Journal of Intellectual Rights Vol 18, September 2013, pp 439-447

Pharmaceutical Examination and its Implications for Self-medication: Parameters and Examples in Brazil

Rachel de Paiva Bucasio, Elizabeth Ferreira da Silva, Iolanda M Fierro and Patrícia P Peralta† Instituto Nacional da Propriedade Industrial – Praça Mauá, 07 – 10º andar – sala 1010, Centro – RJ, CEP: 20081-240 – Brazil Received 14 January 2013, revised 1 July 2013

Self-medication, the use of drugs without any intervention by a physician or other qualified professional, is a very common practice in Brazil and poses a serious health risk, especially when the consumer is misled in the purchase of a particular pharmaceutical trademark. This work addresses the importance of considering the International Non-Proprietary Names, the Brazilian Nonproprietary Names (DCBs in Portuguese) and their prefixes, ‘stems’ and suffixes when examining a sign that will identify a drug as recommended by the World Health Organization. The paper presents a background on and some of their definitions, explains trademarks’ functions and registrability issues, as well as the need for creating a global system of nomenclature for pharmaceutical products. Moreover, this work shows the Brazilian approach and comments on the queries carried out in the trademark database of the Brazilian National Institute of Industrial Property (INPI in Portuguese). Finally suggestions are proposed to improve the examination of signs that will identify drugs, seeking safe use by consumers.

Keywords: Registered trademarks, drugs, INN, Brazilian Nonproprietary Names

The existence of an international nomenclature to pharmaceutical to be marketed. The WHO, together designate active drug substances set forth by the World with the World Organization Health Organization (WHO) known as International (WIPO), encourages national offices to follow these Nonproprietary Name for pharmaceutical substances recommendations when examining drug trademarks. (INN) is fundamental to the safe prescription of drugs The rejection of trademarks composed of INNs is to patients and to the exchange of information among not enforced by any agreement, treaty or other legal health professionals around the world. An INN device, and such procedure is merely in the form of identifies a drug by the name it is globally recognized recommendation. Currently, the examination of drug and is a sign, as discussed later in this trademarks carried out by the Brazilian Trademark article. WHO establishes that ‘each INN is a unique Office (INPI) does not take into consideration WHO name that is globally recognized and is public guidelines. Nevertheless, such parameters could be property’. A nonproprietary name is also known as a standards to prevent the granting of public property generic name.1 For the purposes of this article ‘generic signs as exclusive trademark rights. This would also name’ and ‘generic sign’ will be used interchangeably. avoid the existence of trademarks that could mislead According to WHO recommendations, in order to consumers and endanger their health. avoid misunderstanding, INNs cannot be used as drug This article discusses trademarks, INNs and trademarks, since this could jeopardize patients’ Brazilian Nonproprietary Names (BNNs or DCBs in health. In principle, the same happens to stems Portuguese). The BNNs are extracted from a list derived from these INNs: in case they are used as part based on the INNs adapted to the Brazilian experience of trademarks, they should match the active drug by the National Health Surveillance Agency substances the said trademarks aim at identifying. For (ANVISA). The authors examine the result of some example, trademarks having the suffix –caine should queries carried out in the INPI’s database and present only be employed to identify local anesthetics. suggestions so as to improve the examination of signs National and international nomenclature committees that will be used to identify drugs. work together so as to select a unique and globally Trademarks: The Concept acceptable name to identify each active substance of a Jerome McCarthy, after discussing the advantages ______a trademark offers its consumers and how it should be †Corresponding author: Email: [email protected] chosen, warns about the importance of establishing 440 J INTELLEC PROP RIGHTS, SEPTEMBER 2013

