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NL – Mylan v. Janssen Pharmaceuticals

27 Feb 2014

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.


The alternative which was claimed in the base patent was held not to be inventive. A prior art publication in a related field showed that pain could be fought with combinations of only two active substances which were related to those which were claimed. Whilst it was true that the prior art document also disclosed other combinations, this could not make the claim inventive, as selecting an obvious alternative from a list of other obvious alternatives did not require inventive skill.

Being the victorious party, Mylan claimed its full costs, inter alia stating that Janssen had during negotiations demanded that Mylan would stay off the market for at least the time that the negotiations were ongoing. The Court, however, deemed this insufficient to conclude that there was a real threat that Janssen would enforce its patent or SPC against Mylan also after the negotiations had ended. As for this reason there was no enforcement side to the current invalidity case, the Court declined to award Mylan its full costs.

Read the judgment (in English) here.

Head note: Geert Theuws