Author name: InfoJustice Eds.

Blog, Health & IP

Malaysia exhorts Human Rights Council to prioritize the primacy of public health and human rights over commercial interests

This post was originally published on KEI Online by Thiru Balasubramaniam On Tuesday afternoon, 24 June 2025, the Core Group (Bangladesh, Brazil, China, Egypt, India, Indonesia, Senegal, South Africa, Thailand) convened an informal consultation to consider the revised version draft resolution, “Access to medicines, vaccines and other health products in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” in Room XXVII of the United Nations Palais des Nations. At the informal, Malaysia proposed textual amendments to the resolution and highlighted the limits of certain voluntary licensing arrangements, most notably Gilead and lenacapavir. Malaysia acknowledges that voluntary licensing arrangements have in some instances contributed to expanded access to medicines. However, we must express our reservation that these arrangements have too often failed to ensure adequate, affordable, and timely access to life-saving medical technologies for many developing countries. As noted in the report of the UN Secretary-General’s High-Level Panel on Access to Medicines, right holders frequently retain the unilateral authority to exclude countries from license agreements—effectively denying access to those most in need. This practice fails to meet the principles of equity and solidarity that global health governance aspires to uphold. A stark illustration of this issue is the case of Gilead Sciences and its antiretroviral drug, Lenacapavir. Despite being a promising long-acting injectable treatment for HIV, Gilead’s voluntary license explicitly excluded developing countries, including Malaysia and many others in Asia, Latin America, and Eastern Europe. These are regions with growing HIV burdens and constrained health budgets, yet they are excluded from generic supply due to the originator’s commercial strategy. Such exclusions highlight a systemic problem: when commercial interests are prioritized in voluntary licensing models, the public health needs of developing countries are marginalized. Therefore, we propose language that tackles the structural shortcomings of voluntary licensing, underscores the pressing concerns of many developing countries in accessing life-saving medicines, and advocates for a more equitable, transparent, and needs-driven framework for access to critical medical innovations. In moving forward, we reaffirm the need for legally certain, transparent, and inclusive mechanisms that prioritize public health over commercial discretion—ensuring that no country is left behind in accessing life-saving medicines, vaccines, and technologies. With respect to the draft resolution, Malaysa stated underscored the exigent need for “strengthened international cooperation and solidarity that prioritizes the primacy of public health and human rights over commercial interests”. Malaysia asserted that TRIPS-plus provisions in trade agreements effectively infringe on the right to health and called on developed countries to “refrain from exerting pressure—whether through trade negotiations, diplomatic influence, or investment agreements—on developing countries to adopt intellectual property protections that exceed TRIPS obligations”. We acknowledge the important guidance provided in the 2009 Report of the UN Special Rapporteur on the Right to Health (A/HRC/11/12), which calls upon developing and least developed countries to refrain from introducing TRIPS-plus provisions into national law, and urges developed countries to desist from promoting such provisions through bilateral or regional trade and investment agreements. We express deep concern that TRIPS-plus provisions—including extended patent terms, data exclusivity, patent linkage, and restrictions on compulsory licensing—go beyond the minimum standards required by the TRIPS Agreement, and risk undermining public health safeguards, delaying access to affordable generic medicines, and increasing healthcare costs, thereby infringing upon the right to health, particularly in developing countries already struggling to meet the health needs of their populations. We caution against increasing trends of developed countries to circumvent international based IP rule through bilateral trade agreements to impose their own IP agendas such as TRIPS plus provisions on developing nations, potentially undermining the multilateral system. We further emphasize that developed countries should refrain from exerting pressure—whether through trade negotiations, diplomatic influence, or investment agreements—on developing countries to adopt intellectual property protections that exceed TRIPS obligations. Such practices restrict national policy space, compromise the ability of States to protect public health, restricting access to affordable health products, and risk undermining the integrity of the multilateral rules-based system. Malaysia calls for strengthened international cooperation and solidarity that prioritizes the primacy of public health and human rights over commercial interests. We urge all Member States to ensure that their trade and intellectual property policies are aligned with their obligations under international human rights law, including the right to health, and to reaffirm their commitment to preserving policy space, resisting TRIPS-plus measures, and working toward an international system that places human dignity and health equity at its core. Malaysia proposed the insertion of the following language including a peace clause in Op 4 bis. New PP Acknowledging that voluntary licensing arrangements, while beneficial in some contexts, have often failed to provide adequate, affordable, and timely access to life saving medicines for some developing countries that are usually excluded from the scope of licenses, as right holders reserve the right to identify countries where they intend to sell the product directly or through other agreements; (part from the Report of the UN Secretary General’s High-Level Panel on Access to Medicines) New PP Acknowledging the 2009 Report of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health that calls for developing and least developed countries to not to introduce TRIPS-plus provisions in their national laws and developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs and should be mindful of actions which may infringe upon the right to health.; (Ref A/HRC/11/12 pg 29 para 109)New PP Recalling the 2021 Political Declaration on HIV and AIDS that calls for ensuring that intellectual property rights provisions in trade agreements do not undermine existing flexibilities, as confirmed in the Doha Declaration on the TRIPS Agreement and Public Health (A/RES/75/284 para 68(a)) New Op 4 bis: Call upon States to exercise restraint in undertaking international legal obligations which directly or indirectly undermines the freedom to make use of the TRIPS flexibilities and also urges States to monitor the implications of voluntary licenses in facilitating availability, accessibility and affordability

