Enhancing the protection of Geographical Indications in Latin America

Lesly Nowak
IP expert at Latin America IPR SME Helpdesk

Spanish producers of “Turrón de Alicante” or “Sobrasada de Mallorca” fear no more! Producers of products protected under Geographical Indication in the European Union are getting closer and closer to have the protection of these Geographical Indications extended to Brazilian territory.

But what is a Geographical Indication? How can they benefit your business?

Geographical indications (GIs) are a specific Industrial Property Rights (IPRs) protecting products originating in a given geographical area whose quality or characteristics are due to a particular geographical environment (with its inherent natural and human factors) and all or part of the production steps taking place in the defined geographical area.

GIs involve regulating the already existing methods of production and traditions associated with the protected product so that only those companies producing or marketing products in compliance with the regulated standards can use the GI to distinguish their products. Unlike other categories of IPR, such as Patents (new inventions), Trademarks (new brand names) or Designs (new aesthetical characteristics), GIs do not require innovation. Instead, they tend to protect tradition (existing goods, existing methods of production and existing names of those goods) and are owned only in a collective manner.

GIs are a key tool for groups of SMEs producing local agri-food products in a defined geographical area. Indeed, consumer associate agri-foods with their place of origin and a certain guarantee of quality. In addition, their collective ownership and management (which fits with the nature of the rural and agricultural economy), the lack of innovation required and their commercial attractiveness make GIs one of the most suitable IP rights for agri-food SMEs.

In general, to register a GI you have to go through the following steps*:

1) Identify the specificity of the product, which may derive from its quality, characteristics or reputation.

2) Define the place, territory or region within which the product presents the specificity.

3) Identify the specific conditions of the geographical environment existing in the defined place, territory or region and make sure that the singularity of the product is essentially or exclusively due to those conditions.

4) Define and describe in detail the product and method of production.

5) Register the GI and enjoy the protection granted in the territory for which it has been registered.

GIs are still a sensitive subject. The first indicator is an international system of protection of GIs (Lisbon System). This system enables the applicant entity to obtain protection in several countries (as long as they are part of the Agreement) through a single application filed before the International Bureau. However, so far, this Agreement has had very limited success. In Latin America, only Cuba, Costa Rica, Nicaragua, Mexico and Peru are part of this system. As far as the EU is concern, only the Czech Republic, France, Hungary, Italy and Slovakia have ratified the Agreement.

Secondly, GI owners might have to deal with the fact that Trademarks consisting of or containing the expression protected by the GI (in the country or territory of origin, e.g. the European Union) might have already been registered and/or used in connection with the same goods in third countries. Unfortunately, applicable Law in most Latin America grants priority to those earlier trademarks, unless you can prove that earlier trademarks are deceptive or were applied for in bad faith.

Thirdly, GIs protected in the EU and, consequently, identifying products originating from a specific area and complying with specific characteristics, may, however, be considered generic names in third countries (“Queso Parmesano” in Argentina, for example). In such cases, the offices of third country will deny registration of these Geographical Indications. In some cases, it is the own national legislations that assigned a generic nature to the. This is the case of the Argentinian Food Code, which assigns a generic nature to several GIs protected in the European Union, e.g.: “Turrón de Jijona”, “Turrón de Alicante”. In these cases, registration of the GI will only be possible if it is preceded by negotiations between both parties’ Governments aimed at the mutual recognition of GIs and the abolition of that regulation.

Finally, whereas producers in the EU can benefit from a single registration procedure (with unitary effects in all Member States), recognition of GIs in Latin American countries, in most cases, requires a separate procedure before each national competent authority

It is in this context that bilateral agreements, concluded between the EU and certain Latin American countries, establishing mutual recognition of GIs, become important. In particular, the EU has concluded agreements for mutual recognition of agricultural GIs with Chile, Colombia, Peru, Mexico, Costa Rica, El Salvador, Guatemala and Honduras. We can now add Brazil to this list.

