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.

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.

Effective Strategies to Patent Plastic Surgery Ideas and Intellectual Property.

SUMMARY: Patents are of great importance to plastic surgery, a field fueled by constant innovation. Familiarity with the patent process could promote further innovation by plastic surgeons. By granting proprietary rights to inventors in exchange for publication of their inventions, patents incentivize creativity and innovation while promoting diffusion and transfer of technology. The task of securing patent protection, however, is complex, and begins well before the patent application. Inventors must familiarize themselves with regulations to ensure that their inventions satisfy the criteria for patentability, which can differ among countries. Patents regarding surgical methods should undergo additional ethical deliberation given their potential interference with medical altruism. The patent application must be devised and written thoroughly, as it needs to withstand meticulous examination by patent offices and potential third-party opposition, and professional assistance in doing so should be sought. Filing of the application calls for intricate procedural and timing requirements that bear major benefits if well understood and respected by applicants. Given that patent rights only cover the issuing country's territorial scope, further endeavors must be pursued when seeking patent protection in additional countries. In this regard, two options exist, and the ultimate decision should be tailored to each inventor's personal needs. At every step of the patenting process, financial readiness is key because costs can be unpredictable and escalate quickly. In this article, the authors propose effective strategies directed at plastic surgeons to facilitate patenting of their ideas and protection of their intellectual property.

AOA Critical Issues Symposium: I Have an Idea Now What?

ABSTRACT: The purpose of this symposium was to provide guidance to innovators as they progress from the idea stage to the product development stage,to the issuing of a patent, and to bringing a product or innovation to market. Finding strategic partnerships is a critical component in taking a good idea and turning it into a successful business. Protecting intellectual property through patents and developing an exit strategy are also important parts of making innovation profitable. We strive to empower our colleagues who are pursuing and commercializing ideas to help impact the health-care system at large.

Fios de sutura: um mapeamento da propriedade intelectual / Suture threads: a mapping of intellectual property / Hilos de sutura: un mapeo de la propiedad intelectual

Objetivo: Determinar a situação atual das patentes de produtos e processos tecnológicos relacionados a fios de sutura depositados no Instituto Nacional de Propriedade Industrial do Brasil. Metodologia: Foi realizado um levantamento dos depósitos na base de dados do instituto durante o mês de agosto de 2020. Resultados: Verificaram-se 72 patentes, tendo o Brasil como o maior depositante. As patentes depositadas foram categorizadas em 13 classificações internacionais de patentes, sendo a mais frequente a A61B, cujo objetivo é abranger instrumentos, implementos e processos para fins de diagnóstico e cirurgia. O setor tecnológico de equipamentos e dispositivos médico-cirúrgicos relacionados a fios de sutura apresentam amplas aplicações em diferentes tecidos orgânicos. As invenções inovam a forma de armazenamento e a resistência, reduzem o tempo de procedimento, aumentam o controle da tensão e transporte de medicamentos. Conclusões: Os produtos e processos patenteados e depositados no Brasil possibilitam maior eficiência no procedimento, proporcionando uma melhor e mais segura recuperação no período pós-operatório... (AU)

Objevtive: determine the current status of patents on products and technological processes related to suture threads deposited at the National Institute of Industrial Property in Brazil. Methodology: A survey of deposits was carried out in the Institute's database during the month of August 2020. Results: 72 patents were verified, with Brazil as the largest depositor. The patents filed were categorized into 13 International Patent Classifications, the most frequent being A61B, whose objective is to cover instruments, implements and processes for the purposes of diagnosis and surgery. The technological sector of medical-surgical equipment and devices related to suture threads wide applications in different organic tissues. The selected inventions bring benefits to storage, to the resistance of materials, to the reduction of the procedure time, to the tension control, to the vehicle of medicinal drugs, to antimicrobials, to stem cells. Conclusions: The products and processes patented and deposited in Brazil enable greater efficiency in the procedure and recovery, providing a better and safer recovery of the postoperative period... (AU)

