Trade Mark First, SAHPRA Later; Or SAHPRA First, Trade Mark Later: A Chicken Or Egg Conundrum

The South African Health Products Regulatory Authority (“SAHPRA”) has recently updated its Guideline for proprietary names for medicines governing the proprietary names of medicines and setting out the criteria by which proposed medicine names are evaluated for registration in South Africa.

SAHPRA is the entity that is responsible for the regulation (monitoring, evaluating, investigating, inspecting and registering) of medicines and health products to ensure their safety, efficacy and quality. Its Names and Scheduling Unit evaluates the suitability and applicability of any proprietary name proposed to be used in connection with a medicine. The recently revised naming guideline provides direction to applicants, holders of certificates of registration, and regulatory pharmacists on how SAHPRA assesses the suitability of proposed medicine names.

The guideline addresses three broad types of names:

1. Product Names are the proprietary names of individual, unique, registered medicines and their line extensions. All SAHPRA approved proprietary names must be unique and distinctive, readily recognisable, and differentiable from every other proprietary name to avoid look-alike and sound-alike confusion.
2. Umbrella Names are collective proprietary names used for a range of co-branded but differentiated products targeting specified conditions or therapeutic goals. SAHPRA expresses concerns that umbrella names may blur product differentiation for consumers, potentially impacting appropriate product selection.
3. Company Identifiers or House Brands permit manufacturers to associate their company name with their products, facilitating brand recognition among patients and healthcare professionals.

In terms of the guideline, any proposed name is tested against the possibility that it may directly or indirectly pose public health or safety concerns, be misleading, or place patients and consumers at risk.

The guideline includes that proprietary names should preferably comprise a single invented word, and applicants are encouraged to propose names that are as short as practicable. According to SAHPRA, multiple-word names increase the risk of confusion and abbreviation by users. Hyphenated words and certain symbols (+, &, #, @, =, [, ], ') are prohibited while terms implying absolute efficacy (such as "MAX", "CURE", or "STOP") are discouraged. Ordinary English dictionary words and popular personal names (whether living, dead, or fictional) will not usually be accepted as proprietary names.  The use of qualifiers or abbreviations as part of a product name is acceptable where they provide additional product information, such as strength, route of administration, or dosage form.

As set out in the guideline, approval of a proprietary name by SAHPRA offers a form of exclusivity over the use of that name in a manner both analogous to, and distinct from, the form of exclusivity acquired by the registration of a medicine name as a trade mark in terms of the South Africa's Trade Marks Act (No. 194 of 1993). Both registration systems operate independently and serve different purposes, with SAHPRA's name approval rooted in patient safety and public health, whereas trade mark registration is rooted in the protection of intellectual property and commercial interests.

Critically, registration of a trade mark for a medicine name under the Trade Marks Act will not be taken into consideration when SAHPRA assesses the acceptability of a proposed proprietary name for a medicine.  This means that a pharmaceutical company cannot rely on an existing trade mark registration to secure SAHPRA's approval for use of that name on a medicine. SAHPRA applies its own criteria, centred on safety and clarity, with its assessment evaluating whether a name could be confused with another medicine's name in print, handwriting, or speech and taking into account numerous factors including registered indications, intended patient populations, dosage forms, routes of administration, strengths, dispensing settings, scheduling status, and the potential for harm from prescribing, dispensing, or administration errors.

Additionally, proprietary names must not be misleading with respect to therapeutic effects, product composition, or safety. SAHPRA subscribes to the World Health Organization's guidelines protecting International Non-Proprietary Names through the use of INN stems.

The guideline also expressly disclaims any role in determining whether a particular proprietary name may infringe another’s intellectual property rights. It states that this issue "cannot be one of SAHPRA's concerns and is therefore not taken into account during consideration of the acceptability of a proposed proprietary name." 

Similarly, SAHPRA's approval of a proprietary name cannot be relied upon to support any claims in respect of intellectual property rights over that name.  This means that securing SAHPRA approval does not establish or confirm trade mark ownership or validity.

So, what does all of this mean for when it comes to naming new health products in South Africa?

Choosing medicine names must be carefully and strategically considered, as part of a two-pronged clearance approach, balancing “safety-distinctive” with “marketing-distinctive” name options. A name that is a strong trade mark candidate (highly distinctive) can still be rejected by SAHPRA on safety or misleading grounds. Conversely, a name approved by SAHPRA can still be unavailable or risky from a trade mark perspective because SAHPRA does not test or consider infringement.

Ultimately, the “best” name will be one that is both distinctive, protectable and enforceable as a trade mark, and regulatorily safe with low look-alike/sound-alike risk. Although the guideline confirms that SAHPRA will take into account where a name has been approved by another major regulatory authority, foreign approval does not automatically guarantee acceptance by SAHPRA and so what is acceptable in one jurisdiction might not be acceptable in South Africa specifically. Developing multiple name options as ranked alternatives within a portfolio of options (noting that SAHPRA  recommends submitting three proposed proprietary names per application) and simultaneously conducting trade mark clearance searches on those multiple options is recommended. 

This “timing trap” arising from SAHPRA’s naming requirements and approval process, and third-party IP rights will also likely require applicants to integrate regulatory naming review and trade mark clearance as a single project plan with shared decision points going forward, rather than handing off sequentially between regulatory and trade mark teams.

It will be interesting to see what practical effect the guideline will ultimately have on the proprietary name approval process in South Africa.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.