the difference between ‘trademark name’, ‘trademark’ grounds. Therefore, the legislator has chosen not to give and ‘registered trademark’, since the use of each of examples or rules of what could be considered a these words has specific legal implications.2 trademark, but rather offered a general concept which The Brazilian Trademark Office (INPI), in its left out certain types of signs that may be registrable in Resolution 051/97, defines trademark as ‘Any visually other countries, such as sound, smell and taste signs. perceptive distinctive sign, which identifies and Pharmaceutical Trademarks, Descriptive and distinguishes products and services from others of Deceptive Signs different origin, and which also certifies their compliance The main purpose of a trademark is to distinguish with certain rules or technical specifications.’ products and services for the consumer. According to Adopting a simpler concept and limiting it to 5 3 Ascensão , in Portugal, the distinctive function is the products and services, Tinoco Soares affirms that a only feature legally protected. In Brazil, some trademark is ‘[...] a sign through which a product or juridical experts understand that the distinctive is known and distinguished in the consumer 4 function along with the origin source function, are market or among the users [...].’ According to Olavo , both protected. Although this question remains a trademark is ‘a sign which individualizes products controversial, it is not the aim of this article. For or services and which enables their differentiation instance, the aim of a pharmaceutical trademark is to from others similar or alike.’ aid in the identification of the product the consumer At this point, it is important to highlight another needs by differentiating it from the other trademarks terminology employed in this article: ‘sign’. Before on the market. its granting, any mark filed at the INPI is a sign, Before understanding some of the particularities of because it is not yet a registered trademark. Such pharmaceutical trademarks, it is important to point out understanding is in accordance with Law 9.279/96 that, among the absolute and relative grounds for the (Industrial , IPL) which specifies that a refusal of a trademark, two of them are fundamental mark is ‘any distinctive sign’. However, as this when examining a drug mark: deceptive signs and analysis refers to pharmaceutical trademarks, the descriptive signs (generic, necessary, common, usual article will focus only on signs filed at the INPI for or qualitative signs). These two types of signs are the registration as trademarks for pharmaceuticals. most relevant for this article in view of the possibility The Registration of Exclusive Rights of combining common stems (INNs and BNNs) and The right to a trademark is granted by the pharmaceutical terminologies in the formation of registration of a sign that is in principle distinctive trademarks. On one hand, this may lead to the and available, and duly issued by the responsible creation of deceptive trademarks, that is, trademarks agency. The registration of industrial property rights that have a specific purpose but contain stickers that in general and specifically of trademarks is carried out indicate other therapeutic goals. In Brazil, despite the by the INPI, as established by the IPL. In Brazil, due ‘truthfulness principle’ as a requirement for protection to the attributive characteristic of trademark rights, a of trademarks6, it is not possible to determine whether registration is highly relevant to define who has the a trademark would be deceptive or not, since the priority of ownership. initial claims as pharmaceuticals may not There are three principles which rule the trademark accompanied by a specific therapeutic class. On the registration process: the territorial principle, i.e. the other hand, public domain signs may be wrongly trademark is protected only within the boundaries of granted as trademarks. the country where it has been granted; the attributive In the examination of pharmaceutical trademarks, it principle, that is any trademark must have its would be necessary to accurately investigate the registration issued by the responsible agency in order composition of the sign applied for as a trademark in to be protected; and the specialty principle, i.e. the order to assure that it is not a reproduction of a trademark is protected only in the market segment in descriptive, public domain sign. which its owner is engaged. Barbosa7 indicates that the ‘signs are aligned in a The IPL in its Article 122 establishes that ‘any distinctiveness continuum, ranging from a fanciful visually perceptive distinctive sign, when not prohibited name to the impossible degree of total lack of under law, is susceptible of registration as a mark’. Such independence between the sign and its object’. This prohibitions may be based on relative or absolute total lack of independence is contained in the item VI DE PAIVA BUCASIO et al.: PHARMACEUTICAL TRADEMARK EXAMINATION AND SELF-MEDICATION 441

