Pandemics, intellectual property and 'our economy': A worldview analysis of Canada's role in compromising global access to COVID-19 vaccines.

Despite self-congratulatory rhetoric, Canada compromised COVID-19 vaccine equity with policies impeding a proposed global waiver of vaccine intellectual property (IP) rules. To learn from Canada's vaccine nationalism we explore the worldview - a coherent textual picture of the world - in a sample of Government of Canada communications regarding global COVID-19 vaccine sharing. Analysed documents portray risks and disparities as unrelated to the dynamics and power relations of the Canadian and international economies. Against this depoliticised backdrop, economic growth fueled by strict IP rules and free trade is advanced as the solution to inequities. Global vaccine access and distribution are pursued via a charity-focused public-private-partnership approach, with proposals to relax international IP rules dismissed as unhelpful. Rather than a puzzling lapse by a good faith 'middle power', Canada's obstruction of global COVID-19 vaccine equity is a logical and deliberate extension of dominant neoliberal economic policy models. Health sector challenges to such models must prioritise equity in global pandemic governance via politically assertive and less conciliatory stances towards national governments and multilateral organisations. Mobilisation for health equity should transform the overall health-damaging macroeconomic model, complementing efforts based on specific individual health determinants or medical technologies.

SecureNet: Proactive intellectual property protection and model security defense for DNNs based on backdoor learning.

With the widespread application of deep neural networks (DNNs), the risk of privacy breaches against DNN models is constantly on the rise, resulting in an increasing need for intellectual property (IP) protection for such models. Although neural network watermarking techniques are widely used to safeguard the IP of DNNs, they can only achieve passive protection and cannot actively prevent unauthorized users from illicit use or embezzlement of the trained DNN models. Therefore, the development of proactive protection techniques to prevent IP infringement is imperative. To this end, we propose SecureNet, a key-based access license framework for DNN models. The proposed approach involves injecting license keys into the model through backdoor learning, enabling correct model functionality only when the appropriate license key is included in the input. To ensure the reusability of DNN models, we also propose a license key replacement algorithm. In addition, based on SecureNet, we designed defense mechanisms against adversarial attacks and backdoor attacks, respectively. Furthermore, we introduce a fine-grained authorization method that enables flexible granting of model permissions to different users. We have designed four license-key schemes with different privileges, tailored to various scenarios. We evaluated SecureNet on five benchmark datasets including MNIST, Cifar10, Cifar100, FaceScrub, and CelebA, and assessed its performance on six classic DNN models: LeNet-5, VGG16, ResNet18, ResNet101, NFNet-F5, and MobileNetV3. The results demonstrate that our approach outperforms the state-of-the-art model parameter encryption methods by at least 95% in terms of computational efficiency. Additionally, it provides effective defense against adversarial attacks and backdoor attacks without compromising the model's overall performance.

Intellectual Property Rights: Protection of Biotechnological Inventions in India.

The current Intellectual Property Rights (IPR) framework supports the commercialization of seed improvement, monoculture, and the patent protection of novel plant varieties, microorganisms, and genetically modified animals. As a consequence, our rich biogenetic diversity is irreversibly dissipating. However, we need to figure out how to create a methodology for elective choices that will achieve harmony between the official Intellectual Property (IP) structure and maintainable biodiversity components. The majority of the biotechnology sector's programmes in India are managed by the Department of Biotechnology. It is under the Ministry of Science and Technology. Its goals are to provide services in the fields of study, infrastructure, human resource development, biotechnology popularisation, industry promotion, and establishment of centres of excellence. Implementation of practise biosafety regulations for genetically modified organisms, recombinant DNA products, and programmes is based on biotechnology for the good of society. This creates an information network for India's bioinformatics mission in the local, national, and worldwide scientific community.

CIPSI: An open chemical intellectual property service for medicinal chemists.

The availability of patent chemical data offers public access to a chemical space that is not well covered by other sources collecting small molecules from scholarly literature. However, open applications to facilitate the search and analysis of biologically-relevant molecular structures present in patents are still largely missing. We have developed CIPSI, an open Chemical Intellectual Property Service @ IMIM to assist medicinal chemists in searching and analysing molecules in SureChEMBL patents. The current version contains 6,240,500 molecules from 236,689 pharmacological patents, of which 5,949,214 are confidently assigned to core chemical structures reminiscent of the Markush structure in the patent claim. The platform includes some graphical tools to facilitate comparative patent analyses between drugs, chemical substructures, and company assignees. CIPSI is available at https://cipsi.org.

