KONSTATIN TRONIN / SHUTTERSTOCK.COM
Pharmaceutical trademark owners in Australia should carefully select and register their marks to minimise potential problems associated with including INNs or INN stems, as Geordie Oldfield of Dennemeyer explains.
In Australia, the selection and registration of pharmaceutical trademarks requires special attention. Examiners are much more likely to object to a trademark based on likelihood of causing deception or confusion if the application covers pharmaceuticals or related products. Furthermore, the increasingly crowded state of the trademark register mandates careful management. Nevertheless, consideration of the manner in which pharmaceuticals are distributed and sold can assist pharma trademark applicants in paving a path to registration and use in Australia.
When selecting a pharma trademark for registration in Australia, it is crucial to consider whether the mark is, or contains, an international nonproprietary name (INN), or an INN stem. Managed by the World Health Organisation (WHO), the INN programme aims to identify pharma substances by unique, universally recognisable names. An INN is in effect the generic name for a substance. Paracetamol is an example of an INN. A number of INN databases are available online; one example is the Australian Trade Marks Office’s (ATMO) online search facility for INNs.
The INN programme also guides the use of word stems which are given to pharmacologically related substances. The suffix ‘-astine’ for antihistaminics is an example of an INN stem. The ATMO’s manual for examiners includes a list of INN stems. However, the WHO’s publication called “The use of stems in the selection of INNs for pharmaceutical substances”, available on its website, is a more comprehensive source of INN stem information.
The ATMO routinely objects to applications to register marks for pharmaceuticals or veterinary substances where the mark is, or contains, an INN or an INN stem. The office may object to an INN or INN stem on the basis that:
Because of a connotation of the INN or INN stem, the use of the trademark in relation to the goods would be likely to deceive or cause confusion (under section 43 of the Trade Marks Act 1995); and/or
If the mark in its entirety is identical or confusingly similar to an INN or identical to an INN stem, the mark is not capable of distinguishing the applicant’s goods from those of other persons (under section 41 of the act).
In 2012, the ATMO adopted the practice of raising an INN stem section 43 objection when all of the following criteria apply:
Goods covered by the application include pharmaceutical, veterinary or related class 5 products;
The trademark consists of, or includes, an INN stem;
The goods cited in the application are not restricted to the substance indicated by the INN programme definition; and
In circumstances where a trademark contains one or more elements in addition to the INN stem, the stem is ‘meaningful’ enough to give rise to a section 43 objection.
Concerning the last criterion, the office originally considered a stem not meaningful enough only if it formed part of an ordinary English word. For example, the stem ‘-quin(e)’ within the mark ‘Happy Equine’ would have been considered not meaningful enough to give rise to an objection.
Following some disquiet in the attorney profession and formal hearings to consider some applications with section 43 INN stem objections, the office changed its INN stem examination policy. It now considers whether the following factors are present when assessing whether a stem is ‘meaningful’ enough:
The stem is much shorter than the entire mark;
The presence of the stem is clearly overwhelmed by the meaning of the trademark as a whole;
The suffix is in common use other than in its INN-stem connotation, as shown by both the state of the register and the marketplace;
The INN stem is two or three letters long;
There are other or alternative obvious suffixes present in the trademark; and
The INN stem is non-specific.
The examiner’s manual suggests that either the first or second factor may in itself render the stem not meaningful (part 29, section 4.3.3). A 2012 ATMO hearing decision involving Boehringer Ingelheim suggests that where most of the third to sixth factors are present, a section 43 objection should not apply. In that case, Boehringer overcame a section 43 objection to the stem ‘-ol’ in Zelcivol.
The process adopted by the office is relatively formulaic and therefore straightforward for examiners to execute. It is worth noting, however, that an Australian court has yet to consider circumstances in which an INN stem renders a pharma trademark likely to deceive or cause confusion. A court might well pay more attention to the primary legislative requirements than to the office’s formulaic approach.
