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

Present Situation and Progress of the Research for Polymorphic Chemical Drugs in China / 医药导报

Polymorphism of chemical drugs has become a hot topic in pharmaceutical research at home and abroad. In this review, the phenomena, causes and significance of polymorphism were introduced briefly. The international drug development process and characteristics of the polymorphic drug development in our country were analyzed. Finally, the present situation and development in China was summarized from four aspects including the basic theory, technical methods, intellectual property rights and supervision. This paper can provide a reference for correct understanding the research level of polymorphic drugs in China and clarifying the direction of polymorphic drug research.

Medicamentos biosimilares en Colombia: una revisión desde el consumo informado / Biosimilar Medicines in Colombia: An Approach from the Informed Consumption / Medicamentos biossimilares na Colômbia: uma revisão desde o consumo informado

Resumen Introducción: este artículo presenta un análisis sobre medicamentos biosimilares en Colombia con miras a establecer si existe un consumo informado respecto de estos fármacos, teniendo en cuenta la calidad y cantidad de información que circula en relación con su disponibilidad y acceso económico (precios). Desarrollo: el tipo de estudio es cualitativo con un diseño documental a partir de la revisión en bases de datos como Pubmed, Scopus, Scielo, Vlex y Redalyc, bases de información de registros sanitarios de agencias reguladoras de medicamentos (FDA, EMA e Invima) y el Sistema de Información de Vademecum Med Informática. Uno de los biosimilares autorizados en FDA y cuatro de la EMA se encuentran registrados en el Invima; sin embargo, son más los biosimilares no autorizados ni en FDA ni en EMA que se encuentran registrados en el Invima, los cuales aún no aparecen con esta clasificación de biosimilares ni en la agencia reguladora colombiana ni en ningún otro medio oficial o comercial. De los medicamentos biológicos de referencia de estos biosimilares, 12 tienen control de precios y 7 han sido autorizados al menos una vez vía judicial a los usuarios del sistema. Conclusiones: si bien, la reglamentación ha sido de gran avance en relación con el acceso a biosimilares y, en consecuencia, a sus biológicos pioneros, el sistema aún tiene barreras jurídicas, de información, disponibilidad y acceso que dificultan la protección y efectividad del derecho a la salud de la población en términos de un consumo informado de estos.

Abstract Introduction: This article presents an analysis of biosimilar drugs in Colombia, aiming at critically analyzing whether the consumption of biosimilar drugs in Colombia is fully informed or if it rather is characterized for its lack of information. Informed consumption in the sense of taking into account the quality and quantity of the information circulating in relation to the availability and affordability (prices) of biosimilar drugs. Development: This is a qualitative documentary analysis, based on the review of databases such as Pubmed, Scopus, Scielo, Vlex and Redalyc, and sanitary databases of drugs regulatory agencies (FDA, EMA and the Colombian Invima) and the Vademecum Med Informatica. One of the biosimilars authorized by FDA and four of those by EMA were also registered before by the Invima. However, the number of Invima authorized biosimilars is higher than that authorized by FDA and EMA. It is also important to highlight the fact that any biosimilar is not registered as such neither before the Invima nor before any other official or commercial source. Out of the biological reference products with biosimilars, twelve have regulated price and seven have been authorized at least once via court ruling. Conclusions: Although the regulations are progressive in relation to the access to biosimilars and, consequently, to their biological pioneers, the system still has legal, availability and information barriers that undermine the protection and effectiveness of the right to health.

Resumo Introdução: este artigo apresenta uma análise sobre medicamentos biossimilares na Colômbia com vista a estabelecer se existe um consumo informado respeito destes fármacos, tendo em conta a qualidade e quantidade de informação que circula em relação com a sua disponibilidade e acesso econômico (preços). Desenvolvimento: o tipo de estudo é qualitativo com um desenho documental a partir da revisão em bases de dados como Pubmed, Scopus, Scielo, Vlex e Redalyc, bases de informação de registros sanitários de agências reguladoras de medicamentos (FDA, EMA e Invima) e o Sistema de Informação de Vademecum Med Informática. Um dos biossimilares autorizados em FDA e 4 da EMA, se encontram registrados no Invima, no entanto são mais os biossimilares não autorizados nem na FDA nem na EMA que se encontram registrados no Invima, os quais ainda não aparecem com esta classificação de biossimilares nem na agência reguladora colombiana, nem em nenhum outro meio oficial ou comercial. Dos medicamentos biológicos de referência destes biossimilares, 12 têm controle de preços e 7 têm sido autorizados pelo menos uma vez via judicial aos usuários do sistema. Conclusões: se bem a regulamentação tem sido de grande avanço em relação com o acesso a biossimilares e, consequentemente, a seus biológicos pioneiros, o sistema ainda tem barreiras jurídicas, de informação, disponibilidade e acesso que dificultam a proteção e efetividade do direito à saúde da população em termos de um consumo informado dos mesmos.