of Article 124 of IPL, which establishes generic, would be the terminology created by ordinary people necessary and common signs as non-registrable signs. to identify a certain object. The Examination Gonçalves8 explains that ‘Generic sign is [...] the word Guideline makes no distinction between what is sign that in its own and original meaning exclusively common or usual, as it reads: ‘word, word expression designates the name of the kind of products or services it or a design element that, although it does not aims to identify [...]’. The author also observes that even correspond to the name or to the representation, by when misspelled, the trademark which refers to a generic which the product or service was originally identified, sign cannot be granted as an exclusive right to a single has been established by current use for this purpose, owner. The need to keep certain signs free from exclusive and thus integrated into commercial language’. ownership is essential for business, otherwise it would not With regard to deceptive signs, the prohibition be possible for a trader to inform a consumer about line of related thereto is stated in item X of Article 124 of the product or service he/she is engaged in, if signs like shoes Brazilian IPL. This item sets forth that a sign which (to identify shoes), telecommunications (for suggests a false indication of source, origin, nature, telecommunication services), etc., belonged exclusively to quality or purpose of a certain good or service cannot a single owner. be registered as a trademark. According to a study on 9 In the Brazilian case (keeping in mind that there the IPL carried out by the Instituto Dannemann are similar terminologies but no similar effects) the Siemsen de Estudos Jurídicos e Técnicos (IDS), ‘Any INPI, on regulating the matter brought up by the IPL, sign may be deceitful, whether it is a word, prefix, has conceptualized the generic sign as ‘[...] the term suffix, stem, symbol or icon. [...] Trademarks constitute or word expression or its graphical representation that a true separate language. They create a sign system that (without being of necessary nature in relation to the communicates to the consumer information on the product or service, or indicative of nature, nationality, goods and services they are related to’. 9 weight, value, quality and time of production or Still according to this study , the registration or even service provision) designates the category, the type or the use of a deceptive sign affects the consumer, once it the sort to which a determined product or service often advertises a quality that the good or service does belongs, it not being possible to individualize it, under not have. There may be health damages involved if a penalty of being contrary to the rights of competitors.’ wrongly granted sign becomes a pharmaceutical A ‘descriptive sign’, as Gonçalves8 explains, is a trademark; such a trademark may indicate an active sign in Portuguese or in a foreign language which substance that is not part of the medicine, since the said exclusively and directly describes the production, medicine may be intended to treat a health problem quality, quantity, purpose, value or other feature of different from the one the pharmaceutical terminology the product or service. This definition is similar to the applied to the trademark suggests. one in Brazilian IPL, which states that a descriptive As it will be shown later there are registrations of sign is the one that is related to or designates a pharmaceutical trademarks granted by the INPI which characteristic of the product or service with respect to seem to indicate a specific therapeutic purpose but its nature, nationality, weight, value, quality and actually claim a different function. By considering the moment of production or of rendering of a service. BNNs, one aims to enable the to assess whether a certain sign is capable of misleading Then there are the ‘necessary signs’. According to the public consumer thus, avoiding, the registration of the Brazilian legal doctrine, the said signs are the ones deceptive signs. which are essential and in Portuguese, at the same time exclusive for naming a specific product. A sign The Registrability of Signs as Pharmaceutical is considered to be necessary mainly when there is no Trademarks other name that can be possibly used to designate a The Industrial Property Code of 1971 (IPC, 1971) certain object. In this sense the INPI’s Examination provided for the use of a generic trademark together Guidelines describe a ‘necessary sign’ as ‘word or with a specific one in its Article 61. This type of word expression or a design element which is trademark identified the source of a series of goods or indispensable for designating or representing a products which, in turn, were distinguished by product, a good, a service or their inputs’. specific trademarks. Besides, the Code ruled that a A ‘common sign’ is the common name employed generic trademark could only be used when by the members of a certain society, whereas ‘usual’ accompanied by a specific sign. 442 J INTELLEC PROP RIGHTS, SEPTEMBER 2013

