Patents & Trademarks
The legal framework for patents and trademarks in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
1. In Germany, the Patent Act (Patentgesetz, PatG of 16 December 1980, as last amended on 8 October 2017 forms the legal basis for patents, while the Trade Mark Act (Act on the Protection of Trade Marks and other Signs, Markengesetz, MarkenG, of 25 October 1994, as last amended on 17 July 2017) is the legal basis for trademarks.
If one disregards the possibilities of a European patent, European Union trademark and/or international registrations, national German patents and trademarks will be granted by the German Patent and Trade Mark Office (DPMA) upon application if the respective requirements are fulfilled.
2. A patent is granted for a technical invention which (i) is new, (ii) is based on an inventive step and (iii) is susceptible of industrial application; if none of the statutory exclusions applies.
3. As for trademarks, basically, all signs, objects and designs, but also sounds, three-dimensional shapes, colours and theoretically also smells that are capable of distinguishing products and services from competitive offerings can be protected. In light of a recent change, German trademarks no longer have to be graphically representable. All trademarks which can be represented in the trademark register in such a way that the competent authorities and the public can clearly and unambiguously determine the subject-matter of trademark protection will be admitted for registration.
2. What agencies or bodies regulate patents and trademarks?
The German Patent and Trade Mark Office (DPMA) is the competence centre for all national intellectual property rights – patents, utility models, trademarks and designs.
More information can be found at: https://www.dpma.de/dpma/index.html
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
1. Patents can protect:
products (like devices or compounds used in surgery or therapy) or processes (like diagnostic methods, production processes, methods for obtaining known products, substances or compositions), or certain uses (like the use of compound X for the treatment of Y).
Certain categories of products and processes are expressly excluded from patent protection by law. The most relevant are:
- Mere discoveries, scientific theories and mathematical methods.
- Materials or substances already existing in nature and nuclear materials.
- Aesthetic creations.
- Schemes, rules or methods for intellectual acts, playing a game or doing business and computer programs.
- Presentations of information.
- Inventions whose commercial exploitation is contrary to the public interest or offends common decency, machines for forbidden gambling or for the production of clearly harmful or dangerous food or drinks.
- Plant varieties and animal breeds.
- The human body and the mere discovery of one of its components, including (partial) gene sequences.
- Processes for cloning or modifying the germinal genetic identity of human beings.
- The use of human embryos for industrial or commercial purposes.
- Methods of modifying the genetic identity of animals associated with the suffering of such animals without such methods being of significant medical benefit to humans.
- Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods.
2. The following can be registered as trademarks:
- a sign or set of signs which can be represented in such a way that the subject matter of the trademark protection can be clearly and unambiguously determined.
3. Something completely new under German law is the introduction of the certification mark. A certification mark is a mark which is designated as such at the time of application and for which the owner of the mark guarantees the material, the way in which the goods are manufactured or the services provided, the quality, accuracy or other characteristics. It must be capable of distinguishing itself from marks for which no such guarantee exists. With the certification mark, quality seals or test marks of neutral certification companies can thus obtain trademark protection.
A trademark can only be registered if there are no absolute grounds for refusal. These are, for example:
- Lack of distinctiveness.
- Descriptive indications to be kept free for general use.
- Apparent risk of misleading.
- Violation of public morality or public order.
- Emblem contained in the mark.
4. How can patents and trademarks be revoked?
1. Patents can be revoked in opposition proceedings and nullity actions. Anyone may oppose the grant of a patent within nine months of the publication of the grant of the patent (opposition period). After expiry of the opposition period, a patent can only be attacked in a nullity action before the Federal Patent Court.
Unless a patent is declared void or lapses due to non-payment of the annual renewal fee, the patent is then valid retroactively from the filing date for a maximum of twenty years.
2. In line with the various European Regulations it is possible to receive a supplementary protection certificate (SPC) for certain products, in particular medicinal products, which can, simply said, extend the term of protection for further five years. The Paediatric Medicinal Products Regulation (Kinderarzneimittel-Verordnung) also opens up the possibility of extending the term of protection of a supplementary protection certificate by a further (up to) six months. A prerequisite for this is that the application for the respective medicinal products contains results with regard to medicinal products studies conducted specifically on children that were conducted according to a previously approved paediatric investigation plan.
Grounds for nullity of a German patent may be:
- lack of patentability;
- lack of feasibility;
- inadmissible extension of the subject-matter of the patent compared to the original application as filed;
- unlawful withdrawal of the invention (can only be invoked by an infringer).
The Federal Patent Court will decide by judgment over a nullity action. The contested patent may be maintained (if the action is dismissed) or declared partially or wholly invalid (if the action is partially or wholly successful). If a patent is declared void, the proprietor retroactively loses all legal positions previously based on the application. Appeals against the decision of the Federal Patent Court will be heard by the Federal Court of Justice.
3. As regards German trademarks, proprietors of earlier trademarks have the opportunity to oppose a registration of a new mark in writing within a period of three month after publication of the newly registered trademark. The opposition must be filed with the German Patent and Trademark Office (DPMA). In principle, opposition can be filed if there is a fear that there is a likelihood of confusion between the earlier and newly registered mark. If successful, the newly registered mark will be cancelled.
During the term of the opposition period alternatively, thereafter exclusively, the proprietor of an earlier trademark may also file a cancellation action before the ordinary courts.