Case Studies, TDM Cases

LATAM-GPT: A Culturally Sensitive Large Language Model for Latin America

LATAM-GPT is a groundbreaking large language model developed by the National Center for Artificial Intelligence (CENIA) in Chile, in partnership with over thirty institutions and twelve Latin American countries. The initiative aims to create an open-source AI model that reflects the region’s diverse cultures, languages—including Spanish, Portuguese, and Indigenous tongues—and social realities. Using ethically sourced, regionally contributed data, LATAM-GPT seeks to overcome the limitations and biases of global AI models predominantly trained on English data. The project is designed to empower local communities, preserve linguistic diversity, and support applications in education, public services, and beyond. Its development highlights the importance of ethical data practices, regional collaboration, and policy frameworks that foster inclusive, representative AI. A video version of this case study is available below. 1. Background: Digital Inequality and AI in Latin America Latin America faces unique challenges in digital inclusion, with significant linguistic, cultural, and infrastructural diversity across the region. Global AI models often fail to capture local nuances, leading to inaccuracies and reinforcing stereotypes. Many Indigenous and minority languages are underrepresented in mainstream technology, exacerbating digital exclusion. LATAM-GPT addresses these gaps by building a model tailored to the region’s needs, aiming to democratize access to advanced AI and promote technological sovereignty. 2. Technology and Approach LATAM-GPT is based on Llama 3, a state-of-the-art large language model architecture. The model is trained on more than 8 terabytes of regionally sourced text, encompassing Spanish, Portuguese, and Indigenous languages such as Rapa Nui. Training is conducted on a distributed network of computers across Latin America, including facilities at the University of Tarapacá in Chile and cloud-based platforms. The open-source nature of the project allows for transparency, adaptability, and broad participation from local developers and researchers. 3. Project Overview The project is coordinated by CENIA with support from the Chilean government, the regional development bank CAF, Amazon Web Services, and over thirty regional organizations. LATAM-GPT’s primary objective is to serve as a foundation for culturally relevant AI applications—such as chatbots, virtual public service assistants, and educational tools—rather than directly competing with global consumer products like ChatGPT. A key focus is the preservation and revitalization of Indigenous languages, with the first translation tools already developed for Rapa Nui and plans to expand to other languages. 4. Data Sources and Key Resources LATAM-GPT uses ethically sourced data contributed by governments, universities, libraries, archives, and community organizations across Latin America. This includes official documents, public records, literature, historical materials, and Indigenous language texts. All data is carefully curated to ensure privacy, consent, and cultural sensitivity. Unlike many global AI models, LATAM-GPT publishes its list of data sources, emphasizing transparency and ethical data governance. 5. Legal and Ethical Challenges Copyright and Licensing:The project relies on open-access and properly licensed materials, with explicit permissions from data contributors. This approach avoids the legal uncertainties faced by models that scrape data indiscriminately from the internet. Data Privacy and Consent:CENIA and its partners ensure that sensitive personal information is anonymized or excluded, and that data collection respects the rights and wishes of contributors, especially Indigenous communities. Inclusivity and Bias:By prioritizing local languages and cultural contexts, LATAM-GPT aims to reduce biases inherent in global models. Ongoing community engagement and feedback are integral to the model’s development and evaluation. 6. International and Regional Collaboration LATAM-GPT exemplifies pan-regional cooperation, with twelve countries and over thirty institutions contributing expertise, data, and infrastructure. The project has also engaged international partners and multilateral organizations, such as the Organization of American States and the Inter-American Development Bank, to support its mission of technological empowerment and digital inclusion. 7. Emerging Technology and Policy Issues LATAM-GPT’s open-source model sets a precedent for responsible AI development, emphasizing transparency, ethical data use, and regional self-determination. The project also highlights the need for robust digital infrastructure and continued investment to ensure equitable access to AI across Latin America. As with all large language models, ongoing attention to potential biases, data privacy, and the impact on local labor and education systems is essential. 8. National and Regional Legal Frameworks While LATAM-GPT’s ethical sourcing and licensing practices minimize legal risks, the project underscores the importance of harmonized copyright and data protection laws across Latin America. Policymakers are encouraged to develop frameworks that facilitate data sharing for socially beneficial AI, protect Indigenous knowledge, and promote open science. 9. Contractual or Policy Barriers Some challenges remain in securing permissions for certain data sources, particularly from private publishers or institutions with restrictive contracts. The project’s commitment to open licensing and community engagement helps mitigate these barriers, but continued advocacy is needed to expand access to valuable regional content. 10. Conclusions LATAM-GPT represents a major step forward in creating culturally sensitive, inclusive AI for Latin America. By centering ethical data practices, regional collaboration, and linguistic diversity, the project offers a model for other regions seeking to decolonize AI and ensure technology serves local needs. Continued investment, policy reform, and community participation will be crucial to realizing the full potential of LATAM-GPT and similar initiatives. Video Version Hear from the researchers themselves. Watch the video of this case study below.