Under the 1971 Code, the generic trademark, It is worth noticing that the sign to be protected according to Gusmão10 designated a whole series of as a pharmaceutical trademark has specificities in products manufactured by a company, and said its composition that should be taken into products were identified by a specific trademark. Still, consideration. A more comprehensive knowledge of according to the author, the pharmaceutical trademark nonproprietary names in the pharmaceutical should be used together with the generic trademark, industry is crucial to avoid the issuance of which was the laboratory trademark. The Code itself unfair exclusive rights or the confusion of the stated such obligation in its Article 80: ‘there may be public consumer. registered as trademarks similar names which aim at distinguishing pharmaceutical or veterinary goods INNs, BNNs and Pharmaceutical Trademarks11 with same therapeutic purposes, provided that there is The most important criterion to be considered no possibility of error, doubt or confusion to the when naming a drug is to avoid confusion in relation public consumer’ (IPC, 1971). The rationale behind to its active substances and its purpose. Therefore, this possibility of registration of trademarks generic names are coined in order to render easy composed of similar names for the same therapeutic identification of the chemical substance contained in purposes is that if the consumer made a mistake, the drug. As a result, there is a need to ensure that a he/she would still buy the right medicine to treat the single substance does not have different generic same disease. Article 81 of the same Code reads that a names in different countries. pharmaceutical or veterinary product trademark could In 1948, the United Kingdom developed a only be used together with the generic trademark. The nomenclature system called British Approved Names Code, therefore, aimed at clarifying to the consumer, (BANs), which aimed at creating generic names by the source of the pharmaceutical good.10 which complex chemical compounds present in The current IPL has excluded the generic pharmaceuticals could be easily identified.12 The trademark, retaining only good, service, certification BANs are also employed as the official name for and collective trademarks. Therefore, it is no longer medicines in many countries, mainly British necessary to use the laboratory trademark (generic Commonwealth members, and such names are trademark as understood in the IPC/1971) together approved upon request of the inventor or with the specific good or service trademark. In this manufacturer of the chemical substance. Other paper, we deal only with trademarks of goods, that is countries, such as the , France, and ‘the ones used to distinguish goods or services from Japan have developed similar systems. others which are identical, similar or akin, but from a Given the existence of different national different source’. However, it is important to mention nomenclature systems, the Nomenclature Program of that the generic trademark attested the origin of a the WHO was developed and formally established in pharmaceutical product and provided more complete 1953 with the publication of the first list of information to the consumer and third parties in case International Nonproprietary Name for of pharmaceuticals. The lack of generic (laboratory) Pharmaceutical Substances (INNs). WHO coordinates trademark enhances the importance of the the activities of the national nomenclature committees pharmaceutical trademark, as it is now the only source in order to standardize drug names. In Brazil, the of information to the consumer, and as such, it should ANVISA is responsible for the translation of the INN be examined in a more meticulous way. lists published by WHO. According to Gusmão10, it is important to observe The goal of the INN system is to identify drugs that in order to be registered, a pharmaceutical with a unique, characteristic and globally available trademark should also comply with a specific law name for each one of them. A clear identification other than the Industrial Property Code. Previously, a helps to ensure safe prescription and access of these pharmaceutical trademark required to be in medicines to patients. A new INN is published in the accordance with the Code and with this specific law: WHO Chronicle and transmitted to all Member ‘the registration will only be issued upon submittal of States, to the national committees and to other an office action response receipt as per specific relevant organizations in order to prevent these INNs pharmaceutical law’ (IPC, 1971). This feature too was from becoming exclusive right , such as, for excluded from the current IPL. instance, trademark registrations. DE PAIVA BUCASIO et al.: PHARMACEUTICAL TRADEMARK EXAMINATION AND SELF-MEDICATION 443

