NORWAY Law and Practice Contributed by: Vebjørn Krag Iversen, Nora Bratheim, Kristin Erstad Remvik and Guro S. K. Nybø, Wikborg Rein Advokatfirma AS
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action Revocation Actions
ing a PI, the court may order the claimant to provide a guarantee for compensation to the defendant in the event that it is later established that the injunction was unjustified. A patentee should not delay in commencing the PI action once they become aware of potential imminent infringement or actual infringement. A warning letter with a short deadline (normally two weeks, or shorter if there is urgency) should be issued first, followed by filing a request for a PI fairly soon thereafter – normally within two to four weeks. Inter Partes PIs The timeline in inter partes PI proceedings is typically as follows. • The patentee will file a PI request, together with evidence to support that the defendant’s product constitutes infringement and that infringement is imminent. • The defendant will be notified of the request by the court and then normally allowed a short limited period of time in which to file a defence. • Where matters concerning validity and/or infringe ‑ ment involve complex scientific issues, the court will usually allow time for experts to submit reports – for example, within a limited time period of one or two months. • A hearing takes place in court, which could last between two and ten days. The hearing and the proceedings correspond in many respects to an ordinary case on the merits. • A verdict is normally delivered two to four weeks after the hearing took place. The verdict may be appealed within a month to the Court of Appeal, which normally will assess the matter based on the written pleadings and evidence. Ex Parte PIs The criteria for obtaining an ex parte PI are based on extreme urgency and the threat of substantial harm to the patentee’s interest if inter partes proceedings are allowed. The threshold for the grant of an ex parte injunction in Norway is high in pharma patent cases. In complex patent cases, they are rarely granted.
As long as a patent is in force, any party may initiate an action to have the patent revoked, including indi ‑ vidual co-owners and third parties such as licensees. Infringement Actions The patentee and an exclusive licensee – ie, a licensee that has the exclusive right to make, sell and/or put the invention on the market – has standing to com ‑ mence an action for patent infringement. Registration or recording of an exclusive licensee is not required in order for it to bring an action. The patentee does not need to be joined as a party to the infringement action. However, if infringement proceedings are commenced by a licensee, the paten ‑ tee must be notified. The same applies if the patentee brings an action – licensees registered in the official patent register must be notified. 1.2 Defendants/Other Parties to an Action The parties in life sciences/pharma actions in Norway are, almost without exception, manufacturers of phar ‑ maceuticals. The Norwegian Industrial Property Office (NIPO) is required to be notified if a revocation action is initiated, but it has no role in revocation or infringe ‑ ment actions between pharmaceutical manufacturers. 1.3 Preliminary Injunction Proceedings Preliminary injunctions (PIs) are available in Norway, including ex parte PIs. A PI is available on the con ‑ dition that the claimant establishes as probable that there is either: • an infringement of a patent; or • the defendant has made significant preparatory acts with the aim of carrying out an infringing act. Moreover, the claimant must establish that an injunc ‑ tion is necessary, as pursuing the claim would oth ‑ erwise be substantially more difficult or cause sub ‑ stantial harm or inconvenience. Additionally, the court must find that an injunction is justified when taking into account the interests of both parties. Upon grant ‑
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