USDA’s support to intellectual property enforcement includes the following:
• Trade Agreements: USDA’s Foreign Agricultural Service (FAS) supports USTR in negotiating, implementation, and monitoring and enforcement of free trade agreements (FTAs), and inter- faces with U S agricultural industry groups on intellectual property trade agreement issues
• World Trade Organization: USDA’s FAS supports dispute settlement, accession processes and negotiations in the WTO related to agriculture
• Bilateral and Regional Dialogues and Cooperation: USDA’s FAS participates in intellectual property enforcement discussion in a wide range of trade and economic policy dialogues with trading partners, and in trade and investment framework agreement discussions FAS Attachés overseas and staff in Washington participate in interagency working groups addressing intel- lectual property issues
• Coordination of U.S. Intellectual Property Enforcement Trade Policy: USDA’s FAS participates in the Special 301 process, an interagency venue for resolving intellectual property policy issues
Department of Commerce
International Trade Administration
ITA strengthens the competitiveness of U S industry, promotes trade and investment and ensures fair trade through the rigorous enforcement of our trade laws and agreements As part of its mission, ITA ensures that our trading partners are fulfilling their international trade commitments to enforce and protect intellectual property rights ITA also responds to inquiries, develops trade programs and tools to help U S businesses and citizens enforce and protect their intellectual property rights in foreign markets, and conducts outreach to raise awareness.
The Office of Intellectual Property Rights (OIPR) is responsible for developing and coordinating ITA input on trade-related intellectual property rights policies, programs and practices and for assisting companies to overcome challenges to protecting and enforcing their intellectual property rights overseas The U S Commercial Service, with offices in over 100 U S cities and 77 locations abroad, advocates for the interests of U S companies on intellectual property issues with appropriate foreign government officials, counsels U S companies operating or selling abroad in understanding foreign-country business climates and legal environments and assists companies to identify in-country resources to assist with registering and/or protecting their intellectual property rights through administrative or court actions as part of an overall strategy to educate the U S business community and, in particular, U S Small and Medium Sized Enterprises (SMEs), ITA and USPTO, working with other U S Government agencies and the private sector, have developed the www StopFakes gov/ website and a number of associated tools for small businesses The site includes information on:
• 17 Market-Specific Toolkits, which provide detailed information on protecting U S intellectual property in key markets like China, Brazil and the European Union (EU)
• An online training program developed by OIPR with the Foreign Commercial Service (FCS), USPTO, and the SBA, for SMEs about evaluating, protecting and enforcing intellectual property rights (translated into Spanish and French to broaden outreach)
• A program developed by OIPR and the FCS to promote protection of intellectual property rights at domestic and international trade fairs
• A program developed with the American Bar Association through which American SMEs can request a free, one-hour consultation with a volunteer attorney to learn how to protect and enforce their rights in Brazil, China, Egypt, India, Russia and Thailand
• The Intellectual Property Protection and Enforcement Manual and the No Trade in Fakes Supply Chain Tool Kit, which OIPR encouraged the U S Chamber of Commerce and the Coalition Against Counterfeiting and Piracy (CACP) to develop and release These documents, posted online at www thecacp com/, showcase proven strategies companies, both small and large, use to protect their supply chains from counterfeiters and pirates.
Patent and Trademark Office
USPTO has a long history of encouraging and supporting trading partners, particularly developing and least developed countries, to move beyond mere adoption of laws protecting intellectual property rights to the operation of effective systems for enforcement In 1999, USPTO expanded its technical assistance and capacity building activities to address intellectual property enforcement Such capacity building has included training for foreign government law enforcement officials, prosecutors, the judiciary and customs and border enforcement officials, and technical assistance on drafting laws and regulations on enforcement-related issues.
USPTO has created a flexible team enterprise that meets the challenges of intellectual property enforce- ment in today’s global economy by: (1) carrying out statutory and international treaty obligations to assist developing nations in implementing accessible and effective intellectual property enforcement systems; (2) responding rapidly to changing global and international conditions; (3) establishing alli- ances with other national and international intellectual property organizations to strengthen, protect and enforce American intellectual property rights globally; and (4) working with other U S Government agencies, national intellectual property enforcement authorities and international organizations to increase the accessibility, efficiency and effectiveness of civil, administrative and criminal enforcement mechanisms in global trade, foreign markets and electronic commerce.
