INNs

World Health Organisation (WHO) operates a program of identifying each pharmaceutical substance by a unique, universally recognisable name, known as an International Non-Proprietary Name or INN.

The rationale for the system is to promote safety for health professionals and the public in the identification, prescription and dispensation of pharmaceutical substances.  The INN is effectively the generic name that should be open for use by anyone descriptively.

For example, paracetamol is the INN for the widely used painkiller.

Sibling rivalry - INN stems

INN stems are the building blocks or common word elements used within INNs.

A stem indicates that a drug belongs to a certain pharmacological or chemical class, and often suggests something about its action or target. The INN system governs the use of common, descriptive stems given to families of pharmacological substances. There is an evolving list of INN stems, with each stem relating to a particular group of pharmaceutical substances. Stems can be prefixes, suffixes or infixes.

IP Australia examination of trade marks containing INNs and INN stems

Distinctiveness

Section 41 of the Trade Marks Act1995 (Cth) (the Act) provides that a trade mark is only registrable if it is capable of distinguishing the applicant’s goods or services, either inherently or through use.

IP Australia will raise an objection to registration under section 41 where a trade mark that is to be used in relation to pharmaceuticals or veterinary substances is identical or confusingly similar [1] to a INN or INN stem.  The rationale is that an INN is effectively the generic name for a substance and is therefore something which other traders are likely to want to use on or in connection with their own goods.

Opponents have been unsuccessful in arguing that confusingly similar equates with deceptively similar.[2]  Confusingly similar does not have a definition in the Act and likely lies “somewhere between substantial identity and deceptive similarity.[3]

The practical reality is that unless the trade mark and INN are identical, section 41 distinctiveness objections will be be rare [4] and that section 43, discussed below, will be the most common issue in examination and oppositions.

Confusion as to certain qualities or characteristics

INNs and INN stems should not be used in trade marks for pharmaceuticals or veterinary substances other than those indicated by the INN stem.  Otherwise, use of an INN stem in a trade mark may lead to deception or confusion.  This is one of the critical considerations in the examination of trade mark applications in Class 5 covering pharmaceuticals or veterinary substances.

Section 43 of the Act provides:

An application for the registration of a trademark 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 belikely to deceive or cause confusion.

Section 43 arises where a trade mark to be used in relation to pharmaceuticals or veterinary substances is the same as, or may connote, an INN and use of the trade mark in respect of the goods covered by the specification is not restricted to the particular substance indicated by the INN.  The basis of the objection is that use of such a trade mark would be likely to give rise to deception or confusion.

Examples:

·        Aventis Pharma SA v Alphapharm Pty Ltd [2005] ATMO 15.  ROXIMYCIN for ‘pharmaceutical and medicinal preparations containing antibiotics’ connoted that these goods contained the antibiotic product known by the INN Roxithromycin and the use of ROXIMYCIN on antibiotics not containing Roxithromycin would be likely to cause confusion or deception.

·        Sanofi-Aventis v Eremad Pty Ltd [2009] ATMO 97.  OXALATIN for ‘pharmaceutical preparations and substances’ connoted that these goods contained the anticancer product INN Oxaliplatin on products not containing Oxaliplatin would be likely to cause confusion or deception.

A section 43 ground for rejection maybe overcome by the applicant agreeing to a condition of registration limiting use of the trade mark to goods containing the substance indicated by the relevant INN. The endorsement suggested by the Registrar in these circumstances is:

It is a condition of registration that any use in respect of pharmaceuticals will be limited to such goods containing the substance designated by the International Non-Proprietary Name <INN>.

In examination, IP Australia considers whether the presence of an INN stem in a word is “meaningful” enough to give rise to a connotation leading to likely deception or confusion under section 43.

Meaningful can include:

·        The length of the stem;

·        How it appears within the mark; and

·        The extent to which letters are used other than as an INN Stem in the industry.

The Australian Trade Marks Office provides the following examples [5]:

The presence of ‘aj’ in the term ‘Sansajabendorastine’ is not significant enough to warrant a ground for rejection given the length of the name and other competing references such as ‘astine’. By way of contrast the appearance of ‘aj’ in ‘tenaj’ would more clearly give rise to a section 43 ground for rejection. Other examples of INN stems included in a meaningful way include:

• -flurane   EXIFLURANE
• -mycin    TRIPTOMYCIN
• estr       PREMIUMESTREMAX

In addition, a stem may not be included meaningfully in a trade mark where its presence is clearly overwhelmed by the meaning of the trade mark as a whole. Examples of INN stems not included in a meaningful way include:

• -ast   PAIN GOES FAST
• -quin(e)   HAPPY EQUINE
• som-   SOMALIAN  ALOE
• sal       SMILING SALLY

Because meaningful, can account for commercial realities, an applicant can file evidence and submissions to address the section 43 objection and range of criteria and considerations, including information which may have not been apparent during examination.

Given that branding a new pharmaceutical product is a complex and lengthy process from a regulatory and trade mark perspective, typically in multiple jurisdictions, the INN issue will often be considered in the clearance process.  However, if an issue is raised in examination in Australia, there is scope to resolve the objection.

[1] Glaxo Group Ltd v Pathstream Ltd (1987) 9 IPR 95

[2] Aventis Pharma SA v Alphapharm Pty Ltd (2005) IPR 634 [12]; Sanofi-Aventis v Eremad Pty Ltd [2009] ATMO 97 [10].

[3] Sanofi-Aventis v Eremad Pty Ltd (2009) ATMO 97 [29].

[4] Aventis Pharma SA v Alphapharm Pty Ltd (2005) IPR 634 [17]-[19].

[5] IP Australia Trade Marks Manual of Practice and Procedure 29.5.6

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