We would like to ensure that you are still receiving content that you find useful – please confirm that you would like to continue to receive ILO newsletters.
03 March 2008
Recent IP developments in Argentina have included improvements in the protection of trademark owners’ rights and serious steps backwards in the legal protection of data exclusivity and the granting of preliminary patent injunctions.
Need for Adequate Enforcement
The world is gradually developing a post-industrial economy, in which the system of wealth creation is based on the value of innovation and knowledge, and the adequate protection (and enforcement) of intellectual property is becoming more important as a basic tool of economic development.
Adequate IP protection demands the existence of appropriate written rules which are duly enforced through complementary or regulatory rules and judicial decisions. Proper protection and enforcement of IP rights are critical not only from a local point of view, but also from an international point of view, since weak IP legal protection can be detrimental to international trade.
Recent developments involving preliminary patent injunctions and data exclusivity legal protection have cast a shadow over the Argentine IP regime.
Preliminary Patent Injunctions
Following Argentina's accession to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs), the preliminary measures provided by Article 50 of the treaty were interpreted by the courts as giving self-executory status to trademark disputes, but not to actions brought to court on the basis of patent rights. This was because it was unclear whether such matters should be governed directly by Article 50 of the TRIPs Agreement or by Article 83 of the Patent Act (24,481), which was enacted in 1996. This interpretation of Article 50 of the TRIPs Agreement gave rise to some friction between the US and Argentine governments, which finally resulted in the US government initiating a new case before the World Trade Organization (WTO).
Before the enactment of Act 25,859, preliminary injunctions as provided for in Article 50 of the TRIPs Agreement were granted in at least four cases - Pfizer Inc v Microsules Bernabó (July 3 2001), Eli Lilly (October 11 2001), Bayer AG v Agtrol International Argentina SA (February 12 2002) and Aventis v Sandoz (March 20 2003) - with no need for any additional local rule.
The sequence of events after the WTO case began (including the agreement reached between the US and Argentine governments) updated the Argentine courts' view of this subject without the need to pass any new legislation. Nonetheless, the proceedings continued and the outcome of the negotiations between both governments was a newly proposed amendment to the Patent Act. Congress approved the amendments through Act 25,859, which was passed on December 4 2003.
The amendments to the law make it more difficult for patent owners to obtain preliminary injunctions envisaged by the TRIPs Agreement. The additional burdens of the amendments do not derive from the TRIPs Agreement or from requirements set out in Argentina’s patent or procedural law. These are as follows:
The amendment of Article 83 of the Patent Law through Act 25,859 is a step backwards as it slows down the granting of a preliminary injunction.
Protecting Scientific Data
The health authorities in Argentina continue to rely unfairly on originators' data in order to approve generic versions of innovative pharmaceutical products without the originator’s authorization. The reason for this is that when Argentina enacted the Confidentiality Law (24,766) in December 1996, it was assumed that this rule was directed to adjust local legislation to the requirements of Article 39 of the TRIPs Agreement (specifically, Paragraph 3, which establishes the obligation to protect scientific data that is filed with the health authorities).
However, Act 24,766 fails to grant adequate legal protection for scientific data as required by Article 39(3) of the TRIPs Agreement. Article 39(3) protects data obtained through considerable effort from pre-clinical and clinical research to prove the safety and efficacy of a product. It is submitted to the health authorities to obtain marketing authorization for a new pharmaceutical product. The average process takes 10 years to complete, with corresponding investment and expense.
Since data which meets the requirements of Article 39(3) must be protected against unfair commercial use, when a health authority allows the use of the originator's data by third parties without the originator’s authorization to approve generic products, the authority disregards Article 39(3) of the TRIPs Agreement. This is precisely the case with Law 24,766, since Section 5 allows for such reliance on the originator's data by unauthorized third parties.
The health authorities’ approval of products by similarity under the Confidentiality Law is inconsistent with Article 39(3) of the TRIPs Agreement, since such reliance of a member country on the data filed by an innovator in another member country commercially benefits a competitor of the originator and consequently constitutes unfair commercial use under the terms of Article 39(3).
Improvements in IP Protection
Enacted on December 29 2004, Law 25,986 implemented several amendments to the Customs Code and introduced legislation regarding border measures in accordance with Article 51 of the TRIPs Agreement. Such amendments have raised TRIPs standards not only by providing protection against counterfeit copyrighted goods or trademarked products, but also by broadening the protection of IP rights at borders in order to include all intellectual and industrial property rights regulated by Argentine legislation.
Article 46 of Law 25,986 forbids imports or exports of goods when from the simple verification of the same results it is deemed that the merchandise bears a counterfeit trademark, is a pirate copy or contravenes any other intellectual or industrial property rights granted under Argentine legislation. When infringement is not evident, the Customs Authority can delay clearance of the goods for up to seven working days, allowing time to consult the right owners and enable them to request from the courts the relevant injunction to prevent the products from entering the market.
Trademark owners are entitled to register their trademarks with Customs and then receive notice of any imports or exports of goods bearing those marks. Registration of trademarks within this system - known as a warning registry - is voluntary and free of charge. Registration lasts for two years and may be renewed indefinitely.
In order to be included within the warning registry system, the trademark owner must fulfil the following specific requirements:
The procedure implemented by Resolution 2216 establishes that goods that circulate through Customs and declare a registered right within the bill of lading will be stopped for three working days at the border and notice will be given to the trademark owner. This will give the trademark registrant the opportunity to inspect the goods and, if they are not legitimate, to seek legal measures before the courts to defend its rights.
The warning registry is expected to discourage trademark fraud as it should simplify the detection and detention of counterfeit products at Argentine borders and prevent any such goods from being distributed throughout the country.
While the situations relating to preliminary patent injunctions and data exclusivity protection represent steps backwards in the legal protection of IP rights, the new legislation empowering Customs to prevent counterfeits from entering the country (Law 25,986 and Customs Resolution 2216) represents a step forward for the future of IP protection in Argentina.
For further information on this topic please contact Carlos Octavio Mitelman or Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100) or by fax (+54 11 4311 5675) or by email (firstname.lastname@example.org or email@example.com).
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
ILO is a premium online legal update service for major companies and law firms worldwide. In-house corporate counsel and other users of legal services, as well as law firm partners, qualify for a free subscription.