In July of 2010, the National Health Surveillance Agency (Anvisa) posted Public Consultation No. 72, with a proposed resolution to establish new criteria for drug trade names and differentiating complements.
The objective is to check the establishment of trade names and their complements to prevent health risks associated with confusion caused by similar names for different drugs. These criteria do not apply to generic or immunotherapeutic drugs, which are still required to use the common name of the active agent.
The document defines a drug’s "trade name" as the designation used to differentiate a certain drug from others by the same company or by other companies. Broadly speaking, "trade name" as defined in the proposed resolution is what the market and the Industrial Property Law (IPL) define as "trademark."
The text says that graphic similarity occurs when two products, whether from the same company or not, have trade names that look very much alike and can be confused and cause someone to take the wrong medication. This criterion could affect companies that have trademark families (trademarks that have an element in common). In addition, the criterion seems to encompass not only the trademark’s appearance on the product’s packaging, but also the way it is written on papers and other printed material by doctors, pharmacists and other health professionals, a fact that leaves room for considerable subjectivity.
The text says that phonetic similarity occurs when the pronunciation of the trade names of two different products is so similar that it could lead to error.
§2 of Article 5 establishes that the products whose formulas are similar enough may constitute a family of products and adopt the same trade name. Article 5’s main paragraph describes similar formulas as those that contain the same distinguishing components and have the same therapeutic indications. Understanding this article helps to prepare for problems in registering trademarks for drugs with a second application.
It also prohibits adoption of trade names that employ, wholly or in part, the generic name of the active substances, such as DCB, DCI, CAS or the like, used for these compounds. Of course, there are numerous drug trademarks registered with the BPTO whose root exhibits this very condition (Ex.: ACETILDOR, DESFENIL, etc).
Similarly, it seems extreme to prohibit that trade names may not be formed using Arabic or Roman numerals, even if written form (Ex. COXDOIS), abbreviations, random sequences of letters and words (Ex. XYZAL) or expressions in a foreign language (Ex.: NEW LS MASS I).
The proposed resolution contains other points that must be clarified, among them definition of the spheres of competence of the Brazilian Patent and Trademark Office (BPTO) and Anvisa, as well as the interrelationships of the criteria for trademark analysis and trade name acceptability established by these institutions.
The deadline for submitting suggestions and critical assessment of Anvisa’s proposal was in August. According to Anvisa, over 180 contributions were submitted, one of these from the Brazilian Intellectual Property Association (ABPI), and are now under review. It has not set a date for publishing the final resolution that will regulate the matter.