In the past, the close connection between intellectual property and life sciences has been based almost exclusively on patent protection. The patenting of pharmaceutical discoveries has turned relatively small scientific-based businesses into multimillion-pound global players, able to secure substantial investments in R&D and to succeed as powerful new businesses employing thousands of people.
Perhaps only more recently has full recognition been given to another facet of intellectual property and life sciences: the strategic importance of choosing and working with a strong pharmaceutical brand to allow the fundamental R&D in the product to mature to sales and worldwide product recognition. This choice is now being recognised as a vital part of the success of many products and as a highly valuable business asset.
Research highlights that, apart from their common function of limiting consumer confusion, pharmaceutical trademarks can also have an indirect influence on improving general public health. Strong trademarks not only assist healthcare practitioners in limiting common mistakes when forced to choose from among a large number of medical products with similar names, but also increase the ability of consumers to rapidly identify the drug of their choice.
Double checks for availability of new pharmaceutical trademarks
Given their potential impact on public health and safety, pharmaceutical brand names require the approval of two separate and distinct authorities. First, in Europe, the European Medicines Agency (EMEA) or a national health authority will need to approve the name based on a long list of criteria, including that the mark:
- is not misleading;
- does not risk causing consumer confusion either with prior marks or with existing international non-proprietary names (INN); and
- is not a derivative of a prior mark or existing INN or its stem.
All pharmaceutical products are identified with an INN – a global nomenclature that is used to stress the presence of an active ingredient in the drug. This is particularly helpful for healthcare professionals who need to be able to recognise a drug’s pharmacological properties when prescribing a medication.
Second, the pharmaceutical product name will need to acquire trademark registration for long-term protection and enforcement, which in Europe almost certainly means registration with the Office for Harmonisation in the Internal Market (OHIM) to confer uniform protection throughout the European Union.
Unfortunately, there is no coordination between OHIM and the EMEA, which has led to inconsistency in the decisions of the two bodies. They each address different matters and consequently have different approaches in evaluating the likelihood of confusion of a proposed name.
According to the recommendations of the World Health Organisation (WHO), in order to avoid any confusion – which could affect patients’ health – INNs cannot be used as pharmaceutical trademarks. However, trademark law looks at the question from a completely different perspective and is directed at protecting the business interests of rights holders. Generally, at trademark offices the examiners’ primary concern is to ensure that a term that needs to be kept free for general use is not monopolised by a single business. By contrast, pharmaceutical authorities focus on protecting public health. Health authorities therefore need to ensure that a trademark does not create confusion in terms of creating misunderstandings in the pharmacological effect of medicinal products.
Naming process for pharmaceutical trademarks
Unlike trademark owners in other business sectors, pharmaceutical companies face a variety of additional issues, including health regulatory requirements, linguistic marketing issues and political factors. Finding an effective and acceptable pharmaceutical brand name can thus be an intense and sometimes complex procedure.
The timeline from development of a name to marketing launch can be lengthy. It is therefore advisable to commence the naming selection one to two years before the marketing launch.
Initially, potential candidate names considered suitable for the medication concerned are selected by the in-house pharma marketing team or by an appointed advertising agency. Given the complex legal and regulatory screening, pharmaceutical companies usually identify a large selection of potential names in order to arrive at a choice of between four and five candidate names for each product – the EMEA Invented Names Review Group (NRG) accepts up to four names.
It is common practice to select key words for potential pharmaceutical brands, which will allow end users to rapidly make a connection between the medical product they are looking for and its active ingredients, the disease it is prescribed to cure or at least the organ to which it relates.
A degree of descriptiveness is normal in the pharmaceutical field, since this corresponds to the obvious need for recognition and certainty required for consumers to identify the products they need and to avoid health risks due to non-identification of appropriate medication. Accordingly, the relevant (Italian and European) case law in this field often considers slight modifications or additions to brand names as sufficient to avoid a likelihood of confusion (ie, the threshold for distinctiveness and non-descriptiveness in the pharma field is lower than that in other trademark fields).
