shared website visitors’ activity with third parties. The privacy statement was available via a link at the bottom of each page of the website. According to the Court, the description of sharing data with third parties in the privacy statement combined with the reasonable availability of the privacy statement provided the plaintiff with constructive notice of the practice of sharing data with third parties and resulted in the plaintiff providing implied consent to such sharing, despite the fact that the plaintiff testified she had never read the privacy statement.
Sixth Circuit Holds Newsletter Subscribers Are Not Consumers Under VPPA: The Sixth Circuit affirmed the dismissal of a proposed class action brought by a plaintiff who had subscribed to a digital newsletter from Paramount Global’s 24/7 Sports. The plaintiff alleged that the subscription qualified him as a “consumer” under the Video Privacy Protection Act (“VPPA”) because the newsletter contains links to video content, making the newsletter “audiovisual materials” subject to the VPPA. The Court rejected this argument, stating that the complaint suggests that the linked video content was available to anyone with or without a newsletter subscription and that the plaintiff did not plausibly allege that the newsletter itself was “audiovisual material.” The Court noted that its reading of the VPPA differed from the Second and Seventh Circuits, which have held that the term “consumer” under the statute should encompass any purchaser or subscriber of goods or services, whether audiovisual or not. U.S. Circuit Judge Rachel S. Bloomekatz dissented, stating that the plaintiff is a “consumer” under the VPPA because he is a subscriber of Paramount, which is a “videotape service provider.”
Ninth Circuit Rules VPPA Not Applicable to Movie Theaters: The Ninth Circuit affirmed a District Court’s dismissal of an action against Landmark Theaters (“Landmark”), holding that the Video Privacy Protection Act (“VPPA”) does not apply to in-theater movie businesses. The plaintiff had purchased a ticket on Landmark’s website. As part of that purchase, the plaintiff alleged that Landmark shared the name of the film, the location of the showing, and the plaintiff’s unique Facebook identification number with Facebook. The VPPA prohibits “video tape service providers” from knowingly disclosing personally identifiable information of a consumer without consent. “Video tape service provider” is defined under the VPPA as “any person, engaged in the business .. of rental, sale, or delivery of prerecorded video cassette tapes or similar audiovisual materials.” The Court held that the plain language of the statute and the law’s statutory history did not support a finding that selling tickets to an in-theater movie-going experience is a business subject to the VPPA.
U.S. ENFORCEMENT
Defense Contractor Settles FCA Allegations Related to Cybersecurity Compliance: The U.S. Department of Justice (“DOJ”) announced a settlement with defense contractor Morsecorp Inc. (“Morse”) resolving allegations that Morse violated the False Claims Act (“FCA”) by failing to comply with cybersecurity requirements in its contracts with the Army and Air Force. The DOJ alleged that Morse failed to comply with contract requirements by, among other things, using a third party to host Morse emails without requiring or ensuring that the third party met Federal Risk and Authorization Management Program Moderate baseline and complied with the Department of Defense’s cyber security requirements, failing to implement all cybersecurity controls in NIST Special Publication 800-171 (“SP 800-171”), failing to have a consolidated written plan for each of its covered information systems describing system boundaries, system environments of operation, how security requirements are implemented and the relationships with or connections to other systems, and failing to update its self-reported score for implementation of the requisite NIST controls following receipt of an updated score from a third party assessor. Morse has agreed to pay $4.6 million to resolve the allegations.
New York Attorney General Fines Auto Insurance Company over Data Breach: The Office of New York Attorney General Letitia James announced that it had fined auto insurance company Root $975,000 for failing to protect personal information following a breach that affected 45,000 New York residents. Root allows consumers to obtain a price quote for insurance through its website. After entering limited personal information, the online quote tool filled in other personal information such as driver’s license numbers. The Attorney General alleges that Root exposed plaintext driver’s licenses in a PDF generated at the end of the quote process and that Root had failed to perform adequate risk assessments on its public-facing web applications, did not identify the plain text exposure of consumer personal information, and employed insufficient controls to thwart automated attacks. In addition to the fine, the settlement requires Root to enhance its data security controls by maintaining a comprehensive information security program that uses reasonable authentication procedures for access to private information and the maintenance of logging and monitoring systems, among other things.
New Jersey Attorney General Sues Messaging App for Failing to Protect Kids: New Jersey Attorney General Matthew J. Platkin and the Division of Consumer Affairs announced it had filed a lawsuit against message app provider Discord, Inc. (“Discord”) alleging Discord engaged in “deceptive and unconscionable business practices that misled parents about the efficacy of its safety controls and obscured the risks children faced when using the application.” According to the complaint, Discord violated the New Jersey Consumer Fraud Act by misleading parents and kids about its safety settings for direct messages. For example, Discord allegedly represented that certain user settings related to its safe direct messaging setting would cause the app to scan, detect, and delete direct messages for explicit media content. According to the Attorney General, Discord knew that not all explicit content was being detected or deleted. The complaint also alleges that Discord misrepresented its policy of not permitting users under the age of 13 because of its inadequate age verification processes.
HHS Enters Settlement with Healthcare Network over Phishing Attack that Exposed PHI: The U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced a settlement with PIH Health, Inc. (“PIH Health”), a California healthcare network, relating to alleged violations of the Health Insurance Portability and Accountability Act (“HIPAA”) arising from a phishing attack that exposed protected health information. The phishing attack compromised 45 PIH Health employee email accounts, which resulted in the breach of 189,763 individuals’ protected health information, including names, addresses, dates of birth, driver’s license numbers, Social Security numbers, diagnoses, lab results, medications, treatment and claims information, and financial information. OCR alleges that PIH Health failed to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by PIH Health, and failed to provide timely notification of the breach. Under the terms of the settlement, PIH Health will implement a corrective action plan that will be monitored by OCR for two years and pay a $600,000 fine.
INTERNATIONAL LAWS & REGULATIONS
Cyberspace Administration of China Publishes Q&A on Cross-Border Data Transfers: The Cyberspace Administration of China (“CAC”) published a Q&A on cross-border data transfer policies and requirements for organizations. The Q&A is intended to provide guidance on government administrative policies. China’s regulations on cross-border data transfer require one of three mechanisms to be used if personal data or important data is transferred. Those mechanisms are a regulator-led security assessment, standard contractual clauses, and certification. The Q&A lists several common types of low risk data transfers that are not required to comply with one of the transfer mechanisms, including data related to international trade, cross-border transportation, academic collaborations, and cross-border manufacturing/sales if no important data or personal information is involved and nonsensitive personal information, totaling fewer than 100,000 individuals since 1 Jan. of the current year by noncritical information infrastructure operators. The Q&A also provides additional detail on assessing the necessity of personal data transfer and describes administrative processes available for obtaining clearance for data transfers on a company group basis, among other things.
ICO Releases Anonymization Guidance: The United Kingdom Information Commissioner’s Office (“ICO”) released new guidance on anonymizing personal data to assist organizations in identifying issues that should be considered to use anonymization techniques effectively. The guidance discusses what is meant by anonymization and pseudonymization, how such techniques affect data protection obligations, provides advice on good practices for anonymizing personal data, and discusses technical and organizational measures to mitigate risks to individuals when organizations anonymize data. Among other things, the guidance explains that anonymization is about reducing the likelihood of a person being identified or identifiable to a sufficiently remote level and that organizations should undertake identifiability risk assessments to determine the likelihood of identification when undertaking anonymization efforts, among other recommended accountability and governance measures. The guidance also includes case studies to assist users in understanding the guidance concepts.
Office of the Privacy Commissioner of Canada Releases Guidance on Risk Assessment in Data Breach; Canada Announces First Phase of Cybersecurity Certification Program: The Office of the Privacy Commissioner of Canada (“Privacy Commissioner”) released an online tool to assist organizations in conducting a breach risk self-assessment. The tool guides users through a series of details of the breach to assess whether the circumstances create a real risk of significant harm and is required to be reported. Separately, the Government of Canada announced the first phase in the implementation of the Canadian Program for Cyber Security Certification (“CPCSC”). The CPCSC will establish a cyber security standard for companies that handle sensitive unclassified government information in defense contracting. The Canadian government stated that the CPCSC will be released in phases, with the first phase involving the release of a new Canadian industrial cyber security standard, opening the accreditation process, and introducing a self-assessment tool for level 1 certification to help businesses better understand the program before a wider rollout of the program in successive phases.
