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.

Regulatory considerations and intellectual property rights of repurposed drugs.

Drug repurposing has emerged as a promising approach in the drug discovery and development process as it offers safe and effective therapeutic options in a time effective manner. Though the issues related to pre-clinical and clinical aspects of drug development process are greatly addressed during drug repurposing yet regulatory perspectives gain even more However, like traditional drug development the repurposed drugs face multiple challenges. Such challenges range from the patenting rights, novelty of repurposing, data and market exclusivity to affordability and equitable access to the patient population. In order to optimize the market access of repurposed drugs, regulatory organizations throughout the world have developed accelerated approval procedures. The regulatory bodies have recognized the importance of repurposing approaches and repurposed drugs. Regulatory bodies can encourage the development of repurposed drugs by providing incentives to pharmaceutical companies and more accessible and affordable repurposed agents for the general population. This chapter summarizes the regulatory and ethical considerations pertaining to the repurposed drugs and highlights a few cases of intellectual property rights for repurposed drugs that have helped improve patient's access to safe, efficacious and cost-effective therapeutic options.

Open innovation and confidentiality agreements as key factors of innovative performance in the manufacturing and service industries.

The innovative performance of manufacturing and service companies can be impacted by the existing relationship between open innovation (OI) and the generation of confidentiality agreements (NDAs) as a tool for the protection of intellectual property. Based on the analysis of a cross-sectional sample of 6,798 industrial companies (2019-2020) and 9,304 companies in the service sector (2017-2019) that are part of the directory of the National Administrative Department of Statistics (DANE) in its Technological Innovation and Development Survey (EDIT and EDITS), it can be suggested that the interaction of these two variables (OI and NDAs) generate positive effects for the manufacturing industry but negative ones for the service sector. It could be deduced that the positive effect is due to the greater tradition of OI in the manufacturing industry and the negative effect to the caution that the service sector presents when collaborating with external actors.

Ethical and regulatory challenges of large language models in medicine.

With the rapid growth of interest in and use of large language models (LLMs) across various industries, we are facing some crucial and profound ethical concerns, especially in the medical field. The unique technical architecture and purported emergent abilities of LLMs differentiate them substantially from other artificial intelligence (AI) models and natural language processing techniques used, necessitating a nuanced understanding of LLM ethics. In this Viewpoint, we highlight ethical concerns stemming from the perspectives of users, developers, and regulators, notably focusing on data privacy and rights of use, data provenance, intellectual property contamination, and broad applications and plasticity of LLMs. A comprehensive framework and mitigating strategies will be imperative for the responsible integration of LLMs into medical practice, ensuring alignment with ethical principles and safeguarding against potential societal risks.

Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

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.

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.

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.