INTELLECTUAL PROPERTY
VADEMECUM
Intellectual Property is the right of inventors and creators to protect the fruits of their intellectual labor, to protect the inventions of their minds. It is the recognition of innovation and creativity, of that which has never been done anywhere in the world.
What is the Intellectual Property Vademecum?
It is a quick reference document that summarizes the basic concepts of Intellectual Property and its relationship with the health sector. The objective is to provide accurate but simple information for FIFARMA members and the general public on this fundamental issue for the health of patients in Latin America and the Caribbean.
Three good reasons to protect Intellectual Property
FIFARMA recognizes three fundamental reasons for ensuring adequate protection of Intellectual Property:
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La Propiedad Intelectual permite que las empresas farmacéuticas destinen importantes recursos a investigación y desarrollo, y realicen sofisticados estudios clínicos para comprobar la eficacia y seguridad de nuevos medicamentos y tratamientos que benefician a la población.
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Sin una adecuada protección de los Derechos de Propiedad Intelectual, sería casi imposible desarrollar soluciones que beneficien la salud y mejoren la calidad de vida de millones de personas en el planeta.
GLOSSARY
Intellectual Property (IP)
Intellectual Property is a type of property that implies the right to enjoy and dispose of the creations of human talent or ingenuity produced by its creator. This branch of law includes, among others, copyright and related rights, industrial property, and plant breeders' rights over plant varieties.
Patent
A patent is an exclusive right granted on an invention. That is, about a product or process that generally offers a new way of doing something or a new technical solution to a problem. To obtain a patent, an application must be filed that publicly discloses technical information about the invention.
The patent owner may authorize or license third parties to use his invention, in accordance with mutually agreed terms. The owner may also assign the right to the invention to a third party, who will then become the new owner of the patent. When the patent expires, the protection conferred ends and the invention enters the public domain; in other words, the invention can be commercially exploited without infringing the patent.
Innovation
Innovation is the process by which new solutions are created in response to existing problems. It is the driving force behind the progress of mankind, and we often find it in research, creativity, and experimentation. In addition, it is an important driver of economic and technological development that has led to an increasingly better life for human beings.
World Intellectual Property Organization (WIPO)
(OMPI /WIPO)
The World Intellectual Property Organization (WIPO) is an agency of the United Nations whose objective is to promote and protect intellectual property globally. It is the world's governing body in this area. Promotes innovation and creativity applied to IP-related services, cooperation, policies, and information. It was founded in 1967 and has 193 member states. It is headquartered in Geneva, Switzerland.
Industrial Property
Industrial Property is the area of Intellectual Property that covers patents for inventions, industrial designs (aesthetic creations related to the appearance of products), trademarks, layout designs of integrated circuits, geographical indications, and protection against unfair competition.
Copyrights
Copyright is the field of intellectual property that protects intellectual creations of artistic and literary origin, such as books, musical works, paintings, sculptures, films and works created by technological means such as computer programs and electronic databases.
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)
The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the most comprehensive multilateral agreement on intellectual property. It is essential for facilitating trade in knowledge and creative content, resolving intellectual property-related trade disputes, and giving WTO Members the leeway to achieve their national policy objectives. It establishes a framework for the intellectual property system as it relates to innovation, technology transfer and public welfare. The Agreement is a legal recognition of the importance of the links between intellectual property and trade, and the need for a balanced intellectual property system. The full text is available at this WTO link.
The full text is available at this WTO link.
Generic drug
A generic drug is a drug created to be equal to an already marketed brand-name drug in dosage, safety, strength, route of administration, quality, performance characteristics and intended use . The generic drug concept should only be used for chemically synthesized drugs. The generic drug bases its authorization on the demonstration of bioequivalence with a previously authorized drug and for which the period of data protection or invention patent has expired, if applicable. The generic drug must comply with all the required quality guarantees and must also demonstrate that the active ingredient is absorbed by the body in the same way as the corresponding original drug.
The generic drug bases its authorization on the demonstration of bioequivalence with a previously authorized drug and for which the period of data protection or invention patent has expired, if applicable.
