{"id":4525,"date":"2019-11-29T18:16:14","date_gmt":"2019-11-29T15:16:14","guid":{"rendered":"http:\/\/www.alfapatent-stanadvoka.com\/?p=4525"},"modified":"2021-01-12T08:49:57","modified_gmt":"2021-01-12T05:49:57","slug":"t0031-18","status":"publish","type":"post","link":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/t0031-18\/","title":{"rendered":"29.11.2019 \/T 0031\/18 \/HIGH DRUG LOAD TABLET \/NOVARTIS"},"content":{"rendered":"<p><a href=\"https:\/\/worldwide.espacenet.com\/publicationDetails\/originalDocument?FT=D&amp;date=20070926&amp;DB=&amp;locale=en_EP&amp;CC=EP&amp;NR=1501485B1&amp;KC=B1&amp;ND=4\">EP 1 501 485<\/a>\u00a0patentinin tescil karar\u0131 kar\u015f\u0131s\u0131nda 9 itiraz dosyalanm\u0131\u015f ve \u0130tiraz Birimi\u2019nin karar\u0131 ile T 0571\/11 temyiz dosyas\u0131 kapsam\u0131nda dosya yeniden 5. terditli talep kapsam\u0131nda g\u00f6r\u00fc\u015f\u00fclmek \u00fczere \u0130tiraz Birimi\u2019ne iade edilmi\u015ftir. 5. terditli talebe ili\u015fik ana istem a\u015fa\u011f\u0131daki gibidir:<\/p>\n<blockquote><p>&#8220;1. A tablet comprising a pharmacologically effective amount of Compound I<\/p>\n<p>FORMULA\/TABLE\/GRAPHIC<\/p>\n<p>or a pharmaceutically acceptable salt thereof in an amount from about 30% to 80% in weight of the active moiety based on the total weight of the tablet and cross-linked polyvinylpyrrolidone from 10% to 35% by weight based on the total weight of the tablet.&#8221;<\/p><\/blockquote>\n<p>\u0130tiraz Birimi belgenin \u00fcstteki ana istem ile muhafazas\u0131na karar vermi\u015f olup itiraz sahiplerinden ikisi (O2 ve O9) bu karar\u0131 temyize g\u00f6t\u00fcrm\u00fc\u015ft\u00fcr.<\/p>\n<p>Temyiz sahibinin arg\u00fcmanlar\u0131 uyar\u0131nca dosyada incelenen ana istemin C7 dok\u00fcman\u0131ndaki \u00d6rnek 8 kar\u015f\u0131s\u0131ndaki yenili\u011fi tesis eden fark unsurlar\u0131 \u015funlard\u0131r:<\/p>\n<blockquote><p>i) the amount of compound I (imatinib),<\/p>\n<p>ii) the amount of cross-linked PVP (Polyvinyl pyrrolidone),<\/p>\n<p>iii) the generalisation of Imatinib monomesylate to Imatinib<\/p>\n<p>iv) the presence of cross-linked PVP as possible sole excipient.<\/p><\/blockquote>\n<p>Temyiz sahibinin iddialar\u0131 uyar\u0131nca patent sahibi taraf\u0131ndan kan\u0131t olarak sunulan C76 belgesinde yer alan test sonu\u00e7lar\u0131 kapsam\u0131nda sergilenen teknik etkiler orijinal ba\u015fvuru kapsam\u0131nda a\u00e7\u0131klanmamaktad\u0131r. Temyiz sahibi ba\u015fvuru sonras\u0131nda sunulan deneysel veriyle sergilenen teknik etkilerin bulu\u015f basama\u011f\u0131n\u0131 destekleyemeyece\u011fini ifade etmektedir. Orijinal tarifname bozunma, sertlik derecesi, a\u015f\u0131nma direnci ve gevreklik gibi \u00f6zelliklere dair teknik etkiler konusunda sessizdir.<\/p>\n<p>Patent sahibinin bulu\u015f basama\u011f\u0131n\u0131 desteklemek \u00fczere sundu\u011fu C76A ve C76B belgeleri duru\u015fmadan sadece iki ay \u00f6nce sunulmu\u015ftur. Patent sahibi gecikmeye gerek\u00e7e olarak s\u00f6z konusu kan\u0131tlar\u0131n Temyiz Kurulu\u2019nun \u00f6n g\u00f6r\u00fc\u015f\u00fcne cevaben dosyaland\u0131\u011f\u0131 i\u00e7in ge\u00e7 dosyaland\u0131\u011f\u0131n\u0131 ifade etmektedir. Ancak Temyiz Kurulu\u2019nun duru\u015fma davetiyle birlikte iletti\u011fi \u00f6n g\u00f6r\u00fc\u015f\u00fcnde sundu\u011fu arg\u00fcmanlar temyiz sahiplerinin temyiz dilek\u00e7elerinde zaten yer ald\u0131\u011f\u0131ndan patent sahibinin ge\u00e7 sundu\u011fu belgeler s\u00fcrece kabul edilmemi\u015ftir.<\/p>\n<p>Temyiz Kurulu karar\u0131na g\u00f6re bulu\u015f basama\u011f\u0131n\u0131 sa\u011flayan teknik unsurlar\u0131n etkileri veya \u00e7\u00f6zd\u00fckleri problemin orijinal ba\u015fvuru tarifnamesinde a\u00e7\u0131k a\u00e7\u0131k yaz\u0131lmalar\u0131 veya en az\u0131ndan orijinal tarifnameden hareketle \u00e7\u0131karsanabilmeleri yeterlidir. Orijinal tarifnamenin teknik etkileri destekleyecek test sonu\u00e7lar\u0131na sahip olmas\u0131 zorunlu de\u011fildir. Di\u011fer yandan Temyiz Kurulu ana istemin fark unsurlar\u0131n\u0131n teknik etkilerinin a\u015fikar oldu\u011fu gerek\u00e7esiyle patenti iptal etmi\u015ftir.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EP 1 501 485\u00a0patentinin tescil karar\u0131 kar\u015f\u0131s\u0131nda 9 itiraz dosyalanm\u0131\u015f ve \u0130tiraz Birimi\u2019nin karar\u0131 ile T 0571\/11 temyiz dosyas\u0131 kapsam\u0131nda<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[112],"tags":[],"class_list":["post-4525","post","type-post","status-publish","format-standard","hentry","category-t-kararlar"],"_links":{"self":[{"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts\/4525","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/comments?post=4525"}],"version-history":[{"count":2,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts\/4525\/revisions"}],"predecessor-version":[{"id":5031,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts\/4525\/revisions\/5031"}],"wp:attachment":[{"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/media?parent=4525"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/categories?post=4525"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/tags?post=4525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}