Federal Circuit Confirms Calculation of PTE for Reissue Patents Under Regulatory Review
Highlights
Calculation of patent term extension for drug products under regulatory review is based on the issue date of the original patent, not the reissue patent (if there is one), a recent court ruling said
Calculation of PTE based on the original patent’s issue date is consistent with purpose and legislative intent of Hatch Waxman Act, which is to compensate for patent exclusivity lost while patented drug products are under regulatory review
Cancellation of claims covering drug products under regulatory review in a reissue patent will result in forfeiture of any patent term extension
In Merck Sharp & Dohme B.V. et al. v. Aurobindo Pharma USA, Inc. et al, the U.S. Court of Appeals for the Federal Circuit addressed the narrow question of whether patent term extensions (PTE) for patents covering drug products that are under regulatory review pursuant to 35 U.S.C. § 156(c) is based on the issue date of the original patent or the reissue patent. The Federal Circuit sided with the district court and the patent owner, Merck, finding that the term “patent,” as used in Section § 156(c), refers to the original patent and not the reissued patent. As a result, patent term extension (PTE) is calculated based on the issue date of the original patent.
Merck’s ʼ340 patent covering sugammadex, the active ingredient in BRIDION®, was issued on Dec. 30, 2003. Merck applied for a reissue patent while sugammadex was under regulatory review, adding 12 narrower claims. The reissue patent was issued as the REʼ733 patent on Jan. 28, 2014, and sugammadex was approved by the Food and Drug Administration (FDA) on Dec. 15, 2015. The U.S. Patent and Trademark Office (PTO) granted Merck’s request for a five-year patent term extension—the maximum allowed under Section 156(c)—based on the ʼ340 patent’s original issue date.
Aurobindo, which submitted an Abbreviated New Drug Application for sugammadex, argued that the PTO should have calculated Merck’s PTE based on the issue date of Merck’s reissue patent and not the original patent (in which case Merck would only have been entitled to 686 days of PTE and not the full five years), because the original patent is “dead” upon reissue. The Federal Circuit flatly rejected this argument, relying heavily on the purpose and legislative intent underlying the Hatch Waxman Act, which was “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications.”
Adopting Aurobindo’s argument, the court said, would eviscerate this purpose and compensate patent owners for only a small period of delay caused by FDA review. The Federal Circuit emphasized that Merck was entitled to the full PTE based on the original patent’s issue date because the reissue patent included all of the original claims of the ʼ340 patent that was subject to FDA review.
Takeaways
Because the Federal Circuit’s decision only applies to reissue patents with the same claims as the original patent, patent owners with drug products under regulatory review should think twice before canceling claims in a reissue application, as doing so will result in forfeiture of PTE if the canceled claims cover the drug product that is under review. However, the Federal Circuit did not address how PTE should be calculated when a reissue patent significantly modifies the scope of the original claims but does not cancel them, which remains an open question.
Federal Circuit Opens the Door to Additional Domestic Industry Investment: “Ordinary Importer” No Longer
In its recent decision in Lashify, Inc. v. International Trade Commission, the Federal Circuit opened the door for patent owners to include expanded categories of domestic investment to satisfy the economic prong of the domestic industry requirement under Section 337(a)(3)(B). App. No. 2023-1245, Opinion (Mar. 5, 2025). Post-manufacture activities that previously were not considered—like sales, marketing, warehousing, quality control, and distribution—are now likely includable as domestic industry investments for purposes of establishing a domestic industry under Section 337(a)(3)(B). This is a significant departure from International Trade Commission (ITC) precedent and will likely open the door to a greater number of ITC investigations involving foreign-manufactured articles.
One of the unique aspects of ITC practice is its requirement that the complainant prove the existence of a domestic industry in order to obtain the coveted exclusion order. This requirement involves two prongs—the technical prong, which requires the complainant prove that it practices the patent at issue; and the economic prong, which requires the complainant prove with respect to the articles protected by the patent: (A) significant investment in plant and equipment; (B) significant employment of labor or capital; or (C) substantial investment in exploitation, including engineering, research and development, or licensing. 19 U.S.C. § 1337(a)(3). The Federal Circuit’s decision in Lashify addressed the economic prong.
Since its enactment in 1988, the ITC’s interpretation of Section 337(a)(3)(B) has effectively barred domestic investments directed solely to post-manufacture activities such as sales, marketing, warehousing, quality control, and distribution from establishing the existence of a domestic industry. The ITC often referred to these activities as those of an “ordinary importer,” failing to alone meet the economic prong of the domestic industry requirement because such activities contribute nothing to the actual manufacture of the article. Where manufacture of the article occurs outside of the United States, no additional steps occur in the United States to make the article salable, and thus no cognizable domestic industry activities remain for purposes of establishing the economic prong. Over the years, this interpretation of Section 337(a)(3) has effectively required some form of domestic manufacture or assembly activity to satisfy the economic prong of the domestic industry requirement. This is likely not the case anymore.
Lashify sells artificial eyelash extensions, applicator tools and products, and lash-extension storage containers. While Lashify conducts research and development in the United States, it manufactures its products overseas and ships them to U.S. customers who purchase the products via Lashify’s website. Customers are then able to use a variety of Lashify-provided resources to apply them, such as educational videos on social media, online chats, and video-call sessions. Lashify owns patents directed to these products, including a least one utility patent directed to, for example, certain lash-fusion technology; and design patents directed to, for example, a certain storage cartridge for eyelash extensions. Lashify filed a complaint before the ITC, in which it alleged that importers of similar products were violating Section 337 by infringing these patents.
The Administrative Law Judge (“ALJ”) at the ITC denied Lashify relief under the statute, determining, inter alia, that Lashify did not satisfy the economic prong of the domestic industry requirement. In reaching this determination, the ALJ excluded expenses relating to sales, marketing, warehousing, quality control, and distribution, following decades of ITC precedent considering these investments alone insufficient to meet the economic prong of the domestic industry requirement. The ALJ reasoned that because there were “no additional steps required to make these products saleable” upon arrival into the United States, and because the quality control measures were “no more than what a normal importer would perform upon receipt,” no domestic industry existed under Section 337(a)(3)(B).
The Commission agreed to review the ALJ’s decision and affirmed. The majority agreed with the ALJ that Lashify had not satisfied the economic prong of the domestic industry requirement, reasoning that “it is well settled that sales and marketing activities alone cannot satisfy the domestic industry requirement.” The majority reached the same conclusion with respect to warehousing, quality control, and distribution.
Lashify appealed to the Federal Circuit. The Federal Circuit vacated the ITC’s determination and remanded the investigation to the ITC for redetermination of satisfaction of the economic prong of the domestic industry requirement. The Federal Circuit concluded that the ITC’s determination relied upon an incorrect interpretation of Section 337(a)(3)(B). The Federal Circuit rejected the ITC’s conclusion that Lashify’s analysis was “overinclusive and not supported” because it “included expenses related to warehousing, distribution, and quality control” as well as “sales and marketing expenses.” The Federal Circuit found no support for these categorical exclusions in the text of the statute, relying heavily on its plain text and a thorough review of the legislative history surrounding the 1988 enactment.