The generic drug must comply with all the required quality guarantees and must also demonstrate that the active ingredient is absorbed by the body in the same way as the corresponding original drug.
Biological drugs
Biological drugs (also called biologics) can be made from sugars, proteins, living cells, tissues, or a combination of these. They are made from natural, living sources such as animal and plant cells, and microorganisms such as bacteria and yeasts.
Biological drugs are generally more complex than other drugs. Often their purification, processing and manufacturing are more complicated processes.
Biosimilar drug
Biological drug that is very similar to another biological drug (called reference drug) and that has already been approved by the National Regulatory Authorities. Although biosimilar drugs and reference drugs are made from living organisms, they may be made in different ways and with slightly different substances. For a drug to be called a biosimilar, it must be shown to be as safe, as effective and to work in the same way as its reference drug. It should also be used in the same manner, at the same dosage and for the same condition as the reference drug.This is demonstrated through biosimilarity studies.
Technology transfer
Technology transfer is a collaborative process that allows scientific discoveries, knowledge, and IP to flow from creators, such as universities or research institutions, to public and private users. The goal is to transform inventions and scientific results into new products and services that benefit society. Technology transfer is closely linked to knowledge transfer.
Non-patentable invention
An invention is considered unpatentable when it does not meet the requirements to receive a patent. Although this may vary depending on the IP legislation in each country, there are general agreements on the non-patentability of inventions such as literary or artistic works, living matter, diagnostic methods, scientific theories, or those inventions whose commercial exploitation is contrary to the public order or good customs of each State.
In the following document of the World Intellectual Property Organization (WIPO) you can consult the exclusions for each country.
Clinical studies
Clinical studies are trials to test the efficacy of new drugs, devices, and other forms of treatment, as well as those already approved. Many clinical studies seek new ways to detect, diagnose or measure the extent of a disease. Some are even studying ways to prevent the emergence of diseases. The work of the researchers is still done using human volunteers to test these methods, applying the same rules.
Through clinical trials, physicians find out whether a new drug, treatment, or both in combination, are effective and safe for use in people. Clinical trials are important in the development of new treatments for serious diseases, such as cancer.
Trade secrets
Trade secrets are all information that a company does not want to be known by its competitors. They are part of a legal regime that is responsible for protecting the bonds of trust, and include information such as a company's methodologies.
FAQ ABOUT IP
First, to legally protect the moral and economic rights of creators with respect to their creations and the rights of society in general to have access to them. And secondly, to encourage creativity and the application of the results of the knowledge developed, as well as to promote fair business practices that in turn contribute to economic and social development.
De la importancia que reviste la Propiedad Intelectual se deja por primera vez constancia en el Convenio de Paris para la Protección de la Propiedad Industrial, de 1883, y en el Convenio de Berna para la Protección de las Obras Literarias y Artísticas, de 1886. De la administración de ambos tratados se encarga la Organización Mundial de la Propiedad Intelectual (OMPI).
Intellectual Property is a right that is covered by Article 27 of the United Nations Universal Declaration of Human Rights. Just as we have the right to life, to decent work and to a healthy environment, human beings have the right to protect, enjoy and dispose of the inventions of our minds.
IP is essentially divided into two branches, namely Industrial Property and Copyrights.
Copyright applies to literary and artistic creations such as books, musical works, paintings, sculptures, films, and technology-based works (e.g., computer programs and electronic databases).
Industrial Property is the area of Intellectual Property that covers patents, industrial designs (aesthetic creations related to the appearance of industrial products), trademarks, layout designs of integrated circuits, geographical indications, and protection against unfair competition.
Pharmaceutical companies usually file a patent application in the preclinical phase of their research on potential drugs. Since then, the patent office where the application was filed has been conducting an exhaustive investigation with one objective: to determine whether it is an innovative contribution, unprecedented at a global level.
Once the office has granted the patent, the pharmaceutical company will have the exclusive right over its invention, which may not be subject to exploitation, manufacture, distribution or use without the consent of the owner. In return, the pharmaceutical company provides detailed information about its invention and makes it public so that it can be reproduced at the end of the patent term.