Indeed, as part of the negotiations between Europe and Brazil, in the framework of the MERCOSUR-EU negotiations, the Instituto Nacional da Propiedade Industrial (INPI) published the much-awaited Normative Instruction 79/2017. Take into account that this is all the more important since Brazil is not a member of the Lisbon Agreement or the Madrid System (for GIs protected through collective trademarks or certification mark). This Instruction, from October 30, established the first basis of this publication. The list of GIs was finally published on November 7, including well-known Geographical Indications, such as “Oporto” for Portugal, the Dutch “Gouda”, the Italian “Grana Padano” or even the French “Roquefort”. The list is accessible through INPI Brazil’s website. Be aware, though, that third parties have now 30 days to submit oppositions to the registration of these GIs in Brazil and you can expect opposition.

Take into account that producers are already commercializing most of these products in Brazil. Which leads to the following questions: how will the agrifood related industries be affected? Might this then generate some friction between local producers and GI’s owners in the EU? What EU Gi’s will be next? How will these IPR going to be really enforced? The situation will certainly lead to interesting developments and we will keep you informed from the Latin America IPR SME Helpdesk.

Do you want to know how your business can benefit from Geographical Indications? Are you planning to commercialize your products in Latin America? Do you require further information on costs or proceedings before taking the decision? If so, do not hesitate to check the Latin America IPR SME Helpdesk’s Factsheets on Geographical Indications (general or on Chile).

The EU-funded initiative will provide EU SMEs (either current or potential) with first-line, business focused information on any Intellectual Property related issue in Latin America.

If you require a tailor made consultation, please do not hesitate to contact the Helpline. It is free, fast and confidential! Moreover, the IP experts will support you in English, Spanish, French, German or Portuguese.

*(Source: Latin America IPR SME Helpdesk)

Compulsory licenses in Latin America

Lesly Nowak
IP expert at Latin America IPR SME Helpdesk

Issues regarding competition law and IP can, on their own, provoke sever headaches. However, these are not isolated subjects that never cross paths. Problems can grow exponentially when they do and require every bit of our attention and perspicacity.

Competition law and IP cannot be considered as pursuing opposite goals. Quite on the contrary, they must be seen as complementary. Granting exclusive rights through IP promotes innovation and competition between undertakings, the final beneficiary being the customer. This affirmation is also true when talking about Competition law: ensuring competition on the merits and avoiding distortion of the competition, which in the end will promote general economic welfare. In their dynamic relation, competition does not seek to impede the existence of exclusive rights, rather it seeks to avoid an abuse in the exploitation of those rights.

Compulsory licensing is one of the important ‘flexibilities’ recognized under Article 31 of the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). This is true since it makes it easier for WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector to avoid the trouble of negotiating expensive licenses with big pharmaceutical companies who are in a clear position of power in these negotiations. So far, only two countries in Latin America (Brazil and Ecuador) have made effective use of compulsory licensing provisions.

A compulsory license is generally ordered as a remedy when intellectual property law is not capable to offer a suitable remedy to a situation, usually because the owner of the IPR and the licensee are incapable of reaching a satisfactory settlement. Through these licenses, the owner of intellectual property is required to provide at least one other firm or a government with a right to import, reproduce, and/or sell the intellectual property.

Patent legislation in Latin America provides for different grounds for the granting of compulsory license:

  • Failure to exploit (ANDEAN, Argentina, Brazil, Dominican Republic, Mexico, Chile, Uruguay and Costa Rica).
  • Public interest (ANDEAN, Brazil, Dominican Republic, Honduras, Mexico, Chile, Uruguay and Costa Rica).
  • National emergency (ANDEAN, Argentina, Brazil, Dominican Republic, Honduras, Mexico, Chile, Uruguay and Costa Rica).
  • As a remedy against anti-competitive practices (ANDEAN, Argentina, Brazil, Dominican Republic, Chile, Uruguay and Costa Rica).
  • In case of failure to obtain a license under reasonable terms (Argentina, Dominican Republic and Uruguay).
  • In case of dependent patents (ANDEAN, Argentina, Brazil, Dominican Republic, Honduras, Chile, Uruguay and Costa Rica).

