1. The Umbrella Trade Mark
It is a common experience that the choice of a particular type of product, whatever it may be (pasta, toothpaste, television, etc.), is influenced not only by its price, but also by the knowledge of its brand, understood as coming from a given company.
The trademark is the instrument with which companies legally protect their brand, and is represented by the set of signs (photos, drawings, characters, music, sounds, etc.) used to characterise individual products or services and distinguish them from those of other companies. Associated with the trademark is the logo, which refers to the graphic appearance with which the trademark is proposed, and may consist of a symbol, a word, or a combination of the two.
The trademark, together with the logo, therefore allows the consumer to identify a certain product as coming from a particular company, and is a fundamental part of the sales and launch strategy, being the element with which the producing company is identified and remembered by the general public. As well as enhancing the image of its adopter, the trademark is also destined to increase in value over time, as its notoriety and diffusion increases.
The umbrella brand concerns the hypothesis in which the trademark (not necessarily registered, so even a simple name or denomination) is used to identify several products, even very different from each other.
The umbrella brand allows, in particular, the consumer to recognise a family of products from a single company and transfers the 'value' generated on one product to another product, using the trust enjoyed by the former. The mechanism triggered by the umbrella brand also benefits the producing company, which 'multiplies' the trust in the products covered by the same brand and can obtain greater efficiency from its investments, such as advertising on the brand.
2. The pharmaceutical market and its peculiarities
In the pharmaceutical sector, an umbrella brand is used when the same trademark is used in the names of several medicines belonging to the same proprietor, which differ from each other in certain characteristics (such as, for example, composition, dosage, therapeutic indications, etc.).
There are numerous cases on the market, especially in the self-medication sector, which concern medicines for the treatment of colds (coughs, colds and sore throats), or analgesic medicines, and which represent the so-called 'typical' cases of use of umbrella brands.
But market practice reveals the presence of umbrella brands used to characterise also medicines with different supply or dispensing regimes (SOP, OTC, RR), and even product lines belonging to different product classes (medicines, medical devices, food supplements, cosmetics, etc.).
The peculiarity that characterises the pharmaceutical sector (and, more generally, the entire health field) means, however, that a commercial practice that is widespread and unchallenged in other sectors (think, for example, of the automotive, or clothing, or foodstuffs sectors), in which it is openly permitted for companies to use an umbrella brand to distinguish a series of products that are different from each other but still referable to the same origin, which symbolises a sort of 'guarantee' with respect to the characteristics of the goods and an affinity between the goods themselves, even in their also profoundly different intended uses, does not easily apply to products proposed in the sphere of health, the purchase of which must remain as free as possible from commercial 'conditioning'.
If, in fact, the Industrial Property Code attributes to the owner of the trademark the right to make exclusive use of the trademark itself (it is a private right), limiting itself to establishing that "it is not permitted to use the trademark in such a way (...) as to create a risk of confusion on the market (...), or in any case to mislead the market".), or in any case to mislead the public, in particular as to the nature, quality or origin of the products (...)" (cf. art. 21, para. 2, legislative decree 30/2005), in the case of pharmaceuticals, the issue of potential confusability/confusability is also relevant with reference to the protection of the right to health, enshrined in art. 32 of the Constitution, which could be violated in the event that the consumer, misled by the similarity of the name of the different products, would take one product instead of another.
For this reason, not always and not everywhere have the various national regulatory authorities reached unambiguous approaches on the subject of umbrella brands, in the perennial search for a balance between the protection of freedom of enterprise and the protection of public health.
3. The Italian Situation
In Italy, unlike in other European Union countries, there is no specific ad hoc regulatory framework on the use of umbrella brands in the pharmaceutical (and parapharmaceutical) sector, but a case-by-case approach by the Regulatory Authority (the Italian Medicines Agency - AIFA for medicines, the Ministry of Health for medical devices, food supplements and cosmetics) prevails.
This entails a certain margin of discretion for the Health Authorities (understood as a margin of technical choice for the Administration, to be exercised always in compliance with the canons of the exercise of public powers), which precludes the identification of unambiguous solutions on the subject even at a national level, and envisages the need for an in-depth concrete assessment of the individual case, in order to establish whether and to what extent the use of the same trademark (or name) may be lawful and admissible.