Case Studies, TDM Cases

Blind South Africa: Apps for the Visually Impaired

An initiative led by Christo de Klerk at Blind South Africa focuses on promoting the use of accessible mobile and digital applications for blind and visually impaired people in South Africa. Highlighted at the 2025 Copyright and the Public Interest in Africa conference, the project addresses the importance of robust copyright exceptions and supportive legal frameworks to enable the development and use of apps that work in African languages, read aloud texts, describe images and films, and provide local information. The legal challenges – especially around copyright and licensing of accessible content and the use of visual works as AI training data – point to lessons for responsible, inclusive innovation and policy reform in assistive technology. A video version of this case study is available below. 1. Disability, Inequality, and Digital Exclusion in South Africa South Africa has a high prevalence of visual impairment and blindness, with over a million people affected. Barriers to education, employment, and public participation are exacerbated by inaccessible information and digital services. While assistive technologies offer new opportunities for inclusion, their effectiveness depends on being designed for accessibility, linguistic diversity, and local context. 2. Assistive Technology and Accessibility Assistive technology includes devices and software such as screen readers, braille displays, text-to-speech apps, navigation tools, and AI-powered applications that describe images and films. Development is shaped by international standards like the Web Content Accessibility Guidelines (WCAG) and local policy frameworks, ensuring that accessibility is built into digital tools. 3. Project Overview The BlindSA initiative focuses on raising awareness and supporting the use of existing accessible apps for blind and visually impaired users, particularly those supporting African languages and offering features like scene description and audio narration. Rather than developing new apps, the project identifies, tests, and disseminates information about effective tools. It also advocates for legal and policy changes, including strong copyright exceptions, to empower developers and users in South Africa’s multilingual communities. Community participation and user feedback are central to the approach. 4. Data Sources and Key Resources Apps promoted by the initiative draw on diverse data sources: public domain texts, government information, community-generated content, and web-scraped text and images, including photographs, artworks, and films. Many apps use AI to generate scene descriptions and audio narration, opening up previously inaccessible content. The initiative emphasizes tools that support African languages, providing read-aloud and real-time information (such as weather and news) in Zulu, Sotho, and others. However, reliance on copyrighted materials for AI training and accessible formats raises pressing legal questions about copyright exceptions, licensing, and the need for inclusive legal frameworks. 5. Legal and Ethical Challenges Copyright and Licensing:Many resources needed for accessible apps—books, newspapers, educational materials, artworks, photographs, and films—are protected by copyright. South Africa’s current law offers limited exceptions for accessible formats, making it difficult to legally convert works into braille, audio, large print, or described video without explicit permission. Outdated copyright laws have long denied blind South Africans equal access to information, highlighting the need for robust legal exceptions. Contractual Restrictions:Even when content is publicly available, licensing terms may prohibit adaptation or redistribution in accessible formats. Absence of Research and Accessibility Exceptions:Unlike countries that have ratified and implemented the Marrakesh Treaty, South Africa’s copyright regime remains restrictive. BlindSA’s Constitutional Court case challenged these limitations, emphasizing that the right to read is a fundamental human right and that lack of access excludes blind people from education, employment, and society. 6. The Marrakesh Treaty and the Struggle for Equality The Marrakesh Treaty, adopted by WIPO in 2013, requires signatory countries to create copyright exceptions for accessible formats and enables cross-border sharing. It is a milestone in addressing the “book famine” for blind people and affirms access to information as a fundamental right. South Africa signed the Treaty in 2014, but as of 2025, has not fully implemented it into national law, leaving the blind community at a disadvantage. BlindSA has been at the forefront of advocacy for these reforms, including a Constitutional Court challenge to the country’s copyright law. 7. Generative AI, Copyright Backlash, and the Accessibility Exception The rise of generative AI has sparked backlash from creators concerned about unauthorized use of their works as training data and the risk of AI-generated content substituting for original works. However, experts and advocates for the visually impaired emphasize the importance of copyright exceptions for accessibility. When AI is used for accessible formats—such as describing images or reading text aloud—there is no substitution effect, only an expansion of access and rights. Copyright policy and AI regulation should distinguish between commercial, substitutive uses of AI and socially beneficial uses that enable access for the visually impaired. The Marrakesh Treaty and proposed South African reforms recognize the need to balance creators’ interests with the transformative potential of AI for inclusion. 8. National Legal Reform The Copyright Amendment Bill proposes new exceptions for creating and distributing accessible format copies, as well as a general fair use provision. If enacted, these reforms would significantly improve access to information for the visually impaired in South Africa. 9. Contractual or Policy Barriers The initiative highlights the need for open licensing and permissions from publishers and content providers. Some government and educational materials remain inaccessible due to restrictive licenses or outdated contracts. 10. Conclusions Despite legal and policy challenges, BlindSA’s work has raised awareness of accessible apps and digital resources, including text-to-speech tools, navigation apps, and AI-powered scene description in South African languages. User participation is emphasized: “Accessibility is not a luxury or an afterthought—it is a right.” BlindSA’s experience highlights the urgent need for harmonized copyright exceptions, open standards, and inclusive digital policy. Policymakers, funders, and technology developers should prioritize accessibility and the rights of people with disabilities in all digital innovation efforts. Video Version Hear from the researchers themselves. Watch the video of this case study below.

Blog

WIPO Program and Budget Committee : US opposes all references to the SDGS from the Proposed Program and Budget for 2026/2027