USPTO regularly consults with foreign governments and other U S Government agencies on the sub- stantive, technical aspects of intellectual property enforcement laws, legal and judicial regimes, civil and criminal procedures, border measures and administrative regulations relating to enforcement; advises USTR and DOC on the trade-related aspects of intellectual property enforcement and serves as technical advisors on enforcement provisions in trade agreements by reviewing, analyzing and monitor- ing legislative and legal developments pertaining to intellectual property enforcement mechanisms, administration and public education efforts; develops, conducts, coordinates and participates in training programs, conferences and seminars, and develops training materials, including long-distance learning modules, to improve the level of expertise of those responsible for intellectual property enforcement and the overall enforcement environment; gathers information on and monitors foreign national enforcement systems, and coordinates intellectual property enforcement-related activities undertaken by various intergovernmental and non-governmental organizations; and provides technical expertise on legislation involving intellectual property enforcement
USPTO’s Global Intellectual Property Academy, established in 2006, is a focal point for intellectual property rights technical assistance and training, and a crucial component in an integrated approach to enforcement training and capacity-building, both domestically and internationally In addition, USPTO operates the overseas intellectual property Attaché program, which places resident experts in a number of U S missions abroad in order to provide direct, on-the-ground technical expertise, support and coordination of all intellectual property rights protection and enforcement issues, including training and capacity-building activities for foreign government officials.
Commercial Law Development Program
The Commercial Law Development Program (CLDP) improves the legal environment for U S businesses worldwide by removing non-tariff barriers to trade and ensuring effective implementation of intellectual property policies and enforcement provisions CLDP programs level the playing field for U S industries to compete in developing markets and provide follow-up support to countries that have limited capacity to implement some provisions of trade agreements entered into with the U S Although CLDP technical assistance is largely government-to-government, each program is designed to address a pressing need identified by both local and U S businesses.
CLDP partners with other offices within DOC (including USPTO, ITA and National Telecommunications and Information Administration (NTIA)), as well as DHS, DOJ, DOS/ USAID to provide capacity building and enforcement technical assistance in developing countries CLDP’s intellectual property work with host countries covers drafting legislation, establishing regulations, increasing skills development, promoting public outreach and ensuring transparency Many programs address needs across regions by gathering judiciaries, policy-makers and regulators from multiple countries to share best practices and develop workable solutions to regional problems related to counterfeiting and piracy CLDP’s intel- lectual property work over the years has led to the development of a small library of case studies in a multitude of languages that include technology transfer, licensing and border measures These materi als, frequently shared with other U S Government partners, are essential learning tools for developing countries looking to improve intellectual property enforcement
More information about CLDP’s work and successes related to intellectual property enforcement and capacity building can be found at www cldp doc gov
Department of Health and Human Services | Food and Drug Administration
The FDA is responsible for protecting the public health by assuring the safety and efficacy of medical products, and the safety of foods Expanded markets and more complex supply chains have required the FDA to find new ways to safeguard global public health The FDA is acutely aware of the illegality of and the direct-and-indirect risk posed to the public health by counterfeit medical products, infant formula and foods that falsely represent their identity and/or source Those who manufacture and dis- tribute falsified medical products and foods not only defraud patients and consumers, they also deny ill patients the medical products that can alleviate suffering and save lives and, for a formula that may be an infant’s sole source of nutrition, the healthy start in life that every child needs Consequently, the FDA takes all reports of suspect counterfeits seriously and the FDA’s regulatory officials have responded to this emerging threat by: strengthening its ability to prevent the introduction of falsified medical products and foods into the U S distribution chain, facilitating the identification of falsified medical products and foods, and by minimizing the risk and exposure of patients and consumers to falsified products through recalls, public awareness campaigns and other steps.
As a part of these efforts, the FDA’s OCI expeditiously investigates reports of suspected falsified products in order to protect U S citizens Specifically, OCI investigates counterfeit products that violate 18 U S C Section 2320 and 21 U S C Section 331(i) OCI routinely coordinates counterfeit investigations and intelligence with other international, Federal, state and local law enforcement agencies and has initiated numerous investigations focused on protecting the public health that have led to criminal convictions.