Intellectual Property and the Politics of Public Good during COVID-19: Framing Law, Institutions, and Ideas during TRIPS Waiver Negotiations at the WTO.

CONTEXT: To facilitate the manufacturing of COVID-19 medical products, in October 2020 India and South Africa proposed a waiver of certain intellectual property (IP) provisions of a World Trade Organization (WTO) agreement. After nearly two years, a narrow waiver agreement that did little for vaccine access passed the ministerial despite the pandemic's impact on global trade, which the WTO is mandated to safeguard. METHODS: The authors conducted a content analysis of WTO legal texts, key-actor statements, media reporting, and the WTO's procedural framework to explore legal, institutional, and ideational explanations for the delay. FINDINGS: IP waivers are neither legally complex nor unprecedented within WTO law, yet these waiver negotiations exceeded their mandated 90-day negotiation period by approximately 18 months. Waiver opponents and supporters engaged in escalating strategic framing that justified and eventually secured political attention at head-of-state level, sidelining other pandemic solutions. The frames deployed discouraged consensus on a meaningful waiver, which ultimately favored the status quo that opponents preferred. WTO institutional design encouraged drawn-out negotiation while limiting legitimate players in the debate to trade ministers, empowering narrow interest group politics. CONCLUSIONS: Despite global political attention, the WTO process contributed little to emergency vaccine production, suggesting a pressing need for reforms aimed at more efficient and equitable multilateral processes.

Designing the global vaccine supply chain: balancing intellectual property rights with post COVID-19 vaccine equity.

This article aims to propose practical solutions that coordinate the conflicting interests between the global community and the pharmaceutical industry on the intellectual property (IP) waiver for COVID-19 vaccines and facilitate a more equitable vaccine supply chain in the post-COVID-19 world. We critically conducted a narrative literature review to identify procedural and practical issues in the current vaccine supply chain. The search was conducted across various academic disciplines, including biomedical science, life science, law and social science, using resources such as PubMed, Web of Science, Scopus and Westlaw. After screening 731 articles, 55 studies were selected for review. The narrative review revealed several critical barriers that hinder vaccine supply in less-developed countries (LDCs) as follows: (1) WTO Trade-Related Aspects of Intellectual Property Rights (TRIPs) waiver requests may not be granted due to its stringent consensus rule; (2) the current compulsory license system may not work due to the complexity of IP rights covering COVID-19 vaccine technologies; (3) only a few LDCs have domestic companies capable of manufacturing vaccines, and (4) political and economic tensions among countries exacerbate existing barriers to vaccine distribution in LDCs. Based on these findings, we proposed a comprehensive compulsory license system, which combines TRIPS's compulsory license system with the third-party beneficiary mechanism under Common Law. This integrated approach offers a balanced solution that ensures fair compensation for vaccine developers while facilitating broader vaccine access.

Trade-Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation.

Policy Points Given the challenges associated with negotiating the COVID-19 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver, there are questions as to whether the World Trade Organization is able to effectively address pandemics and global crises under the current architecture. Although the framework set out by the TRIPS Agreement does not view intellectual property (IP) rights as a means to foster public health and development, IP rights should nonetheless be interpreted through a public health lens. Countries should implement compulsory licensing provisions into their patent legislation, which increase access to medicines and allow governments (especially in developing and least-developed countries) to better protect public health. CONTEXT: The protection of intellectual property (IP) rights, given international legal effect through the World Trade Organization (WTO) Trade-Related Aspects of IP Rights (TRIPS) Agreement, has long been a contentious issue. In recent years, the long-standing debate on IP rights as a barrier to the access of affordable medicines has been heightened by the global vaccine inequity evidenced during the COVID-19 pandemic. The TRIPS Agreement contains a number of flexibilities that WTO members can exploit in order to accommodate their policy needs. Among these is the mechanism of compulsory licensing, whereby patent licenses may be granted without consent of the patent holder in certain circumstances. TRIPS Article 31bis created a special mechanism for compulsory licenses specifically for the export of pharmaceutical products to countries with insufficient manufacturing capacity. METHODS: We analyzed domestic patent legislation for 195 countries (193 UN members and two observers) and three customs territories. We analyzed patent legislation for provisions on compulsory licenses, including those defined in Article 31bis of the TRIPS Agreement. FINDINGS: We identified 11 countries with no patent legislation. Of the 187 countries with domestic or regional patent laws, 176 (94.1%) had provisions on compulsory licensing and 72 (38.5%) had provisions implementing TRIPS Article 31bis. CONCLUSIONS: The results of this study have highlighted the gap in the implementation of TRIPS flexibilities in countries' national patent legislation, especially in least-developed countries. Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population's public health. Further discussions are needed to determine whether the WTO can provide effective responses to future pandemics or global crises.

