Mylan B.V. v. Janssen Pharmaceuticals Inc., District Court The Hague, 11 December 2013, Case No. C/09143 1145 / HA ZA 12-1336
The District Court of the Hague invalidated Janssen’s tramadol-acetaminophen combination SPC on account of a lack of inventive step. The claims of the base patent required the presence of a combination between a tramadol compound and acetaminophen as sole active compounds, in a particular range of weight ratios. This was said to have a beneficial additive effect.
The Court held that a prior art document disclosed a combination between a tramadol compound and acetaminophen in the specified range of weight ratios, albeit in the presence of two more active ingredients. However, as the base patent did not disclose that the additive effect was due to a combination of only tramadol and acetaminophen, the court held that there was no reason to assume that the additive effect would not also occur when making use of the prior art combination. It therefore defined the objective technical problem as finding an alternative formulation of the one disclosed in the prior art.