The Federal Circuit observed that the provision “straightforwardly states that domestic industry ‘shall be considered to exist if there is in the United States, with respect to the articles protected by the patent . . . concerned, . . . significant employment of labor and capital.’” 19 U.S.C. § 1337(a)(3)(B). Absent some limitation, the Federal Circuit concluded:
[T]he provision covers significant use of “labor” and “capital” without any limitation on the use within an enterprise to which those items are put, i.e., the enterprise function they serve. In particular, there is no carveout of employment of labor or capital for sales, marketing, warehousing, quality control, or distribution. Nor is there a suggestion that such uses, to count, must be accompanied by significant employment for other functions, such as manufacturing. The Commission’s holdings attribute limitations to clause (B) not found there.
The Federal Circuit went on to conclude that there was no other rationale for imparting a categorical limitation to Section 337(a)(3)(B), precluding reliance on these types of investments from the context of the statute or its legislative history. The Federal Circuit thus directed the ITC, on remand, to “count Lashify’s employment of labor and capital even when they are used in sales, marketing, warehousing, quality control, or distribution, and the Commission must make a factual finding of whether those qualifying expenses are significant or substantial based on ‘a holistic review of all relevant considerations.’”
The Federal Circuit’s decision in Lashify is likely to have a significant impact on ITC practice. Foremost, it is likely to make the ITC available to businesses and industries previously excluded from the venue on the basis of the foreign manufacture of the imported article. Now, foreign manufacture of the article is not likely to be a bar to a patent owner’s ability to claim significant or substantial domestic investment in labor and capital under Section 337(a)(3)(B), even when such labor and capital is devoted to activities that do not make the product saleable or amount to anything more than those post-manufacture activities performed by an ordinary importer. Companies who perform such purely post-manufacture activities—as long as such investments are significant—will have the ability to claim such activities constitute domestic investment for purposes of meeting the economic prong of the domestic industry under Section 337(a)(3)(B).
Key Considerations Before Negotiating Healthcare AI Vendor Contracts
The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools requires a nuanced understanding of the tool’s application, implementation, risk and the contractual pressure points. Before entering the negotiation room, consider the following key insights:
I. The Expanding Role of AI in Healthcare
AI’s role in healthcare is rapidly expanding, offering a wide range of applications including real-time patient monitoring, streamlined clinical note-taking, evidence-based treatment recommendations, and population health management. Moreover, AI is transforming healthcare operations by automating staff tasks, optimizing operational and administrative processes, and providing guidance in surgical care. These technological advancements can not only improve efficiency but also enhance the quality of care provided. AI-driven customer support tools are also enhancing patient experiences by offering timely responses and personalized interactions. Even in employment recruiting, AI is being leveraged to identify and attract top talent in the healthcare sector.
With such a wide array of applications, it is crucial for stakeholders to understand the specific AI service offering when negotiating a vendor contract and implementing the new technology. This knowledge ensures that the selected AI solution aligns with the organization’s goals and can be effectively integrated into existing systems, while minimizing each party’s risk.
II. Pre-Negotiation Strategies
Healthcare AI arrangements are complex, often involving novel technologies and products, a wide range of possible applications, important data use and privacy considerations and the potential to significantly impact patient care and patient satisfaction. Further, the regulatory landscape is developing and can be expected to evolve significantly in the coming years. Vendors and customers should consider the following when approaching a negotiation:
Vendor Considerations:
Conduct a Comprehensive Assessment: Understand the problem the product is addressing, expected users, scope, proposed solutions, data involved, potential evolution, and risk level.
Engage Stakeholders: Schedule kick-off calls with the customer’s privacy, IT, compliance, and clinical or administrative teams.
Documentation: Maintain summary documentation detailing model overview, value proposition, processing activities, and privacy/security controls.
Collaborate with Sales: Develop strategies with the sales team and consider trial periods or pilot programs. Plan for the progression of these programs. For example, even if a pilot program is free, data usage terms should still apply.
Customer Considerations:
Evaluate Within AI Governance Scope: Don’t treat an AI contract like a normal tech engagement. Instead, approach this arrangement within a larger AI governance scope, including accounting for the introduction of ethical frameworks, data governance practices, monitoring and evaluation systems, and related guardrails to work in tandem with the product’s applications.
Engage Stakeholders: Collaborate with legal, privacy, IT, compliance, and other relevant stakeholders from the outset.
Consider AI-Specific Contracts: Use AI-specific riders or MSAs and review standard vendor forms to streamline negotiations.
Assess Upstream Contract Requirements: Ensure upstream requirements can be appropriately reflected downstream.
Perform vendor due diligence:As with any nascent industry, some vendors will not survive or may significantly change their focus or products, which might impact support or the long-term viability of the service. Learn about your vendor and ask questions about their financial stability, privacy and security posture.
III. AI Governance and Risk Assessment
Evaluating AI-related risk requires understanding risk across the full lifecycle of an AI product, including its model architecture, training methods, data types, model access, and specific application context. In the healthcare space, this includes understanding the impact to operations, the effect on clinical care and any other impact to patients, the amount of sensitive information involved, and the degree of visibility and/or control the organization has over the model.[1] For example, the risk is much larger with respect to AI that is used to assist clinical decision-making for diagnostics (e.g., assessing static imaging in radiology); whereas, technology used for limited administrative purposes carries a comparatively smaller risk. Here are three resources that healthcare organizations can use to evaluate and address AI-related risks:
A. HEAT Map
A HEAT map can be a helpful tool for evaluating the severity of risks associated with AI systems. It categorizes risks into different “heat” levels (e.g., informational, low, medium, high, and critical). This high-level visual representation can be particularly helpful when a healthcare organization is initially deciding whether to engage a vendor for a new AI product or platform. It can help the organization identify the risk associated with rolling out a given product and prioritize risk management strategies if it moves forward in negotiating an agreement with that vendor.
For example, both the customer and the vendor might consider (and categorize within the HEAT map) what data the vendor will require to perform its services, why the vendor needs it, who will receive the data, and what data rights the vendor might be asking for, how that data is categorized, whether any federal, state or global rules impact the acceptance of that data, and what mitigations are necessary to account for data privacy.
B. NIST AI Risk Management Framework
The National Institute of Standards and Technology (NIST) has created the NIST AI Risk Management Framework to guide organizations in identifying and managing AI-related risks.[2] This framework offers an example of a risk tiering system that can be used to understand and assess the risk profile of a given AI product, and ultimately guide organizations in the creation of risk policies and protocols, evaluation of ongoing AI rollouts, and resolution of any issues that arise. Whether healthcare organizations choose to adopt this risk tiering approach or apply their own, this framework reminds organizations of the many tools at their disposal to manage risk during the rollout of an AI tool, including data protection and retention policies, education of users, incident response protocols, auditing and assessment practices, changes to management controls, secure software development practices, and stakeholder engagement.
C. Attestations and Certifications
Attestations and certificates (e.g., HITRUST, ISO 27001, SOC-2) can also help your organization ensure compliance with industry standard security and data protection practices. Specifically, HITRUST focuses on compliance with healthcare data protection standards, reducing the risk of breaches and ensuring AI systems that handle health data are secure; ISO 27001 provides a framework for managing information security, helping organizations to safeguard AI data against unauthorized access and breaches; and SOC-2 assesses and verifies a service organization’s controls related to security, availability, processing integrity, confidentiality, and privacy, in order to ensure AI services are trustworthy. By engaging in the process to meet these certification standards, the organization will be better equipped to issue-spot potential problems and implement corrective measures. Also, these certifications can demonstrate to the public that the organization takes AI risks seriously, thereby strengthening trust and credibility amongst its patients and business partners.
