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 Brazil

Brazil remains on the Watch List in 2014. Brazil continues on a generally positive trajectory regarding both its domestic intellectual property rights (IPR) policy and its enforcement of IPR. Brazil has taken steps to address a backlog of pending patent and trademark applications, including by authorizing the hiring of for new examiners, but very long delays still exist. Brazil has also continued to make progress in enhancing the effectiveness of IPR enforcement, conducting raids across the country under the coordination of the National Council to Combat Piracy. Significant concerns remain with respect to the high levels of counterfeiting and piracy, including Internet piracy; however, positive strides have been made in the area of pay-television piracy. Although laudable enforcement efforts also have occurred at the border, greater emphasis on this challenge is needed, particularly in the tri-border region, including the issuance of more deterrent penalties in such cases. Concerns also persist with respect to Brazil's inadequate protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical products. In addition, regulations that provide Brazil's health authority, the National Sanitary Regulatory Agency (ANVISA), with the authority to review pharmaceutical patent applications for patentability requirements are not transparent or predictable and appear to contravene earlier opinions by the Federal Attorney General, which clarified that ANVISA does not have such authority. The United States is also concerned about a series of lawsuits recently filed by Brazil's National Industrial Property Institute (INPI) seeking to invalidate or shorten the term of certain "mailbox" patents for pharmaceutical and agrochemical products. The United States believes it is important for Brazil to continue to create an IP climate that affords both domestic and foreign IP holders with incentives to invest in the market. We look forward to engaging constructively with Brazil in support of its work in the IPR arena and to address remaining concerns.

Bulgaria

Bulgaria is on the Watch List in 2014. Despite some limited improvements, the United States continues to have serious concerns regarding IPR infringement in Bulgaria. Copyright piracy over the Internet in Bulgaria remains a significant problem in this market. Numerous online infringing services operate in the market and enforcement actions seldom result in convictions or deterrent sentences. Investigations on copyright piracy, including against enterprise end-user software piracy, initiated by the Bulgarian anti-cybercrime unit have stalled because that unit's responsibilities and personnel were transferred to a different agency. The number of working sessions of the Council for IPR Protection have declined and there are fewer staff in the Copyright Office of the Ministry of Culture, twin events that have weakened Bulgaria's ability to effectively enforce its IP laws. Collecting societies continue to report serious challenges in collecting royalties and in enforcing their rights through administrative or judicial actions. High levels of trademark counterfeiting also persist. The government has reduced staffing at the Patent Office, which is responsible for registrations (e.g., patents and trademarks) as well as certain enforcement functions (e.g., inspections, issuance of fines, and sentencing in cases referred from criminal courts), thereby hindering that office's ability to make sufficient routine inspections or to conduct adequate enforcement. Bad faith trademark applications are also a 48