NOYB Files Complaint Against ChatGPT over Defamatory Hallucinations: Privacy advocacy organization NOYB has filed a complaint against ChatGPT stemming from false information about an individual provided by ChatGPT in response to a query. Specifically, the complaint alleges that when Norwegian user Arve Hjalmar Holmen queried ChatGPT to determine if it had any information about him, ChatGPT presented the complainant as a convicted criminal who murdered two of his children and attempted to murder his third son. NOYB further alleges that the fake story included real elements of his personal life, including the actual number and the gender of his children and the name of his hometown. The NOYB complaint alleges that the output is not an isolated incident and violates the EU General Data Protection Regulation, including Article 5(1)(d), which requires organizations to ensure the personal data they produce about individuals is accurate.
ICO Fines Company for Lax Cybersecurity Following Ransomware Attack: The ICO announced it has fined Advanced Computer Software Group Ltd. (“Advanced”) £3.07 million for cybersecurity failures relating to a ransomware incident in August 2022. Advanced provides information technology services to businesses, including in the healthcare industry. Hackers had gained access to Advanced systems via a customer account that did not have multi-factor authentication, leading to the disruption of UK National Health Service (“NHS”) operations. The personal information on 79,404 people was exfiltrated in the attack, including details of how to enter the homes of 809 individuals receiving home care. The ICO investigation concluded that Advanced did not have appropriate technical and organizational measures in place to protect personal data prior to the incident. The ICO noted that it reduced the initially proposed fine due to Advanced’s proactive engagement with law enforcement, the NHS, and other steps taken by Advanced to mitigate the risk to impacted individuals.
Daniel R. Saeedi, Rachel L. Schaller, Gabrielle N. Ganze, Ana Tagvoryan, P. Gavin Eastgate, Timothy W. Dickens, Jason C. Hirsch, Adam J. Landy, Amanda M. Noonan, and Karen H. Shin also contributed to this article.
Paint It White: No Sovereign Immunity in Economic Espionage Case
The US Court of Appeals for the Ninth Circuit affirmed a district court’s denial of foreign sovereign immunity to a Chinese company accused of stealing trade secrets related to the production of proprietary metallurgy technology. United States v. Pangang Grp. Co., Ltd., Case No. 22-10058 (9th Cir. Apr. 29, 2025) (Wardlaw, Collins, Bress, JJ.)
Pangang is a manufacturer of steel, vanadium, and titanium. E.I. du Pont de Nemours (DuPont) had a proprietary chloride-route technology used for producing TiO₂, a valuable white pigment used in paints, plastics, and paper. Pangang allegedly conspired with others to obtain DuPont’s trade secrets related to TiO₂ production through economic espionage in order to use the stolen information to start a titanium production plant in China. The US government filed a criminal lawsuit.
In defense, Pangang invoked the Foreign Sovereign Immunities Act (FSIA) and federal common law, arguing that it was entitled to foreign sovereign immunity from criminal prosecution in the United States because it was ultimately owned and controlled by the government of the People’s Republic of China (PRC). In a prior appeal, the Ninth Circuit had found that Pangang failed to make a prima facie showing that it fell within the FSIA’s domain of covered entities. On remand, the district court again rejected Pangang’s remaining claims of foreign sovereign immunity, including its claims based on federal common law.
While the appeal was pending, the Supreme Court’s 2023 decision in Turkiye Halk Bankasi v. United States clarified that common law, not the FSIA, governs whether foreign states and their instrumentalities are entitled to foreign sovereign immunity from criminal prosecution in US courts. This led to a rebriefing of the present appeal to focus on the now-controlling issues concerning the extent to which Pangang enjoys foreign sovereign immunity under federal common law. Under federal common law, an entity must satisfy two conditions to enjoy foreign sovereign immunity from suit:
It must be the kind of entity eligible for immunity.
Its conduct must fall within the scope of the immunity conferred.
The Ninth Circuit concluded that Pangang did not make a prima facie showing that it exercised functions comparable to those of an agency of the PRC and therefore was not eligible for foreign sovereign immunity from criminal prosecution. The Court also found that “[t]he mere fact that a foreign state owns and controls a corporation is not sufficient to bring the corporation within the ambit of [sovereign immunity].” Since Pangang’s commercial activities were not governmental functions, there was no evidence that sovereign immunity should be applied. Therefore, the Ninth Circuit affirmed the district court’s denial of the motion to dismiss based on sovereign immunity.
ECHA Will Propose EU-Wide Restrictions on Certain Hexavalent Chromium Substances
The European Commission (EC) requested that the European Chemicals Agency (ECHA) assess the risks posed by certain hexavalent chromium substances. ECHA announced on April 29, 2025, that it has concluded that a European Union (EU)-wide restriction for hexavalent chromium substances is justified because the substances “are among the most potent workplace carcinogens and pose a serious risk to workers’ health.” ECHA states that it expects to begin a six-month public consultation on a ban on hexavalent chromium substances, except in the following use categories when defined limits for worker exposure and environmental emissions are met:
Formulation of mixtures;
Electroplating on plastic substrate;
Electroplating on metal substrate;
Use of primers and other slurries;
Other surface treatment; and
Functional additives/process aids.
ECHA states that this restriction could replace the current authorization requirements under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, ensuring that the risks associated with hexavalent chromium substances are effectively controlled once they are no longer subject to REACH authorization. ECHA notes that it included barium chromate in the scope of the restriction to avoid regrettable substitution.
ECHA states that stakeholders will have the opportunity to provide information during the six-month consultation, which is expected to start on June 18, 2025. ECHA plans to organize an online information session to explain the restriction process and help stakeholders take part in the consultation. ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will evaluate the restriction proposal and scientific evidence received during the consultation.
DFC to Play Critical Role in New U.S.-Ukraine Minerals Deal
On April 30, 2025, the United States and Ukraine signed an agreement (the “Agreement”) establishing a framework for the creation of the United States-Ukraine Reconstruction Investment Fund (the “Partnership”). The Partnership will be a joint natural resources and infrastructure investment fund between the U.S. and Ukraine. The U.S. International Development Finance Corporation (“DFC”) will play a critical role by serving as a limited partner of the Partnership alongside Ukraine’s State Organization Agency on Support of Public-Private Partnership. The Agreement does not identify the general partner.
The Agreement, by operation of its terms, provides the Partnership with preferential rights to participate in natural resources and public-private partnership projects and DFC (or DFC’s assignee) with preferential rights to negotiate offtake arrangements with respect to critical minerals projects. The U.S. and Ukraine are still in the process of finalizing the limited partnership agreement, which is expected to further clarify the operations of the Partnership. The key provisions of the Agreement, including capital contributions, investment rights, and offtake arrangements, are summarized below.
Capital Contributions
Ukraine will contribute to the Partnership 50% of the amounts received by Ukrainian governmental authorities for licenses, permits, and production sharing agreements relating to the exploration, extraction, and processing of “Natural Resources Relevant Assets.”[1]
The U.S. capital contribution to the Partnership will be increased by the assessed value of any new military assistance the U.S. provides to Ukraine in accordance with the limited partnership agreement.
The Agreement does not indicate how the Partnership will be initially capitalized.
Investment Opportunity Rights
Ukrainian governmental authorities responsible for licenses and permits relating to Natural Resources Relevant Assets and Ukrainian governmental authorities responsible for public-private partnership agreements and concessions must include in the relevant license, permit, or agreement, a provision requiring the recipient thereof to make “relevant investment information” available to the Partnership at any time the recipient is seeking to raise capital.
When the Partnership expresses formal interest in “participating” in one of these natural resources or infrastructure projects, the relevant Ukrainian governmental authority must include in the relevant license, permit, or agreement, provisions requiring the recipient thereof to grant to the Partnership a right similar to a right of first refusal. Specifically, the recipient must engage in good faith negotiations with the Partnership and refrain from granting to any third party materially more favorable economic terms than those offered to the Partnership.
The Agreement does not specify the precise nature of the Partnership’s participation in these projects and whether such participation may extend beyond direct investment.
Market-Based Offtake Rights
The Agreement provides a critical role for DFC, allowing DFC (or DFC’s assignee) to negotiate offtake rights in respect of projects involving Natural Resources Relevant Assets.
