2025 Life Sciences in Norway
BAHR serves as a trusted advisor to professionals within the dynamic life sciences sector, which includes pharmaceuticals, biotechnology, health services, and medical devices. Our team is distinguished for its representation of leading pharmaceutical originators in complex patent disputes. With unparalleled expertise in pharmaceutical regulations and comprehensive industry knowledge, our life sciences team is exceptionally equipped to address a wide range of regulatory issues. Coupled with our litigation and patent experience, our team possesses unmatched proficiency and insight into the legal landscape pertinent to the life sciences industry in Norway.
Our clients can expect to find lawyers who understand their business and commercial opportunities. Our team has extensive experience in negotiating with Regional Health Enterprises and advising clients involved in tender competitions, as well as addressing other market-access related matters such as early access programs. We regularly counsel innovative pharmaceutical clients on various regulatory issues, including pricing, reimbursement, market access, parallel import, stock allocation, shortage situations, substitution, distribution, marketing and promotion, public procurement, and advertising. Additionally, we advise on all aspects of commercial agreements within the life sciences sector, including intellectual property, competition law, data protection, and privacy, such as licensing agreements and agreements related to clinical trials, as well as M&A and technology transfers.
Editor team
Beret Sundet Partner
E bsu@bahr.no
M +47 928 81 385
Hilde-Marie Pettersen Managing Associate
E hipet@bahr.no
M +47 917 699 62
Anna Medbøe Tamuly Associate
E antam@bahr.no
M +47 954 78 586
Eirik Basmo Ellingsen Partner
E eiell@bahr.no
M +47 920 88 112
Tuva Fretheim Walle Associate
E tufwa@bahr.no
M +47 915 98 385
Anja Stensrud Elverum Managing Associate
E anelv@bahr.no
M +47 924 86 485
Ylva Høsøien Associate
E ylhos@bahr.no
M +47 481 36 978
1. Introduction
The life sciences sector in Norway is a dynamic and rapidly evolving field, encompassing a range of industries including pharmaceuticals, biotechnology, health services, and medical devices. This guide aims to provide business professionals and advisors operating within these sectors with a detailed understanding of the legal landscape that governs their activities in Norway.
Recent years have seen a swift adoption of digital technologies in healthcare, enhancing patient care, enabling remote monitoring, and improving data collection for clinical trials. In 2024, Norway experienced a slight increase in clinical trials for human medicinal products, primarily driven by commercial entities, with cancer remaining the leading therapeutic area.
Norway’s regulatory framework for medicinal products and medical devices is largely based on Europe-wide regulations through the European Economic Area (EEA) agreement, with specific national adaptations. Key supervisory bodies, such as the Norwegian Medical Products Agency (NoMA), are instrumental in managing the approval, classification, and monitoring of these products. This guide details the roles of NoMA and other entities like the four Regional Health Authorities (RHFs), which oversee specialist healthcare services, and Sykehusinnkjøp HF, responsible for procurement services.
Pricing and reimbursement of medicinal products are vital components of the Norwegian healthcare system, since the vast majority of healthcare in Norway is provided by the public healthcare system. This guide explains pre-marketing activities, including the processes for
obtaining price approvals and the role of the Regional Health Authorities (RHFs) and the National Insurance Scheme in reimbursing prescription-only medicines (POMs). It also covers the tendering system used by hospitals to ensure competitive pricing for medicinal products in the specialist healthcare system.
Once products are on the market, companies must adhere to pharmacovigilance requirements to monitor safety and efficacy. This guide outlines the obligations of marketing authorisation holders in this regard. Additionally, it discusses the enforcement mechanisms available to regulatory authorities and the remedies available to companies, including administrative and judicial avenues for challenging regulatory decisions.
Intellectual property rights are essential for protecting innovations in the life sciences sector. This guide concludes with a discussion on trade secret and patent protection under Norwegian law, covering the scope of patentable inventions and the use of supplementary protection certificates (SPCs) to extend patent protection for certain products. It also addresses various aspects of patent litigation.
2. Regulatory framework
The Norwegian regulatory framework for medicinal products and medical devices is based on European Union (EU) regulations and directives that are implemented in Norway through the EEA Agreement, with certain national adaptions and requirements.
Although legislation is largely harmonized with the EU within the life sciences area, legislation, decisions and court judgments from the EU institutions do not have direct effect in Norway, and must therefore be implemented or transposed. EEA law questions may be referred to the EFTA Court, which, along with Norwegian courts, follows the European Court of Justice (CJEU) case law. Although CJEU judgments are not formally binding, Norwegian and EFTA courts will strive to adhere to them.
Despite broad harmonization, Norwegian law includes national requirements in certain areas that diverge from EU legislation. Furthermore, different interpretations of legal requirements across Member States introduce variations in national standards within the EU/EEA. Given the presence of major international life sciences companies in Norway, understanding Norwegian pharmaceutical regulations is crucial for ensuring the supply of medicines and medical devices to Norwegian patients, protecting economic interests, maintaining competitiveness, and developing effective market strategies.
The legal landscape in the life sciences industry is evolving and becoming more complex, presenting both challenges and opportunities. In 2023, the European Commission introduced a “pharmaceutical package” proposing a new Directive and Regulation to update EU pharmaceutical legislation. The goal is to enhance accessibility, affordability, and crisis preparedness while boosting the EU pharmaceutical industry’s competitiveness. However, the proposal is under debate and may be amended before final adoption. Norway is expected to implement the reform once adopted.
Unless otherwise stated, all references to laws and regulations are to Norwegian laws and regulations.
3. Overview of the key supervisory bodies and public entities
3.1 Introduction
To offer a comprehensive understanding of Norway’s regulatory framework, we begin with an overview of the key supervisory bodies and public entities in the Norwegian life sciences sector. The Norwegian healthcare system is a dual system, which consists of the primary healthcare service and the specialist healthcare service. The municipalities are responsible for providing the primary healthcare services and the national government is responsible for providing the specialist healthcare services. These entities are essential for the distribution and commercialization of medicinal products and medical devices in Norway.
3.2 The Norwegian Medical Products Agency (NoMA)
The Norwegian Medical Products Agency (NoMA) (Norwegian: Direktoratet for medisinske produkter) is the competent authority for medicinal products and medical devices in Norway. NoMA is subordinate to the Ministry of Health and Care Services. Among NoMA’s responsibilities are managing the approval of medicinal products, ensuring supply security and preparedness, as well as conducting supervision and monitoring. Additionally, NoMA provides information and guidance on medicinal products and medical devices to healthcare professionals (HCPs) and the public. The main legal basis for NoMA’s competence is the Medicinal Products Act, the Medicinal Products Regulation and the Pharmacies Act.
3.3 The four regional health authorities (RHFs)
The national government is responsible for the Norwegian specialist healthcare services, organized into four state-owned enterprises known as the Regional Health Authorities (RHFs) (Norwegian: Regionale helseforetak). These are the Northern RHF, Central RHF, Western RHF, and South-Eastern RHF. Each RHF is responsible for planning and managing the specialist healthcare within its respective region and all RHFs own and operate hospitals, ensuring that the population has access to essential healthcare services.
3.4 New Methods and the Decision Forum
Under Section 4-4 of the Specialist Health Services Act, the RHFs must maintain a unified system to determine which methods are offered through the specialist healthcare services in Norway. This responsibility is managed by New Methods (Norwegian: Nye metoder), owned by the four RHFs, with the Decision Forum (Norwegian: Beslutningsforum) - comprising of the RHFs’ four regional directors - making the final decisions based on health technology assessments (HTAs). The Ordering Forum (Norwegian: Bestillerforum) for New Methods, which includes the RHF’s four regional directors and two representatives from the Directorate of Health (Norwegian: Helsedirektoratet), selects the methods that shall undergo HTAs and determines the type of assessment required. The HTAs are carried out by NoMA or the Norwegian Institute of Public Health (NIPH).
3.5 Sykehusinnkjøp HF (LIS)
The four RHFs collectively own the health enterprise Sykehusinnkjøp HF, often called LIS, which is tasked with delivering procurement services for the specialist healthcare service.
