A Q&A guide to life sciences law in Denmark.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
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This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
Medicinal products are primarily regulated by Act No. 1180 of 12 December 2005 (as amended) (Medicines Act), and a number of regulations issued under the Medicines Act. The Medicines Act regulates issues such as:
Marketing authorisations.
Manufacturing authorisations.
Quality of medicinal products.
Side effects.
Labelling.
Advertising.
Pricing.
Clinical trials.
The Medicines Act complies with EU legislation, including Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive) (as amended).
With effect from 1 March 2012 the Danish Medicines Agency (Lægemiddelstyrelsen) (Board of Health) will be merged into the National Board of Health (Sundhedsstyrelsen) (Board of Health), which is a body under the Ministry of Health (Ministry). The Board of Health is the supreme professional health care authority and key regulatory body and will from 1 March 2012 also administrate the Medicines Act (see box, The regulatory authority).
Biotechnology and combination products are subject to the same legislation (see above, Legislation).
The Danish healthcare system is divided into primary and secondary sectors. The primary sector comprises, among other features:
General practitioners.
Practising specialists.
District nurses.
The secondary sector comprises hospitals.
Administratively, the Danish healthcare system is divided into three levels:
State. The Ministry is primarily responsible for initiating, co-ordinating, advising and legislating on healthcare.
Regions. Five regions are responsible for general practitioners. The regions own and operate the public hospitals.
Municipalities. The municipalities are responsible for, among other things, district nurses and school healthcare.
Most healthcare services are financed by the tax system and are consequently free of charge for patients. The municipalities finance their healthcare services partly through taxes that they levy themselves and partly through block grants from the state. The five regions do not levy taxes, but receive grants from the state.
Private healthcare expenditure is concentrated on medicinal products in the primary sector, dentistry and physiotherapy. A publicly funded reimbursement system covers some of these expenses (see Question 4). Private health insurance schemes also exist.
Generally, an open-market pricing structure applies.
The marketing authorisation holder sets the price and reports it to the Board of Health. The Medicines Tariff (www.medicinpriser.dk) which is published fortnightly, sets out the prices of all registered and marketed medicines. This tariff is used as the basis for calculating pharmacy retail prices, which apply throughout the country. Calculations are made according to centrally determined rules.
The use of medicinal products in public hospitals is free of charge for patients.
In the primary sector, the public health service reimburses part of a patient's expenditure on prescription medicines in accordance with rules laid down in Consolidated Act No. 913 of 13 July 2010 (Health Act). The marketing authorisation holder can apply for the medicinal product to be subject to automatic reimbursement (general or conditional). Single (individual) reimbursements may be granted by the patient's doctor (on application) for a medicinal product not subject to automatic reimbursement.
In 2012, for persons over the age of 18, the annual personal expenditure (before reimbursement) on medicinal products subject to automatic or single reimbursement is as follows:
Expenditure between DKK0 to DKK890: 0% reimbursement.
Expenditure between DKK890 to DKK1,450: 50% reimbursement.
Expenditure between DKK1,450 to DKK3,130: 75% reimbursement.
Expenditure exceeding DKK3,130: 85% reimbursement.
(As at 1 November 2011, US$1 was about DKK5.3.)
A higher level of reimbursement is available for the chronically ill and persons under the age of 18. The reimbursement thresholds are adjusted on 1 January every year.
Personal expenditure is calculated based on a reimbursement price, which is the price of the cheapest product in a reimbursement group. A reimbursement group consists of medicinal products that are used for the same indications and have similar therapeutic effects. Currently, only medicinal products with the same active ingredient(s) are grouped together.
Reimbursement is generally paid to the end user. In practice, the reimbursement is automatically calculated and deducted from the price at the pharmacy.
Companies that manufacture, import, export, stock, deal in, supply, distribute or package medicinal products must be authorised by the Board of Health (section 39, Medicines Act). Applications must be made to the Board of Health using application forms available at www.sst.dk.
National requirements for pharmaceutical companies are based on the requirements of both the:
Code for Human Medicines Directive (see Question 1).
