16 February 2015Jurisdiction reportsEduardo Hallak and Viviane Trojan

Trademarks now allowed for vaccines

The syndicate members make up the majority of manufacturers of vaccines commercialised in Brazil.

Rendered by the fifth panel of the Federal Court of Appeals for the First Circuit, the decision is now final and confirms a preliminary injunction granted back in 2002, when the lawsuit was filed.

The syndicate filed the lawsuit in view of notification 548, issued by the Brazilian Health Surveillance Agency (ANVISA) on February 27, 2002, which prohibited the use of trademarks in vaccines beginning in April of the same year. ANVISA’s act was based on an ancient disposition: article five of decree 79.094/1976, which regulates article five, paragraph four of law 6.360/1976, amended by law 6.480/1977.

Article five of the decree sets forth that “medicines containing a sole active ingredient… cannot display brand names”. However, until the issuance of notification 548, ANVISA (as well as the Secretary of Sanitary Surveillance, which preceded the agency) never enforced the prohibition.

A preliminary injunction obtained at the beginning of the lawsuit prevented ANVISA from enforcing article five against the syndicate’s members. However, due to a political appeal filed by ANVISA, the injunction was suspended until May 21, 2014, when the syndicate’s request for the provisional enforcement of the final decision on the merits was granted. Since then, the pharma companies in the syndicate are allowed to resume importation and commercialisation of vaccines with their trademarks in Brazil.

The fifth panel of the Federal Court of Appeals for the First Circuit maintained the final decision on the merits of the 14th Federal Court in Brasilia, ruling that decree 79.094/1976, edited more than 30 years ago, violates the constitutional right to health and the public interest (ie, having different trademarks identifying different vaccines). This matter is now res judicata.

The appellate court recognised the importance of the identification of the vaccines by their trademarks, as shown by the plaintiff in the lawsuit. Usage of a trademark is essential to avoid risk to public health. Even when designed for the same therapeutic purpose, vaccines from different manufacturers have different concentration, composition, posology (dosage), conservation, immunogenicity (ability to protect the individual) and reactogenicity (ability to produce adverse reactions). For the correct immunisation of a person, doses of vaccines with different trademarks cannot be administered.

"The appellate court recognised the importance of the identification of the vaccines by their trademarks, as shown by the plaintiff in the lawsuit."

The Brazilian Federal Constitution, in article five, item 29, recognises the social interest in trademark use, in view of its function of distinguishing products, identifying their origin and quality, and thereby avoiding confusion among consumers.

In the Industrial Property Act (law 9.279/1996), there is no restriction on the registration and use of trademarks in products such as vaccines. Also, Brazil is one of the signatories of the World Trade Organization’s TRIPS Agreement, approved by legislative decree 30 of December 15, 1994, and promulgated by decree 1.355 of December 30, 1994.

The agreement provides in its article 15.4 and 20 that “the nature of the goods or services to which a trademark is to be applied shall in no case form an obstacle to registration of the trademark” and “the use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements”.

The recognition of the right to use trademarks in vaccines over decree 79.094/1976, edited before the current Brazilian constitution, benefits not only the pharma companies but also patients and doctors, in order to ensure safe administration of the products.

Eduardo Hallak is a partner at  Licks Attorneys. He can be contacted at: eduardo.hallak@lickslegal.com

Viviane Trojan is an associate at Licks Attorneys. She can be contacted at: viviane.trojan@lickslegal.com

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