With any generic product launch, the generic company must decide whether to ‘clear the path’ by applying to invalidate the patent covering the pharmaceutical product before launch, or launch at risk without clearing the path, where the key risk is that the patent owner seeks a preliminary injunction. The pregabalin litigation, heard by the English Court of Appeal in Warner-Lambert v Actavis in May 2016, demonstrates the additional considerations for a second medical use patent.
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