The eligibility of a pharmaceutical trademark for registration depends on the rules set out in the Trademark Act, which to a large extent is based on the EU Trademarks Directive (2008/95/EC), and the Norwegian courts generally interpret the act in line with decisions of the European Court of Justice.
Selection, clearance and registration
In Norway, no separate rules apply to pharmaceutical trademarks. The eligibility of a pharmaceutical trademark for registration depends on the rules set out in the Trademark Act, which to a large extent is based on the EU Trademarks Directive (2008/95/EC), and the Norwegian courts generally interpret the act in line with decisions of the European Court of Justice (ECJ). A trademark may consist of any sign, device, word or combination of words, including slogans, letters, numerals, moving images or the characteristic look of goods or their packaging.
In order to be eligible for registration, the mark must have distinctive character, be non-descriptive and not conflict with public interest (Sections 14 and 15 of the act). If the trademark contains elements relating to, for example, the characteristics or functions of the pharmaceutical, this will generally be considered to be descriptive and the application may be rejected. For example, trademarks containing the name of the active pharmaceutical ingredient or elements similar to the active pharmaceutical ingredient may risk rejection as descriptive.
Trademark applications are handled by the Norwegian Industrial Property Office (NIPO), which conducts a full examination of whether the application meets the registration requirements. Pursuant to Section 16 of the Trademark Act, the NIPO also examines whether the applied-for trademark conflicts with existing trademark rights. If the applied-for trademark is confusingly similar to another trademark registered for pharmaceuticals or similar goods, the application may be rejected.
Certain prefixes and suffixes are considered to be ‘weak’ elements in a pharmaceutical trademark – for example, ‘pharm’, ‘med’ and ‘anti’. Similarity with respect to such weak elements will usually not be decisive when assessing whether a pharmaceutical trademark is confusingly similar to another pharmaceutical trademark.
The assessment of whether one trademark is confusingly similar to another is based on the perception of the trademark in the relevant course of trade. Generally, a higher degree of similarity may be accepted when only professionals constitute the relevant course of trade, as opposed to end consumers also forming part of the relevant course of trade. In principle, the relevant course of trade for pharmaceuticals could be said to vary for over-the-counter (OTC) pharmaceuticals and pharmaceuticals on prescription (see GULE SIDER, Supreme Court Decision Rt 2005 p 1601, paragraph 56). However, this is not a general rule under Norwegian trademark law. Instead, end consumers are generally considered to be part of the relevant course of trade for prescription pharmaceuticals and their perception will generally be part of the assessment of whether one pharmaceutical trademark is confusingly similar to another. Therefore, the perception of end consumers may have an impact on the specific assessment and the accepted degree of similarity, even in relation to prescription pharmaceuticals.
Pursuant to Section 2 of the Trademark Act, it is possible to register three-dimensional (3D) trademarks. 3D trademarks must fulfil the general requirements of distinctiveness – namely, that the shape be perceived as a trademark. This assessment takes into account that the public is generally not used to deriving a product’s commercial origin on the basis of, for example, the shape of a product. Even though the requirements for distinctiveness are the same for 3D trademarks as for other trademarks, in practice it is more difficult to fulfil the requirements for 3D trademarks. On this point, Norwegian case law is also likely to follow ECJ practice (see TRIPP TRAPP, ECJ Decision C-205/13). Thus, such registrations are quite rare.
Similarly, it is also possible to register a colour as a trademark (Section 14, cf Section 2, of the Trademark Act). However, the distinctiveness test will again apply, and in practice may be an obstacle to registration.
Under Section 37 of the Trademark Act, a trademark registration may be deleted on request if the rights holder has not used the trademark within five years of registration or has ceased to use the mark for five years. The obligation to genuinely use the trademark has a few exceptions. For example, there is an exception to the obligation if the holder has reasonable cause for not using the trademark. This may be the case, for example, if the trademark holder is awaiting marketing authorisation for the pharmaceutical product.
