Joined cases Sandoz B.V. and Hexal AG v. AstraZeneca AB and Accord Healthcare B.V. and Accord Healthcare Ltd v. AstraZeneca AB, District Court The Hague, The Netherlands, 7 March 2012, Case numbers 397921 / HA ZA 11-1977 and 397925 / HA ZA 11-1978, with thanks to Willem Hoyng and Jeroen den Hartog, Hoyng Monegier, for sending in the case and a translation in English
Sandoz et al sought to invalidate AstraZeneca’s patent for a sustained release formulation of quetiapine (Seroquel). According to Sandoz et al., AstraZeneca’s patent lacked inventive step as on the priority date there would have been a strong motivation for the skilled man to make sustained release formulation, with a reasonable expectation of success. The District Court of The Hague applied the following test:
“The District Court will take as its point of departure that in the assessment of the inventive step of the patent, also if the problem-solution approach is applied, the question must be answered as to whether the average skilled person - assuming all the knowledge at his disposal on the filing date - was motivated to develop a sustained-release formulation of quetiapine and whether he would have a reasonable expectation of success, i.e. that this would solve the objective problem. In this respect, motivation on the one hand and a reasonable expectation of success are communicating vessels, in the sense that if he is strongly motivated, a less-high expectation of success will be sufficient for the skilled person, whereas he will need a high expectation of success if he is not very motivated. In other words, what is a ‘reasonable’ expectation, depends on the level of motivation.”
In applying this test, the Court held that the motivation to make a sustained release formulation of quetiapine was very limited on the priority date. As the skilled man moreover did not have a high expectation that he could make a sufficiently efficacious sustained release formulation of quetiapine with success, the Court concluded that such formulation was not obvious on the priority date and denied the requested invalidation of the patent.
Read the decision (in Dutch) here.
Read the decision (in English) here.
Head note: Geert Theuws
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