IV. Contract Considerations
Once parties have assessed their organizational needs, engaged applicable stakeholders/collaborators, and reviewed their risk exposure from an AI governance perspective, they can move forward in negotiating the specific terms of the agreement. Here’s a high-level checklist of the terms and conditions that each party will want to pay careful attention to in negotiations, along with a deeper dive into the considerations surrounding data use and intellectual property (IP) issues:
A. Key Contracting Provisions:
Third-party terms
Privacy and security
Data rights
Performance and IP warranties
Service level agreements (SLAs)
Regulatory compliance
Indemnification (IP infringement, data breaches, etc.)
Limitations of liability and exclusion of damages
Insurance and audit rights
Termination rights and effects
B. Data Use and Intellectual Property Issues
When negotiating the terms and conditions related to data use, ownership, and other intellectual property (IP) issues, each party will typically aim to achieve the following objectives:
Customer Perspective:
Ensure customer will own all inputs, outputs, and derivatives of its data used in the application of the AI model;
Confirm data usage will be restricted to service-related purposes;
Confirm the customer’s right to access data stored by vendor or third-party as needed. For example, the customer might want to require that the vendor provide any relevant data and algorithms in the event of a DOJ investigation or plaintiff lawsuit;[3]
Aim for broad, protective IP liability and indemnity provisions; and
Where patient health information is involved, ensure that it is being used in compliance with HIPAA. Vendors want to train their algorithm on PHI. Unless the algorithm is only being trained for the benefit of the HIPAA-regulated entity and fits within a healthcare operations exception, a HIPAA authorization from the data subject will typically be required to train the algorithm for broader purposes.
Vendor Perspective:
Ensure vendor owns all services, products, documentation, and enhancements thereto;
Access customer data sources for training and improving machine learning models; and
Retain ownership over outputs. From the vendor’s perspective, any customer data that is inputted into the vendor’s model is modified by that model or product, resulting in the blending of information owned by both sides. One potential solution to this shared ownership issue is for the vendor to grant the customer a longstanding license to use that output.
V. Conclusion
In conclusion, negotiating contracts for AI tools in healthcare demands a comprehensive understanding of the technology, data use, risks and liabilities, among other considerations. By preparing effectively and engaging the right stakeholders and collaborators, both vendors and customers can successfully navigate these negotiations.
FOOTNOTES
[1] UC AI Council Risk Assessment Guide.
[2] NIST AI 600-1, Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (July 2024).
[3] Paul W. Grimm et al., Artificial Intelligence as Evidence, 19 Northwestern J. of Tech. and Intellectual Prop. 1, 9 (2021).
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China’s National Intellectual Property Administration’s 2025 Work Plan – Crack Down on Abnormal Patent Application and Malicious Trademark Registrations
On March 19, 2025, China’s National Intellectual Property Administration (CNIPA) released their 2025 Work Plan for Administrative Protection of Intellectual Property Rights (2025年知识产权行政保护工作方案). Some highlights include:
continue to crack down on abnormal patent applications and malicious trademark registration and hoarding;
strengthen intellectual property protection in the field of artificial intelligence, and strengthen the publicity and implementation of the “Guidelines for Applications for Artificial Intelligence-Related Invention Patents (Trial);” and
strengthen the construction of the integrity system in the field of intellectual property rights, and strengthen the punishment of dishonesty for trademark and patent infringement, malicious trademark registration, and abnormal patent applications.
A translation follows. The original text is available here (Chinese only).
This plan is formulated to thoroughly implement the important instructions and instructions of General Secretary Xi Jinping on comprehensively strengthening intellectual property protection, resolutely implement the decisions and arrangements of the Party Central Committee and the State Council, vigorously promote the implementation of the “Outline for Building a Powerful Intellectual Property Country (2021-2035)”, the “14th Five-Year Plan for National Intellectual Property Protection and Utilization”, and the “Opinions on Strengthening Intellectual Property Protection”, further improve the intellectual property protection system, strengthen the protection of the entire intellectual property chain, and help create a first-class market-oriented, law-based, and internationalized business environment.
1. Promote the implementation of laws and regulations. Do a good job in the publicity and implementation of the Patent Law and its implementing rules. Cooperate in the revision of the Trademark Law and the Regulations on the Protection of Integrated Circuit Layout Designs. Do a good job in the implementation of the “Administrative Adjudication and Mediation Measures for Patent Disputes”, “Regulations on Regulating Patent Application Behaviors”, “Regulations on the Registration and Administration of Collective Trademarks and Certification Trademarks” and “Regulations on the Protection of Geographical Indication Products”. Implement the “Regulations on Evidence for Trademark Administrative Enforcement”, “Methods for Calculating Illegal Business Volume in Trademark Infringement Cases”, “Regulations on the Causes of Intellectual Property Cases in the Field of Market Supervision (Trial)” and other law enforcement norms.
2. Improve and optimize the protection system. Promote the implementation of the “Implementation Plan for the Intellectual Property Protection System Construction Project” and strengthen the construction of intellectual property protection policies and standards systems, management systems, social co-governance systems, security governance systems, and support systems. Carry out an evaluation of the implementation of the intellectual property protection construction project in a timely manner. Establish a regular communication mechanism with private and foreign-funded enterprises, listen to opinions and suggestions on intellectual property protection in a timely manner, and respond to corporate demands.
3. Standardize the application and use of patents and trademarks. Continue to crack down on abnormal patent applications and malicious trademark registration and hoarding by improving management systems, launching special actions, guiding industry self-discipline, and strengthening supervision of agencies . Strengthen professional guidance on investigating and punishing illegal use of banned trademarks with deceptive and adverse effects. For those that have already been registered, promptly report to the State Intellectual Property Office for invalidation in accordance with the procedures, and increase follow-up and disposal after the invalidation decision takes effect. Promote the implementation of the “Patent and Trademark Agency Service Government Procurement Demand Standard (Trial)”.
4. Strengthen patent protection. Improve the review and submission mechanism for administrative decisions on major patent infringement disputes, strictly review the facts and evidence that meet the circumstances for filing a case, and standardize the issuance of supporting materials. Promote the standardization of administrative decisions on patent infringement disputes, smooth the acceptance channels, optimize the trial model, increase the intensity of case handling, and highlight the quality and efficiency of handling. Accurately identify the facts of infringement, strictly determine the infringement behavior, and actively carry out quick handling of simple cases and fine handling of complex cases. Encourage all localities to fully rely on professional forces such as technical investigation centers, technical investigation officer expert pools, and intellectual property appraisal institutions to provide technical support for case handling.
5. Strengthen trademark protection. Strengthen timely protection, key protection, and cited protection of well-known trademarks. Encourage local governments to strengthen the protection of well-known trademarks such as Chinese time-honored brands and trademarks related to the inheritance and development of cultural heritage through special governance actions and the establishment of corporate credit evaluation systems, and severely crack down on infringements such as “copying famous brands”. Strengthen supervision and professional guidance on hidden infringements such as infringements using keywords in the Internet field, infringements using registered trademarks in combination, and infringements on others’ prior registered trademarks using design patents.
