McNeil AB is the owner of an EP patent, valid in Sweden, for a liquid pharmaceutical formulation comprising nicotine for the administration to the oral cavity.
Niconovum AB markets the product Zonnic, a smoking cessation product, which is available as a mouth spray.
In November 2009, McNeil obtained a preliminary injunction against Niconovum in respect of Zonnic in the Stockholm District Court. Niconovum was thus prevented from marketing the Zonnic mouth spray until final judgment was rendered.
Niconovum appealed this decision to the Svea Court of Appeal, which granted leave to appeal in December 2009.
Court reasoning and ruling
Niconovum inter alia argued that McNeil’s patent at issue was invalid. McNeil requested a limitation of the patent claims and that this limitation should be considered in the preliminary injunction proceedings. Niconovum objected to this, at least that the limitation could be considered in the preliminary injunction proceedings.
The Court of Appeal agreed with the District Court, that the Zonnic product at issue probably fell within the scope of the patent in question, and that McNeil had established it as likely that patent infringement was at hand, provided that the patent was valid.
The Court initially addressed the question whether the patent in its present formulation satisfied the requirements for novelty. On the evidence presented by the parties, the Court considered it likely that the patent in its present form did lack novelty.
It therefore became relevant to consider the question of whether McNeil’s request for reformulation should be taken into consideration in the preliminary injunction proceedings. The Court noted that a request for reformulation of a patent may be made during nullity proceedings, according to section 52(2) Swedish Patent Act.
The law does not, however, specifically address the question of whether such a request can be made during preliminary injunction proceedings. As the requested reformulation concerned the striking out of an alternative arrangement, which is regarded as a simple limitation, the Court did consider the limitation during the preliminary injunction proceedings.
The Court thereafter considered whether the limitation requested by McNeil would heal the previously established lack of novelty of the patent and whether the amended patent would satisfy the requirements for inventive step. The Court, based on the arguments presented by Niconovum, decided that this was unlikely. Even if the requirement for novelty would be met, the Court did not find the invention to be essentially different from the closest state of the art.
The Court of Appeal held it to be likely that the disputed patent, even if considered in its limited form, would be held invalid. With that assessment there was no probable cause established for patent infringement. The Court thereby reversed the decision by the District Court, in favour of Niconovum.
The decision was not appealed by McNeil.
Point of interest
On the basis of this decision, it appears likely that requests for reformulation of patents may be considered not only in nullity proceedings, as explicitly provided for in the Swedish Patents Act, but also within the frame of preliminary injunction proceedings, albeit that the request in this particular case concerned a simple limitation of the patent claims.
Case no. Ö 9316-09, 16 March 2010