Overview

Legislation

What is the primary law governing trademarks in your jurisdiction?

In particular the following European acts are relevant in this regard: the European Union trade mark regulation (EUTMR) ((EU) 2017/1001), the European Union trade mark delegated regulation ((EU) 2018/625), the European Union trade mark implementing regulation ((EU) 2018/626) and the Directive approximating the laws of the Member States relating to trade marks ((EU) 2015/2436).

Agencies

Which agency is responsible for the grant and registration of pharmaceutical trademarks?

The responsible agency for European Union trademarks registered for the territory of the whole European Union is the European Union Intellectual Property Office (EUIPO). It is located in Alicante and is responsible for the registration of European Union trademarks (UM) and registered Community designs (RCDs) pursuant to the EUTMR and Council Regulation No. 6/02 of the Council of 12 December 2001. These registrations provide uniform trademark and design protection throughout the European Union. Accordingly, the EUIPO deals with registration procedures, maintains the public registers of these rights and decides on applications for invalidation of these rights after their registration.

Regulators

What are the relevant national and international regulatory bodies and requirements that need to be considered when clearing a pharmaceutical trademark?

Clearing trademark rights for pharmaceutical trademarks does not differ from clearing other trademarks. Diligent research for possibly conflicting earlier rights mitigates the risks of infringements arising from the trademark application or commencement of use. Such a search is carried out mainly through the databases made available by the EUIPO.

Non-traditional trademarks

What non-traditional trademarks are available in your jurisdiction and how are they registered?

In the European Union, traditional and non-traditional trademarks are not defined separately. The EUTMR contains a non-exhaustive list of types of trademarks, which includes the following non-traditional trademarks: three-dimensional marks, colour marks, sound marks, position marks, tracer marks, pattern marks, motion marks, multimedia marks and hologram marks.

With the filing of the non-traditional trademark at the EUIPO, the applicant should indicate the type of trademark. Moreover, the EU non-traditional trademark needs to be represented on the register in a manner that enables the competent authorities and the public to determine the clear and precise subject matter of the protection afforded.

Cannabis-derived products

Does your jurisdiction allow the registration of cannabis-derived products?

The EUIPO generally allows the registration of trademarks for cannabis-derived products. Not every member state allows the consumption of cannabis, not even for medical purposes. However, a mere prohibition to offer respective goods or services in a member state does not justify the refusal of an EU trademark because of violation of public policy or accepted principles of morality according to article 7 (1) (f) EUTMR. As a rule, not every infringement of law in one EU member state leads to an absolute bar to protection, although according to article 7 (2) EUTMR it is generally sufficient for the refusal of a trademark registration that grounds of non-registrability are obtained in only part of the EU. It is the trademark itself, namely the sign in relation to the goods or services as they appear upon registration of the trademark, that is to be assessed to determine whether it is contrary to public policy or accepted principles of morality (EGC, T-140/02, 13 September 2005, INTERTOPS).

There is some case law regarding the rejection of cannabis trademarks based on absolute grounds according to article 7 (1) (f) EUTMR. For example, the European General Court (EGC) held that the device mark showing cannabis leaves together with the wording 'Cannabis Store Amsterdam' referred to the consumption of cannabis as a psychoactive drug and was therefore contrary to the public policy and to the accepted principles of morality and rejected the registration (EGC, T-683/18, 12 December 2019, Cannabis Store Amsterdam). On the same grounds, the Board of Appeal of the EUIPO rejected the trademark 'Well Weed' because the word 'weed' is a common reference to the psychoactive drug (BoA EUIPO, R213/2021-5, 4 March 2021, Well Weed). Although the applicant cited the European Court of Justice’s ruling concerning the marketing of cannabidiol (ECJ, C 663/2018, 19 November 2020, Marketing of Cannabidiol), according to which cannabidiol and its derivatives may be freely marketed and are not contrary to public policy, the Board did not change its opinion. Another example is the rejection of the device mark 'Bavaria Weed' (EGC, T-178/20, 12 May 2021, Bavaria Weed), which shows a 'Bavarian' lion holding a hemp leaf in combination with the term 'Bavaria Weed'. The association of the term 'weed' with services of a therapeutic nature risks giving the public the impression that the use and manufacture of narcotics, to which the sign alludes, is tolerated or even encouraged. Therefore, the EGC found that the trademark is contrary to public policy within the meaning of article 7 (1) (f) EUTMR. In conclusion, terms commonly associated with cannabis as a psychoactive drug such as 'weed', 'pot', 'marijuana', 'cannabis', 'hemp', 'grass' and 'hash' remain problematic when it comes to registration of cannabis trademarks.

Parallel imports

Regulation

What are the rules governing parallel imports of pharmaceutical goods?

Parallel imports of pharmaceutical products are, among other things, significantly regulated by trademark law. Above all, the principle of exhaustion of trademark rights, as regulated, for example, in article 15(1) of the European Union trade mark regulation, plays an essential role here. The European Court of Justice has made numerous decisions in the past, especially on cases such as the repackaging of medicinal products, the bundling of original packages, and the relabelling and alteration of package inserts.

Strategies against parallel imports

What strategies are available to police and enforce against parallel imports?