LIS is responsible for conducting tenders and managing joint procurement agreements for all Norwegian health enterprises. These agreements are structured to achieve cost savings for hospitals through collective purchasing.
3.6 Norwegian Institute of Public Health (NIPH)
The Norwegian Institute of Public Health (NIPH) (Norwegian: Folkehelseinstituttet) is a government agency under the Ministry of Health and Care Services, with a focus on health monitoring, research and advisory functions. NIPH’s key functions are to monitor the population’s health status, developing public health profiles, and enhancing public health by sharing knowledge and providing guidance to the population. NIPH is also responsible for providing guidelines for the implementation of the Norwegian national vaccination program, including target groups, frequency, and the technical composition of the vaccines.
4. Pre-marketing activities
4.1 Clinical trials
All medical and health-related research on humans, human biological material and health data are governed by the Health Research Act and the Research Ethics Act. Pursuant to Section 9 of the Health Research Act, research projects must be pre-approved by the Regional Committees for Medical and Health Research Ethics (the Regional Ethics Committee).
Since 31 January 2024, all applications for clinical trials must be submitted through the European Clinical Trials Information System (CTIS) in accordance with Regulation (EU) No. 536/2014. The deadline for transferring ongoing studies approved under Directive 2001/20/EC was 30 January 2025.
Medicinal products. The general requirements for clinical trials with medicinal products are set forth in the Norwegian Clinical Trials Act. Clinical trials on medicinal products for humans must be approved by NoMA and the Regional Ethics Committee.
The sponsor of a clinical trial bears the obligation to ensure adherence to regulatory standards during all phases of the trial. The sponsor has the option to delegate its responsibilities to another individual or organization, but it ultimately remains accountable to Norwegian authorities for any violations of regulatory requirements. The sponsor must either be domiciled in the EEA, or appoint a representative domiciled in the EEA.
The requirements applicable to clinical trials with medicinal products in Norway are essentially harmonised with EU law. Clinical trials must be planned and reported in accordance with the Guidelines for Good Clinical Practice and in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects.
Participation in clinical trials is conditional upon fully informed and written, or witnessed, consent. According to the Norwegian Health Research Act, the consent must also encompass the processing of the trial subjects’ personal health data. The Norwegian Data Protection Authority, the Regional Ethics Committee and NoMA have jointly composed a template for informed consent, which also covers the processing of personal data in accordance with the General Data Protection Regulation (GDPR). The authorities recommend using the template to ensure that the information provided is accurate and in accordance with the Guidelines for Good Clinical Practice. In some cases, e.g. clinical emergencies, research may be carried out without consent on certain conditions. In such cases where it is not possible to obtain consent, the only applicable legal basis for processing personal health data can be found in Article 9 (2) of the GDPR. However, consent for any further research should be obtained as soon as possible.
Any study in animal models must comply with the Animal Welfare Act and the Animal Studies Regulation. Studies require approval from the Norwegian Food Safety Authority, cf. Section 6 of the Norwegian Animal Studies Regulation.
Medical devices. A clinical evaluation is required for all medical devices. This evaluation can be based on clinical investigations of the specific device and/or clinical investigations of equivalent devices. The manufacturer must determine whether a clinical investigation is necessary or if the evaluation can be based on existing clinical data. The requirements for clinical evaluations are outlined in Regulation (EU) 2017/745 on Medical Devices (MDR) Article 61. Norwegian law is essentially harmonised with MDR.
Clinical investigations of medical devices that are either not CE-marked or are CE-marked but intended for testing beyond the scope of the manufacturer’s intended purposes must receive approval from both NoMA and the Regional Ethics Committee. This requirement applies to investigations conducted for future conformity assessment and CE-marking (MDR Article 62) as well as those conducted for other purposes (MDR Article 82).
Clinical investigations of CE-marked medical devices, when tested within the scope of their intended purpose and involving additional procedures that are invasive or burdensome beyond normal use, must be notified to NoMA and approved by the Regional Ethics Committee. These investigations are governed by MDR Article 74 (1).
Clinical investigations of CE-marked devices used according to the manufacturer’s intended purpose, where subjects are not exposed to additional invasive or burdensome procedures compared to normal use, only require approval from the Regional Ethics Committee. They do not need to be submitted or notified to NoMA. Such investigations must comply with the requirements of MDR Article 82. Norway has also implemented national specific requirements for clinical investigations. These requirements state that summaries of clinical investigations must be submitted in both Norwegian and English, cf. Section 14 of the Medical Devices Act. Additionally, clinical investigations conducted for purposes other than future conformity assessment and CE-marking, as per MDR Article 82, must meet all the requirements of MDR Article 62, cf. Section 16. However, investigations of CE-marked devices used within their intended purpose are exempt from Section 16.
4.2 Manufacturing
Medicinal products. Manufacturing of medicinal products in Norway requires a manufacturing and import authorisation (MIA), issued by NoMA, cf. the Norwegian Regulation on Manufacturing and Import of Medicinal Products (implementing Directive (EU) 2017/1572 and Directive 2001/83/EC). The MIA encompasses wholesaler activities, such as imports, storage, distribution, and exports of the medicinal products covered by the MIA, including imports from countries outside the EU/EEA. A MIA from another EU/EEA country is valid in Norway for the performance of the activities covered by the MIA. NoMA requests to receive a notification whenever a MIA from another EU/EEA country is used in Norway.
The processing time for an MIA-application is 90 days, cf. Section 2-4 of the Norwegian Regulation on Manufacturing and Import of Medicinal Products. A list of companies holding a manufacturing and import license in Norway at any time is published on NoMA’s webpages.
All manufacturing of medicinal products must comply with the EU Guidelines on Good Manufacturing Practice (GMP). The manufacturer must appoint a qualified person (QP) to be approved by NoMA, who is responsible for compliance with the GMP.
Medical devices. Any manufacturer of medical devices with a business address in Norway is obliged to register with the national medical device register (Norwegian: Utstyrsregisteret), cf. Section 24 (1) of the Norwegian Medical Device Regulation. Manufacturers without a business address in the EEA who are marketing medical devices in the EEA must appoint a responsible representative within the EEA, cf. Section 24 (2) of the Norwegian Medical Device Regulation.
4.3 Imports and exports
Medicinal products. In general, importation and exportation of medicinal products within the EEA are considered wholesale activities and require a wholesale distribution licence (WDA). However, imports and exports may also be conducted on the basis of an MIA. An MIA is always required for the importation and exportation of medicinal products to or from a country outside the EU/EEA. Upon imports from countries outside the EU/EEA, the importer is obliged to perform full inspection and analysis of the products, ensuring that the products in question are manufactured in compliance with the GMP before they are placed on the Norwegian market. These obligations do not apply if Norway has entered into a mutual recognition agreement with the third country in question.
Medical devices. Medical devices with a valid CE-marking and a declaration of conformity to the CE-requirements may be freely imported and do not require a license issued by national authorities. However, the labelling and instructions for use of medical devices placed on the market in Norway, must be presented in Norwegian, cf. Section 6 of the Norwegian Medical Device Regulation.
4.4 Classification and prescription
Medicinal products. The classification of a product as a medicinal product is based on a comprehensive assessment of the specific product. Medicinal products comprise both prescription-only medications (POMs) and over-the-counter medicines (OTCs). Classification as a medicinal product can be made on the basis of function and/or presentation. The definition of a medicinal product according to the Norwegian Regulation on Medicinal Products encompasses any substance, drug, or preparation that is claimed to be suitable for preventing, curing, or alleviating disease, symptoms of disease, or pain, or to affect
physiological functions in humans; or can be used or administered to humans or animals to restore, alter, or influence physiological functions through a pharmacological, immunological, or metabolic action, or to diagnose disease, cf. Section 1-3 letter a. The authority to classify a product as a medicinal product is delegated by law to the Ministry of Health and Care Services and further to NoMA. NoMA also decides whether a product is classified as a POM. As the classification of products are determined nationally, the classification of the same products may differ across countries.
