Sanofi Aventis v. Ratiopharm GmbH and Ratiopharm Nederland B.V., Court of Appeal The Hague, the Netherlands, 1 November 2011, Case No. 200.068.342/01
In its judgment of 1 November 2011, the Court of Appeal of The Hague has confirmed the District Court’s decision that Sanofi-Aventis’ patent EP 0 881 901 relating to a pharmaceutical composition comprising a combination of the active substances clopidogrel and aspirin was invalid for lack of inventive step. Clopidogrel and aspirin have a synergistic effect on the inhibition of blood platelet aggregation, which means the combination product is useful for the treatment of thrombosis.
The Court dismissed Ratiopharm’s argument on claim construction. According to the Court, the term “composition containing ” (both clopidogrel and aspirin) did not necessarily mean that both active substances had to be included in one dosage form. However, the Court did agree with Ratiopharm that the patent was obvious, in light of the prior art publications that indicated to the skilled person that a combination of ticlopidine, an active substance with properties similar to clopidogrel, and aspirin had a synergistic effect on blood platelet aggregation. The skilled person would have had an incentive to replace ticlopidine with clopidogrel, in light of other prior art documents indicating that clopidogrel had shown better results and less side-effects than ticlodipine.
Sanofi-Aventis’ argument that the skilled person would not consider combining the two active substances, in light of the known risk of extended bleeding time, was dismissed. The Court held that the skilled person would not be deterred by the data relating to extended bleeding time from using the combination product, but would weigh the severity of the condition to be treated and the known potential benefits of the combination product against the known risks.
Read the decision (in Dutch) here.
Head note: Jaap Bremer