South Korea introduced the First Generic Exclusivity (FGE) system as part of the patent linkage system to promote patent challenges and market entry of generic drugs. Evaluating the impact of FGE on the number of generic entrants is central to assessing the system. This study elucidates factors-including patent characteristics-that influence the number of FGE applicants and holders at the ingredient level. Using data from the Ministry of Food and Drug Safety, 85 ingredients with FGE applications filed between 2015 and 2025 were analyzed. For each ingredient, originator-based characteristics-including manufacturer type, patent characteristics, and drug characteristics-were collected, and the year of the first FGE application for each generic was identified. Negative binomial regression analysis was performed to determine factors affecting the number of FGE applicants, holders, and non-holders. Among 85 ingredients, the mean number of FGE applicants was 6.59 (SD = 9.52, IQR 1-9), and the mean number of FGE holders was 4.61 (SD = 8.08, IQR 0-4). Regression results showed that the number of FGE applicants was positively associated with the number of patents and approval year, but negatively associated with the reimbursement price. The number of FGE holders showed positive associations with approval year and negative associations with reimbursement price. The application year was negatively correlated only with the number of FGE holders. Although the introduction of the FGE system and the expansion of patent portfolios increased patent challenges by generic manufacturers, this did not consistently translate into actual generic market entry, underscoring the need to reexamine whether the FGE system is effectively designed to foster substantive competition.

This article examines the system of state mechanisms for regulating labor migration in the Russian Federation from 2019 to 2025. The analysis focuses on legal instruments, administrative regulators, and organizational forms of managing migration flows — from the patent system for visa–free migrants to the mechanism for organized recruitment under interstate agreements. The methodological basis of the study is based on comparative legal and statistical methods, an institutional approach to assessing regulatory systems, and an analysis of data from the Ministry of Internal Affairs, Rosstat, and the Eurasian Economic Commission for 2020–2025. The study examines the structural contradictions of the current regulatory model: the declared restrictive measures coexist with an objectively growing demand for foreign labor — in 2024, approximately 3.15 million of the 6.3 million foreign nationals who arrived had the purpose of entering for work. The study’s findings demonstrate that the current system creates a persistent gap between a migrant’s legal status and their actual situation in the labor market, and that control mechanisms are systematically overburdened. Suggested areas for improvement include a transition to targeted labor migration under employer responsibility, digitalization of records, and stronger coordination between agencies. The State Migration Policy Concept for 2026–2030 outlines a number of these areas, but their practical implementation requires structural institutional changes.

DS2PT: A Deep Two-Stage Patent Text Segmentation Framework Informed by Low-Latency Neural Network Characteristics.

ABSTRACT As a major institutional innovation designed to improve the timeliness of patent-right confirmation, the patent fast-track examination system plays an important role in shaping firms’ innovation incentives. Using panel data on Chinese A-share listed companies, this study examines whether exposure to the patent fast-track examination system affects firms’ innovation boundaries and investigates the underlying mechanisms. The results show that exposure to the system significantly expands firms’ innovation boundaries, and this finding remains robust after a series of checks, including alternative variable definitions, controls for contemporaneous policy shocks, and corrections for potential selection issues. The effect is more pronounced for firms with stronger external knowledge infrastructure, greater innovation subsidies, higher human capital, and stronger innovation aspirations. Additional channel analyses suggest that policy exposure enhances firms’ innovation focus and strengthens their iterative innovation capability. In addition, the induced expansion of innovation boundaries is not associated with a rise in patent invalidation, but is accompanied by higher patent value and greater firm productivity, suggesting positive real economic consequences. These findings provide useful policy implications for improving patent examination institutions and fostering more exploratory innovation.

ABSTRACT Patent disclosure quality is critical to the efficiency of patent systems, yet empirical evidence remains limited. This study applies natural language processing and machine learning techniques to measure patent disclosure quality and examine its effect on technical information diffusion. Using decisions from the Chinese Patent Reexamination Board, we construct a disclosure quality model based on 44 linguistic features. The optimal Random Forest model achieves an F1-score of 72.5% and is applied to 129,166 Chinese patents filed during 2010–2015. Empirical results show that patents with higher disclosure quality diffuse technical information more rapidly to subsequent inventors, but within a narrower range of industries. These findings provide new evidence on the role of patent disclosure quality in shaping technical information diffusion and improving the efficiency of the Chinese patent system.

