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.