Thursday, May 3, 2007

INN = Generic

What's INN? INN stands for International Nonproprietary Names which are the generic names used to identify pharmaceutical substances or active pharmaceutical ingredients. It's a list of some 7000 names maintained by the World Health Organization. The purpose of INN is

to provide health professionals with a unique and universally available designated name to identify each pharmaceutical substance. The existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for the clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.

So what's the trademark significance of INN's? According to the WHO:

Over the years, the need to maintain the integrity of the INN system has become urgent. This is reflected in the following extract from the Fifth Report of the WHO Expert Committee on the Use of Essential Drugs which met in November 1991 :

"The procedure for selecting INNs allows manufacturers to contest names that are either identical or similar to their licensed trade-marks. In contrast, trade-mark applications are disallowed, in accordance with the present procedure, only when they are identical to an INN. A case for increased protection of INNs is now apparent as a result of competitive promotion of products no longer protected by patents. Rather than marketing these products under generic name, many companies apply for a trade-mark derived from an INN and, in particular, including the INN common stem. This practice endangers the principle that INNs are public property; it can frustrate the rational selection of further INNs for related substances, and it will ultimately compromise the safety of patients by promoting confusion in drug nomenclature."

These concerns were debated during the sixth International Conference of Drug Regulatory Authorities (ICDRA), in Ottawa, in October 1991. Based on recommendations made by the WHO Expert Committee on the use of Essential Drugs, the resolution WHA46.19 on Nonproprietary names for pharmaceutical substances was adopted by the Forty-sixth World Health Assembly in 1993, requesting Member States to:

- "…enact rules or regulations, as necessary, to ensure that international nonproprietary names (or the equivalent nationally approved generic names) used in the labelling and advertising of pharmaceutical products are always displayed prominently; - …encourage manufacturers to rely on their corporate name and the international nonproprietary names, rather than on trade-marks, to promote and market multisource products introduced after the expiry of a patent; - …develop policy guidelines on the use and protection of international nonproprietary names, and to discourage the use of names derived from them, and particularly names including established stems, as trade-marks."

In the note verbale, attention is drawn to this resolution concerning the use and protection of INN.

As a matter of principle, it may thus be recommended that trade-marks should not be derived from INN. In particular, the intentional incorporation of meaningful INN stems in trade-marks should be avoided.

So, pharaceutical companies, when naming their next blockbuster drug will, in addition to a trademark search, will conduct an INN search. For instance, the job description for Trademark Counsel with GlaxoSmithKline includes "INN search and clearance."

If you're looking for a place to search for INNs, IP Australia has a search engine for INNs.

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