6. Strengthen the protection of geographical indications. Implement the Implementation Plan for the Unified Recognition System of Geographical Indications, and promote the transformation of original agricultural product geographical indications in an orderly manner. Promote the construction of national geographical indication protection demonstration areas with high quality, and strengthen the supervision of the implementation process of geographical indication protection projects. Promote the implementation and evaluation of the 14th Five-Year Plan for the Protection and Use of Geographical Indications. Encourage all regions to use means such as origin traceability to improve the characteristic quality assurance system of geographical indications and improve the professional geographical indication inspection and testing system. Establish and improve the approval, cancellation and supervision system for the use of special geographical indication marks, and standardize the use of special marks.
7. Strengthen protection of new fields and new formats. Actively cooperate in data intellectual property registration services, organize publicity and promotion, policy interpretation, registration guidance and other work for the public in a timely manner, and guide and encourage the public to actively register. Strengthen intellectual property protection in the field of artificial intelligence, and strengthen the publicity and implementation of the “Guidelines for Applications for Artificial Intelligence-Related Invention Patents (Trial)”. Increase the protection of intellectual property rights in forward-looking strategic emerging industries such as new energy vehicles, lithium batteries, and photovoltaics, improve the working mechanism in combination with industrial and regional characteristics, strengthen the handling of patent administrative rulings and other cases, and provide precise guidance services.
8. Strengthen protection in hot areas of people’s livelihood. Focus on areas related to public interests and the vital interests of the people, such as food and medicine, rehabilitation aids, children’s toys, household appliances, and green and low-carbon technologies, and increase the daily supervision of intellectual property infringement and illegal acts and the guidance of trademark and patent administrative law enforcement. For areas where infringements are frequent in the region, carry out special intellectual property governance in a timely manner. Increase the protection of seed industry intellectual property rights, and strengthen professional guidance on investigating and handling counterfeiting, copying and other infringements.
9. Strengthen the protection of major events and important nodes. Provide good protection for the intellectual property rights of major events such as the 9th Asian Winter Games, the 12th World Games, and the 15th National Games, and crack down on infringements such as counterfeiting of sports souvenirs and cultural and creative products. Strengthen the protection of intellectual property rights of large exhibitions such as the China Import and Export Fair, the China International Import Expo, the China International Fair for Trade in Services, and the China International Consumer Goods Expo, strengthen pre-exhibition inspections, exhibition inspections, and post-exhibition tracking, open up complaint channels, and quickly handle intellectual property disputes. Provide good protection for intellectual property rights during festivals such as May Day, Mid-Autumn Festival, and National Day, strengthen supervision of e-commerce platforms, supermarkets, and professional markets, and prevent the circulation of infringing and counterfeit goods. Carry out risk investigation and special rectification at the time when seasonal geographical indication products are concentrated on the market, and strictly regulate the illegal use of geographical indications without authorization.
10. Strengthen the protection of foreign-related intellectual property rights. Promote the establishment of a working mechanism for the protection of foreign-related intellectual property rights in the region. Improve the service system for the protection of foreign-related intellectual property rights, handle all types of cases fairly and impartially, and protect the legitimate rights and interests of foreign and foreign-invested enterprises equally. Strengthen the construction of local sub-centers for overseas intellectual property dispute response guidance, and focus on strengthening the guidance services for private enterprises to deal with overseas disputes. Improve the overseas risk early warning mechanism, strengthen the early warning monitoring of disputes such as “337 investigations”, cross-border e-commerce litigation, and malicious trademark registration, and improve the timeliness and initiative of serving enterprises. Strengthen coordination and docking with the commerce department, and strictly manage the transfer of technology export intellectual property rights in accordance with the law.
11. Deepen rapid and coordinated protection. Further promote high-quality rapid and coordinated protection of intellectual property rights, strengthen the operation and management of national intellectual property protection centers and rapid rights protection centers, conduct reviews of patent pre-examination record entities and agencies, and strengthen pre-examination quality and public opinion monitoring management. Gather multi-party intellectual property resources, strengthen communication and collaboration between departments, standardize smooth connection procedures, and promote the rapid handling of intellectual property disputes. Encourage national intellectual property protection centers and rapid rights protection centers to provide assistance or technical support for administrative adjudication, administrative mediation, etc. Encourage multi-mode trials of patent reexamination and invalidation cases in national intellectual property protection centers to promote the connection between patent confirmation and administrative adjudication and administrative mediation of infringement disputes. Encourage national intellectual property protection centers to set up workstations in original innovation clusters such as national laboratories and large scientific facilities. Establish an intellectual property public service mechanism in science and technology parks and industrial parks, and support qualified intellectual property public service institutions to carry out information services such as overseas intellectual property rights protection and infringement warning.
12. Strengthen cross-departmental and cross-regional collaboration. Strengthen cooperation and coordination with the people’s courts, procuratorates, and public security organs, establish a long-term liaison mechanism, and promote the unification of administrative and judicial protection standards for intellectual property rights. Deepen cross-regional intellectual property administrative protection collaboration in Beijing-Tianjin-Hebei, the Yangtze River Delta, the Pan-Pearl River Delta, Chengdu-Chongqing, etc., do a solid and detailed job of information sharing, joint evidence collection, mutual recognition of results, etc., strengthen the tracking and handling of transferred clues, strengthen the collaborative protection and effect evaluation of key trademarks and geographical indications, and solve new problems such as “hidden” infringements across regions.
13. Promote social co-governance in dispute resolution. Strengthen administrative mediation work on patent ownership disputes, invention rewards and remuneration disputes, strengthen case handling guidance and linkage, and improve mediation quality and efficiency. Strengthen the professionalization of people’s mediation organizations, strengthen the construction of mediation teams by setting up full-time mediators and establishing expert databases, and enhance the professionalism and credibility of mediation. Promote online litigation and mediation of intellectual property disputes. Strengthen arbitration of intellectual property disputes and expand the use of arbitration channels to resolve intellectual property disputes. Strengthen the construction of the integrity system in the field of intellectual property rights, and strengthen the punishment of dishonesty for trademark and patent infringement, malicious trademark registration, and abnormal patent applications . Give full play to the role of typical cases of multi-party mediation of intellectual property disputes, do a good job in case selection, push, and release, and increase the promotion of experience exchange.
14. Strengthen professional guidance for law enforcement. Strengthen professional guidance for law enforcement in the field of intellectual property rights, and effectively combat all types of infringement and illegal activities. Standardize the case request handling system, and do a good job in case analysis and legal analysis for difficult cases and respond in a timely manner. Strictly implement the written reply filing system of provincial intellectual property management departments. Increase the follow-up and handling of the cases replied, and improve the quality and efficiency of case handling. Do a good job in case file review. Strengthen the selection and submission of guiding cases.
15. Promote smart supervision and protection. Continue to explore the application of new technologies such as the Internet, big data, cloud computing, and blockchain in intellectual property supervision. Promote the use of the national intellectual property protection information platform, support local governments to accelerate the construction of intellectual property public service platforms and independent and controllable thematic databases, and strengthen data sharing and business collaboration. Steadily promote the implementation of the national standards “Intellectual Property Protection Specifications for Commodity Trading Markets” and “Intellectual Property Protection Management for E-commerce Platforms”, and encourage qualified regions to use big data technology to carry out infringement and illegal risk monitoring, and realize real-time monitoring of clues of infringement and illegal behavior on e-commerce platforms.