Parallel imports and repackaging
Norwegian legislation and case law with respect to parallel imports and repackaging are generally based on EU legislation and ECJ case law, as described above. Pursuant to Section 6 of the Trademark Act, a registered trademark does not prevent use of the trademark for goods put on the market under the trademark within the European Economic Area (EEA) by the rights holder or with its consent, unless the rights holder has legitimate reasons to oppose commercialisation of the goods – for example, if the condition of the goods has changed or been impaired after they were put on the market. Essentially, the issue is the extent to which the exclusive rights conferred by a valid trademark may be invoked as a means to hinder parallel imports.
Parallel imports are generally allowed under Norwegian trademark law. However, a rights holder may object to marketing which is capable of damaging the reputation or standing of its trademark (Section 6 of the act).
As a starting point, any interference with the product as such usually justifies an objection from the rights holder. The main function of the trademark is to guarantee the origin of the product and this function cannot be fulfilled if the parallel importer has interfered with the product. Further, the rights holder generally has the right to object to repackaging, which includes removing the rights holder’s trademark and affixing the rights holder’s trademark to new packaging.
However, the parallel importer can carry out repackaging which involves removing and re-affixing the trademark to the extent necessary to avoid artificial market divisions and ensure efficient access to the market. For example, if it is necessary for the parallel importer to repackage the goods due to Norwegian statutory requirements concerning the size or type of the packages, the rights holder cannot prevent repackaging based on its trademark rights. However, when repackaging, the parallel importer must ensure that the rights and interests of the rights holder are properly safeguarded.
Certain EU requirements must be met for repackaging to be permissible, based on ECJ case law. The repackaged goods shall include the names of both the repackaging entity and the manufacturer. Further, the rights holder must be given notice in advance and, on request, be sent a sample of the repackaged product. The repackaging shall in no way harm the interests of the rights holder; therefore, it cannot be defective, be of poor quality or appear incomplete. If these requirements are not met, the rights holder may invoke the Trademark Act to prohibit repackaging and parallel import.
Anti-counterfeiting and enforcement
Measures explicitly targeted at preventing the marketing of counterfeited pharmaceuticals were recently introduced into Norwegian law for the purpose of implementing the EU Counterfeit Pharmaceuticals Directive (2011/62/EC). The measures in question have primarily been implemented into national regulations issued under the Medicinal Products Act and the Pharmacies Act.
The relevant measures include:
- requirements for manufacturers to place safety features on the outer packaging of pharmaceuticals;
- pharmacies’ and OTC outlets’ control of products’ authenticity based on such safety features;
- introduction of the concept of brokers of medicinal products and pre-registration requirements for brokers;
- new compliance control and reporting obligations for manufacturers, wholesale distributors and brokers, including control of good distribution practice compliance and other necessary authorisations in previous links of the distribution chain; and
- requirements for manufacturers to obtain written confirmation of compliance with good manufacturing practice from relevant authorities when importing active ingredients from countries outside the European Union or EEA.
The anti-counterfeiting measures introduced into Norwegian law also impose further restrictions on private imports by shipment of pharmaceuticals. Previously, it was possible to import pharmaceutical products from the EU/EEA area, but not from outside this area. Under the new regime, all imports of prescription pharmaceuticals will be prohibited. However, imports of OTC pharmaceuticals in quantities corresponding to three months’ personal use from the EU/EEA area will be permitted, provided that:
- the pharmaceuticals are imported for personal medical use;
- they are legally acquired in the country of purchase and this can be documented;
- the seller may legally sell and export the relevant pharmaceuticals;
- the pharmaceuticals are covered by a valid marketing authorisation in Norway; and
- the importer is at least 18 years old.
This amendment was announced on November 7 2013, but has not yet entered into force.
Moreover, the Medicinal Products Act has been amended to empower Customs to immediately withhold, seize and destroy illegally imported pharmaceuticals. Before Customs destroys suspected illegally imported pharmaceuticals, the recipient shall be notified and given the opportunity to file a statement within a certain deadline.
The trademark legislation may be used to remove counterfeit products from the market. Norwegian trademark legislation encompasses both civil and criminal penalties, with civil penalties being most practical. Civil penalties include compensation and damages, but also other remedies such as prohibition against future infringements and withdrawal or destruction of goods. Goods suspected of infringing trademark rights may be seized by Customs. The owner may obtain a customs seizure pursuant to an interim injunction from a court.