Commission's Guide to Good Manufacturing Practice.
There are no restrictions on foreign applicants.
The prescribed application form must be submitted to the Board of Health.
The Board of Health should process first-time and renewal applications within 90 days of receipt of a complete application form. If an application is rejected, applicants can appeal to the Ministry.
The fees charged for authorising companies to manufacture and import medicinal products and intermediates are set out in Executive Order No. 1617 of 14 December 2010. An application fee and an annual fee are payable. The fees are adjusted on 1 January every year.
In 2012 the application fee for manufacturers is DKK15,726 and the annual fee is DKK16,068. When a medicinal product is manufactured in a non-EU country, an additional application fee and annual fee must be paid. In 2012, the additional fee is DKK6,785.
An authorisation is valid for up to three years. The authorisation can be renewed on application.
The Board of Health is responsible for regulating manufacturing authorisation holders and monitors the following aspects of a product:
Content.
Composition.
Quality.
Storage.
The way in which it is manufactured.
The Board of Health can (and frequently does) inspect the premises of authorisation holders, without a court order, to monitor compliance with the requirements of the manufacturing authorisation (section 44, Medicines Act). The frequency of inspections is determined by the degree of risk that the company's activities pose to patients. The Board of Health can take samples of medicinal products and may require all information and material necessary for its regulatory function. Inspections without prior notification can only take place if the Board of Health has reason to believe the manufacturing rules have been violated (section 44(4), Medicines Act).
The Board of Health can, at any time, suspend or withdraw an authorisation if the company infringes the general regulations or any specific term imposed in the individual authorisation (section 41, Medicines Act). These decisions can be appealed to the Ministry.
The Board of Health can prohibit marketing of a medicinal product and order the product to be withdrawn from the market if the terms of a manufacturing authorisation are breached (section 46, Medicines Act). Fines or imprisonment can be imposed for violations (section 104, Medicines Act).
Clinical trials are regulated by sections 88 to 92 of the Medicines Act, Order No. 744 of 29 June 2006 and Order No. 295 of 26 April 2004, as amended. The rules implement parts of Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive) and Directive 2005/28/EC on good clinical practice for medicinal products for human use (GCP Directive). Rules on the ethical committee system are set out in Act No. 402 of 28 May 2003 on a biomedical research ethics committee system and the processing of biomedical research projects.
Clinical trials must be approved by the Board of Health and a regional research ethics committee (REC). On submitting the application to the Board of Health, the sponsor must inform the manufacturer of the medicinal product about the trial. The sponsor or its representative must have its registered office in an EU or European Economic Area (EEA) member state.
Non-interventional trials (that is, trials in which the medicinal products are usually prescribed in compliance with the conditions in the marketing authorisation) do not generally require approval.
If the Board of Health objects to the application, the application can be amended to avoid rejection. The Board of Health must process satisfactory applications within 60 days (90 days for medicinal products for gene therapy).
The REC is responsible for supervision and compliance, and can only grant authorisation if:
Any risks connected with implementation of the project are justifiable in themselves or in relation to the project's expected benefits.
The project may be justified by its expected therapeutic and public health benefits.
The scientific standard of the project meets the requirement that the project must contribute to the development of new, valuable knowledge.
There are sufficient grounds for implementing the project, and the expected conclusions of the project are justified.
The REC must also ensure that:
Participants in the trial have been fully briefed and have given their informed consent.
There is written documentation of, among others, what financial support the applicant will receive (for example, from private companies and funds).
The trial complies with good clinical practice and there are sufficient grounds for undertaking it.
Participants in the trial must be fully briefed and give their consent in writing.
See above, Authorisations.
After initiating the trial, the sponsor must report the following to the Board of Health:
Any suspected or unexpected serious adverse reactions (SUSARs) during the trial (immediately).
A complete list of all serious adverse reactions that have occurred during the trial period and a report on the trial subjects' safety (once a year).
The reason a trial has been terminated sooner than planned (within 15 days of it ending).
