{"id":4571,"date":"2019-07-30T19:54:05","date_gmt":"2019-07-30T16:54:05","guid":{"rendered":"http:\/\/www.alfapatent-stanadvoka.com\/?p=4571"},"modified":"2021-01-12T21:06:12","modified_gmt":"2021-01-12T18:06:12","slug":"t1491-14","status":"publish","type":"post","link":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/t1491-14\/","title":{"rendered":"30.07.2019 \/T 1491\/14 \/VORTIOXETINE \/LUNDBECK"},"content":{"rendered":"<p><a href=\"https:\/\/worldwide.espacenet.com\/publicationDetails\/originalDocument?FT=D&amp;date=20111221&amp;DB=EPODOC&amp;locale=en_EP&amp;CC=EP&amp;NR=2219647B1&amp;KC=B1&amp;ND=4\">EP 2 219 647<\/a>\u00a0patenti 1 ve 3 numaral\u0131 istemler ba\u011f\u0131ms\u0131z olmak \u00fczere 4 istemle tescil edilmi\u015ftir.<\/p>\n<blockquote><p>&#8220;1. A use of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl] piperazine and pharmaceutically acceptable salts thereof in the manufacture of a medicament for the treatment of a disease selected from depression, anxiety, abuse or chronic pain, wherein said medicament is for use in a patient who has previously received another medication for the treatment of said disease which medication was ceased or reduced due to sleep or sexually related adverse events.&#8221;<\/p>\n<p><span style=\"font-family: Arial, Verdana;\">\u00a0<\/span><\/p>\n<p>&#8220;3. 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine and pharmaceutically acceptable salts thereof for use in the treatment of a disease selected from depression, anxiety, abuse or chronic pain in a patient who has previously received another medication for the treatment of said disease which medication was ceased or reduced due to sleep or sexually related adverse events.&#8221;<\/p><\/blockquote>\n<p>Temyiz edilen karar \u0130tiraz Birimi\u2019ne ait 3. terditli talebe ait istemlere dayal\u0131 karard\u0131r. Karar hem itiraz sahibi hem de patent sahibi taraf\u0131ndan temyiz edilmi\u015ftir.<\/p>\n<p>1 ve 3. istemlerde tan\u0131mlanan hasta grubu s\u0131n\u0131rlay\u0131c\u0131 kabul edilmemi\u015ftir zira farkl\u0131 bir klinik durumu yans\u0131tmamaktad\u0131rlar. Bunun gerek\u00e7esi ise depresyon i\u00e7in birinci basamak tedavi g\u00f6ren ve bir s\u00fcre sonra b\u0131rakan hastalar\u0131n, ne fizyolojik ne de patolojik olarak di\u011fer hastalardan ay\u0131rt edilememesidir. Bu durum hasta grubunun, hastan\u0131n sosyal ve ki\u015fisel ko\u015fullar\u0131 gibi teknik olmayan fakt\u00f6rler taraf\u0131ndan motive edilen zihinsel bir faaliyet \u00fczerinden tan\u0131mlanmas\u0131 nedeniyle ortaya \u00e7\u0131kmaktad\u0131r. Bu zihinsel faaliyet istemlerde uyku durumu veya cinsel ili\u015fki ile ilgili olumsuz yan etkilerin ortaya \u00e7\u0131kmas\u0131 nedeniyle ilac\u0131 durdurma veya azaltma karar\u0131 \u015feklinde tan\u0131mlanm\u0131\u015ft\u0131r. Temyiz sahibinin g\u00f6r\u00fc\u015f\u00fcne g\u00f6re bu nedenden \u00f6t\u00fcr\u00fc olu\u015fan teknik \u00f6zellik eksikli\u011fi, \u0130stem 1 ve 3&#8217;teki hastalar\u0131n herhangi di\u011fer hastalardan ayr\u0131\u015fmas\u0131n\u0131 \u00f6nlemektedir. Oturmu\u015f i\u00e7tihat kararlar\u0131 \u0131\u015f\u0131\u011f\u0131nda sadece zihinsel nitelikteki \u00f6zelliklerin EPC Md. 54 yenilik de\u011ferlendirmesi bak\u0131m\u0131ndan teknik \u00f6zellikler olarak addedilmeyecekleri g\u00f6r\u00fc\u015f\u00fc ortaya konmu\u015ftur. \u0130stem 1 ve 3&#8217;\u00fcn tan\u0131mlad\u0131\u011f\u0131 hasta grubu, yenili\u011fin de\u011ferlendirilmesi i\u00e7in s\u0131n\u0131rland\u0131r\u0131c\u0131 anlamda dikkate al\u0131namaz.