Fortifying Health Care Intellectual Property Transactions With Blockchain.

BACKGROUND: Intellectual property (IP) is a substantial competitive advantage in the health care industry. However, the COVID-19 pandemic highlighted the need for open innovation and collaboration for the greater good. Despite this, the industry faces challenges with innovation owing to organizational and departmental barriers. A secure platform is necessary to facilitate IP sharing without compromising the rights of IP owners. OBJECTIVE: This study proposes a blockchain-based framework to secure IP transactions in health care and bring social impact. METHODS: This study reviews existing researches, publications, practical cases, firm and organization websites, and conferences related to blockchain technology, blockchain in health care, blockchain in IP management, IP pledge research, and practice of IP management blockchain. The platform architecture has 7 components: pledgers, advanced research technology (ART), IP pledge platforms, IP databases, health care research, seeking ART, and transaction condition setting. These components work together seamlessly to support the sharing and pledging of ART and knowledge, while ensuring the platform's transparency, security, and trust. RESULTS: The open IP pledge framework can promote technology dissemination and use, reduce research and development costs, foster collaboration, and serve the public interest. Medical organizations' leadership and support and active participation from stakeholders are necessary for success. By leveraging blockchain technology, the platform ensures tamper-proof and transparent transactions and protects the rights of IP owners. In addition, the platform offers incentive mechanisms through pledge tokens that encourage stakeholders to share their ART and contribute to the platform. CONCLUSIONS: Overall, the proposed framework can facilitate technological innovation, tackle various challenges, and secure IP transactions. It provides a secure platform for stakeholders to share their IP without compromising their rights, promoting collaboration and progress in the health care industry. The implementation of the framework has the potential to revolutionize the industry's approach to innovation, allowing a more open and collaborative environment driven by the greater good.

Bioprecariedad. El poder de las patentes y su impacto en la salud pública / Bioprecarietat. El poder de les patents i el seu impact en la salut pública / Bioprecariousness. The power of patents and their impact on Public Health

El objetivo del presente artículo es analizar el poder de las patentes y su papel en la confrontación actual entre el derecho a la salud (pública) y los derechos a la propiedad intelectual (patentes), ambos reconocidos por la Declaración Universal de Derechos Humanos. Este poder se basa en el control monopolístico de material biológico mediante las patentes biotecnológicas o “patentes de lavida”. La Oficina Española de Patentes y Marcas define las patentes como “un título que reconoce el derecho de explotar en exclusiva una invención, impidiendo a otros su fabricación, venta o utilización sin consentimiento del titular”. Este monopolio permite establecer precios elevados a los productos patentados, condenando a miles de personas a lo que denominamos “bioprecariedad” entendida como la violencia estructural contra la vida por la falta de acceso a productos patentados básicos para la supervivencia (vacunas, semillas, medicamentos, tratamientos o kits de diagnóstico). En el escenario de la pandemia del Covid-19, la Bioprecariedad ha sido la protagonista, especialmente en el desigual reparto de las vacunas entre países ricos y países pobres. Nuestra propuesta es crear un marco normativo y comités de ética de patentes que sirva para poner límites éticos a las patentes según los criterios de responsabilidad y cautela; justicia global; y capacidades y desarrollo humano.(AU)