Specifically, the Agreement requires Ukrainian governmental authorities responsible for licenses or special permits relating to Natural Resources Relevant Assets to include in the relevant license or permit: (1) provisions allowing DFC (or DFC’s assignee) to negotiate offtake rights on market-based commercial terms, and (2) prohibiting the license or permit recipient from offering to any third party materially more favorable economic terms for offtake than those provided to DFC (or DFC’s assignee).
The Agreement provides a broad framework for U.S.-Ukraine cooperation in investing in critical minerals and infrastructure projects in Ukraine. DFC will play a critical role by serving as limited partner of the Partnership and by having the right to negotiate offtake arrangements for a wide array of natural resource projects in Ukraine. Further details regarding the limited partnership agreement and implementation of the Agreement are expected in the near future.
[1] The Agreement defines “Natural Resource Relevant Assets” as the sites, reserves, and deposits in the territory of Ukraine of aluminum, antimony, arsenic, barite, beryllium, bismuth, cerium, cesium, chromium, cobalt, copper, dysprosium, erbium, europium, fluorine, fluorspar, gadolinium, gallium, germanium, gold, graphite, hafnium, holmium, indium, iridium, lanthanum, lithium, lutetium, magnesium, manganese, neodymium, nickel, niobium, palladium, platinum, potash, praseodymium, rhodium, rubidium, ruthenium, samarium, scandium, tantalum, tellurium, terbium, thulium, tin, titanium, tungsten, uranium, vanadium, ytterbium, yttrium, zinc, zirconium, oil, natural gas (including liquified natural gas), and other minerals or hydrocarbons otherwise agreed by DFC and Ukraine’s State Organization Agency on Support of Public-Private Partnership.
China Issues the 2025 Intellectual Property Nation Building Promotion Plan To Accelerate the Construction of a Powerful Intellectual Property Country
On May 7, 2025, China’s National Intellectual Property Administration (CNIPA) published the 2025 Intellectual Property Nation Building Promotion Plan (2025年知识产权强国建设推进计划) authored by the Office of the Inter-ministerial Joint Conference on Building a Powerful National Intellectual Property Rights. The Plan lists the key tasks of 2025 to “accelerate the construction of a powerful intellectual property country.” Some of the key tasks including revising various laws and regulations, including the Trademark Law and issuing new guidelines, such as the Guidelines on Standard-Related Patent Policy.
A translation follows. The original text is available here (Chinese only).
This plan is formulated to implement the Outline for Building a Powerful Intellectual Property Country (2021-2035) (hereinafter referred to as the Outline) issued by the CPC Central Committee and the State Council and the National Intellectual Property Protection and Utilization Plan for the 14th Five-Year Plan (hereinafter referred to as the Plan) issued by the State Council, deepen the implementation of the strategy of building a powerful intellectual property country, accelerate the construction of a powerful intellectual property country, and clarify the key tasks for 2025.
This plan is formulated to implement the Outline for Building a Powerful Intellectual Property Country (2021-2035) (hereinafter referred to as the Outline) issued by the CPC Central Committee and the State Council and the National Intellectual Property Protection and Utilization Plan for the 14th Five-Year Plan (hereinafter referred to as the Plan) issued by the State Council, deepen the implementation of the strategy of building a powerful intellectual property country, accelerate the construction of a powerful intellectual property country, clarify the key tasks for 2025.
I. Improve the intellectual property system(I) Improve intellectual property laws, regulations and rules1. Accelerate the revision of the Trademark Law of the People’s Republic of China and the Regulations on the Protection of Integrated Circuit Layout Designs. (The National Intellectual Property Administration and the Ministry of Justice are responsible)2. Accelerate the revision of the Regulations on the Implementation of the Copyright Law of the People’s Republic of China and the Regulations on Collective Management of Copyrights, accelerate the revision of the Trial Measures for Voluntary Registration of Works, and promote the formulation of the Regulations on the Protection of Copyright of Folk Literature and Art Works. (The Central Propaganda Department and the Ministry of Justice are responsible)3. Promote the revision of the Regulations on the Protection of New Plant Varieties of the People’s Republic of China. (The Ministry of Agriculture and Rural Affairs, the National Forestry and Grassland Administration, and the Ministry of Justice are responsible)4. Study and demonstrate the Regulations on the Management of Access to Biological Genetic Resources and Benefit Sharing. (The Ministry of Ecology and Environment is responsible)5. Promote the revision of the Regulations of the People’s Republic of China on Customs Protection of Intellectual Property Rights. (General Administration of Customs is responsible)6. Promote the legislative process of the Regulations on the Protection of Traditional Chinese Medicine Knowledge. (State Administration of Traditional Chinese Medicine, National Health Commission, National Intellectual Property Administration is responsible)7. Promote the revision of the Regulations on National Defense Patents. (Equipment Development Department of the Central Military Commission, State Administration of Science, Technology and Industry for National Defense is responsible)8. Revise and issue the Regulations on the Protection of Trade Secrets. (State Administration for Market Regulation is responsible)9. Promote the revision of relevant judicial interpretations of the Trademark Law and Copyright Law. (Supreme People’s Court is responsible)
(II) Reform and improve major intellectual property policies10. Open up the entire chain of intellectual property creation, application, protection, management and service, and promote the establishment of an efficient comprehensive intellectual property management system. (National Intellectual Property Administration and relevant member units of the Joint Conference are responsible)11. Do a good job in the preparation of the “15th Five-Year Plan” intellectual property planning. (National Intellectual Property Administration and relevant member units of the Joint Conference are responsible)12. Promote the implementation of the “Reform Plan for the Division of Financial Powers and Expenditure Responsibilities between the Central and Local Governments in the Field of Intellectual Property”. (Ministry of Finance, National Intellectual Property Administration, Central Propaganda Department and other departments are responsible)13. Study and summarize the results of the World Bank’s business environment assessment, and issue and implement the “Opinions on Further Optimizing the Business Environment in the Intellectual Property Field”. (The National Intellectual Property Administration, the Central Propaganda Department, the National Development and Reform Commission, the Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Administration for Market Regulation, and the Chinese Academy of Sciences are responsible)14. Formulate the “Guiding Opinions on Accelerating the High-quality Development of Copyright Work”. (The Central Propaganda Department is responsible)15. Formulate and issue the “Guidelines on Standard-related Patent Policy”. (The State Administration for Market Regulation and the National Intellectual Property Administration are responsible according to their respective duties)16. Formulate high-quality policy documents to promote the rapid and coordinated protection of intellectual property rights, study and issue guiding opinions on strengthening the arbitration of intellectual property disputes, and formulate guidelines for administrative adjudication and mediation of patent disputes. (The National Intellectual Property Administration and the Ministry of Justice are responsible)17. Study and formulate opinions on strengthening the protection of trade secrets. (The State Administration for Market Regulation is responsible)18. Formulate and issue the “Opinions on Strengthening the Intellectual Property Protection Work of Public Security Organs”. (The Ministry of Public Security is responsible)19. Accelerate the promotion of the “Measures for the Identification of Synthetic Content Generated by Artificial Intelligence” and the issuance of supporting mandatory national standards. (The Central Cyberspace Affairs Commission and the Ministry of Public Security are responsible)20. Issue and implement the “Implementation Plan for Major Biodiversity Conservation Projects (2025-2030)”. (Ministry of Ecology and Environment is responsible)
(III) Improve intellectual property rules in emerging and specific fields 21. Accelerate the research and construction of data intellectual property protection rules. (National Intellectual Property Administration and Ministry of Industry and Information Technology are responsible)22. Carry out the revision of the “Patent Examination Guidelines” and improve the patent examination standards for new fields and new formats. (National Intellectual Property Administration is responsible)23. Explore and improve the intellectual property protection rules for new fields and new formats such as big data, artificial intelligence, and blockchain. Improve the intellectual property protection rules in the Internet field. (The Central Propaganda Department, the Central Cyberspace Affairs Commission, the Supreme People’s Court, the Ministry of Industry and Information Technology, the State Administration for Market Regulation, and the National Intellectual Property Administration are responsible for their respective duties)24. Accelerate the improvement of judicial judgment rules for intellectual property rights in new technologies, new fields, and new formats, and judgment rules for e-commerce platform competition cases, and explore judicial rules for big data competition protection. (Supreme People’s Court is responsible)25. Support the free trade pilot zones to connect with international high-standard economic and trade rules, carry out pilot projects first, and replicate and promote them to a larger scale. (The Central Propaganda Department, the Ministry of Commerce, and the National Intellectual Property Administration are responsible according to their respective duties)26. Explore the copyright protection of traditional culture and traditional knowledge, and improve the copyright protection mechanism of sports events, variety shows, e-commerce platforms, and search engines. (The Central Propaganda Department is responsible)27. Actively explore the application of technologies such as artificial intelligence and blockchain in the confirmation, use, and protection of copyright in the fields of radio, television, and online audio-visual, and strengthen the development of blockchain application standards and related standards in the fields of radio, television, and online audio-visual. (The Ministry of Industry and Information Technology and the State Administration of Radio, Film, and Television are responsible according to their respective duties)28. Study and formulate guiding opinions on strengthening intellectual property work in the fields of culture and tourism. (The Ministry of Culture and Tourism, the Central Propaganda Department, the State Administration for Market Regulation, and the National Intellectual Property Administration are responsible)29. Continue to promote the construction of a database for the protection of traditional Chinese medicine knowledge and the publication of a list.(The State Administration of Traditional Chinese Medicine is responsible)