POMs are divided into three prescription groups (Group A, B and C), which are subject to different requirements pertaining to the prescribing rights of HCPs, the duration of prescriptions, and the number of times a prescription can be dispensed, cf. the Prescribing and Dispensing of Medicinal Products Regulation. POMs are prescribed based on the entity covering the cost of the product. There are three main types of prescriptions; White prescription (Norwegian: Hvit resept), Blue prescription (Norwegian: Blå resept) and H-prescription (Norwegian: H-resept). As a general rule, the cost for a White prescription product is fully covered by the patient. For Blue prescription products, the National Insurance Scheme partially covers the cost. H-prescription products are used in the specialist healthcare service and intended for use outside the hospital, with all costs covered by the RHF in question. The Norwegian reimbursement system is explained in more detail in section 5.
Medical devices. Medical devices are defined by law in the Medical Devices Act, which is harmonized with the MDR Article 2 (1). Medical devices include any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more specific purposes stipulated in Section 3 of the Norwegian Medical Devices Act. Pursuant to Section 3, subsection 2 of the Medical Devices Act, accessories to medical devices and devices that are otherwise involved in the use of medical equipment, are also considered medical devices.
The classification of a device as a medical device is based on the device’s intended purpose, as declared by the manufacturer. Medical devices encompass a broad spectrum, from simple items like band-aids to complex technologies such as implants, pacemakers, and stand-alone software. The authority to classify a product as a medical device is delegated by law to the Ministry of Health and Care Services and further to NoMA.
In-vitro diagnostic medical devices. In vitro diagnostic medical devices (IVDs) refer to tests used on biological samples to the determine the status of a person’s health. The requirements set forth in in Regulation (EU) 2017/745 (IVDR) concerning In-vitro diagnostic medical devices are incorporated into Norwegian law, cf. Section 1 of the Medical Devices Act. The definition of an IVD is set forth in IVDR Article 2 (2) and includes any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for specific purposes set forth in the Regulation.
Medical devices and IVDs are divided into four distinct risk categories. Medical devices are divided into classes I, IIa, IIb and III, whilst IVDs are divided into classes A, B, C and D. The classification of a device is based on the manufacturers intended purpose for the device in question and the potential risks associated with the use of the device. The different risk categories are subject to different requirements concerning technical, clinical and safety documentation.
4.5 Marketing authorisations for medicinal products
General rules on marketing authorisations. Marketing authorisations (MAs) are, as a general rule, a necessary prerequisite for the commercial distribution of medicinal products in Norway. Furthermore, price approvals are necessary for the commercial distribution of POMs (see section 4.4). Marketing authorisations and price approvals are granted by NoMA.
A Norwegian marketing authorisation may be obtained through the centralised procedure, the mutual recognition procedure, the decentralised procedure or by national procedure. The formal requirements depend on the type of application and the procedure. Marketing authorisations granted by the European Commission must be adopted nationally by NoMA to be valid in Norway. If the product has obtained marketing authorisation through the centralised procedure, NoMA is obliged to issue an equivalent Norwegian marketing authorisation within 30 days of the decision from the Commission.
It is not mandatory for the manufacturer or the holder of the marketing authorisation to be based in Norway, nor is there a requirement to designate a local representative, provided that the manufacturer or the holder of the marketing authorisation (or their appointed representative) is established within the EEA. The holder of the marketing authorisation bears full responsibility for all statutory obligations associated with the marketing authorisation, including pharmacovigilance and informational and marketing activities in Norway. For practical reasons, it may prove beneficial to employ a local agent to liaise with NoMA.
When applying for marketing authorisations, generics may rely on the original product’s documentation (as the reference drug), cf. Section 3-9 (1) of the Medicinal Product Regulation, provided that the regulatory data exclusivity period has lapsed (see section 6.4), and therefore need only submit bioequivalence studies.
Under certain circumstances, market access can be granted without a Norwegian marketing authorisation. One of these circumstances is in the context of clinical trials, which is described under section 4.1 above. The other circumstances will be explained in the following paragraphs.
“Compassionate use, named patient” (Norwegian: Godkjenningsfritak for enkeltpasient). This arrangement allows physicians to prescribe medicines without a Norwegian marketing authorisation to individual patients when, for medical reasons, no suitable alternatives exist within the country. The treating physician is responsible for initiating and justifying the application to NoMA for this exemption. Dispensation of these medicines must occur through standard pharmacy channels. The legal basis for this arrangement is Section 2-5 of the Medicinal Product Regulation and Directive 2001/83/EC Article 5.
“Compassionate use program” (CUP) (Norwegian: Godkjenningsfritak på gruppenivå ). The term CUP may refer to two different pathways for market access prior to grant of a MA.
The first arrangement is where the physician submits an application to use a product without an MA in its medical practice, for a defined group of patients. The application for such use follows the same procedure as for a “Compassionate use, named patient” program, where the physician must submit an application to NoMA. The requirement is that the physician provides a medical reason for why no licensed products may be used. The legal basis for this arrangement is Section 2-5 last subsection of the Medicinal Product Regulation and Directive 2001/83/EC Article 5.
The second arrangement allows manufacturers to make a medicinal product available without a granted marketing authorisation in Norway for a group of patients because of specific circumstances, by initiating a CUP. Before a CUP can be initiated, NoMA has to assess and approve the application. The applicant is the manufacturer of the medicinal product in question. For a CUP application to be approved, the following requirements must be met:
i) CUP is only for patients with chronic, life-threatening, long-lasting or serious disabling diseases,
ii) CUP is only for patients that cannot be included in ongoing clinical trials and that do not benefit from the use of medicinal products with marketing authorisation,
iii) the benefit-risk ratio for the patient population of interest must be positive, supported by sufficient evidence on the effect and safety of the medicinal product, and
iv) the applicant has submitted an application for marketing authorisation and/or has ongoing clinical trials with the medicinal product in question.
The medicinal product in CUP must be supplied through the usual pharmacy channels, ensuring that it reaches patients in a controlled and regulated manner. Patients who are already receiving treatment through a CUP can continue their treatment even after the medicinal product has received marketing authorisation. New patients can be included in the program until the medicinal product has been priced and the HTA is completed.
Doctors at public hospitals must clarify the potential use of unlicensed medicines with their healthcare institution to ensure compliance with regulations and institutional policies, which includes a requirement to enter into a national standard agreement with the RHFs, as described below. The legal basis for this arrangement is Section 2-8 of the Medicinal Product Regulation and Regulation (EC) 726/2004 Article 83.
It is important to distinguish CUP from ”Early Access Programs” (EAP) or other internal arrangements that pharmaceutical companies might use to promote use of the medicinal product before obtaining marketing authorisation. While companies are prohibited from marketing these arrangements, they are permitted to inform healthcare professionals about clinical studies and CUPs approved by NoMA.
Exemptions from the marketing authorisation requirement in special cases. NoMA is authorised to grant additional exemptions from the marketing authorisation requirement ”in special cases” beyond those previously outlined. This authority is provided for under Section 2-8 (3) of the Medicinal Products Regulation. According to New Methods’ guidelines (see below), this exemption applies in very special cases to products that fall under the legal definition of medicinal products, such as PET tracers. These exemptions are justified by particular clinical needs and are of limited duration.
New Methods’ guidelines on the use of new medicinal products prior to marketing authorisation. NoMA maintains a national list of certain new medicinal products without marketing authorisation for which it is expected that the responsibility to consider reimbursement will belong to the specialist healthcare services (i.e. not the primary healthcare services). For the medicinal products on this list, the national guideline mandates that a standard agreement must be in place for all uses that are not part of an approved clinical trial.