This post was originally published on KEI Online by Thiru The World Intellectual Property Organization (WIPO) convened the 39th session of its Program and Budget Committee (PBC) from 16 June 2025 to 20 June 2025. With respect to WIPO’s proposed Program and Budget for 2026/2027, the PBC passed the following decision: The PBC further requested to refer the outstanding items discussed during PBC 39 to the 66th series of meetings of the WIPO Assemblies: i. Removal of all references to the 2030 Agenda for Sustainable Development and SDGs from the Proposed Program and Budget for 2026/2027 As flagged by KEI in early May, the United States “expressed its antipathy to WIPO’s engagement with the Sustainable Development Goals (SDGs)” at the 34th session of WIPO’s 34th session of the Committee on Development and Intellectual Property (CDIP) in May 2025. On Wednesday, 18 June 2025 (on the third day of the June PBC), the United States stated: First, as stated repeatedly at PBC 38, the United States objects to the framing of this document in terms of the Sustainable Development Goals.WIPO should not be prioritizing the implementation of the SDGs or directing its work in an attempt to implement the SDGs. At PBC 38, the Secretariat clarified that WIPO does not budget for the SDGs but rather budgets for WIPO’s expected results in the Strategy House. The inclusion of unnecessary aesthetic elements, graphics and language implying WIPO’s Program of Work and Budget is guided by the UN 2030 Agenda for Sustainable Development and the SDGs gives a false impression of the manner in which WIPO’s work is driven. As such, the United States requests these elements be removed from the proposed Program of Work and Budget. At PBC 38, the Secretariat also clarified that WIPO’s implementation strategies are driven not by the SDGs but by the expected results of the Medium Term Strategic Plan. The extent to which WIPO’s work can be labeled as a contribution to the SDGs is simply a product of WIPO working towards its expected results. The United States also requests removing from the proposed Program of Work and Budget any language calling for WIPO to conduct its work or devote resources towards implementing the SDGs, including, for example, the regional and national development sector’s fourth priority and the section of the narrative on global challenges and partnership sector entitled 2030 Agenda for Sustainable Development and the Sustainable Development Goals. In response to the US intervention on WIPO and its work toward the implementation of the UN SDGS, several Member States responded. Brazil Brazil would like to start by thanking the Distinguished Delegation of the United States of America for sharing additional proposals during this afternoon.We look forward to receiving specific language in writing on this matter. With regard to the first and third points raised, we would like to add our voice to what has just been said by the Distinguished Representative from the African Group. This Delegation would like to reiterate our view on the pertinence and accuracy of the explicit reference on the proposed work program of work and budget to both the WIPO Development Agenda and to the Sustainable Development Goals, the SDGs. As we have already expressed during the PBC38, it is our view that the current document adequately reflects WIPO’s strategic priorities and is fully aligned with the organization’s medium-term strategic plan for 2022-2026, which we were able to collectively agree upon all Member States. This Delegation, therefore, supports our shared and continued efforts to ensure that IP system is inclusive, representative and responsive to the needs and priorities of all, including our Developing Countries. Brazil is particularly pleased with the increased budget allocation to developmental activities, including through the creation of the Development Acceleration Fund, which we consider is a significant step to strengthening WIPO’s commitment to development of oriented initiatives and to the effective implementation of WIPO’s Development Agenda Recommendations. Finally, Mr. Chair, we still trust that the discussions during the sessions will be able to reflect a common understanding that WIPO financial sustainability needs to go hand-in-hand with its development oriented responsibility being WIPO, a UN system organization. We remain committed to working constructively with all Delegations and with the Secretariat to advance a proposed program of work and budget that is balanced, transparent and development oriented. I thank you very much. Egypt Thank you, Mr. Chair.Our Delegation aligns itself with the statement delivered by the Distinguished Delegate of Namibia on behalf of African Group and we thank the Distinguished Delegate of the United States for their proposal. [The] Egypt Delegation highly values WIPO’s continued commitment to its Development Agenda and UN 2030 Sustainable Development Goals and supports in this regard the current proposal of the Programme of Work and Budget with regard to the allocation of resources to the Development Agenda as will add the new Development Acceleration Fund which demonstrates the pivotal role WIPO is playing in fostering innovation and supporting Development Agenda in respective Member States and comes in alignment with WIPO Medium Terms Strategic Plan 2022/2026. I thank you, Mr. Chair. Thank you very much for your intervention Mexico Thank you, Chair.Mexico also aligns itself with Delegations which have expressed their support to referencing the Sustainable Development Goals in the draft budget and the Development Acceleration Fund as currently reflected.Work on references to SDGs does not imply an external mandate above and beyond WIPO’s mandate but rather underpinning WIPO’s mandate within IP as a development tool. WIPO’s agenda is supported by all Member States and already intends to support IP in development. Including information on the SDGs in the budget is complimentary. This helps us to map out how projects help foster national and international development, increaseaccountability and ensures the evaluation of projects. This also helps us articulate our work better with the international system and other agencies and it helps us mobilize funds.So this does not limit our sovereignty but rather opens up greater opportunities for collaboration. The majority of Member States recognize that SDGs are an

Blog, Traditional Knowledge

WTO: Brazil, India and Peru call for the inclusion of a mandatory disclosure requirement in the WTO TRIPS Agreement

This post was originally published on KEI Online by Thiru On 18 March 2025, the World Trade Organization (WTO) published a communication (IP/C/W/719) by Brazil, India, and Peru entitled, “Revising discussions on the relationship between the TRIPS Agreement and Convention on Biological Diversity“. Brazil, India, and Peru have called for the inclusion of a mandatory disclosure requirement in the TRIPS Agreement based on a 2011 proposal (TN/C/W/59) by Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group in 2011 to amend Article 29 of the TRIPS Agreement. The paper makes no explicit reference to digital sequence information (DSI). While this topic was broached at the March 2025 TRIPS Council meeting, this topic will be addressed at the next TRIPS Council meeting (26-27 June 2025). In the chapeau of the March 2025 paper, the demandeurs (Brazil, India, and Peru) articulated the interplay between traditional medical knowledge, modern medicine, traditional and complementary medicine use, the misappropriation of genetic resources, intellectual property, and biopiracy: 2. A WTO-WIPO-WHO joint study of 2020 titled ‘Promoting Access to Medical Technologies and Innovation’ notes the profound influence of traditional medical knowledge on modern medicine. With 88% of WHO members acknowledging traditional and complementary medicine use, international trade in these products is growing rapidly. However, the study notes that this has come on the back of the rampant misappropriation of genetic resources (GR) and associated traditional knowledge (TK). Some prominent examples of biopiracy include neem (India), turmeric (India), kava (Pacific Islands-Fiji and Vanuatu), ayahuasca (Brazil), quinoa (Peru), and hoodia (South Africa). Assessing the economic loss to developing countries due to biopiracy is a complex task involving multiple factors, such as the loss of intellectual property (IP) rights, restricted access to genetic resources, negative impact on traditional industries, and discouragement of research and development in the country of origin. In relation to biodiversity, the co-sponsors of IP/C/W/719 quoted a WHO Global Report on Traditional and Complementary Medicine from 2019, “developing countries, especially those with rich biodiversity in Asia, Africa, and South America, supply approximately two-thirds of the plants used in western and global medical systems”. Furthermore, the demandeurs noted: While recent data is publicly unavailable, a 1999 report by the United Nations Development Program estimates that if a 2% royalty were charged on genetic resources developed by local innovators in the South, the North would owe over USD 300 million in unpaid royalties for farmers’ crop seeds and more than USD 5 billion in unpaid royalties for medicinal plants. In the 719 paper, Brazil, India, and Peru described the Convention on Biological Diversity (CBD) and the Nagoya Protocol as having a “significant shortcoming” noting that the CBD and Nagoya Protocol do not “link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.” 4. The CBD (1992) marked the first step towards recognising the sovereign rights of states over their biological resources. It conditioned access to biological resources and associated traditional knowledge with prior informed consent (PIC) and access and benefit sharing (ABS) with local communities, who are the rightful holders of such knowledge. The Nagoya Protocol, which came into force in 2014, further developed the legal framework established under the CBD to operationalise the requirements of PIC and ABS. A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context. The 719 paper points to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted in May 2024, as the culmination of over two decades of work to address some of the shortcomings in the CBD and Nagoya Protocol. 6. The WIPO treaty requires patent applicants to disclose the source of the genetic resources and traditional knowledge on which their claimed invention is based. The disclosure requirement, if complied with by the applicant, would aid the patent office in conducting a prior art search. It would help prevent the patenting of inventions based on genetic resources and associated traditional knowledge that do not fulfil the requirements of novelty and inventiveness. Genetic resources and associated traditional knowledge obtained from one country are often used as a basis for seeking a patent in another. In such situations, the disclosure requirement would make the patent office the checkpoint to identify instances of transboundary utilisation of genetic resources and traditional knowledge. While hailing the WIPO Treaty on IP, Genetic Resources and Associated Traditional Knowledge, the 719 demandeurs are cognizant that the WIPO treaty “does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems”. The demandeurs call for the amending of the TRIPS Agreement to integrate the mandatory disclosure requirement into the WTO’s institutional architecture, including its binding dispute settlement system. 7. While a progressive instrument, the WIPO treaty could be further strengthened by integrating these commitments under the TRIPS Agreement. First, the WIPO treaty does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems. Second, the WIPO treaty does not address the requirements to obtain PIC under mutually agreed terms (MAT). Hence, even though the treaty introduces the disclosure requirement, it does not provide for compliance with the ABS requirements. The WIPO treaty shifts the burden to ensure compliance on the government agencies and local communities of the provider country, who must monitor published patent applications worldwide to ensure compliance and enforce ABS through PIC under MAT. Thus, amending the TRIPS Agreement to integrate the mandatory disclosure requirement could subject this commitment to the WTO’s legal framework. Further, the TRIPS Agreement could build on the WIPO treaty to require evidence of PIC and benefit-sharing arrangements as a prerequisite for patent grant or commercialization, thereby reinforcing the