Abstract This article explores the impact of the Japanese Intellectual Property High Court (IPHC) 2025 Thaler decision, critically reflecting on how the court approached the issue of DABUS and artificial intelligence (AI) inventors, building to a more international and comparative reflection on the legal points raised. The Japanese judgment demonstrates that, in many ways, the Thaler cases have globally reached their endpoint. Throughout the judgment, the court interprets AI as an inventor through the prism of rights. However, even the most inventive, creative or autonomous AI system cannot be recognized within the patent system as an inventor because it cannot hold rights, thereby suppressing the more abstract consideration of what it means for an AI to be truly ‘creative’ in a patent context. The decision emphasizes the interconnected nature of patent law. Allowing an expansive interpretation of the naming requirement in patent law would have consequences in the legal system more generally. Ultimately, the judgment necessarily defers the question of modifying these interconnections to a more appropriate legislative context, highlighting the international task of AI reform in patent law.

The concept of evergreening in pharmaceutical patents has emerged as a critical issue at the intersection of intellectual property law and public health in India. Evergreening refers to the strategic practice by pharmaceutical companies of obtaining multiple patents on minor modifications of existing drugs, thereby extending their market exclusivity beyond the original patent term. This study undertakes a comprehensive legal analysis of evergreening within the framework of the Indian Patents Act, 1970, particularly focusing on Section 3(d), and examines its compatibility with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). India has adopted a cautious and public health-oriented approach to patent protection, aiming to balance innovation incentives with access to affordable medicines. Section 3(d) serves as a key safeguard by denying patents to new forms of known substances unless they demonstrate enhanced therapeutic efficacy. This provision has been instrumental in preventing the misuse of patent rights through incremental innovations that lack substantial clinical benefit. The landmark judgment in Novartis AG v. Union of India is analyzed to understand the judicial interpretation of Section 3(d) and its role in curbing evergreening practices. The research further evaluates whether India’s patent regime aligns with its international obligations under TRIPS, which mandates minimum standards of patent protection while allowing member states certain flexibilities. It argues that India has effectively utilized these flexibilities to design a patent system that prioritizes public health without violating TRIPS norms. The study also highlights ongoing debates surrounding the tension between pharmaceutical innovation and accessibility, especially in developing countries. By critically examining statutory provisions, judicial precedents, and international frameworks, this paper concludes that India’s legal stance on evergreening represents a balanced and pragmatic model. It not only discourages trivial patent extensions but also ensures that genuine innovations are rewarded. The analysis underscores the importance of maintaining this equilibrium to promote both technological advancement and equitable healthcare access in the evolving global patent landscape.

As the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge 2024 (WIPO GRTK Treaty) mandates ‘disclosure’, its operationalization may generate a surge in patent information worldwide. The CBD–Nagoya framework also requires disclosure of information on the utilization of genetic resources (GRs) and associated traditional knowledge (ATK) as part of the user country measures. Extensive mapping of the checkpoint communique issued under the Nagoya Protocol highlights trends in compliance and interaction between users and providers. The effective use of these information systems by biodiversity-rich countries becomes essential for preventing misappropriation of GRs and ATK and reinforcing access and benefit-sharing (ABS) objectives. This work explores how integrating information between biodiversity governance and patent systems can enhance biodiversity governance and improve the quality of patents globally while preserving the independence of intellectual property offices and biodiversity regulatory bodies.

ABSTRACT A patent system is a central tool in innovation policy. The prospect of monopolistic pricing supposedly encourages firms to innovate. However, there is scant empirical evidence supporting the existence of higher markups for patent‐protected products. Using an original dataset that links consumer products to the patents that protect them, we study the impact of patent protection on product prices. Exploiting exogenous variations in patent status, we find that a loss of patent protection leads to an 8%–10% drop in product prices. The price drop is larger for more important patents and is more pronounced in more competitive product markets.