3.1. Historically, with particular reference to proprietary medicinal products, AIFA's approach to the legitimacy of the use of the umbrella brand has proved to be restrictive (albeit without unambiguous outlets) and, in this regard, the guidelines expressed by AIFA's Technical Scientific Committee (CTS), in some informal documents dating back to 2006 and 2008[1] which, although not binding, reflect the Agency's modus operandi on the subject under discussion, are significant.
In particular, both documents stated that "it is also possible to use the same trademark to identify medicinal products with different active ingredients, dosages and therapeutic indications", provided, inter alia, that the condition that the trademark is "always accompanied by additional elements referring exclusively either to the therapeutic medicinal product category, or to the indications of the medicinal product, or to other information that unambiguously identifies the product and allows the patient a specific identification with respect to other packages bearing the same trademark is respected: Fancy names or names intended to characterise the medicinal product according to improper suggestions of use are not permitted'.
Moreover, in the 2006 document, the CTS had also specified that 'the name (brand) used must not induce surreptitious, improper or dangerous consumption of products that fall under the same brand name, especially if some of them fall under the classification "subject to prescription"'[2] .
In any case, both documents were clear in expressing the opinion that "the name (trademark) must not be used, even partially, for goods other than medicinal products (e.g. medicinal/integrator, medicinal/cosmetic, medicinal/surgical medical device, etc.)".
3.2. These guidelines have been more recently taken up and 'codified' by AIFA in the document 'Questions & Answers on Authorisation Processes for National, Mutual Recognition and Decentralised Procedures' of March 2022, where it was reiterated that:
"It is possible to propose as a name for a medicinal product an "umbrella brand", i.e. a trademark that is the same or similar to that of a medicinal product already on the market, accompanied by additional elements called "qualifiers". The use of the umbrella brand is considered acceptable only if the following conditions are met:
1) the umbrella brand must always be accompanied by additional elements referring exclusively either to the pharmaco-therapeutic category, or to the indications of the medicinal product, or to other information that unambiguously identifies the product and allows the patient a specific identification in relation to other packages with the same or similar trademark: trademarks intended to characterise the medicinal product according to improper suggestions of use are not permitted;
2) the name (trademark) must not be used, not even in part, for goods other than medicinal products (e.g.: medicinal product/integrator, medicinal/cosmetic product, medicinal/surgical aid, etc.)'.
3.3. It follows, therefore, from the foregoing that the Agency's concern seems to refer, in particular, to the fear that a link through the use of an umbrella brand between different medicines could lead to confusion among patients as to the nature of the products, with possible consequent inappropriate consumption choices, or improper and even dangerous uses, since the similarity between trade names of different medicines constitutes one of the most frequent risk factors of errors in therapy. Hence the need to "unambiguously identify the product" and to "allow the patient a specific identification" of the same with respect to other medicines having the same brand name, especially if they have a different active ingredient, dosage and/or therapeutic indication.
Moreover, the position implies the need to prevent the phenomenon of the so-called 'halo effect' of advertising, in two respects
- possibility that advertising to the general public of products for which such activity is permitted (e.g. medical devices, but also OTC and SOP) reverberates on products for which, conversely, advertising is not permitted (e.g. RR medicines);
- attribution of a medical aura to products that have no such connotation nor can have it (e.g., food supplements, medical devices and cosmetics) due to the effect of the reflex generated by a name that is equal, even only in part, to that of a medicine.
In reality, as has been said, the rigorousness of this approach does not always find correspondence in market practice, which we know to be multiform and varied, inasmuch as it is the result of a reflection of the activities of the Authorities that have powers over authorisations (e.g. in the field of medicinal products), acknowledgements (e.g. on notifications of supplement labels) and supervisory activities (common to the various sectors).