Objetivo: Determinar la situación actual de las patentes de productos y procesos tecnológicos relacionados a hilos de sutura depositados en el Instituto Nacional de Propiedad Industrial de Brasil. Metodologia: Fue realizado un levantamento de los depósitos en la base de datos del instituto durante el mes de agosto de 2020. Resultado: Se verificaron 72 patentes, teniendo a Brasil como el mayor depositante. Las patentes depositadas fueron categorizadas en 13 clasificaciones internacionales de patentes, siendo la más frecuente la A61B, cujo objetivo es cubrir instrumentos,implementos y procesos com fines diagnósticos y cirugia. El sector de equipamentos tecnológicos y dispositivos médico-quirúrgicos relacionados a hilos de sutura presentan amplias aplicaciones en diferentes tejidos orgánicos.. Las intervenciones innovan las formas de almacenamiento y la resisténcia, reducen el tiempo de procedimiento, aumentan el control de la tensión y transporte de medicamentos. Conclusiones: Los productos y procesos patenteados y depositados en Brasil posibilitan mayor eficiência en el procedimiento, proporcionando uma mejor y más segura recuperación en el período póst operatório... (AU)

Intellectual property and data ownership in the age of video recording in the operating room.

BACKGROUND: Recording intraoperative videos has become commonplace during surgery, with applications in video-based assessment, education and research. These videos can be both manually and automatically analyzed for performance analysis. A number of commercial entities providing video acquisition and processing has flourished over the recent years. As these companies expand, a number of medico-legal, licensing, intellectual property and data sharing related questions have been raised. METHODS: We performed a qualitative survey of surgeons, hospital administrators, lawyers and commercial entities offering video recording capabilities for serious issues that the average surgeon who records their videos should consider. To address these concerns, we reviewed relevant legal precedent and currently available contracts. RESULTS: We identified several key medico-legal constraints, including data ownership and storage, FDA compliance, privacy and potential for use in litigation, present the legal background and potential solutions. CONCLUSION: Given the availability of surgical recording and the future of video-based performance analysis, surgeons need to become comfortable with the medico-legal issues and the potential solutions available with national physician-led lobbying.

How to Host a Virtual Educational Conference.

SUMMARY: Virtual education is a promising tool for expanding surgical training and continuing education. The authors present their preferred platforms for virtual surgical education, and discuss security and privacy concerns. Maintaining communication and keeping sessions engaging require special consideration when education is done virtually. The limitations to virtual education may soon be mitigated by new technologies. In this article, the authors aim to describe the benefits, current modalities, tips for use, and future directions for virtual education as it pertains to plastic surgeons and trainees during the current coronavirus pandemic.

COVID-19: los insumos medicinales deben eximirse de patentes y derechos de propiedad intelectual / COVID-19: Medicinal supplies should be exempted from patents and intellectual property rights

El tsunami de moralidad con que los medios de comunicación masivos distraen a la Argentina y buena parte del mundo, ni siquiera coloca entre paréntesis la conducta inmoral de la Organización Mundial de Comercio (OMC), entidad que se resiste al tratamiento y aplicación del proyecto de suspensión de patentes y derechos de propiedad intelectual (DPI) presentado al organismo por la India y Sudáfrica en octubre de 2020

The tsunami of morality with which the mass media distract Argentina and much of the world, does not even put the immoral conduct of the World Trade Organization (WTO) , an entity that resists the treatment and application of the project for the suspension of patents and intellectual property rights (IPR) submitted to the organization by India and South Africa in October 2020

The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement.

BACKGROUND: It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization's (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. METHODS: We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries. RESULTS: Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions. CONCLUSIONS: Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

Diplomacia científico-tecnológica: a trajetória de Júlio Constâncio de Villeneuve / Scientific and technological diplomacy: the trajectory of Júlio Constâncio de Villeneuve

Resumo Partindo de uma investigação sobre a vida, a obra e o pensamento do diplomata Júlio Constâncio de Villeneuve, conde de Villeneuve, o artigo propõe uma reflexão sobre iniciativas e objetivos da diplomacia brasileira nas últimas décadas do Segundo Reinado. O foco da análise recai sobre o papel que objetos concernentes ao campo científico-tecnológico assumiam em um contexto de profundas transformações nas diretrizes de política externa do Império, sendo tomados como fatores importantes em uma nova estratégia de inserção internacional adotada após a Guerra da Tríplice Aliança.