L'objectiu del present article és analitzar el poder de les patents i el seu paper en la confrontació actual entre el dret a la salut (pública) i els drets a la propietat intel·lectual (patents), tots dos reconeguts per la Declaració Universal de Drets Humans. Aquest poder es basa en el control monopolístic de material biològic mitjançant les patents biotecnològiques conegudes com “patents de la vida”. L'Oficina Espanyola de Patents i Marques defineix les patents com “un títol que reconeix el dret d'explotar en exclusiva una invenció, impedint a altres la seva fabricació, venda o utilització sense consentiment del titular”. Aquest monopoli permet establir preus molt elevats,condemnant a milers de persones al que denominem “Bioprecarietat” entesa com a violència estructural contra la vida per la manca d'accés a productes patentats bàsics per a la supervivència (vacunes, llavors, medicaments, tractaments o kits de diagnòstic).En l'escenari de la pandèmia del Covid-19, la Bioprecarietat ha estat protagonista, especialment en el desigual repartiment de les vacunes entre països rics i pobres. La nostra proposta és crear un marc normatiu i comitès d'ètica de patents que serveixin per a posar límits ètics a les patents segons els criteris de responsabilitat i cautela; justícia global; i capacitats i desenvolupament humà.(AU)

This article is focused on the analysis of the power of patents and their role in the current confrontation between the right to (public) health and the right to Intellectual property (patents), which are both human rights recognised by the Universal Declaration of Human Rights. This power is based on the monopoly controlling life (biological material) by means of biotechnological patents or “patents of life”. The Spanish Patent and Trademark Office defines a patent as “a title recognising the right to exclusively exploit aninvention, preventing third parties from manufacturing, selling or using it without prior consent of the owner”. This monopoly involves high prices for patented products, which condemns thousands of people to what we call “bioprecariousness” defined as structural violence against life due to the lack of access to basic patented products (vaccines, seeds, medicines, treatments and tests). Bioprecariousness has also been present in the Covid-19 pandemic, given that there has been an unequal distribution of vaccines between rich and poor countries. We propose a new ethical framework and ethical patent committees aimed at setting ethical limits to patents according to the criteria of responsibility and caution; global justice, and capabilities and human development.(AU)

After biosovereignty: The material transfer agreement as technology of relations.

Increasingly, countries in the Global South-notably South Africa, Brazil, and Indonesia-are introducing material transfer agreements (MTAs) into their domestic laws for the exchange of scientific material. The MTA is a contract securing the legal transfer of tangible research material between organizations such as laboratories, pharmaceutical companies, or universities. Critical commentators argue that these agreements in the Global North have come to fulfill an important role in the expansion of dominant intellectual property regimes. Taking Indonesia as a case, this article examines how MTAs are enacted and implemented differently in the context of research involving the Global South. Against the conventionally understood forms of contract that commodify and commercialize materials and knowledge, the MTA in the South can be understood as a legal technology appropriated to translate a formerly relational economy of the scientific gift to a market system of science. As a way of gaining leverage in the uneven space of the global bioeconomy, the MTA functions as a technology for 'reverse appropriation', a reworking of its usage and meaning as a way of countering some of the global power inequalities experienced by Global South countries. The operation of this reverse appropriation, however, is hybrid, and reveals a complex reconfiguration of scientific exchange amidst a growing push for 'open science'.

Carbon emission reduction effects of intellectual property institution construction in China.

Institutions are the fundamental determinants of carbon emission performance. However, the environmental impact of intellectual property institution, especially its impact on carbon emissions, has been paid little attention. Therefore, the main purpose of this study is to assess the effect of intellectual property institution on carbon emission reduction, revealing a new solution to control carbon emissions. To achieve the goal, this study regards the National Intellectual Property Demonstration City (NIPDC) policy in China as a quasi-natural experiment of intellectual property institution construction and exploits the difference in difference approach to objectively evaluate the impact of intellectual property institution on carbon emission reduction based on the panel data of China's cities. The study draws the following important conclusions. First, compared with non-pilot cities, the NIPDC policy has reduced urban carbon emissions by 8.64% in pilot cities. In particular, the "carbon emission reduction dividend" of the NIPDC policy is in the long term but not in the short term. Second, the influence mechanism analysis shows that the NIPDC policy can promote carbon emission reduction by stimulating technology innovation, especially breakthrough innovation. Third, the space overflow analysis reveals that the NIPDC policy can mitigate carbon emissions in adjacent areas, resulting in obvious spatial radiation effect. Fourth, the heterogeneity analysis confirms that the carbon emission reduction effect of the NIPDC policy is more obvious in low administrative hierarchic cities, small and medium-sized cities, and western cities. As a result, Chinese policymakers should orderly promote the construction of NIPDCs, strengthen technology innovation, give full play to the spatial radiation role of NIPDCs, and optimize the role of government, so as to better release the carbon emission abatement effect of intellectual property institution.