II. Strengthen intellectual property protection(I) Strengthen judicial protection of intellectual property30. Issue the “Opinions of the Supreme People’s Court on Serving and Safeguarding Scientific and Technological Innovation with High-quality Trials” and publish typical cases. (The Supreme People’s Court is responsible)31. Improve the national level intellectual property case appeal mechanism and strengthen the construction of a professional trial system. (The Supreme People’s Court is responsible)32. Adhere to strict protection, improve and fully implement the punitive compensation system for infringement. Strengthen the overall coordination of batch litigation and increase the crackdown on manufacturers and other sources of infringement. (The Supreme People’s Court is responsible)33. Formulate the “Interpretation on Several Issues Concerning the Application of Laws in Handling Criminal Cases of Intellectual Property Infringement”. (The Supreme People’s Court and the Supreme People’s Procuratorate are responsible)34. Deepen the comprehensive performance of intellectual property prosecution and further promote the professionalization of intellectual property prosecution. (The Supreme People’s Procuratorate is responsible)35. Formulate the “Management Measures for Technical Investigators of the Intellectual Property Procuratorate Office of the Supreme People’s Procuratorate” and improve the system of intellectual property prosecution professionals assisting in case handling. (The Supreme People’s Procuratorate is responsible)36. Regularly carry out supervision of malicious intellectual property litigation and publish typical cases of intellectual property prosecution protection. (The Supreme People’s Procuratorate is responsible)37. Organize and carry out special projects such as “Kunlun-2025” and “Anxin” to continue to crack down on intellectual property infringement crimes with high pressure. (The Ministry of Public Security is responsible)
(II) Strengthen administrative protection of intellectual property38. Carry out the “Sword Net 2025” special action to combat online infringement and piracy, and carry out special work on youth copyright protection and cinema film copyright protection. (The Central Propaganda Department, the Central Cyberspace Affairs Commission, the Ministry of Industry and Information Technology, the Ministry of Public Security, and the Ministry of Culture and Tourism are responsible for their respective duties)39. Carry out in-depth special law enforcement actions to “protect intellectual property rights”. Promote the pilot work of full-chain law enforcement of intellectual property rights. (The State Administration for Market Regulation is responsible)40. Organize and carry out market competition status assessments in key areas, and strengthen anti-monopoly supervision of standard essential patents, patent pools, etc. in key areas such as information and communications before, during, and after the whole chain. (The State Administration for Market Regulation is responsible)41. Deepen the national pilot work on trade secret protection innovation and form institutional results that can be replicated and promoted. Organize and carry out the third “Enterprise Trade Secret Protection Capacity Improvement Service Month” activity. (The State Administration for Market Regulation is responsible)42. Strengthen the construction of geographical indication review capabilities. Promote the construction of national geographical indication protection demonstration areas with high standards, and implement the geographical indication protection project in depth. (The State Intellectual Property Office is responsible)43. Continue to clean up and rectify infringement, counterfeiting, illegal and irregular information, urge websites and platforms to fulfill their main responsibilities, and improve the ability to review content related to intellectual property rights. (The Central Propaganda Department and the Central Cyberspace Affairs Commission are responsible according to their respective responsibilities)44. Improve the early resolution mechanism for pharmaceutical patent disputes. (The National Intellectual Property Administration and the State Food and Drug Administration are responsible according to their respective responsibilities)45. Continue to strengthen the protection of seed industry intellectual property rights, and severely crack down on counterfeiting, counterfeiting, infringement and other illegal acts. Strengthen the construction of technical support capabilities, improve the DNA molecular fingerprint database, and promote the implementation of variety ID card management. (The Ministry of Agriculture and Rural Affairs is responsible)46. Organize and carry out special actions for customs protection of intellectual property rights, and accelerate the construction of customs smart intellectual property business scenarios. (The General Administration of Customs is responsible)47. Continue to consolidate the results of software legalization work and carry out software legalization supervision work. (The Central Propaganda Department, the Ministry of Industry and Information Technology, the State Administration of State Administration and other units are responsible according to their respective responsibilities)48. Strengthen intellectual property protection in the field of intangible cultural heritage. (The Ministry of Culture and Tourism is responsible)
(III) Improve the pattern of coordinated protection of intellectual property rights49. Strengthen the connection between administrative law enforcement and judicial protection and cross-departmental and cross-regional law enforcement cooperation. (The Central Propaganda Department, the Supreme People’s Court, the Supreme People’s Procuratorate, the Ministry of Public Security, the Ministry of Agriculture and Rural Affairs, the Ministry of Culture and Tourism, the General Administration of Customs, the State Administration for Market Regulation, the National Intellectual Property Administration, and the National Forestry and Grassland Administration are responsible for their respective duties)50. Implement the intellectual property protection system construction project, guide the construction of intellectual property protection highlands, and optimize the layout of national intellectual property protection centers and rapid rights protection centers. (The National Intellectual Property Administration is responsible)51. Promote the construction of a national pilot project for the standardization of administrative adjudication of patent infringement disputes. (The National Intellectual Property Administration and the Ministry of Justice are responsible)52. Promote the establishment of an efficient foreign-related intellectual property protection work mechanism, improve the overseas dispute response guidance work system, and set up a number of overseas intellectual property dispute response guidance sub-centers. (The National Intellectual Property Administration, the Central Propaganda Department, the Ministry of Commerce, and the China Council for the Promotion of International Trade are responsible)53. Continue to promote the diversified resolution of intellectual property disputes, strengthen the construction of intellectual property dispute mediation organizations and arbitration institutions, and improve the docking mechanism between intellectual property administrative law enforcement and arbitration and mediation. (The Central Propaganda Department, the Supreme People’s Court, the Ministry of Justice, the National Intellectual Property Administration, and the China Council for the Promotion of International Trade are responsible according to their respective duties)54. Manage the transfer of intellectual property rights involving national security in accordance with the law, and study and formulate guidelines for the review of the transfer of patent rights in technology exports. (The Central Propaganda Department, the Ministry of Science and Technology, the Ministry of Agriculture and Rural Affairs, the Ministry of Commerce, the National Intellectual Property Administration, and the National Forestry and Grassland Administration are responsible according to their respective duties)55. Improve the credit supervision system in the field of intellectual property rights in accordance with the law, and strengthen the collection and sharing of relevant credit information in the field of intellectual property rights. (The Central Propaganda Department, the National Development and Reform Commission, the People’s Bank of China, the State Administration for Market Regulation, and the National Intellectual Property Administration are responsible according to their respective duties)56. Promote the political and legal organs to crack down on crimes involving intellectual property protection in accordance with the law, and investigate and deal with infringements in accordance with the law. (The Central Political and Legal Affairs Commission is responsible)
III. Improve the operation mechanism of the intellectual property market(I) Improve the quality of intellectual property creation57. Promote the improvement of the quality of patent applications, improve the quality-oriented indicator system and evaluation system, and establish a pre-patent application evaluation system with industrialization prospect analysis as the core. (The Ministry of Education, the Ministry of Science and Technology, the National Intellectual Property Administration, and the Chinese Academy of Sciences are responsible according to their respective duties)58. Continue to improve the quality and efficiency of patent and trademark examinations, optimize resource allocation, meet the examination needs of key areas, and steadily promote the application of multimodal large model technology in examination work. Deepen the reform of the trademark examination and approval mechanism, and launch a new generation of trademark examination system. (The State Intellectual Property Office is responsible)59. Study and promote the construction of a unified national copyright registration mechanism for works, standardize the standards and processes for copyright registration and examination of works, enhance the informatization level of copyright registration of works, and continuously improve the quality of copyright registration of works. (The Central Propaganda Department is responsible)60. Improve the work system of intellectual property rights to support key core technology research and development, deepen the patent navigation in key areas, and strengthen the creation and layout of high-value patents. (The State Intellectual Property Office, the Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State-owned Assets Supervision and Administration Commission of the State Council, and the Chinese Academy of Sciences are responsible)61. Study and improve the supporting system for intellectual property management of national science and technology plan projects, and do a good job in intellectual property management of national key R&D plan projects. (The Ministry of Science and Technology and the competent departments of each project are responsible according to their respective responsibilities)62. Optimize the acceptance and examination process of new plant variety rights, improve the online application and examination system, and improve the efficiency of authorization. (The Ministry of Agriculture and Rural Affairs and the National Forestry and Grassland Administration are responsible according to their respective responsibilities)
