NORWAY Law and Practice Contributed by: Vebjørn Krag Iversen, Nora Bratheim, Kristin Erstad Remvik and Guro S. K. Nybø, Wikborg Rein Advokatfirma AS
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 con ‑ sidered an infringing act in Norway. Responding to a request for tender, where supply would take place after expiry of the relevant 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. 2.2 Regulatory Data and Market Exclusivity EU legislation on data and market exclusivity is includ ‑ ed in the EEA Agreement and implemented in Norwe ‑ gian law under the Norwegian Medicine Regulation of 18 December 2009 No 1839 (NMR). Chapter 3 of the NMR, as a main rule, distinguish ‑ es 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”). During the two-year period after expiration of the data protection, the market protec ‑ tion prohibits the placing on the market of a generic medicinal product but does not prohibit preparatory actions prior to putting the product on the market. 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 exclusivity if the MA holder is granted further marketing authorisation for a significant new indication for the relevant medicinal product (the “8+2+1 system”). However, Chapter 3 of the NMR does not distinguish 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 Novem ‑ ber 2005 and 11 January 2010, and CP applications filed prior to 1 November 2005, enjoy a ten-year period of data protection with no additional market protec ‑ tion period (Sections 3-10 (b), 3-10a(a), 3-11 (a) and
3-11a(a)). NP applications filed prior to 1 November 2005 enjoy a six-year data protection period with no additional market protection period (Sections 3-10 (a) and 3-11 (a)). 2.3 Acceptable Pre-Launch Preparations The Bolar exemption introduced in Directive 2001/83/ EC Article 10 (6) has been implemented in the Norwe ‑ gian Patent Act Section 3 (3) No 5. The Bolar exemp ‑ tion applies to patents and Supplementary Protection Certificates (SPCs) covering pharmaceuticals, and allows the undertaking of “tests, trials and similar” of pharmaceuticals that are necessary for obtaining mar ‑ ket authorisation. Furthermore, the Bolar exemption is applicable for obtaining marketing approvals in all WTO-signatory countries – ie, the Bolar exemption is not limited to EU/EEA countries. As mentioned previously, applying for an MA or a pricing and reimbursement (P&R) decision is not an infringing act and will not in itself be considered suf ‑ ficient for the grant of a PI. See 2.1 Infringing Acts for exceptions. 2.4 Publicly Available Drug and Patent Information Publicly Available Information The Norwegian Medicinal Product Agency (NMPA), which is the authority responsible for granting MAs and P&R decisions, publishes updates to the following different lists on their website. • A list, which is updated from time to time, of first- time generic and hybrid mutual recognition proce ‑ dure (MRP), decentralised procedure (DCP) and NP applications. The list includes information about the active ingredient, marketing status, Anatomical Therapeutic Chemical (ATC) classification, pro ‑ cedure, grounds for the application (eg, hybrid or generic application), and date of the application. The product name, the applicant and other coun ‑ tries involved (including the reference country) are not published. • A list containing all new granted MAs in CP, MRP, DCP and NP applications is updated on a monthly basis and thus becomes publicly available. The list includes information about product name, MA status, MA date, MA holder, MA number, appli ‑
151 CHAMBERS.COM
Powered by FlippingBook