Border seizure measures in particular are suitable for preventing unauthorised parallel imports at an early stage by means of trademark rights. In addition, trademark owners have access to the courts. Important for successful action against illegal parallel imports is appropriate evidence to prove that the products concerned were not put on the market with the consent of the trademark owners. This can include control numbers, but also invisible identification systems integrated into the packaging, which can prove the origin of the goods.

Anti-counterfeiting and enforcement

Types of proceedings

What types of legal or administrative proceedings are available to enforce against infringing products?

Against trademark-infringing products (or services) action may be brought before the court, for example for injunctive relief (article 9 (2) of the European Union trade mark regulation). Preliminary, an attempt is often made to issue a warning to the infringer and to obtain from him or her a cease-and-desist declaration with a penalty clause. If this is unsuccessful, a temporary injunction can be obtained in particularly urgent cases. In addition, there is the possibility to file a criminal complaint. In administrative proceedings, on the other hand, trademark applications or registrations are challenged that infringe the company's own opposing property rights.

Remedies

What are the available remedies for infringement?

The trademark owner can obtain a temporary injunction in court to enforce a temporary regulation, and possibly also to obtain information and grant seizure. Subsequently, further claims for damages or for recall and destruction of the illegally designated goods can be enforced by legal action.

Border enforcement

What border enforcement measures are available to halt the import and export of infringing goods?

Applications for border seizure can be submitted to the German Directorate General of Customs in accordance with European law (EU Regulation No. 608/2013) for both national and EU property rights for one or more countries. The scope of application differs, as the respective property right must be valid in the country in which the application is to apply. An (additional) application under national law is useful to prevent infringements of intellectual property rights in the movement of goods between the member states of the European Union and to have original goods, which have been marked or licensed with the consent of the rights holder, but that are to be imported or exported without the consent of the rights holder, thus bypassing contractually defined distribution channels (parallel or grey imports), also seized and destroyed by customs.

Online pharmacy regulation

What rules are in place to govern online pharmacies?

The dispatch of medicines is not uniformly regulated in the EU. While the dispatch of over-the-counter medicines is permitted throughout the EU's internal market, this only applies to prescription medicines in some member states (eg, Germany, Denmark and the Netherlands). Countries regulate the shipping of medications in Europe themselves and this consequently leads to many differences. Most EU countries want to keep control over ingredients and the mail order of medicines. These considerations are for the health of the population and have nothing to do with a general rejection of the mail order of medicines in Europe. Since 2015, all shippers in the EU who sell medicines over the internet have been required to display a safety logo in their national language on each of their websites. The rules to govern online pharmacies are found in national laws and are not regulated across the EU. For example, in Germany there are certain restrictions that are laid down in section 43 (1) (1) of the Drug Act (AMG) and section 11a of the Pharmacy Act (ApoG). First of all, online pharmacies may only be installed after permission has been issued by the competent authority. The competent authority varies from state to state (for Bavaria for example, it is the Landratsamt and for Lower Saxony it is the Apothekerkammer). Secondly, online pharmacies may only be operated in addition to a retail pharmacy. The sole operation of an online pharmacy is therefore not allowed. Further, shipping must be handled out of a public pharmacy. This excludes hospital pharmacies or pharmaceutical wholesalers as well as the distribution by mere logistics companies. In addition, the pharmacist must put a quality assurance system in place regarding the packaging, transport and distribution of drugs (including transport insurance and shipment tracking). That is to ensure that the quality of the drug is maintained and that the drug is given to the correct person. Any consultation with the customer must be in German. Furthermore, section 11a ApoG holds that all drugs must be shipped within two days upon receipt of the order (unless otherwise stated) and that online pharmacies must provide the full range of drugs available in Germany (hence there is no cherry picking). The online pharmacy must also guarantee to have an appropriate system to inform customers about known risks of pharmaceuticals. Finally, section 17 (2) of the Pharmacy Operating Regulations provides that drugs may not be sold online if there is a need for advice on the safe use of the drug that can only be provided by personal information from a pharmacist. To obtain the permission of the authority, the pharmacist must guarantee in writing that he or she complies with the aforementioned requirements. However, authorities may also carry out random checks.

Recent cases

What are the most notable recent cases regarding the enforcement of pharmaceutical marks?

A case of interest was Actelion Pharmaceuticals Deutschland v Kohlpharma (District Court of Hamburg judgment of 21 May 2015 – 327 O 487/14; Higher Regional Court of Hamburg judgment of 28 March 2019 – 3 U 66/15). With regards to parallel imports, the court had to decide whether a parallel importer had to comply with the same rigorous information and documentation system as the national licensee. Combining pharmaceutical regulations and unfair competition laws, the court ruled that it was in fact a violation of the AMG that the parallel importer did not monitor who prescribed their pharmaceuticals and handed out information to those doctors, as well as tracked results and complications of therapies with their preparations, therefore resulting in claims under the Unfair Competition Act. However, whereas the court of first instance saw a violation of the licensed mark’s reputation as a basis for the licensee’s claims, the court of second instance ruled that only the owner of the trademark, and not the licensee, could assert these claims under article 102 (1) (2) of the of the German Trade Mark Act (old version), sections 14 (6) and 19 (3) of the German Trade Mark Act and section 242 of the German Civil Code.