The article provides a comprehensive analysis of Ukraine’s accession to the European Patent Convention as a strategically and institutionally necessary stage of the country’s integration into the unitary patent protection system of the European Union. The study goes beyond the traditional approach, under which EPC membership is viewed as an optional step, and substantiates it as a structural prerequisite for Ukraine’s full participation in the European innovation and legal space. The role of the European Patent Organisation and the European Patent Office in shaping the European patent infrastructure is examined, as well as the institutional link between the EPC and the functioning of the unitary patent protection system and the Unified Patent Court. It is determined that the further evolution of EU patent law is largely based on the procedures, examination standards, and administrative practices developed within the EPC framework. Particular attention is paid to the concept of initiative-driven European integration in the field of intellectual property, which involves the voluntary and proactive approximation of national legislation and institutions to European standards, even in the absence of a direct obligation under the Association Agreement. In this context, accession to the EPC is considered an element in reducing the regulatory gap between Ukraine and the EU, enhancing legal certainty for investors, and strengthening trust in the national patent system. The article also substantiates the need to establish a structured preparatory stage for Ukraine’s accession to the EPC, encompassing political, regulatory, institutional, кадровий, judicial, and economic-innovation dimensions. It is demonstrated that strategic planning in the field of intellectual property and the development of a Roadmap for accession to the EPC are key instruments for transforming a declarative European integration course into a consistent policy of patent integration. The findings confirm that Ukraine’s accession to the EPC should be regarded not as a technical stage of harmonisation, but as an institutional foundation for the country’s future participation in the unitary patent architecture of the EU.

Abstract We investigate whether participants in the patent system are sensitive to information quality by examining how they treat inaccurate information. We use a novel approach to identify patents with inaccurate information: patent-paper pairs where the paper has been retracted and the corresponding patent contains the retracted material. Despite containing inaccurate information, we find that these patents are prosecuted and maintained by many applicants, are not rejected by examiners, and continue to be cited by some downstream readers after retraction. Insensitivity to inaccurate information may lead to erroneous decisions during examination and has implications for patent quality, disclosure, and knowledge flows.

Abstract Traditional medicine—including complementary, integrative, Indigenous, and ancestral practices—remains a vital source of healthcare for billions worldwide, particularly in the Global South. Despite its widespread use and biomedical relevance, traditional medicinal knowledge has long been excluded from dominant intellectual property systems shaped by Western legal traditions. This exclusion has enabled persistent biopiracy and inequitable commercialization of community‐held knowledge. The 2024 WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge marks a historic attempt to address these imbalances. It introduces mandatory disclosure of origin in patent applications and reaffirms the role of the intellectual property system in promoting innovation, knowledge transfer, and economic development—to the mutual benefit of providers and users of genetic resources and associated traditional knowledge. However, the treaty's effectiveness remains uncertain due to its narrow scope, vague provisions, and reliance on national implementation. While analyses of the WIPO Treaty have largely focused on its disclosure requirements, legal enforceability, and implications for patent systems, relatively little attention has been paid to the treaty's implications for traditional medicines. Yet, traditional medicines represent one of the most significant areas where genetic resources and associated traditional knowledge intersect in practice. This paper critically evaluates the treaty's potential and limitations as applied to traditional medicine and advocates for a more justice‐oriented, health‐aligned IP framework—one that centres Indigenous values, ensures equitable governance, and protects traditional medicine.

As one of the essential carriers of knowledge, patents can provide rich cross-domain knowledge support for the product innovation design process. However, the main challenge facing most patent-assisted innovation design systems is identifying and delivering patents relevant to design requirements from the vast number of cross-domain patents. Given this problem, this paper proposes a new patent classification and recommendation method based on a multi-dimensional product life cycle dictionary. Firstly, the method defines a multi-dimensional product life cycle dictionary, which includes six main categories: function, structure, material, process, transportation, and recycling (FSMPTR), and supplements the feature keywords of each subcategory based on the Claude model. Secondly, the FSMPTR classification of patent data is completed based on the constructed dictionary, and the patent data set under the functional category is extracted. Thirdly, the TF-IDF algorithm is used to extract the features of the functional patent data set, and the similarity calculation is carried out with the synonym extension technology to accurately identify the patents related to the design requirements to form the candidate patent set related to the design requirements. Finally, a patent classification and recommendation prototype system is developed using the proposed method. Based on the system, a design example of the electric toothbrush is completed, which verifies the feasibility and practicability of the method and system. This study can provide theoretical and methodological support for product innovation design.