Abstract This article examines the life, work, and thinking of the diplomat Júlio Constâncio, Count of Villeneuve, reflecting on the initiatives and objectives of Brazilian diplomacy during the final decades of Emperor Pedro II's reign. The analysis is based on the role that objects related to science and technology played within a context of profound changes in the Empire's foreign policy, as important factors in a new strategy to position the country internationally after the War of the Triple Alliance.

A propriedade intelectual na judicialização da assistência farmacêutica: uma demanda estrutural em defesa do Sistema Único de Saúde / Intellectual property in the judicialization of pharmaceutical assistance: a structural demand in defense of the Brazilian National Health System

Resumo Este trabalho investiga a participação do Sistema de Justiça no processo de efetivação do direito à saúde por meio do confronto de dois caminhos para a atuação judicial. De um lado, a forma predominante, marcada pela individualização das demandas, pela incapacidade de alcançar as falhas políticas que determinam a extensão da oferta de prestações em saúde e pelo potencial de desorganizar o Sistema Único de Saúde (SUS). De outro, uma perspectiva estrutural de atuação que aproxima a intervenção judicial dos conflitos determinantes para a consolidação e sustentabilidade do sistema público de saúde. A partir da análise de pedidos judiciais para acessar os fármacos ranibizumabe e bevacizumabe em Minas Gerais, investiga-se a mudança de cenário esperada no caso de uma atuação judicial estrutural pelo Supremo Tribunal Federal no tratamento das Ações Diretas de Inconstitucionalidade nº 4.234/DF e 5.529/DF. Os resultados apontam para a importância de o Sistema de Justiça privilegiar uma perspectiva estrutural. No atual contexto, marcado por ataques cada vez mais explícitos ao direito à saúde, é fundamental que o Sistema de Justiça participe do processo de efetivação do SUS de forma mais coerente e consciente dos conflitos que definem as possibilidades de construção de um sistema público universal. A crise econômica, o agravamento do subfinanciamento da saúde (em especial devido à Emenda Constitucional nº 95/2016) e o preço insustentável dos novos medicamentos - implicando sua crescente participação na totalidade dos gastos em saúde - apontam para a necessidade de que questões estruturais alcancem centralidade na judicialização da saúde.

Abstract This work investigates the participation of the Justice System in the process of realizing the right to health through the confrontation of two paths for judicial action. On the one hand, the predominant path, marked by the individualization of demands, the inability to reach political failures that determine the extent of health benefits provision and the potential to disorganize the Brazilian National Health System (SUS). On the other one, a structural perspective which brings judicial interventions closer to decisive conflicts that impact the consolidation and sustainability of the public health system. Based on the investigation of lawsuits requesting access to ranibizumab and bevacizumab in Minas Gerais, we analyzed the change of scenario that would be expected if the Federal Supreme Court made structural decisions when judging the Direct Actions of Unconstitutionality 4,234/DF and 5,529/DF. The results point to the importance of the Justice System privileging a structural perspective. In the current context, marked by increasingly explicit attacks to the right to health, it is essential that the Justice System participate in the process of implementing SUS in a coherent way, aware of the conflicts that define the possibilities of building a universal public system. The economic crisis, the worsening of the underfunding of health (especially due to the Constitutional Amendment 95/2016) and the unsustainable price of new drugs - resulting in their increasing participation in the totality of health expenditures - point to the need for structural issues to achieve centrality in the judicialization of health.

From Concept to Counter: A Review of Bringing an Orthopaedic Implant to Market.

Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.

[Scientific and technological innovation and achievement transformation promote the medical development].

