On Jun 15, 2018, the Danish Maritime & Commercial High Court granted preliminary injunction against Sandoz’ generic product & rejected invalidity challenges.

As reported on “EP law blog”, the Court found that DK/EP 1173181 patent showed surprising effect that Tadalafil can be used daily and is effective at low doses with a minimum of side effects. The Court specifically found that the use of a unit dosage comprising 1 to 5 mg Tadalafil up to a maximum total dose of 5 mg daily would not have been obvious to the person skilled in the art in view of prior arts.

Thus, Court granted preliminary injunction against Sandoz’ 2.5mg & 5mg strengths but not for 10mg strength because Eli Lilly had not rendered it probable that sale of Sandoz’ 10 mg tablets constituted an indirect infringement.