{"id":11779,"date":"2013-04-18T12:19:53","date_gmt":"2013-04-18T11:19:53","guid":{"rendered":"https:\/\/faus-moliner.com\/en\/las-estrategias-ante-la-aprobacion-genericos-las-normas-defensa-la-competencia\/"},"modified":"2016-04-18T15:41:58","modified_gmt":"2016-04-18T14:41:58","slug":"the-strategies-in-view-of-the-approval-of-generics-and-the-rules-of-competition-defense","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/the-strategies-in-view-of-the-approval-of-generics-and-the-rules-of-competition-defense\/","title":{"rendered":"The strategies in view of the approval of generics and the rules of competition defense"},"content":{"rendered":"

Background<\/strong><\/p>\n

The generic clopido\u001fgrel based medicinal products that were approved starting from July 2008, when the basic patents of this product expired, showed two diffe\u001frences with respect to Plavix\u00ae that was the reference medicinal product: the generics contained a clopidro\u001fgel salt different from the one used for Pla\u001fvix\u00ae and could not include, among their approved indications, the treatment of acute coronary syndrome in combination with acetylsalicylic acid.<\/p>\n

These differences were due to the fact that both the clopi\u001fdogrel salt used for Plavix\u00ae as well as the indication in question were protected by specific patents until February 2013 and February 2017 respectively.<\/p>\n

It is known that the European regulation provides that the different salts of an active ingredient shall be considered the same active ingredient, unless they have significantly different properties with regard to safety and\/or efficacy and that the authorization of gene\u001frics with exclusion of indications of the original medicinal product that are still protected by patents is also permitted.<\/p>\n

In this situation, the French Competition Authority ruled about a matter regarding the information that the company that holds the\u00a0 marketing authorization of the reference medicinal product can provide, where appropriate, to healthcare professionals, before the launch of the generic medicinal product.<\/p>\n

Information versus abuse<\/strong><\/p>\n

In this ca\u001fse, the French Authority considered that Sanofi-Aventis had designed and implemented a communication strate\u001fgy specifically designed to generate con\u001ffusion regarding the prope\u001frties of the generics and therefore it achieved that the penetration of the generics in the market was much lower than the normal level of penetration.<\/p>\n

Without entering into an analysis of the decision, which is not relevant for our remarks, we must highlight two aspects. In the first place, we would like to draw the attention to the type of procedure chosen by the generic company that filed the complaint. To file a complaint against an information or promotional campaign on the basis of the competition defense rules is possible, and may be more attractive than filing a complaint before the ordinary courts or before self-regulatory systems. The decision of the French Authority is a pre\u001fcedent to bear in mind.<\/p>\n

In the second place, the rules that prohibit the abuse of a dominant position or unfair conduct must always be taken into account when considering the strategies to adopt in the event of changes in the market structure. To defend the position that has been achieved thanks to innovation and to the own efforts is legitimate, but the line between abuse and disloyalty can be very fine; and the reading of this Decision proves that some administrations are willing to enter into this discussion.<\/p>\n","protected":false},"excerpt":{"rendered":"

Background The generic clopido\u001fgrel based medicinal products that were approved starting from July 2008, when the basic patents of this product expired, showed two diffe\u001frences with respect to Plavix\u00ae that was the reference medicinal product: the generics contained a clopidro\u001fgel salt different from the one used for Pla\u001fvix\u00ae and could not include, among their approved… <\/p>\n

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Read More<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72,389,390,86,217],"tags":[],"coauthors":[],"class_list":["post-11779","post","type-post","status-publish","format-standard","hentry","category-capsulas-en","category-generics","category-generics-2","category-pharmaceutical-and-life-sciences-law","category-pharmaceutical-and-life-sciences-law-2"],"acf":[],"yoast_head":"\nThe strategies in view of the approval of generics and the rules of competition defense - Faus Moliner<\/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:\/\/faus-moliner.com\/en\/the-strategies-in-view-of-the-approval-of-generics-and-the-rules-of-competition-defense\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The strategies in view of the approval of generics and the rules of competition defense - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Background The generic clopido\u001fgrel based medicinal products that were approved starting from July 2008, when the basic patents of this product expired, showed two diffe\u001frences with respect to Plavix\u00ae that was the reference medicinal product: the generics contained a clopidro\u001fgel salt different from the one used for Pla\u001fvix\u00ae and could not include, among their approved... 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