Patents and Trademarks
The legal framework for patents and trademarks in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The legal condition to obtain a patent or a trademark in Spain is to validly register it before the Spanish Patent and Trade Mark Office. In order to do so, there are certain basic requirements to be fulfilled:
Pursuant to Law 24/2015, regulating patents, the basic legal requirements to obtain a patent are: (i) to have a new invention in any field of technology; (ii) that such invention involves an inventive step; and (iii) that such invention is susceptible of industrial application.
Pursuant to Law 17/2001, regulating trademarks, the basic legal requirement to obtain a trademark is to have a sign subject of graphic representation which has a distinctive character and which is not identical with or similar to earlier trademarks, in order to avoid likelihood of confusion on the part of the public.
2. What agencies or bodies regulate patents and trademarks?
The Spanish Patent and Trademark Office (www.oepm.es).
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
The products, substances, and processes that can be protected by patents are those which can be considered as ‘inventions’, meeting the basic legal requirements referred in Question 1, which are not subject to any of the exceptions to patentability:
- inventions the commercial exploitation of which would be contrary to “ordre public” or morality principles, including but limited to processes for cloning human beings, processes for modifying the germ line genetic identity of human beings, uses of human embryos for industrial or commercial purposes, or processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes;
- plant or animal varieties; however, it is possible to patent plant or animal varieties if the technical feasibility of the invention is not confined to a particular plant or animal variety;
- essentially biological processes for the production of plants or animals, meaning those processes which consist entirely of natural phenomena such as crossing or selection; however, it is possible to protect by patent inventions consisting in microbiological or other technical process, or a product obtained by means of such processes;
- methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; however, it is possible to patent products, in particular, substances or compositions, for use in any of these methods;
- 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; however, it is possible to patent 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, even if the structure of such element is identical to that of a natural element; or
- a mere DNA sequence, without indicating any biological function.
The law does not define the term ‘invention’ but it states what cannot be considered as such. To such effect, the following cannot be regarded as inventions:
- discoveries, scientific theories and mathematical methods;
- literary, artistic or scientific works or any other aesthetic creations;
- schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers; or
- ways to present information.
On the other hand, trademark protection is possible for any signs meeting the basic legal requirements referred to in Question 1, provided that such signs do not fall within any of the following prohibitions:
- those consisting 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;
- those consisting exclusively of signs or indications which have become customary in the current language or in the bona fide and established practices of the trade;
- signs consisting exclusively of: (i) the shape, or another characteristic, which results from the nature of the goods themselves; (ii) the shape, or another characteristic, of goods which is necessary to obtain a technical result; (iii) the shape, or another characteristic, which gives substantial value to the goods;
- signs which are contrary to “ordre public” or morality principles;
- signs which are deceiving the public, e.g. to the nature, quality or geographical origin of the goods or service;
- signs which have not been authorized by the competent authorities and are to be refused or invalidated;
- signs copying or imitating the armorial bearings, flag, insignias and other emblems of Spain, its Autonomous Regions, municipalities, etc.
4. How can patents and trademarks be revoked?
Pursuant to article 102 of the Law 24/2015, a patent can be invalidated based on any of the following grounds:
- if the subject matter of the patent is not patentable, (please refer to Questions 1 and 3);
- if the invention is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;
- if its subject-matter exceeds beyond the content of the application as filed, or, if the patent was granted on a divisional application or on a new application filed by a non-entitled person, beyond the content of the earlier application as filed;
- if the protection of the patent was extended after its grant; or
- if the holder of the patent is not its rightful owner as provided in the law.
Pursuant to the provisions contained in article 105 of Law 24/2015, the holder of a patent can request the Spanish Patent and Trademark Office to revoke the patent at any time during its validity. To such effect, an official form must be filled-out, and the corresponding fees paid. The authorities can deny such request in certain cases, for example, if the patent is subject to rights or licenses dully recorded in the Patent Registry.