16. Strengthen publicity and training. Coordinate traditional media and emerging media, make good use of integrated media, and publicize the measures and results of intellectual property protection through multiple channels. Make full use of important opportunities such as the National Intellectual Property Publicity Week to vigorously carry out centralized publicity, publish typical cases and experience practices, and create a good atmosphere for strengthening administrative protection. Strengthen the publicity and training of newly issued policies and regulations such as the “Administrative Adjudication and Mediation Measures for Patent Disputes” and the “Provisions on Evidence for Administrative Enforcement of Trademarks”, actively carry out business training, case discussions, skills competitions and other activities, and enhance the administrative protection capabilities of intellectual property rights at the grassroots level.
17. Strengthen organizational guarantees. All provincial-level intellectual property offices should conscientiously organize and implement, clarify the division of responsibilities, refine work measures, and make targeted improvements and upgrades in accordance with the shortcomings and deficiencies in intellectual property protection in the 2024 central quality, food safety and intellectual property protection assessments. Strengthen supervision and guidance, commend units and personnel who are responsible for their work and have outstanding achievements, criticize those who have frequent infringements and poor protection effects, supervise and improve in a timely manner, report work progress to the National Intellectual Property Office as required, and report important matters in a timely manner.
Patent Trial and Appeal Board Designates “Informative” Decision Regarding Claim Construction
On 20 March 2025, the Patent Trial and Appeal Board (PTAB) designated as “Informative” the majority opinion in the Decision Denying Institution in IPR2024-00952, a decision originally entered on December 13, 2024.
The primary reason for denial centered on the interplay between district court claim construction and claim construction in the Petition.
In a co-pending district court litigation involving the same patent, the Petitioner argued that certain claim terms “should be means-plus-function terms governed by §112(f) and that such terms are indefinite for failure to identify corresponding structure to perform the recited functions.” In the Petition, however, the Petitioner argued for plain and ordinary meaning because that was the Patent Owner’s litigation position.
Patent Owner opposed institution by arguing, among other things, that the Petition should be denied due to the Petitioner’s failure to adequately address the claim construction, particularly the means-plus-function issue, as required by 37 C.F.R. § 42.104(b)(3).
The Board determined that the Petition was deficient under 37 C.F.R. § 42.104(b)(3) because it failed to identify the specific portions of the specification that describe the structure corresponding to the claimed functions. The Board emphasized that the Petitioner had previously highlighted the importance of resolving whether these terms were means-plus-function limitations district court litigation yet failed to address this in the Petition. The Board highlighted that the Petition should have at least explained why inconsistent positions are warranted.
This now Informative decision highlights the complexities associated with claim construction and the importance of addressing all procedural requirements in IPR petitions. The decision underscores the PTAB’s discretion in denying petitions that do not adequately address claim construction issues, particularly when means-plus-function terms are involved, or claim construction positions in district court are inconsistent with the claim construction being advanced in an IPR. To the extent differences are necessary or appropriate, effort should be undertaken to explain why such inconsistencies exist and why any impact of those inconsistencies are minimal at best.
Power Play: Pull the Plug on Parallel District Court Litigation, ITC Investigation
The US Court of Appeals for the First Circuit vacated a preliminary injunction, explaining that the district court should have immediately issued a statutory stay of the proceeding under 28 U.S.C. § 1659(a) because a co-pending case at the International Trade Commission involved the same issues and parties. Vicor Corp. v. FII USA Inc., Case No. 24-1620 (1st Cir. Mar. 6, 2025) (Gelpí, Thompson, Rikelman, JJ.)
Vicor filed a § 337 complaint with the Commission against Foxconn asserting power converter module patents while simultaneously suing Foxconn for patent infringement in a Texas district court. Under § 1659, at the request of the party charged in the § 337 complaint, a federal district court must stay proceedings in a civil action between the same parties “with respect to any claim that involves the same issues [as those] involved” in the Commission action. Foxconn successfully secured a stay of the Texas litigation under § 1659.
Foxconn then initiated arbitration in China before the China International Economic and Trade Arbitration Commission (CIETAC), claiming that Vicor had agreed to such arbitration under the terms of their purchase order. The Commission’s administrative law judge denied Foxconn’s request to terminate the § 337 case, finding that Foxconn had waived that defense by failing to timely raise an arbitration defense.
Vicor then sued Foxconn in a Massachusetts district court, disputing any arbitration agreement. The district court issued a temporary restraining order (TRO) and later a preliminary injunction, blocking the CIETAC arbitration. In the Massachusetts litigation, Foxconn sought a § 1659 stay and sought to vacate the TRO. Although the district court agreed that a stay would be permitted, the court rejected the motion to vacate the TRO. The court referenced the All Writs Act, which provides that federal courts “may issue all writs necessary or appropriate in aid of their respective jurisdictions,” as justifying injunctive relief. Foxconn appealed.
The First Circuit agreed that § 1659 applied in the Massachusetts litigation and found that the statute’s plain text required an immediate stay upon Foxconn’s request without granting Vicor a preliminary injunction. The primary issue before the First Circuit was whether Vicor’s claims against Foxconn at the Commission involved the same issues as those in the Massachusetts litigation.
Reviewing the text of § 1659, the First Circuit determined that Vicor’s district court claims in the Massachusetts litigation encompassed the same issues as those raised in the § 337 proceeding. In its Massachusetts litigation, Vicor sought relief under the Federal Arbitration Act to enjoin the CIETAC arbitration and relief under the Declaratory Judgment Act for a ruling that Vicor was not bound by the arbitration terms of the purchase order agreements with Foxconn. Central to both proceedings was Vicor’s argument that it had not agreed to the purchase order terms. Because this issue was common to both the § 337 proceedings and the Massachusetts litigation, the First Circuit determined that the district court needed to issue an immediate stay to Foxconn under § 1659.
Vicor argued that for § 1659 to apply, all issues in a district court case must align with those in the Commission proceeding. Vicor argued that because the Massachusetts litigation did not involve the same patent infringement claims as the § 337 investigation or the Texas litigation, the issues were not identical. Vicor also argued that § 1659 was inherently ambiguous because § 337 proceedings involve elements (such as the existence of a domestic industry) that district court patent infringement claims do not. Foxconn countered that § 1659’s plain text recitation of “the same issues” does not require complete overlap but a substantial identity of issues between the two proceedings. The First Circuit agreed with Foxconn, interpreting § 1659’s language as clear and unambiguous.
Vicor further argued that ambiguity required examination of the legislative history. Even though the First Circuit found the statute clear, it reviewed the legislative history of § 1659 and confirmed the statute’s purpose, which was to prevent duplicative litigation at the Commission and the district courts. The First Circuit also disagreed with the district court’s grant of the preliminary injunction, explaining that the All Writs Act cannot override specific congressional enactments.
