1. KIRA M. ALVAREZ DEPUTY ASSISTANT USTR AND CHIEF NEGOTIATOR FOR IPR ENFORCEMENT USTR Trends in Intellectual Property Rights in U.S. Trade Agreements

2. Free Trade Agreements

3. FTAs help provide certainty and predictability for American exporters of IP-intensive goods and content General IPR trade negotiating objectives:  to further promote adequate and effective protection and enforcement of IPR  to secure fair, equitable, and nondiscriminatory market access opportunities for U.S. persons that rely upon IPR  to respect the Doha Declaration on the TRIPS Agreement and Public Health

4. Free Trade Agreements Australia, Bahrain, Canada (NAFTA), Chile, Colombia, Costa Rica (CAFTA-DR), Dominican Republic (CAFTA-DR), El Salvador (CAFTA- DR), Guatemala (CAFTA-DR), Israel, Jordan, Korea, Mexico (NAFTA), Morocco, Nicaragua (CAFTA-DR), Oman, Peru, Singapore Most recent FTAs with Colombia, Korea, Panama. U.S. FTAs include comprehensive, state-of-the- art IPR provisions, and are subject to FTA dispute settlement provisions

5. Trans-Pacific Partnership (TPP) Australia, Brunei Darussalam, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam Key initiative through which the U.S. seeks to advance the multi-faceted U.S. trade and investment interests in the Asia-Pacific region. Goal is to negotiate an ambitious, 21 st century regional agreement, in order to create a platform for integration across the region. IP will be an important component

6. What types of IPR provisions are typically found in U.S. FTAs?

7. Protection for Copyrighted Works in the Digital Economy  Protection for TPMs/Digital Locks  Term of protection equivalent to US law; Life+70  Rules to prohibit unauthorized receipt/distribution of satellite signals State of the Art protection for Trademarks  Development of online system of registration  First in Time/First in Right vis a vis GIs, as well as due process for TM and GI registrations  Dispute resolution system for trademarks used in domain names

8. What types of IP provisions are typically found in U.S. FTAs? Strong Protection for Patents and Clinical Trial Data  Extension of patent terms to compensate for delays in granting the original patent  Limits the grounds for revoking patents, protecting against arbitrary revocation  Assures protection for newly developed plant varieties and animals  Clarifies that test data and trade secrets submitted to a government for the purpose of product approval will be protected against unfair commercial use for 5 years for pharmaceuticals or 10 years for Ag chem.

9. What IP enforcement provisions are typically found in U.S. FTAs? Comprehensive civil, criminal, and customs provisions. Criminal penalties for significant willful copyright or related rights infringements that have no direct or indirect motivation of financial gain; and willful infringements for purposes of commercial advantage or private financial gain. Counterfeit or illicit labels or documentation Legal incentives for service providers to cooperate with copyright owners in deterring unauthorized storage and transmission

10. ACTA

11. What is ACTA? Builds on existing international IPR rules Establishes and strengthens standards for enforcement issues where international legal frameworks do not exist or need to be strengthened Increases international cooperation, strengthening the framework of practices that contribute to effective enforcement of intellectual property rights Focused on counterfeiting and piracy activities that significantly affect commercial interests, rather than on the activities of ordinary citizens

12. Why is ACTA Needed? Proliferation of counterfeit and pirated goods in international trade poses threat to development of the world economy. Trade in these goods causes significant financial losses for the right holders and legitimate businesses and, in some cases, represents a risk to consumers. Expertise, innovation, quality, and creativity are the main factors for success in knowledge- based economies.

13. Objectives Provide a framework to more effectively combat the challenges of IPR infringement today, particularly in the context of piracy and counterfeiting.  Commitments to strong laws  Framework for ongoing cooperation and  Promotion of effective enforcement practices. Establish a Leadership agreement, setting a positive example for on strengthening IPR enforcement. Growth over time, reflecting the growing international consensus on the need for strong IPR enforcement.

14. Participants in the Negotiations Australia Canada EU (and its Member States) Japan Korea Mexico Morocco New Zealand Singapore Switzerland United States

15. Provisions of the Agreement Three main areas: International Cooperation: capacity building and technical assistance in improving enforcement, and international cooperation among enforcement agencies. Enforcement Practices: Formal or informal public/private cooperation; Fostering of specialized intellectual property expertise within law enforcement structures; and Measures for raising consumer public awareness. Legal Framework

16. Civil Enforcement provisions dealing with issues such as damages, injunctions to stop further infringements, recovery of costs and attorneys’ fees, and destruction of infringing goods. Border Measures (customs procedures) regarding both import and export shipments. Criminal Enforcement:  requirements for criminal remedies, including clarification of what constitutes copyright piracy on a commercial scale;  a requirement for criminal remedies for use or importation of labels for packaging of counterfeit goods;  a provision on unlawful camcording of movies in theaters;  commitments on seizure and destruction of fake goods, seizure of the equipment and materials used in their manufacture, and criminal proceeds. Enforcement of IPR in the Digital Environment, including  A balanced framework that addresses the challenge of copyright piracy on digital networks while preserving fundamental principles such as freedom of expression, fair process, and privacy; and  Requirements to provide strong regimes against circumvention of digital locks (i.e. technological protection measures); 16

