provide adequate data protection, establish linkage for pharmaceutical products and to improve the registration process for pharmaceuticals, including by reducing the lengthy registration period.
DOMINICAN REPUBLIC
In March 2004, the Dominican Republic concluded an FTA with the United States that will require the Dominican Republic to upgrade considerably the level of intellectual property protection in the Dominican Republic. However, concerns still remain regarding the protection and enforcement of intellectual property, particularly with respect to copyright piracy and patent protection. As such, the Dominican Republic shall remain on the Watch List. We remain concerned by the levels of copyright piracy in the Dominican Republic. While the Telecommunications Authority (Indotel) and the Copyright Office (ONDA) have taken some positive steps to enforce intellectual property, such actions have failed to deter infringements. A key problem has been the delays in obtaining judicial remedies, particularly criminal remedies, against violators. In addition, U.S. concerns regarding the patent provisions of the Industrial Property Law and the subsequent Presidential decrees remain. These concerns include, but are not limited to, issues regarding the issuance of compulsory licenses, subject matter eligibility for patents, and data exclusivity. We encourage the Government of the Dominican Republic to take measures to address these concerns as soon as possible. Furthermore, we look forward to the increased reporting and improved enforcement from the Government of the Dominican Republic to effectively address broadcast piracy and deter other copyright infringements, and its efforts to ensure an expeditious resolution of pending judicial cases. Finally, we urge the Dominican Republic to be vigilant in submitting legislation, enhancing enforcement, providing training, and making other necessary preparations to meet its FTA obligations.
ECUADOR
Ecuador has shown little progress in improving IPR protection over the last year, and although it has a generally adequate IPR law, enforcement of the law remains a significant problem. Lack of effective protection for innovative pharmaceutical products is a serious concern. Ecuador does not provide protection of confidential test data, and the number of copy products granted marketing approval by the health authority continues to increase, due to the lack of any linkage system between the health and patent agencies. The United States urges the Government of Ecuador to protect confidential data from unfair commercial use and to facilitate an effective linkage system between its health and patent agencies. Enforcement of copyrights also remains a significant problem, especially with respect to sound recordings, computer software, and motion pictures, as does enforcement of trademark rights. As a result, there continues to be an active local trade in pirated audio and video recordings, computer software, and counterfeit brand name apparel. Music piracy is rampant in the streets of key cities, yet the local authorities appear to have made no efforts to prevent the sale of pirated music, nor have they investigated the duplication and distribution sources for these products. The Ecuadorian Government has yet to establish the specialized intellectual property courts required by the 1998 IPR law. Even though Ecuador's current substantive copyright legislation appears generally in line with its international obligations, the performance of Ecuador's judiciary remains deficient, in that the courts appear unwilling to enforce the law. The United States urges Ecuador to strengthen enforcement of IPR and will closely monitor Ecuador's efforts to address IP-related concerns.
GUATEMALA
The United States commends Guatemala for implementing data protection last year for pharmaceutical and agricultural chemical products, which is in line with international standards. However, legislation
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