Don’t sleep on trademarks! – The importance of trademark registration for pharma products in the EU

ASPIRIN and the value of pharma trademarks

It is one of the most iconic and best known drug brands in the world: ASPIRIN. Registered as a trademark at the Kaiserliches Patentamt (Imperial Patent Office) in Berlin on 6 March 1899, and despite an eventful history that saw the trademark confiscated i.a. in the US as a consequence of Germany’s loss in the First World War, this product of the Bayer AG is for now over 125 years probably one of the best-selling pharmaceutical products in history. And despite of a number of generic alternatives, it maintains on the German market, among others, by far the most important market share of products with the same active ingredient.

This success story shows: Even long after technical property rights such as patents would have expired, strong brands still provide the opportunity to defend your market share against alternative products and offer considerable marketing potential. In addition, strong brands have added advantages: They generally contribute to product safety as they make it easier for the relevant public to recognize the products. This is not only the case for consumers, but – in particular with regard to trademarks protecting the color or shape of the product or packages thereof – also for healthcare professionals. Further, a strong brand can advance to a sign of quality, as the relevant public often has more faith in the “original” branded product than the cheaper generic alternatives.

So what exactly are trademarks?

A trademark is commonly defined as a sign that functions as an indicator of commercial origin of certain goods and services. However, this is nowadays not restricted to words or logos, but any sign capable of being represented in the trademark register in such a way as to "enable the competent authorities and the public to determine clearly and precisely the subject-matter of the protection accorded to its proprietor" can in theory constitute a trademark.

Accordingly, there exists a wide range of possible trademarks, including non-conventional signs such as sounds, smells and haptic sensations as well as – more importantly in the field of pharmaceuticals – the shape or color of a product or even the shape of the packaging.

Examples for such trademarks can again be found for the ASPIRIN product and its packaging design:

To register or not to register…

One of the most common misconceptions about trademarks in Europe is that trademarks do not need to be registered to be protected. However, unlike for example the US, the European trademark system is not based on use, but on registration. This means that – except for well-known trademarks who have a special status under the respective jurisdictions in Europe and certain notable exceptions such as Italy where unregistered marks are protected at certain conditions – only the registration confers any level of protection to a trademark.

Where do trademarks fit in the complex system of intellectual property rights?

Intellectual property rights often seem opaque and overlap in some instances. But they have specific goals and advantages as well as disadvantages.

The first and with regard to the development of new pharmaceutical products predominant intellectual property right is patent protection. Patents protect an invention, usually a product or a process, which must i.a. be new and involve what is known as an inventive step (i.e. must possess a degree of inventiveness over what has gone before). However, the term of a patent is limited to 20 years, even though there exists the possibility for specific medicinal and plant protection products to extend the protection through supplementary protection certificates (SPCs).

The second intellectual property right of significance are designs. Unlike patents, designs do not protect technical aspects but merely the appearance of the whole or part of a product, for example a specific form of a pill or the packaging. In the EU, a design can have protection without registration, although registration provides greater certainty in case of infringements. However, designs are limited in time and may only be protected up to 25 years.

This is one of the aspects, where trademarks come into play. As described above, trademarks may amongst others cover the shape or packaging of goods as long as they have enough distinctiveness and can be considered as an indication of the origin. In contrast to patents and designs, there is no time limit on trademarks. In the EU (and many other countries), trademarks are registered for 10 years renewable for subsequent 10 year periods.

The fact that trademarks can provide a means to defend a product against third parties also years after the market introduction is particularly attractive in the pharmaceutical sector in light of the high investments that have to be made to get a new product developed and approved by the regulatory  bodies. Patent protection offers the possibility of keeping third parties out of the market for a limited period of time allowing to capitalize on the unique position on the market. However, this period of market exclusivity also offers the opportunity to raise awareness for and establish the product, its name and its properties on the market. It can therefore be used to build the brand around the product which will then allow to maintain a greater market share once the patent protection has expired. Indeed, it is possible that a certain trademark has acquired notoriety over time. The right holder may thus rely on added value (i.e. the trademark reputation) to leverage sales even when patent protection is no longer an option.

The trademarks can additionally be used to act against any third party that would introduce a product with a name or other distinctive feature that create a risk of confusion to your protected trademark which raises the distinctiveness of your pharmaceutical product.

Not considering trademarks before market authorization is risky

Finally, the trade name of the planned pharmaceutical product should be cleared before filing for market authorization to minimize risks from third parties’ trademarks. Failing to do so bears an inherent major risk for the pharmaceutical product, since the product name could infringe third party trademark rights. In this regard, it is worth noting that the market authorization bodies do not consider or check any third party trademark rights, and the market authorization of a pharmaceutical product is no indication that it does not infringe third party rights. Since the trade name of a pharmaceutical product has to be filed with the application in the market authorization proceedings, it is of paramount importance to clear the name from a trademark perspective before filing for market authorization. Additionally, the planned trade name should have successfully been registered as a trademark. Although a registration as a trademark does not guarantee that there are no conflicting third party rights, it is nevertheless a good indication and can minimize the risk. We will go in more depth into the topic of filing strategies and the relevance of trade mark authorisation proceedings in a later article of this series.

What’s to come…

After giving you an idea of what trademarks are and where they fit in the system of the most relevant IP rights, we will focus in our next article on the functioning of the trademark system in Europe. This will be crucial to understand the issues arising from the protection and defense of trademarks and also for the development of a viable trademark strategy. So stay tuned!

Authored by Maria Luce Piattelli and Frederic Urbanek.