NORWAY LAW AND PRACTICE Contributed by: Lars Erik Steinkjer, Nora Bratheim and Guro S K Nybø, Wikborg Rein Advokatfirma AS
Freedom of Information Requests Freedom of information requests to NOMA are available under the Freedom of Information Act. Usually, when requests under the Norwegian Freedom of Information Act are made to NOMA, a reference will be made to the published lists and databases without giving any additional information. Additional information about pend - ing applications is generally classed as trade secrets, and therefore excluded from the right to information (see Section 13 of the Norwegian Freedom of Information Act and Section 30 of the Norwegian Medicine Act). NOMA will not notify the generic MA applicant/holder if some - one (eg, the MA holder of the reference product) requests information under the Norwegian Free - dom of Information Act. 2.5 Reimbursement and Pricing/Linkage Markets Generally, NOMA will neither consider the patent situation on its own, nor act upon notifications from the patent holder covering an innovative product, when it comes to marketing authori - sation, pricing and reimbursement, and generic substitution. There is one exception. According to Section 2.3 of NOMA’s guidelines regarding the substitution list, generic drugs covered by a second indica - tion patent are still added to the substitution list – albeit with the instruction that the drug is not to be substituted if the pharmacy is aware that the drug is prescribed for the patented use. Hence, the holder of a second indication patent will regularly notify NOMA following the grant of an MA to a generic product for which the origina - tor holds a second indication patent. The holder of the MA for the reference product is not notified of any MA, P&R or listing appli - cations made by a generic or biosimilar, nor of
the grant of such applications. Information may be obtained through freedom of information requests or, alternatively, by monitoring publicly available lists and databases (see 2.4 Publicly Available Drug and Patent Information ). 3. Biosimilar Market Entry 3.1 Infringing Acts See 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity See 2.2 Regulatory Data and Market Exclusiv- ity . 3.3 Acceptable Pre-Launch Preparations See 2.3 Acceptable Pre-Launch Preparations . 3.4 Publicly Available Drug and Patent Information See 2.4 Publicly Available Drug and Patent Information . 3.5 Reimbursement and Pricing/Linkage Markets See 2.5 Reimbursement and Pricing/Linkage Markets . 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates SPC protection is available in Norway. This is regulated 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.
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