{"id":5929,"date":"2016-09-02T21:30:34","date_gmt":"2016-09-02T21:30:34","guid":{"rendered":"https:\/\/www.olartemoure.com\/web\/en\/?p=5929"},"modified":"2017-04-25T20:03:54","modified_gmt":"2017-04-25T20:03:54","slug":"om-weekly-digest-02-09-2016","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/om-weekly-digest-02-09-2016\/","title":{"rendered":"OM Weekly Digest (02-09-2016)"},"content":{"rendered":"<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-6258\" src=\"https:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01.jpg\" alt=\"\" width=\"800\" height=\"108\" srcset=\"https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01.jpg 800w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-300x41.jpg 300w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-768x104.jpg 768w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-461x62.jpg 461w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-260x35.jpg 260w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-50x7.jpg 50w, https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Cabezote2-eng-01-150x20.jpg 150w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>ECUADOR, ANDEAN\u00a0COMMUNITY | Intellectual Property, Patents | Domestic Intellectual Property Bill &#8211;<em>C\u00f3digo INGENIOS<\/em>&#8211;\u00a0has reached second debate<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">\u00a0<\/span><\/p>\n<p style=\"text-align: justify;\">Further to the <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/en\/om-weekly-digest-05-08-2016\/\">OM Weekly Digest of 5 August 2016<\/a><\/span> regarding to the Ecuadorian pending bill titled <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/08\/160902-ECUADOR-CODIGO-INGENIOS-Informe-Segundo-debate-9.pdf\"><em>C\u00f3digo INGENIOS<\/em><\/a><\/span>, (Spanish only) on 10 August 2016, the Commission for Education, Culture, Science and Technology to the National Assembly approved the report to the second and last debate in the legislative process. To become a Law, the bill has to go through the second debate, the approval of the plenary of the National Assembly, and presidential approval.<\/p>\n<p style=\"text-align: justify;\">As to the content, the final draft kept the controversial provisions related to the intellectual property rights being conditioned to the role and social responsibility of the Ecuadorian state (now in Article 86) and the exclusion of new forms of a substance, polymorphs, etc., as patentable subject matter (now Article 268).<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>BRAZIL\u00a0| Regulatory\u00a0|\u00a0New criteria for pricing Biosimilars<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 11 August 2016, the Executive Office of the Brazilian Pharmaceutical Market Regulation Chamber published the <span style=\"text-decoration: underline;\"><a href=\"http:\/\/portal.anvisa.gov.br\/documents\/374947\/407643\/Comunicado+n%C2%BA+9%2C+de+10+de+Agosto+de+2016.pdf\/e37d4bfb-3817-498e-8c52-ee71d964de6c\">new criteria<\/a><\/span> (Portuguese only) to be applied in the pricing of non-innovative biological products, which are those containing a molecule similar to another biological on the market in Brazil.<\/p>\n<p style=\"text-align: justify;\">The criteria establishes: i) for medicines with proven therapy improvement, the factory price cannot be higher than the lowest factory price fixed for the same products in determined countries; ii) for medicines with no proven therapy improvement, and therefore new to the list of drugs marketed by a company, the factory price is based on the average treatment cost of the products with similar molecules and cannot be higher than the lowest factory price for the same products in determined countries; and iii) for drugs with no proven therapy improvement, but where a company has a similar marketed product, the factory price shall be based on the average cost of the treatment for the product marketed by the same company.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>BRAZIL\u00a0| International Law\u00a0|\u00a0Apostille Convention entered into force in Brazil<\/strong><\/span><\/h3>\n<p><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">The <span style=\"text-decoration: underline;\"><a href=\"http:\/\/www.olartemoure.com\/wp-content\/uploads\/2016\/08\/160902-Apostille-Convention-BRASIL.pdf\">Apostille Convention<\/a><\/span> finally entered into force in Brazil on 14 August 2016. \u00a0This means that documents, such as Powers of Attorney, no longer need to be legalized through complex consular procedure.