{"id":53761,"date":"2021-02-17T16:18:07","date_gmt":"2021-02-17T19:18:07","guid":{"rendered":"https:\/\/www.daniel-ip.com\/?p=53761"},"modified":"2023-04-05T14:30:55","modified_gmt":"2023-04-05T17:30:55","slug":"brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications","status":"publish","type":"post","link":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/","title":{"rendered":"Brazil: FDA issues guidelines for examination and prior consent of patent applications"},"content":{"rendered":"

Rafael Salom\u00e3o Romano and Samantha Salim of Daniel Law outline how the instructions will improve transparency and accountability in the Brazilian pharmaceutical patent scene<\/em><\/p>\n

The Brazilian National Agency for Sanitary Surveillance (ANVISA \u2013 Brazilian FDA) has issued four guidelines related to examination and prior consent of pharmaceutical patent applications. The main purpose of these guidelines is to provide clear and objective guidance to the examiners of the agency in examining patent applications received from the Brazilian National Institute for Industrial Property (INPI \u2013 Brazilian PTO), in addition to providing greater transparency for patent owners and attorneys in relation to the steps and criteria used during examination.
\nIn Brazil, all patent applications from the pharmaceutical field (including biotech cases) are sent to ANVISA to obtain prior consent, in addition to the ordinary prosecution held at INPI. Once the prior consent is given, INPI resumes its prosecution. ANVISA is responsible for analysing whether the subject matter of a patent application represents a threat to public health, through the protection of substances\/products whose use is prohibited in Brazil.<\/p>\n

However, whenever the claimed matter of an application may be of interest to the Brazilian universal healthcare system (SUS), prior consent is usually accompanied by a technical opinion on patentability, in addition to public health issues. ANVISA\u2019s opinion is not binding and is considered by INPI as third-party observations.<\/p>\n

ANVISA\u2019s guidelines specify therapeutic destinations that serve as the basis for the publication of prior consent with subsidies to the examination, as well as the understanding of this agency in relation to the patentability criteria, which differs from INPI in some relevant aspects, such as the protection of invention of selection, polymorphism, hybridoma and second medical use claims.<\/p>\n

With the guidelines, it is expected that the agency\u2019s actuation will be subject to more transparency and accountability.<\/p>\n