As INNs are unique names they must be distinct and Ordinance 01/83 has updated the list, and ensured not susceptible to confusion with other names in common compliance with official nomenclature and its use in all use. WHO has granted INNs the status of public property1 official documents. With Ordinance no 971 issued by to be used as common information by all and meant to be the Ministry of Health on 10 August 1993, the an essential feature for maintaining communication Brazilian Nonproprietary Names list was published. It within the health system. Therefore, an INN can be used is regularly updated by the Subcommittee of Brazilian by all pharmaceutical manufacturers also for business Nonproprietary Names and is available at the ANVISA purposes of providing information to potential consumers website.13 The list currently in force was published in of the medicines. As such, no one is entitled to have November, 2006 in RDC 211/2006 text, and has been exclusive rights over an INN or part thereof by means of subsequently updated by several ANVISA resolutions. industrial property protection. Whenever a new This list comprises around 9,300 generic terminology becomes an INN, it falls into the necessary, denominations, and is an official document of public essential information category in its segment and is no property employed in drug registration files, public longer available for exclusive right ownership. bids, pharmaceutical compounding, input tracking, An INN consists of two parts: a randomly chosen medical prescriptions, legislation and in all types of fancy name and a stem. The stem corresponds to a scientific work or research. pharmacological category which identifies the drug The commercial success of a medicine depends not properties. Therefore, INNs that are pharmacologically only on its therapeutic efficacy, but also on its related but containing different chemical substances, share popularity promoted by several marketing strategies, a common stem. Table 1 shows some examples of stems such as, for instance, trading it under a trademark in and their corresponding pharmacological categories. order to build customer loyalty.11 Thus, drugs that In general, stems are employed as suffixes, but have the same generic name may be traded under sometimes they can be used as prefixes, as seen in different trademarks. For example, Tylenol®, Table 2. The stems are the most important part of the Panadol®, Crocin® and Calpol® are trademarks for INNs, as main function of the medicine is conveyed the generic name drug paracetamol. by these stems. The main criteria for choosing a pharmaceutical INNs are translated into Portuguese by ANVISA trademark are the following11: and are known as Brazilian Nonproprietary Names • The name must be different, easy to pronounce (BNNs, DCBs in Portuguese). The importance of and to remember having an official was • The name may indicate how the drug works, its acknowledged in Brazil during the early 1970s. therapeutic purpose or the part of the body for However, only in January 1981 the Brazilian Ministry which it will be used of Health published the first official list of generic names, which became compulsory in the application One seeks to correlate a drug with its therapeutic for new pharmaceuticals (Ordinance SNVS 8/1981). purpose because trademarks can be seen as pieces of information to the consumer as well as to the doctor Table 1  Stems and pharmacological categories who prescribes them, with an aim avoid confusion or mistakes on the part of the consumer. Besides, this INN stem Pharmacological category use of the therapeutic purpose together with the easy- -gli Antihyperglycaeamics remembrance factor helps the consumer’s decision- -grel Platelet aggregation inhibitors -azepam Diazepam derivatives making process and saves time. Moreover, it supports -aldrate Antacids the idea that the protection of a trademark is proportional to the cost-benefit it offers to the society. Table 2  The use of stems in INNs A trademark becomes the distinctive element which INN Fancy term Stem educates the consumer about the commercial source of Clopidogrel clopido -grel products and, unlike INNs and BNNs, it can be Ramipril rami -pril exclusively appropriated by its owner. That is, whereas Lisinopril lisino -pril Glimepiride mepiride gli- common denominations indicate information that Gliclazide clazide gli- renders products equal (apart from their therapeutic Escitalopram es-(radical)-opram cital- purposes), trademarks aim at differentiating one Source: http://mednet.who.int, ref. 8, p. 8 product of another, regardless of whether they have 444 J INTELLEC PROP RIGHTS, SEPTEMBER 2013