(II) Strengthen the transformation and application of intellectual property rights63. Deeply implement the special action of patent transformation and application. On the basis of the previous review and inventory of existing patents, strengthen data sharing among departments, strengthen the precise connection between supply and demand, continue to activate the existing stock, optimize the incremental stock, promote the strengthening and efficiency of intellectual property rights in key industries, summarize experience and practices, and form a long-term mechanism. (The Ministry of Education, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Ministry of Agriculture and Rural Affairs, the National Health Commission, the State-owned Assets Supervision and Administration Commission of the State Council, the National Intellectual Property Administration, and the Chinese Academy of Sciences are responsible for their respective duties)64. Vigorously cultivate and develop patent-intensive industries and copyright industries. Carry out the accounting and publication of the added value of patent-intensive industries. Conduct a survey on the contribution of copyright industries to the national economy. (The National Bureau of Statistics, the National Intellectual Property Administration, and the Central Propaganda Department are responsible for their respective duties)65. Promote the construction of key industry intellectual property innovation consortiums, key field patent pools, and intellectual property operation centers in an integrated manner, and create a model for patent industrialization to promote the growth of small and medium-sized enterprises. Accelerate the high-quality development of the science and technology service industry, cultivate and expand high-level science and technology service institutions, create a national unified technology transaction service platform, accelerate the transformation and industrialization of scientific and technological achievements, and help small and medium-sized enterprises innovate and develop. (National Intellectual Property Administration and Ministry of Industry and Information Technology are responsible)66. Deepen the reform of intellectual property rights distribution, study and promote the pilot experience of the reform of empowering the rights of scientific and technological achievements in official positions and the reform of separate asset management, and promote the establishment of a due diligence exemption mechanism. (Ministry of Education, Ministry of Science and Technology, Ministry of Finance, State-owned Assets Supervision and Administration Commission of the State Council, National Intellectual Property Administration, and Chinese Academy of Sciences are responsible according to their respective duties)67. Promote the implementation of the declaration system for the formation of intellectual property rights in financially funded scientific research projects. (National Intellectual Property Administration, Central Propaganda Department, Ministry of Science and Technology, Ministry of Finance, National Natural Science Foundation of China, State Administration of Science, Technology and Industry for National Defense, and Equipment Development Department of the Central Military Commission are responsible)68. Promote the construction of a “center + node” university scientific and technological achievement transformation system with the national university regional technology transfer and transformation center as the hub and the national university science and technology park as the node, build a “full chain” public transformation platform, and strengthen the construction of intellectual property professional service teams. (Ministry of Education is responsible)69. Deepen the implementation of the patent open licensing system and promote more scientific and technological achievements from laboratories to the industrial chain. (National Intellectual Property Administration, Ministry of Education, Ministry of Industry and Information Technology, and Chinese Academy of Sciences are responsible)70. Dynamically optimize the patent ranking index system of central enterprises, and guide central enterprises to strengthen the creation, application and protection of high-value patents. Encourage central enterprises to strengthen industry-university-research cooperation, and cultivate high-value patents through innovation alliances and other means. (SASAC and the State Intellectual Property Office are responsible)71. Vigorously implement the trademark brand strategy, and deepen the action of geographical indications to help rural revitalization. (The State Intellectual Property Office is responsible)72. Promote the quality grading of agricultural products with geographical indications and promote quality improvement. (The Ministry of Agriculture and Rural Affairs is responsible)73. Continue to carry out pilot work on the protection and promotion of folk art copyrights. (The Central Propaganda Department is responsible)74. Accelerate the implementation of the substantial derivative variety system, formulate guidelines for the determination of substantial derivative varieties and the first batch of substantial derivative variety system catalogs, and preliminarily select a batch of appraisal institutions. (The Ministry of Agriculture and Rural Affairs and the National Forestry and Grassland Administration are responsible according to the division of responsibilities)75. Continue to promote the implementation of intellectual property standards by units affiliated to the Chinese Academy of Sciences. (The Chinese Academy of Sciences is responsible)76. Promote the construction of intellectual property service export bases. (The Central Propaganda Department, the Ministry of Commerce, and the National Intellectual Property Administration are responsible for their respective duties)
(III) Promote the market-oriented operation of intellectual property77. Actively and steadily develop intellectual property finance, give full play to the role of the national intellectual property pledge information platform, and coordinate the promotion of intellectual property pledge financing, securitization, and insurance. (The Central Propaganda Department, the National Development and Reform Commission, the People’s Bank of China, the Financial Regulatory Commission, the China Securities Regulatory Commission, and the National Intellectual Property Administration are responsible for their respective duties)78. Gradually expand the internal evaluation pilot of intellectual property pledge financing and improve the level of convenience for intellectual property pledge registration. Guide local governments to increase support for intellectual property financing guarantees. (The Central Propaganda Department, the People’s Bank of China, the Financial Regulatory Commission, and the National Intellectual Property Administration are responsible for their respective duties)79. Encourage insurance companies to optimize intellectual property insurance products and services and focus on developing insurance products related to international trade intellectual property protection. (The Central Propaganda Department, the Financial Regulatory Commission, and the National Intellectual Property Administration are responsible for their respective duties)80. Improve the supervision system for intellectual property asset securitization business, guide exchanges to innovate intellectual property asset securitization models, and encourage technology-based enterprises to carry out financing through intellectual property asset securitization. (The China Securities Regulatory Commission, the Central Propaganda Department, and the National Intellectual Property Administration are responsible)81. Promote the benefit of new varieties of forest and grassland plants to farmers and pledge financing of variety rights. (National Forestry and Grassland Administration, People’s Bank of China)
IV. Improve the efficiency of intellectual property services(I) Strengthen the supply of intellectual property public services82. Deeply implement the intellectual property public service benefit project, and solidly promote the pilot of intellectual property public service standardization. Establish and improve the “good and bad review” system for intellectual property government services. (National Intellectual Property Administration)83. Promote the establishment of an intellectual property public service work mechanism to support the key core technology research in key areas. (National Intellectual Property Administration)84. Study and formulate the “Guidelines for the Analysis and Utilization of Intellectual Property Information”. (National Intellectual Property Administration)85. Launch the national intellectual property protection information platform, explore the construction of a national integrated intellectual property digital public service platform, support the construction of an independent and controllable intellectual property database, and expand the open sharing of basic data. (National Intellectual Property Administration)86. Promote the connection and application of intellectual property-related public service platforms with the national network identity authentication public service platform to strengthen user information security. (National Intellectual Property Administration, Ministry of Public Security)87. Optimize the service application scenarios of grassroots organizations of the patent information resource system and empower grassroots intellectual property services. (China Association for Science and Technology is responsible)
(II) Promote the development of intellectual property services88. Comprehensively strengthen the supervision of the intellectual property agency industry, strengthen the comprehensive governance of the industry, and improve the professional capabilities and level of intellectual property service institutions. (National Intellectual Property Administration is responsible)89. Accelerate the formation of a standard system for the intellectual property service industry, promote the construction of intellectual property service industry clusters, and establish a regional cooperation and assistance mechanism for the intellectual property service industry. (National Intellectual Property Administration is responsible)90. Promote the use of the “Patent and Trademark Agency Service Government Procurement Demand Standard (Trial)”. (Ministry of Finance and National Intellectual Property Administration are responsible)91. Strengthen and improve the supervision of copyright collective management organizations, guide copyright collective management organizations to expand their business, and encourage copyright collective management organizations to cooperate with relevant industry associations. Promote the standardization of certification work by overseas copyright certification agencies. (Central Propaganda Department is responsible)
