Australian objections to registration of pharmaceutical trade marks based on the inclusion of an International Non-Proprietary Name (INN) stem in the mark, remain a concern for trade mark applicants following a recent hearings decision.

Three earlier cases had found in favour of the trade mark applicants suggesting a significant change in the assessment of pharmaceutical trade mark applications. However, the latest decision suggests that any change practice may not be as great as some applicants had hoped.

Ceva Sante Animale (“Ceva Sante”) sought protection in Australia of an International Registration for the trade mark SYNCROSTIM for “veterinary products” in class 5.

The SYNCROSTIM trade mark was examined and IP Australia raised a ground for objection under Section 43, which provides:

An application for the registration of a trade mark in respect of particular goods or services must be rejected if, because of some connotation that the trade mark or a sign contained in the trade mark has, the use of the trade mark in relation to those goods or services would be likely to deceive or cause confusion.

The basis for the objection was that the trade mark contains the suffix –STIM, which is listed as an INN stem used to indicate that the pharmaceutical preparation incorporates colony stimulating factors. The Examiner contended that use of the trade mark for goods not containing such a substance would be likely to mislead or confuse consumers.

As is standard practice, the Examiner invited Ceva Sante to agree to a condition of registration limiting its use of SYNCROSTIM to goods containing substances belonging to the pharmacological group designated by the INN stem –STIM. Submissions were filed but failed to overturn the objection and Ceva Sante elected to be heard before a delegate of the Registrar of Trade Marks.

In earlier INN stem decisions concerning the trade marks ZELCIVOL (-OL), SERAQUIN (-QUIN) and CELOMID (CEL-) respectively, the delegates had found that similar conditions of registration should not be required. They referred to the policy objectives inherent in the Act as explained by the courts and stated:

The purpose of the current Act was given judicial consideration by French J in Registrar of Trade Marks v Woolworths [1999] FCAFC 1020; [1999] FCA1020; (1999) 93 FCR 365; (1999) 45 IPR 411; [1999] AIPC 91-499 at [47]:

The policy of the 1995 Act can be said to some extent to have shifted the balance of the objectives of trade mark law more towards the identification and protection of commercial products and services than the protection of consumers, although the latter remains an objective. In respect of deceptive trade marks the interests of consumers are also protected by comprehensive Federal and State laws relating to conduct which is misleading and deceptive or likely to mislead or deceive.

In other words, the Trade Marks Office is not an enforcement agency and other government bodies are better placed to assess and address instances of deception in the marketplace. Consequently, a ground under Section 43 will exist only where there is a real tangible danger of deception or confusion arising from a connotation within a trade mark.

In this context, Examiners are required to consider whether the presence of an INN stem in a trade mark is “meaningful” enough to give rise to a connotation sufficient to lead to deception or confusion.

The Woolworths case mentioned above also affirmed that there is to be a presumption of registrability during examination, and in opposition decisions it has been clear that strong evidence is needed to support an opposition based on s43. However, official objections to pharmaceutical trade mark applications under s43 appear to have little or no evidentiary basis.

In the earlier hearings decisions, the hearings officers considered as relevant factors such as: • use of the relevant stem by other traders;

  • the state of the Register;
  • acceptance in other countries;
  • the maturity of the Australian marketplace and the regulatory regime within that marketplace; and
  • the availability of comprehensive Federal and State laws relating to conduct which is misleading or deceptive or is likely to mislead or deceive.

After assessing the applications in the context of these factors, it was decided in each of those cases that a condition of registration was not required.

In the SYNCROSTIM case, the applicant provided evidence of:

  • parties using marks containing the part word STIM on veterinary products that do not contain a colony stimulating factor, and evidence of regulatory approval being granted for the sale of such products;
  • the state of the Register with respect to Class 5 marks, showing a significant number of unrestricted registrations for marks containing the suffix –STIM, or otherwise containing the part word STIM; and
  • information concerning registration in other countries.

The applicant argued that there is no evidence that persons will not recognise the suffix –STIM as being an INN stem, or understand it as having an INN stem meaning. It was pointed out that the suffix STIM is derived from the word “stimulate”. Since all veterinary pharmaceuticals “stimulate” a beneficial reaction within an animal’s body, it was stated that persons may reasonably view that part word in the trade mark as alluding to a product that stimulates reaction. It was also pointed out and acknowledged that generic names identifying the active ingredient in the product appear separately on the packaging of veterinary pharmaceuticals.

Although there was no contrary evidence, the hearings officer nevertheless concluded that relevant consumers would recognise the INN stem –STIM and be confused if the product did not contain substances belonging to the pharmacological group designated by the INN stem –STIM.

The practical outcome of such decision is that while applicants will not be prevented from using such marks, they may not be allowed the protection of a trade mark registration. No INN stem objection has yet been the subject of review by the courts.