The Danish Maritime & Commercial Court turns down Teva's PI application for inhaler

Yesterday, the Danish Maritime and Commercial High Court (Sø- og Handelsretten) gave its decision in injunction proceedings relating to a patent covering a separate dose counter for use in a metered dose inhaler (“MDI”).

 Norton Healthcare is the proprietor of a patent comprising a certain type of dose counter for use in MDIs. In February 2014, Sandoz (represented by Horten) had introduced its AirFluSal Forspiro pharmaceutical product, which consisted of 60 doses of pharmaceutical product stored in a blister strip. Each individual blister of the strip carried indicia (individual doses numbered) to inform the user of the number of doses remaining in the inhaler. 

Norton Healthcare (and Teva) submitted an application for an interim injunction with the Danish Maritime and Commercial High Court, claiming that the blister strip of the AirFluSal Forspiro inhaler, which carried indicia, constituted a dose counter which infringed the patent in suit. 

Sandoz argued that the scope of protection of the patent in suit was limited to dose counters for a specific category of medicament inhalers, namely MDIs. Furthermore, Sandoz argued that, on the priority date of the patent in suit, the term “metered dose inhaler” was used by the person skilled in the art as the term for a certain category of medicament inhalers, characterized by the medicament being stored in a “bulk reservoir” from which individual doses were metered out, preferably by means of a valve. The AirFluSal Forspiro – in Sandoz’ view – did not fall within the MDI type of inhaler as it was based on a completely different means of delivery, in that the doses contained in the AirFluSal Forspiro had already been metered off in the course of the production of the blister strip. 

Norton Healthcare (and Teva) argued that the term “metered dose inhaler” did not refer to a particular type of inhale, and, accordingly, the AirFluSal Forspiro – due to the fact that the blister strip carried indicia – was within the scope of the patent in suit. As a second line argumentation, Norton Healthcare/Teva asserted that the AirFluSal Forspiro infringed the patent in suit by means of equivalence.

The Maritime and Commercial High Court ruled in favour of Sandoz, stating that – in the Court’s view – the person skilled in the art would understand the term “metered dose inhaler” in the patent in suit to refer to “bulk reservoir” inhalers with a metering function. As the AirFluSal Forspiro was not of this type, the Court ruled that this was not a case of literal infringement. With regard to infringement by means of equivalence, the Maritime and Commercial Court stated that the Forspiro device used a completely different technology than that of the patent in suit, which did not give rise to the particular technological problem that the patent in suit claimed to solve. 

Accordingly, Norton Healthcare’s/Teva’s application was dismissed.

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Anders Valentin

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