Article
Infringement Of Second Medical Use Claims And Proof Of Infringement
European and Turkish courts are reshaping how second medical use patent infringement is determined, moving beyond simple SmPC carve-outs to examine real-world prescribing patterns and market behavior. Recent landmark decisions establish that generic pharmaceutical companies may face liability even when patent-protected indications are removed from product documentation, if off-label or cross-label use occurs to a sufficient extent. The evolving legal framework now requires courts to assess both objective ma
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