Introduction and Profound Consideration on Intellectual Property Rights Protection Standard Terms Relat-ed to Drugs beyond the Regulations of TRIPS / 中国药房

OBJECTIVE:To improve response capacity of China to deal with intellectual property rights protection standard terms (Trips-plus terms) beyond the regulations of Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and to provide reference for improving national intellectual property rights protection policy. METHODS:Trips-plus terms and their common types were introduced to analyze their characteristics and consider about their adverse effects. RESULTS & CONCLU-SIONS:Common TRIPS-plus terms involve data protection,patent interlinkage,patent period extension,limitation of compulsory licensing and parallel importation,etc. These terms pose a significant challenge to developing countries,resulting in delaying entry of generics,increasing drug price,influencing drug accessibility and posing a great threat to public health. China,as the largest de-veloping country mostly relying on generic drugs,should scientifically assess the effects of TRIPS-plus on public health,drug ac-cessibility and pharmaceutical industry in the process of domestic legislation and negotiating a free trade agreement,and make effec-tive use of the TRIPS flexibility to protect the public health.

Aproximación al estudio de libertad de operación para una línea transgénica de arroz en Colombia / Aproach study of freedom to operate for transgenic line rice in Colombia

El desarrollo de una variedad genéticamente modificada (GM) es un reto científico y legal, tanto por las técnicas de ingeniería genética, como por los derechos de propiedad intelectual (DPI) implicados. Se realizó una aproximación al análisis de libertad de operación para una línea GM derivada de una variedad colombiana de arroz, que exprese una versión optimizada del gen cry1Ac, con el propósito de procurar su liberación comercial en Colombia. Para ello, se efectuó una deconstrucción de la innovación, con la cual se determinaron los elementos potencialmente protegibles por DPI, sobre los cuales se efectuaron búsquedas de patentes y solicitudes de patentes en el contexto nacional e internacional, en bases de datos de acceso público. Se encontraron 59 patentes y solicitudes de patentes en el escenario internacional. En la Superintendencia de Industria y Comercio de Colombia (SIC) se encontraron tres solicitudes de patentes que pueden incidir en la libertad de operación para esta innovación. Se concluye que es alta la posibilidad de desarrollar una línea GM de arroz que exprese el gen cry1Ac sin afectar interés de terceros, siempre y cuanto se cree para comercializarla en el país.

The development of a genetically modified variety (GM) is a scientific and legal challenge, by genetic engineering techniques used and the intellectual property rights (IPR) involved. Approximate analysis of freedom of operation for a GM line derived from a Colombian rice variety, express an optimized version of the cry1Ac gene; in order to pursue their commercial release in Colombia was made. To do this, a deconstruction of innovation, which potentially protectable elements DPI on which patent searches and patent applications were made in the national and international context, databases were determined public access was performed. 59 patents and patent applications were found in the international arena. The Superintendency of Industry and Trade of Colombia (SIC) three applications for patents that may affect the freedom of operation for this innovation were found. It is concluded that the higher the possibility of developing a GM rice line expressing cry1Ac gene without affecting the interest of third parties , as long as it is done in the country to commercialize.

El acceso a los medicamentos: conflictos entre derechos de propiedad intelectual y protección de la salud pública / O acesso aos medicamentos: conflitos entre direitos de propriedade intelectual e proteção da saúde pública / The access to drugs: conflicts between intellectual property and public health protection

Entre los mayores obstáculos que enfrenta en todo el mundo el acceso a los medicamentos se encuentran las cuestiones relativas a los derechos de propiedad intelectual y la falta de competencia, unido al retardo y postergación en la generación de investigación y desarrollo (I+D) sobre aquellas enfermedades que afectan de manera importante a la población de países en desarrollo y países menos adelantados. En este trabajo se analiza el fortalecimiento de la patente farmacéutica contemplada en el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual (ADPIC) de la Organización Mundial de Comercio (OMC) y el actual régimen de incentivo imperante para medicamentos nuevos, sus consecuencias y actuales conflictos. En ellos suelen enfrentarse los intereses de países desarrollados, presionados por una poderosa industria farmacéutica, con los intereses de países en desarrollo y países menos adelantados.

