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Trade Marks Office outlines relevant principles for objecting to trade marks containing INN stems

By and |

Boehringer Ingelheim International GmbH [2012] ATMO 117 (30 November 2012)

A recent decision of the Australian Trade Marks Office will be welcomed by pharmaceutical companies seeking to register trade marks containing an INN stem.

The decision indicates the Office may be willing to take a more flexible and practical approach, considering all the relevant circumstances, when considering whether a trade mark containing an INN stem is likely to deceive or cause confusion as a result of the INN stem within the mark having a connotation.

DCC recently reported on the strict approach that has, until now at least, prevailed at the Office with respect to class 5 marks containing INN stems.

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, -on).

What is the basis for objection to trade marks containing INN stems?

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 of the Trade Marks Act 1995 (Cth)).

Grounds for rejection under section 43 exist where a trade mark to be used in relation to pharmaceuticals, veterinary substances or pesticides contains an INN stem in a meaningful way, and the goods covered by the specification are not restricted to substances indicated by the INN stem.

Boehringer's application for ZELCIVOL:

Boehringer Ingelheim International GmbH ("Boehringer") requested protection in Australia of an International Registration Designating Australia ("IRDA") for the trade mark ZELCIVOL for "pharmaceutical preparations" in class 5.

The application received a section 43 objection on the basis that the mark contained the suffix –OL which is an INN stem said by the Examiner to indicate ALCOHOL or PHENOL derivatives. If the mark was not to be used for goods or services containing or relating to these substances, the Examiner considered the mark would be likely to deceive or confuse consumers. The objection would, however, be overcome by agreeing to the following endorsement on the registration:

It is a condition of registration that any use in respect of pharmaceuticals will be limited to such goods containing substances belonging to the pharmacological group designated by the International Non-Proprietary Name stem OL.

Trade mark registrations in Australia can be cancelled on the ground that such a condition entered in the Register in relation to the trade mark has been contravened. Arguably, such a condition could also expose the registration to the risk of partial removal for non-use in time.

Boehringer requested a hearing.

Relevant factors to be considered by the Office in relation to INN Stems

The Hearing Officer found that the use of the INN stem was unlikely to deceive or cause confusion and accepted Boehringer's IRDA for protection in Australia.

Taking a sensible and pragmatic approach, he considered the following factors were relevant:

  • The suffix –OL is in comparatively widespread use in Australia in relation to pharmaceuticals which do not relate to the INN stem, as reflected by the state of the Register and the marketplace. The applicant had put in evidence ten examples of registered –OL marks in Australia in respect of pharmaceutical preparations which were unrestricted and without endorsement as to their chemical nature.
  • The suffix –OL is used by pharmaceutical companies as a "diminutive" to signify that the goods are pharmaceuticals, rather than a particular kind of pharmaceutical.
  • The suffix –OL is short in the context of the mark under consideration, and is not obviously being used as an INN stem because the prefix ZELCIV- does not conform to the usual formula for construction of names for alcohols or phenols.
  • The more logical suffix in the trade mark ZELVICOL is –VOL rather than –OL.
  • Other countries in which protection of the IRDA has been extended have not restricted the scope of protection on this basis. The applicant put in evidence that the protection of the IRDA, or separate national registrations for ZELVICOL, had been granted by 16 other Trade Marks Offices, including OHIM (for the EU), the USA and Canada, and that the market for pharmaceuticals in many of those countries was analogous to that in Australia.
  • Use of the trade mark on drugs other than those containing alcohol or phenol would be unlikely to deceive or cause confusion because of the above factors and the maturity of the Australian marketplace, the regulatory regime within that marketplace and the availability of comprehensive Federal and State laws relating to conduct which is misleading or deceptive. The Hearing Officer referred to comments of the Federal Court in Woolworths1  regarding the shift of balance of the objectives of trade mark law to protect commercial interests in favour of solely protecting consumers, the latter being protected by comprehensive laws. The Hearing Officer stated, "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 only exist where there is a real tangible danger of deception or confusion arising…".

General principles when considering INN stems:

Accordingly, the Hearing Officer considered it was possible to extract the following general principles, such that where most of the following factors are present a section 43 objection should not be raised on the basis of an INN stem contained within a mark:

  • The suffix is in common use other than as an INN stem, as evidenced by both the state of the Register and the marketplace.
  • The INN stem is 2 or 3 letters long.
  • There are other or alternative obvious suffixes present in the trade mark.
  • The INN stem is non-specific – in the context of the trade mark, the stem would not generally be apprehended as indicating only a particular kind of pharmaceutical.

The Hearing Officer also observed that discontinuance and removal of an INN stem from the official list does not stop it being an INN stem – relying on advice from the WHO, he considered a stem never loses its protected status.

Impact for pharmaceutical companies in relation to trade marks containing INN stems

The Trade Marks Office is currently conducting a review of its practice with regard to trade marks containing INN stems, with an outcome expected in early 2013. This decision may signal a shift in the practice, suggesting a more sensible and flexible approach may be taken with respect to future applications.

DCC has been in discussions with the Trade Marks Office regarding the Office's practice for several months, and we believe this decision is a welcome one, reflecting many of the principles that DCC has raised with the Office as important relevant considerations in such cases.

Lessons for pharmaceutical companies

This decision should be welcomed by pharmaceutical companies, seeking to clear global product names in Australia. Pharmaceutical companies should review their pending applications facing class 5 objections to determine whether further submissions might now overcome the objection in light of this recent decision. New filings for marks which have previously been restricted by an endorsement or allowed to lapse should be considered.


  1. ^ Registrar of Trade Marks v Woolworths [1999] FCAFC 1020, French J at [47].

Filed under: Legal briefing Trade Marks Pharmaceuticals

This legal briefing was written in 2013 and may not reflect the latest legal developments. We encourage you to contact us for up-to-date advice for your particular circumstances.