Blog

Fair Use Isn’t Optional: Judges Can Help Reclaim It for Creators

By Yuanxiao Xu. This post was originally published on Authors Alliance. “One need not be a copyright scholar to evaluate fair use. One need only understand the purpose of copyright. — Leval wins my heart forever” Brandon Butler’s drawing of Judge Leval. CC BY 4.0. If you have spent much time exploring U.S. copyright law, you’d likely have encountered the writings—or at least the influence—of Judge Pierre Leval. Among many other contributions, his “Toward a Fair Use Standard” article built a solid foundation for modern fair use jurisprudence. On the bench, Judge Leval’s opinions are famed for their clarity and balance, always mindful of “copyright’s overall objective of contributing to public knowledge,” as can be seen in his landmark decision in Authors Guild v. Google.  On May 23rd, another very important opinion was authored by Judge Leval for the Second Circuit Court in Romanova v. Amilus Inc. Although we won’t delve into it further in this blog post, his opinion provides much-needed clarification on “justification” post-Warhol—guidance that we hope many courts will follow in the coming years. The case facts in Romanova were simple and straightforward: a photographer sued a website for republishing her photo without permission. The district court wrongly found fair use, and the Second Circuit reversed.  The opinion authored by Judge Leval was characteristically thoughtful, not only in its substantive treatment of fair use, but also in its strong affirmation of the district court’s decision to raise fair use sua sponte (Latin for “of one’s own accord “—sua sponte is used to indicate that a court has taken notice of an issue on its own motion, without prompting or suggestion from either party). This post focuses on that procedural dimension of Romanova and goes one step further, explaining why fair use should never have been treated as an affirmative defense in the first place. For decades, Campbell v. Acuff-Rose has been celebrated as a decision that fortified fair use. But ironically, the decision also ossified the view that fair use is strictly an affirmative defense—significantly limiting the power of fair use to safeguard free expression in practice. Even where lower courts are doubtful, they nevertheless feel bound by the way the Campbell court construed fair use as an affirmative defense. In a footnote in Suntrust Bank v. Houghton Mifflin, the Eleventh Circuit Court mused: “fair use is commonly referred to an affirmative defense, see Campbell v. Acuff-Rose Music . . . Nevertheless, the fact that the fair use right must be procedurally asserted as an affirmative defense does not detract from its constitutional significance as a guarantor to access and use for First Amendment purposes.” Now, Judge Leval (whose influential scholarship was cited with approval in Campbell) is helping to restore the power of fair use as a fundamental right—one that cannot be waived, forfeited, or overlooked due to procedural missteps.  Although the case facts and substantive fair use ruling in Romanova are relatively routine, its procedural holding stands out as especially noteworthy. It restores to fair use its legal force and its human dimension.  The district court in Romanova, acting on its own initiative, dismissed the plaintiff’s copyright infringement claim on the basis of the defendant’s use being a fair use, even though the defendant had not appeared in court and never raised the fair use defense.  The Second Circuit upheld the decision of the district court to consider fair use sua sponte. While the court did not go so far as to declare that fair use is not an affirmative defense, Judge Leval’s opinion strips away some of the harmful consequences of treating fair use procedurally rigidly. According to Judge Leval, justice should not depend on one party’s ability to afford litigation, and that courts are always empowered to consider obvious, meritorious fair use defenses. Recognizing how imbalances in power play out in costly copyright litigation, Judge Leval reasoned with clairvoyance: At times, small corporations simply cannot afford the expense of counsel needed to defend a suit. Default does not necessarily preclude the court’s consideration of affirmative defenses available to the defendant, especially when they have obvious merit and their applicability is evident from the face of the complaint. Otherwise, plaintiffs could often easily inflict unjustified harms on small corporate enemies. Intimidation tactics would threaten to strip small creators of their content, and would silence the numerous small platforms that need the protection of the fair use doctrine. (emphasis added) He concluded: The district court here believed that its consideration of the fair use defense would serve justice and advance the goals of copyright. [The district] court misunderstood the fair use defense, which in fact had no proper application to these facts. But we cannot fault the district court for considering a defense which it believed (albeit mistakenly) was valid and important. While district courts should indeed be cautious before sua sponte invoking affirmative defenses on behalf of defaulting defendants, they should also be cautious about not considering such defenses. Up until this opinion, many courts have doggedly followed the mistaken belief that defendants must plead fair use in their answer or a motion to dismiss, or risk waiving it—because fair use has been characterized rigidly as an affirmative defense, a position reinforced by lower courts’ reading of Campbell.  An affirmative defense first admits that a wrongful act has occurred, then offers a justification or excuse that negates culpability. The wrongfulness of the act is central to the concept of an affirmative defense. For example, a bribe given in a foreign country is wrongful by nature, but if the foreign country’s written law allows for such payments, it can serve as an affirmative defense; a board of directors neglecting fiduciary duty is wrongful by nature, but they can use a later shareholder rectifying vote as an affirmative defense; most famously, perhaps, killing another human is wrongful by its nature, but self defense is an affirmative defense. Because of the innate wrongfulness of the acts in such circumstances, it seems reasonable that the presumed wrongdoer must raise an affirmative defense and support it with evidence.  However, fair use is not a wrongful act by nature, and treating it as though it were fundamentally misunderstands its role in copyright law. Unlike bribery, breach of fiduciary