With the worldwide adoption of minimally invasive surgery, innovation again becomes the theme. In the past hundred years, molecular biology technology, minimally invasive surgery technology, pharmaceutical research and therapies have been constantly innovated to promote the development of medicine. As the subject of medical innovation, the innovative idea from medical staff is also very important. For surgeons, the invention and improvement of a new operation or surgical instrument directly depends on curiosity and exploration. Whether a novel idea or technology can be transformed and used in clinical practice depends on its commercial prospects and the adjustment of macro health policies. The protection of intellectual property and appropriate distribution of interests are the key to ensure sustainable innovation. We should put scientific and technological innovation and achievement transformation in the important position of the "healthy China" strategy, take scientific and technological innovation as the basis and achievements transformation as the means, promote the development of China's health protection, implement the healthy China strategy, and make our own contribution to provide people with all-round health services.

[Thoughts of the combination of medicine and engineering and collaborative innovation on surgery in China].

The combination of medicine and engineering is a new interdisciplinary subject, which is a mode of cross integration and collaborative innovation between medical science and engineering. The combination and collaborative innovation of medicine and industry means more about the improvement, innovation and R&D of medical devices. However, the combination of traditional industry with biomedical engineering, modern medical imaging technology, electronic information technology and other high-tech in medical device industry is a reflection of the manufacturing industry and high-tech level of a country. The development mode of medical industry integration and collaborative innovation in China is mainly to merge medical colleges and universities with science and engineering colleges, promote the cross of different departments, and set up biomedical engineering specialty under the support of a series of relevant national policies, relying on large-scale comprehensive hospitals and research institutes, establish numerous research centers of translational medicine, thus achieving a series of achievements. Our team has made some explorations in the practice of the combination of medicine and engineering, including the utility model patent "reusable simple anal expander" and "incision protective cover of transanal multi-channel endoscopic surgery operation platform", which have been authorized by the State Intellectual Property Office, meanwhile the ultra-fine laparoscope, intragastric gasbag and other projects have been demonstrated by relevant research and development teams and are to be transformed into production. On January 10, 2020, with the approval of Guangdong Pharmaceutical Association, the Medical Innovation and Transformation Expert Committee of Guangdong Pharmaceutical Association was established jointly with the representatives of medical colleagues, scientific research institutions and enterprises, who are interested in the combination of medical industry and collaborative innovation. This Committee provides a platform for the exchange of medical colleagues, scientific research institutions and enterprises. We realize that clinical practice is the source of the combination of medical workers and collaborative innovation, and clinicians are the driving force of the combination of medical workers and collaborative innovation. At present, the main problems faced by the development of medical industry integration in China are as follows: insufficient integration of medical industry integration disciplines in the basic research stage; less interaction of clinical application needs in the application research stage; difficult transformation of scientific research achievements; the unconnected whole chain of "production, learning, research and application". If we can increase the investment in scientific research and policy incentives, strengthen the communication and interaction with enterprises, pay more attentions to the social and economic benefits of the promotion of achievements, open the whole process of the combination of medicine and industry, and improve the evaluation mechanism of the innovation ability of such combination, combination of medicine and engineering and collaborative innovation in China will enter the golden period of rapid development.

A propriedade industrial pode limitar o combate à pandemia? / Nota Técnica n. 61 (Diset): A propriedade industrial pode limitar o combate à pandemia? / Português

Esta nota técnica apresenta alguns dos pontos que vêm sendo debatidos em meio à pandemia: i) as disputas e os acordos envolvendo empresas e seus direitos de propriedade industrial (DPIs), já em andamento e com potencial de aumentar ao longo do tempo; ii) as mudanças legais que já estão sendo discutidas e adotadas por alguns países para facilitar o licenciamento compulsório de patentes; e iii) os movimentos internacionais para a adoção de uma solução global.

Pharmaceutical patents: reconciling the human right to health with the incentive to invent.

In developed countries that protect core aspects of the fundamental human right to the highest attainable standard of health, how does that right intersect with intellectual property rights? Here, the human rights implication of providing access to all cancer drugs recommended by experts in a developed country is considered in the context of conflict between the incentive to invent and the rights of others to access medicines. Effective incentives to innovate in developed countries can lead to global improvements in access to medicine if the intellectual property system is calibrated to permit this. This depends partly on the usefulness of compulsory licensing and alternative mechanisms facilitating global access to drugs. This review considers tensions between fundamental rights to access essential medicines and rights of the inventor and investors, including the pharmaceutical industry.