The advertising of pharmaceuticals with Norwegian marketing authorisation is primarily governed by Chapter 7 of the Medicinal Products Act and Chapter 13 of the Medicinal Products Regulation. The main requirement is that any advertising for pharmaceuticals be sober and unbiased, and not give a misleading or exaggerated impression of the pharmaceutical’s characteristics and medicinal benefits.
The definition of ‘advertising’ is quite wide under Norwegian law. Pursuant to Section 13(2) of the Medicinal Products Regulation, any kind of written or oral statement, picture or sample which is designed to promote the sale or use of pharmaceuticals is considered to be advertising.
Only OTC pharmaceuticals may be advertised to the public. A significant number of negative requirements in relation to the content apply to such advertising. Among other things, the advertising may not:
- contain recommendations from doctors or similar;
- mention serious diseases such as tuberculosis, AIDS, cancer or diabetes;
- contain statements to the effect that the pharmaceutical has no possible side effects or is equivalent to or better than other treatments or pharmaceuticals; or
- indicate that a person’s health condition may be worsened by not taking the pharmaceutical.
It is further prohibited to direct any advertisement towards children and to indicate that the pharmaceutical is a nutriment or a cosmetic product. Certain positive requirements in relation to the content also apply to such advertising. Among other things, the advertisement shall always contain the name of the pharmaceutical and the active ingredient, as well as information regarding correct use. Advertising on television is not allowed under any circumstances and there are also restrictions with respect to the use of illustrations.
Prescription pharmaceuticals may be advertised to healthcare professionals. Section 13(7) of the Medicinal Products Regulation explicitly lists a number of positive requirements that the content of advertisements directed at healthcare professionals must meet and prohibit advertisements with gifts, favours or other contributions attached. Samples of pharmaceuticals may be handed out only to medical professionals and only pursuant to a written requisition.
Generic substitution of an original pharmaceutical product is permissible under Norwegian law and is encouraged by the Norwegian authorities. Pursuant to Section 6(6) of the Pharmacies Act, pharmacies may substitute an original pharmaceutical product with a cheaper generic product (or parallel imported product) when the latter has been approved for substitution by the Medicines Agency. The provision is worded as a right for pharmacies to offer generic substitution, thus suggesting that pharmacies may freely choose not to offer such substitution. However, in practice, substitution may be avoided only if the prescribing physician has made an explicit and medically justifiable reservation against substitution on the specific prescription, or if the patient opposes substitution. In the latter case, the patient will be required to pay the difference between the price of the original product and the price of the generic substitute.
Approved generic substitutions are listed on the Medicines Agency’s website and the list is updated twice a month. Before a pharmaceutical is approved for generic substitution, the Medicines Agency conducts an assessment of whether the generic product is equivalent to the original product.
Pursuant to Section 42 of the Pharmacy Regulation, pharmacies can sell OTC pharmaceuticals online. However, prescription pharmaceuticals cannot be sold online.
There are certain reporting requirements for pharmacies selling pharmaceuticals online. Further, there are certain requirements regarding the content on websites offering pharmaceuticals for sale. For example, pharmacies are obliged to include a link to the Medicines Agency’s website, on which a list of authorised online sellers is published. Further, the general requirements in the Electronic Commerce Act (eg, in respect of information to be included on the pharmacy’s website) must also be met.
Any marketing of pharmaceuticals online must also conform with the general rules on advertising and the special advertising rules for pharmaceuticals (in particular, the Marketing Control Act and Chapter 13A of the Medicines Act).
Under Norwegian law, general guidance on a website is considered as potential advertising, since such guidance is not individualised. Therefore, general guidance on websites will be subject to the rules on advertising. Individualised guidance is normally not considered to be advertising. Such guidance is subject to the rules in the Healthcare Personnel Act.
Camilla Vislie, Andreas Nordby, and, Kirti Mahajan Thomassen.
This article first appeared in World Trademark Review. For further information please visit www.worldtrademarkreview.com.