Eli Lilly wins erectile dysfunction patent case

The Danish Maritime and Commercial High Court has granted Eli Lilly a preliminary injunction against a medicinal product marketed by the pharmaceutical company Mylan. Plesner assisted Eli Lilly in the case.

The case concerned Mylan's sale of a medicinal product containing tadalafil for the use in treatment of erectile dysfunction (impotence) which Eli Lilly Danmark A/S, Eli Lilly and Company and Icos Corporation ("Eli Lilly") claimed infringed its patent.
The main issue in the case was whether Eli Lilly's patent was valid. Mylan claimed that the patent was invalid due to lack of inventive step.

In this connection, Mylan claimed that there was no presumption that the patent was valid, as Eli Lilly had previously had the patent limited through EPO's limitation procedure, and that the EPO during the limitation procedure does not assess whether the amended patent claims have inventive step.

Preliminary injunction granted
In its decision of 1 February 2019, the Maritime and Commercial High Court granted
a preliminary injunction against Mylan's medicinal product containing 5 mg tadalafil.

The Court found that even though the patent had been limited, there still existed a presumption that the patent was valid. In this connection the Court, inter alia, referred to the fact that during the limitation procedure the EPO ensures that the limited patent claims actually constitute a limitation of the originally granted claims, and that the limited patent claims only provide protection for a smaller part of the originally granted patent.

On the evidence, the Court did not find sufficient grounds to establish that the patent lacked inventive step and Eli Lilly had thus rendered it probable that the patent is valid.

At this point, it is not known whether there will be an appeal of the decision.

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