What's in a Name? Protecting Your Pharma Brand
To successfully market a pharmaceutical product in Australia, it is important to effectively manage the branding of your product through careful selection of a trade mark, labels, marketing slogan, company name, logo and company image. A well-chosen and registered pharmaceutical trade mark will provide you with a valuable proprietary right to use, and prevent others from using that trade mark.
When selecting a trade mark for a pharmaceutical product, there are a number of general considerations, and a number of considerations particular to pharmaceuticals.
Generally, you should ensure that a chosen mark is distinctive and is not descriptive of the therapeutic goods to which the mark is applied; identical or similar to a registered trade mark for similar products; similar to a well known trade mark which has acquired a reputation in Australia; or a geographic name or common name of persons.
Particular to pharmaceuticals, you should firstly ensure that the selected mark is not substantially identical to a notified International Non-Proprietary Name (INN) or identical to a notified INN stem (generic stem). INNs are generic names indicating the pharmaceutical substances or active pharmaceutical ingredients which are identified by the World Health Organization. Generally, INNs or INN stems are not available for trade mark registration for pharmaceutical goods. INN stems are intended for use by medical practitioners, pharmacists, or anyone dealing with pharmaceutical products to enable them to recognize that the substance belongs to a group of substances having similar pharmacological activity.
For example, if you wish to register the trade mark BLUCAINE, the Trade Marks examiner will require 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 CAINE.
The stem –caine in the INN system refers to substances containing local anaesthetics. The Office will not accept the application for registration of this mark without the endorsement.
A full list of INN stems can be found here: http://www.who.int/medicines/services/inn/StemBook2009.pdf
A further requirement to be considered when selecting a trade mark for your pharmaceutical product is that the mark meets the requirements under the Therapeutic Goods Act 1989 (Cth) ("the TGA Act") in respect of selection of trade/brand names for therapeutic goods, if you intend to register or list your product on the ARTG. The TGA will closely examine the trade mark (brand name) of the product to ensure that the name, once registered or listed, will not mislead or confuse the public. In determining whether to grant approval for registration or listing, the TGA considers, inter alia, under section 3(5) of the TGA Act, “If a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients.”
In respect of prescription medicines, the Australian Regulatory Guidelines for Prescription Medicines set out the factors which need to be taken into account when assessing a proposed trade/brand name for prescription medicines. A proposed trade/brand name for prescription medicines should not (inter alia): “…be able to be confused with another trade/brand name of an existing product either when spoken or written down.”
If the proposed name for the prescription medicine or product is not acceptable, the sponsor will be requested to change the name.
In conclusion, careful and considered selection of a trade mark for your pharmaceutical product is essential. Prosecution costs can be greatly minimized, and you have a strong mark with which to market your product. An experienced trade marks attorney can be invaluable in assisting with the searching and selection process.