International Nonproprietary Names and Trademarks: A Public Health Perspective

• Published date: 01 March 2008
• Author: Kappoori M. Gopakumar,Nirmalya Syam
• DOI: http://doi.org/10.1111/j.1747-1796.2008.00335.x
• Date: 01 March 2008

International Nonproprietary Names and

Trademarks: A Public Health Perspective

Kappoori M. Gopakumar and Nirmalya Syam

Centre for Trade and Development, New Delhi

International Nonproprietary Name (INN) is a system of international nomenclature for

pharmaceutical substances that is recommended by the World Health Organization (WHO).

Commonly known as generic names, an INN may be used for marketing purposes by any

manufacturer of a particular medicine without excluding other manufacturers of the same

substance from doing the same. However, to maintain the nonproprietary nature of INNs

and to ensure the future development of related INNs, it is necessary that INNs are not

appropriated as trademarks. Hence, resolution 46.19 of the World Health Assembly of the

WHO exhorts member states to regulate the use of INNs and discourage their use as

trademarks. The Trade Marks Act of India specifically prohibits the registration of names

that are deceptively similar to INNs. Nevertheless, there are reported incidents of marketing

of drugs under names that are similar to INNs. The WHO has brought the same to the

attention of the Drug Controller General of India. In this context, this study examines the law

and policy relating to the use of INNs in different countries with specific reference to India,

identifies deficiencies in the international and domestic institutions responsible for the

regulation of INNs and makes some policy recommendations.

Keywords International nonproprietary names; trademarks; pharmaceutical substances;

WHO

Drugs are generally marketed and prescribed under brand names. However, for

purposes such as international trade in drugs, or in international expert committee

lists such as the World Health Organization (WHO) List of Essential Medicines,

and for all pharmaceutical exchanges and scientific research methods, reference to

drugs is made by their generic names (Phadke, 2005). Civil society organizations

and individuals engaged in public health issues are also lobbying vigorously for the

use of only generic names for the sale of drugs. They have urged the government to

abolish the widespread use of brand names and instead promote the use of generic

names to describe the drug along with the name of the manufacturer (Phadke,

2005). This will enable consumers to choose from multiple sources of the same

pharmaceutical substance in a cost-effective manner.

The WHO administers an international generic nomenclature system called

International Nonproprietary Names (INN). This programme evolved when the

WHO Expert Committee on the Unification of Pharmacopoeias drew up rules

of nomenclature that were adopted by the 1950 World Health Assembly

(WHA) resolution 3.11 (WHO, 1997, p. 13). Once the WHO recommends an

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doi: 10.1111/j.1747-1796.2008.00335.x

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INN for a pharmaceutical substance, the INN may be used for marketing purposes

by all manufacturers of that substance. Moreover, pharmacologically related sub-

stances that may be developed in the future should also have an INN that can

establish its pharmacological family. Thus,all INNs for medicines used for treating a

particular conditionmust have a common stem. Therefore, INNs should be protected

from being appropriated as trademarks. Hence, WHA resolution 46.19 of 1993 calls

upon member states to take necessary measures to regulate the use of INNs and to

discourage the use of names derived from INN stems as trademarks (WHO, 1993).

While many countries have legal or administrative measures in place for regulating

the use of INNs or generic names, the use of brand names that aresimilar to INNs in

the market has been reported. Moreover, the INN system can also be threatened by

provisions in free trade area (FTA) agreements that may accord a position of pre-

eminence to the use of trademarks over INNs. For instance, the agreement on the

FTA of the Americas statesthat the requirements relating to the use oftrademarks in

relation to the common names (INN) must not impair the use or effectiveness of the

trademark (Red Colombiana de Acci ´

on frente al Libre Comercio y el ALCA, 2007,

p. 4). This could restrict the use of INNs as an instrument for consumer drug

information and limitthe adoption and implementation of provisions that encourage

the use of INNs. This can also leadto an escalation in health care expenditure due to

an increase in the prices of branded medicines (Gamba, 2006, p. 6).