identical therapeutic purposes or not. Pharmaceutical Methodology trademarks identify the product and match it to their Trademark examination was carried out for each sign manufacturing laboratory. A trademark is a proprietary seeking registration filed with the Office. A trademark right which seeks to be distinct from competitors, examiner uses the IPL, the examination guideline and rather than being a nomenclature available for the use other manuals, proceedings and classifications available. of any competitor, thereby making competitor’s The examination aims at ascertaining whether the products indistinguishable in the market. requested sign is capable of being a registered trademark Companies have different strategies for choosing the according to IPL provisions. names of their pharmaceutical trademarks. Said names Initially, a spreadsheet with all pharmaceutical often derive from parts of common denominations or trademarks filed until 30 June 2009, with dead and from words that help identify the therapeutic action, the alive entries, belonging to the pharmaceutical name of the manufacturer, drug administration, dosage classification was obtained from the INPI’s Computer and scheme. Sometimes they are atypical names, such and Technology Coordination Center (CGMI in as Xanax®, Prozac® or Viagra®. There may be other Portuguese). The spreadsheet comprised specifically techniques like using a part of an already successful the following data: application/registration number, like ‘Penagra’ and ‘Kamagra’ from the original filing date, trademark, owner, file status, issuance date brand ‘Viagra’. Sometimes, companies may follow and class (pharmaceuticals). INN nomenclature like ‘Trizivir’ grom INN abacivir or Of these, only those applications/registrations in ‘Zestril’ from lisinopril, etc.11 force were selected. Then data was filtered by filing It is important to point out that when a new date (from 14 May 1997 onwards, the date on which INN/BNN is to be created, the existence of a trademark the IPL took effect) and by file status (registrations that already uses part of the stem of this new INN/BNN without any kind of appeal filed). A total of 18,236 may threaten the creation of such denominations; the granted trademarks were compiled. owner of the trademark may oppose the new INN/BNN Using this as base data, the medicines most in view of his/her property right. commonly used for self medication was selected; The Expert Committee on the Use of Essential such a subset was expected to be illustrative for a Drugs observed that instead of marketing their group of medicines that are more likely to lead to products under generic names, many companies apply consumer error. for a trademark registration derived from an INN or The list of medicines used in this paper was from a common stem. Resolution 46.19 of World obtained from Arrais et al.14 In this article, the authors Health Assembly urges Member States to develop indicate that the therapeutic categories mostly policies related to the use of INNs and their employed for self-medication in Brazil are (sorted in protection. INNs may be legitimately used for descending order): analgesic drugs, nasal marketing purposes; however their use as exclusive decongestants, anti-inflammatory and anti-rheumatic property must be discouraged. Even though the term drugs, antimicrobials and chemotherapy drugs, ‘discourage’ does not indicate a prohibition on the use vitamins, antispasmodic drugs, antacid/antiulcerative/ of INNs as trademarks, it allows some degree of antiflatulent drugs, sexual hormones, antihistaminic flexibility for each country to establish means of drugs for systemic use, cough and cold preparations, regulating the use of INNs, including the exclusion of muscle relaxants, anti-diarrhea/anti-infection drugs common denominations as trademarks. In Brazil, an and anti-asthma drugs. INN may be refused as a trademark based on the legal Accordingly, 112 stems in the Brazilian provisions of Article 124 of IPL. Nonproprietary Names list were identified. They are As mentioned earlier, however, such prohibition is listed in Portuguese in Table 3. not ruled by any agreement, treaty or any other legal These 112 stems were searched for in the 18,236 provision, whether international or otherwise; such trademarks initially selected, in order to check refusal is a mere recommendation. Perhaps that is the whether the pharmaceutical trademarks were granted reason why the INPI’s examination for the according to the Industrial Property Law and in registration of pharmaceutical trademarks is not compliance with WIPO and WHO guidelines. That is, obliged to take into consideration orientation and whether the stem composing the trademark matches other parameters suggested by the WHO. the right therapeutic category. DE PAIVA BUCASIO et al.: PHARMACEUTICAL TRADEMARK EXAMINATION AND SELF-MEDICATION 445