No, patents are territorial rights. This means that they are only valid in the country or region where they have been granted. However, this does not mean that the same invention can be patented by different persons in different countries
The response varies depending on the country where it was granted, but the average time worldwide is 20 years from the time the patent application was filed. It is important to clarify that patents cannot be renewed. Once the protection period has expired, the patent expires, the holder's exclusive rights cease and the invention becomes public domain, so anyone can produce it.
At the heart of Intellectual Property lies a vital element for the pharmaceutical industry: innovation. IP encourages and protects those who take the risk of creating never-before-seen inventions. This makes special sense for pharmaceutical companies, which invest billions of dollars in research and clinical trials to develop innovative treatments for complex diseases. A process that involves great risk: out of 5000 molecules that enter preclinical testing, only 5 (on average) are tested in human trials, and only 1 receives approval for therapeutic use. In addition, Intellectual Property promotes both the dissemination and transfer of knowledge. This is reflected, for example, in the fact that patents must be published, thus generating the possibility that others can take advantage of the knowledge built and innovate from it.
Además, la Propiedad Intelectual promueve tanto la difusión como la transferencia de conocimientos. Esto se ve reflejado, por ejemplo, en el hecho de que las patentes deben ser publicadas, generando así la posibilidad de que otros puedan aprovechar el conocimiento construido, e innovar a partir de él.
Every medical innovation, be it a drug, a treatment, or a medical device, has been developed thanks to Intellectual Property protection. That is, the great advances in the control of all types of cancer, to give just one example, have been achieved by IP-protected research. That means that medical and pharmaceutical innovations help preserve and increase the quality of life and life expectancy of billions of patients on the planet; and that is what really justifies their existence and need for protection.
Although the discussion around Intellectual Property is full of nuances, there are four concrete reasons why it is important to promote and protect it. a. To encourage innovation by providing economic and legal incentives that allow us to research and develop new ideas, new technologies and products. This, of course, motivates inventors and creators to keep innovating, and to keep pushing the frontier of what is possible for all mankind. b. To catalyze economic development, as the creation of new products, industries and technologies can lead to the creation of new jobs and fields of work, and to increased production and productivity. c. To protect the rights of creators and inventors, which is basically a matter of justice, as it ensures that they receive fair remuneration for their work. d. To promote fair competition, protecting both creators and inventors, as well as the general public from piracy and counterfeiting. This, of course, ensures that we know that the products and services are authentic, safe and of quality, which is of particular importance for the healthcare sector and people's lives.
- To encourage innovation by providing economic and legal incentives that allow us to research and develop new ideas, new technologies and products. This, of course, motivates inventors and creators to keep innovating, and to keep pushing the frontier of what is possible for all mankind.
- To catalyze economic development, as the creation of new products, industries and technologies can lead to the creation of new jobs and fields of work, and to increased production and productivity.
- To protect the rights of creators and inventors, which is basically a matter of justice, as it ensures that they receive fair remuneration for their work.
- Para promover la competencia justa protegiendo tanto a los creadores e inventores, como al público en general de la piratería y la falsificación. Esto, por supuesto, garantiza que sepamos que los productos y servicios son auténticos, seguros y de calidad, lo cual es de particular importancia para el sector de la salud y la vida de la gente.
