Regulation of the term “BIO” as an example of the conjuntion between Regulatory and Trademark issues 1

24 Jun 2013

For a trademark to be successfully used as a distinctive sign of a product that is regulated by sanitary norms such as pharmaceutical or alimentary law, it has to comply with two simultaneous and necessary legal requirements: 1) to be authorized by the sanitary authority (or at least not rejected), as the “commercial name” of the product, and 2) its application must not to be rejected by the trademark office.

Like in other regions of the world, in most Latin-American countries such as ARGENTINA and CHILE, each sanitary agency has its own regulations and different legal and institutional standards and interpretation criteria (often non-written, based on administrative customs).

For this reason, whenever it is possible (depending on the particular circumstances of each case), it is recommendable to perform an extensive evaluation to check the compatibility between the health (sanitary law) and registrability (trademark law) aspects of a case.

For instance, in ARGENTINA, Trademark Law No� 22.362 sets forth very broad rules but the existing rich jurisprudence has resulted in very precise guidelines, particularly regarding pharmaceutical products.

On the contrary, the Law of Drugs Nr. 16.463 and the dispositions of the sanitary authority (the “ANMAT” for pharmaceutical products) do not have any precise rule that allows to predict if a trademark of a cosmetic or pharmaceutical product will be admitted or not2. That is why the health authority can deny the use of a registered trademark as a drug name, which has often happened.

Rejection of the registrability of the term “BIO” by the trademark office based on health regulations.

As an example of this possible divergence between trademark and sanitary regulations regarding agro-alimentary products, let us see what would happen with the following hypothetical case:
On the one hand, the SENASA (the Argentine sanitary authority for agro-food as well as other related products related to animal and vegetal protection) authorizes the marketing of a domestic animal food which commercial name includes the prefix “BIO” (proposed trademark “BIODOG”).
Meanwhile, the INPI (the Argentine Trademark Office) rejects the registration of that trademark based on Art. 11 of Decree 97/2001 and on Art. 3 d) of Law 22.362 (makes reference to the case where a trademark induces the consumers to error).

What kind of solution or claim could be raised?

Fist, it is worth mentioning that Decree 91/2001 was enacted by the Federal Administration to implement Law 25,127 (issued by the Congress) and that art. 11 of said Decree forbids the use of the terms “biological, ecological or organic, eco or bio” as a trademark.
Nevertheless, the aforesaid Law 25,127 was issued to regulate the certification of the agro industrial methods called “ecological, biological or organic” applied to “ecological products” (art. 2), in order to offer “healthy products”.

In this context, it would be possible to argue that the word “biological” is meant for “allowing the unquestionable identification of the products” with the aim of avoiding confusion between consumers.

Therefore, taking into account the type of products regulated by the law, it would be possible to claim that the prohibition of art. 11 of Decree 97/2001 applied to products for animal feeding (instead of applied to humans, who are the consumers protected by the law) is contrary to Law 25.127, and therefore should be declared unconstitutional.
Besides, it should be bear in mind that the competent authority to enforce Law 25.127 and Decree 97/2001 is SENASA and not INPI, which is the agency that in our example denied the trademark based on sanitary Decree.


The Regional Regulatory Affairs Department of Moeller has the opinion that:

  1. The ban on the use of the term “BIO” as a trademark (according to Decree 97/2001) exclusively applies to those alimentary products covered by Law 25.127. Lacteal products are excluded, which can use “BIO” in their trademarks like “Prebio 1” owned by Societe des Produits Nestl�.
  2. The aforesaid prohibition should not include agro industrial products for domestic animal feeding (like in the above example of the rejection of “BIODOG” commented).
  3. Pharmaceutical and agrochemical products should clearly be excluded of the prohibition.
  4. The possibility of using the term “bio” or “biological” within a trademark could be claim before the particular authority when the nature of the product justifies it, for example when a biotechnological method is used within the product to be distinguished by the trademark.

Regarding the particular legal mechanisms available if a term is rejected as a trademark, it should be considered (besides other alternatives):

  1. File an administrative appeal before the rejecting authority;
  2. Initiate a legal action petitioning for the registration/recognition of the trademark;
  3. In the case of the use of “bio” for domestic animal feeding or any other similar case, raise the unconstitutionality of the administrative particular act and the supporting regulation (which would validate the claim before the Supreme Court of Justice).

1 Editor: Mariano Municoy, IP Lawyer at Moeller IP Advisors. Copyright: Moeller IP Advisors, June 2008.
2 In CHILE, art. 36 of Supreme Decree 1876/95 states: “A medical specialty can not be designated with a fantasy name when that act lead to confusion or mistake due to its similarity with the name of another registered product” (paragraph b).
3 In these cases and due to the lack of regulation, the defense of the trademark should be performed using arguments provided by the pharmaceutical law.

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