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violators. The United States also encourages Brazil to take the necessary steps to formalize the Federal Attorney General opinion clarifying that Brazil's sanitary regulatory agency, ANVISA, does not have the authority to review patentability requirements when analyzing pharmaceutical patent applications. The United States continues to be concerned about the widespread availability of pirated and counterfeit products in Brazil, especially pirated books, and about the growing challenge of piracy over the Internet. The United States urges Brazil to strengthen pending amendments to its copyright law to better protect IPR in the digital environment. Brazil should also continue to strengthen its border enforcement efforts. The United States encourages Brazil to clarify and strengthen its system for protecting against unfair commercial use, as well as unauthorized disclosure, of test and other data generated to obtain marketing approval for pharmaceutical products. The United States encourages Brazil to continue to take concrete steps to address its backlog of pending patent applications, including by developing a new electronic patent application system. The United States looks forward to continuing to work with Brazil to address these and other matters.

Brunei Darussalam

Brunei remains on the Watch List in 2012. Brunei made progress in 2011 by establishing its first patent office, and authorities also recently issued notices warning some retailers to remove pirated and counterfeit goods. The United States hopes that such actions will lead to a significant and permanent reduction in Brunei's high piracy and counterfeiting rates. Further, rights holders have established an organization to assist law enforcement officials in their efforts, and to assist the Bruneian Authors and Composers Association, which is actively negotiating with television and radio broadcasters for payment of music royalties due. The United States remains concerned, however, that Brunei has not enacted pending copyright amendments, and IPR enforcement authorities still lack ex officio authority. Brunei should also take steps to further educate its business community on IPR and to improve its enforcement efforts, including by pursuing criminal prosecutions, imposing deterrent-level sentences, and ensuring that enforcement officials have adequate resources. The United States looks forward to continuing to work with Brunei to address these and other matters, including through the Trans-Pacific Partnership negotiations.

Colombia

Colombia remains on the Watch List in 2012. Colombia continued to make progress in 2011 by improving its enforcement operations, including by increasing the number of investigations and raids that were conducted. In addition, Colombia enhanced coordination of enforcement efforts among its agencies. Colombia is also continuing its efforts to improve its legislative framework for IPR protection and enforcement through the implementation of the United States-Colombia Trade Promotion Agreement. However, concerns remain with respect to IPR enforcement. A lack of resources and training continue to hamper enforcement efforts. The United States looks forward to working with Colombia on the implementation of obligations regarding protections against piracy over the Internet, which is a growing problem in Colombia, and to Colombia

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