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Court of The Hague rules on set value in patent (Netherlands)

27 October 2016

The Court of The Hague in the Netherlands has deemed that a set value described in a patent claim is irrelevant for the assessment of whether that patent was valid.

On 26 October 2016, the Court of The Hague ruled in Actelion Pharmaceuticals Ltd v. Icos Corporation that Icos’s carboline compound patent is invalid because it lacks an inventive step. The compound has certain beneficial size characteristics, allowing for instance a rapid therapeutic effect, or “onset”.

Actelion had intended to bring tadalafil on the Dutch market, to be used for the treatment of sexual disorders, and requested that the court invalidate the Icos patent for a free drug form of carboline particles (wherein at least 90% of the particles have a particle size of less than about 40 microns.

The court compared the patent claim with the prior art at the date of the patent application and decided that the only difference was the size of the particles. The technical effect of the small-sized particles mentioned in the patent was that the onset of the therapeutic effect of tadalafil is improved as compared to existing formulations. When the onset improves, the bioavailability improves as well. The court held that a skilled person would know that particles of poorly soluble substances can be made smaller by way of micronization, which leads to a more rapid absorption. The skilled man would further realise that this leads to a more rapid therapeutic effect. Whether the skilled man would reduce particles to 40 micron or less is irrelevant, because it is not clear that the technical effect has to be attributed to said value. In other words, no inventiveness can be derived from said value. Taking that into account, the court held that the patent was obvious for the skilled man, and therefore invalid.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, November 2016 Issue (Thomson Reuters).