Artificial Intelligence, Blog

The Great Flip: Can Opt-Outs be a Permitted Exception? Part II

Lokesh Vyas and Yogesh Badwal This post was originally published on Spicy IP. In the previous part, we examined whether the opt-out mechanism, as claimed in Gen-AI litigations, constitutes a prohibited formality for the “enjoyment and exercise” of authors’ rights under Article 5(2) of the Berne Convention. And we argued no. In this post, we address the second question: Can opting out be permitted as an exception under the three-step test outlined in Article 9(2)? If you haven’t seen the previous post, some context is helpful. (Or, you can skip this part) As we mentioned in the last post, “Many generative AI models are trained on vast datasets (which can also be copyrighted works) scraped from the internet, often without the explicit consent of content creators, raising legal, ethical, and normative questions. To address this, some AI developers have created and claimed “opt-out mechanisms,” allowing copyright holders or creators to ask that their works not be used in training (e.g., OpenAI’s Policy FAQs).  Opt out under the Copyright Exception A  question arises here: What are the other ways opt-out mechanisms can be justified if the states want to make a mechanism like that? One may say that opt-outs can be valid under the Berne Convention if an exception (e.g., an AI training exception with an inbuilt opt-out possibility) passes the three-step test. And this way, opt-outs can be regarded as a legitimate limit on holders’ exclusive rights. For reference, the three-step test was created in the 1967 revision conference, later followed in Article 13 of TRIPS and Article 10 of WCT. The test creates a room for the nations to make certain exceptions and limitations. Article 9(2) authorises the member countries “to permit the reproduction” of copyright works in 1.) “certain special cases, provided that such reproduction 2.) does not conflict with a normal exploitation of the work and 3.) does not unreasonably prejudice the legitimate interests of the author”.  Although we don’t delve into the test, how opting out can be a part of an exception can be understood from an example. For instance, as Ginsburg exemplifies, if a country states that authors lose their translation rights unless they explicitly reserve or opt out of them, it would violate Article 5(2) because such rights under Berne must apply automatically, without formalities. This actually happened with Turkey in 1931, whose application for membership was rejected due to the condition of deposit for translation rights in its domestic law. (See Ricketson and Ginsburg’s commentary, paragraph 17.18.)  But if an exception (like allowing radio retransmissions in bars) already complies with Berne’s provisions and applies equally to all authors, then letting authors opt out of that exception would give them more rights than Berne requires. And this should be permissible.  Notably, introducing an exception, such as for AI training, must first pass the three-step test. Opt out can be built therein. However, remember that every exception presupposes a prima facie infringement. Within that frame, the opt-out offers the author a chance not to lose. Thus, it creates an inadvertent expansion of her rights beyond the convention.  Additionally, opt-out can fare well with the three-step test due to the factor of “equitable remuneration to authors.” As Gompel notes in his piece, “…‘opt out’ eases compliance with the three-step test because it mitigates some of the adverse effects of the proposed copyright exception. That is, it enables authors to retain exclusivity by opting out of the compensation scheme.”  Another question also exists: Did Berne contain particular provisions that directly allowed an opt-out arrangement? Well, the answer is Yes. Does opting out equal the right to reserve under Article 10bis? Not really. Setting aside the debate over formality and the three-step test, the Berne Convention contains an opt-out-style provision, albeit limited, where authors must explicitly reserve their rights to avoid specific uses of their work. Relevant here is Article 10bis of the Convention, which allows member countries to create exceptions for the reproduction of works published in newspapers on, among other topics, current economic, political, or religious issues. However, it also allows the authors to ‘expressly reserve’ their work from reproduction. Indian Copyright Act, 1957 also contains a similar provision in Section 52(1)(m). Interestingly, the right to reserve exploitation has been part of the Berne Convention since its earliest draft. It first appeared in Article 7 alongside the provision on formalities, which was numbered Article 2 in the draft. Article 7 became Article 9(2) in 1908, when formalities were prohibited and the no-formality rule entered the Berne Convention.  This historical pairing raises a strong presumption: opting out of a specific mode of exploitation cannot automatically be deemed a prohibited formality. Ginsburg confirms this, citing the 1908 Berlin Conference, which clarified that the reservation/opt-out clause (then Article 9(2)) was not considered a formality. But can this special setting (created in Article 10bis(1)) be used to open the door for general opt-out AI exception measures by countries? We doubt it. As the negotiation history of the 1967 revision conference suggests, Article 10bis(1) is a lex specialis, i.e., a narrow and specific exception (See page 1134 of Negotiations, Vol. II). This means that it may derogate from the general no-formalities rule, but it cannot serve as a model for broader declaratory measures.  Conclusion The upshot is that opt-outs may be de facto formalities. However, not all formalities are prohibited under the Berne Convention. The convention enables countries to make some formalities on “the extent of protection.” Three key points emerge from this discussion: One, opting out may not be a formality that prevents the enjoyment and exercise of rights, as Gompel and Sentfeln confirm, and Ginsburg argues otherwise. Two, it can be a part of an AI training exception if such an exception can pass the three-step test. When applying this test, opting out would support the factor of equitable remuneration. Three, Article 10(bis) on the right to reserve cannot be read expansively. While it can be used to justify the three-step test as Sentfleben does, it might not be extended generally. Okay. That’s it from our end. À bientôt’ Primary Sources:-

