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 Brazil

Brazil remains on the Watch List in 2013. Brazil continued to make progress in 2012 by conducting notable enforcement efforts across the country under the coordination of the National Council to Combat Piracy. However, the United States is concerned about recent regulations that provide Brazil's sanitary regulatory agency, ANVISA, with the authority to review pharmaceutical patent applications for meeting patentability requirements. These regulations appear to contravene an earlier opinion by the Federal Attorney General that clarified that ANVISA did not have this authority. The United States urges Brazil to continue to work with stakeholders to ensure that its patent examination process is transparent and predictable. Brazil continues to experience widespread piracy and counterfeiting, and the availability of pirated books is a particular concern to the United States. The United States urges Brazil to take steps to address the growing challenge of piracy over the Internet, and to strengthen pending amendments to its copyright law to better protect against IPR violations in the digital environment. The United States also encourages Brazil to strengthen its border enforcement efforts, and strengthen enforcement generally by more consistently arresting and prosecuting IPR violators, and by imposing deterrent-level penalties for those who are convicted. The United States encourages Brazil to clarify and strengthen its system for protecting against unfair commercial use, as well as unauthorized disclosure, of undisclosed test or other data generated to obtain marketing approval for pharmaceutical products. The United States also encourages Brazil to address its backlog of pending patent applications. The United States looks forward to continuing to work with Brazil to address these and other matters.

Bulgaria

Bulgaria is on the Watch List in 2013. Bulgaria has taken only limited steps to address persistantpersistent [sic] U.S. concerns regarding IPR infringement. Piracy over the Internet in Bulgaria remains a serious and growing concern. Numerous online infringing services operate in the market and enforcement actions have seldom resulted in convictions. Collecting societies continue to report serious challenges in collecting royalties and in enforcing their rights through administrative or judicial action. Bad faith trademark registrations have also become increasingly common and are often registered due to constraints of the Bulgarian Patent Office, which is responsible for trademark registrations. These and other concerns are compounded by inadequacies in the Bulgarian judicial system. Generally, rights holders face significant delays in the adjudication of IPR disputes, many of which do not reach final sentencing, and when they do, remedies are non-deterrent. Bulgaria's Government should coordinate with rights holders, and other interested parties, such as ISP, to develop recommendations for reducing Internet piracy. Notwithstanding these continuing issues, the United States recognizes the positive steps Bulgaria has taken to address IPR infringement in its market. For example, Bulgaria has engaged in enforcement actions, including by the Ministry of Culture as well as the Ministry of the Interior's Cybercrime Unit, and has cooperated with rights holders on campaigns to address software piracy. Bulgaria also undertook a software legalization initiative in 2012. The United States encourages Bulgaria to continue to enhance its IPR protection and enforcement efforts, and to work with the United States to devise strategies to resolve these issues. The United States looks forward to continuing to work with Bulgaria to address these and other issues.

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