<\/p>\n<p>Dok\u00fcman D4, depresyon, anksiyete, k\u00f6t\u00fcye kullan\u0131m ve kronik a\u011fr\u0131n\u0131n vortioksetin ile tedavisine y\u00f6nelik oldu\u011fu i\u00e7in en yak\u0131n \u00f6nceki tekniktir. \u0130stem 1 ve 3, belirli bir hasta grubuna y\u00f6nelik bir tan\u0131m yapmas\u0131ndan \u00f6t\u00fcr\u00fc \u00f6nceki teknikten farkl\u0131l\u0131k g\u00f6stermektedir ancak temyiz sahibi bu farkl\u0131l\u0131\u011f\u0131n keyfi bir hasta grubu se\u00e7imine dayal\u0131 oldu\u011fundan teknik bir etkisi olmad\u0131\u011f\u0131n\u0131 \u00f6ne s\u00fcrmektedir.<\/p>\n<p>Patent sahipleri duru\u015fma s\u0131ras\u0131nda\u00a0<u>bir hasta grubunun \u00f6nceden bilinen bir y\u00f6ntemi yeni k\u0131lmas\u0131 i\u00e7in<\/u>\u00a0kar\u015f\u0131lamas\u0131 gereken kriterleri \u015f\u00f6yle a\u00e7\u0131klam\u0131\u015ft\u0131r:<\/p>\n<blockquote><p>i) Hasta grubu, \u00f6nceki teknikte a\u00e7\u0131klanmam\u0131\u015ft\u0131r.<br \/>\nii) Gruba ait hastalar fizyolojik veya patolojik durumlar\u0131 ile \u00f6nceki tekni\u011fin hastalar\u0131ndan ay\u0131rt edilebilir.<br \/>\niii) Fizyolojik veya patolojik durumlar\u0131n\u0131 karakterize etme ile terap\u00f6tik tedavi aras\u0131nda fonksiyonel bir ili\u015fki vard\u0131r ve bu nedenle hastalar\u0131n se\u00e7imi keyfi de\u011fildir.<\/p><\/blockquote>\n<p>Temyiz Kurulu her ne kadar yerle\u015fik i\u00e7tihatta bu konuda bir tan\u0131m olmasa da patent sahipleri taraf\u0131ndan sunulan tan\u0131m\u0131n istemi yeni k\u0131ld\u0131\u011f\u0131 kanaatine varm\u0131\u015ft\u0131r. Temyiz Kurulu \u00fc\u00e7 kriterin \u0130stem 1 ve 3\u2019teki hasta gruplar\u0131 taraf\u0131ndan kar\u015f\u0131land\u0131\u011f\u0131 kanaatine varm\u0131\u015ft\u0131r.<\/p>\n<p>Vortioksetinin, plasebo seviyesinde (yani m\u00fcmk\u00fcn olan en d\u00fc\u015f\u00fck seviyede) veya biraz \u00fcst\u00fcnde uykuya ve cinsel ili\u015fkiye ba\u011fl\u0131 yan etkilere neden oldu\u011fu bilinmektedir. Vortioksetinin, duloksetin ve venlafaksin gibi referans SRI antidepresanlar\u0131ndan daha d\u00fc\u015f\u00fck uyku ve cinsel olarak ili\u015fkili advers etkiler \u00fcretti\u011fi de g\u00f6sterildi\u011finden yenili\u011fin yan\u0131nda bulu\u015f basama\u011f\u0131 da \u0130tiraz Birimi\u2019nce uygun g\u00f6r\u00fclen birinci terditli talebe dayal\u0131 olarak teslim edilmi\u015f ve \u0130tiraz Birimi karar\u0131 onanm\u0131\u015ft\u0131r.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EP 2 219 647\u00a0patenti 1 ve 3 numaral\u0131 istemler ba\u011f\u0131ms\u0131z olmak \u00fczere 4 istemle tescil edilmi\u015ftir. &#8220;1. A use of<\/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-4571","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\/4571","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=4571"}],"version-history":[{"count":3,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts\/4571\/revisions"}],"predecessor-version":[{"id":5078,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/posts\/4571\/revisions\/5078"}],"wp:attachment":[{"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/media?parent=4571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/categories?post=4571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.alfapatent-stanadvoka.com\/tr\/wp-json\/wp\/v2\/tags?post=4571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}