So Let's Design a Peptide . . . A Physician's Approach.

This paper outlines a process undertaken by a physician to design a peptide aimed at impacting the extracellular matrix. From a position of very little expertise, a new peptide was designed with amino acid constituents based on the structural proteins collagen and elastin. Sequencing was also considered, given the periodic repetition observed in these proteins, and a peptide with reasonable molecular weight and physical characteristics was designed using available software. The sequence of events concerning intellectual property, functionality investigation, and eventual use of the peptide in new formulations is detailed. This may be of interest to physicians who consider this exercise out of the scope of the usual practice. J Drugs Dermatol. 2024;23(5):347-352.    doi:10.36849/JDD.7921.

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.

Comprehensive intellectual property ability and firm productivity: A quasi-natural experiment based on national intellectual property demonstration advantage firm policy in China.

Intellectual property is crucial for the development of firms. At the micro level, firm comprehensive intellectual property ability involves abilities about intellectual property creation, utilization, protection, and management. In order to develop the comprehensive intellectual property ability of firms, the China National Intellectual Property Administration began to implement the national intellectual property demonstration advantage firm (NIPDAF) policy in 2013. Based on this exogenous policy shock, using data from listed companies from 2011 to 2020 as the research sample, the time-varying DID method is used to test the impact of the NIPDAF policy intended to cultivate comprehensive intellectual property ability on firm productivity. The results show that after policy implementation, the total factor productivity of NIPDAFs increased by about 3.3% compared to the control group. This finding is robust after a series of tests. Furthermore, the NIPDAF policy promotes firm productivity through stimulating technology innovation, improving investment efficiency, and enhancing competitive advantage. In addition, the NIPDAF policy has a more significant incentive effect on the total factor productivity of non-state-owned enterprises, firms in the eastern region, and firms in patent intensive industries.

Paucity of intellectual property rights information in the US biologics system a decade after passage of the Biosimilars Act.

In this Policy Forum piece, Robin Feldman discusses how current legislation contributes to informational deficits around drug patents for biologic drugs in the United States.

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.

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.

Herbal Technological Prospects of Morus nigra L.: A Systematic Patent Analysis Review.

BACKGROUND: Morus nigra L. is a plant with significant potential for drug development due to the presence of numerous bioactive compounds in its various parts. OBJECTIVES: This article aims to compile the technological perspectives of Morus nigra L. towards drug development and therapeutic indications based on registered patents in databases. METHODS: The study analyzed patents published within the last five years, focusing on products derived from different parts of the Morus nigra L. plant. Patent databases such as the European Patent Office (EPO), the United States Patent and Trademark Office (USPTO), the World Intellectual Property Organization (WIPO), and the National Institute of Industrial Property Databases (INPI) were examined. RESULTS: A total of 45 patents were categorized by country of origin, type of applicant, extraction method, and therapeutic indications. China had the highest number of patent filings (43.48%), and private companies were the primary technology patent holders (38.64%). Noteworthy extraction methods included ultrasound-assisted extraction, decoction, infusion, and maceration. The most utilized plant parts were leaves (44.44%), followed by fruits (35.56%), root bark (15.56%), and stems (4.44%). The main therapeutic indications identified were the treatment of hyperglycemia and dyslipidemia (43.33%), along with digestive problems, cosmetics, nutrition, and cleaning applications. CONCLUSION: The study of patents covers discoveries and advancements often absent in scientific articles, making a review focused on this advanced information crucial for expanding existing scientific knowledge. Even if some therapies have been explored previously, patents can reveal innovative approaches and fresh perspectives that contribute to sustained scientific progress.

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 funding: fueling Chinese synbio.

As China emerges as a synthetic biology (synbio) global leader, it faces distinct science-society challenges. Our series offers a snapshot of China's synbio state, emphasizing the intersection and its policy implications. The debut piece elucidates the intellectual property rights (IPR)-funding interplay in China's expanding synbio territory, underlining its key role in driving innovation and commercialization.

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.

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.

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.

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)