Patents and Trademarks
The low-down on the situation regarding patents and trademarks in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.
1. What are the basic requirements to obtain patent and trademark protection?
In Denmark, a patent can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according to the Patent Cooperation Treaty (“PCT”) system, or iii) filing a European patent application with the European Patent Office (“EPO”).
Danish patents and supplementary protection certificates are granted by the DKPTO. After a patent has been granted by the EPO, the patent must be validated in Denmark within three months. The DKPTO undertakes such validation. Under the PCT system, the DKPTO acts as receiving office for Danish nationals, resident or legal entities.
Applications for the registration of a trademark must be filed with the DKPTO subject to payment of a fee
In Denmark, a trademark right can also be established through use.
2. What agencies or bodies regulate patents and trademarks?
The DKPTO is a governmental office under the Danish Ministry of Industry, Business and Financial Affairs, and is responsible for patent and trademark regulation.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
A patent confers on the patent holder an exclusive right to exploit the patented invention commercially. The right of exclusivity entails that the patent holder may restrict others from exploiting the invention, including by:
- producing, offering for sale, putting on the market or using a patented product or importing products for such purposes;
- using or offering for use a patented process in Denmark, if the person offering the process knows or has reason to believe, that the process must not be used without consent of the patent holder; or
- offering, putting on the market or using a product manufactured by a patented process, or importing or possessing the product for such purposes.
Certain exemptions to the exclusivity apply. For example, the exclusivity of a patent right does not include:
- non-commercial activities,
- activities concerning products which have been placed on the market in Denmark or the EU/EEA by the patent holder or with his consent,
- experimental activities relating to the subject matter of the patented invention,
- acts limited to the subject-matter of the patented invention, which are necessary for obtaining a marketing authorization for a medicinal product for humans or animals in the EU, in an EU member state or in other countries, or
- an individual preparation in a pharmacy of remedies according to a prescription.
The three main criteria for patentability are novelty, industrial application, and inventiveness.
As a starting point, inventions may be patented within all areas of technology. However, certain subject matters are inherently not patentable.
The Danish Patent Act (Consolidated Act no. 90 of 29 January 2019, “Patent Act”) provides the following examples of subject matters that will not be regarded as patentable inventions:
- discoveries, scientific theories and mathematical methods,
- aesthetic creations,
- schemes, rules or methods for performing mental acts, games or doing business or programs for computers,
- presentations of information,
- methods for the treatment of the human or animal body by surgery or therapy or diagnostic methods practiced on the human or animal body,
- plant or animal varieties,
- biological processes for the production of plants or animals, and
- 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.
Furthermore, patents will not be granted for inventions for which the commercial exploitation will be contrary to ordre public or morality.
A trademark confers on the proprietor an exclusive right, which entitles the proprietor to prevent others from using commercially any sign that:
- is identical with the trademark and is used in relation to goods or services which are identical with those for which the trademark is registered,
- is identical with, or similar to, the trademark and is used in relation to goods or services which are identical with, or similar to, the goods or services for which the trademark is registered, if there exists a likelihood of confusion on the part of the public (including likelihood of association between the sign and the trademark),
- is identical with, or similar to, the trademark irrespective of whether it is used in relation to goods or services which are identical with, similar to, or not similar to, those for which the trademark is registered, where the latter has a reputation in Denmark and where use of that sign without due cause takes unfair advantage of, or is detrimental to, the distinctive character or the repute of the trademark.
According to the Danish Trademark Act (Consolidated Act no. 88 of 29 January 2019, “Trademark Act”), a trademark may consist of any signs, in particular words, including personal names, or designs, letters, numerals, colours, the shape of goods or of the packaging of goods, or sounds, provided that such signs are capable of:
- distinguishing the goods or services of one undertaking from those of other undertakings, and
- being represented on the register in a manner which enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded to its proprietor.
A trademark will not be registered if there are absolute grounds for refusal, for example if the trademark:
- is devoid of any distinctive character,
- consists exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin, or the time of production of the goods or of rendering of the service, or other characteristics of the goods or services,
- is contrary to law, ordre public or to accepted principles of morality,
- is likely to deceive the public or is otherwise contrary to law.
Also, signs which consist exclusively of i) the shape of the goods themselves, ii) shapes of the goods which are necessary to achieve a technical result, and iii) shapes which provide the goods with substantial value, are rejected from registration.
Furthermore, a trademark may be rejected from registration if an objection based on are any relative grounds of refusal is made, for example
- if there are similar or identical earlier rights (e.g. national trademarks, EU trademarks, trademarks registered under the Madrid Protocol which have effect in Denmark, well-known trademarks), or
- If the trademark may be prohibited due to another earlier right, such as a right to a name, personal portrayal, and copyright
4. How can patents and trademarks be revoked?
If the annual renewal fee is not paid, the patent will lapse as from the beginning of the fee year for which the fee has not been paid.
A patent may be revoked by a court decision if:
- it has been granted despite that the patentability requirements were not complied with (e.g. unpatentable subject matter, lack of utility, novelty, or inventive step),
- it relates to an invention which is not disclosed in a manner sufficiently clear to enable a person skilled in the art to carry out the invention on the basis of the description,
- its subject matter of the patent extends beyond the contents of the application, or
- the scope of the protection conferred by the patent has been extended after the DKPTO has notified the applicant of the patent grant.
