{"id":5458,"date":"2014-06-24T22:21:41","date_gmt":"2014-06-24T22:21:41","guid":{"rendered":"https:\/\/www.olartemoure.com\/web\/en\/pharma-test-data-protection-legal-nature\/"},"modified":"2016-10-12T15:34:13","modified_gmt":"2016-10-12T15:34:13","slug":"pharma-test-data-protection-legal-nature","status":"publish","type":"post","link":"https:\/\/olartemoure.com\/en\/pharma-test-data-protection-legal-nature\/","title":{"rendered":"Pharma test data protection legal nature"},"content":{"rendered":"<p align=\"right\"><a style=\"line-height: 1.5em;\" href=\"http:\/\/olartemoure.com\/om\/portfolio\/andres-rincon\/\" target=\"_blank\">Andr\u00e9s Rinc\u00f3n Usc\u00e1teg<\/a><a style=\"line-height: 1.5em;\" href=\"http:\/\/olartemoure.com\/om\/portfolio\/andres-rincon\/\" target=\"_blank\">ui <\/a><img decoding=\"async\" class=\"size-full wp-image-2708 alignnone\" style=\"line-height: 1.5em;\" src=\"http:\/\/olartemoure.com\/om\/wp-content\/uploads\/2014\/06\/ARU_thumb-02.png\" alt=\"ARU_thumb-02\" width=\"150\" height=\"128\" srcset=\"https:\/\/olartemoure.com\/wp-content\/uploads\/2014\/06\/ARU_thumb-02.png 150w, https:\/\/olartemoure.com\/wp-content\/uploads\/2014\/06\/ARU_thumb-02-50x43.png 50w, https:\/\/olartemoure.com\/wp-content\/uploads\/2014\/06\/ARU_thumb-02-88x75.png 88w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/><\/p>\n<p><strong><i style=\"line-height: 1.5em;\">Abstract (full text only in <a href=\"http:\/\/olartemoure.com\/om\/legal-nature-of-test-data-protection-for-pharmaceuticals\/\">Spanish<\/a>)<\/i><\/strong><b><\/b> Although not an intellectual property asset as such, such as a patent, the protection of test data that demonstrates the safety and efficacy of a drug is an important tool for an industry whose research and development costs are high.\u00a0 For this reason, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), seeks a minimum standard of protection to prevent the unfair commercial use of such information to the extent that it is not disclosed and involves considerable effort to generate, and which, if not protected, would generate a market imbalance given the failure to recognize such effort. \u00a0This article seeks to contribute to the discussion on the legal nature of the protection of test data as an intangible asset, analyzing what the generation of this data implies, what is the risk involved, where lies the nondisclosure of information, why it cannot be considered secret information, its importance to those who are not willing to generate it, and the most appropriate way to protect it.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Andr\u00e9s Rinc\u00f3n Usc\u00e1tegui Abstract (full text only in Spanish) Although not an intellectual property asset as such, such as a patent, the protection of test data that demonstrates the safety and efficacy of a drug is an important tool for an industry whose research and development costs are high.\u00a0 For this reason, the Agreement on [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[49,51],"tags":[],"class_list":["post-5458","post","type-post","status-publish","format-standard","hentry","category-publications","category-patents"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - 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