International Non-Proprietary Names (INN) are globally recognized names for pharmaceutical substances or active pharmaceutical ingredients and are also known as generic names. The INNs were first initiated by the World Health Assembly in 1950 with a view to designate universally recognisable names for pharmaceutical substances. In furtherance to this, the WHO has published a list of over 7000 generic names since its inception. The WHO guidelines states the importance of INNs as follows:
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.
As the name suggests, such names are ’non-proprietary’ and cannot be owned by any individual or company to designate or identify pharmaceutical substances. This article is with specific reference to the trademark law in India, India’s obligation to comply and the Indian Trademark Office’s indifference to such obligation.
India’s International Obligation
The Preamble of the TRIPS Agreement, amongst other things, states that is aims to establish a mutually supportive relationship between the WTO and the WIPO as well as other relevant international organizations. As mentioned earlier, the WHO publishes a list of INNs (as published on the Indian Registry) and in effect, all members bound by the WTO and TRIPS Agreement, are required to comply with the terms of these agreements and therefore India is also under the obligation to do so.
The law in India
Section 13 of the Trademarks Act in unambiguous terms states that no word which is commonly used and accepted as a chemical element or compound or has been declared by the World Health Organisation as an INN or any name deceptively similar thereof, is entitled to registration under the Act. Further, it provides that any such registration will be deemed to be without sufficient cause or an entry wrongly remaining on the register.
The Revised Draft Manual of Practice and Procedure (found here) makes reference to Section 13 with respect to INNs and adds that this provision applies to all applications made under class 5 for pharmaceuticals, pesticides and veterinary substances. Also, it clearly states that marks that are identical or a variation of INNs are open to objection on the grounds that they lack distinctiveness under Section 9(1)(a) read with Section 13.
Registration of INNs in India
Contrary to the provisions of law, on conducting a public search for some of the INNs, it can be found that there are a number of INNs registered as trademarks. There are a number of registrations for INNs like Paracetamol, Erythromycin, Ibuprofen, Xenon, Ciprofloxacin etc. It would be unfair not to mention that there have been instances where the Registry has objected or refused marks on the grounds of Section 13. Judicial precedents also indicate that the Courts have given life to the provisions of Section 13 and have prohibited such marks from being registered.
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As can be seen from the image above, a public search clearly indicates that Paracetamol is an INN, however, there are marks that are registered and infact, one of the marks has been advertised before acceptance. This is a reflection of the Registry’s indifference towards its international obligations.
The Indian Trademark Office in the recent past has been working closely with international organisations to ensure smooth functioning of the applications under the Madrid Protocol and in general to improve the functioning and efficiency of the Registry. In this connection, it would be great if international organisations like INTA (Trademark Office Practices Committee – Asia-Pacific TMO Relations Subcommittee), PTMG and the like collaborate with the Indian Registry to ensure that INNs are not registered as trademarks. Also, it is important that the Trademark Registry should take suo motu action to cancel or remove INNs which have been registered or in the process of registration in order to comply with international standards and obligations.
INNs shouldn’t be allowed registration for the reason that the law mandates it and also because they are generic names and designated to be so in order to make them universally recognisable. Therefore, allowing such names to be registered defeats the purpose of specifically designating these names to be INNs and makes India open to criticism for not complying with international obligations. We can only hope that the Registry will take action on this in due course of time.