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:
1
2
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.
3
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 Medication
A generic medication is a drug created to be identical to a brand-name medication already marketed in terms of its dosage, safety, potency, route of administration, quality, performance characteristics, and intended use. The concept of a generic medication should only be used for chemically synthesized drugs.
The authorization of generic medication is based on demonstrating bioequivalence with a previously authorized medication for which the data protection or patent period has expired, if applicable.
Generic medication must meet all required quality assurances and additionally demonstrate that the active ingredient is absorbed by the body in the same manner as its corresponding original medication.
Biological Medications
Biological medications (also called biologics) can be made from sugars, proteins, living cells, tissues, or a combination thereof. They are made from natural and living sources such as animal and plant cells, and microorganisms like bacteria and yeast.
Biological medications are generally more complex than other medications. Their purification, processing, and manufacturing are often more intricate processes.
Biosimilar Medication
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.
FREQUENT QUESTIONS
REFERENCES
1.) ¿Qué es la propiedad intelectual? (n.d.).
https://www.wipo.int/about-ip/en/index.html
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
11.) Medicamentos genéricos. Mejoras tú. Mejoramos todos y todas. – ¿Qué es un medicamento genérico? (n.d.).
12.) Research, C. F. D. E. A. (2020). Conceptos básicos de los Biosimilares para los pacientes. U.S. Food And Drug Administration. https://www.fda.gov/drugs/biosimilars/conceptos-basicos-de-los-biosimilares-para-los-pacientes
13.) Diccionario de cáncer del NCI. (n.d.). Instituto Nacional Del Cáncer.
14.) Propiedad intelectual y transferencia de tecnología. (n.d.).
https://www.wipo.int/technology-transfer/es/
15.) Tipos y fases de los estudios clínicos. (n.d.).
https://www.cancer.org/es/cancer/como-sobrellevar-el-cancer/tomar-decisiones-sobre-el-tratamiento/estudios-clinicos/lo-que-usted-necesita-saber/fases-de-los-estudios-clinicos.html
16.) Secretoscomerciales. (n.d.).
https://www.wipo.int/tradesecrets/es/
17.) El secreto comercial: el otro derecho de propiedad intelectual. (n.d.).
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
19.) 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
20.) La innovación y la propiedad intelectual. (n.d.).
https://www.wipo.int/ip-outreach/es/ipday/2017/innovation_and_intellectual_property.html
21.) Preguntas frecuentes: Patentes. (n.d.).
https://www.wipo.int/patents/es/faq_patents.html
22.) Preguntas frecuentes: Patentes. (n.d.-b).
https://www.wipo.int/patents/es/faq_patents.html
23.) Patentes.(n.d.).
https://www.wipo.int/patents/es/
24.) Patentes. (n.d.-b).
https://www.wipo.int/patents/es/
25.) Preguntas frecuentes: Patentes. (n.d.-c).
https://www.wipo.int/patents/es/faq_patents.html
26.) Pérez, A. (2021, September 7). Cuánto dura una patente y otras respuestas sobre Propiedad Intelectual. OBS Business School.
https://www.obsbusiness.school/blog/cuanto-dura-una-patente-y-otras-respuestas-sobre-propiedad-intelectual
27.) Patentes. (n.d.-c).
https://www.wipo.int/patents/es/
28.) Preguntas frecuentes: Patentes. (n.d.-d).
https://www.wipo.int/patents/es/faq_patents.html
29.) Patentes. (n.d.-d).
https://www.wipo.int/patents/es/
30.) Preguntas frecuentes: Patentes. (n.d.-e).
https://www.wipo.int/patents/es/faq_patents.html
31.) ¿Que es la Propiedad Intelectual? (n.d.). CERLALC.
https://cerlalc.org/wp-content/uploads/documentos-de-interes/odai/ODAI_DOCUMENTOS_DE_INTERES_Que_es_la_propiedad_intelectual_V1.pdf
32.) Preguntas frecuentes: Patentes. (n.d.-f).
https://www.wipo.int/patents/es/faq_patents.html
33.) Principios básicos de la propiedad industrial. (n.d.). WIPO.
https://www.wipo.int/edocs/pubdocs/es/wipo_pub_895_2016.pdf
34.) ¿Quees la Propiedad Intelectual? (n.d.). CERLALC.
https://cerlalc.org/wp-content/uploads/documentos-de-interes/odai/ODAI_DOCUMENTOS_DE_INTERES_Que_es_la_propiedad_intelectual_V1.pdf
35.) Integra,& Integra. (2022b). La propiedad intelectual, motor fundamental del desarrollo económico | La Innovación Necesaria. La Innovación Necesaria | Blog Sobre Tecnología, Business Intelligence, Marketing Digital, Cloud Y Seguridad.
https://www.integratecnologia.es/la-innovacion-necesaria/la-propiedad-intelectual-motor-fundamental-del-desarrollo-economico/