There are numerous intellectual property bodies at the regional and global level. Here we list some of them:
Latin America and the Caribbean
- SIC: Superintendency of Industry and Commerce - Colombia – https://www.sic.gov.co/
- AAAPI: Argentine Association of Industrial Property Agents Argentina – http://www.aaapi.org.ar/
- INPI: National Institute of Industrial Property (INPI) Brasil – https://www.gov.br/inpi/
- IMPI: Mexican Institute of Industrial Property México – https://www.gob.mx/impi
- INAPI: National Institute of Intellectual Property Chile – https://www.inapi.cl/
- SENADI: National Service of Intellectual Rights (formerly IEPI) Ecuador – https://www.propiedadintelectual.gob.ec/
- INDECOPI: National Institute for the Protection of Competition and Intellectual Property - Perú – https://www.indecopi.gob.pe/
- SENAPI: National Intellectual Property Service Bolivia – http://www.senapi.gob.bo/
- MIEM-DNPI: National Directorate of Industrial Property Uruguay – https://www.dnpi.gub.uy/
- ACPI: Colombian Intellectual Property Association Colombia – http://www.acpi.org.co/
- ABPI: Brazilian Intellectual Property Association Brasil – https://www.abpi.org.br/
- ASPI: Peruvian Association of Intellectual Property Perú – http://www.aspi.org.pe/
- AUDAPI: Uruguayan Association of Industrial Property Agents Uruguay – http://www.audapi.org.uy/
- ONAPI: National Industrial Property Office República Dominicana – http://www.onapi.gov.do/
- ASIPI: Inter-American Association of Intellectual Property – https://www.asipi.org/
Worldwide
- WIPO: World Intellectual Property Organization – https://www.wipo.int/es/
- INTA : International Trademark Association – https://www.inta.org/
- EUIPO: European Union Intellectual Property Office – https://euipo.europa.eu/ohimportal/es/
REFERENCES
1.) ¿Qué es la propiedad intelectual? (n.d.).
https://www.wipo.int/about-ip/es/
2.) Que es: Propiedad Intelectual. (n.d.). Universidad Nacional De Colombia.
https://propiedadintelectual.unal.edu.co/acerca-de/que-es/
3.) Propiedad Industrial: Propiedad Intelectual. (n.d.). Universidad Nacional De Colombia.
https://propiedadintelectual.unal.edu.co/acerca-de/propiedad-industrial/
4.) La innovación y la propiedad intelectual. (n.d.).
https://www.wipo.int/ip-outreach/es/ipday/2017/innovation_and_intellectual_property.html
5.) Peiró, R. (2019). Innovación. Economipedia.
https://economipedia.com/definiciones/innovacion-2.html
6.) La OMPI por dentro. (n.d.).
https://www.wipo.int/about-wipo/es/
7.) OMPI. Organización Mundial de la Propiedad Intelectual. Principios básicos de la Propiedad Industrial (2016). Disponible en: https://www.wipo.int/edocs/pubdocs/es/wipo_pub_895_2016.pdf
8.) OMPI. Organización Mundial de la Propiedad Intelectual. Principios básicos del Derecho de Autor y los Derechos Conexos (2016). Disponible en: https://www.wipo.int/edocs/pubdocs/es/wipo_pub_909_2016.pdf
9.) OMC Propiedad Intelectual – portada. (n.d.).
https://www.wto.org/spanish/tratop_s/trips_s/trips_s.htm
10.) Research, C. F. D. E. A. (2018). Medicamentos Genéricos: Preguntas y Respuestas. U.S. Food And Drug Administration. https://www.fda.gov/drugs/generic-drugs/medicamentos-genericos-preguntas-y-respuestas#:~:text=Un%20medicamento%20gen%C3%A9rico%20es%20un,de%20rendimiento%20y%20uso%20previsto
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13.) Diccionario de cáncer del NCI. (n.d.). Instituto Nacional Del Cáncer.
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https://www.wipo.int/technology-transfer/es/
15.) Tipos y fases de los estudios clínicos. (n.d.).
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16.) Secretoscomerciales. (n.d.).
https://www.wipo.int/tradesecrets/es/
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https://www.wipo.int/wipo_magazine/es/2013/03/article_0001.html
18.) La Propiedad Intelectual y su importancia actual – INAPI. Institucional. (n.d.).
https://www.inapi.cl/portal/institucional/600/w3-article-839.html#:~:text=En%20primer%20lugar%2C%20para%20proteger,tener%20acceso%20a%20las%20mismas
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https://www.wipo.int/ip-outreach/es/ipday/2017/innovation_and_intellectual_property.html
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https://www.obsbusiness.school/blog/cuanto-dura-una-patente-y-otras-respuestas-sobre-propiedad-intelectual
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