Although some Free Trade Agreements (FTAs) have been signed between Latin American countries and Europe (with Mexico, Chile and Colombia, for example) such agreements have not introduced any limitations on the possible grounds for compulsory licenses.

When granting a compulsory license, the competent authority will face a number of different challenges. First, it must justify the grant of such a license under one of the conditions above mentioned. Second, the authority will have to establish the life of the compulsory license. Finally, setting a correct level of royalty payment is another challenge to ensure proper retribution of the patent owner.

Real life cases: Brazil and Ecuador

In 2007, Brazil decided to override the patent on an AIDS drug in order to make it available under the country’s free treatment program.

Prior investigation lead the government to note that Merck was selling its drug at cheaper prices in countries at the same development level but with fewer people in need of treatment than Brazil; the Indian generic versions were much cheaper than Merck’s product.

Prior to the grant, the Brazilian government engaged in negotiations with the patent holder in order to achieve an acceptable price reduction. During these negotiations, Merck offered a price reduction from US$1.59 to 1.10 per dose, which was deemed unsatisfactory by the Brazilian government. Hence, through Presidential Decree No. 6.108 (4 May 2007) the government decided the grant of a “compulsory license, on the ground of public interest, of Efavirenz’s patents, for public non-commercial use” for a period of 5 years (renewable for the same period31) and a royalty fee for the patent owner of 1.5 % of the finished product.

This decision was far from popular. Although health activists, such as Médecins Sans Frontières, reacted positively, pharmaceutical industries were not pleased with the decision.

In Ecuador, the granting of compulsory licenses is based on the Presidential Decree No. 118 of November 16, 2009, that established “of public interest, access to medicines used for the treatment of diseases that affect the population of Ecuador and that are priorities for public health”. It also specifically specified that compulsory licenses could be issued for patents protecting medicines for human use that are necessary for the treatment of such diseases.

Following this Presidential Decree, the IEPI (Insituto Ecuatoriano de la Propiedad Intelectual) issued a Resolution (Resolution No. 10-04 P) with Guidelines on how to issue a compulsory license in the case of pharmaceutical patents.

Thanks to these instruments, on April 2010, the government of Ecuador granted a compulsory license for an anti-retroviral drug, to Eskegroup SA, a local distributor of a generic produced by an Indian company.

The government of Ecuador, on June 2012, granted a second compulsory license to Acromax Laboratorio Quimico Farmaceutico S.A. regarding a drug protected by and held by the Glaxo Group. After confirmation by the Ministry of Public Health that the pharmaceutical was a priority medicine, the compulsory license was finally granted. The compulsory license is available until the expiry of the patent in May 2018. This action was taken in order to enable the government to further expand access to more affordable treatments for HIV and facilitate local production of the product, leading to an important reduction in costs.

Conclusion

As examined above, although only used in three cases so far, compulsory licenses have been used against pharmaceutical patents. The European Court of Justice has been more inclined to use compulsory licenses as a “punishment” in cases of abuse of dominant position, rather than as a pressure element. In Europe, case law on the subject is rather abundant starting with Magill, which set the basic requirements, later on developed through IMS Health.

In any case, this opens up an interesting debate about pharmaceutical patents, drug prices, health imperatives and incentives. Some medicines are not even available -period- in some markets. One of the reason is that our current patent system does not provide sufficient incentives in R&D for solutions to problems that mostly affect the poor. Another challenge arises from the very nature of the patent regime: innovators are rewarded with a temporary monopoly. In the context of life-saving drugs or vaccines, this monopoly will have a more meaningful impact on poor people who cannot afford the essential drug.

One solution to face this challenge might be voluntary licensing involving contracts with generic manufacturers to distribute and sell drugs in markets where there is no profit to make for branded companies. Voluntary licensing could present several advantages: generic manufacturers would be able to distribute patented medicines in certain countries; multiple licensees can be granted allowing to sell generic versions at prices freely established in certain low and middle-income nations; royalties will be paid to patent owners or economies of scale can be made. All the above would avoid raising competition concerns by creating effective competition through licenses offered to multiple generic manufacturers.

Anyways, the topic surely gives food for thought…