3.4. To make the picture described above more complex, the revision of AIFA's Q&A Document last June (Rev. 1 of 1 June 2024) introduced the clarification that 'reference is made, for further information, to the EMA document 'Guideline on the acceptability of names for human medicinal products processed through the centralised procedure' (Rev. 7 of 4 December 2023), which, in turn, lays down a very detailed and precise set of criteria for the evaluation by the European Agency of brand-names proposed as names for medicinal products within the centralised procedures.
The latter deal with the same umbrella brand issue in Section 4.1.11, but in substantially different terms. It is in fact stated (a clarification absent in the previous Rev. 6 of 22 May 2014) that "As a general principle, the inclusion of a common umbrella segment (e.g. part of the name of the sponsor) within the invented names of different medicinal products is not acceptable as it creates a link which may lead to confusion and medication errors (see section 4.1.5). Other forms of umbrella branding, such as those related to the composition of active substances, may be accepted on a case-by-case basis. The use of an umbrella segment may be accepted in a first instance for a proposed invented name, only if the portion used is not significant and evident when the name is considered as a whole. However, the NRG [Name Review Group] will not accept the use of the same segment in a second instance"[3] .
However, a textual reading of the EMA document does not clearly show the actual scope of application of the provision, especially in the part where it distinguishes between "first and second instance". It should be borne in mind that this point was the subject of a number of proposed amendments in the public consultation held between 16 December 2021 and 16 March 2022. As a result of that consultation, in particular, a text was 'dismissed' in which a 'umbrella segment' (e.g, part of the sponsor's name), while allowing possible exceptions (e.g. with regard to the composition of the active ingredients), to be assessed (and justified) on a case-by-case basis, having regard to the concrete risk of confusion (and consequent therapeutic error) to which such use might give rise.
This, moreover, is in accordance with Section 4.1.5 of the same EMA Guidelines, which, in turn, state that "The invented name of a medicinal product should not include the full invented name of another medicinal product. Exceptions may apply on a case-by-case basis depending on the potential for confusion and the level of similarity identified"[4] .
4. Open issues
Now, the combined reading of the two documents of AIFA and EMA raises some perplexities: the criteria enunciated by EMA appear, indeed, more restrictive than those (fully) indicated by AIFA. In particular, the 'relationship' between general rule and particular rule seems to be inverted: at the European level, the inclusion of a common umbrella segment within the invented names of several medicinal products is 'not acceptable, subject to exceptions'; for national procedures, on the other hand, the use of the umbrella brand is 'allowed provided that' certain precautions are observed. On the other hand, according to AIFA, such use is not permitted, not even in part, for goods other than medicinal products, and it is not clear whether this prohibition (unknown to the EMA Guidelines) can admit of particular exceptions.
These are not merely nominal differences, because then, in the context of procedural dialectics, the choice of one criterion or the other may entail different burdens and outcomes. Suffice it to consider the burden of proof: is it the Authority that must concretely contest the unacceptability of the mark proposed by the company, or is it the latter that must demonstrate the recurrence of a valid 'exception' to a fundamental prohibition? And again: the reuse, in the second instance, of the same umbrella brand (where, that is, the same has already been the subject of a previous authorisation), precluded by the EMA, how will it be assessed by AIFA?
It is clear that, as things stand, AIFA's Q&A document, with its 'referral' to the EMA Guidelines, instead of providing a contribution of clarification and transparency, risks generating confusion and potentially contradictory decisions with implications for the market. Leaving aside any assessment of the nature and legal effectiveness of this type of act, in fact, the hypothesis of a refusal in cases that have been positively assessed up to now, justified by the 'referral' to the EMA Guidelines, appears anything but abstract and remote, considering that some companies have already received a 'warning' from the Agency to this effect to be valid for future applications for authorisation relating to the naming of medicinal products.
If, therefore, this new approach were to be activated, it could also lead to serious distortions in the market, in which some companies, already operating for some time with their own umbrella brand, would continue to benefit from the more favourable conditions previously granted, while other operators - all things being equal - would be precluded from using the umbrella brand. In fact, it is natural to assume that - with unchanged legislation - the introduction of new (non-binding) 'criteria' for the usability of the umbrella brand does not in and of itself constitute a sufficient prerequisite to impose a generalised revision of all the designations already granted, unless (as has already happened) a proven situation of concrete danger to patient safety is ascertained in individual cases.