V. Create a good intellectual property humanistic and social environment(I) Vigorously advocate intellectual property cultural concepts92. Organize and hold large-scale activities such as World Intellectual Property Day, National Intellectual Property Promotion Week, China International Copyright Expo, International Copyright Forum, and China Brand Day. We will do a good job in building a strong country in intellectual property rights and publicize the achievements of intellectual property development during the 14th Five-Year Plan period. We will strengthen external publicity of intellectual property rights through platforms such as the China International Import Expo and the China International Fair for Trade in Services, and tell the story of Chinese intellectual property rights well. (The Central Propaganda Department, the Central Cyberspace Affairs Commission, the Ministry of Foreign Affairs, the National Development and Reform Commission, the Ministry of Commerce, the State-owned Assets Supervision and Administration Commission of the State Council, the State Administration for Market Regulation, the State Administration of Radio, Film and Television, the National Intellectual Property Administration, and the China Council for the Promotion of International Trade are responsible for their respective duties)93. Organize activities related to the 40th anniversary of the implementation of the Patent Law of the People’s Republic of China. (The National Intellectual Property Administration is responsible)94. Promote the implementation of the “whoever enforces the law shall popularize the law” responsibility system in all regions and relevant departments, and strengthen the publicity of intellectual property law. Strengthen the use of new media and new technologies, and actively carry out popularization of law through cases in China’s popularization of law “one network, two microblogs, and one terminal”. (The Ministry of Justice is responsible)95. Make full use of important time nodes such as the National Science Popularization Month, the National Science and Technology Activity Week, and the National Intellectual Property Promotion Week to carry out intellectual property science popularization activities. Relying on the China Science Popularization Information Platform, strengthen the all-media dissemination of intellectual property science popularization resources. (The Ministry of Science and Technology and the China Association for Science and Technology are responsible)96. Carry out a series of publicity activities on customs protection of intellectual property rights, and release the status of intellectual property protection in China’s customs in 2024. Optimize the functional layout of the customs intellectual property protection exhibition center, and create an “Internet +” intellectual property customs protection publicity position. (The General Administration of Customs is responsible)
(II) Lay a solid foundation for the development of intellectual property rights97. Increase the training of intellectual property administrative personnel and build a high-quality professional cadre talent team. (The Central Propaganda Department and the National Intellectual Property Administration are responsible according to their respective duties)98. Deepen the implementation of the professional and technical personnel knowledge update project, and increase the training of high-level professional and technical personnel in the field of intellectual property rights. Improve the intellectual property talent evaluation system and the professional title evaluation method for intellectual property professionals. (The Central Propaganda Department, the Ministry of Human Resources and Social Security, and the National Intellectual Property Administration are responsible according to their respective duties)99. Vigorously cultivate international talents such as foreign-related intellectual property lawyers. (The Ministry of Justice and the National Intellectual Property Administration are responsible according to their respective duties)100. Promote the construction of intellectual property professional degrees and related disciplines in colleges and universities, do a good job in the construction of the co-construction of intellectual property colleges, and strengthen the collaborative training of intellectual property talents. (The Ministry of Education, the National Intellectual Property Administration, and the Central Propaganda Department are responsible according to their respective duties)101. Strengthen the construction of technical managers, expand the scale of training, improve the quality of training, and promote the transformation and industrialization of scientific and technological achievements. (Ministry of Industry and Information Technology, Ministry of Science and Technology)102. Promote the construction of intellectual property think tanks and strengthen research on major theoretical and practical issues. (Central Propaganda Department, Supreme People’s Court, Ministry of Education, National Intellectual Property Administration, Chinese Academy of Sciences are responsible according to their respective duties)
VI. Deeply participate in global intellectual property governance103. Carry out consultations in various fields under the framework of the World Intellectual Property Organization, promote the formulation of international rules for intellectual property in new fields and new formats, and promote the inclusion of Chinese language consultations in the Madrid system. (National Intellectual Property Administration, Central Propaganda Department, Ministry of Foreign Affairs, Ministry of Justice)104. Organize the 2025 series of cooperation directors’ meetings of the five intellectual property offices of China, the United States, Europe, Japan and South Korea, and jointly hold related activities for the 40th anniversary of cooperation between the China-EU Intellectual Property Offices. (National Intellectual Property Administration)105. Actively participate in discussions on relevant issues under multilateral platforms such as the WTO and APEC, deepen bilateral exchanges and cooperation on intellectual property rights with trading partners such as the EU, Japan, Russia, and Switzerland in the economic and trade fields, and actively promote negotiations on intellectual property rights issues in free trade agreements and the entry into force of the second batch of product lists of the China-EU Geographical Indications Agreement. (Ministry of Commerce, Central Propaganda Department, and National Intellectual Property Administration are responsible)106. Promote the deepening and implementation of the “Belt and Road” intellectual property cooperation, and implement the results of the third “Belt and Road” intellectual property high-level meeting. Hold the 2025 China-ASEAN Intellectual Property Office Directors’ Meeting, promote the improvement of the BRICS intellectual property cooperation mechanism, and support the holding of the second China-Central Asia Intellectual Property Office Directors’ Meeting. (National Intellectual Property Administration, Central Propaganda Department, and Ministry of Foreign Affairs are responsible)107. Promote substantive consultations on international treaties such as the Treaty on the Protection of Broadcasting Organizations and the Treaty on the Protection of Traditional Cultural Expressions. Do a good job in the implementation of key international copyright treaties such as the Beijing Treaty on Audiovisual Performances and the Marrakesh Treaty. (Central Propaganda Department and State Administration of Radio, Film and Television are responsible according to their respective duties)108. Seriously implement the International Convention for the Protection of New Varieties of Plants, deepen multilateral and bilateral technical exchanges and cooperation, and participate in the formulation of relevant international standards. (The Ministry of Agriculture and Rural Affairs, the National Intellectual Property Administration, and the National Forestry and Grassland Administration are responsible for their respective duties)109. Relying on the multilateral and bilateral law enforcement cooperation mechanism, strengthen communication and cooperation with foreign law enforcement departments around key transnational infringement and counterfeiting criminal cases. Give full play to the main channel role of Interpol and actively participate in joint law enforcement actions organized by it. (The Ministry of Public Security is responsible)110. Actively participate in international intellectual property affairs under multilateral frameworks such as the World Customs Organization, and promote the establishment of multilateral and regional cooperation mechanisms. (The General Administration of Customs is responsible)111. Strengthen the construction of overseas intellectual property information service platforms, release early warning information in a timely manner, provide services to enterprises in key areas and key links, and do a good job in risk investigation and rights protection guidance. (The Central Propaganda Department, the Ministry of Commerce, the National Intellectual Property Administration, and the China Council for the Promotion of International Trade are responsible for their respective duties)112. Carry out the establishment of training projects in the field of intellectual property and promote human resources development cooperation in the field of intellectual property. (The Central Propaganda Department, the National Intellectual Property Administration, and the National International Development Cooperation Agency are responsible for their respective duties)113. Prepare for the 2025 Global Business Rule of Law Conference and strengthen exchanges and cooperation with non-governmental international intellectual property organizations. (China Council for the Promotion of International Trade is responsible)
VII. Strengthen organizational guarantees114. Carry out a five-year summary and evaluation of the Outline and the Plan, strengthen statistical monitoring of indicator data, and supervise and inspect the implementation of work tasks. (Joint Conference Office and member units of the Joint Conference are responsible)115. Collect and promote the fourth batch of typical cases for the construction of a strong intellectual property country. (Joint Conference Office is responsible)116. Give full play to the role of the Expert Advisory Committee for the Construction of a Strong Intellectual Property Country and the National Intellectual Property Strategy Implementation Research Base, and strengthen policy consultation and research support. (Joint Conference Office is responsible)117. Implement tax and fee support policies to support scientific and technological innovation and encourage enterprises to increase their own investment in scientific and technological innovation. (The Ministry of Finance and the State Administration of Taxation are responsible according to their respective duties)118. Prepare and publish the annual development report on the construction of a strong intellectual property country. (Joint Conference Office is responsible)In the above-mentioned division of labor, if multiple departments are responsible, the department listed first is the leading department, and the others are participating departments.