The issue of falsified medical products and food is a global issue that requires a global solution and the FDA is working with its international regulatory partners to address the public health aspects of counterfeit medical products and foods The FDA has also worked with our partners in foreign markets to strategically establish FDA offices worldwide that help provide technical assistance, among other things, to help countries enhance their regulatory systems to ensure that counterfeits are kept out of the legitimate supply chain so consumers receive safe, effective and quality products In addition, the FDA is also working with U S medical product supply chain stakeholders to put measures in place in the U S to ensure the integrity of the U S closed distribution system, such as the tracking and tracing of prescription drugs, in order to keep counterfeits out of this system.
Department of Homeland Security
DHS plays a key role in the protection of intellectual property rights In the pursuit of an effective intellectual property enforcement strategy, DHS aims to ensure the facilitation of legitimate trade, while enforcing U S trade and intellectual property rights laws, as well as investigating intellectual property rights violations, specifically trademark, counterfeiting and copyright piracy In February 2010, DHS presented the Quadrennial Homeland Security Review (QHSR) to Congress, which outlines a strategic framework for DHS’ mission Intellectual property rights enforcement falls within Mission 2 of the QHSR, which identifies the safeguarding of lawful trade and travel as one if its key goals DHS is able to execute its mission through its components, including CBP, ICE, U S Secret Service (USSS) and others
DHS actively engages with international organizations like the WCO and INTERPOL; works to develop increased information sharing and partnership programs involving trade; actively participates in global intellectual property rights training; and works with other U S Government agencies to further build and enhance intellectual property rights efforts DHS components continue to work toward enhancing its intellectual property enforcement capabilities within its agency-wide mission to secure the nation and to facilitate the secure flow of legitimate goods through legitimate trade and travel.
DHS conducts several joint operations to investigate and act against intellectual property violations For example, Operation Guardian is a DHS-led, multi-agency public health and safety initiative, conducted with ICE, CBP, FDA, the Consumer Product Safety Commission (CPSC), USPIS, USDA, and the Government of Mexico’s Tax Administration Service Since Operation Guardian’s inception in FY 2008, ICE has initiated
437 investigations which have resulted in 102 criminal arrests, 25 administrative arrests, 155 search war- rants and, with CBP, 925 seizures valued at over $26 million Further, Operation Apothecary is another DHS-led multi-agency operation, conducted with ICE, CBP, FDA and USPIS that identified vulnerabilities in the mail and express courier entry process that allowed for the smuggling of commercial quantities of counterfeit, unapproved and/or adulterated drugs Since Operation Apothecary’s inception, ICE has initiated 274 investigations which have resulted in 87 criminal arrests, 58 search warrants and, with CBP,
664 seizures valued at over $2 7 million.
Customs and Border Protection
As the Federal agency responsible for the management, control and protection of U S borders, CBP is critical to enforcement of intellectual property rights CBP acts under its own authorities to seize and forfeit goods that infringe on trademarks, trade names and copyrights; conduct audits; and impose and collect fines and penalties against intellectual property infringement CBP also enforces exclusion and seizure and forfeiture orders issued by the ITC for imports that are determined to be intellectual property rights infringing CBP is implementing a 5-year strategy for intellectual property enforce- ment to ensure the competitiveness of America’s businesses, prevent harm to consumer health and safety and protect our way of life against threats to critical infrastructure and national security posed by the theft of intellectual property CBP has laid out a number of initiatives, including private sec- tor partnership programs to facilitate legitimate trade, enhanced targeting and training to increase interdictions of intellectual property infringing goods and levying penalties and conducting audits more effectively to deter intellectual property violations CBP’s 5-year strategy leverages resources and partnerships with U S industry, other Federal agencies and foreign governments in a compre- hensive plan to attack intellectual property rights infringement throughout the international trade process CBP receives allegations of illegal importation through its on-line e-allegations website at
http://www cbp gov/xp/cgov/trade/trade_programs/e_allegations/ Allegations of trade violations may also be reported by calling 1-800-BE-ALERT
Immigration and Customs Enforcement
ICE is a lead U S agency for the investigation of criminal intellectual property violations involving the illegal production, smuggling, and distribution of counterfeit and pirated products, as well as associated money laundering violations ICE seizes for forfeiture goods associated with these investigations, such as those that infringe on trademarks, trade names, and copyrights ICE criminal investigations focus on identifying, disrupting and dismantling the transnational criminal organizations that promulgate this activity In addition to the 26 Special Agent in Charge offices responsible for conducting domestic enforcement actions, ICE has 63 Attaché Offices in 44 countries that coordinate with host governments to conduct intellectual property enforcement that extend beyond U S borders.