The agreement cannot be modified or replaced with agreements containing different terms unless such terms are approved by the regional medical directors. The company, as the supplier of a medicinal product, commits to providing the medication free of charge to healthcare institutions and patients after treatment initiation until the Decision Forum makes a decision regarding its implementation and the product becomes available at the agreed price. If the medication is not approved for implementation, the company is obligated to continue supplying it free of charge to these patients until treatment is concluded for medical reasons. The medication must be distributed through regular sales channels, namely approved pharmaceutical wholesalers and pharmacies. All costs related to the medication and delivery throughout the supply chain (wholesaler, pharmacy) must be covered by the manufacturer, including transportation, manufacturing, and any regulatory fees. The manufacturer must enter into a separate standard agreement with the supplying hospital pharmacy before commencing patient treatment.
The inclusion of medicines on this list is determined by the RHFs in consultation with NoMA. The list is updated monthly or as needed. Medicines are removed from the list once they receive marketing authorisation or as decided by the RHFs.
4.6 Conformity assessment for medical devices
Medical devices must be CE-marked to be commercially distributed in Norway, cf. Section 5 of the Medical Devices Act. CE-marking is applied to the medical device as a symbol indicating that the device has been subject to a conformity assessment and obtained a declaration of conformity. The criteria for obtaining CE-marking vary based on the risk-category of the medical device (see section 4.4).
Conformity assessments are not required for custom-made medical devices nor medical devices intended solely for exhibition or clinical investigations, cf. Section 5 of the Medical Devices Act.
4.7 Norwegian Drug Insurance
In Norway, liability for injuries caused by medicinal products is governed by a national liability regime instituted by the Norwegian Product Liability Act, which creates a special insurance scheme; Norwegian Drug Insurance (NDI). All manufacturers and importers of medicinal products intended for commercial use in Norway are obliged to obtain insurance through NDI, cf. Section 3-5 of the Product Liability Act.
Either the manufacturer or the importer of a medicinal product in Norway must obtain membership of the Drug Liability Association (owner of NDI) and pay an insurance premium as a fixed percentage of the value. Claims handling is conducted by the System of Patient Injury Compensation (NPE), a public agency under the Ministry of Health and Care Services. Calculation of damages follows the general principles under tort law. If the claim is rejected, the injured person may bring a civil action against NDI.
NDI does not pertain to medical devices. Liability for injuries caused by medical devices is governed by general product liability rules. The Act on Product Liability is adapted to Directive 1985/374/EC. Liability is dependent on the product being defective, and responsibility rests with the producer. Claims are enforced in the civil courts.
5. Pricing and reimbursements for medicinal products
5.1 Introduction
All POMs must obtain a maximum pharmacy purchase price (PPP) and a maximum pharmacy retail price (PRP) before entering the Norwegian market. The Norwegian PPP is determined by NoMA on the basis of the average market price for the product in question in a number of EEA countries. The PPP will normally be set as the average of the three lowest market prices for the product in Sweden, Finland, Denmark, Germany, Great Britain, The Netherlands, Austria, Belgium and Ireland. Both NoMA and the marketing authorisation holder may adjust or apply for an adjusted price yearly. Generic prescription drugs are granted the same PPP as the original product. The PRP is set by adding the maximum pharmacy mark-up to the PPP. NoMA sets out the maximum pharmacy mark-up, which varies based on the type of POM.
The financing of POMs in the Norwegian healthcare service is divided between the RHFs, the municipalities and the National Insurance Scheme through reimbursement. For POMs not subject to reimbursement, the patient must cover the full cost. As explained in section 4.4 there are different types of prescriptions based on the financing entity.
There is no price regulation for OTCs. The pricing and reimbursements of medical devices are not specifically regulated by law but are governed by general schemes on health services and care.
5.2 The step price system
When generic prescription products are launched on the Norwegian market, NoMA may include the original and generic products in the so-called ‘step price’ model, which reduces a product’s maximum PRP in steps.
The size of the price cuts depend on annual sales of the original product prior to the establishment of generic competition and the time since competition was established. The prices are reduced in one to three steps, and there are different reduction rates for synthetic and biological medicinal products. Additionally, the size of the prize cut depends on whether the sales of the original medicinal product were above or below NOK 100 million before the first generic medicinal product entered the market. The rates range from a reduction of 25 to 81 per cent from when generic competition is established, and for biological medicinal products subsequently within a range of 50 to 70 per cent after six months, depending on the total sales of the product at the time generic competition was launched. Lastly, 18 months after the generic competition launched, NoMA may determine a further depreciation ranging from 60 to 90 per cent, depending on the total sales of the product and whether it is a synthetic or biological medicinal product. The price cuts are bigger for active ingredients with high annual sales than for active ingredients with lower annual sales. Parallel imported medicinal products are given the same maximum price as the directly imported medicinal products.
For medicinal products included in the step price system, the maximum reimbursed price is equal to the step price. Consequently, if the patient does not accept the generic product offered by the pharmacy at step price, the patient must cover the difference in price between the step price at which the generic product is offered and the price of the original product.
The step price does not affect the PPP, as the obligation to offer a product at step price rests with the wholesaler and the pharmacy, and not the holder of the marketing authorisation. Inclusion in the step price system and on the substitution list (see section 6.5) will, however, lead to loss of market share as the pharmacy and wholesalers will have strong economic incentives to purchase the cheaper generic alternative instead of the originator’s product.
5.3 Reimbursements
POMs prescribed in the primary healthcare services may be reimbursed through the National Insurance Scheme. For POMs prescribed in the specialist healthcare services, the financing obligation rests with the RHFs. The municipalities are responsible for financing medicinal products used in its institutions and for vaccines in the Norwegian national vaccination program. The holder of a marketing authorisation may apply for general reimbursement.
In order to be included in the reimbursement scheme, both in the primary and specialist healthcare services, the costs of the medicinal product must be deemed reasonable compared to its therapeutic value (cost-benefit analysis), whilst also taking into consideration the severity of the relevant indication. Should the indication be deemed highly severe, the acceptance of higher costs relative to the therapeutic value may occur.
For the primary healthcare services, NoMA assesses whether the expenses related to treatment with certain medicinal products should be covered by the National Insurance Scheme. NoMA may decide that a product is to be reimbursed on an individual basis only.
Reimbursements by the specialist healthcare service are decided by the Decision Forum in New Methods, as outlined in section 3.4. With the PRP as a starting point, LIS conducts price negotiations with the supplier of a medicinal product on behalf of the RHFs. The negotiated price forms the basis for the cost-benefit analysis which is presented in a health technology assessment (HTA) on which the Decision Forum bases its decision of whether the product shall be approved. A new medicinal product will only receive funding from the RHFs and be available to patients in the specialist healthcare service if the Decision Forum approves it. Without approval, the method is effectively banned from use in Norway, regardless of its potential medical benefits.
5.4 Tendering by LIS
The main pricing policy for medicinal products used in the specialist healthcare service is tendering, unless there is only one supplier who can provide a medicinal product for the medical need in question. Tenders are conducted by LIS on behalf of the RHFs.
LIS performs tenders in accordance with the Public Procurement Act and Regulation (which implements Directive 2014/24/EU on Public Procurement). This is normally done on a yearly basis, although the contracts usually contain a right to expand for an additional time period. All suppliers, manufacturers and wholesalers are addressed in what is normally an open tender procedure. In case of a single-supplier situation, LIS will purchase the medicinal product in question directly from that single supplier. The tenders are published in the Doffin and TED database, and the process is co-ordinated by LIS through the Mercell portal.
The tenders for medicinal products are indication-based. Together with medical specialists, LIS will prepare “comparison groups” for an indication, with specific active ingredients that the specialists consider will offer the patients medically equivalent treatment. As a result, different active ingredients that have in common that they may be used in the treatment of the indication in question are often included in the same comparison group. Products in the same comparison group compete against each other in the tenders. For medicinal products, price is often the only award criterion, although this is considered on a case-by-case basis, and if relevant, may also include functional characteristics such as durability and ability to blend, packages such as unit-dose, labelling (readability, strength specification), package varieties (unity), product variety such as administration form, formulation, strength varieties and help with medical enquiries and delivery.
The prices are the same for all hospitals and indication-based pricing is not permitted. Products that are procured for several indications will therefore have the same price bid in each tender. There is no bundling of products in the tendering process.