European Union Adopts 16th Package of Sanctions Against Russia
In a bid to further increase the pressure on Russia, the Council of the European Union has adopted additional measures which have been introduced in its 16th sanctions package. The new measures amending the framework Council Regulation (EU) 833/2014 are found and included in Council Regulation (EU) 2025/395 (EU’s 16th Package). They target systemically important sectors of the Russian economy, including energy, trade, transport, infrastructure and financial services.
Additional Listings
An additional 48 individuals and 35 entities have been targeted by asset freezes and travel bans. The EU’s 16th Package adds new criteria for listing individuals and entities that are part of support or benefit from Russia’s military-industrial complex. This is in addition to any entities or individuals who are active in sanctions circumvention, maritime or Russian crypto assets exchanges.
Anti-Circumvention Measures
An additional 74 vessels, bringing the total number of listed vessels to 153, have been added. These vessels are part of the shadow fleet or contribute to Russia’s energy revenues.
Trade Measures
Ban on Primary Aluminium Imports
The EU’s 16th Package also adopts further restrictions on the trade of goods and services. An aluminium import ban on EU imports of primary aluminium from Russia has been included. The exception to this is that it includes a “phase-in period” permitting the import of 275,000 tons over a 12-month period.
Export Bans
Export restrictions have been added which target 53 new companies, which include 34 companies outside of Russia and which support Russia’s military-industrial complex.
Dual-use export restrictions have been extended to additional items in order to cut Russia’s access to key technologies, including the following:
Dual-use chemical precursors to produce chloropicrin and other riot control agents used as chemical weapons by Russia in violation of the Chemical Weapons Convention.
Software related to computer numerical control machine tools used to manufacture weapons and video game controllers used by the Russian army to pilot drones on the battlefield.
Chromium ores and compounds due to their military applications.
Additional export restrictions on industrial goods, such as steel products, fireworks and certain minerals and chemicals, have been included.
Energy Measures
The EU’s 16th Package prohibits temporary storage or the placement under free zone procedures of Russian crude oil or petroleum products in EU ports, which was, until now, allowed if the oil complied with the price cap and went to a third country. This prohibition will inflict additional costs on the transport of Russian oil.
The package extends the prohibition to provide goods, technology and services for the completion of Russian liquefied natural gas projects to also crude oil projects in Russia, such as the Vostok oil project.
The package extends the existing software ban to restrict the export, supply or provision of oil and gas exploration software, which includes drilling processes, geological inspections and reservoir calculations, to Russia.
Infrastructure Measures
With immediate effect, a full transaction ban on specific Russian infrastructures—ports and airports which are believed to have been used to transport combat-related goods and technology or to circumvent the oil price cap by transporting Russian crude oil via ships in the shadow fleet—have been included in this latest package as they contribute to Russia’s military efforts.
The restrictions are broadly drafted and will apply to any transactions with relevant ports and airports (as listed in Annex XLVII of the EU’s 16th Package), even if there is no direct transaction with the port authorities themselves.
Transport Measures
One of the most notable changes under Article 5ae of the EU’s 16th Package is the imposition of a full flight ban which provides for the possibility to list any third-country airline operating domestic flights within Russia or supplying, selling, transferring or exporting, directly or indirectly, aircraft or other aviation goods and technology to a Russia air carrier or for flights within Russia.
If listed in Annex XLVI of the EU’s 16th Package, these air carriers, as well as any entity owned or controlled by them, will not be allowed to land in, take off from or fly over EU territory.
The flight ban will not apply to the following:
• In the case of an emergency landing or an emerging overflight.• If such landing, take-off or overflight is required for humanitarian purposes.
Financial Measures
An additional 13 Russian banks and three non-Russian banks, namely Bank BelVEB, Belgazprombank and VTB Bank (PJSC) Shanghai Branch (due to their use of the system for Transfer of Financial Messages of the Central Bank of Russia), have been either disconnected from the Society for Worldwide Interbank Financial Telecommunication international payment system or subjected to a transaction ban, intensifying financial isolation of Russia.
The European Union has also extended a transaction ban to allow it to target financial institutions and crypto asset providers circumventing the oil price cap so as to further isolate Russia’s financial network.
Measures Against Disinformation
To combat media manipulation and distortion of events, further restrictive measures have been placed on broadcasting activities. Eight additional media outlets, namely EADaily, Fondsk, Lenta, NewsFront, RuBaltic, SouthFront, Strategic Culture Foundation and Krasnaya Zvezda, have had broadcasting suspended because they are under the permanent control of Russian leadership and participate in spreading misinformation and propaganda.
Concluding Remarks
These increased enforcement efforts and highlighted sanctions are not just symbolic but impactful. As the European Union strengthens its sanctions framework and expands enforcement efforts, businesses must proactively assess their compliance strategies to mitigate legal and operational risks.
From Blocks to Rights: Privacy and Blockchain in the Eyes of the EU data Protection Authorities
On April 14, 2025, the European Data Protection Board (EDPB) released guidelines detailing how to process personal data using blockchain technologies in compliance with the General Data Protection Regulation (GDPR) (Guidelines 02/2025 on processing of personal data through blockchain technologies). These guidelines highlight certain privacy challenges and provide practical recommendations.
Challenges Under the GDPR
Blockchain’s immutability conflicts with rights to data rectification and deletion (Articles 16 and 17 GDPR). Its decentralized nature makes it difficult to comply with GDPR principles like data minimization, storage limitation (Article 5) and data protection by design (Article 25). International data transfers are also complicated, prompting the EDPB to recommend using standard contractual clauses for node participation to ensure Chapter V compliance.
Key Recommendations for Organizations
In order to minimize risks and ensure GDPR compliant data processing when using blockchain, the EDPB establishes certain rules for organizations to follow.
Roles and Responsibilities
Roles must be clearly defined based on service nature, governance and relationships. The EDPB makes a special mention of nodes in public permissionless blockchains. Nodes in public blockchains may be considered data controllers. A legal entity (e.g., a consortium) is encouraged when nodes jointly determine processing purposes.
Technical and Organizational Measures
Organizations should assess:
Whether personal data will be stored
If so, why is the blockchain needed
The type of blockchain to be used (public only if necessary)
The adequate technical safeguards to be implemented
Public blockchains should be avoided unless essential. Personal data should only be identifiable if necessary and justified via a Data Protection Impact Assessment (DPIA). The techniques the EDPB suggests limiting the identifiability of the personal data include:
Encryption – Protects data, but remains personal under GDPR.
Hashing – Offers security, but risks remain if keys are compromised.
Cryptographic commitments – Securely obscure data when original inputs are deleted.
GDPR Principles and Data Subject Rights
Deletion and objection – Due to blockchain’s permanence, erasure may require deleting parts of the chain or anonymizing data. Off-chain storage of personal data is preferred.
Data retention – If data isn’t needed for the blockchain’s full life, it shouldn’t be stored on-chain unless anonymized.
Security – Suggested safeguards include emergency protocols, breach notifications and protections against 51% attacks and rogue participants.
Rectification – If rectification requires deletion, standard erasure methods apply. Otherwise, new transactions must correct prior data without altering old entries.
Automated decisions – Controllers must meet Article 22 GDPR requirements even if a smart contract has executed.
Next Steps
Public consultation is open until June 9, 2025. The final version is expected to remain largely consistent with the draft, offering essential guidance for GDPR-compliant blockchain use.
This article was co-authored by Damian Perez-Taboada
The European Commission’s Guidance on Prohibited AI Practices: Unraveling the AI Act
The European Commission published its long-awaited Guidelines on Prohibited AI Practices (CGPAIP) on February 4, 2025, two days after the AI Act’s articles on prohibited practices became applicable.
The good news is that in clarifying these prohibited practices (and those excluded from its material scope), the CGPAIP also addresses other more general aspects of the AI Act, which comes to provide much-needed legal certainty to all authorities, providers and deployers of AI systems/models in navigating the regulation.
It refines the scope of general concepts (such as “placing on the market”, “putting into service”, “provider” or ” deployer”) and exclusions from the scope of the AI Act, provides a definition of others not expressly included in the AI Act (such as “use”, “national security”, “purposely manipulative techniques” or “deceptive techniques”), as well as takes a position on the allocation of responsibilities of providers and deployers using a proportionate approach (establishing that these responsibilities should be assumed by whoever is best positioned in the value chain).