No Bull: Historically Generic Term Can Become Non-Generic
The US Court of Appeals for the Federal Circuit affirmed Trademark Trial & Appeal Board rulings, finding that a previously generic term was not generic at the time registration was sought because at that time the mark, as used in connection with the goods for which registration was sought, had achieved secondary meaning. Bullshine Distillery LLC v. Sazerac Brands, LLC, Case Nos. 23-1682; -1900 (Fed. Cir. Mar. 12, 2025) (Moore, C.J.; Reyna, Taranto, JJ.)
In 2015 Bullshine sought to register the trademark BULLSHINE FIREBULL for its line of “[a]lcoholic beverages except beers.” Sazerac, the owner of the FIREBALL marks used for liqueurs and whiskey, opposed registration. Sazerac argued that the registration of BULLSHINE FIREBULL would likely cause consumer confusion due to its similarity to Sazerac’s FIREBALL marks. Bullshine counterclaimed, asserting that the term “fireball” had become generic and was commonly used to describe a type of alcoholic drink, thus invalidating Sazerac’s claim to exclusivity.
The Board found that the FIREBALL mark was not generic either at the time of registration nor at the time of trial, and that BULLSHINE FIREBULL was not likely to cause confusion with Sazerac’s marks. The Board determined that the FIREBALL mark was “commercially strong but conceptually weak,” that the respective marks of Sazerac and Bullshine were dissimilar when considered in their entireties, and that Bullshine did not act in bad faith in choosing its marks. The Board denied Sazerac’s opposition to the BULLSHINE FIREBULL mark as well as Bullshine’s counterclaim that the FIREBALL mark was generic. Both parties appealed.
Bullshine argued that the Board applied the incorrect legal standard in finding FIREBALL not generic and that consequently, the finding of non-genericness (upon consideration of secondary meaning) was erroneous. Bullshine argued that since “fireball” was a generic term prior to Sazerac’s registration (as both parties agreed), that fact should have precluded Sazerac’s registration, and the Board erred in considering evidence of secondary meaning. Bullshine argued that if a term was generic at any time prior to registration, it remains generic, regardless of how it might be understood at the time of registration (i.e., once generic, always generic). Sazerac argued that the time to assess genericness is at the time of registration. The Federal Circuit agreed with Sazerac.
The Federal Circuit explained that the genericness inquiry is ultimately guided by “what consumers would think at the time of registration,” and that this ruling is supported by the statutory scheme of the Lanham Act. The Court explained that the Lanham Act, in addition to preventing registration of generic terms, also provides for cancellations of marks “[a]t any time,” and even marks with incontestable statuses can be challenged based on genericness. Therefore, Congress intended that the analysis of whether a term is generic can change over time, and Bullshine’s argument was inconsistent with the statute. This conclusion follows from the legal premise that impression of consumers is “necessarily contemporaneous with the time of registration.”
Bullshine cited the 1961 CCPA decision in Weiss Noodle in support of its argument that a term cannot be registered regardless of the time interval between the finding of genericness and the registration. The Federal Circuit disagreed, noting that in Weiss Noodle, the mark for which registration was sought was the Hungarian word for noodles, and “no amount of secondary meaning would make the common name of a product registerable.”
The Federal Circuit also affirmed that the Board did not err in finding that the FIREBALL mark was not generic. The Board found that the record evidenced a preponderance of evidence against genericness, noting that record recipes related to the term “fireball” were from specialized publications and hence did not represent the impression of general consumers of whiskey and liqueurs.
On the likelihood of confusion issue, Sazerac argued that the Board made three errors in its analysis:
Analyzing the fame of FIREBALL.
Finding that the mark was conceptually weak.
Not considering the sixth DuPont
The Federal Circuit rejected all three arguments.
The Federal Circuit found that the Board’s finding that FIREBALL was not famous was supported by substantial evidence. The primary reason for the Board’s finding was that there was no context for Sazerac’s sales and advertising figures and how those compared with other brands of whiskey and liqueurs. The evidence presented by Sazerac was mostly related to shots, a subset of the genus of identified goods. Moreover, since the Board held that (despite not finding fame) FIREBALL was commercially strong and entitled to a broad scope of protection, even if the Board erred in its fame analysis, the error would have been harmless.
The Board found the FIREBALL mark conceptually weak because it was highly suggestive. There was evidence that Sazerac had admitted in the past that its mark was “not inherently distinctive,” that the term was suggestive of the taste of Sazerac’s product, and that the term was used to describe recipes having whiskey/liqueur as ingredients. Sazerac also admitted that its product had the same flavoring as the “Atomic Fireball” candy, and that third parties widely used the term to denote flavor in items such as popcorn and liquid flavorings added to food and beverages. Even though Sazerac argued that it was an error to consider dissimilar goods (such as popcorn), it failed to persuasively explain its reasoning. The Federal Circuit pointed out that even if considering use of the mark in connection with dissimilar goods was an error, other record evidence satisfied the requirements of substantial evidence and hence supported the Board’s findings.
The Federal Circuit also rejected Sazerac’s arguments that the Board erred by not considering the sixth DuPont factor (number and nature of similar marks in use on similar goods). The Court explained that the Board found in favor of Sazerac regarding the sixth DuPont factor but determined that Sazerac’s mark was “so conceptually weak” that the two marks were too different for consumer confusion to occur.
Practice Note: Attorneys should not solely rely on historical evidence of genericness but should provide substantial evidence, including surveys and expert testimony (if possible), in support of genericness at the time registration is sought.
Eminem’s Ex-Employee Faces Charges After Leaking Over 25 Unreleased Songs: “The Damage Can’t Be Overstated!”
Eminem’s Ex-Employee Faces Charges After Leaking Over 25 Unreleased Songs: “The Damage Can’t Be Overstated!” In a shocking turn of events, Eminem’s 14-year-old trusted employee has been accused of a betrayal that could change the future of the rapper’s legacy forever. The once-trusted studio worker, Joseph Strange, is now at the center of a massive […]
Palette of Evidence: PTAB Must Consider Entire Record to Determine Prior Art Status
The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board patentability determination, finding that the Board failed to consider the entire record regarding the prior art status of a sample and did not explain why it did not do so. CQV Co., Ltd. v. Merck Patent GmbH., Case No. 23-1027 (Fed. Cir. Mar. 10, 2025) (Chen, Mayer, Cunningham, JJ.)
Merck owns a patent that covers alpha-alumina flakes included in paints, industrial coatings, automotive coatings, printing, inks, and cosmetic formulations to impart a pearlescent luster. CQV petitioned the Board for post-grant review (PGR) of the patent, arguing that the challenged claims were obvious in view of prior art samples of Xirallic®, a trademarked product produced by Merck. In its final written decision, the Board found that CQV had not adequately supported its contention that the alleged Xirallic® lot qualified as prior art and therefore had not shown by a preponderance of the evidence that the challenged claims were unpatentable. CQV appealed.
The Federal Circuit reviewed the Board’s finding under the substantial evidence standard. The Court found that the Board erred in failing to consider the entire record and did not provide any basis for that failure. In terms of the prior art status of the Xirallic® samples, the Court found that the Board failed to consider testimony regarding the availability of Xirallic® for customer order and the length of the quality control process. The Court could not “reasonably discern whether the Board followed a proper path” in determining that CQV failed to show by a preponderance of the evidence that the sample of Xirallic® constituted prior art. The Court remanded, suggesting that the Board carefully consider whether the sample of Xirallic® would have been publicly available as of the alleged critical dates.