The tender documents usually also include a requirement for approval by Decision Forum which is a prerequisite for delivering products under the contract once a contract is awarded, but not for submitting a tender bid. Decision Forum bases its decisions on inter alia an evaluation of the products’ cost-effectiveness.
The results of the tenders are publicly available information, and the tenders are subject to the Freedom of Information Act. The Freedom of Information Act contains exceptions for the disclosure of trade secrets, and disclosing net unit prices can be regarded as a disclosure of trade secrets which is therefore prohibited. However, a case-specific assessment will be made by LIS, and there has in the past been disputes between LIS and suppliers regarding the confidentiality of net unit prices.
The tendering system is designed to ensure competitive prices, and net unit prices in the tendering process are usually discounted compared to the approved maximum prices.
In 2023, tendering for certain Blue prescription products, which is part of the primary healthcare services, was introduced. The products eligible for such tenders are certain patented products for which there are at least two therapeutically equivalent alternatives on the market, and for which tenders are expected to result in significant cost savings for the National Insurance Scheme. The Blue prescription tenders are conducted by LIS.
6. Post-marketing activities
6.1 Pharmacovigilance
Once the medicinal product has been launched on the market, Norwegian law requires the marketing authorisation holder to implement and manage a system for pharmacovigilance, cf. Section 8-5 of the Norwegian Medicinal Products Regulation. The marketing authorisation holder is required to have a qualified person (QP) domiciled and working in the EEA who is responsible for the pharmacovigilance system, cf. Section 10-2 of the Norwegian Medicinal Products Regulation. The name and contact information of the responsible person must be submitted to NoMA. Adverse effects will be reported in periodic safety reports at certain intervals depending on the timing of the marketing of the medicinal product, cf. Section 10-6 of the Norwegian Medicinal Products Regulation. Information on adverse side effects must be submitted to NoMA in the forms set out in Directive 2001/83/EC, Directive 2001/82/EC and Regulation (EC) 726/2004.
In addition to the regular reporting requirements, NoMA may at any time request additional or updated information from the marketing authorisation holder on the medicinal product’s risks and benefits, information regarding the sales volume of the medicinal product, information concerning prescriptions and a copy of the master file for the pharmacovigilance system, cf. Section 8-7 of the Norwegian Medicinal Products Regulation.
6.2 Promotional activities
Advertising and promotional activities pertaining to medicinal products are governed by the Medicinal Products Act, the Medicinal Products Regulation and the code of conduct adopted by the Association of the Pharmaceutical Industry in Norway (LMI Code).
The LMI Code is based on the regulations of the European Federation of Pharmaceutical Industries and Associations (EFPIA), to which LMI is affiliated. The LMI Code is further based on agreements between LMI and the RHFs, the Norwegian Medical Association, the Norwegian Nurses’ Association, the Norwegian Association of Pharmacists and the Norwegian Federation of Organisations of Disabled People. The LMI Code is considered to represent good industry practice in Norway, but is only binding for LMI members.
Norwegian legislation differentiates between advertising aimed at the public and advertising aimed at HCPs. Advertising of POMs to the public in Norway is prohibited. Promotion of POMs is exclusively permitted when targeting HCPs and must conform to applicable legal and ethical guidelines. In contrast, advertisements of OTCs to the public, including by way of televisions commercials, are permissible provided that the advertisement complies with certain criteria. In short, advertisement of OTCs must be factual and truthful, avoiding misleading claims about effects or properties. Such advertising is allowed only for products with a marketing authorisation in Norway and must align with approved product information. Advertisements should promote rational use without exaggeration. Public advertising is permitted only for conditions not requiring a doctor’s or dentist’s intervention and must clearly identify the product as medicinal. Section 13-6 of the Norwegian Regulation on Medicinal Products specify information that must always be included in advertisements to the public, as well as information that should not be included.
The requirements pertaining to advertising of medical devices in Norway are harmonised with EU law and governed by the MDR and IVDR. Advertisements for medical devices may be directed at both HCPs and the public. All promotional materials of medical devices should be objective and truthful, offering accurate information about the product. Additionally, the advertising must align with the manufacturer’s instructions and clearly communicate the device’s intended use, proper application, and safety precautions.
6.3 Distribution, wholesale and pharmacies
Distribution of a medicinal product requires, as a general rule, a WDA according to the Norwegian Wholesaler Regulation. Wholesaler activities may also be conducted on the basis of an MIA covering the relevant products (see section 4.2). NoMA is the issuing authority for both WDAs and MIAs in Norway. Wholesaler activities in Norway may also be conducted on the basis of a WDA issued by another EU/EEA Member State, upon notification to NoMA. The admission to perform wholesaler activities in Norway is restricted to only the medicinal products and the activities covered by the WDA in question.
As of February 2024, NoMA no longer issues national WDAs to Norwegian branch offices (Norwegian: Norsk utenlandsk foretak/NUF) of companies established outside Norway. Therefore, obtaining a Norwegian WDA requires the establishment of an independent legal entity in Norway.
Imports of medicinal products from other EU/EEA Member States may be conducted on the basis of a WDA issued either in Norway or another EU/EEA Member State. However, imports
from third countries requires an MIA and may not be conducted on the basis of a WDA (see section 4.2). According to a statement issued by NoMA in February 2024, purely financial transactions with third countries are also considered as imports and may therefore not be conducted on the basis of a WDA.
All wholesaler activities in Norway must be carried out in compliance with the EU Guidelines on Good Distribution Practice (GDP). Additionally, the Wholesaler Regulation outlines specific operational requirements for the wholesalers. A key requirement for wholesalers supplying to pharmacies, is a duty to be able to supply their entire product range anywhere in Norway within 24 hours. Exceptions are made for areas with challenging communication conditions, where delivery must occur within 48 hours, or if there are special circumstances and NoMA has granted an exemption, cf. Section 4 of the Wholesaler Regulation. Wholesalers distributing medications to pharmacies are also required to maintain an additional stock of emergency medications, as specified in Section 5 of the Wholesalers Regulation. Furthermore, wholesalers must employ a person with a cand. pharm. degree or equivalent education to oversee the pharmaceutical aspects of the business. They must also have access to sufficiently large and suitable premises, along with the necessary equipment, to ensure that medicinal products are stored and handled safely and securely, as outlined in Sections 6 and 7. Another key obligation is that wholesalers may only purchase medications from manufacturers with a manufacturing license or from approved wholesalers or importers, as set out in Section 12. Currently, there are three wholesalers offering a full product range of pharmaceuticals to the Norwegian market: Norsk Medisinaldepot AS, Apotek 1 Gruppen AS and Alliance Healthcare Norge AS. Each is vertically integrated within their own pharmacy chain.
Wholesaler activities including narcotics or psychotropic substances requires a WDA or MIA specifically covering such products. NoMA determines whether a product belongs to the narcotics and psychotropics category. NoMA may determine that the importation and exportation of certain products on the narcotics list requires a special certificate. Further, NoMA may prohibit the importation or exportation of a product, pursuant to the Medicinal Products Act and the Narcotics Regulation.
Norwegian pharmacies function as retail outlets for medicinal products, offering both prescription and over-the-counter products. The pharmacies maintain a monopoly on the sale of prescription products in Norway. Operating a pharmacy requires a license for pharmacy ownership (Norwegian: apotekkonsesjon) and a license for pharmacy operation (Norwegian: driftskonsesjon), as stipulated in Section 1-4 of the Pharmacies Act. NoMA is responsible for assessing applications and granting licenses for pharmacy ownership and pharmacy operation.
In Norway, there are over 1,000 pharmacies, organised as independent pharmacies, pharmacy chains, hospital pharmacies, or online pharmacies. The largest chains include Apotek1, Vitusapotek, and Bootsapotek, and these three are in turn each owned by a pharmacy wholesaler. Hospital pharmacies primarily supply medications to hospitals and are owned by the RHFs, forming part of the specialist healthcare service.
