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Its 2020 and 2021 guidance documents on Orange Book patent listing made clear that only patents claiming the approved drug itself or its approved method of use may be listed [5]
This risk is elevated in women, but has not been seen in men
Restrictions apply
Amarin will be a watershed moment for this strategy, as it will define whether routine marketing statements are sufficient to plead induced infringement even when a label is technically compliant with carve-out regulations
They will determine your eligibility for various programs