Information about the end of the trial (within 90 days of the trial finishing) and trial results (as soon as possible).
The Board of Health regulates the sponsor and those who carry out the clinical trial. It can inspect, without a court order, companies, hospitals and other places involved in the clinical trial.
The Board of Health can require the clinical trial to be changed, temporarily stopped or prohibited. If stopped or prohibited, the Board of Health must immediately inform the REC, the European Medicines Agency (EMA), the European Commission and all of the other EU and EEA member states.
A medicinal product cannot be placed on the Danish market unless it has valid marketing authorisation, which can be issued by either:
The Board of Health (under the national procedure, the mutual recognition procedure or the decentralised procedure).
The EMA (under the centralised procedure).
Medicinal products must:
Be of satisfactory quality.
Be safe to use.
Have the desired effect.
Holders of marketing authorisations for medicinal products must be established in an EU or EEA member state.
The company must notify the price of the product to the Board of Health at least 14 days before marketing.
Applications for marketing authorisation must be submitted to the Board of Health and must meet the requirements set out in the Order on Marketing Authorisation for Medicinal Products (Order No. 1239, 12 December 2005 as amended). Applications must be accompanied by a full research dossier proving quality, safety and efficacy. The documentation must comply with the requirements of the Code for Human Medicines Directive. The Board of Health should process a satisfactory application within 210 days (for a new, national application).
If the Board of Health decides to reject an application, the decision can be appealed on points of law to the Ministry.
In 2012 the application fee for a marketing authorisation application under the national procedure with pharmaceutical, toxicological and clinical documentation (that is, full research dossier documentation) is DKK78,556. The annual fee for a marketing authorisation is DKK8,799.
Marketing authorisations are valid for five years. Once renewed, an authorisation is valid indefinitely (unless the Board of Health decides to put a time limit on the renewal). Even though the authorisation (after renewal) has no time limit, the Board of Health can revoke the authorisation if the conditions of the authorisation are no longer met. The application for renewal must be submitted to the Board of Health no later than three months before the expiry of the authorisation. The renewal fee is DKK16,705. Marketing authorisations that have not been used at any point within three successive years will lapse.
Companies must continuously monitor and report adverse reactions from the medicinal products that they market. Adverse reactions are reported through spontaneous adverse reaction reports and periodic safety update reports (PSUR).
Any suspected serious adverse reaction must be reported to the Board of Health within 15 days.
A full research dossier is not required if the applicant can show that the medicinal product is a generic of a reference medicinal product which is, or has been, authorised for not less than eight years in an EU or EEA member state.
Further, a full research dossier is not required if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use in the EU for at least ten years, with recognised efficacy and an acceptable level of safety. The test and trial results are replaced by appropriate scientific literature.
Marketing authorisations issued by the EMA are recognised. Marketing authorisations issued, or applications made, in other EU member states can be used under the mutual recognition procedure or the decentralised procedure:
Mutual recognition procedure. An applicant that wants the Board of Health to recognise a marketing authorisation, which has already been issued by another EU member state, must attest that the documentation submitted to the Board of Health is identical to the documentation that the other EU member state has accepted. At the same time, the applicant must inform the Committee for Medicinal Products for Human Use (part of the EMA) about the application. Unless the Board of Health has objections to the medicinal product, it will recognise the other EU member state's decision and issue a marketing authorisation.
Decentralised procedure. In cases where the medicinal product has not yet received a marketing authorisation at the time of application, the applicant must ask the reference member state to prepare a draft assessment report, labelling and a package leaflet. The applicant can ask the Board of Health to act as reference member state.
The Board of Health monitors how medicines are traded and supplied. The Board of Health can inspect a company's premises without a court order to monitor compliance with the terms of a marketing authorisation, and can require all information and material necessary for its regulatory function.
Breaching the rules relating to marketing authorisations can be punished with fines or, in severe cases, by imprisonment. The sanction, if any, is determined by the ordinary courts.