6.4 Market protection and data exclusivity
Market protection for an original medicinal product refers to a specified time period during which the marketing authorisation holder has exclusive rights to market the medicinal product. Market protection is separate from patent protection and is granted upon the regulatory approval of a new medicinal product. During the protection period, no generics are permitted to enter the market. This exclusivity safeguards the significant investments made by life sciences companies in the development of new medicinal products.
In addition to market protection, the marketing authorisation holder of a new medicinal product is granted data exclusivity. A marketing authorisation application must be supported by comprehensive documentation, referred to by EMA as the common technical document (CTD), which demonstrates the quality, safety and efficacy of the medicinal product, including non-clinical pharmacology and toxicology data, as well as detailed clinical trial reports. The documentation included in the CTD represents considerable investments on the part of the marketing authorisation holder. Data exclusivity prevents competitors from relying on the data included in the CTD of the originator’s product for marketing authorisation applications for generic or biosimilar products, for a limited time period.
A new medicinal product automatically receives data exclusivity based on the marketing authorisation for the first application in the EEA. For products for which the first filing of marketing authorisation happened after 12 January 2010, the product will have a data exclusivity period of eight years and market protection of ten years, cf. Sections 3-10 and 3-11 of the Medicinal Products Regulation. Market protection can be extended to eleven years if new indications of significant clinical importance are approved during the data exclusivity period (i.e., the first eight years), cf. Section 3-11b. For a well-established substance (with or without generic competition), one year of data exclusivity can be granted for a new therapeutic indication, provided that significant pre-clinical or clinical studies are submitted in relation to the approval of the new indication, cf. Section 3-11d.
As regards applications for generic or biosimilar medicinal products made under the centralised procedure, Norwegian data exclusivity is harmonised with EU law.
6.5 The substitution list
The Pharmacies Act provides for an arrangement permitting pharmacies to substitute prescribed medicinal products with ‘generically equivalent’, ‘biosimilar’ or parallel imported products. The substitution right is limited to products having been approved as substitutable by NoMA. Substitutable products are listed on the so-called ‘substitution list’ (Norwegian: Byttelisten). Once NoMA has included a product on the substitution list, substitutions can be
made by the pharmacy without prior consultation with the prescribing physician. The pharmacy is not obligated to substitute an original product with a generic product. However, if two or more products are included on the substitution list, the pharmacy is obliged to inform the customer of the cheapest alternative, unless the price difference is insignificant. Substitutions shall not take place against the prescribing physician’s or the patient’s express wishes, cf. Section 6-6 of the Norwegian Pharmacy Act.
6.6 Regulatory sanctions
6.6.1 Supervisory bodies and sanctions
NoMA’s surveillance department monitors the distribution of medicinal products throughout the distribution chain. NoMA has the authority to demand all information deemed necessary to supervise the market. Breach of the applicable rules may be sanctioned with warnings, coercive fines and withdrawal of licences.
In addition, LMI has established the Committee for Information on Medicinal Products (the Committee) (Norwegian: Rådet), which acts as a voluntary self-regulating supervisory body for all members of LMI. The Committee has the authority to issue fines up to a maximum of NOK 300 000 to member companies in cases of breach of the LMI Code.
NoMA is also the supervisory authority for medical devices and conducts inspections of manufacturers, either scheduled or unannounced. Upon inspections, NoMA may require access to facilities, storage, and any relevant documentation. Breach of the applicable rules may be sanctioned with warnings, sales bans, recalls, and destruction of non-compliant products.
6.6.2 Appeal of decisions by NoMA and other administrative authorities
Decisions by NoMA can be appealed through either an administrative complaint or judicial review, provided the decision qualifies as an ”individual decision” under Section 2 of the Public Administration Act.
Decisions adopted by NoMA may be appealed to the Ministry of Health and Care Services, which may maintain the decision, or instruct the underlying authority to reassess the case. An administrative complaint must normally be filed within three weeks, counting from the date the party received information about the decision, or – if the complaint is filed by an interested third party – from the date when the third party obtained or should have obtained knowledge of the decision, cf. Section 29 of the Public Administration Act.
Decisions of administrative authorities may also be challenged by bringing an action in the civil courts, provided that the plaintiff demonstrates a legal interest and a ‘genuine need’ to initiate an action before the courts (standing), cf. Section 1-3 of the Dispute Act. The plaintiff may also request a preliminary injunction if there is an urgent need for a decision, cf. Section 34-1 of the Dispute Act.
7. Intellectual property rights
7.1
Introduction
In addition to navigating the regulatory legal landscape, companies and other stakeholders operating in the life sciences industry in Norway must also understand and manage the Norwegian legal landscape associated with intellectual property rights (IP rights). A thorough comprehension of the IP rights available in Norway is crucial for these companies to protect their interests effectively. This guide focuses on the key aspects of Norwegian IP rights within the life sciences sector, emphasizing the protection of newly developed medicinal products and therapies. This section will provide an overview of rights pertaining to patent protection and the enforcement of such rights. First, we will provide a brief introduction to the rules on the protection of trade secrets.
7.2 Protection of trade secrets
When knowledge cannot be patented or is unsuitable for patent protection, treating it as a trade secret can be an effective alternative. Keeping this information confidential is strategically important to prevent competitors from accessing, using, or disclosing it.
The Trade Secrets Act, which implements Directive (EU) 2016/943 (the EU Trade Secrets Directive), was adopted in 2020. Under Section 2, a ”trade secret” is defined as information that (i) is not generally known or easily accessible, (ii) has commercial value due to its secrecy, and (iii) has been subject to reasonable efforts to keep it secret. Protectable information includes algorithms, source code, clinical data, and process information, but excludes general experience and skills acquired by employees.
Trade secret holders are protected against infringement, including unlawful acquisition, use, and disclosure. Infringing goods are prohibited, covering production, marketing, importation, export, or storage when the person involved knows or should have known about the infringement.
Both ongoing and imminent trade secret infringements are prohibited. Courts may order corrective and preventive measures regarding infringing goods, such as market recall, removing infringing qualities, or destruction, c.f. Section 6 of the Trade Secrets Act.
According to Section 8, infringers may be ordered to pay (i) compensation equivalent to a reasonable license fee plus damages for unlicensed use, (ii) damages for losses from the infringement, or (iii) compensation based on the infringer’s financial gain, whichever benefits the trade secret holder most. This aligns with compensation and damages provisions in the Patents Act and Trademarks Act, including contributory negligence.
7.3 Patent protection
7.3.1 Introduction
Norway is a party to most significant international conventions in the area of intellectual property rights, including the Paris Convention, the TRIPS Agreement, the Patent Cooperation Treaty and the European Patent Convention (EPC). The Patents Act from 1967 has been amended several times and is harmonised with the provisions of Directive 98/44/EC on the legal protection of biotechnological inventions. It incorporates Regulations 469/2009 and 1610/96 introducing supplementary protection certificates (SPCs) for medicinal and plant pharmaceutical products. Further, Norway has harmonised its laws with Regulation 1901/2006/EC and Regulation 1902/2006/EC on paediatric extension of SPCs.
The Unitary Patent, established within the EU in year 2023, is not applicable to Norway, as Norway is not a member of the European Union. Similarly, the European Commission’s proposal of a unitary SPC will likely not be applicable in Norway, and Norway is not party to the Unified Patent Court.
7.3.2 Patentable inventions
According to the Patents Act, patents shall be granted for any inventions in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application. Mere abstract creations, including discoveries and business methods, are not patentable. Patents may neither be granted for plant or animal varieties, essentially biological processes, nor for surgical, therapeutic or diagnostic methods.
7.3.3 The scope of patent protection
As in most other countries, patent protection in Norway may be upheld for 20 years from the filing date of the application.
According to Section 3 of the Patents Act, the following actions constitute patent infringement:
1. producing, offering for sale, putting on the market or using a product protected by the patent, or by importing or possessing the product for such purposes;
2. using or offering to use a process protected by the patent or, whilst knowing, or it being obvious from the circumstances, that the use of the process is prohibited without the consent of the patent holder, offering the process for use in this country;
3. offering for sale, putting on the market or using a product made by a process protected by the patent, or importing or possessing the product for such purposes.
