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ARTICLE · 20 NOVEMBER 2025

Biyobenzer İlaçlar ve Patent Tecavüzü Karinesi

Gün + Partners
Gün + Partners
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Gün + Partners

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Jeneriklere karşı patent haklarının ileri sürülmesi için açılabilecek davaların öncesinde patent hakkı sahibi esasen karanlıkta ilerler.

TurkeyIntellectual Property
Aysel Korkmaz Yatkın
Aysel Korkmaz Yatkın
Selin Sinem Erciyas
Selin Sinem Erciyas
Zeynep Çağla Üstün
Zeynep Çağla Üstün
Beste Turan
Beste Turan
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Jeneriklere karşı patent haklarının ileri sürülmesi için açılabilecek davaların öncesinde patent hakkı sahibi esasen karanlıkta ilerler. Çünkü özellikle jenerik ilacın kısa ürün bilgisinin henüz yayınlanmadığı veya patentin ihlal edilip edilmediğinin kısa ürün bilgisinde yer alan sınırlı bilgilerle anlaşılamadığı durumlarda, jeneriğe ait ruhsat dosyasının ilgili kısımlarının incelenmesi ile patentin ihlal edilip edilmediğinin değerlendirilmesi gerekir ki bu da ancak bir mahkeme kararı ile mümkündür. Mahkemeyi böyle bir incelemenin gerekli ve makul olduğuna ikna eden en önemli unsur ise patentin ihlalinin kuvvetle muhtemel olduğu olgusu bir diğer deyişle tecavüz karinesidir.

Ruhsatlandırma yönetmeliğinin kısaltılmış ruhsat başvurusunu düzenleyen ilgili hükümleri uyarınca bir jenerik ürünün veri imtiyazı süresi dolmuş bir orijinal ürüne ait ruhsat dosyasını referans göstererek ve referans ürün ile temelde benzer olduğunu iddia ve ispat ederek kısaltılmış

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