Parallel imports of medicinal products are allowed in Denmark. They are regulated by both:
Sections 35 to 40 of the Order on Marketing Authorisation for Medicinal Products, No. 1239 of 12 December 2005.
The Board of Health's Guideline on Parallel Imports No. 44 of 14 July 2008.
Regulation of parallel imports is in accordance with case law from the European Court of Justice (ECJ).
The following conditions must be satisfied:
The directly distributed product must have a marketing authorisation in Denmark.
The parallel imported product must come from another EU or EEA member state.
The product must have a marketing authorisation in another EU member state.
There must be no differences of therapeutic significance between the parallel import and the original product.
The repackaging of medicinal products is an infringement of the original manufacturer's trade mark. However, repackaging is allowed if it is necessary for certain reasons as set out by the ECJ such as:
National requirements on the use of a specific pack size.
National health rules under which only certain pack sizes are reimbursable.
National fixed prescription practices.
Requirements for packaging, labelling and leaflets of original products also apply to parallel imports. Foreign language texts on packaging are acceptable provided the information complies with Danish rules. A label with Danish text can be placed over foreign text. If a parallel imported product differs (for example, in colour, appearance and taste), the outer packaging must display a warning to draw attention to the difference.
Blister packs that are marked with days indicating the dosage are acceptable, even if the daily dosage does not correspond to the dosage approved in Denmark, provided both:
The outer packaging and blister pack states that the prescribed dosage should be followed.
The days marked on the blister packs should, if necessary, be disregarded.
The Board of Health accepts minor variations in the names of products given on the inner packaging (compared to the approved product name) provided the outer packaging carries a warning about the difference. The expiry date on the outer and inner packaging must correspond to the date approved for the parallel import in Denmark.
The grant or offer of economic advantages to healthcare professionals (such as rebates, bonuses and goods) is generally prohibited when promoting the sale of medicinal products. Hospitality can, within reasonable limits, be used to inform healthcare professionals about products. The Board of Health is responsible for supervision and enforcement. In addition, the Danish pharmaceutical industry has set up a self-regulatory board (the Ethical Board of the Pharmaceutical Industry) to enforce the regulations on gifts and other economic incentives, and additional requirements under the industry's ethical code.
The Danish Penal Code contains anti-bribery rules. The rules can also apply to actions occurring outside Denmark.
There are no special rules relating to the marketing of medicinal products online, by e-mail or mail order. This type of marketing is regulated by the ordinary rules on sale and distribution of medicinal products, including Executive Order No. 1224 of 7 December 2005 on import of medicinal products by private individuals. A private person can buy medicinal products in foreign countries or online if the following conditions are satisfied:
The medicinal product is intended for personal use and for prevention or treatment of an illness.
The medicinal product is sold by a pharmacy or another business entitled to sell medicinal products to consumers.
The medicinal product is dispatched from a country which is an EU or EEA member state.
The medicinal product does not contain euphoriant substances or substances that are subject to doping legislation.
The purchase of prescription-only medicinal products requires a valid prescription, which must be sent to the pharmacy. The Board of Health is of the opinion that prescriptions cannot be sent by e-mail or through any other online service.
Advertising is regulated by:
Sections 63 to 71c of the Medicines Act, which is based on the Code for Human Medicines Directive.
The Order on Advertisements for Medicinal Products (Order No. 272, 21 March 2007 as amended).
The Board of Health supervises and enforces these regulations.
The regulations prohibit the advertising of:
Medicinal products that are not legally sold or dispensed in Denmark.
Magistral medicinal products (that is, medicinal products that are prepared for an individual person on instructions from a doctor).
Medicinal products for non-clinical trials and clinical trials, if a marketing authorisation has not been issued for the relevant medicinal products.
Medicinal products sold or dispensed under a special compassionate use permit (section 29, Medicines Act).
Sera, vaccines, specific immune globulins and other immunological investigational medicinal products that are both:
not covered by a marketing authorisation; and
sold or dispensed from the Statens Serum Institut or the National Veterinary Institute, Technical University of Denmark, under section 30 of the Medicines Act.