Construing Unambiguous Claim Language and Qualifying Challenged Expert as POSITA
Addressing the issues of claim construction and the requisite expert qualifications to testify on obviousness and anticipation, the US Court of Appeals for the Federal Circuit vacated a Patent Trial & Appeal Board decision invalidating half of the challenged patent’s claims and instructed the Board to clarify whether the patent owner’s expert was indeed qualified as a person of ordinary skill in the art (POSITA). Sierra Wireless, ULC v. Sisvel S.P.A., Case Nos. 23-1059; -1085; -1089; -1125 (Fed. Cir. Mar. 10, 2025) (Moore, CJ: Schall, Taranto, JJ.)
Sisvel owns a patent directed to methods for retrieving data lost during wireless transmission. The prior art taught methods for flagging lost protocol data units (PDUs) so that the data transmitter could retry the transmission. Sisvel’s patent includes a timer that prescribes a period of time to elapse before alerting a transmitter of a missing PDU, allowing the transmission to be completed without notification. The patent has 10 claims, two of which are independent. The primary independent claim has four limitations, including one related to stopping the timer before a status report issues if the missing PDU is located and another related to issuing a status report upon the timer’s expiration. The limitations are linked by the word “and.”
Sierra Wireless initiated inter partes review (IPR), arguing that all 10 of the claims were both anticipated and obvious in light of the “Sachs” prior art patent. The Board found that half of the claims, including both independent claims, were anticipated and obvious. In finding that the other claims were not unpatentable, the Board relied on the testimony of Sisvel’s expert. Both parties appealed.
Sisvel raised two arguments in support of the claims the Board found unpatentable. First, Sisvel argued that the Board misconstrued the two above-noted limitations as mutually exclusive. Sisvel argued that the prior art had to teach both limitations to invalidate the claim. Second, Sisvel argued that the Board’s interpretation of Sachs’ teachings to include the first of the two limitations was unsupported by substantial evidence.
The Federal Circuit agreed. On the claim construction issue, the Court found that the two limitations in issue could not be mutually exclusive because the claim language linked them using the word “and.” To construe the limitations as mutually exclusive would be inconsistent with the unambiguous claim language. With regard to the prior art, the Court looked to Sachs Figure 5, which the Board relied upon in determining that the prior patent had taught the first limitation. Both the figure and the patent’s surrounding language made clear that the time referenced therein was dependent upon reordering of PDUs, not upon receiving missing ones. The Court thus vacated the Board’s invalidity determination as not supported by substantial evidence.
In its appeal, Sierra argued that the Board’s reliance on Sisvel’s expert’s testimony to find certain claims not unpatentable was an abuse of discretion. The Federal Circuit agreed, finding that the Board abused its discretion by not finding that the proposed expert qualified as a POSITA before relying upon his testimony. The Court found that the proposed expert’s qualifications fell outside the parameters the Board itself set when defining who qualified as POSITA. The Court noted that while the proposed expert had more work experience than the Board required, he lacked the requisite electrical engineering degree. The Court further noted that his work experience was not identical to the adopted level of skill in the art. Because obviousness and anticipation are both viewed from the perspective of one of ordinary skill in the art, it was improper for the Board to rely on the proposed expert’s testimony. The Court thus vacated the Board’s decision and remanded with instructions that the Board determine whether the proposed expert qualified as a POSITA.
Get a Grip: Not All Cords Have Handles
The US Court of Appeals for the Federal Circuit vacated a district court’s grant of summary judgment of noninfringement because the district court improperly narrowed a claim term during its construction. IQRIS Technologies LLC v. Point Blank Enterprises, Inc. et al., Case No. 2023-2062 (Fed. Cir. Mar. 7, 2025) (Lourie, Linn, Stoll, JJ.)
IQRIS sued Point Black and National Molding for infringing its patents related to “quick release systems on tactical vests.” The patent claim vests include a “pull cord.” When pulled, the pull cord causes releasable hooks to disengage, detaching the front and rear portions of the vest. The defendants moved for summary judgment of noninfringement, arguing that the claimed “pull cord” is “a cord on the exterior of the ballistic garment grasped by a user that is capable of disengaging the releasable fastener or releasable hook when a user pulls on the pull cord.” IQRIS argued that the term should be construed as “a component which, when put into tension, can result in activating the releasable fastener.”
The district court construed “pull cord” as a “cord that can be directly pulled by a user to disengage a releasable fastener or releasable hook,” a construction that excluded cords with a handle. The district court found that one of the accused products featured a “trigger manifold” that enabled the user to apply “indirect force to [an] internal wire by applying a direct force to the trigger.” As a result, the district court determined that no reasonable jury could find infringement for that product. For another product, the district court found summary judgment to be appropriate because to rule otherwise, the accused vest would improperly encompass prior art criticized in the “background of the invention” portion of the patent specification. The specification criticized prior art having “cutaway vests with ‘handle’ release systems.”
IQRIS appealed. The Federal Circuit considered whether the district court correctly restricted “pull cord” to cords that are “directly pulled by a user.” The Court found that the claim language, which made no reference to “who or what pulls,” did not distinguish between direct and indirect pulling. Citing the patent specification, the Federal Circuit disagreed with the lower court’s interpretation, noting that the specification referred to a directly pulled element as a “pull cord” but an indirectly pulled element as just a “cord.” The Court noted that even though all disclosed embodiments depicted a directly pulled pull cord, “our precedent counsels against reading this requirement into the claims when the claims do not expressly require as much.”
The Federal Circuit next considered whether the proper construction of the term “pull cord” excluded cords with handles. The Court found that “nothing in the claim language, specification, or prosecution history supports this construction.” The claim language was “silent about the structure of the pull cord,” and the specification “suggest[ed] otherwise because each of the figures depicts a circular ball at the end of the pull cord[], suggesting that the inventors contemplated pull cords with handles.” While the specification criticized the cutaway vests with “handle release systems,” it made no criticism of the handles themselves. The Court concluded that the patent’s criticism of pull cords with handles did not rise to the level of disavowal: “[T]he standard for disavowal is exacting, requiring clear and unequivocal evidence that the claimed invention includes or does not include a particular feature.” The Federal Circuit therefore determined that the district court erred by excluding pull cords that include handles.
“Regulations of the State Council on the Settlement of Foreign-Related Intellectual Property Disputes” Unveils Countermeasures Against Those That Use IP Disputes as an Excuse “to Contain and Suppress China”
On March 19, 2025, China’s State Council released the Regulations of the State Council on the Settlement of Foreign-Related Intellectual Property Disputes (国务院关于涉外知识产权纠纷处理的规定), effective May 1, 2025. As compared to last year’s draft, this final version unveils new articles 15-17 to counter countries, individuals and organizations that “use intellectual property disputes as an excuse to contain and suppress China” perhaps in response to Secretary Lutnick’s comments regarding Chinese IP at his confirmation hearing. This final version also maintains article 8 that “encourages law firms to…establish practice institutions abroad through the establishment of branches…”
A translation follows. The original is available here (Chinese only).