 <\/p>\n

Article published on MIP. Read it here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Rafael Salom\u00e3o Romano and Samantha Salim of Daniel Law outline how the instructions will improve transparency and accountability in the Brazilian pharmaceutical patent scene The Brazilian National Agency for Sanitary Surveillance (ANVISA \u2013 Brazilian FDA) has issued four guidelines related to examination and prior consent of pharmaceutical patent applications. The main purpose of these guidelines […]<\/p>\n","protected":false},"author":125,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[11,373],"tags":[],"ppma_author":[166,174],"acf":[],"yoast_head":"\nBrazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Brazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW\" \/>\n<meta property=\"og:description\" content=\"Rafael Salom\u00e3o Romano and Samantha Salim of Daniel Law outline how the instructions will improve transparency and accountability in the Brazilian pharmaceutical patent scene The Brazilian National Agency for Sanitary Surveillance (ANVISA \u2013 Brazilian FDA) has issued four guidelines related to examination and prior consent of pharmaceutical patent applications. The main purpose of these guidelines […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/\" \/>\n<meta property=\"og:site_name\" content=\"DANIEL LAW\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-17T19:18:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-04-05T17:30:55+00:00\" \/>\n<meta name=\"author\" content=\"Rafael Salom\u00e3o, Samantha Salim\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Rafael Salom\u00e3o\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/\",\"url\":\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/\",\"name\":\"Brazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW\",\"isPartOf\":{\"@id\":\"https:\/\/www.daniel-ip.com\/en\/#website\"},\"datePublished\":\"2021-02-17T19:18:07+00:00\",\"dateModified\":\"2023-04-05T17:30:55+00:00\",\"author\":{\"@id\":\"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/3fa854fabac1a8ff9535d772adadaf1e\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.daniel-ip.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Brazil: FDA issues guidelines for examination and prior consent of patent applications\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.daniel-ip.com\/en\/#website\",\"url\":\"https:\/\/www.daniel-ip.com\/en\/\",\"name\":\"DANIEL LAW\",\"description\":\"Intellectual Property Firm in Brazil\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.daniel-ip.com\/en\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/3fa854fabac1a8ff9535d772adadaf1e\",\"name\":\"Rafael Salom\u00e3o\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/image\/6d4afaf4e2395eb846495074882f7906\",\"url\":\"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png\",\"contentUrl\":\"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png\",\"caption\":\"Rafael Salom\u00e3o\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/in\/rafael-salom%C3%A3o-romano-93099163\/\"],\"url\":\"https:\/\/www.daniel-ip.com\/en\/author\/rafael-salomao\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Brazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/","og_locale":"en_US","og_type":"article","og_title":"Brazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW","og_description":"Rafael Salom\u00e3o Romano and Samantha Salim of Daniel Law outline how the instructions will improve transparency and accountability in the Brazilian pharmaceutical patent scene The Brazilian National Agency for Sanitary Surveillance (ANVISA \u2013 Brazilian FDA) has issued four guidelines related to examination and prior consent of pharmaceutical patent applications. The main purpose of these guidelines […]","og_url":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/","og_site_name":"DANIEL LAW","article_published_time":"2021-02-17T19:18:07+00:00","article_modified_time":"2023-04-05T17:30:55+00:00","author":"Rafael Salom\u00e3o, Samantha Salim","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Rafael Salom\u00e3o","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/","url":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/","name":"Brazil: FDA issues guidelines for examination and prior consent of patent applications - DANIEL LAW","isPartOf":{"@id":"https:\/\/www.daniel-ip.com\/en\/#website"},"datePublished":"2021-02-17T19:18:07+00:00","dateModified":"2023-04-05T17:30:55+00:00","author":{"@id":"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/3fa854fabac1a8ff9535d772adadaf1e"},"breadcrumb":{"@id":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.daniel-ip.com\/en\/articles\/brazil-fda-issues-guidelines-for-examination-and-prior-consent-of-patent-applications\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.daniel-ip.com\/en\/"},{"@type":"ListItem","position":2,"name":"Brazil: FDA issues guidelines for examination and prior consent of patent applications"}]},{"@type":"WebSite","@id":"https:\/\/www.daniel-ip.com\/en\/#website","url":"https:\/\/www.daniel-ip.com\/en\/","name":"DANIEL LAW","description":"Intellectual Property Firm in Brazil","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.daniel-ip.com\/en\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/3fa854fabac1a8ff9535d772adadaf1e","name":"Rafael