17. 10 Key Strengths of ACTA 1. ACTA will create a first-of-its-kind alliance of trading partners representing more than half of world trade to cooperate in the fight against piracy and counterfeiting. 2. ACTA will go beyond TRIPS in requiring that border enforcement authorities be empowered to act on their own initiative against both imports and exports of counterfeit and pirated goods. 3. ACTA will be more explicit than TRIPS in requiring availability of criminal penalties when piracy or counterfeiting is carried out for commercial advantage (such as companies using pirated software). 4. ACTA will require criminal remedies against importation or use of labels or packaging for counterfeit goods. 5. ACTA will require that criminal authorities be able to act on their own initiative (“ex officio”) in IP cases, rather than waiting for a complaint.

18. 10 Strengths (con’t) 6. ACTA will include commitments on criminal seizure and destruction of fake goods, seizure of the equipment and materials used in their manufacture, and seizure of the criminal proceeds from IP offenses. 7. ACTA will clarify existing international requirements for remedies against circumvention of technological protections used in the digital environment (such passwords or encryption) and trade in circumvention devices. 8. ACTA will go beyond TRIPS in calling on parties to addresses widespread distribution of pirated copyrighted works on digital networks while preserving fundamental principles such as freedom of expression, fair process, and privacy. 9. ACTA will enhance the TRIPS framework for civil enforcement provisions dealing with issues such as damages, provisional measures, recovery of costs and attorneys’ fees, and destruction of infringing goods. 10. ACTA will be the first international agreement to promote practices that contribute to effective enforcement of IPRs, such as specialization, data analysis, internal coordination, stakeholder consultation, risk management, transparency, public awareness, and environmentally sound destruction of fake goods.

19. Facts about ACTA ACTA recognizes of the need for balance: ACTA is explicitly premised on the desire of participating governments for IP enforcement that “…balances the rights and interests of the relevant right holders, service providers, and users.” Preamble: “Desiring to address the problem of infringement of intellectual property rights, including infringement taking place in the digital environment, in particular with respect to copyright or related rights, in a manner that balances the rights and interests of the relevant right holders, service providers, and users” ACTA recognizes the importance of free expression, fair process, and privacy: ACTA is the first and only international IP agreement to explicitly provide that enforcement of intellectual property rights in the context of the Internet “shall be implemented in a manner that … preserves fundamental principles such as freedom of expression, fair process, and privacy” Article 27.2: “Further to paragraph 1, each Party’s enforcement procedures shall apply to infringement of copyright or related rights over digital networks, which may include the unlawful use of means of widespread distribution for infringing purposes. These procedures shall be implemented in a manner that avoids the creation of barriers to legitimate activity, including electronic commerce, and, consistent with that Party’s law, preserves fundamental principles such as freedom of expression, fair process, and privacy.”

20. Facts about ACTA ACTA protects privacy laws: Nothing in the ACTA requires parties to disclose information “contrary to … laws protecting privacy rights.” Article 4.1: “Nothing in this Agreement shall require a Party to disclose … information, the disclosure of which would be contrary to its law, including laws protecting privacy rights, or international agreements to which it is party.” ACTA helps authorities protect public health and safety against the threat posed by potentially unsafe counterfeit goods. Counterfeit products can pose a significant risk to public health, such as toothpaste with dangerous amounts of diethylene glycol (a chemical used in brake fluid), military systems with untested and ineffective components to protect soldiers, auto parts of unknown quality that play critical roles in securing passengers, and suspect semiconductors used in life-saving defibrillators. Protecting intellectual property rights helps ensure adherence and compliance with numerous public health and safety regulations designed to protect our communities.

21. Facts about ACTA ACTA recognizes the Doha Declaration on TRIPS and Public Health, and does not mandate civil enforcement or border measures for patents. Preamble: “Recognizing the principles set forth in the Doha Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001, at the Fourth WTO Ministerial Conference.” In addition, the increased border measures contemplated by ACTA will not impede the transit of generic medicines, as ACTA explicitly notes that the border measures provisions will NOT apply to the enforcement of patents or undisclosed information. ACTA protects against abuse: ACTA stipulates that IP enforcement procedures “shall be applied in such a manner so as … to provide for safeguards against their abuse.” Article 6.1: Each Party shall ensure that enforcement procedures are available under its law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their

22. Facts about ACTA ACTA is not secret: A draft was released in April 2010, while negotiations were still ongoing. The final text has been public for more than a year. ACTA is one tool governments can use to cooperate: It is certainly not a new international organization, and it does not rival or replace any existing organization.

23. Thank You! Gracias! KIRA M. ALVAREZ DEPUTY ASSISTANT USTR AND CHIEF NEGOTIATOR FOR IPR ENFORCEMENT KIRA_ALVAREZ@USTR.EOP.GOV