Article 1 These Regulations are formulated in order to strengthen intellectual property protection, promote citizens and organizations to handle foreign-related intellectual property disputes in accordance with the law, safeguard the lawful rights and interests of citizens and organizations, promote high-level opening up to the outside world, and promote high-quality economic development.
Article 2 The department of the State Council responsible for the management of intellectual property rights such as trademarks, patents, and copyrights (hereinafter referred to as the intellectual property management department) and the commercial authorities shall strengthen guidance and services to citizens and organizations in handling foreign-related intellectual property disputes, and other relevant departments of the State Council shall perform related work in accordance with their division of responsibilities.
The relevant departments of the State Council will strengthen work coordination and information communication, and jointly do a good job in handling foreign-related intellectual property disputes.
Article 3 Local people’s governments at or above the county level and their relevant departments shall, in light of the actual conditions of their respective regions, do a good job in handling foreign-related intellectual property disputes.
Article 4 The intellectual property management department of the State Council and relevant departments such as commerce and judicial administration shall, in accordance with their respective responsibilities, promptly collect and publish information on foreign intellectual property legal systems, improve the public service system for intellectual property information, and provide foreign intellectual property information query services to the public.
Article 5 The intellectual property management department and the commercial department of the State Council shall, in accordance with their respective responsibilities, strengthen tracking and understanding of key information such as changes in foreign intellectual property legal systems, conduct analysis and research on typical cases, issue risk warnings in a timely manner, and provide the public with foreign-related intellectual property warnings.
Article 6 The intellectual property management department and the commercial department of the State Council shall improve the guidance work institutions and work procedures for handling foreign-related intellectual property disputes in accordance with the division of responsibilities, and provide response guidance and rights protection assistance to citizens and organizations in handling foreign-related intellectual property disputes.
Article 7 Support commercial mediation organizations and arbitration institutions to participate in the resolution of foreign-related intellectual property disputes, provides citizens and organizations with efficient and convenient channels for resolving foreign-related intellectual property disputes, and encourages and guides citizens and organizations to quickly resolve foreign-related intellectual property disputes through reconciliation, mediation, arbitration, etc.
The judicial administrative department of the State Council will strengthen guidance on the mediation and arbitration of foreign-related intellectual property disputes.
Article 8 Encourage law firms, intellectual property service agencies, etc. to improve their foreign-related intellectual property service capabilities, establish practice institutions abroad through the establishment of branches, joint operations, etc., and provide high-quality and efficient foreign-related intellectual property services to citizens and organizations.
The judicial administrative department and the intellectual property management department of the State Council will take measures together with relevant departments to create conditions for law firms, intellectual property service agencies and other organizations to strengthen foreign-related intellectual property related services.
Article 9 Support enterprises in establishing mutual assistance funds for the protection and maintenance of foreign-related intellectual property rights, encourages insurance institutions to conduct foreign-related intellectual property rights-related insurance business in accordance with market principles, and reduces the costs of rights protection for enterprises.
Article 10 Encourage chambers of commerce, industry associations, cross-border e-commerce platforms and other organizations to build foreign-related intellectual property rights protection assistance platforms, open service hotlines, and provide public services such as consultation and training.
Article 11 Enterprises shall enhance their awareness of the rule of law, establish and improve internal rules and regulations, strengthen the reserve of intellectual property talent, and intensify the protection and use of intellectual property rights; when entering foreign markets, they shall take the initiative to understand the legal system and intellectual property protection status of the country or region where they are located, carry out production and business activities in accordance with the law, and actively safeguard their legitimate rights and interests.
The intellectual property management department and the commercial department of the State Council, together with relevant departments, focus on the intellectual property protection needs of enterprises in their foreign-related production and operation activities, carry out publicity and training for enterprises around key areas and key links of foreign-related intellectual property disputes, and introduce experiences and practices in handling foreign-related intellectual property disputes in accordance with the law based on typical cases, so as to enhance enterprises’ awareness of foreign-related intellectual property protection and dispute resolution capabilities.
The judicial administrative departments of the State Council shall, in accordance with the requirements of the legal education responsibility system of “whoever enforces the law shall educate the public on the law”, strengthen legal publicity and education related to intellectual property rights, and comprehensively enhance citizens’ and organizations’ awareness of intellectual property protection and their ability to safeguard their rights in accordance with the law.
Article 12 The service of documents and investigation and collection of evidence within the territory of China shall be handled in accordance with international treaties concluded or acceded to by China, as well as the Civil Procedure Law of the People’s Republic of China, the Law of the People’s Republic of China on International Criminal Judicial Assistance and other laws. No organization or individual may violate the laws of China when serving documents or investigating and collecting evidence within the territory of China.
Article 13: Organizations and individuals within the territory of China that participate in overseas intellectual property-related litigation or are subject to overseas judicial or law enforcement investigations and need to provide evidence or related materials to overseas countries shall comply with laws and administrative regulations on maintaining state secrets, data security, personal information protection, technology export management, judicial assistance, etc. If approval by the competent authority is required according to law, relevant legal procedures shall be followed.
Article 14 The competent commerce department of the State Council may, in accordance with the Foreign Trade Law of the People’s Republic of China, investigate the following matters and take necessary measures:
(1) Imported goods infringe intellectual property rights and endanger foreign trade order;
(2) The intellectual property rights holder prevents the licensee from questioning the validity of the intellectual property rights in the licensing contract, conducts compulsory package licensing, stipulates exclusive re-grant conditions in the licensing contract, etc., and endangers the fair competition order in foreign trade;
(3) Other countries or regions fail to accord national treatment to Chinese citizens and organizations in terms of intellectual property protection, or are unable to provide adequate and effective intellectual property protection for goods, technologies or services originating from China.
Article 15: Where foreign countries violate international law and basic norms governing international relations, use intellectual property disputes as an excuse to contain and suppress China, adopt discriminatory restrictive measures against Chinese citizens and organizations, and interfere in China’s internal affairs, the relevant departments of the State Council may, in accordance with the Foreign Relations Law of the People’s Republic of China, the Anti-Foreign Sanctions Law of the People’s Republic of China, and other laws, include organizations and individuals that directly or indirectly participate in the formulation, decision-making, and implementation of discriminatory restrictive measures in the countermeasure list and adopt corresponding countermeasures and restrictive measures.
Article 16 No organization or individual may implement or assist in the implementation of discriminatory restrictive measures taken by foreign countries against Chinese citizens or organizations under the pretext of intellectual property disputes.
If any organization or individual violates the provisions of the preceding paragraph and infringes upon the legitimate rights and interests of our citizens or organizations, our citizens or organizations may, in accordance with the law, bring a lawsuit to the people’s court and demand that it stop the infringement and compensate for the losses.
Article 17 The relevant departments of the State Council shall strengthen coordination and cooperation, and take corresponding measures in accordance with the National Security Law of the People’s Republic of China, the Foreign Relations Law of the People’s Republic of China, the Anti-Foreign Sanctions Law of the People’s Republic of China and other laws against those who use intellectual property disputes to endanger China’s sovereignty, security and development interests; those who abuse intellectual property rights to exclude, restrict competition or implement unfair competition shall be dealt with in accordance with the Anti-Monopoly Law of the People’s Republic of China, the Anti-Unfair Competition Law of the People’s Republic of China and other laws.
Article 18 These Provisions shall come into force on May 1, 2025.