In addition, prescription-only medicinal products can only be advertised to health professionals.
Advertising for medicinal products (both prescription-only and over-the-counter (OTC)) must be:
Adequate.
Objective.
Compatible with the approved summary of product characteristics.
Not misleading.
Not an exaggeration of the qualities of the medicinal product.
Further, advertising must contain a number of compulsory details about the product, for example its name, field of application, adverse effects, risks and price.
Certain information is explicitly prohibited in adverts aimed at non-health professionals. This includes statements giving the impression that:
It is unnecessary to consult a doctor.
General well-being will improve if the medicinal product is used.
General well-being will worsen if the product is not used.
Generally, benefits such as gifts and bonuses must not be offered or given to health professionals as part of advertising or with the intention of promoting the sale of a medicinal product. However, this prohibition does not extend to gifts of an insignificant value if the gifts are either:
Relevant to the practice of the recipient.
Given in connection with a noteworthy day (for example, the recipient's promotion or a significant birthday).
Advertising on the internet is subject to the same rules (see above, Restrictions). Advertising that is generally accessible is considered to be advertising to the public.
Requirements are set out in the Medicines Act and the Order on labelling of and package leaflets for Medicinal Products (Order No. 1210, 5 December 2005), which are enforced by the Board of Health.
The information about the medicinal product must include:
Its name.
Its strength.
Its pharmaceutical form.
The package size.
Its use and, if necessary, route of administration.
Technical information (if not stated in the package leaflet).
An indication for OTC medicinal products, herbal medicinal products and "strong" vitamin and mineral preparations.
Relevant warnings.
Storage conditions.
Batch number and expiry date.
The name and address of the marketing authorisation holder.
The marketing authorisation number.
Special precautions, if any, for disposal of the product.
The size of the packaging must be appropriate to the therapeutic purpose and shelf life of the individual drug. The packaging must also be appropriate for physical and mechanical purposes (for example, it should be able to be opened by elderly people, but not children), and be designed to leave no room for misunderstandings about how the product should be used. In addition, it should not be possible to mistake it for a nutritional or cosmetic product.
The label and the leaflet must be in Danish. Information in additional languages is acceptable provided that the information is identical to the Danish text (in relation to packaging and labelling for parallel imports, see also Question 12, Packaging and labelling).
The package, label and leaflet must not contain any advertising. The marketing authorisation holder's logo can be printed on the package.
Specific rules relating to herbal medicinal products are contained in the Order on Herbal Medicines and Traditional Herbal Medicinal Products (Order No. 1233, 12 December 2005), which implements Directive 2004/24/EC on traditional herbal medicinal products (Traditional Herbal Medicines Directive). Herbal medicinal products contain naturally occurring substances that are both:
In concentrations that are not substantially greater than those found in nature.
Only intended for oral consumption, use on skin or local use on mucous membranes.
Medicinal products are considered as traditional herbal medicines if they fulfil all the following criteria:
They have indications exclusively appropriate to traditional herbal medicinal products which, due to their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes, or for prescription or monitoring of treatment.
They are exclusively for administration according to a specified strength and posology.
They are an oral, external and/or inhalation preparation.
They have been in medicinal use for at least 30 years, including at least 15 years within the EU.
The data on the traditional use of the medicinal product are sufficient. In particular the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of long-standing use and experience.
The documentation requirements for traditional herbal medicines to obtain marketing authorisation are less stringent than for medicinal products. The mutual recognition and decentralised procedures apply (see Question 10). Non-pharmaceutical retailers can sell traditional herbal medicines; they do not need an authorisation to handle medicinal products and are subject to less stringent rules.
The essential criteria are that the invention must:
Be new.
Involve an inventive step.
Be capable of industrial application.
The Patent Act (Consolidated Act No. 91, 28 January 2009, as amended) sets out the criteria for patentability of all inventions, including medicinal products.
Biotechnological inventions are patentable under Directive 98/44/EC on the legal protection of biotechnological inventions (Biotech Directive), which has been incorporated into the Patent Act. Therefore, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, are not patentable. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, can be a patentable invention, even if the structure of that element is identical to that of a natural element.