A trademark may be cancelled upon application if it has been registered contrary to § 3 or § 8 of the Trademark Act (absolute grounds for refusal):
- if it consists exclusively of a shape which results from the nature of the goods themselves, which is necessary to obtain a technical result, or which gives substantial value to the goods.
- if it is devoid of distinctive character for the goods or services; consists exclusively of signs or indications which have become customary in the current usage or in the bona fide and established practices of the trade to designate the goods or services; is of a nature to mislead the public; is contrary to public policy or to accepted principles of morality; contains certain state symbols or official certification marks which are excluded from trademark protection; has been applied for in bad faith.
In the case of relative grounds for refusal, it must be borne in mind that the likelihood of confusion must always be assessed from the point of view of the end consumer, who is less understanding than the person skilled in the art. In the case of absolute grounds for refusal, it is exactly the other way round: the skilled person is just as familiar with the special labelling habits in the medical sector as he is with the specialist medical vocabulary of the Latin and Greek languages.
In addition to absolute and relative grounds for refusal which may be raised in a cancellation action, a trademark shall be cancelled upon application if, after registration, the trade mark has not been used within a period of five years. Proof of use of the trademark in dispute is then required.
Finally, the owner of a trademark may waive the trademark at any time, particularly by non-payment of the renewal fee. Until January 2019 registered trademarks were protected for a period of ten years until the end of the month in which the trade mark was applied for. For all new trademarks registered from 14 January 2019, the ten-year term will now expire exactly ten years after the filing date.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
1. Because of the territoriality principle, patents and trademarks are valid only in the country for which they are granted. German patents and trademarks granted by the German Patent and Trademark Office (DPMA) are therefore valid for the Federal Republic of Germany only.
However, in addition to a German national application, patent protection can of course also be sought in several countries with one single application in case of European patent or an international registration. Moreover, it is possible to claim the priority of an earlier foreign patent application for the same invention within a period of 12 month following the filing date of the earlier application.
2. European patents are centrally filed and examined at the European Patent Office (EPO). They can be granted for the contracting states of the European Patent Organisation. The procedure is governed by the European Patent Convention (EPC). Once a European patent is granted, a “bundle patent” is created, which then breaks down into several individual national patents (e.g. in those countries where the applicant chose to validate the patent). Once granted, a European patent has the same effect in each contracting state for which it has been granted and is subject to the same regulations as a national patent granted in that state.
3. Trademark protection can also be extended to other countries. A trademark application can directly be filed in the countries where protection is sought.
If it is intended to label products uniformly throughout the EU, registration of a European Union trademark valid throughout the EU can be applied for.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
1. The Medicinal Products Act provides for a non-patent related way to extend an exclusive position for medicinal products vis-à-vis generics. Under the Medicinal Products Act, an application for marketing authorisation of a generic medicinal product can only refer to the data of the reference medicinal product if the reference medicinal product has been authorised for at least eight years (data exclusivity).
The generic medicinal product can then only be placed on the market after an additional period of two years (market exclusivity). In addition, market exclusivity can be extended by one more year if the marketing authorisation holder of the reference medicinal product, during the first eight years after marketing authorization, obtains authorisation for one or more new therapeutic indications with significant clinical benefit in comparison with existing therapies. Consequently, the maximum period for data and market exclusivity is eleven years (so-called “8+2+1 provision”).
2. Moreover, Regulation (EC) No 141/2000 on orphan medicinal products applies in Germany.
Therefore, orphan medicinal products enjoy market exclusivity for ten years. Orphan medicinal products are products intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition. During this period another application for a marketing authorisation will neither be accepted nor will a marketing authorisation for the same therapeutic indication be granted for a similar medicinal product. Moreover, an application to extend an existing marketing authorisation for such medicinal product will not be accepted. The period of market exclusivity can be reduced under certain circumstances. There are two exceptions to the exclusive position of the investor: The period can be shortened from ten to six years if the original designation criteria are no longer met after five years.
The purpose of this so-called shortening clause is in particular to regulate the case where, contrary to expectations, an orphan medicinal product develops into a “hit” due to changed circumstances, e.g. a sudden increase in the incidence of the disease in question, and thus the prerequisite for the special protection of competition of this medicinal product is no longer met due to sufficient profitability.
3. In addition, a similar medicinal product may exceptionally be approved before the expiry of the ten (or six) year period if the first holder of an orphan medicinal product license agrees to the second license, if the medicinal product itself cannot be supplied in sufficient quantities, or if the second applicant can prove in his application by means of clinical tests that his medicinal product is safer, more effective or otherwise clinically superior or at least makes a significant contribution to the diagnosis or treatment of patients.
4. On the other hand, for paediatric orphan medicinal products the total term of protection can be extended up to twelve years in accordance with Regulation (EC) 1901/2006 on medicinal products for paediatric use.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Other than the ones already described, there are no specific restrictions regarding the patent protection of medicines and/or devices.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No. There is no such requirement. An approval of a license and/or an entry of the license in the patent register is not necessary for the validity of the acquisition of the license.
However, it is possible to register the grant of an exclusive license under a patent in the German Patent and Trademark Register, but the entry of the license in the patent register has no material legal significance for the legal relations between the contracting parties and between the licensee and third parties. However, for evidence reasons it is recommendable to conclude license agreements in writing.
Moreover, there are some special rules that apply in the event that a patent or trademark is enforced by a licensee (e.g. standing to sue, entitlement to own damages claims, etc.). For trademarks, most of these rules are stipulated in § 30 of the Trademark Act, as for patents, most of these rules are based on case law.