AstraZeneca had filed an application for interim relief based on two patents, DK/EP 1250138 T4 (“EP 138”) and DK/EP 2266573 T3 (“EP 573”) against Sandoz, which conceded that to the extent that the patents were valid, the Sandoz product “Fulvestrant Sandoz” infringed upon the two patents.
Sandoz took the position, however, that the patents should be held invalid for lack of inventive step, arguing that both patents-in-suit make mention of articles detrimental to inventive step (articles by Howell et al. and McLeskey).
In 2015, the EPO Opposition Division upheld EP 138 after the appellant withdrew its opposition. In that connection, EPO held that Howell et al. and McLeskey in combination did not take away inventive step.
In a subsequent decision, in 2017, the EPO Opposition Division held EP 573 invalid for lack of inventive step and the Opposition Division noted in that connection that it disagreed with the conclusion reached in relation to EP 138, now holding that in combination with the knowledge derived from the articles by Howell et al. and McLeskey there was no inventive step.
The Maritime and Commercial Court held that the EPO decision regarding EP 573 must result in a material weakening of the presumption in favour
of that patent being valid, and the fact that the decision had been appealed by AstraZeneca could not lead to a different assessment, even if the EPO appeal had suspensive effect.
Based on an analysis of Howell et al., McLeskey and further citations filed for the Danish proceedings, the court arrived at the conclusion that the skilled person would have had a reasonable expectation of success by using a formulation from McLeskey, and that the invention to the skilled person would therefore be obvious in relation to the prior art.
Consequently, the Danish Maritime and Commercial Court held that AstraZeneca had neither rendered probable or proven that it was the proprietor of an exclusive right that could be infringed, and so the application for interim relief was turned down.
It is very rare for a Danish court to turn down applications for interim relief based on an inventive step defense.
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When looking at the file, it appears that the opposition division dealing with EP 2266573 (divisional) NEVER stated that it disagreed with the decision taken by the opposition division in EP 1250138 (grand parent).
It merely said, that it was not bound by any previous EPO or national decision on the grand parent patent. See point XV of the facts and submissions or point 2. of the annex to the summons in case 573′. There, it was merely noted that the decision in 138′ was taken without oral proceedings and after withdrawal of the only opposition filed. This is correct, and it cannot be said that the decision was criticised or disagreed with.
It might nevertheless appear surprising that on more or less similar subject-matter the EPO came to a totally different conclusion. But the composition of the opposition division was different and the situations were totally different. One opponent, having withdrawn the opposition, vs. 5 opponents all being big generic pharmaceutical companies.
It is worth noting that in case 138′, the opposition division in yet another different composition, originally rejected the opposition. This decision was set aside and D 1=D4=Mac Leskey and D 15=D4=Howell were admitted in the procedure, and the file remitted to the opposition division. The latter then decided to maintained the 138′ patent as amended.