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ARTICLE · 14 FEBRUARY 2022

Jenerik Ruhsat Başvuruları Ile İlgili Bilgi Alma Hakkı

Gün + Partners
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Ruhsatlandırma Yönetmeliği'nin "Kısaltılmış Başvuru" başlıklı 9. maddesi uyarınca, bir ilaca daha önceden ruhsat verilmiş olması halinde, bu araştırma ve testlerin tekrar...

TurkeyIntellectual Property
Aysel Korkmaz Yatkın
Aysel Korkmaz Yatkın
Fatma Sevde Tan
Fatma Sevde Tan
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Ruhsatlandırma Yönetmeliği'nin "Kısaltılmış Başvuru" başlıklı 9. maddesi uyarınca, bir ilaca daha önceden ruhsat verilmiş olması halinde, bu araştırma ve testlerin tekrar yapılması ve testlere ilişkin verilerin ruhsatlandırma için tekrar sunulması gerekmemekte, önceden ruhsat verilen ilacın ruhsat bilgilerine referans verilmesi ile yetinilmektedir.

Ancak referans başvuruya konu ürünün aynı zamanda patentlerle korunan orjinal ürün ile temelde benzer olma zorunluluğu nedeniyle, patent haklarına kuvvetle muhtemel bir tecavüz tehlikesi de doğmaktadır. Her ne kadar ruhdatlandırma işlemleri patent hakkından istisna edilmilmişse de, referans ürüne ruhsat verildikten sonra girişlecek faaliyetlerin patent tecavüzü tehlikesi yaratıp yaratmadığının tahlili ve kanundan doğan hakların patent sahiplerince efektif kullanılmasının sağlanması amacıyla patent hakkı sahibinin bahsi geçöen referans başvurular hakkında bilgi sahibi olması gerekmektedir. Bu kapsamda patentle korunan

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