INNs in the Context of IPRs – Ukrainian Regulation and Court Practice

The original purpose of a pharmaceutical product name was to inform both professionals and end-consumers of its composition. However, it has now become an object of commercialisation – a manufacturer’s profit often depends on the level of awareness of its pharmaceutical product’s trade name. And it is common practice for manufacturers to transform a trade name of a pharmaceutical product into an intellectual property right.

Transformation of a pharmaceutical product name into an intellectual property right

A pharmaceutical product name does not render any intellectual property rights per se. In order to acquire intellectual property rights, including the right to prohibit other manufacturers from registering a pharmaceutical product with a similar name, the pharmaceutical product name must be registered as a trade mark. Obviously, not every name may be registered as a trade mark and granted legal protection; for example, generic names of pharmaceutical products or their ingredients, better known as ‘international non-proprietary names’ (INNs) are not registrable.

INN: the notion and special aspects of its use as a pharmaceutical product name and in a trade mark

By its nature, an INN is the name of a pharmaceutical substance that is recognised globally and serves as an universal identifier of active pharmaceutical ingredients of which a medicine is composed. INNs have been assigned by the World Health Organisation since 1953 so that professionals and consumers from any country can identify certain pharmaceutical substances in a medicine. INNs are deemed to belong to the public domain and may not be registered as a trade mark or as components thereof (Resolution WHA46.19 of the World Health Assembly of the World Health Organisation on Non-Proprietary Names dated 12 May 1993). In other words, INNs may be used by any manufacturer of a pharmaceutical product, however they may not be owned by any person as an intellectual property right. The Ukrainian legislation is in line with this global practice in that it allows any manufacturer to use INNs as names of pharmaceutical products. When a pharmaceutical product is registered in the State Register of Pharmaceutical Products of Ukraine, the information both on its trade name and its INN is included in the Register, whereas a prescription issued by a doctor shall contain the INN only, and not the trade name of the pharmaceutical product. The trade mark law in Ukraine contains no provisions concerning the non-registrability of INNs or designations similar to them as trade marks. Nevertheless, in accordance with established practice, INNs are held nonregistrable due to their attribution to common names or terms, or, in other words, to a lexical item specific for a certain field of science (pharmacology). Hence, INNs may not be registered as trade marks. However, a part of an INN acting as a stem may be registered as a trade mark in certain circumstances. Such part of an INN shall indicate a group of medicines, the mode of action, or the chemical or biochemical bond. In this context, the judicial dispute regarding the name ‘Smecta’ for a pharmaceutical product (INN – Smectite dioctaedric) manufactured by IPSEN PHARMA S.A.S. is illustrative. The plaintiff alleged that the existence of the ‘Smecta’ trade mark resulted in an unlawful monopolisation by IPSEN PHARMA S.A.S. of the Smectite dioctaedric INN in the Ukrainian pharmaceutical market. The claim was, however, dismissed. The court relied on the expert opinion in the case, and found that the name ‘Smecta’ was formed by just using the INN as the stem and, thus, it was distinctive and not descriptive (case No. 910/8422/17 O.D. Prolisok LLC vs. IPSEN PHARMA S.A.S. and the PTO). A similar case dealt with the use of the part ‘ena’ in names of pharmaceutical products containing the active pharmaceutical ingredient Enalapril (Enasil, Enarenal, Enafril, Enal). The part ‘ena’ in similar designations was held to be a weak element and non-distinctive; it fulfils a function of the stem, and indicates the active pharmaceutical ingredient of a pharmaceutical product – Enalapril. Moreover, there has been a wide-spread practice of registering trade marks which contain an INN and a distinctive part of a trade (brand) name of a pharmaceutical product manufacturer (cf. ‘Guidelines on the use of INNs for Pharmaceutical Substance developed by the World Health Organization’, 1997). In the Ukrainian market, such approach is being actively explored, and hence, certain INNs are now included as part of trade names of pharmaceutical products, along with a distinctive part of the brand (trade) name of the manufacturer (e.g. trade names Diclofenac Darnytsia, Diclofenac-Teva, Chlorhexidine Zdorovya, Chlorhexidine-Viola etc.).

