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…

Intellectual Property is an intangible with significant economic potential

“Chile has built a balanced property system that seeks to protect the interests of creators and innovators, as well as users and society as a whole,” says Martin Correa, Head of the Intellectual Property Department of the General Directorate of International Economic Relations (Direcon) of the Ministry of Foreign Affairs. The Department coordinates and conveys Chile’s position on international negotiations before the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO).

Intellectual Property is precisely the focus of the Latin America Intellectual Property SME Helpdesk project, which belongs to the Directorate General for Research and Innovation (COSME Program) of the European Union. The Eurochile Foundation is a partner of this project.

The subject is highly relevant, since a wider knowledge and respect for intellectual property rights leads to improved opportunities for Chilean companies.

“Today, IP has been gaining importance, since it has been proven that it may be an intangible with a significant economic potential not only for consolidated and larger companies, but also for small and medium enterprises. In this sense, knowing the value of IP enables SMEs to value their trademarks and generate spin-offs when granting licenses,” states Correa.

“Additionally, having an invention patent, for example, can be a plus when applying for loans to continue the development of an SME or even for expanding. Finally, IP can encourage the sale of traditional niche products by granting geographical indications. They create communities among small producers of the same product by recognizing its added value. As you can see, being aware and knowing the economic potential of IP can allow SMEs to make better business decisions and to benefit from the profits IP can generate,” he adds.

– What is the state of Intellectual Property protection in Chile?

“The country has made great strides in recent years, introducing major changes to the intellectual property system, such as the enactment of Law 17,336 on Intellectual Property, the reform of Law 19,039 on Industrial Property and the creation of the National Industrial Property Institute (Inapi, in Spanish). There has also been progress in creating tools to bring people closer to IP through programs such as the origin seal and Inapi Proyecta, as well as in boosting the role of the intellectual rights keeper belonging to the Chilean Libraries, Archives and Museums Board (Dibam, in Spanish).”

– What are the pending issues in this regard?

“Chile has a strong intellectual property system with clear and strict rules, comparable to the standards of major international institutions that cover these issues, such as the WTO and the WIPO. Nevertheless, it is important to recognize that new technologies and recent innovations in the digital environment pose new challenges not only for Chile, but for the international community. It should address the interaction between IP and these new developments.”

– What is Chile’s level of compliance regarding international agreements and obligations on this matter?

“Chile has fulfilled its international obligations on intellectual property. In this sense, the current institutional framework in Chile reflects the standards described in our free trade agreements (FTA). It even went beyond what was agreed on the FTAs. However, there are still some issues to be addressed internally, derived mainly from the FTA with the US. One example is complying with technological protection measures linked to copyright, which has not been addressed yet. Therefore, Direcon’s efforts have been instrumental in coordinating thematic working tables to address this issue internally in the near future.”

– What are the most common problems for a foreign company wishing to do business with Chile, in terms of IP?

“Even though the rules on intellectual property in Chile are relatively similar to those in most developed countries, there are some differences that must be taken into consideration when doing business. They have to do with the territorial nature of IP. In this regard, it is important to be aware of certain basics, such as the civilian origin of Chile’s legal tradition and the balance of our system when pondering the interests of creators and innovators, and the interests of users and society as a whole. They differ in each country. Therefore, it is indispensable to learn about the system as a whole in order to enjoy the economic benefits of IP in all its dimensions.”