It also comments on the interplay of the AI Act with other EU laws, explaining that while the AI Act applies as lex specialis to other primary or secondary EU laws with respect to the regulation of AI systems, such as the General Data Protection Regulation (GDPR) or EU consumer protection and safety legislation, it is still possible that practices permitted under the AI Act are prohibited under those other laws. In other words, it confirms that the AI Act and these other EU laws complement each other.
However, this complementarity is likely to pose the greatest challenges to both providers and deployers of the systems. For example, while the European Data Protection Board (EDPB) has already clarified in its Opinion 28/2024 on certain data protection aspects related to the processing of personal data in the context of AI models (adopted in December 2024) that the “intended” purposes of AI models at the deployment stage must be taken into account when assessing whether the processing of personal data for the training of said AI models can be based on the legitimate interest of the providers and/or future deployers. The European Commission clarifies in Section 2.5.3 of the CGPAIP that the AI Act does not apply to research, testing (except in the real world) or development activities related to AI systems, or AI models before they are placed on the market or put into service (i.e. during the training stage). Similarly, the CGPAIP provides some examples of exclusions from prohibited practices (i.e., permitted practices) that are unlikely to find a lawful basis in the legitimate interests of providers and/or future users of the AI system.
The prohibited practices:
Subliminal, purposefully manipulative or deceptive techniques (Article 5(1)(a) and Article 5(1)(b) AI Act)This prohibited practice refers to subliminal, purposefully manipulative or deceptive techniques that are significantly harmful and materially influence the behavior of natural persons or group(s) of persons, or exploit vulnerabilities due to age, disability or a specific socio-economic situation.
The European Commission provides examples of subliminal techniques (visual and auditory subliminal messages, subvisual and subaudible queueing, embedded images, misdirection and temporal manipulation), as well as explains that the rapid development of related technologies, such as brain-computer interfaces or virtual reality, increases the risk of sophisticated subliminal manipulation.
When referring to purposefully manipulative techniques (to exploit cognitive biases, psychological vulnerabilities or other factors that make individuals or groups of individuals susceptible to influence), it clarifies that for the practice to be prohibited, either the provider or the deployer of the AI system must intend to cause significant (physical, psychological or financial/ economic) harm. While this is consistent with the cumulative nature of the elements contained in Article 5(1)(a) of the AI Act for the practice to be prohibited, it could be read as an indication that manipulation of an individual (beyond consciousness) where it is not intended to cause harm (for example, for the benefit of the end user or to be able to offer a better service) is permitted. The CGPAIP refers here to the concept of “lawful persuasion”, which operates within the bounds of transparency and respect for individual autonomy.
With respect to deceptive techniques, it explains that the obligation of the provider to label “deep fakes” and certain AI-generated text publications on matters of public interest, or the obligation of the provider to design the AI system in a way that allows individuals to understand that they are interacting with an AI system (Article 50(4) AI Act) are in addition to this prohibited practice, which has a much more limited scope.
In connection with the interplay of this prohibition with other regulations, in particular, with the DSA, the European Commission recognizes that dark patterns are an example of manipulative or deceptive technique when they are likely to cause significant harm.
It also provides that there should be a plausible/reasonably likely causal link between the potential material distortion of the behavior (significant reduction in the ability to make informed and autonomous decisions) and the subliminal, purposefully manipulative or deceptive technique deployed by the AI system.
Social scoring (Article 5(1)(c) AI Act)The CGPAIP defines social scoring as the evaluation or classification of individuals based on their social behavior, or personal or personality characteristics over a certain period of time, clarifying that a simple classification of people on said basis would trigger this prohibition and that the concept evaluation is inclusive of “profiling” (in particular to analyze and/or make predictions on interests or behaviors), that leads to detrimental or unfavorable treatment in unrelated social contexts, and/or unjustified or disproportionate treatment.
Concerning the requirement that it leads to detrimental or unfavorable treatment, it is established that such harm may be caused by the system in combination with other human assessments, but that at the same time, the AI system must play a relevant role in the assessment. It also provides that the practice is prohibited even if the detrimental or unfavorable treatment is produced by an organization different from the one that uses the score.
The European Commission states, however, that AI systems can lawfully generate social scores if they are used for a specific purpose within the original context of the data collection and provided that any negative consequences from the score are justified and proportionate to the severity of the social behavior.
Individual Risk Assessment and Prediction of Criminal Offences (Article 5(1)(d) AI Act)When interpreting this prohibited practice, the European Commission outlines that crime prediction and risk assessment practices as such are not outlawed, but only when the prediction of a natural person committing a crime is made solely on the basis of a profiling of said individual, or on assessing their personality traits and characteristics. In order to avoid circumvention of the prohibition and ensure its effectiveness, any other elements being taken into account in the risk assessment will have to be real, substantial and meaningful for them to be able to justify the conclusion that the prohibition does not apply (excluding therefore AI systems to support the human assessment based on objective and verifiable facts directly linked to a criminal activity, in particular when there is human intervention).
Untargeted Scraping of Facial Images (Article 5(1)(e) AI Act)The European Commission clarifies that the purpose of this prohibited practice is the creation or enhancement of facial recognition databases (a temporary, centralized or decentralized database that allows a human face from a digital image or video frame to be matched against a database of faces) using images obtained from the Internet or CCTV footage, and that it does not apply to any scraping AI system tool that can be used to create or enhance a facial recognition database, but only to untargeted scraping tools.
The prohibition does not apply to the untargeted scraping of biometric data other than facial images, or even if it is a database that is not used for the recognition of persons. For example to generate images of fictitious persons and clarifies that the use of databases created prior to the entry into force of the AI Act, which are not further expanded by AI-enabled untargeted scraping, must comply with applicable EU data protection rules.
Emotion Recognition (Article 5(1)(f) AI Act)This prohibition concerns AI systems that aim to infer the emotions (interpreted in a broad sense) of natural persons based on their biometric data and in the context of the workplace or educational and training institutions, except for medical or security reasons. Emotion recognition systems that do not fall under this prohibition are considered high-risk systems and deployers will have to inform the natural persons exposed thereto of the operation of the system as required by article 50(3) of the AI Act.
The European Commission refers here to certain clarifications contained in the AI Act regarding the scope of the concept of emotion or intention, which does not include, for example, physical states such as pain or fatigue, nor readily apparent expressions, gestures or movements unless they are used to identify or infer emotions or intentions. Therefore, a number of AI systems used for safety reasons would already not fall under this prohibition.
Similarly, the notions of workplace, educational and training establishments must be interpreted broadly. There is also room for member states to introduce regulations that are more favorable to workers with regard to the use of AI systems by employers.
It also clarifies that authorized therapeutic uses include the use of CE marked medical devices and that the notion of safety is limited to the protection of life and health and not to other interests such as property.
Biometric Categorization for certain “Sensitive” Characteristics (Article 5(1)(g) AI Act)This prohibition is for biometric categorization (except where purely ancillary to another commercial service and strictly necessary for objective technical reasons) that individually categorize natural persons on the basis of their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation.
The European Commission clarifies that this prohibition, however, does not cover the labelling or filtering of lawfully acquired biometric datasets (such as images), including for law enforcement purposes (for instance, to guarantee that data equally represents all demographic groups).
Real-time Remote Biometric Identification (RBI) Systems for Law Enforcement Purposes (Article 5(1)(h) AI Act)The European Commission devotes a substantial part of the CGPAIP to the development of this prohibited practice, which refers to the use of real-time RBI systems in publicly accessible areas for law enforcement purposes. Exceptions, based on the public interest, are to be determined by the member states, through local legislation.
The CGPAIP concludes with a final section on safeguards and conditions for the application of the exemptions to the prohibited practices, including the conduct of Fundamental Rights Impact Assessments (FRIAs), which are defined as assessments aimed at identifying the impact that certain high-risk AI systems, including RBI systems, may have on fundamental rights, and which, it is clarified, do not replace the existing Data Protection Impact Assessment (DPIA) that data controllers (i.e., those responsible for processing personal data) must conduct and have a broader scope (covering not only the fundamental right to data protection but also all other fundamental rights of individuals) and which complement, inter alia, the required DPIA, the registration of the system or the need for prior authorization.