Artificial Intelligence, Blog

The Great Flip: Is Opt Out a Prohibited Formality under the Berne Convention? Part I

Lokesh Vyas and Yogesh Badwal This post was originally published on Spicy IP. Bonjour, Lately, we’ve been cogitating on this curious concept called the “opt-out”, which has been cropping up with increasing frequency in generative AI litigation, including in India. The EU and the UK are taking the idea seriously and considering giving it statutory teeth. On the surface, it is sold as a middle path, a small price to pay for “balance” in the system. However, at least prima facie, it seems like a legal absurdity that fractures its modern foundational logic, where authors receive default copyright without any conditions. The opt-out model, the argument goes, reintroduces formality through the back door, a de facto formality of sorts. This shifts the burden onto authors and rights holders to actively monitor or manage their works to avoid unintended inclusion in the AI training. There have been questions about whether such an opt-out scheme is compatible with the Berne Convention, which prohibits the same under Article 5(2), e.g., here, here, and here.  Given the complex nature of this issue and the fact that many such discussions happen behind paywalls, making them inaccessible to the public, we thought it would be beneficial to share our ideas on this topic and invite further reflection. This two-part post mainly focuses on the legality of opting out without addressing its implementability and applicability, which raises several questions (e.g., as discussed recently in Martin Sentfleben’s post). In short, we probe whether opt-outs violate the Berne Convention—the first international copyright law treaty binding on all members of the TRIPS and WCT.  We answer it through two questions and discuss each one separately. First, is opt-out a prohibited formality for the “enjoyment and exercise” of authors’ rights under Article 5(2) of the Berne Convention? Two, can it be permitted as an exception under the three-step test under Article 9(2)? We answer the first question in the negative and the second in the positive. Additionally, we also examine whether Berne already has a provision that can allow this without looking at the details.  This post addresses the first question. What Makes Opts Outs So Amusing – The Flip? Many generative AI models are trained on vast datasets, which can also include copyrighted works scraped from the internet without the explicit consent of content creators, raising legal, ethical, and normative concerns. To address this, some AI developers have created and claimed “opt-out mechanisms,” allowing copyright holders or creators to ask that their works not be used in training (e.g., OpenAI’s Policy FAQs).  Herein lies the catch: it requires authors and copyright holders to explicitly say “No” to training by adding a robots.txt tag to their website with specific directives that disallow web crawlers from accessing their content. (E.g., see this OpenFuture’s guide here) Thus, instead of creators being protected by default, they are supposed to opt out to prevent exploitation. One could say that this flips the logic of copyright on its head–from a presumption of protection to a presumption of permission. But that’s not so simple.  Notably, opting out is not a novel argument. In fact, it can be dated back at least to the 1960s in the Nordic countries’ model of “Extended Collective Licensing” (ECL), which mandates collective licensing while preserving the author’s right to opt out. Other notable academic literature on opt-out can be found here, here, here, and here, dating back over two decades. Swaraj also covered this issue a decade ago. In particular, we must acknowledge the scholarship of Jane Ginsburg, Martin Sentfleben, and Stef van Gompel, who have significantly influenced our thinking on the topic. Two Key Questions: Opt out as a Formality and opt out under a permitted Exception Formality Argument first.  Here, the argument goes that the opt-out is a prohibited formality under Article 5(2) and should not be allowed. However, we doubt it. Let’s parse the provision first. Which states: “(2) The enjoyment and the exercise of these rights shall not be subject to any formality; such enjoyment and such exercise shall be independent of the existence of protection in the country of origin of the work. Consequently, apart from the provisions of this Convention, the extent of protection, as well as the means of redress afforded to the author to protect his rights, shall be governed exclusively by the laws of the country where protection is claimed.” (Authors’ emphasis) For context, the provision pertains to “Rights Guaranteed outside the Country of Origin” for both national and foreign authors. And the question of no-formality pertains particularly to foreign authors. In other words, by removing formality requirements in the country where protection is claimed, the provision enabled authors to automatically receive protection without needing to satisfy foreign formalities. This matters because while countries can impose conditions on their own nationals, it’s generally assumed that they will not treat their own authors worse than foreign ones. The post follows this presumption: if a country cannot burden foreign authors, it’s unlikely to impose stricter terms on its own people. Although the removal of formalities had been discussed in the international copyright law context as early as the 1858 Brussels Conference, an important event in the development of international copyright law, it was not implemented until 1908. This change addressed practical difficulties, including identifying the “country of origin” when a work was published in multiple countries, and the challenges courts faced in enforcing rights without formalities. (See International Bureau’s Monthly Magazine, January 1910) Tellingly, while a country can make formalities for its people, it cannot do so for foreign authors. It’s generally assumed that a country would not obligate its authors more than it does to foreign authors. Textual Tensions of Article 5(2) While the phrase “any formality” in the first line of the provision might suggest that all kinds of formalities—including de facto ones like opt-out mechanisms—are prohibited, that is arguably not the case. We say this because the provision is divided into two parts, and the prohibition on formalities applies only to the first part, which is germane to enjoying and exercising rights. The second part of the provision, beginning with “Consequently”, gives leeway to the states wherein they can make formalities regarding the ‘extent of protection’ and

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EIFL publishes new provision on Secondary Publication Rights