Topics related to intellectual property rights and lack of competency are found among the major obstacles facing the access to drugs in the world, together with the delay and postponement in the generation of R+D about those diseases affecting disproportionately to the population of developing countries and least developed countries. In this study, the strengthening of pharmaceutical patents included in the Agreement on trade-related aspects of intellectual property rights of the World Trade Organization (WTO) and the current prevailing incentive towards new drugs, their consequences and current conflicts are analyzed. In these, generally, the developed countries interests are confronted -pressed by a powerful pharmaceutical industry- with the interests of developing countries and least developed countries.

Entre os maiores obstáculos que enfrenta em todo o mundo, o acesso aos medicamentos se encontram as questões relativas aos direitos de propriedade intelectual e a falta de competência, aliado ao retardo e postergação na geração de I+D sobre aquelas enfermidades que afetam de maneira desproporcionada a população dos países em desenvolvimento e países menos adiantados. Neste trabalho se analisa o fortalecimento da patente farmacêutica contemplada no Acordo sobre os Aspectos dos Direitos de Propriedade Intelectual (ADPIC) da Organização Mundial de Comércio (OMC) e o atual regime de incentivo imperante para medicamentos novos, suas consequências e atuais conflitos. Neles devem ser enfrentados os interesses de países desenvolvidos -pressionados por uma poderosa indústria farmacêutica- com os interesses de países em desenvolvimento e países menos adiantados.

Construc tion of Chinese medicine intellectual propre ty rights evalu ation system based on standard deviation method and TOPSIS method / 中华医学图书情报杂志

Indicators for evaluation of Chinese medicine intellectual property rights evaluation system were selected interms of patent right, copyright, trademark right, geographical mark, protection of Chinese medicine, and intangible cultural heritage to construct a Chinese medicine intellectual property rights evaluation system which is consisted of 6 class A,15 class B and 18 class C indicators .Domestic data of Chinese medicine intellectual property rights were col-lected from 2004 to 2013,the weight of each evaluation indicator was determined using standard deviation method,and the evaluation system was studied according to the weighted TOPSIS method with its rationality and practicality validated.

Development of intellectual property rights in tea industry of China from 2004 to 2013 / 中华医学图书情报杂志

After an evaluation system of intellectual property rights in tea industry was constructed according to the investigation of literature and networks , the development of intellectual property rights in tea industry of China from 2004 to 2013 was analyzed , which showed that although the comprehensive strength of intellectual property rights in tea industry of China has steadily increased , a number of problems still exist such as its copyright , trademark rights, geographical indications, intangible cultural heritage, and new plant strain rights.Further analysis of patent invention rights, practical patents, and outward appearance designs showed that the number of tea processing patent inventions is the largest with a stable patent right, followed by tea processing and tea sets, tea sets and tea pack-age.Suggestions were put forward for the development of intellectual property rights in tea industry of China.

Protection of intellectual property rights for traditional village culture and its model / 中华医学图书情报杂志

The protection model of intellectual property rights for traditional village culture were studied by investi-gating its current situation , related problems and why they exist in Yongzhou City , Hunan Province , China .

Current status of nanotechnology patents in traditional Chinese medicine / 国际中医中药杂志

With the advancement of modernization in traditional Chinese medicine, the application of nanotechnology in traditional Chinese medicine has been paid increasing attention. This article outlines the current status of nanotechnology patents in traditional Chinese medicine, and indicates that the awareness of intellectual property rights protection in the field of traditional Chinese medicine has been weak in China. This article also analyzes the characteristics and directions of development of nanotechnology-related patents in traditional Chinese medicine, and points out that university-industry cooperation should be strengthened to accelerate the industrialization of the patents.

Políticas internacionais em ciência e saúde: a pesquisa celular e a medicina regenerativa / International policies in science and health: cellular research and regenerative medicine

O desenvolvimento de medicamentos e terapias baseados nos princípios científicos das biociências e das biotecnologias da saúde - com base em células vivas e difíceis de serem estandardizadas - tem sido um tema de amplos debates públicos em nível global. A área tem sido recentemente demarcada como medicina regenerativa, que inclui as pesquisas e terapias com células-tronco (PCT e TC), foco deste estudo. No presente artigo, apresentam-se os principais eventos históricos na área de pesquisa celular, descreve-se o estágio atual na evolução da medicina regenerativa e as características das principais políticas desenvolvidas, em especial pelos países de liderança global, e em relação à regulamentação dos direitos de propriedade intelectual. Desenvolve-se análise quantitativa e qualitativa com dados secundários coletados em nível internacional, revisão bibliográfica e de informações em arquivos das instituições de regulamentação globais, resenhas jornalísticas atualizadas, assim como de artigos especializados publicados em revistas internacionais. A revisão da informação é guiada pelas seguintes perguntas: quais são as trajetórias principais de inovação em ciência e saúde nessa área? Quais fatores incidem principalmente na sua evolução? Conclui-se com reflexões específicas sobre os impactos dos desenvolvimentos associados na Saúde Coletiva...

