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Pharma Trademark: Sanitary Agency Authorization for Its Effective Use 1

24 Jun 2013

Introduction

In the marketing strategy of the pharmaceutical industry the trademark has a leading role: as Intellectual Property right, the trademark distinguishes and continuous protecting the pharmaceutical product from the generic versions, even when the patents linked to it have expired.
From the process of trademark selection to the consolidation of the right of effective use for the pharmaceutical product, the trademark has to pass through different phases:

  1. Selection of the candidates;
  2. Screening of the trademarks (candidates and cited) in different data bases;
  3. Registration with the Trademark Office;
  4. Sanitary agency authorization of the trademark as product denomination.

It is worth emphasizing that the registration is an advisable step in order to obtain an exclusive right of the chosen sign.

The Denomination of Pharmaceutical Products

From a commercial point of view, the medicines identify themselves through their trademark and the social denomination of the owner or “brand name”, which links them to the pharmaceutical laboratory that commercializes, manufactures and/or imports them.
In addition, the health regulation classifies the different drug categories starting from their active ingredients, identifying them through the International Common Denomination2 o or Non-Proprietary Name (the scientific denomination).
This is the reason why, on an international basis, a large number of health regulations allow pharmaceutical products to be identified by their “commercial name”, fantasy name or “trademark”, along with the generic name of the active ingredient. This way, the sanitary agency authorizes the commercialization of the product under that commercial name (being a registered trademark or not), which must be approved (granted).
Independently from the intervention of the sanitary agency, in legislations such as Argentine legislation, the trademarks themselves -as a category of IPR- confer their holders the ability of exclusive use through their registration with the Trademark Office.

Sanitary Agency Intervention regarding the Authorization for Pharma-Trademark Use

According to the aforesaid, for the exclusive use of the pharma-trademark 3 the intervention of both mentioned national agencies is needed, although they usually have different criteria and independent registers (unlinked). Besides, the legislations of the different countries are quite heterogeneous.
These facts affect the foresight of the acceptance of a trademark. In countries such as ARGENTINA, CHILE, and others in Latin America, each sanitary agency has its own regulations and different legal and institutional standards and interpretation criteria which are often non-written and based on administrative customs.

Effective Strategy for the Selection of a Pharma Trademark

When it comes to choosing a trademark and in order to foresee more accurately the mentioned matters, it is advisable to consider:

  1. A searching process at a regional or international level.
  2. That the trademark is not one of the unregistrable signs according to law (for example, generic name exclusively).
  3. A selection process that includes simultaneously not only the registration criteria of the trademark office but also the one of the different sanitary agencies of the different countries where the authorization will be requested.

The third process is critical, since the sanitary agencies can, under different circumstances, reject the candidate trademark to identify the medicine, although it might have been properly registered. And as a matter of fact, they do. For example, they can reject the proposed trademark arguing “confusion” with another trademark previously authorized by them, or because it does not fit in with their interpretation criteria of legal requirements.
It is worth highlighting that trademark legislation is more predictable due to some requirements that the sign to-be-registered has to fulfill:

  1. It must not be the necessary or common designation of the product or service to be distinguished;
  2. It must not be identical to an already registered trademark;
  3. It must not be similar to other registered or required trademarks that distinguish the same products;
  4. It must not lead the consumer to confusion regarding the nature, properties, origin, etc., of the product to be distinguished.

It is clear that this is not the case with the legislation applied by the health authority.
ARGENTINA does not have a sanitary regulation 4 that allows one to know in advance what the applicable criteria to accept or reject a medicine trademark will be.
In CHILE and SPAIN 5, although there is a regulation that establishes the non-authorization of a trademark when “it could lead to confusion or deception, being the name similar to the one of another registered product 6”, it does not set any standard to evaluate, according the authority criteria, when confusion exists between similar signs 7, or if this single condition would be enough. It is left to the subjective criteria of the health official who evaluates the trademark, increasing the lack of foresight.
In PERU, the regulation prohibits the use of the trademark when it is identical to another already registered, but it also states that the product submitted to approval has to have a composition different to the previously registered one.8
In the cases where a trademark is rejected due to confusion, an argument against the health authority decision could be based on the fact that the Trademark Office (and possibly third parties during opposition) have already evaluated the possible confusion of the new trademark, without objecting to it.
Notwithstanding this, there is a double control regarding the confusability of a trademark in the practice. This seems to be the understanding of the Court of Justice of the ANDEAN COMMUNITY in its prejudicial interpretation 9 to differentiate the jurisdiction of both trademark and health authorities, giving the latter the jurisdiction concerning the “subsequent aspects related to quality or hygienic conditions of the product for its commercialization” and excluding its interference in “the proper trademark field”.