Intellectual Property in Facial Plastic and Reconstructive Surgery: The Importance and Process of Obtaining Intellectual Property Rights.

Understanding the purpose and process of obtaining intellectual property rights (IPR) is fundamental to health care innovation. Facial plastic and reconstructive surgeons are natural innovators; however, knowledge deficit in this space may hinder the ability to move ideas from the "bench to bedside." Here we provide an overview of IPR, outlining the steps necessary to obtain intellectual property protection in an academic setting while highlighting recent U.S. Food and Drug Administration (FDA) approvals pertaining to facial plastic and reconstructive surgery.

Intellectual property protection for traditional medical knowledge in China's context: a round peg in a square hole?

This article is an examination of the extent to which traditional medical knowledge in China can be protected by intellectual property laws. The analysis begins by providing a global picture with regard to the historic origin of intellectual property, exploring the reasons why China does not have indigenous counterparts to the western system of intellectual property rights protecting its traditional knowledge (including traditional medical knowledge) and stating the problems of transplanting western intellectual property standards in China. A discussion follows on how China, under foreign pressure, has made efforts to comply with the changing standards mandated by various international, regional, and bilateral arrangements related to intellectual property, with examples of the development of China's patent law. China's approach towards the protection of traditional medical knowledge in various international fora related to intellectual property is explored. Finally, there is a specific examination of the compatibilities between the western system of intellectual property rights and traditional medical knowledge in China, at the national and community levels. This article argues that the system of intellectual property rights does not easily fit with China's traditional medical knowledge because of China's unique cultural traits, distinctive historical context and wide ethnic, religious, and local community diversity.

Subsidies versus intellectual property rights when innovators operate in two markets.

Intellectual property rights are monopoly rights, which have undesirable welfare properties. Therefore, several studies suggest using rewards as incentives for innovation instead. However, these studies have thus far had little effect on actual policy, possibly because such rewards may be difficult to implement in practice. We suggest a new way of providing incentives to originators, which is easier to implement. Our suggestion can be used if there is an additional market in which originators operate, where copying is not easily possible. In this case, intellectual property rights in one market can be replaced by subsidies in the other market. Taking the music industry as example, copyrights in the records market could be replaced by subsidies in the market for live performances. We develop a partial equilibrium model that can be used to analyze in which cases the replacement of intellectual property rights in one market with subsidies in another market is welfare improving and better for the originator. A numerical application example suggests that the subsidy scheme may indeed be better in the music industry. The subsidy scheme can be implemented as a voluntary option, which would even be possible without changing the legal framework of intellectual property rights.

Review on 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020 Emphasizing Intellectual Property and Regulatory Considerations for Reformulations and New Combinations.

Repurposing is considered an attractive approach for developing new drug products. However, it consists of challenges relating to intellectual property (IP) protection, and regulatory approvals. This study aimed to analyze the recent trends in repurposed drugs approved by USFDA from 2010 to 2020 and to assess the challenges connected with bridging study requirements, patent protection, and exclusivities. Out of 1001 NDAs, 570 were approved via 505(b)(2) pathway. Of 570 NDAs, the highest number of approvals are allied to type 5-new formulations (42.4%), followed by type 3-new dosage forms (26.4%) and type 4-new combinations (13.1%). Of 570 NDAs, 470 are considered to examine the patent and exclusivity protection of which 341 have patent and/or exclusivity. A total of 97 type-3 and type-5 and 14 type-4 drugs have been approved based on human bioavailability/bioequivalence (BA/BE) data. For 131 type-3 and type-5 and 34 type-4 drugs, the applicants conducted new clinical (efficacy and/or safety) studies along with BA/BE (100 drugs) or without BA/BE (65 drugs) studies. In this review, mechanistic reasons for conducting new clinical investigations, IP and regulatory considerations along with broader perspective on new pharmaceutical approaches employed in 505(b)(2) drugs are illustrated that provide guidance for development of reformulations and combinations.