GeneralIP LawTrademarksPharmaceutical Trademarks and Patient Safety

Trademark law is fundamentally concerned with the identification of commercial origin. By enabling consumers to distinguish the goods of one undertaking from those of another, trademarks facilitate competition, protect business reputation and support informed purchasing decisions. In the pharmaceutical sector, however, the significance of a product name extends beyond these conventional functions. The name of a medicinal product may influence prescribing decisions, dispensing practices and the selection of the medicine ultimately administered to a patient. A name that is insufficiently distinguishable from that of another product may therefore give rise to consequences that extend well beyond the commercial interests of competing undertakings.

This particular characteristic of the pharmaceutical market calls for a closer examination of the relationship between trademark protection and public health. Pharmaceutical companies have a legitimate interest in creating distinctive, commercially valuable names that enable their products to establish a recognisable identity. Yet the exercise of that commercial freedom cannot be considered independently of the risks associated with medication errors. A name may be memorable and commercially attractive while remaining unsuitable because of its similarity to another medicinal product or the misleading impression it creates about efficacy, safety or composition. The legal assessment of pharmaceutical names must consequently account for both their commercial function and their potential implications for the safe use of medicines.

This relationship is reflected in the Turkish Medicines and Medical Devices Agency’s (TITCK) Guideline on the Naming of Human Medicinal Products (IRD-KLVZ-25), which is scheduled to enter into force on 1 January 2027. The Guideline seeks to prevent medication errors arising from pharmaceutical names and establishes the procedures governing the assessment of proposed names. Its approach is particularly relevant to trademark law because it places the reliable identification of medicinal products and the protection of public health alongside the need to distinguish one product from another.

Under Article 4 of Turkish Industrial Property Code No. 6769, a trademark must be capable of distinguishing the goods or services of one undertaking from those of other undertakings. Distinctiveness is therefore not merely a commercial advantage; it is a fundamental requirement of trademark protection. Article 5 of Turkish Industrial Property Code No. 6769 sets out the absolute grounds for refusal, including lack of distinctive character and, subject to the statutory conditions, signs that are descriptive or liable to deceive the public. These principles acquire particular practical importance in the pharmaceutical sector, where the ability to distinguish between products may affect decisions made by healthcare professionals as well as patients.

The distinctiveness of a pharmaceutical name should not, however, be assessed solely by considering whether it appears sufficiently original when viewed in isolation. The circumstances in which the name is likely to be encountered are also relevant. Medicinal products may be selected from electronic prescribing systems, identified in dispensing lists, communicated orally or referred to in handwritten prescriptions. A difference that appears obvious in a carefully presented written comparison may be considerably less apparent when a name is read quickly or spoken aloud. The practical question is therefore whether the proposed name provides a sufficiently clear means of distinguishing the product from other medicines in the circumstances in which it will be used.

Article 6 of the TITCK Guideline addresses this issue by identifying factors relevant to the assessment of similarity between commercial names, including common prefixes or suffixes, identical initial or final letters, and similarities in length and syllabic structure. The Guideline also requires account to be taken of the names of medicinal products whose marketing authorisation procedures are still pending. These requirements recognise that the risk of confusion cannot be assessed exclusively by reference to products already authorised and available on the market. Names under consideration may also be relevant to the overall assessment.

The relationship between distinctiveness and patient safety becomes even more apparent when the likelihood of confusion is considered. Under Article 6 of Turkish Industrial Property Code No. 6769, an application may be refused where the relevant statutory conditions concerning an earlier trademark and the likelihood of confusion are satisfied. Article 7 defines the scope of trademark rights and provides protection against certain unauthorised uses of identical or similar signs. In determining the likelihood of confusion, the relationship between the goods, the similarities between the signs and the perception of the relevant public must be considered in accordance with the applicable legal framework.

In pharmaceutical cases, the consequences of confusion may be particularly serious. Two names that are easily mistaken for one another may lead to the selection of a medicine containing a different active substance, a different strength or a different pharmaceutical form. The potential consequences are not limited to financial loss, damage to reputation or the diversion of customers from one undertaking to another. Depending on the circumstances, an error may affect the treatment received by a patient. This does not mean that the trademark law test for confusion should automatically be replaced by a patient-safety assessment. Rather, it highlights the importance of examining the practical context in which pharmaceutical names are used when applying the relevant legal principles.