Salom\u00e3o","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.daniel-ip.com\/en\/#\/schema\/person\/image\/6d4afaf4e2395eb846495074882f7906","url":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png","contentUrl":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png","caption":"Rafael Salom\u00e3o"},"sameAs":["https:\/\/www.linkedin.com\/in\/rafael-salom%C3%A3o-romano-93099163\/"],"url":"https:\/\/www.daniel-ip.com\/en\/author\/rafael-salomao\/"}]}},"authors":[{"term_id":166,"user_id":125,"is_guest":0,"slug":"rafael-salomao","display_name":"Rafael Salom\u00e3o","avatar_url":{"url":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png","url2x":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Rafael-Salomao.png"},"pratice_areas":"","linkedin":"https:\/\/www.linkedin.com\/in\/rafael-salom%C3%A3o-romano-93099163\/","user_url":"","last_name":"Salom\u00e3o","cargo":"S\u00f3cio","education":"Master\u2019s degree in Regulatory Law from Funda\u00e7\u00e3o Get\u00falio Vargas \u2013 FGV Direito Rio;\r\nPostgraduate degree in Intellectual Property Law from the Pontifical Catholic University of Rio de Janeiro (PUC-Rio, 2015), with a published paper on the production of technical evidence for Intellectual Property litigation in accordance with the new Federal Rules of Civil Procedure from 2015;\r\nBachelor of Laws (LL.B.) degree from the Pontifical Catholic University of Rio de Janeiro (PUC-Rio, 2013), with concentration on Litigation. Rafael received a scholarship for his academic achievements, including 1st place approval at the university admission exam, and a research scholarship from the Brazilian government for three consecutive years.","affiliations-commissions-and-collegiate":"","afiliacoes-comissoes-e-colegiados":"","areas-de-atuacao":"","formacao":"Mestrado em Direito da Regula\u00e7\u00e3o pela Escola de Direito do Rio de Janeiro da Funda\u00e7\u00e3o Get\u00falio Vargas (FGV Direito Rio);\r\nP\u00f3s-gradua\u00e7\u00e3o em Direito da Propriedade Intelectual pela Pontif\u00edcia Universidade Cat\u00f3lica do Rio de Janeiro (PUC-Rio, 2015), com monografia publicada sobre as normas da prova pericial no C\u00f3digo de Processo Civil de 2015 e sua aplica\u00e7\u00e3o aos lit\u00edgios envolvendo\r\nPropriedade Intelectual;\r\nGradua\u00e7\u00e3o em Direito pela Pontif\u00edcia Universidade Cat\u00f3lica do Rio de Janeiro (PUC-Rio, 2013), com \u00eanfase em Contencioso. Rafael obteve bolsa de desempenho acad\u00eamico por ter sido aprovado em 1\u00ba lugar no vestibular. Foi tamb\u00e9m bolsista de inicia\u00e7\u00e3o cient\u00edfica do CNPQ por tr\u00eas anos consecutivos.","position":"","first_name":"Rafael","description":""},{"term_id":174,"user_id":133,"is_guest":0,"slug":"samantha-salim","display_name":"Samantha Salim","avatar_url":{"url":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Samantha-Salim.png","url2x":"https:\/\/www.daniel-ip.com\/wp-content\/uploads\/2021\/09\/Samantha-Salim.png"},"pratice_areas":"","linkedin":"https:\/\/www.linkedin.com\/in\/samantha-salim-55771938\/","user_url":"","last_name":"Salim","cargo":"Especialista de Patentes","education":"Graduated in Intellectual Property Law from the Pontifical Catholic University of Rio de Janeiro \u2013 PUC-Rio, 2016, with the dissertation \u201cSelection invention: a comparative study encompassing concepts, patentability criteria and case law on this theme\u201d;\r\nDegree in Chemical Engineering from the Fluminense Federal University (UFF) in 2012, with the dissertation \u201cTrend analysis to improve delayed coking units\u201d.","affiliations-commissions-and-collegiate":"","afiliacoes-comissoes-e-colegiados":"","areas-de-atuacao":"","formacao":"P\u00f3s-gradua\u00e7\u00e3o em Direito da Propriedade Intelectual pela Pontif\u00edcia Universidade Cat\u00f3lica do Rio de Janeiro (PUC\/RJ), 2016, com trabalho de conclus\u00e3o intitulado \u201cInven\u00e7\u00e3o de sele\u00e7\u00e3o: um estudo comparativo envolvendo conceitos, crit\u00e9rios de patenteabilidade e jurisprud\u00eancias sobre o tema\u201d;\r\nGradua\u00e7\u00e3o em Engenharia Qu\u00edmica pela Universidade Federal Fluminense \u2013 UFF, no ano de 2012, com trabalho de conclus\u00e3o intitulado \u201cEstudo de tend\u00eancias para aprimoramento das unidades de coqueamento retardado\u201d.","position":"","first_name":"Samantha","description":""}],"_links":{"self":[{"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/posts\/53761"}],"collection":[{"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/users\/125"}],"replies":[{"embeddable":true,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/comments?post=53761"}],"version-history":[{"count":1,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/posts\/53761\/revisions"}],"predecessor-version":[{"id":143511,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/posts\/53761\/revisions\/143511"}],"wp:attachment":[{"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/media?parent=53761"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/categories?post=53761"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/tags?post=53761"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/www.daniel-ip.com\/en\/wp-json\/wp\/v2\/ppma_author?post=53761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}