Medicine and therapy developments based upon scientific principles of biosciences and health biotechnologies - with the use of live cells which are difficult to standardize - have been subject of wide public debates at the global level. The area has been recently defined as one of regenerative medicine that includes stem cell research and therapy, the focus of our study. This paper presents the main historical research events in cellular research, describes regenerative medicine's present stage of evolution and the characteristics of the main public policies developed, most especially in the leading countries and in relation to the regulation of intellectual property rights. A quantitative and qualitative analysis is developed, drawing upon different sets of secondary data collected internationally, bibliographic and archival information from global regulatory institutions, updated journal reviews as well as of specialized articles published in international journals. This information is reviewed guided by the following questions: which are the main trajectories in health innovation in this area? Which factors have most highly influenced its evolution? The paper concludes with reflections on the specific impacts of associated developments on collective health...

Estudio de libertad de operación para una línea genéticamente modificada de papa (Solanum tuberosum L. ) / Study of freedom to operate for a genetically modified potato (Solanum tuberosum L. ) line

Durante el desarrollo de los productos biotecnológicos son utilizados materiales y procesos, que pueden estar protegidos por derechos de propiedad intelectual. Para evitar problemas legales en su comercialización, se deben realizar estudios de libertad de operación. Este estudio se realizó sobre una línea genéticamente modificada (GM) de papa (Solanum tuberosum L.) derivada de la variedad Pastusa Suprema, que expresa el gene Cry1Ac de Bacillus thuringiensis, desarrollada por la Corporación de Ciencias Biológicas y la Universidad Nacional de Colombia, Sede Medellín. El punto de partida, fue la deconstrucción del producto, cuyo resultado fue la lista de materiales y procesos usados en el desarrollo del producto. Se buscaron en bases de datos nacionales e internacionales de acceso público, las solicitudes de patentes y patentes relacionadas. En el nivel internacional, se encontraron cuatro solicitudes de patentes y dieciocho patentes relacionadas, la mayoría de las cuales, no han sido solicitadas en Colombia. En el nivel nacional, se encontraron 13 solicitudes de patentes, que han caducado, han sido negadas, abandonadas, desistidas, o están en requerimiento. Se encontró que la variedad tiene registro comercial, pero no título de obtentor. También se examinaron documentos de las instituciones participantes, que contuvieran cláusulas sobre propiedad intelectual, y otros documentos de interés, como los acuerdos de transferencia de materiales (ATM). Se concluye que la libertad de operación puede estar afectada más por problemas detectados en los ATM y en la complejidad de los acuerdos interinstitucionales suscritos, que por los derechos de propiedad intelectual.

During the development of biotechnological products, some materials and processes are used, which can be protected by intellectual property rights (IPR's). In order to avoid legal problems related to their marketing, freedom-to-operate studies need to be done. This study was made on a genetically modified (GM) potato (Solanum tuberous L.) derived from variety "Pastusa Suprema", which expresses the gene cry1Ac from Bacillus thuringiensis, developed by Corporation for Biological Research (Corporación para Investigaciones Biológicas - CIB) and National University of Colombia at Medellín (Universidad Nacional de Colombia, sede Medellín). The starting point was the deconstruction of the product, whose result was the list of materials and processes used in the development of the new product. Patents and related applications were searched in national and international databases. At the international level, four applications and eighteen patents were found, most of which have not been applied for in Colombia. At the national levee, thirteen applications were found, which have expired, have been denied, abandoned, desisted or are currently on request. The plant variety has commercial registration but not breeder's certificate. Documents of the partaker institutions with IP clauses and other documents of interest, such as Material Transfer Agreements (ATM), were examined. It can be concluded that the freedom to operate might be affected for issues related to the ATMs and to the complexity of inter-institutional agreements, rather than for intellectual property rights.

Protection of intellectual property rights for academic information resources on internet / 中华医学图书情报杂志

The protection of intellectual property rights for information resources on internet was studied by analy-zing the types of information resources covered in library itself-developed database, OA database and online books, their access methods and involvement of intellectual property rights, and suggestions were put forward for enforcing the protection of intellectual property rights by establishing copyright law for information resources on internet and introducing advanced technologies.

