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NO – Teva v. Boehringer Ingelheim / Tiotropium

25 Jul 2016

Teva Norway AS vs. Boehringer Ingelheim Pharma GmbH & Co KG, Oslo District Court, Norway, 17 June 2016, Case No. 15-082184TVI-OTIR/04

The decision concerns part of the patent claims for Boehringer Ingelheim’s patent NO 332 857, which pertains to inhalation capsules containing the active ingredient tiotropium.

The disputed claims pertains to powder inhalation capsules containing a mixture of tiotropium and the physiological acceptable excipient lactose, wherein the capsule material used is cellulose-derivative hydroxypropyl methylcellulose (HPMC), and the capsule material had a reduced level of moisture, more specifically TEWS or halogen drier moisture content of ≤ 5% (claim 6), less than 4% (claim 7) and less than 2% (claim 8). Among the disputed claims were also dependent claims concerning the concentration of tiotropium, particle size of the excipient, various forms of tiotropium salt, the use of the capsules in a medicament and the use of the capsules for the treatment of asthma or COPD.

According to the decision, Teva initiated invalidity proceedings based on the original patent, whereas Boehringer subsequently filed an application for an administrative limitation of the patent. The Norwegian Industrial Property Office awarded a limitation of the patent in accordance with Boehringer’s application, thus the subject matter before the court was the limited claims.

On 17 June 2016, Oslo District Court found that the disputed claims of the patent were invalid due to lack of inventive step. The court based this on using the problem solution approach, finding that based on the relevant closest prior art, it would be obvious to the skilled person invent tiotropium for the use in HPMC capsules.

Concerning the specific levels of moisture, the parties disagreed on whether or not these levels are normal for capsules with HPMC. The court did not find it necessary to determine what constituted normal levels, since it found it obvious that due to tiotropium’s sensitivity to moisture, the skilled person would be induced to experiment with capsules with different moisture levels, and conclude that capsules with low moisture levels would be preferable. Nevertheless, the court did assess the situation under the presumption that the skilled person would not experiment with capsules with different moisture levels, and came to the same result.

With regards to the dependent claims, the court also found that they did nothing to add inventiveness. The disputed claims (claims 6-13) of the patent were therefore found invalid.

The validity of a patent pertaining HPMC-capsules containing tiotropium was also the subject for a court case in the UK last year, see [2015] EWHC 2963 (Pat) reported here.

Read the decision (in Norwegian) here.
Read the decision (in English) here.

Head note: Håkon Austdal, Haavind