Table 3  List of the most frequently used self-medication therapeutics

Most frequent therapeutic categories Corresponding stems (in Portuguese) Analgesic drugs (painkillers) -adol, -adol-, -adom, -azocina, -azona, -butazona, -buzona, -cef-, -eridina, -etidina, - fenina, -fentanila, -nab-, nal-, -orfano, -orfano- Nasal decongestants -azolina, -drina, -frina Anti-inflammatory/anti-rheumatic drugs -aco, -azona, -butazona , -buzona, -cort, -fenamato, -fenâmico, -flapona, -icam, -lubanto, -metacina, -onida, -oxicam, -profeno, -sal-,-nixino Antimicrobials/chemotherapy drugs -adina, -bactam, -cacina, -carbefe, cef-, -ciclina, -cidina, -cilina, -dapsona, -dox, -fosina, -fungina, -gilina, -ibina, mer-, -mer-, -micina, -monam, nifur-, -oxacino, -oxefe, -parcina, -planina, -platina, -penem, -prim, -quin-, -quina, rifa-, -rozol, -rubicina, salazo-, sulfa-, - sulfano, -tecana, -tepa, -tricina, -ur, -uracila, -uridina, -vudina Vitamins -calci- , nic- , nico-, -retin- Antispasmodic drugs -trop-, -verina Antacid/antiulcerative/antiflatulent drugs -aldrato , -alox, -prazol, -prostila, -tidina Sexual hormones -andr-, -bol-, -estr-, -gest-, -ifeno, -mifeno, -oxifeno, -ster-, -sterida, -terona Antihistaminic drugs for systemic use -aste , -astina , -azolina, -cromil, -rizina, -xanox Cough and cold preparations -cisteína, -steína, -exina Muscle relaxants No corresponding stem Anti-diarrhea/anti-infection drugs No corresponding stem Anti-asthma drugs -aste, -flapona, -lucaste, -prenalina, -terol, -trodaste Results bought by consumers without a prescription. With a According to Revista da Associação Médica view to restricting the study to examination of Brasileira (Brazilian Medical Association Magazine)15, pharmaceutical trademarks, only the searches with the ‘self-medication is a widely spread habit not only in most relevant results were included. Therefore, Brazil [...] the majority of the pharmaceuticals the searches by prefix, stem or suffix with irrelevant population consumes is sold without prescription’. results, e.g., not within the timespan selected Self-medication is used to relieve all kinds of (14 May 1997 to 30 June 2009), were left out. symptoms, the most typical ones, such as those caused Searches (in Portuguese) by stems -adol-, -nab-, -sal-, by common viruses. In Brazil, at least 35 per cent of -mer-, -quin-, -calci-, -retin-, -estr- and -gest-, by the medicines are accessible for self-medication.16 prefixes cef-, nal-, mer-, nic-, nico- and by suffixes - The major complaints discussed in Nielsen’s aste, -aco, -dox, -icam and -ur, were also considered research17 on how consumers worldwide treat their irrelevant because the results revealed pharmaceutical diseases, were related to ‘headaches, colds, sleep trademarks in which the stems, prefixes and suffixes disorders and backaches’. The study revealed that did not clearly characterize their therapeutic purposes. consumers are loyal and habitual buyers of over-the- As can be seen from the Table 4, several search counter (OTC) drugs that relieve pains. Still results showed that the specification of according to the same research, the three factors that pharmaceutical trademarks was very broad as, for influence consumers’ attitudes when they become ill instance, ‘medication for human use’ or indicated are: strong ‘loyalty’ to ‘tested and approved products’ several therapeutic purposes, such as ‘muscle trademarks (i.e., drugs that consumers have already relaxant, analgesic, antipyretic and anticonvulsant’. taken); ‘trust in medical professionals’; and ‘strong This prevents the trademark examiner from verifying culture of using homemade medicines’.17 Nearly half if the trademark is really applied to a specific of such consumers (42 per cent) turned to their therapeutic purpose, as recommended by WHO. A habitual medicines, already ‘tested and approved’ more precise specification would be extremely during illnesses, and one out of three admitted seeing important for carrying out a more efficient a doctor or going to a drugstore seeking a examination. recommendation for an OTC drug. Another point to highlight is the issuance of Taking into consideration the risks posed by self- deceptive trademark registrations which could medication corroborated by studies like those above, mislead the consumer, i.e., trademarks that infringe the results in this research were based only on item X of Article 124 of IPL. For example, the trademarked pharmaceutical products that can be trademarks Deprozol® and Thyrozol®, in view of 446 J INTELLEC PROP RIGHTS, SEPTEMBER 2013

Table 4  Research compilation

Stems Trademarks Infringement of Infringement of In compliance with WHO and Problems with specification (either too (in Portuguese) analysed item VI of IPL item X of IPL IPL recommendations broad or indicating several products)

-adol 10 0 3 3 4 -azona 2 0 0 0 2 -eridina 1 0 1 0 0 -drina 1 0 1 0 0 -oxicam 2 0 0 1 1 -cort 39 1 9 3 26 -adina 3 0 2 0 1 -bactam 1 0 0 1 0 -ciclina 4 0 0 2 2 -cilina 15 0 0 9 6 -micina 19 1 5 7 7 -penem 2 0 0 2 0 -rubicina 2 0 0 2 0 -tricina 1 0 0 1 0 -platina 3 0 0 3 0 -prim 1 0 0 1 0 rifa- 9 0 0 6 3 sulfa- 11 0 1 7 3 -rozol 5 0 3 2 0 -verina 2 0 0 1 1 -alox 3 0 2 0 1 -prazol 6 0 0 1 5 -andr- 6 0 2 3 1 -ifeno 2 0 2 0 0 -oxifeno 1 0 1 0 0 -sterida 1 0 1 0 0 -astina 2 0 2 0 0 -cromil 1 0 1 0 0 -exina 2 0 1 0 1 -terol 7 0 2 3 2