Sanitary Authorization Criteria of the Pharma Trademark

Although health regulations do not establish requirements for the acceptance of a trademark, there are some technical practices of the agencies and jurisprudence criteria of each country that make that the results of the evaluation of trademarks could be more foreseeable for pharmaceutical companies. The knowledge of these interpretation rules is unavoidable when a marketing authorization is required.
One of them indicates that the sanitary agencies have as rational principle to guarantee the health of the consumer of medicines, avoiding that their designations or trademarks lead the professional of health or the consumer to an error that might produce damage to the health of the latter. In general, this principle favors the authorization of safe products.
To that end, agencies like ANMAT (Argentina) or the FDA (USA) evaluate the requested commercial name, comparing it to commercial names of authorized products (being registered trademarks or not), generic names, class particles and indications of use among others, in order to avoid the confusion or mistake with other authorized products that may take place at the moment of the prescription (physician), the dispensation (drugstore) or the use on the part of the patient.

From a regulatory point of view, if the chance of harm cannot be demonstrated in spite of the resemblance between the requested trademark and other already authorized, the sanitary agency could not refuse the use of the trademark.
At this point, it is undeniable that the appreciation of the resemblance depends on the methods used to perform the comparison of signs.
To illustrate this, the FDA performs a procedure called “Pre-marketing Risk Assessment”, after which the sponsor of the product can ask for a “Review Decision”, step in which the FDA carries out an evaluation called “description of prescription simulation”. By doing this, it 1) dismisses confusion or error by handwriting, b) studies the prescription by commercial name, 3) applies POCA (Phonetic Orthographic Computer Analysis), and 4) evaluates safety through a risk analysis.
The EMEA applies the “Name Invented Review Process”, which is less complex and faster than the one of the FDA, but also with results that are more unforeseeable. Four options have to be put under the authority’s consideration in between 4 and 18 months before the submission of the product.
Following, a guide to put the most relevant aspects during the selection process of a pharma-trademark under consideration:

  1. Geographical range of the trademark search
    • In which countries or regions will the trademark be registered?
    • �What is the comparison criteria?
  2. During the regulatory process of authorization of the candidate
    • Will the trademark be accepted by the sanitary agency?
    • Is there a replacement trademark?
    • Could the trademark lead to confusion with an authorized commercial or brand name?
    • Is the trademark in conflict with any generic name or official denomination of the country?
    • Could it be objected due to potentially causing the health professional to make an error or the consumer to make an error or mistake? Under which circumstances?
    • Is the rival product with the authorized commercial name in the market?
  3. Rejection of the commercial name by the sanitary authority
    • What administrative and legal appeals does the legislation establish in case of rejection?
  4. Acceptance of a rival’s easily mistaken commercial name by the sanitary authority?
    • Under what circumstances does the sanitary legislation establish the revocation of an easily mistaken commercial name?
    • Could the decision of acceptance be questioned according to the Law of Fair Trade?

Notes:
1 By Estela De Luca, Mariano Municoy and Marta Pentz.
2 WHO Denomination
3 It includes the so-called “regulated” products, such as cosmetics, food and others.
4 In Drug Law 16.463, except for some regulatory dispositions issued by ANMAT. For medical specialty registration it is required to have a commercial name.
5 Spain: Law 29/2006, July 26th, of Warranties and Rational Use of Medicines and Health Care Products. Sec. 14. Identification warranties. “In the cases of commercial or brand names, the naming of the medicine must not be mistaken with a Spanish official or an internationally common name, or lead to error about its therapeutic properties or nature of the product.” Previously, Drug Law dated December 20, 1990, sec. 15, ap. 5 (repealed).
6 Chile: Supreme Decree 1876/1995, sec. 36, b).
7 The Trademark Law refers to a “confusing similarity” between antagonist signs.
8 Supreme Decree 010-97-SA – Section 24 – No registration shall be granted for a product which brand name corresponds to another product that already obtained its sanitary registration.
9 Proceeding 38-IP / 98.




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