ABSTRACT Human rights discourses traditionally centre around interference with the freedom of expression, association and movement, or other abuses by states and their agents. Nonetheless, new biotechnologies, specifically synthetic biology, and patent rights that contend with human rights principles, equally deserve attention. Synthetic biology is a new phase of modern biotechnology pioneering essential treatments, and other breakthrough solutions to humanity’s diverse needs. This article contends that, despite its potential to improve human life, synthetic biology and the existing patent system threaten human rights, especially the right to health, by discriminating against individuals, who cannot afford medical products and services, thereby heightening the risk of exclusion from essential healthcare. The article relies on relevant laws, judicial, as well as patent office determinations, and other literature. It suggests that human rights norms should be accorded a more prominent role in biotechnological innovation and patenting to enable them contribute meaningfully to the enhancement of human life and advancement of science.

‘Human health or Intellectual Property Rights protection?’ is one of the highly debated issues of the world in the last few decades. While health is a fundamental human right indispensable for the exercise of other human rights, protection of intellectual property rights is considered as the essential booster for the innovators to invent. Starting from the Universal Declaration of Human Rights, 1948, number of International Covenants, Treaties relating to human rights recognize right to health is a basic human right. However, study reports indicate that despite progress made in the last few decades, millions of the people in the developing countries, including India do not have access to medicines. With the advent of Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Patent regime of many countries, including India has changed from process patenting to product patenting and resulted in denial of access to essential medicines to the poor segments of the society. it is argued that the changes incorporated to the patent system of India directly impacted the right to health of the people of India. In this background, this paper attempts to analyze the provisions of Patent law on pharma Patent in India to examine whether right to health and patent rights, specifically, the pharmaceutical patentees rights are adequately balanced in India. Keywords: Intellectual Property Right, Pharma Patent, Right to health, TRIPS Agreement

The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (GRATK Treaty) represents a significant doctrinal development in international intellectual property (IP) law. It introduces a mandatory disclosure requirement obliging patent applicants to indicate the origin or source of genetic resources and associated traditional knowledge on which claimed inventions are based. This article situates the GRATK Treaty within the global access and benefit-sharing (ABS) regime complex, examining its interaction with the Convention on Biological Diversity and Nagoya Protocol. It argues that the Treaty constitutes a path-dependent yet normatively consequential response to the problem of biopiracy, strengthening procedural transparency within the patent system while maintaining coherence with existing international legal regimes. By analyzing its disclosure, sanctions, mutual supportiveness, and institutional provisions, the article demonstrates that the GRATK Treaty consolidates the benefit appropriation sub-regime despite not creating any new IP rights. Although its effectiveness will depend on ratification and implementation by major patent jurisdictions, the Treaty marks an incremental but important step toward reconciling IP governance with core elements of the global ABS regime.

India's Ministry of Commerce and Industry has, on March 15, 2024, notified the Patents (Amendment) Rules, 2024, thereby marking a major development in the Indian patent system. The amendments have made drastic changes to the patent prosecution timelines, opposition procedures, and patent working disclosure requirements. The article discusses in detail the three key changes: the shortening of Request for Examination (RFE) deadlines from 48 months to 31 months based on the priority date; the speeding up of the opposition review timelines for both pre-grant and post-grant oppositions; and the major change in the Form 27 working statement from annual to triennial filing intervals with significantly simplified information disclosure. The study's methodology includes an in-depth legal doctrinal analysis, case law scrutiny, and a comparative approach to jurisprudence. It has evaluated the consequences of the new patent rules for patent applicants, patent holders, and public interest groups, especially in the pharmaceutical industry. The article pinpoints significant research gaps related to empirical enforcement data, compulsory licensing under Section 83-84, and access to medicines implications, while also suggesting methodological frameworks for future studies. Keywords: Patent Rules 2024, Request for Examination, Form 27, Working Requirements, Opposition Timelines, Pharmaceutical Patents, India, Patentability, Patent Prosecution