The TITCK Guideline accordingly discourages names that are difficult to pronounce or contain sequences of vowels or consonants liable to cause misidentification. Its emphasis on the written and spoken characteristics of names reflects the need for pharmaceutical products to remain distinguishable in ordinary clinical and dispensing practice. The broader significance of these provisions lies in their recognition that a name can perform its commercial function inadequately if it cannot be reliably distinguished from the names of other medicines.

Nevertheless, the regulatory assessment of pharmaceutical names must be distinguished from the examination of trademark registrability and infringement. Article 2 of the Guideline expressly excludes matters relating to the protection of trademarks and trademark infringement from its scope. A name considered acceptable by TITCK is therefore not necessarily free from conflicts with earlier trademark rights. Equally, registration of a trademark does not establish that the name satisfies the regulatory requirements applicable to medicinal products. The two regimes may address overlapping concerns, particularly similarity and confusion, but they operate for different legal purposes and under different procedures.

A similar relationship can be observed in the treatment of misleading names. Under Article 5(1)(f) of Turkish Industrial Property Code No. 6769, signs that are of such a nature as to deceive the public, particularly as to the nature, quality or geographical origin of goods or services, may be refused registration. In the pharmaceutical sector, misleading implications concerning efficacy, safety or therapeutic indications are especially sensitive because they may influence the expectations of healthcare professionals and patients. The name of a medicine should not suggest that the product is more effective than the available evidence supports, that it is free from risk or that it can be used for indications beyond those for which it has been authorised.

Article 6 of the TITCK Guideline directly addresses such concerns. It identifies as problematic names that imply unsupported superiority, exaggerate efficacy, present the product’s risk profile in an unjustifiably favourable manner or create a misleading impression concerning the range of its therapeutic uses. The examples given in the Guideline, including “NoRisk” and “MultiCure”, illustrate how a commercial name can communicate more than a product’s identity. Such expressions may lead users to infer that a medicine has no meaningful risks or offers a broader therapeutic benefit than has been established.

From a trademark law perspective, the issue is not whether a name is persuasive or commercially appealing in itself. The relevant concern is whether the sign falls within the applicable legal restrictions on misleading indications and whether its use complies with the regulatory requirements governing pharmaceutical names. A commercially attractive name cannot be considered suitable merely because it distinguishes the product from competing brands. Its implications for the understanding of the product must also be taken into account.

The distinction between commercial names and International Nonproprietary Names (INNs) further illustrates the particular nature of pharmaceutical branding. INNs, established through the World Health Organization, provide standardised names for active substances and serve a function different from that of a trademark. An INN identifies the active substance, whereas a trademark identifies the commercial origin of a product. Maintaining a clear distinction between these two functions is important both for reliable pharmaceutical nomenclature and for the proper operation of trademark protection.

The TITCK Guideline addresses this distinction by restricting the derivation of commercial names from INNs and the use of INN stems in commercial names. It also requires potential similarities between proposed names and existing INNs to be considered. These provisions seek to reduce the risk that a commercial name will be confused with the name of an active substance or with terminology associated with another substance. They also raise a broader concern familiar to trademark law: exclusive rights should not unnecessarily restrict terminology that other market participants need to identify or describe their products.

The relevant legal analysis must nevertheless remain within the limits of the applicable provisions. The Guideline’s restrictions on pharmaceutical naming should not be treated as identical to the rules governing the registrability of descriptive signs under Turkish Industrial Property Code No. 6769. Although both frameworks are concerned with clarity and the proper function of names, their legal tests and consequences are distinct. For pharmaceutical businesses, the practical implication is that a proposed brand should establish its own commercial identity rather than rely excessively on the established name or stem of an active substance.

The same distinction between commercial identity and product identification applies to strength, pharmaceutical form and route of administration. These elements may accompany a trademark without themselves performing the same distinguishing function as the commercial name. Nevertheless, they are essential to the accurate identification of the medicinal product. Articles 5 and 8 of the TITCK Guideline regulate the structure of proposed names and the expression of strength, including the use of appropriate units of measurement and the presentation of quantities for products containing multiple active substances. The Guideline also addresses the expression of micrograms as “mcg” or in full rather than using the symbol “μg”, in order to reduce the risk of prescribing errors.