In a likelihood of confusion case (Bayer Intellectual Property v Merck et al, District Court of Hamburg, judgment of 8 October 2020 – 327 O 267/19), the claimant unsuccessfully tried to assert its trade dress and brands related to a pharmaceutical to treat headaches against another pharmaceutical tackling allergy symptoms.

In a decision concerning the combination mark ‘SelenO’ (30 W (pat) 13/19), the German Patent Court upheld a sign comprising the name of a chemical element and a – vaguely – moon-‘shaped ‘O’ figure, drawing a fine line between descriptiveness and distinctiveness.

Finally, in Novartis Pharma v Orifarm (Higher Regional Court of Cologne, judgment of 11 October 2019 – 6 U 142/19 and prior judgements), the Cologne court decided in a case where the ‘new’ Directive 2011/62/EU (prevention of falsified medicinal products) concerned parallel importation and repackaging. It decided that complete repackaging was not necessary and therefore violated trademark rights even if the new security details under the Directive are broken by partial repackaging.

Advertising

Regulatory bodies

Which bodies are responsible for oversight of pharmaceutical advertising in your jurisdiction (and what are their powers)?

There are no authorities as such that govern the oversight of pharmaceutical advertising (as, for example, an ombudsperson in other jurisdictions). Compliance with the advertising law provisions happens, therefore, solely at the level of civil law in the relationship between different competitors or by competition and consumer protection agencies that can take legal action against unlawful advertising in the civil courts. The latter are associations that are dedicated to consumer protection on the basis of a government mandate (eg, the Centre for Protection against Unfair Competition in Germany). Experience shows that this is a very effective tool for compliance. Violations are usually prosecuted very quickly by way of interim injunctions.  

Advertising rules

What specific rules are in place regarding the advertising of pharmaceutical products?

The European Community sees a need for harmonisation in the advertising of medicinal products and justifies this in particular by stating that, although all member states have enacted regulations on the advertising of medicinal products in their countries, these are structured very differently. These differences have an impact on the functioning of the internal market because national advertising can have repercussions on the other member states.

The provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 harmonise the rules on the advertising of medicinal products, although the Directive expressly provides that a member state may adopt certain provisions in derogation of the Directive.

Other national regulations that deviate from the Directive are only permitted in compliance with the conditions set out in article 95 (4-6) of the EU Treaty.

In Germany, for example, the Drug Advertising Act (HWG) is based on the directives. Other important laws include the Drug Act and the Unfair Competition Act.

In addition, there is the code of the Financial Supervisory Authority (FSA). Numerous important pharmaceutical companies have joined forces to form the Voluntary Self-Monitoring Association for the Pharmaceutical Industry. The FSA’s rules and regulations also contains provisions on advertising. Anyone can report violations of the rules to the FSA, and the FSA Arbitration Board can sanction these violations with fines of up to €400,000 and issue public reprimands. The HWG generally differentiates between drugs and medical devices and between advertising to professionals and to laypersons. Advertising for prescription drugs is only allowed to professionals, for example (section 10 HWG). The HWG also contains a general prohibition of misleading advertising in section 3 HWG, which can also be a criminal offence. Section 11 HWG lists various marketing tools that are prohibited in advertising to laypersons, such as advertising with celebrities, the distribution of samples or specimens of drugs, or before and after pictures that are misleading or repulsive. Another important provision can be found in section 7 HWG regarding promotional gifts, discounts or other gratuities that are only allowed within very narrow limits. Promotional gifts, for instance, are only allowed if they have a very low value. In addition, section 4 HWG provides a list of mandatory information that every advertisement for drugs (not medicinal products) must include, such as the area of application and any side effects.

The advertising of medicinal products in France is mainly regulated by the French Public Health Code and the French Consumer Code. The recommendations issued by the French National Agency for the Safety of Medicinal and Health Products also applies. There are also other recommendations or codes that apply.

In Spain, on the other hand, the following laws apply: Royal Decree 1416/1994 of 16 October on advertising of medicines for human use (RD 1416/1994); Circular 6/95 issued by the Spanish Agency of Medicines and Medical Devices, further developing the RD 1416/1994; and the Guidance dated June 2019 issued by the Ministry of Health on advertising to the general public of medicines for human use, further developing RD 1416/1994.

According to these, advertising to the general public is prohibited for unauthorised medicines, prescription-only medicines, medicines under research and medicines containing narcotics or psychotropic substances.

Generic substitution

Legality

Is generic substitution permitted in your jurisdiction?

Yes, if any intellectual property rights pertaining to the medical product in question have lapsed.

Regulations

Which regulations govern generic substitution by pharmacists of brand-name drugs?

See www.lexology.com/gtdt.

Update and trends

Key developments and future prospects

What were the key judicial, legislative, regulatory and policy developments of the past year in relation to the protection and enforcement of pharmaceutical trademarks? What are the prospects for future developments?

See www.lexology.com/gtdt.

Law stated date

Correct on

Give the date on which the above information is accurate.