{"id":17401,"date":"2022-09-14T07:02:24","date_gmt":"2022-09-14T07:02:24","guid":{"rendered":"http:\/\/legalblog.ie\/?p=17401"},"modified":"2022-09-24T22:06:09","modified_gmt":"2022-09-24T22:06:09","slug":"supplementary-protection-2","status":"publish","type":"post","link":"https:\/\/legalblog.ie\/supplementary-protection-2\/","title":{"rendered":"Supplementary Protection [EU]"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_63 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/legalblog.ie\/supplementary-protection-2\/#Supplementary_protection_certificates\" title=\"Supplementary protection certificates\">Supplementary protection certificates<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/legalblog.ie\/supplementary-protection-2\/#Purpose\" title=\"Purpose\">Purpose<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/legalblog.ie\/supplementary-protection-2\/#Key_Points\" title=\"Key Points\">Key Points<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/legalblog.ie\/supplementary-protection-2\/#Application_Background\" title=\"Application &amp; Background\">Application &amp; Background<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/legalblog.ie\/supplementary-protection-2\/#MAIN_DOCUMENTS\" title=\"MAIN DOCUMENTS\">MAIN DOCUMENTS<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"Supplementary_protection_certificates\"><\/span>Supplementary protection certificates<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>for medicines and plant protection products<\/p>\n<p>Regulation (EC) No 1610\/96 \u2014 supplementary protection certificate for plant protection products<\/p>\n<p>Regulation (EC) No 469\/2009 \u2014 supplementary protection certificate for pharmaceutical products<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Purpose\"><\/span>Purpose<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale.<\/p>\n<p>Amending Regulation (EU) 2019\/933 introduced a manufacturing waiver to the protection given by a supplementary protection certificate (SPC)* for pharmaceutical products that allows EU-based companies to manufacture a generic or similar version of an SPC-protected medicine during the term of the certificate:<br \/>\neither for exporting to a non-EU market; or<br \/>\nfor stockpiling during the final 6 months of an SPC, ahead of entry into the EU market.<\/p>\n<p>This European Union protection is designed to even out any disparities and shortcomings in national pharmaceutical and plant protection product patent systems.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Key_Points\"><\/span>Key Points<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Any pharmaceutical or plant protection product may receive an SPC, where:<br \/>\nit is protected by a national patent (the basic patent);<br \/>\nit must have national or EU authorisation before it may be sold (marketing authorisation); and<br \/>\nit does not already have a certificate.<\/p>\n<p>The SPC confers the same rights as those provided by the basic patent, apart from the limitations of the manufacturing waiver explained above.<\/p>\n<p>The SPC application must be lodged with the relevant national industrial property office:<br \/>\nwithin 6 months of the marketing authorisation being granted; or<br \/>\nwhere the marketing authorisation is granted before the basic patent is granted, within 6 months of the date on which the patent is granted.<\/p>\n<p>The SPC takes effect when the basic patent expires, and is valid for up to 5 years. The overall protection a patent and an SPC can provide may not be more than 15 years from the granting of the first marketing authorisation.<\/p>\n<p>The SPC may be extended once for 6 months for pharmaceutical products for children where a paediatric investigation plan has been prepared. The overall protection provided is then 15,5 years.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Application_Background\"><\/span>Application &amp; Background<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Regulation (EC) No 1610\/96 has applied since 8 February 1997, except in those countries whose national law did not cover the patentability of plant protection products, where it has applied since 2 January 1998.<\/p>\n<p>Regulation (EC) No 469\/2009 codifies Council Regulation (EEC) No 1768\/92. It has applied since 6 July 2009.<br \/>\nAmending Regulation (EU) 2019\/933 has applied since 1 July 2019.<\/p>\n<p>The time between applying for a patent for a new pharmaceutical or plant protection product and receiving authorisation to place it on the market reduces the effective period of patent protection. The SPC aims to offset that reduction in the effective patent protection in these fields of research to encourage innovation and prevent these industries moving away from EU countries.<br \/>\nFor more information, see:<br \/>\nSupplementary protection certificates (European Commission).<\/p>\n<p>KEY TERMS<\/p>\n<p>Supplementary protection certificate: an intellectual property right for a specific product that acts as an extension of a patent.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"MAIN_DOCUMENTS\"><\/span>MAIN DOCUMENTS<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Regulation (EC) No 1610\/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198, 8.8.1996, pp. 30-35)<\/p>\n<p>Successive amendments to Regulation (EC) No 1610\/96 have been incorporated into the basic text. This consolidated version is of documentary value only.<\/p>\n<p>Regulation (EC) No 469\/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (OJ L 152, 16.6.2009, pp. 1-10)<\/p>\n<p>See consolidated version.<\/p>\n<p>RELATED DOCUMENT<\/p>\n<p>Regulation (EU) 2019\/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469\/2009 concerning the supplementary protection certificate for medicinal products (OJ L 153, 11.6.2019, pp. 1-10)<\/p>\n<!--themify_builder_content-->\n<div id=\"themify_builder_content-17401\" data-postid=\"17401\" class=\"themify_builder_content themify_builder_content-17401 themify_builder tf_clear\">\n    <\/div>\n<!--\/themify_builder_content-->\n","protected":false},"excerpt":{"rendered":"<p>Supplementary protection certificates for medicines and plant protection products Regulation (EC) No 1610\/96 \u2014 supplementary protection certificate for plant protection products Regulation (EC) No 469\/2009 \u2014 supplementary protection certificate for pharmaceutical products Purpose They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale. Amending Regulation (EU) 2019\/933 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[210],"tags":[],"_links":{"self":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17401"}],"collection":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/comments?post=17401"}],"version-history":[{"count":2,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17401\/revisions"}],"predecessor-version":[{"id":18465,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/posts\/17401\/revisions\/18465"}],"wp:attachment":[{"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/media?parent=17401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/categories?post=17401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legalblog.ie\/wp-json\/wp\/v2\/tags?post=17401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}