IPR Center
To more effectively counter the flood of infringing products, ICE established the IPR Center The mis- sion of the IPR Center is to address and combat predatory and unfair trade practices that threaten our economic stability and national security, restrict the competitiveness of U S industry in world markets, and place the public’s health and safety at risk The IPR Center brings together key domestic and foreign investigative agencies and industry partners to increase the efficient and effective leverage of resources, skills and authorities to provide a comprehensive response The IPR Center maintains an intellectual prop- erty theft reporting system through its website at www ICE gov, through email at IPRCenter@dhs gov and through a toll free phone number at 866-IPR-2060.
U.S. Secret Service
USSS investigates violations of laws relating to counterfeiting of obligations and securities of the U S ; financial crimes that include, but are not limited to, access device fraud, financial institution fraud, identity theft, computer fraud; and computer-based attacks on our nation’s financial, banking and telecommunications and critical infrastructure As part of the investigative mission of safeguarding the nation’s financial infrastructure, USSS investigations discover links to intellectual property violations In response to the growing problem of intellectual property theft, USSS, through its Electronic Crimes Task Force (ECTF) program will continue to support Federal, state and local law enforcement agencies and prosecutors to combat computer and intellectual property crime and promote information sharing between government and the private industry.
Department of Justice
Aggressive enforcement of intellectual property laws is a high priority of DOJ DOJ combats intellectual property theft and related intellectual property crime utilizing the full resources of its Criminal Division, U S Attorneys’ Offices and Civil Division, as well as the investigatory and law enforcement resources of the FBI and other law enforcement partner agencies DOJ’s intellectual property priorities include the investigation and prosecution of intellectual property crimes involving: (1) health and safety; (2) trade secrets and economic espionage; and (3) commercial on-line piracy and counterfeiting In addition, DOJ affirmatively supports the intellectual property enforcement efforts of its state and local partners through the use of targeted intellectual property-focused grant programs.
Criminal Division and U.S. Attorneys’ Offices
DOJ prosecutes the most serious perpetrators of intellectual property crimes involving a wide range of criminal offenses Since 1999, when then-Deputy Attorney General Holder announced DOJ’s first intel- lectual property enforcement initiative, the Criminal Division has dramatically increased its intellectual property focus, resulting in an 800% increase in the number of intellectual property investigations and prosecutions DOJ’s intellectual property prosecution mission is handled by the 94 U S Attorneys’Offices and the Criminal Division’s Computer Crime and Intellectual Property Section (CCIPS).
Intellectual property prosecutions through DOJ’s 94 U S Attorneys’ Offices utilize the knowledge and skills of highly specialized Assistant U S Attorneys working under its Computer Hacking and Intellectual Property (CHIP) coordinator program The program consists of a network of over 220 specially-trained Federal prosecutors in U S Attorneys’ Offices across the country who aggressively pursue computer crime and intellectual property offenses Each U S Attorney’s Office has at least one CHIP prosecutor; in addition, 25 U S Attorneys’ Offices have CHIP Units, which consist of two to eight CHIP attorneys each Each CHIP prosecutor has four core responsibilities to: (1) prosecute computer crime and intellectual property offenses; (2) serve as the district’s legal counsel on matters relating to those offenses, and the collection of electronic or digital evidence; (3) train prosecutors and law enforcement personnel in the region; and (4) conduct public and industry outreach and awareness Most CHIP prosecutors also work on other non-intellectual property cases, depending on the needs of their respective districts.