Total 164 2 39 58 66 100% 1% 24% 35% 40% their suffix -rozol, should only represent antimicrobial A broad specification does not let the examiner verify and chemotherapy drugs, rather than anthelmintic whether the sign applied for as a trademark falls into drugs and drugs indicated for treating thyroid the prohibitions set forth in item X of Article 124 of problems, respectively. Another example is the IPL; probably leading to the grant of deceptive trademark Faulblastina® that, due to its suffix – trademarks. On the other hand, granted trademarks astina, should designate antihistaminic drugs instead that infringe items VI and X of IPL amount to 25 per of the antineoplastic drug that it actually is. cent of the total of trademarks analysed. Another interesting fact that came to light is the infringement of item VI of Article 124 of IPL, viz., Conclusion the granting of the sign betazol in the trademark In Brazil, although there is an ANVISA regulation Betazol Cort®. This sign is a Brazilian concerning the trading and of medicines Nonproprietary Name, therefore it should not be that can be bought over the counter, there is no granted as an exclusive right. regulation or orientation for the people who use them. In Table 4, a compilation of the research results is The data analysed in this study suggest that the non presented. The occurrence of broad specifications or compliance with WHO orientation regarding specifications that comprise a great array of pharmaceutical trademark examination procedures therapeutic uses is the biggest problem in the may have severe consequences on public health, examination of pharmaceutical trademarks, as it either with drugs that mislead the consumer or with represents 40 per cent of the 164 analysed trademarks. the registration of signs which are public property. DE PAIVA BUCASIO et al.: PHARMACEUTICAL TRADEMARK EXAMINATION AND SELF-MEDICATION 447

Thus, according to the results of this research, it is 8 Gonçalves L M C, Direito de marcas (Almedina, Coimbra), indispensable for the improvement of trademark 2003, p. 72. examination, to strictly adhere to the BNNs and stem 9 IDS - Instituto Dannemann Siemsen de Estudos Jurídicos e Técnicos, Comentários à lei da propriedade industrial lists made available by ANVISA during the (Renovar, Rio de Janeiro), 2005, p. 216. examination, which would decrease the granting of 10 Gusmão J R, L'acquisition du droit sur la marque au Bresil, deceptive and public property signs as exclusive Strasbourg/France, These pour le doctorat en Droit, trademark right, in accordance with the Brazilian Université Robert Schuman (Strasbourg III) Faculté de Droit Industrial Property Law provisions. et des Sciences Politiques, 1989. 11 Gopakumar K M & Syam N, A study on the use of International Nonproprietary Names in India (Centre for References Trade & Development (Centad), New Delhi), 2007. 1 http://www.who.int/medicines/services/inn/en/ (2 January 2013). 12 http://www.pharmacopoeia.org.uk/guiding.cfm (2 January 2013). 2 Mc Carthy J, Marketing Básico, Vol 2 (Zahar, São Paulo), 13 www.anvisa.gov.br (2 January 2013). 1978, p. 432. 14 Arrais P S D, Perfil da automedicação no Brasil, Revista de

3 Tinoco Soares J C, Comentários ao Código da Propriedade Saúde Pública, 31 (1) (1997) 71-77. Industrial (Resenha Universitária, São Paulo), 1981, p. 151. 15 Editorial, Automedicação, Revista da Associação Médica 4 Olavo C, Propriedade industrial. Sinais distintivos do comércio Brasileira, 47 (4) (2001) 269-270. concorrência desleal (Almedina, Coimbra), 2005, p. 71.

5 Ascensão J O, As funções da marca e os descritores 16 Aquino D S, Por que o uso racional de medicamentos deve (metatags) na Internet, Revista da ABPI, 61 (2002) 44-52. ser uma prioridade? Ciência & Saúde Coletiva, 13 (Sup) 6 Superior Tribunal de Justiça, MS 90.0000845.0 no :0000328, (2008) 733–736. Primeira Seção, j. 24.04.1990, DJ de 21.05.1990, p. 04421. 17 Nielsen, Doenças e medicações do consumidor: um relatório 7 Barbosa D B, Proteção das marcas - uma perspectiva de consumo global da Nielsen, http://br.nielsen.com/reports/ semiológica (Lumens Juris, Rio de Janeiro), 2008, p. 71. documents/automedicacao_ago2007.pdf (2 January 2013).