A trademark may be invalidated on the basis of the absolute and relative grounds mentioned above. Furthermore, a trademark can be invalidated on the grounds of non-use or degeneration.
A trademark may be revoked following a request for cancellation. A request for cancellation may be based on claims for invalidity due to an absolute or relative ground of refusal (please see above). Furthermore, a request for cancellation may be based on claims regarding lack of use of the trademark or degeneration of the trademark.
For Danish trademarks or trademarks based on the Madrid Protocol with effect in Denmark, the request for cancellation must be filed with the DKPTO. In case of request for cancellation of EU trademarks, the request must be filed with the European Intellectual Property Office (“EUIPO”). A revocation of the trademark can also be effected by way of a court decision. Proceedings must be instituted against the proprietor by anybody with a legal interest.
With regard to non-use, the Trademark Act states that if within a period of five years from the termination of the registration procedure the proprietor of a registered trademark has not put the trademark to genuine use in connection with the goods and services for which it is registered, the registration can be revoked. A condition for invalidation due to non-use is that a third party must make a request for invalidity. Subsequently, the proprietor must prove that there are proper reasons for the non-use, or prove that the trademark has been genuinely used.
5. Are foreign patents and trademarks recognized and under what circumstances?
Patents are territorial rights. Therefore, as a starting point, a Danish patent will only confer exclusive rights in Denmark, and a patent will only be recognised in Denmark if issued in accordance with the Danish rules.
As mentioned in Question 1, a patent in Denmark can be obtained by i) filing of a patent application with the Danish Patent and Trademark Office (“DKPTO”), ii) filing a patent application according to the Patent Cooperation Treaty (“PCT”) system, or iii) filing a European patent application with the European Patent Office (“EPO”).
International and European patents applied to Denmark have the same effect as national patents, unless otherwise provided in Patent Act.
International patents under the PCT system and European patents must be validated and maintained in the individual designated countries.
However, with the upcoming system for European patents with unitary effect, patents may be given unitary effect for the territory of up to 26 member states participating tin the unitary patent system. The system will enter into force when the Agreement on a Unified Patent Court enters into force (i.e. when the members have all ratified the agreement). The prospect for entry into force of the Unified Patent Court is currently dependent on Germany’s ratification of the agreement.
Traditionally, the protection conferred by a trademark right is only enforceable in the specific jurisdiction in which the rights have been granted.
In Denmark, a trademark may be obtained by i) by submitting an application to the DKPTO, ii) submitting a EUTM application, or iii) by submitting an application based on the Madrid Protocol (which is administered by the World Intellectual Property Organisation (“WIPO”)).
As mentioned above, in Denmark, a trademark right can also be established through use. Trademarks established through use will only cover the goods and services for which the trademark has commenced to be used and for which it is continuously used, and provided the range of use of such trademark is beyond a mere locally delimited use. If, however, the trademark is excluded from registration due to its nature, the use of the mark does not establish any trademark rights. If the trademark is devoid of the required distinctive character at the commencement of use, the right shall only be established when and if a distinctive character is acquired by the use of the mark.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Following expiry of patent protection, or in case no patent has been obtained, innovative medicinal products may be ‘copied’ and generic versions may enter the market.
It is imperative for manufacturers of generic medicinal products to be able to rely on the data established by the reference medicinal product. The possibility of relying on established data – as opposed to having to carry out costly trials to establish the required documentation – means that the generic manufacturers can penetrate the market much quicker and with fewer expenses.
As mentioned above in Question 6 on Regulatory, Pricing and Reimbursement, abridged procedures are available for marketing authorizations for generic medicinal products (i.e. products that have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as a specific authorised reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies).
Pursuant to the rules on the abridged procedure, a generic applicants will not be required to provide the results of pre-clinical tests and clinical trials if it is possible to demonstrate that the medicinal product is a generic of a reference medicinal product that is or has been authorised for not less than eight years in a country of the EU/EEA.
This means that a manufacturer of a generic medicinal product will not be able to obtain a marketing authorization on the basis of an abridged procedure until the reference medicinal product has been authorised in the EU/EEA for at least eight years. Essentially, the reference medicinal product’s data is protected during this eight year period.
Furthermore, a generic medicinal product may not be placed on the market until ten years have passed from the initial authorization of the reference medicinal product. This rule confers a market exclusivity for the reference medicinal product of ten years from its authorization.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Please see Question 3 above on patentability requirements and patentable subject matters.
The Trademark Act does not contain special provisions relating to trademarks for pharmaceutical products, and DKPTO does not keep a separate registry.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
The licensing of patents is regulated by Chapter 6 of the Patent Act. Generally speaking, licence agreements will be subject to normal contractual rules.
The Patent Act provides that, unless otherwise agreed, a licensee is not allowed to assign his rights to anyone else. In some cases a compulsory licence may be obtained.
The transfer of a patent or the grant of a licence, must on request be entered in the DKPTO’s patent register.
A trademark may also be licensed. If a trademark has been licensed, the license agreement may be registered with the DKPTO.