However, in order not to create weak or confusingly similar trademarks, it is advisable to avoid certain prefixes and/or suffixes (eg, ‘pharma’ or ‘anti’).
It is also common practice for many pharmaceutical companies simply to add further letters to a specific pharma stem (based on the drug’s chemical compositions), thus forming names that are very close to the name of the active ingredient or INN name – although this does carry the risk of rejection from the EMEA. It is advisable to try to avoid similarities in spelling and pronunciation with existing trademarks, generic names and ingredient names. It is also advisable to avoid medical abbreviations, dose designation or symbols that might contribute to medical errors. Best practice also suggests avoiding modifiers that consist of numerals, as well as avoiding modifiers of trademarks that have no established meaning or that might otherwise cause confusion. It is advisable to avoid referring to inert or inactive ingredients which could be misleading.
The pros and cons of the practice of adding letters to the generic stems are evident: on the one hand, this system reduces the risk of confusion between medications as well as the risks of medical errors, since healthcare professionals can immediately identify the pharmacological properties of a drug through the name given by the brand owner. On the other hand, abusing this practice may have an opposite and counterproductive effect. In the presence of a large number of very similar names relating to products in the same category, both professionals and consumers are likely to be more confused than ever. What is more, relying on a mark that is very close to the active ingredient name could limit the ability of consumers to link a medication to a specific company with a reputation, which is unlikely to result in favourable sales figures from a business perspective.
Pharmaceutical trademark and regulatory clearances
Identifying potential candidate names is just the start – legal and regulatory approval is the next, more difficult hurdle. Considering that pharmaceutical products are usually intended for the global marketplace, trademark availability across multiple countries is fundamental, especially in countries where the final products are to be sold or where the business has subsidiary offices.
Global pharmaceutical trademark clearance searches are therefore vital when launching a new product. This is advisable not only to avoid confusion with prior marks in the registers, but also to avoid names which – due to the language of the local jurisdiction – may have negative connotations. As indicated above, obtaining the go-ahead from both the health authority and the appropriate trademark registry or registries, depending on the jurisdictions involved, is essential.
Trademark and regulatory searches, including legal opinions from specialised trademark attorneys or law firms, can be expensive. However, this cost can be reduced by narrowing searches down to the most important countries first. In the event of evident obstacles to registration in one of the selected countries, companies may revert to a different name, thus avoiding unnecessary expense for simultaneous global searches and applications.
Slogans and taglines
A recent trend for companies seeking original and highly recognisable brands is to register slogans and taglines as trademarks. Although the relevant regulations do not explicitly list slogans and taglines among the signs that are likely to constitute a trademark, in principle they can be protected under Article 4 of the EU Community Trademark Regulation (207/2009), which states: “a Community trade mark may consist of any signs capable of being represented graphically, particularly words.” The presence of the plural has been interpreted as covering a combination of words, including slogans.
The power of slogans and taglines has transformed marketing techniques for some businesses – a prime example being Pfizer’s ‘More than Medication’ taglines. However, slogans continue to represent a challenge for pharmaceutical companies.
Slogans must conform to the usual conditions set out for other trademarks, which means that they generally need to appear on the packaging. For pharmaceutical owners, positioning all information on the packaging can represent a practical concern where minimum requirements must be included in the labelling and packaging of pharmaceutical products, since special rules ensuring a degree of standardisation within the European Union apply. In addition, pharmaceutical products are subject to specific packaging sizes, making room for slogans or taglines on the product itself impractical.
However, even if slogans and taglines are sometimes regarded as unnecessary or unsuitable for the pharmaceutical industry, they are nevertheless effective marketing tools. Even if not applied directly on the products, slogans and taglines may be strategically placed alongside the drugs on promotional pharmacy displays or in advertising campaigns. Success in the pharmaceutical arena – as in all other areas – requires that product names acquire a high degree of distinctiveness. It is long been proven that strong slogans and taglines are excellent tools in allowing companies to build and maintain brand identity in the minds of consumers.
