Patents & Trademarks
Patents & trademarks in Norwegian Pharma – a comprehensive legal overview. Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The requirements for obtaining patents and the protection thereof is regulated by the Norwegian Patent Act ( LOV-1967-12-15-9).
The basic requirements for obtaining a patent are:
- An invention within a technical field susceptible of industrial application (section 1).
- The invention must be novel on the day of application (section 2).
- The invention must involve an inventive step (section 2).
In addition, some specific types of inventions, which may fulfill the basic requirements above, may not be patentable (see question 3).
Once granted, a patent grants its owner the exclusive right to the invention, including the right to profit from its applications, for 20 years from the date of filing the application. This entails that the patent owner can prevent any third parties from, i.a. , producing, using, marketing, selling or importing any product implementing the technology covered by the patent, without the patent owner’s consent.
Patents in the pharmaceutical sector may obtain an additional exclusivity period up to five years following the expiry of the patent, through the rules regarding supplementary protection certificates (“SPC” nw. supplerende beskyttelsessertifikater). As described in the previous chapters , especially Chapter 1 and 2 , the process for obtaining MA for medicines is complicated, costly and time consuming.
Since patent applications usually are filed in an early stage of the development of new medicines, it can take several years from the application until the inventor can market the inventions, and thus get economic returns for its investments. To make up for the lost “effective” patent period, an SPC grants exclusivity and extended period after the regular patent protection expires. The additional SPC protection is calculated as follows: the time passed between the filing of the patent and being granted MA minus five years. Thus, if the process of obtaining MA has taken less than five years from the patent application, no SPC protection is granted. The additional SPC protection may not exceed 5 years.
The requirements for obtaining trademarks and regulation thereof is regulated by the Norwegian Trademark Act (LOV-2010-03-26-8).
The basic requirements for obtaining trademark are:
- That it constitutes sign that can be reproduced graphically in the official register in a way that makes the scope of the protection granted clear. The sign may be i.a. words, slogans, names, product shapes, color(s), pictures, sounds (section 14 and section 2)
- The sign must be distinctive as a trademark for the goods and services it is seeks registration for. I.e. it must differentiate the products and/or services of a company from the products and/or services of other companies. This entails that trademarks that exclusively or only with insignificant changes or additions, consists of signs that indicate the kind, quality, quantity, intended purpose of the goods or services cannot be registered (section 14).
- The mark must not be descriptive of the goods and services of which it is sought registered
- The use of the trademark would not infringe the rights of another entity in Norway (section 16).
In addition some types of marks, which may fulfill the basic requirements above, may not be registered as trademarks (see question 3).
Once granted, the trademark grants its owner the exclusive right to use the trademark. Particularly, the trademark owner is entitled to prevent commercial third parties, from:
- Using signs that are identical to the trademark in relation to identical products and/or services.
- Using signs that are identical or similar to the trademark in relation to identical and/or similar products and/or services if there is a likelihood of confusion between the two.
- If the registered trademark is considered “well-known” in the realm, some additional protection is granted (Kodak-protection). If the trademark is well-known, it is protected against third party use of identical or similar (note, similar is a lower threshold than likelihood of confusion) trademark for similar or any other goods or services, if the if the use of that sign would takes unfair advantage of, or is detrimental to, the distinctive character or repute (goodwill) of the well-known trademark.
Trademarks are granted for 10 years from the date of application. The registration can be renewed unlimitedly for additional periods of 10 years.
2. What agencies or bodies regulate patents and trademarks?
Both trademarks and patents are regulated by the Norwegian Industrial Property Office (“NIPO”). NIPO is the competent agency for:
- Examining patent and trademark applications.
- Granting patent and trademark registration
- Applying for renewal (trademarks) or SPC protection (patents)
- Deciding on opposition to trademark or patent applications or registrations.
Furthermore, the ordinary civil courts have jurisdiction over claims relating to patent and/or trademark rights, including nullity and infringement claims.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
All products, substances and processes fulfilling the general requirements of patentability in the Patent Act section 1 and 2 (see question 1 a) can be patented, subject to some explicit exceptions listed below.
The Patent Acts section 1 also exemplifies some subject matters not regarded as inventions:
- discoveries, scientific theories and mathematical methods;
- aesthetic creations;
- schemes, rules or methods for performing intellectual, gambling or business activities and software; and
- presentations of information.
Further, the following subject matters are not subject to patent protection;
- methods for surgical or therapeutic treatment or diagnostic methods, practiced on humans or animals.
Please note that this does not prevent grant of patents for products for use in such methods
- plant or animal varieties;
- biological processes to produce plants or animals
- Inventions where their commercial exploitation would be contrary to public order or morality.
All marks fulfilling the general requirements for trademark protections in the Trademark Act (see question 1 b) can be registered, subject to some explicit exceptions listed below:
- signs that consist exclusively of a shape that results from the nature of the goods themselves, is necessary to obtain a technical result or adds substantial value to the goods (section 2).