Patent applications can be submitted to the Danish Patent and Trademark Office (Patent og Varemærkestyrelsen) (DPTO), or to the European Patent Office (EPO). International applications (that is, those made under the Patent Cooperation Treaty 1970) must be submitted to the DPTO. The application form for national, EU and international applications is available at www.dkpto.dk. It is also possible to apply online. Information on the application procedure is provided on the website.
In early 2012 the application fee is DKK3,000, which covers ten patent claims. The fee for each additional patent claim is DKK300. To keep the patent, annual fees must be paid. For the first three years, the annual fee is DKK500. After that, the fee increases each year.
Since inventions are only patentable if they are new, it is important that the application is submitted to the DPTO before the invention is revealed to the public. The application and its patent claims determine the scope of the patent. It is in the interest of the inventor that the description of the invention and the patent claims are formulated as widely as possible without causing the application to be turned down. The application process is complicated. Therefore, for companies that do not have a patent division, it is advisable that they contact a patent agent. It usually takes up to three years to apply for a national or EU patent.
Before applying for an international patent, it is possible to ask the DPTO to carry out an international investigation (for anywhere outside of Denmark) into whether the invention is new. There is no maximum time limit in which an investigation must be completed.
A sample of the material must be deposited no later than the application's filing date, if performing the invention involves the use of biological material which either:
Is not available to the public.
Cannot be described in the application documents in such a manner as to enable a person skilled in the art to perform the invention.
Patent protection can last for up to 20 years. Annual fees must be paid to keep the patent active. A patent cannot be renewed beyond the 20 year period, except for the supplementary protection certificate which increases the duration of the patent for a period equal to the time between the date the patent application was filed and the date of the first marketing authorisation, reduced by five years.
For medicinal products, the 20-year protection period is considered to be too short because the health authorities' approval of products is often granted many years after the submission of the patent application. However, a supplementary protection certificate can be sought to increase the duration of the patent, for a period equal to the time lapsed between the date on which the application for the basic patent was filed and the date of the first market authorisation, reduced by five years (Regulation (EEC) 1768/92 concerning the creation of a supplementary protection certificate for medicinal products (Medicinal Products Supplementary Protection Certificate Regulation)). This generally means that medicinal products have a 15-year patent protection period from the first market authorisation of the product.
In addition, a medicinal product has a ten-year data protection period, starting from the date of its first market authorisation which prevents the marketing authorisation of generics in this time period using the abridged procedure (see Question 9).
A patent is revoked if it is proved that the invention did not satisfy the patent criteria at the time of application. In addition, if the fees to the DPTO are not paid in time or if certain translations are not produced in time, the patent is, in most cases, revoked.
Generally, a patent is infringed if anyone other than the patent holder uses the patent commercially, without the patent holder's permission. However, whether a patent is infringed is often difficult to ascertain. The extent of the patent depends on an overall assessment of the patent document. The equivalence doctrine applies to medicinal products. Accordingly, the replacement of one element of a patent with a new equivalent element is not a new invention outside the patent's scope. However, this raises the question of whether the new element is equivalent to the replaced element. Each case must be considered individually. Directive 2004/48/EC on the enforcement of intellectual property rights (Intellectual Property Directive) has been implemented.
Infringement cases can be brought in the ordinary courts or the Maritime and Commercial Court. An interim injunction can be issued by the bailiff's court to stop the infringing act. In most cases, a financial guarantee must be given by the claimant to the court for it to issue an interim injunction.
The court can order measures to prevent the use of infringing products produced according to the patented invention without the patent holder's permission. These court measures can include altering or destroying the infringing products. If the infringement is deliberate, the person or company in question can be fined. In aggravating circumstances, imprisonment for one year is possible. The patent holder is entitled to damages and a reasonable payment, in some cases even if the infringement was neither deliberate nor negligent. Further, the infringer can be ordered at its own expense to publish the court's decision in full or in part.
