Entacapone, Levodopa, and Carbidopa – Belgium

On May 9, 2017, the Brussels court of commerce handed down its decision in the context of an infringement action initiated by Orion and its exclusive licensee Novartis against Belgian generic company Eurogenerics.

The proceedings relate to Orion’s European patent EP 1 189 608 (expiring on Jun 29, 2020), concerning an oral three-in-one solid composition of entacapone, levodopa and carbidopa, wherein a substantial portion of carbidopa is separated from entacapone and levodopa. On the basis of EP ‘608, Novartis commercializes the medicinal product Stalevo® used in the treatment of Parkinson’s disease. Eurogenerics obtained a marketing authorization for an alternative three-in-one formulation of entacapone/levodopa/carbidopa using Stalevo® as reference medicinal product. Novartis considers that the generic product of Eurogenerics falls under the scope of protection of EP ‘608 and therefore initiated an infringement action, based on either a literal infringement or an infringement by equivalence.

Although Eurogenerics contested the infringement of EP ‘608, it challenged its validity by way of a counterclaim. The Brussels court of commerce confirmed that EP ‘608 is invalid due to a lack of inventive step applying the problem-solution approach. As the combination of entacapone, levodopa and carbidopa was already disclosed in the prior art, in particular in one of Orion’s earlier patents, only the separation of carbidopa from the other two active substances claimed in EP ‘608 had to be assessed on its validity. The court noted in this regard that the separation of active substances was part of the prior art. The fact that such separation was only carried out when strictly necessary, does not imply that this process was exceptional, new or inventive. Considering the known chemical instability between levodopa, carbidopa and entacapone, a skilled person would have a clear incentive to separate one of the active substances in order to guarantee (and maintain) the chemical stability of the three-in-one formulation.

Finally court determined that, as a separation of carbidopa was an obvious choice any alleged unexpected therapeutic efficacy resulting from this separation could not render the invention inventive. Given the absence of a valid patent Eurogenerics could not infringe the invoked patent rights of Orion and Novartis.