- Contrary to law or public order or is liable to cause offence,
- Is liable to deceive, e.g. in respect to the nature, quality or geographical origin of the goods or services
- Marks that violate the Penal code section 165 and 166 (use of flags, public uniforms, Norwegian or foreign official coat of arms, mark or seal)
4. How can patents and trademarks be revoked?
Patents may be revoked by either filing a request for an administrative review to NIPO or a suit to the ordinary courts. Filing administrative reviews to NIPO is intended as a quick simple and cheap alternative to ordinary court proceedings.
A patent may be revoked if the requirements of section 1 and 2 of the Patent Acts (see question 1 a) are not fulfilled or it is unlawful (see question 3 a).
Trademarks may also be revoked by filing a request for an administrative review to NIPO or a suit to the ordinary courts.
A trademark may be revoked if it is deemed invalid, degenerated or in case of non-use of the mark.
- A mark is invalid if it does not fulfill the requirements of registration pursuant to the Trademark Act, see question 1 b) or if it was unlawful on the date of registration or since has become unlawful, see question 3 b)
- A mark is considered degenerated if it has lost its distinctive and has become a general designation in the relevant market/industry for goods or services of the type for which it is registered
- The mark can also be revoked if the trademark holder (or authorized licensee) did not use the mark within five years following registration or if the use has stopped for five consecutive years, without legitimate reasons.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
The Norwegian system does not automatically recognize foreign patents. However, foreign patents may obtain protection in Norway through the following application procedures:
- International patent application procedure (“PCT”);
- European patents filed through the European patent Office (“EPO”) can later be made applicable in Norway (validated).
The international patent application procedure was established through the Patent Cooperation Treaty.
Through this path, the applicant may apply for patents in various jurisdictions (signees to the patent Cooperation Treaty) by filing a single application. The applicant must indicate Norway among the countries where he/she seeks protection.
To validate a European patent in Norway the applicant must file and application for validation as well as a Norwegian translation latest three months after the European Grant Date.
As with patents, the Norwegian system does not automatically recognize foreign trademarks. However, foreign applicants may obtain trademark protection in Norway through the following application procedures
• International trademark applications (“WIPO”).
The international trademark application were established by the Madrid Protocol and the Madrid Agreement. Through the Madrid system for the international registration of marks, it is possible to protect a mark in a large number of countries by obtaining an effect in each of the designated jurisdiction (that is a contracting party to the Madrid system). To obtain protection in Norway the applicant/trademark holder must designate Norway as a jurisdiction for protection.
In addition anyone who has filed an application for registration of a trademark in a foreign state that is a party to the Paris Convention of 20 March 1883 for the Protection of Industrial Property or the WTO Agreement of 15 April 1994 Establishing the World Trade Organization and who, within six months thereafter, applies for registration of the trademark in Norway, may claim that the new application be considered to have been filed at the same time as the first application.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The most relevant non-patent/trademark barriers for the protection of medicines or devices are the protection granted to trade secrets.
Trade secrets are currently regulated by the Marketing Control Act sections 28 and 29 which prohibits the unlawful exploitation of trade secrets, as well as the Penal Code Sections 207 and 208 where the unlawful exploitation of trade secrets is penalized by fines or imprisonment up to 2 years.
What constitutes a trade secret is not defined in neither the Marketing Control Act nor the Penal Code. However through court practice the following conditions must be met for information to be considered trade secrets
- The information is specific to the business;
- The information has commercial value to the business;
- The information is secret;
- The information is subject to reasonable steps by its holder to keep it a secret.
If the information is considered a trade secret the holder/originator is protected against third parties unlawful use of such information. The owner can demand courts stopping the unlawful use (including preventing products made through the use of trade secrets being put on the market) and may sentence the infringer to pay renumeration or compensation for the unlawful use.
The protection against unlawful use of trade secrets does not only cover situation where the infringer has actual knowledge that the information in question were trade secrets, but also where he/she should have known that the information in question were trade secrets.
Norway has implemented Directive (EU) 2016/943, on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. The Trade Secrecy Act (LOV 2020- 03-27-15) e.i.f. 27 March 2020. The implementation has not radically changed the current protection of trade secrets in Norway but will simplify the regulation, provide a definition of what constitutes trade secrets as well as offering some additional enforcement measures such as recall of the infringing goods from the market, depriving the infringing goods of their infringing quality and destruction of the infringing goods.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
We refer to our answer above in question 1 and question 3, which outlines the general requirements for obtaining trademark and patent protection, as well as some explicit exceptions.
For medicines and medical devices please note that the Patent Act provides that no patent protection may be granted to diagnosis methods or surgical or therapeutic treatments applied to the human or animal bodies. As noted in question 3 a) above, patent protection may be offered to products used in such treatments or methods.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Neither patents nor trademark licenses with foreign licensors require governmental of regulatory approval in Norway.
Further, there are no requirement to register either trademark or patent licenses for them to be valid and enforceable. However, transfer of a patent, a patent application or a supplementary protection certificate to third parties or the grant of a license shall be recorded in the Patent Register or the Register of the NIPO Office for European patent applications at the request of one of the parties. If such registration has taken place, the licensee has legal protection against i.e. seizure by the licensor’s bankruptcy estate.