However, this does not apply if a third party has acquired the product in good faith.
A medicinal product has a ten year data protection period, which prevents generics from obtaining a marketing authorisation through the abridged procedure (see Question 9).
Medicinal products with orphan drug status (granted by the European Commission) receive marketing exclusivity in the EU for ten years after approval.
Product brands can be protected as trade marks if (Trade Mark Act (Consolidated Act No. 90, 28 January 2009, as amended)):
The name of the brand is distinct (that is, the brand name differentiates the product from other companies' products or services).
The brand is not descriptive (that is, it does not have a meaning which refers to any characteristics of the goods or services, including the type, quality or intended purpose).
The trade mark is able to be represented graphically.
Trade marks including medicinal product brands can consist of all kinds of signs that meet these requirements, for example, letters, numbers, words, names and pictures.
Applications must be made to the Danish Patent and Trademark Office (www.dkpto.dk/int). The website contains guidance on the application procedure and fees.
As at 2012 the application fee is DKK2,350 for up to three categories. An additional fee of DKK600 applies for each additional category.
To avoid unnecessary marketing costs, a planned trade mark should be investigated at an early stage to see whether it is already protected. On payment, the DPTO investigates whether there are any hindrances, which takes two to three months.
Registered trade marks must be used within five years after registration. If this requirement is not met, the trade mark can be invalidated in relation to the goods and services for which it has not been used. DPTO decisions can be appealed to the Patent Board of Appeal (Patentankenævnet).
A registered trade mark is protected for ten years.
Trade mark registrations can be renewed for additional ten year periods as long as the conditions for registration are met. The renewal fee is the same as the registration fee. Payment of the fee is taken as an application for renewal and must be made no earlier than six months before and no later than six months after the trade mark registration expires. The DPTO sends an invoice to the registered trade mark owner or its lawyer. However, the DPTO is not responsible if the invoice is not received.
See above, Duration and renewal.
Registered trade marks can be revoked if any of the following apply:
It is established that the trade mark infringes an older trade mark.
The trade mark has not been used for five years.
The trade mark has become generic (that is, due to the trade mark holder's passivity, it has become a commonly used term for products or services within the relevant line of trade).
The infringement definition in the Trade Mark Act is identical to the definition in Directive 2008/95/EC relating to trade marks. Consequently, a later trade mark infringes an earlier trade mark if any of the following apply:
The later trade mark is identical to an earlier trade mark and the goods or services are identical to the goods or services for which the earlier trade mark is protected.
Because of its identity with, or similarity to, the earlier trade mark and the identity or similarity of the goods or services covered by the trade marks, there is a likelihood of confusion on the part of the public, which includes the likelihood of association with the earlier trade mark.
The later trade mark is identical, or similar, to an earlier trade mark and is registered or applied for goods or services which are not similar to those of the earlier trade mark, where the earlier trade mark has a reputation and where the use of the later trade mark without due cause would take unfair advantage of, or be detrimental to, the distinctive character or repute of the earlier trade mark.
If a trade mark is infringed, a trade mark holder has the same remedies as a patent holder (see Question 22, Claim and remedies). Infringement cases can be brought before the ordinary courts or the Maritime and Commercial Court. An interim injunction can be issued by the bailiff's court to stop the infringing act.
There is no such requirement.
Denmark is party to, among others, the:
WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention).
Patent Cooperation Treaty 1970.
European Patent Convention 1973.
Agreement Relating to Community Patents 1989.
WIPO Protocol Relating to the WIPO Madrid Agreement Concerning the International Registration of Marks 1989.
WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1957.
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS).
WIPO Trademark Law Treaty 1994.
Under the Product Liability Act (Consolidated Act No. 261, 20 March 2007, as amended), which implements Directive 85/374/EEC on liability for defective products (Product Liability Directive), a manufacturer is liable for damage caused by a defect in its product, including medicinal products. A product liability system based on case law also applies.
The Product Liability Act and Product Liability Directive do not cover state of the art injuries (that is, injuries caused because there was not sufficient knowledge at the time of the injury to prevent it happening).
