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PHARMACEUTICAL TRADEMARKS UNDER TURKISH LAW THE LIKELIHOOD
OF CONFUSION AND THE INN ISSUE
Likelihood of confusion is one of the key elements in a commercial market from the aspects of trademark protection and consumer welfare. When a pharmaceutical becomes the subject of a confusion, consumer welfare and public health issues take a step ahead. That is why the world health authorities have significant concerns on confusion of pharmaceuticals by both healthcare professionals and end users. Researchers reveal that 39% of drug administration mistakes are being caused by doctors’ prescriptions, which prove that these concerns are not unfounded. In order to analyse the likelihood of confusion concept for pharmaceuticals, it shall first be examined which terms can be used as pharmaceutical names/trademarks, how they co-exist in the market, who shall be considered as their relevant public and what level of attention is required during their purchase or assignment. International Non Proprietary Names
International Non Proprietary Names (INNs) is a very important concept on what can constitute pharmaceutical names/trademarks. INNs are unique generic names in the public domain, defining active substances of pharmaceuticals, annually listed by World Health Organization (“WHO”). The INN system enables health professionals to recognize and link pharmaceutical substances through the common INN stems used, as substances with the same INN stems belong to a group of substances with similar pharmaceutical effects, ie. “–apine” or “–pine” stems are used for compounds in the form of psychoactive tricyclic antidepressants, thus metiapine, olanzapine, petiapine are active substances with tricyclic antidepressants effects. In order to eliminate the confusion of pharmaceuticals, the tendency is to avoid the use of INNs, INN stems or terms derived from such, as pharmaceutical names and trademarks. In this respect, health authorities interfere at the licensing stage while approving pharmaceutical names, and trademark registration authorities are also urged to do so while registering pharmaceutical In Turkey, it is clearly stated under article 4 of the Regulation on Packaging and Labeling of Pharmaceutical and Medicinal Products that a pharmaceutical name cannot be confusingly similar with INNs or a product’s widely used name. However, even though the abolished 1995 dated Regulation on Licensing of Pharmaceutical Products had provisions explicitly referring to WHO rules on INN protection, no explicit provision can be seen in the current Regulation on Licensing of Pharmaceutical and Medicinal Products of 2005 which is the law regulating the pharmaceutical licensing process, including pharmaceutical name approval by the Ministry of Health. On the other hand, Turkey, as a party to the WHO Constitution, is subject to all WHO The Turkish Ministry of Health (“MoH”), the authority for licensing and approving the names of the pharmaceuticals, revealed its approach on the issue with the letter dated September 5, 1995, sent to the Turkish pharmaceutical industry, in order to draw attention to the appropriate naming of pharmaceuticals. The letter is important as it not only handles the issue from the pharmaceutical name approval aspect but also from the trademark registration aspect. The letter stated that the MoH had been in communication with the Turkish Patent Institute (“TPI”) and it was ensured that the TPI followed INN lists published by the WHO and INNs and INN derived names could not be registered as trademarks. INNs and INN derived names may indeed not be registered as trademarks under absolute grounds of refusal set forth under article 7 of the Decree Law Pertaining to Protection of Trademarks No.556 as they are generic terms in public domain descriptive of goods’ nature and if registered, their cancellation can be sought under article 42. Even though the explicit provisions are present, their application can be said to be rather rare. We come across only one precedent on INN disputes, where the Ankara IP Court, in its final decision dated 27.07.2006 and numbered 2004/774E, 2006/488K., held that “Azapin” trademark registered in the name of a pharmaceutical company shall be cancelled as it was confusingly similar with “Olanzapin” WHO listed INN and the use of “-apin” INN stem in the trademark would create confusion on behalf of healthcare professionals as used for products not containing Today, the pharmaceutical trademarks similar to or bearing INN names or stems can still be seen in the Turkish market. In this respect, it is highly important for the TPI to follow the INN lists and facilitate their protection; for the Ministry of Health to continue the initiative of 1995 to raise awareness on the issue; and for the pharmaceutical companies to comply with the mentioned provisions when choosing names/trademarks for their products in order to provide accurate protection against confusion in the market. The Relevant Public for Pharmaceuticals
One of the key factors in the assessment of confusion is the relevant public and the presumed level of attention required during purchasing of the product. However, the issue becomes relatively complex for pharmaceuticals. Depending on whether it is a prescribed or a non- prescribed pharmaceutical, the question arises whether a higher level of attention of a healthcare professional or reasonable attention of the average consumer should be taken into account. In Europe, it can be said that OHIM’s application sets a higher threshold for the level of attention required, whereas there are European Court of First Instance (“CFI”) decisions both approving and overruling this approach. In the Daflon decision (T-442/05) of December 16, 2005 , the CFI held that the relevant public is composed of doctors and pharmacists, and the average consumer had no impact during the purchasing stage. Therefore the Court held that there was no likelihood of confusion between Daflon and Cafon trademarks. On the other hand, in its decision of October 17, 2006, the CFI held that even though the pharmaceuticals were assigned by doctors and delivered by pharmacists, the average consumer should also be included within the relevant public. The CFI further found that the high level of attention of healthcare professionals cannot eliminate the likelihood of confusion between the The ambiguity had continued until the European Court of Justice (“ECJ”) on April 26, 2007, provided clarity to the issue by stating in its decision of C-412/05 that “the fact that intermediaries such as healthcare professionals are liable to influence or determine the choice made by the end-users is not, in itself, capable of excluding the end users from the assessment of the likelihood of confusion between the trademarks” and it held that the matter should be balanced by taking into account both the role of the healthcare professionals and the fact that the end users may influence the healthcare professional by their trademark preferences and needs. Despite the European approach, which is moving towards the elimination of prescribed/non- prescribed pharmaceutical difference and lowering the threshold for the level of attention required, the same approach cannot be yet observed in Turkish practice. In its decision dated June 22, 1954 (11 H.D. 1953/3804E., 1953/4715K.) the Turkish Court of Appeal (“CoA”) held, by taking into account the facts at the time, that as the pharmaceuticals Oftalin and Oftarjin, despite being prescription-mandatory, were sold without a prescription in practice, it was the average consumer with a reasonable degree of attention that should have However, in a much more recent decision of January 13, 2003 (11 H.D. 2002/7864E., 2003/48K.) the CoA held that no likelihood of confusion existed between the Lipidil and Lipidrol marks as they were sufficiently differentiated for the perception of the doctors and pharmacists and rejected the finding in the legal expert report that there is always a risk of confusion between the pharmaceutical names consciously chosen but improperly hand written by the doctor or wrongfully perceived by the pharmacist due to high similarity between trademarks like Lipidil This high threshold set by the CoA and the consideration that healthcare professionals would not make any mistakes can be said to be an erroneous interpretation. In fact, many reported drug administration errors indicate that some trademarks are confused even by professionals, during over the phone orders or computer recordings. Based on these different interpretations of the CoA, it is hard to conclude what concrete approach is adopted by the Turkish Courts regarding the determining of the relevant public in pharmaceutical trademark cases. In fact, it was suggested in the doctrine that the CoA decisions finding likelihood of confusion between Pyramidon-Puramiton, Disinol-Disinal, Atarax- Ataraxin and Oftalin-Oftarjin trademarks cannot be considered as a reflection of the CoA’s view on the issue as these trademarks are highly similar which may cause confusion on the part of the public segment, the attention level of which is considerably high. Therefore, the future precedents of the Turkish Courts, which will hopefully provide certainty to the relevant public issue in the pharmaceutical trademarks, are eagerly awaited by the Selma Toplu Ünlü & Özge Atılgan Karakulak
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