Filed and granted Indian Patents in dentistry from 2005-2009: A critical analysis and review.

Background: Patent policies have proved to be extremely important for several countries to develop. India has achieved its global status since 2005; a critical analysis of the patents at IPO will help us to identify the potential, available for patents with Indian Dental Fraternity. Aim: The aim of this study is to critically analyze and review Indian Patents in the field of Dentistry from 2005-2009 for evaluation of status of Indian Patents in Dentistry. Materials and Methods: A total of 110 patents were scrutinized from 2005-2009 available by IPO on www.patentoffice.nic.in. Following which a preliminary data were collected from individual patents and recorded in a record sheet. Statistical Analysis: The data collected were analyzed using SPSS 16.0 software and were subjected to ANOVA test. Results: All patents scrutinized were applied for dental materials (100%). Company applicants (70%) were the maximum followed by the individual applicants (27.2%). A total of 87.3% of patents had enrolled for International Application. Priority country had maximum favor with USA (39.2%) followed by Europe (36.1%). Single inventors (44.5%) were the maximum followed by two inventors (22.7%). Europe (37.3%) had the maximum first inventor, followed by United States of America (30%) and India (10.9%). Individual inventors were maximum in Europe (38.8%) followed by USA (20.4%) and India (16.3%). Conclusion: Contribution from Indian Nationals as inventors for patents in the field of Dentistry is limited, thus reducing the pace of progress and development. Indian inventors in the field of Dentistry have to go a long way to compete with the fellow mates of developed countries like USA and Europe. Continuing Dental Education programs on Intellectual property rights should be conducted on regular basis especially for Dentist's involved in research.

Preliminary Study of Bioinformatics Patents and Their Classifications Registered in the KIPRIS Database

Whereas a vast amount of new information on bioinformatics is made available to the public through patents, only a small set of patents are cited in academic papers. A detailed analysis of registered bioinformatics patents, using the existing patent search system, can provide valuable information links between science and technology. However, it is extremely difficult to select keywords to capture bioinformatics patents, reflecting the convergence of several underlying technologies. No single word or even several words are sufficient to identify such patents. The analysis of patent subclasses can provide valuable information. In this paper, I did a preliminary study of the current status of bioinformatics patents and their International Patent Classification (IPC) groups registered in the Korea Intellectual Property Rights Information Service (KIPRIS) database.

Patent law in dentistry: An overview.

Dentistry in recent years has developed interest in the field of intellectual property rights (IPR) and Patents due to extensive research in the fraternity and existing competition. There have been various patent applications and grants in the field of dentistry abroad due to better understanding of IPR but India still has very few patent grants and applications on the subject matter. This review article in particular deals with the understanding of IPR and Patents as a whole, especially for dental professionals involved in research and development. Hence, this would also act as an asset for dental researchers to explore and expand their scope of activities, with special privileges empowered for their work.

Practice of intellectual property management at the Southern Medical University / 中华医学科研管理杂志

The intellectual property rights weight much in the research capacity of a university.This article focuses on the practice and achievements of Southern Medical University in the field of intellectual property management after the transformation of the university.

A preliminary study of intellectual property system affecting the reward system of science and technology / 中华医学教育探索杂志

With Chira's proposal of building an innovative country and implementing national intellectual property strategy,the rapid development of intellectual property,reward system of science and technology had a profound effect.This article made preliminary discussion from the level of scientific and technological achievements,the evaluation system and the types of science and technology rewards.

Intellectual property rights system of hospitals and the safeguard mechanism / 中华医院管理杂志

Intellectual property rights system and its safeguard mechanism are critical and fundamental for intellectual property rights of hospitals, yet few academic studies have been made in this regard. The author defined the content of various intellectual property rights of hospitals, along with discussions and summary for the inner structure of such intellectual property rights. Based on objective analysis of the vulnerabilities causing loss of intellectual property rights of hospitals in China, the author came up with three mechanisms for loss prevention, remedy and development. These recommendations are designed to build a relatively complete intellectual property rights system and the safeguard mechanism for hospitals.

from Thalland's Legislative Protection / 国际中医中药杂志

In recent years, the problems about the protection of intellectual property rights on the traditional medicine has got attentions around the world. Among them, Thailand explored a set of national legislations to protect the intellectual property right about the traditional medicine knowledge, which is very instructive to the developing countries. On the basis of summing up the Thailand traditional medicine intellectual property protection policy, the thesis proposed ideas on the protection of the traditional medicine in China.