A further and different problem then relates to the possibility that AIFA's guideline may also apply in the (opposite) case of the use, for a new product other than a medicinal product (e.g. a medical device, or a food supplement, or a cosmetic), of a name (even partial) already adopted for a medicinal product. From this point of view, in fact, we know that AIFA's competence is limited to medicinal products, but nevertheless it is not possible to exclude a priori that, in turn, the Ministry of Health may autonomously 'adhere' to the orientation expressed by the Agency or, failing that, that the Agency may intervene in self-defence by revoking previous authorisations issued, in the light of the changed factual context (presence on the market of products belonging to different product categories with a name equal, even only in part, to that of a medicinal product).
5. Conclusions
In the light of the foregoing, it is therefore quite clear that there is a situation of great uncertainty and substantial and a priori injustice in which companies would find themselves operating should AIFA really intend to prohibit a priori the use of umbrella brands for medicinal products, especially given that the regulatory context has remained unchanged, nor does it appear that new and objective evidence has arisen in the meantime such as to require a reassessment of the Agency's previous position.
But even if we were indeed faced with a concrete problem of public health protection, it would be primarily up to the legislature (and not to AIFA) to intervene on the point. On the contrary, in the absence of an express statutory prohibition, the use of umbrella brands must be considered, in principle, permissible even for proprietary medicinal products, with the Agency, if anything, being able to intervene at the authorisation stage, introducing possible limits and prescriptions (to the extent strictly necessary to protect the overriding interest of public health), having regard to the risk that, in the concrete case, a given name might actually mislead patients/consumers.
Otherwise opining, an a priori denial of the use of the umbrella brand would have the effect of creating a 'schism' between the 'before' and the 'after' (there being on the market, as has been said, many examples of the use of umbrella brands to identify several medicinal specialities and even products belonging to different classes), as well as leading to the 'debasement' of the trademark (in particular for companies already operating for some time on the market, which could no longer rely on the recognition, reputation and visibility acquired by their brand to launch new products under the same name).
What is certain is that, pending any developments in the application practice of the Regulatory Authorities, the intention to use umbrella brands in the field of health products immediately suggests that companies should adopt prudential measures, from which one can deduce the absence, in practice, of deceptiveness of the trademark and, thus, of potential health risks, not only through recourse to those 'additional elements' referred to in the Q&A Document of AIFA, capable of identifying the product in an unambiguous and immediate manner (e.g., suffixes, prefixes, or other descriptive elements), but also by means of the adoption of graphic devices that are in turn distinctive (e.g., the different characters of the product names and/or the characteristics of the packaging in terms of colours and images and/or the presentation/advertising, etc.).
Lawyer Sonia Selletti (*)
Lawyer Annalisa Scalia (**)
(*) Astolfi e Associati Studio Legale, Milano.
E-mail: [email protected].
(**) Astolfi e Associati Studio Legale, Milano.
E-mail: [email protected].
[1] These are the minutes of the SCT of 12-13 December 2006 and of 15-16 January 2008.
[2] In this regard, already the circular of the Ministry of Health No. 115 of 30 November 1975 provided for the non-admissibility, among over-the-counter (OTC) products, of medicinal products whose brand name was common to specialties belonging to another category, although this restrictive interpretation was overcome and nullified in subsequent years by the same Ministry.
[3] Trad: "As a general principle, the inclusion of a common umbrella segment (e.g. part of the sponsor's name) within the invented names of several medicinal products is not acceptable as it creates a link that may lead to confusion and medication errors (see section 4.1.5). Other forms of umbrella branding, such as those relating to the composition of active ingredients, may be accepted on a case-by-case basis.
The use of an umbrella segment may only be accepted in the first instance for a proposed invented name if the portion used is not significant and obvious when the name is considered as a whole. However, NRG will not accept the use of the same segment in the second instance".
[4] Trad: "The invented name of a medicinal product shall not include the full invented name of another medicinal product. Exceptions may be applied on a case-by-case basis depending on the potential for confusion and the level of similarity identified'.