Selection, clearance and registration

Like all trademarks, pharmaceutical trademarks are subject to general trademark rules regarding validity and use.

Until recently, both French and European law required a trademark to be capable of graphical representation. This requirement allowed the registration of shapes, colours and sounds, but excluded signs such as smells. The European trademark law reform, comprising EU Directive 2015/2436 and the EU Trademark Regulation (2017/1001), deleted the graphical representation requirement from trademark law. This change marks a dramatic step forward in trademark law and could make it easier to register smells and other non-traditional trademarks.

A trademark must be capable of distinguishing the goods or services of one undertaking from those of others. It serves as a guarantee of origin for the goods or services t hand. In this regard, the shapes of products have been the subject of heated debate. For a shape to be registered as a trademark, it must not be determined solely by the nature or function of the product in question. Further, it must not give substantial value to the goods. In practice, many shape marks fall within one of the excluded categories – especially in the field of pharmaceutical products, in which no trademark application representing the shape of a product has yet been considered valid.

In any case, under Article L5121-10-3 of the Public Health Code, the holder of IP rights in the shape or texture of a pharmaceutical product cannot prohibit the use of an identical or similar shape for a generic product. EU law provides no such exception.

A pharmaceutical trademark must be distinctive. Therefore, a descriptive or generic mark will not be considered valid. The law also specifically excludes certain marks and provides that marks that are misleading or contrary to public policy cannot be considered valid.

In addition to these absolute grounds for refusal, the trademark must not infringe prior rights. The prior rights listed in Article L711-4 of the IP Code, and supplemented by case law, include:

• Trademarks
• Company names
• Trade names and shop signs
• Designations of origin
• Copyrights
• Designs
• Names or images or persons or personality rights
• The names, images or reputations of territorial collectivities, and
• Domain names, provided that the website in question:
• Is operational before the application, and
• Applies to the same or a similar field of activity

The registration of a pharmaceutical trademark must not create a risk of confusion with any of the prior rights listed above. The risk of confusion must be assessed in consideration of the relevant public, usually comprising medical professionals and patients (European Court of Justice (ECJ), Alcon v OHMI-Biofarma, C-412/05, April 26 2007; General Court, Ferring v OHIM – Tillotts Pharma (OCTASA)T‑502/12, April 9 2014). The risk of confusion must take into account the weak distinctive character of the elements that comprise pharmaceutical trademarks, which is due to the fact that they usually refer either to the active components of the product or to the area of treatment (March 30 2011; Court of Cassation, Commercial Chamber, Laboratoires Brothier v Ipsen Pharma, 10-18141, April 27 2011; Paris Court of Appeal, 2014/03379, June 18 2015).

For example, in the field of allergy treatments, the prefix ‘Allerg-’ is commonly used in France. Case law tends to take this reality into account, concentrating on the other elements while disregarding the identical but common use of these prefixes (Paris Court of Appeal, Allergan v Directeur de l’INPI & Sté Santé Nature Distribution).

After five years, a trademark may be subject to revocation for non-use. The trademark owner must therefore prove that it is exploiting the trademark for all goods and services designated in the registration. European and French case law consider the category of ‘pharmaceutical preparations’ to be sufficiently broad to divide into sub-categories, each of which is considered autonomously (General Court, GlaxoSmithKline v OHIM; T-493/07, T-26/08 and T-27/08, September 23 2009; Paris Civil Court, 11/16569, January 10 2014). Therefore, if a trademark owner is exploiting products in one sub-category only, it may not be deemed to have exploited products for the entire category of pharmaceutical preparations.

Regulatory approvals

In order for a pharmaceutical trademark to be registered, no prior authorisation is needed per se. Unlike in other countries, in France the trademark owner is independent from the party exploiting the trademark and need not possess a particular quality (eg be a pharmacist or be authorised to sell the product).

However, prior authorisation is required in order to exploit a pharmaceutical trademark; in practice, this is often sought at the same time as the trademark application is filed. Authorisation can be issued by the European Medicines Agency (EMA) or the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). A delay in the issue of this authorisation may constitute a legitimate excuse for the trademark owner not exploiting the trademark within five years (Paris Court of Appeal, 89/023824, November 12 1991).

Confusion with INNs

The aim of international non-proprietary names (INNs) is to facilitate the identification of pharmaceutical substances and active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property. It is also known as a generic name.

Article R5121-2 of the Public Health Code provides that a pharmaceutical trademark must not create a risk of confusion with an INN. This requirement is taken into account by national and European trademark offices, which consider whether an applied-for trademark is likely to be confused with an INN during the examination process. Should this be the case, the trademark application will be rejected.

Even if the trademark application is accepted by the relevant trademark office, there remains the risk of cancellation by a court should it identify possible confusion between the trademark and an INN (Lyon Court of Appeal, Merial v Virbac, 13/08055, May 13 2015).

Read the full article