National pharmaceutical names: Ukrainian practice

In addition to INNs, the list of which is approved by the World Health Organization, in some countries a list of national pharmaceutical names (NDNs) may be established. These NDNs, similar to INNs, can be used by several manufacturers, and are considered common designations and may not be granted legal protection as a trade mark. The lists of NDNs exist, for instance, in the United Kingdom (British Approved Names), France (Dénominations Communes Françaises), Japan (Japanese Adopted Names), and the USA (United States Accepted Names). With a few exceptions, NDNs almost completely coincide with the approved INNs. In Ukraine, there is no established list of NDNs; however, there was an attempt to regulate this issue in the ‘Rules for Consideration of Proposed Names for Pharmaceutical Products Submitted for State usually include trade names of pharmaceutical products which were manufactured during the period of the former Soviet Union and have been manufactured since, and which are known to experts and patients for several generations. In this context, the peculiarity of the pharmaceutical industry in the former Soviet Union should be noted. Then, a pharmaceutical product with the same name was made by many manufacturers and owned exclusively by the state. The trade name of a pharmaceutical product was not registered as a trade mark, because there was no market competition and, as a result, there was no need to distinguish between the goods of one manufacturer from those of another. Respectively, a name of a pharmaceutical product was associated only with pharmacological properties without being associated with a specific manufacturer. After the fall of the Soviet Union, manufacturers of pharmaceutical products in Ukraine (as well as in some other post-Soviet states) made numerous attempts to register some trade names of pharmaceutical products as a trade mark. As a result, well-known pharmaceutical products are owned by separate manufacturers who have been successfully selling such pharmaceutical products up to the present day. In Ukraine, designations which have been granted legal protection as a trade mark may only be invalidated for being a common name by a court. Currently, there is only one case in Ukraine where a designation has been found to be a common name and, consequently, the trade mark was invalidated, and that case is the ‘Promedol’ designation (case No. 910/16093/18 KALCEKS, AS vs. Zdorovya Pharmaceutical Group LLC and the PTO). Registration in Ukraine’, as approved by the State Pharmacological Centre of the Ministry of Health of Ukraine. This document determined the NDNs as common names (e.g. Euphylline, Furacillin, the Ringer-Lockes, Riboxinum, Dimedrol, Analgin, Citramon and even Aspirin). In accordance with these rules, common names usually include trade names of pharmaceutical products which were manufactured during the period of the former Soviet Union and have been manufactured since, and which are known to experts and patients for several generations. In this context, the peculiarity of the pharmaceutical industry in the former Soviet Union should be noted. Then, a pharmaceutical product with the same name was made by many manufacturers and owned exclusively by the state. The trade name of a pharmaceutical product was not registered as a trade mark, because there was no market competition and, as a result, there was no need to distinguish between the goods of one manufacturer from those of another. Respectively, a name of a pharmaceutical product was associated only with pharmacological properties without being associated with a specific manufacturer. After the fall of the Soviet Union, manufacturers of pharmaceutical products in Ukraine (as well as in some other post-Soviet states) made numerous attempts to register some trade names of pharmaceutical products as a trade mark. As a result, well-known pharmaceutical products are owned by separate manufacturers who have been successfully selling such pharmaceutical products up to the present day. In Ukraine, designations which have been granted legal protection as a trade mark may only be invalidated for being a common name by a court. Currently, there is only one case in Ukraine where a designation has been found to be a common name and, consequently, the trade mark was invalidated, and that case is the ‘Promedol’ designation (case No. 910/16093/18 KALCEKS, AS vs. Zdorovya Pharmaceutical Group LLC and the PTO).

Summary

Summing up the above, the laws and regulatory enforcement in Ukraine generally comply with Ukraine’s international obligations on the use and registration of an INN or a part thereof as a trade mark. Ukrainian law and practice in this field, however, are still in their infancy and require further clarification.

AUTHORS: Ganna Prokhorova, Counsel Mamunya IP and Ilona Boliubash, Associate Mamunya IP

VERIFIER: Taras Kulbaba, Partner Bukovnik & Kulbaba IP Guardians