Abstract This article examines how policy and regulatory approaches to environmental protection in Tanzania integrate intellectual property rights (IPR) perspectives as a key intervention. It focuses on patents as a subset of IPR and one of the key drivers of green innovation, while other types of IPR are discussed peripherally. The concern emanates from the ubiquity of IPR and its centrality in shaping policy and regulatory reforms in diverse fields, including environmental protection. The debate on the interface between patents, as a subset of IPR, and environmental protection is steadily gaining momentum globally, partly because environmental protection issues are central to fostering the sustainable development agenda. Consequently, several regulatory measures have been implemented, including a focus on the use of environmentally friendly technologies to mitigate the impact of intrusive human activities on the environment. Although Tanzania's national environmental policy and legal framework support the use of various scientific and technological tools to mitigate the harm caused by human activity to the environment, there is no explicit mention of patents as one of the strategic drivers. The patent system is structured to, among other things, advance and safeguard scientific and technological advancements. Thus, its inclusion and integration into Tanzania's national environmental protection measures could be a valuable addition. The review employs an exploratory and rights discourse approach in analysing the regulatory gaps and potential setbacks. The article highlights a lack of regulatory nexus between patent protection and environmental conservation measures, as evident in Tanzania's current environmental policies and laws. Thus, the article advocates for the explicit integration of patent protection as one of the interventions in environmental protection measures, promoting institutional coordination between the national IPR office and the authority responsible for environmental protection to achieve effective and sustainable environmental protection.

Rapid technological innovation has made navigating millions of new patent filings a critical challenge for corporations and research institutions. Existing patent recommendation systems, largely constrained by their static designs, struggle to capture the dynamic pulse of an ever-evolving technological ecosystem. At the same time, their “black-box” decision-making processes severely limit their trustworthiness and practical value in high-stakes, real-world scenarios. To address this impasse, we introduce TEAHG-EPR, a novel, end-to-end framework for explainable patent recommendation. The core of our approach is to reframe the recommendation task as a dynamic learning and reasoning process on a temporal-aware attributed heterogeneous graph. Specifically, we first construct a sequence of patent knowledge graphs that evolve on a yearly basis. A dual-encoder architecture, comprising a Relational Graph Convolutional Network (R-GCN) and a Bidirectional Long Short-Term Memory network (Bi-LSTM), is then employed to simultaneously capture the spatial structural information within each time snapshot and the evolutionary patterns across time. Building on this foundation, we innovatively introduce uncertainty modeling, learning a dual “deterministic core + probabilistic potential” representation for each entity and balancing recommendation precision with exploration through a hybrid similarity metric. Finally, to achieve true explainability, we design a feature-guided controllable text generation module that can attach a well-reasoned, faithful textual explanation to every single recommendation. We conducted comprehensive experiments on two large-scale datasets: a real-world industrial patent dataset (USPTO) and a classic academic dataset (AMiner). The results are compelling: TEAHG-EPR not only significantly outperforms all state-of-the-art baselines in recommendation accuracy but also demonstrates a decisive advantage across multiple “beyond-accuracy” dimensions, including explanation quality, diversity, and novelty.

The statutory typification of absolute rights in patent transactions has received limited attention in Chinese academic discourse. While the principle of numerus clausus (a closed list of real rights) does not directly apply to patent law, the creation of new types of absolute rights within this domain is nonetheless subject to significant legal constraints. A typological analysis of absolute rights in the patent system reveals significant constraints on their contractual creation. Paradoxes arising from the contractual creation of absolute rights demonstrate that existing legal provisions fail to substantiate the erga omnes effect of licenses and therefore fail to justify contractual freedom in defining absolute rights. Even under the principle of party autonomy, the distinctive features of patent transactions indicate that the absence of statutory typification of absolute rights would lead to increased transaction costs, compromised transaction security, and undue restrictions on third-party conduct.