"Although the myriad of existing pharma trademarks raises challenges, Australian trademark law takes into account the particularities of the pharma market and allows somewhat similar marks to coexist."
After identifying an INN stem in a proposed trademark, it is also important to carefully review the WHO INN publication itself. Information in the publication will sometimes assist in formulating arguments against a section 43 objection. For example, in respect of some stems, the publication:
Lists names in which the stem has been used but not in accordance with its definition; and/or
Includes a note that the stem is no longer formally acknowledged by the INN programme.
A crowded class
On the Australian trademark register the number of marks in class 5, and in particular the number of marks relating to pharmaceuticals, is relatively high. Although Australia is not one of the largest pharma markets, the absence of a continuing requirement to periodically prove use of the trademark results in broad statements of goods and a relatively high number of marks remaining on the register.
Implications of the crowded state of the register include:
Objections based on substantially identical or deceptively similar earlier-filed trademarks are more common (under section 44 of the 1995 act);
Applicants are well advised to consider adopting and protecting less traditional types of trademarks; and
It is increasingly important to conduct an Australian clearance search before using the trademark in Australia.
When comparing marks under Australian trademark law, it is appropriate to consider the nature of the goods and the markets through which they will be purchased. Pharma trademarks that are somewhat similar are most likely to be allowed to coexist, but there are competing considerations:
On the one hand, pharma products are often selected by trained professionals who would be less likely to be deceived or confused when faced with somewhat similar trademarks. Furthermore, when allowing marks with a similar element to coexist, a court will be influenced by the number of marks already coexisting with those same elements, and the register is rife with coexisting pharma marks having similar or identical elements.
On the other hand, the potential public health consequences of deception or confusion in the field of pharmaceuticals are particularly significant.
A pharma applicant may be able to overcome a section 44 objection by restricting the goods to prescription pharmaceuticals. In 2005, a federal court judge provided the view that “prescription drugs are not likely to be confused with each other even when they are sold under a mark which is similar sounding or looking to a mark of another drug”. In that case, the trademark ‘Livalo’ was accepted for registration notwithstanding an existing registration for ‘Livial’, as both marks were used in relation to prescription pharmaceuticals (Kowa Company v NV Organon). Before restricting goods to prescription pharmaceuticals, however, a pharma applicant should first carefully consider whether a prescription pharmaceutical may, in the future, come off prescription and be sold over the counter.
As well as traditional word and/or logo marks, pharma applicants are well advised to consider adopting other distinctive packaging elements and registering, for example:
Combinations of colours applied to goods or packaging, for example a combination of two colours applied to a pharmaceutical capsule; and/or
Combinations of shape and one or more colours.
Such non-traditional trademarks will often need to be accompanied by a carefully worded endorsement.
A search to ascertain whether a trademark is available for use and registration in Australia will always include the trademark register. As the Australian trademarks system operates on a ‘first to use’ basis, a clearance search should also seek to find indications of relevant existing common law rights, such as business and company names, domain names and internet websites.
Where pharma goods are contemplated, additional searches are required of:
The Australian Register of Therapeutic Goods, which lists therapeutic goods that can be lawfully supplied in Australia; and
INN and INN stem databases.
Specialised management of pharma trademark selection and registration in Australia can minimise potential problems associated with the inclusion of INNs or INN stems. Although the myriad of existing pharma trademarks raises challenges, Australian trademark law takes into account the particularities of the pharma market and allows somewhat similar marks to coexist.
Applicants are well advised to consider producing distinctive products and obtaining trademark protection beyond the traditional word and logo marks. The importance of searching and obtaining local advice before deciding on a trademark is particularly important in the high-stakes, crowded pharmaceuticals field.
Geordie Oldfield is a principal at Dennemeyer. In addition to working with a large Australian IP firm, he previously worked within the European head office of an international pharmaceutical company. His current practice includes pharmaceutical trademark and patent matters. He can be contacted at: email@example.com
ATMO, INNs, Dennemeyer, Geordie Oldfied, IP, Australia, trademark, WHO,