The Complaint and Compensation within the Healthcare System Act (No. 547, 24 June 2005, as amended) provides for compensation to patients who suffer physical injury as a result of the properties of medicines used in, for example, medical examinations and treatments. The scheme also applies to people who participate in clinical trials, and to organ tissue and fluid tissue donors.
Compensation is payable if medicine has been supplied commercially in Denmark for consumption or clinical testing through a pharmacy, hospital, doctor or dentist. No injury is deemed to have resulted from a drug if the illness or injury is due to the drug not having had the intended effect or if it was negligently or mistakenly prescribed. Compensation is only payable if the side effects are worse than the injured party could reasonably be expected to accept. This applies to known, unknown, predictable and unpredictable side effects.
The manufacturer or the supplier is liable if all the following apply (Product Liability Act and relevant case law):
The medicinal product in question is defective. This is the case if the product does not provide the safety a person is entitled to expect.
The user of the product is injured (suffered damage).
The injured person is able to prove the damage, the defect and the causal relationship between the defect and the damage.
If the injured person has contributed to the damage intentionally or negligently, compensation can be denied or reduced.
The manufacturer is generally liable on a no-fault basis for a defective product (Product Liability Act). The supplier is liable unless it can prove that the damage was not its fault. However, the supplier is liable for the manufacturer's fault-based liability.
The state finances the compensation under the Complaint and Compensation within the Healthcare System Act, which applies in some cases where the product liability rules do not (such as state of the art injuries). Where both the product liability rules and the Complaint and Compensation within the Healthcare System Act apply, the state succeeds to the patient's claim against the manufacturer and/or the supplier according to the product liability rules, if the patient chooses to claim compensation from the state.
Liability is generally limited to a period of three years from the date on which the claimant became aware, or should reasonably have become aware, of the damage, the defect and the identity of the manufacturer.
Liability is further limited to a period of ten years from the date that the manufacturer marketed the defective product (Product Liability Act).
As of 1 January 2008 class actions for product liability claims are allowed in Denmark (Danish Administration of Justice Act, No. 594, 20 June 2008). It is possible to file a class action if the following apply:
Several persons have rightful claims.
The claims are factually and legally uniform (although the claims do not need to be identical).
It is possible to identify and notify the group members and to point out a group representative.
The Danish courts are the proper forum for all claims and have territorial and subject-matter jurisdiction over at least one of the claims.
Class actions for product liability claims are not common in Denmark.
Foreign claimants can bring claims before the Danish courts, provided the Danish courts have jurisdiction. Claimants do not have to be a resident of Denmark nor must they have used the product in Denmark to be able to bring a claim in your jurisdiction.
Apart from the limitation period defence (see Question 32, Limitation periods), the typical defences of the manufacturer and the supplier include that:
The medicinal product was not defective.
The medicinal product did not cause the damage.
The injured person caused the damage by negligence, for example by using the medicinal product for another indication than it is approved for or by not following the instructions on the label and leaflet.
The claimant can claim damages and interest. Punitive damages are not allowed.
New rules aimed at preventing and reducing the amount of illegal medicinal products were introduced in 2011. Legislation also introduced new rules on the sale of medicinal products over the internet (internet pharmacies).
W www.sst.dk. Information may continue to be available at www.dkma.dk.
Main areas of responsibility. The Board of Health is responsible for all regulatory aspects of medicinal products.
T +45 33 34 50 00
F +45 33 34 50 50
E phe@bruunhjejle.dk
W www.bruunhjejle.com
Qualified. Denmark, 1989
Areas of practice. Life sciences; energy; public law; administrative law.
Recent transactions
For more details of recent transactions, publications, and so on, see full PLC Which lawyer? profile here.
T +45 33 34 50 00
F +45 33 34 50 50
E nkl@bruunhjejle.dk
W www.bruunhjejle.com
Qualified. Denmark, 2006
Areas of practice. Life sciences; energy; public law; administrative law.
Recent transactions