<\/p>\n<p style=\"text-align: justify;\">All documents legalized before 14 August 2016 will continue to be accepted in Brazil until <a href=\"http:\/\/cgwashington.itamaraty.gov.br\/en-us\/general_information_from_august_14th_2016.xml\"><span style=\"text-decoration: underline;\">14 February 2017<\/span>.<\/a>\u00a0 Furthermore, Brazilian consular missions will continue to provide legalization services for those countries that have not yet adhered to the Apostille Convention.<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">\u00a0<\/span><\/p>\n<h3 style=\"text-align: center;\"><span style=\"text-decoration: underline;\"><strong>COLOMBIA\u00a0| Regulatory\u00a0|\u00a0Cancellation of the Suspension of the Mandatory Sanity Notification (NSO) as a precautionary measure<\/strong><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"color: #ffffff;\">.<\/span><\/p>\n<p style=\"text-align: justify;\">On 17 August 2016, The Direction of Cosmetic, Cleaning, Pesticide and Domestic Hygiene Products of the INVIMA (Colombian Regulatory Health Authority), published in its website certain tips in order to lift the NSO suspension.<\/p>\n<p style=\"text-align: justify;\">The suspension of the NSO is an administrative sanction, imposed by the INVIMA when the NSO does not comply with legal requirements (e.g. when the applicant fails to provide product instructions). \u00a0This sanction can be cancelled upon the title holder\u00b4s request and the fulfillment of said legal requirements.<\/p>\n<p style=\"text-align: justify;\">For further information, click <span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.invima.gov.co\/suspensi%C3%B3n-de-la-nso-como-medida-sanitaria-de-seguridad.html\">here<\/a><\/span> (Spanish only).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>. ECUADOR, ANDEAN\u00a0COMMUNITY | Intellectual Property, Patents | Domestic Intellectual Property Bill &#8211;C\u00f3digo INGENIOS&#8211;\u00a0has reached second debate \u00a0 Further to the OM Weekly Digest of 5 August 2016 regarding to the Ecuadorian pending bill titled C\u00f3digo INGENIOS, (Spanish only) on 10 August 2016, the Commission for Education, Culture, Science and Technology to the National Assembly [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6260,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[59],"tags":[],"class_list":["post-5929","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-newsletter-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>OM Weekly Digest (02-09-2016) - OlarteMoure | Intellectual Property<\/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:\/\/olartemoure.com\/en\/om-weekly-digest-02-09-2016\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OM Weekly Digest (02-09-2016)\" \/>\n<meta property=\"og:description\" content=\". ECUADOR, ANDEAN\u00a0COMMUNITY | Intellectual Property, Patents | Domestic Intellectual Property Bill &#8211;C\u00f3digo INGENIOS&#8211;\u00a0has reached second debate \u00a0 Further to the OM Weekly Digest of 5 August 2016 regarding to the Ecuadorian pending bill titled C\u00f3digo INGENIOS, (Spanish only) on 10 August 2016, the Commission for Education, Culture, Science and Technology to the National Assembly [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/olartemoure.com\/en\/om-weekly-digest-02-09-2016\/\" \/>\n<meta property=\"og:site_name\" content=\"OlarteMoure | Intellectual Property\" \/>\n<meta property=\"article:published_time\" content=\"2016-09-02T21:30:34+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2017-04-25T20:03:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/olartemoure.com\/wp-content\/uploads\/2016\/11\/Imagen-eng-03.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"842\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\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\":\"Article\",\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/olartemoure.com\\\/#\\\/schema\\\/person\\\/d3c1a99aa6e1d8fc8bb6a5c4dee16807\"},\"headline\":\"OM Weekly Digest (02-09-2016)\",\"datePublished\":\"2016-09-02T21:30:34+00:00\",\"dateModified\":\"2017-04-25T20:03:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/\"},\"wordCount\":494,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/olartemoure.com\\\/wp-content\\\/uploads\\\/2016\\\/11\\\/Imagen-eng-03.jpg\",\"articleSection\":[\"Newsletter\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/\",\"url\":\"https:\\\/\\\/olartemoure.com\\\/en\\\/om-weekly-digest-02-09-2016\\\/\",\"name\":\"OM Weekly Digest (02-09-2016) - 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