NORWAY Law and Practice Contributed by: Vebjørn Krag Iversen, Nora Bratheim, Kristin Erstad Remvik and Guro S. K. Nybø, Wikborg Rein Advokatfirma AS
4. Patent Term Extensions for Pharmaceutical Products
of a PI shall take place as soon as requested by the claimant, and must follow the rules of the Enforcement Act of 1992. If the court has required a bond in relation to a PI, the PI will not take effect before a bond is in place. The value of the bond is normally calculated on the basis of the potential damage the defendant could suffer in the period before delivery of judgment in the first instance (after which the PI will be lifted, if the defend ‑ ant is successful). For a PI to be enforced, the patentee is not required to have commenced a main action; however, the claim in question must normally be established as probable. If a PI is granted, the courts will normally set a deadline for the patentee to initiate main proceedings. 5.2 Final Injunctive Relief Final injunctions are granted if the claimant is suc ‑ cessful at proving at trial that infringement or signifi ‑ cant preparatory acts with the aim of carrying out an infringing act took place. Such injunction will normally not be enforceable pending an appeal. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) Preliminary Injunctions The court will assess the proportionality of a PI in PI proceedings. In such assessment, the court may also take public interest arguments into account. Final Injunctions If requested by the defendant, a court may – in lieu of a final injunction – award a licence against reasonable compensation to the patentee. However, the defend ‑ ant must establish that there are some special circum ‑ stances in order for such a licence to be awarded. To date, this narrow exception has not been used by a Norwegian court. 5.4 Damages Damages are calculated on the basis of lost profits. In order to estimate the potential damages exposure, one would need to provide proof of the suffered dam ‑ ages (eg, loss of sales of a generic or biosimilar). The time period for claiming damages based on a pat ‑ ent infringement is three years from when the cause
4.1 Supplementary Protection Certificates SPC protection is available in Norway. This is regu ‑ lated by the relevant EU regulations and these have been implemented into Norwegian law by application of the EEA agreement. SPCs are therefore available for patents that cover an authorised medicinal or plant pharmaceutical product. The relevant law is Regulation 469/2009 concerning the supplementary protection certificate for medicinal products; however, this has been amended at EU level through Regulation 2019/933 implementing the SPC manufacturing waiver. The waiver enables manufac ‑ turers of generics and biosimilars to manufacture such medicines for the purpose of exporting them outside the EU during the SPC protection term. After a lengthy process, the waiver entered into force in Norway on 1 February 2023 by amendment of the Norwegian Pat ‑ ents Act Section 62a. 4.2 Paediatric Extensions Paediatric extensions are available in Norway and reg ‑ ulated by EU law. The Paediatric Regulation was intro ‑ duced into Norwegian law and entered into force on 1 September 2017, bringing some statutory amend ‑ ments that make it possible to apply for a six-month extension to the period of validity of SPCs. 4.3 Paediatric-Use Marketing Authorisations There are no special MAs available for medicines spe ‑ cifically developed for children. 4.4 Orphan Medicines Extensions A supplementary protection certificate may, upon request, be extended by a further period of six months if it is granted for a medicinal product which is encom ‑ passed by Article 36 of EU Regulation No 1901/2006.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
The court may provide for when the PI should be enforced and how long it should last. Enforcement
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