Trademark registration strategy
Having found an attractive, memorable and marketable name, a wise and cost-effective registration strategy is essential.
Besides national registrations, European companies – depending on their locations – have three main choices when seeking trademark protection in overseas territories:
- national registration;
- a Community trademark; and/or
- an international registration.
In order to benefit from the advantages offered by national trademark registrations, larger pharmaceutical companies tend to file national trademarks in key countries – generally, in those countries where their subsidiaries are located. By contrast, the vast majority of companies follow the Community trademark or international registration route, due to the obvious cost benefits.
In most circumstances, Community trademark registration represents the best option for companies seeking to market products in Europe, since it offers a unified system of protection throughout the European Union. On the other hand, limiting registration to Community trademark registration is insufficient for companies operating globally, where international registrations through the Madrid Protocol are instead required, enabling businesses to protect their rights in member states – including the United States, Russia, China, India, Australia and Switzerland.
Registering a trademark ensures that pharmaceutical companies can enforce their IP rights both through customs authorities and through the courts in the event of trademark infringement and counterfeiting.
Handling social media exposure
Social media represents the most dynamic marketing tool available to businesses. Over the last few years, pharmaceutical companies have been more reluctant than businesses in other sectors to enter this arena, due to the risk of liability for communications published on their own websites or discussion boards, feeds and posts on their social media pages that violate strict pharma advertising laws for medicinal products.
However, social media has become increasingly important, allowing companies to reach a larger global target market. In particular, social media allows pharmaceutical companies to interact more closely with individuals, as well as larger groups of patients, and has also become a brilliant tool for promoting understanding of drugs and their side effects.
Pharmaceutical companies using these tools can rely to some extent on the remedies that social media provides to rights holders. Reporting and closing down sites selling counterfeit products is now commonplace, and special branches of the police throughout the world work closely with Interpol to prevent sales of counterfeit and dangerous drugs being traded under blockbuster pharma brand names.
Alarming research studies report that the sale of counterfeit pharmaceutical products continues to increase dramatically. This has a twofold negative impact: first for public health in general and second for the businesses concerned in terms of lost profits and harm to image and reputation. Counterfeit products are often poor quality – while they may be completely harmless (eg, white flour), they do sometimes contain dangerous substances, which creates serious risks for health and safety.
As indicated above, pharmaceutical businesses can take positive measures to prevent the marketing of counterfeit pharmaceuticals by requesting local border control and customs authorities to prevent the import of goods that are suspected of infringing their rights. Rights holders can file an application with the customs authorities, providing them with useful information to help distinguish between genuine and counterfeit products. The information relating to the original products may include not only descriptions of the products, but also:
- examples of holograms and bar codes;
- an indication of the exact position of features on the goods and their appearance; and
- typical features of the markings, labels and packaging.
Identifying counterfeits is often a difficult task that requires substantial effort on the part of both the rights holders and the customs and border control authorities. Experience illustrates that – at least in Italy – close collaboration can bring about effective results.
The road to bring a new pharmaceutical brand name from conception to market is often arduous, time consuming and expensive. Diligent pre-filing screening processes with the relevant health authorities and trademark registries are essential to ensure a safe passage to application for registration and trademark protection and enforcement later down the line. It is only with effective applications for registration and registrations in place that a product will be ready for marketing launch. If a memorable and marketable mark is identified and the correct processes are followed, research confirms that the chances of increased sales are substantially higher. Further, when infringement and counterfeiting ultimately surface – as they inevitably will with any successful product, whether pharmaceutical or otherwise – the rights holder will be well equipped to carry out appropriate enforcement measures and protect its carefully chosen brand.
This article first appeared in IAM magazine. For further information please visit www.iam-magazine.com.