NORWAY LAW AND PRACTICE Contributed by: Lars Erik Steinkjer, Nora Bratheim and Guro S K Nybø, Wikborg Rein Advokatfirma AS
2.2 Regulatory Data and Market Exclusivity
second instance. The expert lay judges are nor - mally appointed upon (often joint) proposal from the parties and have their background within the technical field to which the case relates. Expert lay judges cannot be appointed in PI pro - ceedings, but it is common to use court-appoint - ed experts in such proceedings. These experts are not associated with any of the parties and will be appointed to assist the legal judge in their assessment of the case. They are not part of the panel of judges, but will hear the trial and deliver an opinion on the matter in open court. Often, they also deliver a written opinion. An application for a marketing authorisation (MA) is not an infringing act, and will not in itself be considered sufficient for the grant of a PI. How - ever, the court will consider if there are additional circumstances that – together with the grant of an MA – constitute sufficient evidence that infringement is either imminent or likely in the near future. A communication to customers of the intended launch date after patent term expiry will normally be viewed as an offer to deliver after expiry; this is generally considered an infringing act in Nor - way. Responding to a request for tender, where supply would take place after expiry of the rel - evant rights, may equally be classed as an act of patent infringement. In theory, a PI application could be made on such basis, but the authors are not aware of any such PI being granted in Norway. 2. Generic Market Entry 2.1 Infringing Acts
EU legislation on data and market exclusivity is included in the EEA Agreement and imple - mented in Norwegian law under the Norwegian Medicine Regulation of 18 December 2009 No 1839 (NMR). Chapter 3 of the NMR, as a main rule, distin - guishes between an eight-year period of data protection (Section 3-10(c) and 3-10a(b)) and a ten-year period of market protection (Section 3-11(b) and 3-11a (b)) (the “8+2 system”). Dur - ing the two-year period after expiration of the data protection, the market protection prohibits the placing on the market of a generic medici - nal product but does not prohibit preparatory actions prior to putting the product on the mar - ket. In addition, under Chapter 3, Sections 3-11b and 3-11d, the MA holder of the reference product may qualify for another year of market exclusiv - ity if the MA holder is granted further marketing authorisation for a significant new indication for the relevant medicinal product (the “8+2+1 sys - tem”). However, Chapter 3 of the NMR does not distin - guish between the data and market protection where the reference product application was filed prior to: • 12 January 2010, if made by way of the national procedure (NP); or • 1 November 2005 (or later), if made by way of the central procedure (CP). NP applications filed in the period between 1 November 2005 and 12 January 2010, and CP applications filed prior to 1 November 2005, enjoy a ten-year period of data protection with
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