Trade marks are extremely important in the life sciences sector.
A strong brand name can endure, and sustain a market leading position, long after a patent has expired. However, due to the nature of the sector, trade mark protection is highly regulated with brand names having to satisfy the requirements of both trade mark offices and health authorities.
Choosing a name
When branding a new product pharmaceutical companies face a long, challenging and expensive process. This usually begins three to four years before a product launch with names creation. The active ingredient of a pharmaceutical product will have an international non-proprietary name (INN) which is considered public property and which no one can monopolise. A trade mark in the sector must not be too close to or derived from an INN.
A pharmaceutical trade mark must also not make an overt claim as to the effect of the product, nor be misleading as to its effects or composition. The made-up word can have positive connotations as to the product (for example the Pfizer–BioNTech COVID-19 vaccine is named "Comirnaty" which intentionally references the ideas of "COVID-19", "mRNA", "community" and "immunity") but the absolute grounds for refusal of trade marks should always be borne in mind. A trade mark will be refused registration if:
- It is deceptive
- It is devoid of distinctive character
- It consists exclusively of an indication or sign which may designate the kind, quality, quantity, intended purpose, value, geographical origin or the time of production of the goods or of rendering of the service, or other characteristics of the goods or service.
Clearance
Once potential names have been identified, the next stage is to carry out searches of trade mark registers around the world to assess whether there are pre-existing trade mark rights that may be confusingly similar to those names. Often, 50 to 70 potential names are taken through to the clearance stage. The key Nice Classification classes for clearance of pharmaceutical trade marks are Class 5 (medicines) and Class 10 (medical apparatus and instruments). There are some goods outside these classes which trade mark offices may consider "similar" to pharmaceutical products, such as cosmetic products which fall within Class 3.
When considering whether the similarity between an existing trade mark and a potential trade mark may cause a likelihood of confusion in the minds of the consumer, trade mark offices will take into account the relatively high level of attention consumers pay to Class 5 and Class 10 goods. This would generally lessen the likelihood of confusion. However, pharmaceutical companies will take a cautious stance since the overriding concern is always patient safety. Even if a mark may make it through trade mark office examination, health authorities will take a much more conservative approach to whether there is an unacceptable likelihood of confusion with another medicine based upon a similarity in names.
To manage the costs of the clearance exercise, pharmaceutical companies often take a cascade approach to clearance searching, starting in key jurisdictions then taking viable names further through the process. A significant challenge in this is making a similarity assessment when taking a multi-jurisdiction approach which encompasses various languages. The process will usually result in a consolidated clearance report which rates names by level of risk.
Marketing and safety research
Generally, around 15 names will still be on the table when marketing and safety research is carried out. This involves prescription simulation studies which seek to assess the risk of dangerous confusion between medical brand names when health professionals prescribe products. Such studies will look at written, verbal and computerised simulations of how the name may be used; and will take into account the practices of health professionals in different countries.
Names will also be cross-checked against common medical terms and abbreviations, and screened for any inappropriate, exaggerative or promotional claims in various languages, taking into account pronunciation and slang terms.
Medical and health agencies
The final hurdle in the process of branding a pharmaceutical product is obtaining regulatory approval of health agencies, such as the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency or the US Food and Drug Administration, whose remit is to address any public health or safety risks and to protect the INN stems. Health agencies will review potential names to ensure that they are not confusing with the common or scientific names for any medicines and that they are in general acceptable as a name for a medicine. They tend to be conservative in approach, particularly the European Medicines Agency which must take into account differences in national practices and languages across all member states of the EU.
Non-traditional trade marks
In additional to a strong brand name, many pharmaceutical companies use non-traditional trade marks as part of brand protection strategies. Depending on the jurisdiction, non-traditional marks can include colour, shape, sound, trade dress, scent and moving images, with colour and shape marks most commonly utilised for medicinal products. For example, Pfizer owns registered trade marks for the 3D diamond shape and the blue colour of Viagra pills. However, seeking registration of such marks is not as straightforward as for word or figurative marks. For instance, Glaxo has tried and failed to register a particular shade of purple in respect of its inhalers and asthma treatments, with the EU courts finding that such a mark lacked distinctive character and had not, despite survey evidence submitted by Glaxo, acquired distinctiveness through use. Glaxo has also failed in the English High Court to prevent competitor Sandoz from using the colour purple on its rival inhalers.
In summary, therefore, the path to market for pharmaceutical product names is a complex one and, more so than in any other industry, requires careful planning and consideration.
Elaine O'Hare