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Teva Pharmaceuticals Europe B.V. v. Boehringer Ingelheim Pharma GmbH & CO.KG, District Court The Hague, the Netherlands, 7 September 2016, Case number 489185 / KG ZA 15-15-625

In the present proceedings initiated by Teva against Boehringer before the District Court of The Hague, Teva successfully claims annulment of certain (amended) claims of the Dutch part of a European patent held by Boehringer due to a lack of inventive step.

Boehringer is the holder of European patent EP 1 379 220 (“EP 220”) for ‘Inhalation
capsules’, granted on 29 December 2004  inter alia for the Netherlands. In the present proceedings, Boehringer defends its patent in amended form. In short, the (amended) claims of EP 220 seek to protect the use of HPMC as capsule material for inhalation capsules (containing tiotropium) with a maximum average moisture content. The District Court in its discussion of the facts of the case refers to the judgments of the German Bundesgerichtshof and the British High Court, wherein the respective national parts of EP 220 were annulled.

The District Court in its validity assessment applies the problem/solution approach and states that the closest prior art in the present case is a phase II clinical trial study on a tiotropium formulation contained in capsules for an inhaler. The District Court notes, in line with the expert opinions submitted by Boehringer, that the skilled person would have understood the capsules that were the subject of the trials to have been made from gelatin.

The District Court subsequently described the distinguishing features in the light of the amended claim 6 of EP 220 and the closest prior art as (i) the use of HPMC as capsule material and (ii) said material’s moisture content of 5% or less. The District Court emphasizes that the technical effects of the distinguishing features must be made plausible for the average skilled person in the patent. Because EP 220 does not contain any explanation or substantiation of the technical effects (of the HPMC material or the moisture content), the post-published evidence submitted by Boehringer is discarded by the District Court. The moisture content is left out of the for-mulation of the technical problem and with regard to the HPMC material, the District Court rules that its technical effect on the basis of EP 220 at best can described as similar to the technical effect of a gelatin capsule, so that the HPMC material is merely an alternative to gelatin.

The District Court concludes that the technical problem is to provide an alternative capsule material for tiotropium to be administered by means of an inhaler and rules that this problem would be solved by the skilled person without inventive step in the light of an article titled “HPMC Capsules – An Alternative to Gelatin”. Boehringer’s defenses with regard to (the merits of) this article, the motivation of the skilled person to look for an alternative and ‘pointers away’ are rejected by the District Court and Teva’s (amended) claim for annulment of certain (amended) claims of EP 220 is granted.

A copy of the judgment (in Dutch) can be found here.

Head note: Tim Iserief, NautaDutilh