Additionally, patent infringement may occur through indirect means by supplying or offering to supply means related to an essential element of the invention, if the supplier knows or should reasonably know that these means are intended for exploiting the invention. This is known as indirect patent infringement.
The scope of protection of a patent is governed by Section 39 of the Norwegian Patents Act, which corresponds to Article 69 EPC, i.e. that the extent of protection is determined by the claims. The description and drawings are used to interpret the claims. The scope of protection is however not limited to the literal wording of the claims. Pursuant to the doctrine of equivalents, as set out in the EU Protocol on the Interpretation of Art. 69 EPC, the extent of patent protection shall also take into account any element which is equivalent to an element specified in the claims.
7.3.4 Supplementary Protection Certificate
For certain categories of patents, the general patent protection period may prove insufficient for the time and resources spent on developing the invention. This is the case for medicinal products, plant pharmaceutical products and paediatric medicinal products, which all are subject to extensive testing before being placed on the market, resulting in an actual protection period substantially shorter than for other inventions. These products may therefore obtain an extension of the patent protection period through an SPC. For medicinal and plant pharmaceutical products, patent protection may be extended by the grant of an SPC for a maximum of five additional years. Medicinal products that have been made subject to a paediatric research programme, may be entitled to additional six months of protection, cf. Regulation 1901/2006 EC.
The Norwegian legislation related to the grant of an SPC follows from EU Regulations 469/2009 and 1610/96 introducing SPC’s for medicinal and plant pharmaceutical products in the EU and Regulation 1901/2006/EC and Regulation 1902/2006/EC on paediatric extension of SPCs. The grant is made by the Norwegian Industrial Property Office (NIPO), upon application within six months from the date on which the basic patent was granted, or from the date when the first marketing authorisation for the product was available in Norway, if this is later, cf. the Patent Guidelines Part C, Chapter V, Item 4.1.1.1.
An SPC extends protection to the product covered by the marketing authorisation for the corresponding medicinal or plant pharmaceutical product and applies to any authorised use of that product. Multiple SPCs may be granted based on the same basic patent if the patent encompasses several medicinal products, provided that each product has received a marketing authorisation in Norway.
7.4 Administrative patent proceedings
There are two available options for challenging the validity of a patent belonging to someone else or limiting the claims of one’s own patent: administrative procedures or legal proceedings.
Administrative procedures are available for the purpose of (i) limiting the patent claims, in order to strengthen the validity of the patent, cf. Section 39 b of the Patents Act, (ii) for the filing of a post-grant opposition to a third party patent, cf. Section 24 of the Patents Act, or (iii) for the filing of a request for an administrative review of a third party patent, cf. Section 52 b of the Patents Act, requesting that the patent shall be declared invalid.
Decisions in administrative proceedings are rendered by NIPO and appeals may be heard by the Board of Appeal for Industrial Property Rights. If the Board of Appeal rejects an application or revokes a patent, the applicant or patentee may request judicial review by the ordinary civil courts, with the District Court of Oslo as the mandatory venue.
7.5 Patent litigation
7.5.1 Main action patent litigation cases
Norway does not have a specialized patent court, unlike the systems in place in some other countries, such as Sweden and Germany. First instance patent cases regarding infringement or validity are heard at the Oslo District Court as the mandatory venue, cf. Section 63 of the Patents Act, due to the need for specialised expertise and a uniform patent practice.
First instance patents actions before the Oslo District Court usually have a duration of 9–18 months from filing a statement of claim until a decision from the court is handed down. The court will assess the evidence provided to it based on the balance of probabilities. The burden of proof lies on the party asserting a fact. A party may rely on all kinds of documents, statements and evidence to prove its case. In patent infringement proceedings, the claimant usually has the burden of proof to establish infringement.
Norwegian court procedure is based on an oral principle. This means that most proceedings are conducted orally, and the basis for the decision, including the claims, arguments, and reviewed evidence, should be read out in court or stated verbally before the adjudicating court during the oral hearing.
There are three main types of patent proceedings: infringement proceedings, declaratory non-infringement proceedings, and invalidity proceedings.
i. Infringement action:
An infringement action may be started if infringement has occurred or if an imminent threat of infringement exists, cf. Section 56 a of the Patents Act. An imminent threat of infringement
exists if the patentee has reasonable grounds for suspecting that an act of infringement may occur in the near future. In practice, most infringement cases start with the patentee sending a notice letter to a possible infringer, requesting relevant information, such as process documentation and product samples. If the possible infringer does not respond, or responds inadequately, a threat of infringement will often be considered to be present.
Anyone who intentionally infringes a patent, or who is an accessory thereto, may be penalised by fines or by imprisonment for a term not exceeding one year, cf. Section 57 of the Patents Act. Criminal charges are, however, extremely rare in Norway.
In civil proceedings, the infringer is liable to pay compensation for the unlawful exploitation of the invention. The patentee is entitled to (i) compensation corresponding to a reasonable license fee for the infringing use, as well as damages for loss which would not have been incurred had the patent been licensed, (ii) damages suffered as a result of the infringement, or (iii) compensation corresponding to the financial gain obtained by the infringer, whichever is the most favourable to the patentee. If the infringer has acted wilfully or in gross negligence, the patentee is entitled to twice the reasonable licence fee. If the infringer acted with care and in good faith (i.e. without being negligent), the court may, to the extent found reasonable, order the infringer to pay a reasonable licence fee or the financial gain obtained by the infringer, cf. Section 58 of the Patents Act. To prevent further infringement, the court may also decide that infringing products shall be altered, destroyed, confiscated or be surrendered to the patentee against compensation, cf. Section 59 of the Patents Act.
ii. Declaratory non-infringement action:
A declaratory non-infringement action may be initiated if a party has a reasonable need for a clarification of an infringement issue. A declaratory non-infringement action is normally initiated by the plaintiff sending the patentee a request to state whether or not the patent will be invoked against the plaintiff. Provided the patentee invokes the patent or reserves its right to invoke the patent, and provided, furthermore, that the plaintiff intends to exploit the potentially infringing product or process in Norway, a declaratory non-infringement action may be filed.
iii. Invalidity proceedings:
An invalidity action may be initiated by anyone, with no need to provide a specific interest in the action. A defendant in an infringement action may challenge the validity of the patent as a defence, but only by way of a counterclaim for invalidity. The validity of a patent can be contested on several grounds, each addressing different aspects of the patent’s adherence to legal requirements. The primary grounds for challenging patent validity include:
i. Excluded Subject Matter: A patent can be contested if its subject matter is excluded from patentability under applicable laws, cf. Sections 1 and 2 of the Patents Act.
ii. Lack of Novelty: A patent can be invalidated if it is demonstrated that the invention was already known or disclosed in prior art before the patent application’s filing date, cf. Section 2.
iii. Obviousness (Inventive Step): A patent can be invalidated if the invention lacks inventive step, i.e. that it was obvious to a person skilled in the art, cf. Section 3.
iv. Insufficiency of Disclosure: A patent can be challenged if the disclosure is not clear and complete enough for a person skilled in the art to carry it out, cf. Section 8.
v. Added Matter: The content of a patent application or granted patent cannot be amended to include new matter that extends beyond the protection granted by the original application as filed, cf. Section 13.
A patent may be fully or partially invalidated by a court decision if any of the aforementioned grounds are found to be present.
7.5.2
Request for evidence
In Norway, there is a general duty of disclosure that requires parties to ensure that the factual basis of a case is accurately and thoroughly presented, cf. Section 21-4 of the Dispute Act. Under Section 21-5, all persons have a duty to provide testimony regarding factual circumstances and to allow access to objects and other materials that may serve as evidence in legal proceedings, with certain limitations. Parties may therefore be obligated to present evidence that does not support their case.
Pretrial submission of evidence can be requested to secure evidence, provided it is reasonable to assume the evidence will be important in a subsequent court case and there is a clear risk of it being lost or impaired if not secured, according to Section 28-2 of the Norwegian Dispute Act. However, such requests are often time-consuming. It is more common to request the disclosure of specific evidence once proceedings have commenced.