This study attempts to understand and examine the legal and policy measures

relating to the use of INNs for the marketing of drugs and how they are being

implemented. This analysis has been conducted in the context of the current

discourse on the use of generic names for marketing of pharmaceutical products.

A detailed analysis of these issues is undertaken in the light of the international legal

framework for the protection of INNs. It also discusses the implementation of

safeguards against the misappropriation of INNs and, based on the findings,

suggests options to improve the existing regime. The analysis in this study comprises

a general overview of the law and policy on the use of INNs in different countries

like the United Kingdom (UK), the United States and the European Union (EU).

However, the study specifically focuses on the legal and policy regime pertaining to

the use of INNs in India because proper implementation of INN safeguards in India

can have a significant impact on access to medicines. This is because India is a

leading manufacturer of pharmaceutical products, with the presence of a large

number of generic drugs with regard to a single pharmaceutical substance. There is

also an explicit provision in India’s Trade Marks Act that safeguards INNs from

being appropriated as trademarks. Hence, the proper implementation of this

safeguard may enhance the ability of consumers to choose an affordable substitute

for a particular brand of medicine based on its INN. Nevertheless, there have been

reported instances of drugs being marketed in India under brand names that are

similar to INNs. This makes it necessary to examine the reasons why such practices

have taken place in spite of the explicit safeguards in the law and to suggest possible

solutions that may help strengthen the regime.

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International Nonproprietary Names and TrademarksKappoori M. Gopakumar and Nirmalya Syam

The INN System

Until the Second World War, most drugs were extracts of natural products. After

the War, however, synthetic drugs became more common. As the chemical names of

these drugs were too lengthy and complex, they became incomprehensible

for general use. It was necessary, therefore, to develop simple names that would

help to identify the chemical composition of drugs. To address this need,

the UK established the system of British Approved Names (BANs) in 1948 to

provide convenient generic names by which the increasingly complex compounds

for pharmaceutical substances could be identified (Thompson, 2001, pp. 223–4).

Thereafter, the United States, France, Italy and Japan also developed similar

systems.

1

Need for an International System of Nomenclature

The most important criterion relating to the use of names for a pharmaceutical

substance is to avoid names that create confusion about the ingredients and

usage of the drug. Hence, generic names are selected with the objective of enabling

easy identification of the active pharmaceutical substances contained in a medi-

cinal product. As a result, there is a need to ensure that the same substance does not

carry different generic names in different countries. For example, a person

consuming a drug having a particular generic name in country A may be confused

when buying the same drug bearing a different generic name in country B. In a

world with very few national generic nomenclature systems, it may not be difficult

to ensure that the same substance does not have different generic names. However,

with the existence of different national nomenclature systems, the necessity for an

internationally standardized system assumed greater significance. The WHO-INN

Programme was developed to address this need. In this study, we have used the

abbreviation ‘‘INN’’ to include all generic names including those that are recom-

mended as INN by the WHO.

The purpose of the INN system is to identify pharmaceutical substances

or active pharmaceutical ingredients. The system aims to provide a unique

and universally available designated name to identify each pharmaceutical sub-

stance. Clear identification on the basis of INN helps in ensuring safe prescription

and dispensing of medicines to patients. INNs also facilitate communication

and exchange of information among health professionals, scientists and other

interested people throughout the world. Because INNs are unique names, they

should be distinctive and not liable to confusion with other names in common use.

As the word ‘‘nonproprietary’’ suggests, the WHO has formally placed these names

in the public domain (WHO, 1997). Hence, an INN is open to being used by all

manufacturers of the pharmaceutical substance to which it relates. While such

names can also be used for commercial purposes, no private proprietary interest

may be acquired over these names. In other words, nobody can claim exclusive

rights to an INN or any part thereof through intellectual property protection.

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International Nonproprietary Names and Trademarks Kappoori M. Gopakumar and Nirmalya Syam