The Latin America IPR SME Helpdesk team contributes to the EU-LAC bi-regional dialogue in the field of Intellectual Property

Latin America IPR SME Helpdesk
Protecting your Intellectual Property in Latin America

Micro, Small and Medium-sized Enterprises (MSMEs) are a fundamental component of the productive fabric of the majority of the world’s economies. The European Union, CAINCO (Chamber of Commerce of Santa Cruz in Bolivia), ECLAC (the UN Economic Commission for Latin America and the Caribbean), EUROCHAMBRES (the Association of European Chambers of Commerce) and PROMÉXICO organized a series of thematic events in Mexico City on 10th– 14th October in order to share experiences and to consolidate the cooperation between the European and the Latin American and the Caribbean private and public actors that support the development of the MSMEs. Other EU-funded programmes, such as the Latin America IPR SME Helpdesk, ELAN Network, ELAN Biz and ADESEP for Central America have also been involved in the organization of the economic cooperation week.

The EUROMIPYME seminar “Latin America and Europe facing technological disruption: a new era of policies and institutions for MSMEs” organized by ECLAC opened the series of events. The seminar facilitated the discussion on how to build a common language for the design of a new generation of development tools for MSMEs, where cooperation between both regions, supported by a fluid public-private dialogue, can become a key factor for transformation. Eli Salis, IP expert of the Latin America IPR SME Helpdesk intervened as panellist during the session on public private dialogue.

On the 11th of October, Paolo Baldan, from EUROCHAMBRES, as partner of the Latin America IPR SME Helpdesk, presented the services of the Helpdesk to the CEOs of the European Bilateral chambers and EUROCAMARAS of the 7 countries covered by the ELAN BIZ programme (Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico and Perú). He reiterated the full availability of the Helpdesk to organize free of charge training modules on Intellectual Property (IP) on use and protection of trademarks, designs, patents and copyright in Latin America. The Helpdesk will obviously adapt the session according to the priority countries, sectors and topics and time availability. The Helpdesk was also represented on the 12th of October at the EU-LAC Business Forum organized by CAINCO and EUROCHAMBRES bringing in the role of IP protection in the market access facilitation and innovation process. The importance of the bi-regional cooperation on building information schemes on Intellectual Property and the provision of training and capacity building programmes such as the Latin America IPR SME Helpdesk was underlined in front of an audience of 200 EU and LAC private and public sector representatives. The event was also an occasion to outline a series of business driven proposals and recommendations which should guide decision-makers in adopting an EU-LAC policy framework for a business friendly environment that is conducive to sustainable growth.

Lastly, César Elvira Fernandez, IP expert of the Latin America IPR SME Helpdesk, presented the Helpdesk services and business cases of success at the annual event of the AL-Invest 5 programme, organised by CAINCO on 13 October 2017.

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…

Marcas no convencionales: Unión Europea vs América Latina

Eli Salis
Partner at DISAIN IP

Aquellos que nos dedicamos a la propiedad intelectual tenemos la fecha del 1 de octubre señalada en rojo en nuestros calendarios desde que se aprobara el nuevo Reglamento (UE) Nº 2015/2424 que modifica reglamentos anteriores sobre la marca comunitaria, ya que será el momento en el que entren en vigor las últimas novedades del mismo, introduciendo importantes cambios en cuanto a la representación de las marcas europeas se refiere, con la finalidad de modernizar el sistema de marcas dentro de la Unión Europea, haciéndolo más accesible, eficiente y coherente en su conjunto.

Como ya es sabido por todos, el nuevo Reglamento hace desaparecer el requisito de la representación gráfica para los signos que se pretendan registrar, sustituyéndolo por los criterios adoptados oportunamente por el TJUE en el caso Sieckmann, según los cuales será suficiente con que la marca pueda reproducirse en el registro de manera “clara, precisa, completa en sí misma, fácilmente accesible, inteligible, duradera y objetiva”, por medio de cualquier tecnología generalmente disponible.

De este modo se abriría a priori la puerta al registro de marcas no convencionales que, hasta el momento, veían privado su acceso registral al no poder superar el obstáculo de la representación gráfica. Sin embargo, debemos tener presente que, a partir de ahora, determinadas marcas no convencionales podrán representarse mediante el uso de medios electrónicos de reproducción. Tal es el caso, por ejemplo, de las marcas sonoras, de movimiento, de posición, hologramas o multimedia.

Sin embargo, si bien es cierto que se presagia un nuevo futuro para determinadas marcas no convencionales, otras, como las olfativas, táctiles o gustativas, seguirán encontrando dificultades, ya que no existe actualmente tecnología disponible que permita su representación de forma precisa, inteligible y, sobre todo, duradera y objetiva.

Además de la falta de medios técnicos, otro obstáculo de nuevo cuño introducido por la propia reforma del Reglamento (y de la Directiva) es la inclusión de la muletilla “y otras características” a la prohibición absoluta recogida en el artículo 7.1 (e), que originalmente se refería en exclusiva a la forma del producto y ahora se extiende a otros tipos de marcas, en un intento por contrarrestar el efecto flexibilizador de la supresión del requisito de la representación gráfica. Tendremos que estar a la práctica de la EUIPO y de los Tribunales para ver cómo se interpreta esta nueva disposición.

Por otra parte, si bien estos estándares se van a aplicar de manera uniforme dentro de la UE, en el ámbito extracomunitario -y más concretamente en Latinoamérica- los requisitos para el registro de marcas varían de un país a otro, por lo que estas marcas pueden encontrar nuevos obstáculos al tratar de ampliar la protección a nivel internacional.

De este modo, encontramos que en casi la totalidad de países latinoamericanos (con algunas excepciones) sigue vigente el requisito de la representación gráfica (o de un signo visualmente perceptible), aunque gran parte de ellos plantean una definición amplia del concepto de marca, posibilitando la entrada, si bien de forma progresiva, a las marcas no tradicionales.

Así, en Argentina es posible registrar marcas sonoras desde hace varios años, existiendo incluso alguna decisión favorable de los Tribunales sobre la registrabilidad de marcas olfativas. También en Uruguay se permite el registro de marcas sonoras. En la Comunidad Andina, como en Chile, algunos de estos tipos de marcas están expresamente enumerados en sus correspondientes disposiciones legales como signos que constituyen una marca. Así encontramos que, por ejemplo, en Colombia se han registrado más de 850 marcas no convencionales, entre las que se encuentran marcas tridimensionales, de color, de posición, sonoras e incluso gestuales y táctiles aunque no se ha concedido ninguna marca de olor. En otros países, sin embargo, como es el caso de Brasil o México, las marcas no tradicionales todavía tienen un largo camino por recorrer.

Por tanto, y retomando la práctica europea, habrá que esperar a ver cómo se interpretan estas nuevas modificaciones y, sobre todo, la restricción comprendida en el nuevo artículo 7.1 (e) antes de augurar un futuro prometedor a las marcas no convencionales en Europa que realmente suponga un avance considerable con respecto a las legislaciones de otros países de nuestro entorno.

Este artículo ha sido elaborado en colaboración con Gracia Tordesillas.