If evidence is not voluntarily disclosed, the opposing party may request the court to order the disclosure of relevant documents held by another party or a third party, provided the evidence is significant for the case and reasonably required. A party may refuse to disclose evidence if it contains trade secrets, as per Section 22-10 of the Norwegian Dispute Act. Nonetheless, the
court may still order the production of such evidence if deemed necessary for the case. In such instances, the court will impose confidentiality obligations and prohibit the use of any trade secrets derived from the disclosed evidence. Additionally, proceedings may be conducted behind closed doors (in camera) to exclude public access.
The Dispute Act incorporates these confidentiality obligations and prohibitions on use in accordance with Directive 2016/943 (the Trade Secrets Directive). In recent years, there has been a noticeable increase in procedural disputes related to disclosure requests and access to evidence, particularly when one party asserts that the evidence constitutes trade secrets. If a party refuses to present relevant evidence, the court may consider this refusal when assessing the evidence and may decide against that party.
7.5.3 Request for preliminary injunction
Preliminary measures are available if infringement has occurred or is likely to occur in the immediate future. In the field of pharmaceuticals, typical trigger events for such imminent infringement are a price grant, reimbursement grant or a product launch. Such acts may, alone or combined, confirm that infringement is likely in the immediate future. Other factors, such as a confirmation of imminent launch or distribution agreements concluded with wholesalers, will further contribute to the assertiveness of the trigger events.
There is no specific time limit on when a request for preliminary injunction must be made. It is essential to act promptly while also ensuring that adequate evidence of infringement is gathered. Generally, a timeframe of a few weeks to at most 2-3 months from the trigger event is considered acceptable.
Unlike main action patent cases, requests for preliminary injunctions are possible in any of the 23 district courts with jurisdiction, i.e. the domicile of defendant or “where the property, asset or object is located or is expected to arrive in the near future”, cf. Section 32-4 of the Dispute Act, cf. Section 4-4. However, Oslo District Court will usually have jurisdiction for preliminary injunctions in patent cases, even if the defendant is not domiciled in Oslo, because the alleged infringing object usually is, or is expected to be, imported within the court’s district.
A request for a preliminary injunction will normally be processed within two to three months. In most cases there will be an oral hearing with presentation of evidence and statements from expert witnesses. In special cases, where the threat of infringement is highly imminent, a preliminary injunction may be granted ex parte, cf. the Dispute Act Section 32-7.
The requirements for granting preliminary injunctions are that (i) the main claim is substantiated by a balance of probabilities, which usually means that infringement will occur, (ii) that the patentee will suffer serious or irreparable damage unless an injunction is granted (urgency), and (iii) that a balancing of interests is in favour of granting a preliminary injunction, cf. Sections 34-1 and 34-2 of the Dispute Act. If infringement is found, a preliminary injunction will normally be granted unless the defendant provides substantial and persuasive evidence of invalidity or demonstrates that the loss or inconvenience to the
defendant is clearly disproportionate to the interest of the petitioner in the preliminary injunction being granted. If the court in the main action decides that the petitioner’s claim was unjustified, the petitioner shall compensate any loss that the defendant has sustained as a result of the preliminary injunction on a strict liability basis.
7.5.4 Expert judges, party-appointed expert witnesses and court-appointed experts
Patent disputes in the Oslo District Court are usually decided by a panel consisting of three judges. This panel includes one legal judge, whose presence is compulsory, and two technical expert judges, whose appointment is discretionary, cf. Section 9-12 of the Dispute Act and Section 88 of the Courts of Justice Act. The technical expert judges, who have expertise in the pertinent technical field, can be appointed at the request of the parties, which is frequently a joint request, or by the court on its own initiative. One or both of the expert judges may be patent attorneys. If technical expert judges are not appointed, disputes in the District Court are heard by one legal judge.
Expert evidence is permissible and normally key in patent disputes. Expert evidence may be provided by party-appointed expert witnesses. Party-appointed expert witnesses usually produce a written report submitted in advance of the hearing and are present during the oral hearing to provide oral testimony. These experts are also permitted to pose questions to the parties, witnesses, and other experts, cf. Section 25-6 of the Dispute Act.
The court can also appoint one or more independent experts at the request of a party or on its own initiative when it is deemed necessary to establish a solid factual foundation for the case’s judgment, cf. Section 25-2 of the Dispute Act. The court will specify the matters for the courtappointed expert to address and provide appropriate guidance on, cf. Section 25-4. These experts should maintain impartiality from the parties involved. They are allowed to attend the trial and, if needed for their assignment, question the parties, witnesses, and other experts. Typically, they present a written statement to the court, which is then elaborated upon with oral testimony. The written statement can be prepared prior to the hearing, based on the parties’ written submissions, or during the hearing, based on the parties’ oral presentations and presentations of evidence.
7.5.5 Alternatives to litigation
Infringement issues are almost exclusively decided by the ordinary civil courts. For invalidity challenges the third party may opt for administrative proceedings by filing a notice of opposition or by requesting administrative review of validity. If, however, infringement proceedings are pending or are likely to be initiated, defendants generally prefer to invoke invalidity as part of court proceedings by filing a counterclaim for invalidity.
Alternatively, intellectual property cases may be decided by arbitration, provided that the parties agree to this. An arbitral decision will have effect only for the parties to the arbitration. An arbitral court does not have the competence to declare a patent invalid. Arbitration is rarely the preferred route for intellectual property disputes in Norway.
7.6 Recent decisions on pharmaceutical patents in Norway
Merck Sharp & Dohme LLC v. the State represented by the Norwegian Board of Appeal for Industrial Property Rights. This case involved a request from Merck Sharp & Dohme LLC (MSD) to impose an administrative limitation on two dependent claims in an existing patent related to sitagliptin, a diabetes treatment. MSD sought to limit the dependent claims to include only the combination of sitagliptin and metformin to establish a more secure basis for SPC protection. The District Court ruled that a substantive reduction in the scope of protection under Section 39a of the Patents Act requires changes to independent claims, not just dependent ones, to ensure the patent’s scope is genuinely reduced to avoid invalidation due to new prior art. The Court of Appeal dismissed the appeal, stating that Article 105a of the European Patent Convention (EPC) and Section 39a should be interpreted in the same manner. However, the Supreme Court has recently granted leave to appeal.
Teva Pharmaceutical Industries Ltd. and Teva Norway AS v. Bristol-Myers Squibb Holdings Ireland Unlimited Company. Teva challenged the validity of a patent and SPC for apixaban, a blood clot treatment, on grounds of lack of inventive step and added matter, specifically the purported lack of plausible technical effect. This case was the first in Norway to address plausibility post the Enlarged Board of Appeal’s decision in G 2/21. The Court of Appeal found that the patent met the requirements for inventive step, stating it must be credible to a skilled person that the claimed technical effect is achieved. The Court accepted post-filed evidence to substantiate the technical effects, aligning with EPO practice. BAHR represented BMS before the District Court in this matter.
Bayer Intellectual Property GmbH v. Glenmark Pharmaceuticals Nordic AB and Sandoz A/S. Bayer successfully defended its patent for a dosing regimen using rivaroxaban for thromboembolic disorders against an invalidity action by Sandoz. The District Court decision was the first decision on the merits in Europe in this global case complex. While awaiting the Court of Appeal hearing, Bayer obtained preliminary injunctions to prevent the launch of generic rivaroxaban in Norway. The decision granting the preliminary injunctions emphasized the importance of phase II trial confidentiality in maintaining novelty. The District Court found that the presented trial information was not publicly available, preserving the patent’s novelty. This case highlights the intersection of patenting and clinical trials, a crucial issue for the pharmaceutical industry. The Court of Appeal is scheduled to hear the case in May 2025. BAHR represents Bayer in this case.
Updated in June 2025.
DISCLAIMER
This publication contains information in summary form and is therefore intended for general guidance only. It is not intended to be relied upon as legal advice or be a substitute for detailed research or the exercise of professional judgement. Please refer to your advisors for specific advice.
BAHR will not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any material in this publication.