The U.S. Chamber of Commerce’s (Global Intellectual Property Center) submission (7 February 2014, USTR-2013-0040) to USTR’s 2014 Special 301 expressed concerns with aspects of Brazilian IP policy which included the role of ANVISA in the granting of patents, patentability criteria, test data protection, compulsory licensing and local content requirements for cable television.
The Chamber urged a speedy resolution to the WTO cotton dispute between Brazil and the United States and called for “full compliance with the U.S.-Brazil Cotton Framework Agreement, which includes resumption of payments to the Brazilian Cotton Institute by the USG” because the Chamber is wary of the potential of Brazilian cross-retaliation on US IPR assets.
The Brazilian Foreign Trade Board (CAMEX) recently announced that they will formally reopen public consultations on potential cross-retaliation on U.S. IP rights as a result of the WTO cotton dispute. The Chamber supports a definitive solution to the WTO cotton dispute in order to avoid hundreds of millions of dollars in Brazilian trade retaliation and ‘cross-retaliation,’ respectively, against U.S. goods and intellectual property rights.
Brazil
In recent years, there was a recognition that both in the Brazilian private sector and among the economic policy-related agencies of the Government of Brazil (GOB) that higher intellectual property (IP) rights protection and enforcement standards play a key role in fostering innovation, growth, and social and economic development. However, there continues to be a number of specific challenges faced by United States businesses in protecting and enforcing their rights in Brazil, most notably in the proposed changes to Brazilian Patent Law.
Prior Consent
The proposed changes to Brazil’s Patent Law (H.R. 5402/2013) would make the granting of patents for pharmaceutical products dependent upon prior consent from the Brazilian National Health Surveillance Agency (ANVISA). Therefore, the decision to grant a patent is not based solely upon the examination officials at the Brazilian National Industrial Property Institute (INPI). The Article would create a dual examination requirement which could be a violation of Article 27 of TRIPS. We encourage the U.S. Government to work with the GOB through bilateral dialogues and engage with the Brazilian National Congress to ensure that the proposed changes to the Patent Law, including the prior consent provision, are both TRIPS compliant and improve the intellectual property environment.
Patentability
The proposed changes to the Patent Law (H.R. 5402/2013) would also narrow patentability criteria even further disallowing patents on new uses or new forms of known substances unless a significant improvement to the known efficacy is present. The Chamber believes that such changes to the Patent Law, represents a significant erosion of the IP environment. In order create a economy which fosters innovation, we recommend that the U.S. Government work with the GOB to reconsider the patentability requirements in the proposed law.
Data Protection
The Chamber is concerned that data protection for pharmaceuticals made for human use are not covered by existing regulation. As a result, innovative pharmaceutical and biotechnology companies have found it difficult to operate in Brazil. To improve its innovative environment, we encourage Brazil to implement five years of data protection for pharmaceutical innovators and twelve years for biologic medicines.
Patent Prosecution Highway Agreement (PPH)
The Chamber supports the negotiation and implementation of a United States-Brazil Patent Prosecution Highway (PPH). The PPH is a key policy tool to improve the bilateral intellectual property environment and to foster trade in knowledge between both countries. The Brazilian private sector and INPI have already shown great interest in pursuing such agreement with the United States, creating momentum for its achievement.
Compulsory Licensing
The Chamber encourages the U.S. Government to continue to engage the GOB on the benefits of a strong intellectual property rights protection and enforcement regime in order to avoid the use of unwarranted compulsory licensing by Brazil, in particular by helping facilitate dialogue between stakeholders.
Copyright
Piracy
The Chamber encourages the GOB to strengthen the Brazilian National Anti-Piracy Council (CNCP) human resources infrastructure and focus on increasing its resources to adequately enforce its broad mandate, particularly in connection with emerging issues in the digital world. Furthermore, we stress the importance of ensuring that rules that may be adopted with respect to internet governance and responsibility, such as in Marco Civil, maintain a clear distinction between legitimate and infringing content, and do not interfere with the ability to effectively and quickly address the distribution of infringing materials over the internet.
Cable TV Local Content/Forced Localization
Brazil’s recently implemented local content restrictions for Cable TV have a negative effect on the access of foreign intellectual property owners to Brazil’s market. These new restrictions limit foreign-owned and created productions in Brazil and are an attempt to force the transfer of intellectual property to Brazilian nationals.Pending Federal Legislation
The Chamber encourages both governments to discuss current intellectual property rights regime reform in Brazil, particularly in the fields of copyrights and the Internet. There are a number of intellectual property-related bills being considered in Brazil. It is imperative that new laws in Brazil strengthen protection for intellectual property and do not erode or limit the ability or liability of rights holders to protect their intellectual property, particularly online. Additionally, as Brazil revises its law on criminal penalties, it has an opportunity to provide a more clear law against the scourge of camcording.
Other
WTO Cotton Dispute
The Brazilian Foreign Trade Board (CAMEX) recently announced that they will formally reopen public consultations on potential cross-retaliation on U.S. IP rights as a result of the WTO cotton dispute. The Chamber supports a definitive solution to the WTO cotton dispute in order to avoid hundreds of millions of dollars in Brazilian trade retaliation and ‘cross-retaliation,’ respectively, against U.S. goods and intellectual property rights. In the meantime, the Chamber supports full compliance with the U.S.-Brazil Cotton Framework Agreement, which includes resumption of payments to the Brazilian Cotton Institute by the USG.