Such requirements demonstrate why pharmaceutical naming cannot be reduced to the creation of a distinctive commercial sign. A name may satisfy the requirements of trademark distinctiveness while the accompanying strength information remains ambiguous. Conversely, accurate dosage information does not, by itself, render a commercial name distinctive. The two functions must therefore be considered together without being conflated: the trademark indicates commercial origin, while the associated information assists in identifying the particular medicinal product and its characteristics.

These considerations are particularly important for fixed combination medicinal products containing more than one active substance. The TITCK Guideline recognises that including the names of all active substances may create difficulties in electronic prescribing and dispensing systems, while referring to only one substance may give the misleading impression that the product contains no others. The proposed name must therefore be assessed in light of the product’s composition and the potential for confusion with other medicines, rather than on the basis of commercial branding considerations alone.

The Guideline also calls for particular attention to be paid to the naming of high risk medicinal products. This reflects the fact that the consequences of a naming error may vary according to the product concerned. Where an incorrect selection could have serious or lasting effects, ambiguity in the name or associated dosage information may warrant especially careful scrutiny. From a trademark law perspective, this reinforces the importance of considering the nature of the goods and the practical circumstances in which a sign will be encountered. It does not, however, mean that the Guideline automatically creates a separate trademark registration standard for high risk medicines. Trademark registrability and infringement remain governed by the applicable provisions of Turkish Industrial Property Code No. 6769, while the Guideline addresses the regulatory acceptability of pharmaceutical names.

The distinction between trademark protection and regulatory approval also has practical consequences for the development of pharmaceutical brands. Under Articles 11 and 12 of the TITCK Guideline, proposed names are submitted through the relevant application process and undergo preliminary assessment using the TITCK Name Compliance and Similarity Analysis System (TIBAS). Names meeting the applicable preliminary criteria are referred to the relevant scientific commission or board for final assessment. The Guideline provides for the submission of up to five proposed names and establishes the relevant assessment periods and validity requirements.

The similarity score generated by TIBAS forms part of this regulatory process. It should not, however, be treated as a substitute for the legal assessment of trademark similarity or infringement. A technical similarity score and the likelihood of confusion under trademark law are related but distinct matters. The former assists the regulatory assessment of pharmaceutical names; the latter must be determined under the applicable legal framework, taking account of the relevant circumstances and statutory requirements.

For this reason, pharmaceutical businesses should address trademark clearance and regulatory naming requirements as separate but coordinated stages of product development. A name may encounter objections under one regime even if it has been accepted under the other. Conducting trademark searches without considering pharmaceutical naming requirements may expose a business to regulatory difficulties, while relying solely on regulatory approval may leave it vulnerable to claims based on earlier trademark rights. An integrated assessment can reduce these risks while ensuring that commercial naming decisions support the reliable identification of medicines.

Ultimately, the TITCK Guideline demonstrates that pharmaceutical naming involves interests extending beyond the ordinary commercial relationship between trademark proprietors and competitors. Distinctiveness remains essential to trademark protection, and businesses retain a legitimate interest in creating recognisable and commercially valuable brands. Yet the name of a medicinal product must also be capable of distinguishing the product reliably, must not create misleading expectations concerning its characteristics, and must be consistent with the applicable requirements for presenting information about its strength and pharmaceutical form.

The relationship between trademark law and pharmaceutical regulation should not be understood as requiring commercial interests to yield entirely to public health. Rather, it calls for those interests to be pursued within a framework that recognises the consequences of inaccurate or confusing product identification. Trademark distinctiveness, the prevention of confusion and the prohibition of misleading signs provide relevant legal principles, while pharmaceutical regulation addresses the particular risks associated with the naming and use of medicinal products.

A pharmaceutical name is therefore more than a commercial label. It is an identifier used in a setting where ambiguity can have consequences for treatment and patient safety. The legal assessment of such a name must consequently extend beyond its capacity to distinguish one undertaking’s goods from those of another. It must also take account of whether the name supports accurate identification, avoids misleading associations and reduces the risk of confusion in the circumstances in which medicines are prescribed, dispensed and used. The challenge for pharmaceutical branding is to preserve the commercial value of a distinctive trademark without compromising the clarity and reliability on which the safe use of medicinal products depends.

 

References

• Turkish Industrial Property Code No. 6769