Luca Schirru and Sean Flynn EIFL Draft Law on Copyright On May 27, 2025, EIFL launched an updated version of its Draft Law on Copyright, featuring a new provision on Secondary Publication Rights (SPRs) (more information about the process can be found here). The new provision reads as follows:  This provision is part of the EIFL Draft Law on Copyright, a “practical guide to assist librarians, policy-makers and legislators when copyright laws are being updated.” The guide aims to support libraries and is continually updated considering recent policy and legislative developments and the impact of new technologies.  Secondary Publication Rights According to Angelopoulos (2022, p.4), a Secondary Publication Right is a “right for the author of a scientific publication to make it available online for free following a given embargo period”. Countries such as Austria, Belgium, Bulgaria, France, Germany, Italy, the Netherlands, and, more recently, Slovenia, already have provisions addressing SPRs in their legal frameworks.  In Belgium, for example, even in cases where the author has assigned their rights to a publisher, if the research was publicly funded, the author can make the manuscript publicly available in open access after 12 months for the humanities and social sciences, and 6 months for other sciences (Belgium Code of Economic Law, Art. XI. 196 2 §). Secondary Publication Rights are also present in South Africa’s Copyright Amendment Bill, through the insertion of section 12D in Act 98 of 1978, as follows: SPRs are also closely linked to open access policy goals, as demonstrated by the Commission Recommendation 2018/790 on access to and preservation of scientific information. This Recommendation states that Member States should implement policies and action plans related to open access and that, as a result, “whatever the channel of publication[…], open access to publications resulting from publicly funded research be granted as soon as possible, preferably at the time of publication, and in any case no later than six months after the date of publication (no later than 12 months for social sciences and humanities).” Footnotes:

Artificial Intelligence, Blog

Fair Use and Generative AI: Reading Between the Lines of the USCO Report

Luca Schirru and Sean Flynn At the beginning of May, the report “Copyright and Artificial Intelligence. Part 3: Generative AI Training” was released, sparking a wide range of debates due to its content and the political issues surrounding its release. In this short contribution, we aim to briefly introduce the report and touch on some of the key content and political issues currently being discussed. SCOPE AND STRUCTURE OF THE REPORT The first thing that stands out about the report appears right on its first page: “pre-publication version”: a label reported as unusual and potentially unprecedented. The 113-page document addresses one of the most controversial issues at the intersection of copyright and Generative AI: the use of protected content to train Generative AI systems.  While most sources focus on fair use, the report also includes sections on “technical background,” “infringement,” and “licensing for AI training”, all of which are a “must read,” especially for those just joining the discussion and feeling overwhelmed by the hundreds of thousands of articles, blogs, books, and other resources available on the topic. The report attempts to summarize some of the main issues in both the legal and technical fields. The approach taken by the USCO is sometimes described as “favorable to copyright owners” or as “a mixed bag”, receiving both praise and criticism on multiple fronts, as we will illustrate below. POLITICAL CONTEXT AND CONTROVERSIES The timing of the report While it may be early to determine the precise reasons behind the (unusual) release of a pre-publication version, several explanations have been speculated, though none have been confirmed. The report states that its early release was made “in response to congressional inquiries and expressions of interest from stakeholders.” However, questions have been raised that may relate to concerns about potential restrictions under Trump Administration, which is arguably aligned with positions favorable to big technology companies, as well as fear that the report could be buried in the event of the dismissal of the Register of Copyright, or the potential influence on ongoing legal cases. Regarding the latter, there have been concerns about the timing of the report and how it could interfere with the outcomes, especially the fair use analysis, of ongoing lawsuits. As noted, “it could put a thumb on the scale for how the courts will resolve these cases,” without giving the parties an opportunity to address any potential gaps in the report, which could have a significant impact on other GenAI cases. Leadership changes and copyright policy While the timing of the notice of dismissal of Shira Perlmutter (Register of Copyrights at the time the report was drafted) and the release of the report could give rise to the inference that the report was the sole reason for her dismissal, other events may have influenced the decision as well. The day before the release of the (pre-publication version of the) report, the Librarian of Congress, Carla Hayden, who had appointed Shira Perlmutter, was dismissed. Therefore, concerns about additional leadership changes may also have played a role in the decision to release the pre-publication version. An extra layer of complexity arises when one considers that Perlmutter’s position was one appointed and overseen by the legislative branch. The argument that the report may have contributed to the dismissal has often been linked to an alleged alignment between the Trump Administration’s position and that of big tech companies. This connection can be inferred from Rep. Joe Morelle’s statement, reported by POLITICO, claiming it is “no coincidence [Trump] acted less than a day after [Perlmutter] refused to rubber-stamp Elon Musk’s efforts to mine troves of copyrighted works to train AI models.” Finally, as reported by Authors Alliance, on April 30, “American Accountability Foundation urges President Trump to fire ‘deep state’ librarians, targeting Carla Hayden and Shira Perlmutter,” based on the claim that Hayden was supporting Biden policies, particularly in the areas of intellectual property and transgender rights. FAIR USE AT THE HEART OF THE DEBATE While the report addresses multiple issues, both legal and technical, the most debated (and anticipated) topics are those related to whether the use of protected content to train Generative AI systems qualifies as fair use. The fair use chapter is the longest in the report, comprising nearly half of its content. It includes a factor-by-factor analysis applied to different scenarios, with the USCO identifying the first and fourth factors as taking on particular prominence in the analysis. In the section titled “weighing the factors,” the Office states the following: “As generative AI involves a spectrum of uses and impacts, it is not possible to prejudge litigation outcomes. The Office expects that some uses of copyrighted works for generative AI training will qualify as fair use, and some will not. On one end of the spectrum, uses for purposes of noncommercial research or analysis that do not enable portions of the works to be reproduced in the outputs are likely to be fair. On the other end, the copying of expressive works from pirate sources in order to generate unrestricted content that competes in the marketplace, when licensing is reasonably available, is unlikely to qualify as fair use. Many uses, however, will fall somewhere in between.” (p.74) While there has been some agreement with certain parts of the report, such as the acknowledgment that litigation outcomes cannot be prejudged, and the view that “research and academic uses should be favored under the fair use analysis”, one of the most criticized aspects is the interpretation of the fourth factor in the fair use analysis, in which the Report concludes that original works created by AI that are not substantially similar to works used in the training may nonetheless result in “market dilution” that should weigh against a fair use analysis. According to USCO’s report: “While we acknowledge this is uncharted territory, in the Office’s view, the fourth factor should not be read so narrowly. The statute on its face encompasses any “effect” upon the potential market.373 The speed and scale at

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