On the other hand, a trademark can be revoked due to failure to renew it, withdrawal by the owner or failure to pay the maintenance fees. Also, according to article 54 of Law 17/2001, a trademark can be revoked pursuant to a request filed before the Spanish Patent and Trademark Office or a counterclaim in trademark infringement proceedings, based on any of the following grounds:
- if during a five-year period the trademark has not been put to genuine use in Spain for the products or services for which it has been registered;
- if, due to acts or inactivity of the proprietor, the trademark has become the common name in the trade for a product or service in respect of which it is registered; or
- if, due to the use of the trademark by the proprietor or with the proprietor’s consent in respect of the goods or services for which such trademark is registered, if can mislead the public, particularly as to the nature, quality or geographical origin of those goods or services.
5. Are foreign patents and trademarks recognized and under what circumstances?
Both patents and trademarks are territorial rights, meaning that they are only applicable and enforceable in the country in which they have been filed and granted. Therefore, in order to be recognized in Spain, patents and trademarks must be validated / registered before the Spanish Patent and Trademark Office. In this regard, pursuant to the European Patent Convention, a European patent validated in Spain has the same effect of and is subject to the same conditions as a Spanish national patent.
As regards trademarks, it is possible to fill a request for an EU trademark before European Union Intellectual Property Office. The EU trademark has a unitary character and, thus, is effective throughout the entire territory of the European Union.
Also, according to the so-called Madrid System, which includes two international treaties: the Madrid Agreement and the Madrid Protocol, it is possible to fill an international trademark request. Such request can be filed before the Spanish Patent and Trademark Office, in case the applicant is Spanish or based in Spain. The protection granted will be applicable in countries belonging the Madrid System (currently 119 countries, including Spain).
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Yes, there are non-patent/trademark barriers to competition when it comes to protecting medicinal products in Spain.
On the one hand, there is the data exclusivity period regulated under Spanish Law on Medicinal Products. The data exclusivity period is the one during which the applicant of a generic medicinal product cannot cross-reference the clinical data (i.e. results of pre-clinical tests and clinical trials) of the reference medicinal product. This period lasts 8 years from the approval of the first marketing authorization of the reference medicinal product by the authorities of any Member State (not necessarily Spain) or the European Union. Once this 8-year period has expired, the applicant of a marketing authorization for a generic medicinal product is not required to provide the results of pre-clinical tests and clinical trials.
On the other hand, there is another barrier to competition related to medicinal products known as the market exclusivity period. Once a generic medicinal product is authorized using the results of pre-clinical tests and clinical trials of the reference medicinal product, it cannot be launched until the expiry of the marketing exclusivity period of 10 years counted from the first marketing authorization of the reference medicinal product in the EU. The exclusivity period of 10 years may be extended for 1 additional year, i.e. up to 11 years maximum, if, during the first 8 of those 10 years, the holder of the marketing authorization of the reference medicinal product obtains an approval for new indication(s) having significant clinical benefit in comparison with existing therapies.
As regards orphan medicinal products, there is a market exclusivity period conferred by Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, which is directly applicable in Spain. Pursuant to the provisions contained in article 8 of this Regulation, when there is a marketing authorization granted in Europe for an orphan drug, the authorities in Europe and in all Member States must refrain during a 10-year period from accepting another marketing authorization application or from granting another marketing authorization, when there is an existing marketing authorization for a similar medicinal product having the same therapeutic indication. Such 10-year market exclusivity period may be shortened to 6 years if, at the end of year 5, it is established that the product no longer meets the criteria laid down for granting the orphan designation in the first place, and it is proven that such product is sufficiently profitable not to justify maintenance of market exclusivity. However, the market exclusivity period for orphan drugs will not apply, and therefore another marketing authorization may be granted for a similar medicinal product having the same therapeutic indication if:
- the holder of the marketing authorization for the original orphan medicinal product has given his consent to the second applicant, or
- the holder of the marketing authorization for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or
- the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Not specifically. Please refer to Question 3.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No, Spanish government or regulatory bodies do not need to approve or accept patent/trademark license agreements.