New rules about names of pharmaceutical products enacted in Brazil Gustavo Piva de Andrade, Dannemann Siemsen In October 2014, the Brazilian Health Surveillance Agency (ANVISA) enacted Resolution RDC nº 59/2014 setting several criteria for the formation of names for pharmaceutical products. The new rules are likely to cause a significant impact to the practice of the pharmaceutical industry. As a result, it is imperative that regulatory and IP professionals are aware of the new regulations enacted by the Brazilian health surveillance authorities. The first refers to terminology. ANVISA has finally abandoned the term “trade name” to refer to the trade mark of a pharmaceutical product. From now on, ANVISA will use the term “drug name”, which is more appropriate than its predecessor, since the term “trade name” is commonly used as a synonym of “corporate name” in Brazil. The second good news is even more important: the new Resolution revokes the “3-letter rule”, according to which “the name of a medication could be similar to an already registered name as long as they differ in at least 3 different letters”. That rule was in blatant disagreement with traditional principles of trade mark law. After all, there might exist confusingly similar trade marks that differ in three or more letters and sufficiently distinct marks that differ in just two. Thus, ANVISA acted correctly in revoking the 3-letters rule and replacing it by section 7, sole paragraph, of the current Resolution. This section provides that “the intended drug name must have sufficient graphic and phonetic distinction in relation to the names of other registered drug products”. The existence of the term “preferably” indicates that the one-word structure is not mandatory. The spelling rule, in its turn, indicates that ANVISA can reject names that can cause certain inconsistencies as to the way they are spoken or written. For example, when seeing the mark THERAHAIR identifying a medication used to stimulate hair growth, a Brazilian consumer familiarized with the English language would probably face no difficulty in pronouncing the term correctly. The purpose of this article is to provide an overview about Resolution RDC n° 59/2014 and comment about the aspects which should be considered in the selection and adoption of drug names by a pharmaceutical company. It also examines the Resolution from a practical perspective, shedding light on the interface between the new rules and some fundamental tenets of trade mark law. The same, however, would probably not occur with a consumer who is not acquainted with the English language, since when positioned in the middle of the word, letter h produces no sound in Portuguese. Reach of the new Resolution Firstly, an important disclaimer: Resolution RDC nº 59/2014 makes clear, in its article 20, that product registrations granted under the prior rules will not be reviewed by ANVISA. This means that the new regulation does not affect already granted registrations and will be limited to future registrations or to product applications that have not yet been approved by the agency. It is precisely this kind of inconsistency that ANVISA seeks to avoid. As a result, it is imperative that pharmaceutical companies take this rule into consideration while selecting a new mark to be used in the Brazilian market. Prohibitions set forth by the new Resolution Resolution RDC n° 59/2014 provides, in its article 15, that trade marks of drug products and their complements cannot use: As seen above, the current rule mandates that the name to be registered before the agency must be graphically and phonetically different as opposed to prior registered names. Although other criteria could have been added, this is unquestionably an improvement in respect of the prior rule, since the conflict assessment between two names should be done on a case-by-case basis and should not be governed by mathematical standards. Pharmaceutical companies therefore do not need to bring into line existing product registrations to the new rules, which denotes ANVISA’s praiseworthy concern to protect vested rights. Criteria for names of pharmaceutical products Resolution RDC nº 59/2014 brings forth two positive aspects in respect of the names of pharmaceutical products. The new Resolution also provides that the trade mark of a pharmaceutical product should preferably comprise only one word and its intended pronunciation in Portuguese must have direct relation to its spelling. 11 • The suffixes of nonproprietary names recommended for each therapeutic class of pharmaceutical substances, even if in a position different to that usually recommended – this rule prohibits the use of suffixes recommended for each therapeutic class of the pharmacology, such as - ADOL for analgesics and CICLOVIR for antiviral compounds (according to the Manual of the Brazilian Nonproprietary Names); • The parcel of the nonproprietary name of the drug substance, usually associated with a particular active