Change of practice in Australia for pharmaceutical Trade Marks containing INN stems

Change of practice in Australia for pharmaceutical Trade Marks containing INN stems

Change of practice in Australia for pharmaceutical Trade Marks containing INN stems

We have previously reported on our lobbying efforts regarding the practice of the Australian Trade Marks Office to object to trade mark applications for pharmaceutical products in class 5 that contain an INN stem. The Office has been proactive in reviewing extensive feedback from practitioners and industry, and we are pleased to report it has now changed its practice to reflect many of the concerns raised.

What are INN stems?

International Nonproprietary Names (INNs) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized, public property and is approved by the World Health Organization (WHO). For example, in respect of PANADOL® paracetamol, paracetamol is the global INN for the pharmaceutical substance, while PANADOL is the brand name for the particular paracetamol product originating from the GlaxoSmithKline group of companies.

The names of pharmacologically related substances share a common INN “stem” which assists medical practitioners, pharmacists and others to recognise that the substance belongs to a particular group of substances having similar pharmacological activity.

Some stems are relatively inherently distinctive (eg. -gliflozin), whereas others are arguably not (eg. –ine).

What is the objection to INN stems within trade marks?

The Trade Marks Act 1995 (Cth) provides that a trade mark application will receive an objection if, because of some connotation of or within the trade mark, the use of the trade mark in relation to the applied for goods or services would be likely to deceive or cause confusion (section 43).

The Trade Marks Office will object under the section 43 ground to a trade mark in respect of pharmaceuticals, veterinary substances or pesticides which contains an INN stem:

  • if the INN stem is contained within the mark in “a meaningful way”. This has previously been given a very narrow application. The Office has previously considered INN stems are contained in a meaningful way unless they form part of an ordinary English word. For example, the stem –AST would be objectionable in an application for SIMIANAST but not in an application for FAST. The Office also gives the example that the presence of ‘aj’ in the term ‘Sansajabendorastine’ would not warrant objection given the length of the name and other competing references, but current experience suggests that slightly less extreme examples will warrant objection; and/or
  • the goods covered by the specification are restricted to substances belonging to pharmacological group pertaining to the INN stem.

The previous Office practice did not adequately recognise that some stems are not likely to be associated with a particular pharmacological group, for instance because the stem has not been used for several decades or because the relevant consumers are accustomed to seeing a high number of products on the market with trade marks containing the stem but which relate to a range of pharmacological groups.

The new practice for Trade Marks containing INN stems

The Office has now formalised a more flexible approach which we consider better takes into account the commercial realities relating to pharmaceutical trade marks.

The Office practice now qualifies the question of whether an INN stem will be viewed as being contained within the mark in a “meaningful way” with the following principles, indicating that where most of the following factors are present the section 43 ground for objection should not be raised as it is unlikely that the use of the INN-stem would deceive or cause confusion:

  • Both the state of the Register and the marketplace indicate that the suffix is in common use other than as an INN stem;
  • The INN stem is two or three letters long;
  • The INN stem will not necessarily be perceived as the suffix – such as where there are other obvious suffixes present. For example, in EXIMAL, -AL or –MAL might be seen as the suffix; and
  • In the context of the mark as a whole, the INN stem would not be generally considered as indicating only a particular kind of pharmaceutical because the prefix does not conform with the usual formulation relevant to the INN stem.

When do the INN stem changes come into effect?

The formal change of practice was implemented with amendments to the Examiner’s Manual as of 14 February 2013. However, we have noted a trend in recent months whereby individual examiners have already been applying the new, more flexible criteria and considerations. We have resolved several cases for our clients in recent months on this basis, without the need for clients to go to the expense of a formal hearing.

Implications for pharmaceutical companies in relation to Trade Marks containing INN stems

The formalisation of the change of practice suggests that pharmaceutical companies should receive less frequent objections to class 5 marks on the INN stem basis in future. In addition, when such objections are raised, a more flexible range of criteria will be considered in order to overcome the objection on the basis that a mark does not in fact contain a misleading connotation with respect to the INN stem.

The change of practice is a positive development for pharmaceutical companies, particularly those seeking to roll out global brands to Australia.

Trade mark owners in the pharmaceuticals, veterinary and pesticides field should continue to consult the list of INN stems when clearing names and be wary of selecting names in Australia containing an INN stem unless the product is destined for the relevant pharmacological group or can be shown not to contain an INN-stem connotation.