DOJ’s CHIP program is complemented by the Criminal Division’s CCIPS, a highly specialized team of 40 prosecutors focused on computer crime and intellectual property offenses Fourteen CCIPS attorneys are devoted exclusively to the intellectual property criminal enforcement program These attorneys prosecute intellectual property cases; assist in developing and implementing DOJ’s criminal intellectual property enforcement strategy and legislative and policy initiatives; provide advice and guidance to agents and prosecutors in the field on a 24-hour basis; develop training and resource materials for prosecutors and investigative agents both domestically and abroad; work with Federal agency partners to strengthen overall U S intellectual property enforcement efforts; and provide public outreach and training to intellectual property creators, owners and industry.
The cornerstone of DOJ’s strategy to strengthen international intellectual property criminal enforcement is the Intellectual Property Law Enforcement Coordinator (IPLEC) program With support from DOS, DOJ has deployed two experienced Federal prosecutors to serve as IPLECs in Bangkok, Thailand for Southeast Asia, and in Sofia, Bulgaria for Eastern Europe The IPLECs provide operational assistance and critical intellectual property training to increase in-country enforcement capacity In addition, in the past five years, DOJ attorneys have provided training and education on intellectual property enforcement to over 10,000 prosecutors, police, judicial officers and other government officials from over 100 countries.
DOJ has also incorporated intellectual property into its existing International Organized Crime Strategy and has assigned a prosecutor to serve as Counsel to the IOC-2 DOJ’s Criminal Division, the FBI, DHS, and other relevant participating Federal agencies are coordinating their efforts through IOC-2 and working to ensure that critical intellectual property-related intelligence and case information is contributed to its data pool.
Civil Division
Intellectual property enforcement is also an integral part of the mission of three sections of the Department’s Civil Division: the Intellectual Property Section, the National Courts Section and the Office of Consumer Litigation Through the Civil Division’s Intellectual Property Section, DOJ assists with prosecution of civil actions to recover penalties imposed by CBP with respect to the importation of counterfeit goods, brings affirmative cases when U S intellectual property is infringed, and consults with other sections of DOJ and other agencies on intellectual property matters The National Courts Section prosecutes civil actions to recover various penalties or customs duties arising out of negligent or fraudulent import transactions, many of which include importation of counterfeit goods The National Courts Section also defends CBP enforcement of the ITC’s Section 337 exclusion orders at the Court of International Trade; these orders are an important tool for intellectual property enforcement Finally, the Office of Consumer Litigation enforces and defends the consumer protection statutes of the FDA, including the criminal provisions of the Food, Drug, and Cosmetics Act that govern counterfeit drugs and medical devices.
Federal Bureau of Investigation
The FBI’s strategic objective is to disrupt and dismantle state sponsored groups and international and domestic criminal organizations that steal, manufacture, distribute and otherwise profit from the theft of intellectual property The highest priorities for intellectual property rights investigations are counterfeit health and safety products and theft of trade secrets The FBI aggressively pursues intellectual property enforcement through liaison with private industry, domestic and foreign law enforcement partners and its partnership with the IPR Center The FBI’s Intellectual Property Rights Unit (IPRU) became fully operational within the IPR Center on April 15, 2010, and now includes five dedicated FBI agents who work full time at the Center In addition, by the end of FY 2010, the FBI intends to employ over 50 Special Agents exclusively devoted to pursuing intellectual property investigations operating in field offices throughout the country and four enhanced intellectual property squads.
Additionally, the FBI’s IPRU is fully engaged with other FBI divisions, including the Criminal Investigative Division and Organized Crime and Health Care Fraud Units, as well as the Counterintelligence Division Economic Espionage Unit, to coordinate and track theft of trade secret investigations that have a state sponsorship nexus The objective of the FBI’s Counterintelligence Division’s Economic Espionage Program is to prevent the loss of trade secrets to foreign agents, governments and instrumentalities as defined by the Economic Espionage Act of 1996 These collaborations act as a force multiplier allowing for multiple criminal charges resulting in higher penalties for offenders.
The FBI also established an Intelligence Fusion Group at the IPR Center Together the partner agencies define the intellectual property rights threat picture, share tactical and strategic intelligence, establish IPR Center joint collection requirements, produce joint intelligence products and develop the national strategy.
The FBI also trains domestic and international law enforcement officials in intellectual property rights matters The FBI is collaborating with its partner agencies to develop more comprehensive and advanced intellectual property training curriculum The curriculum will ensure a uniform foundation across law enforcement agencies conducting intellectual property rights investigations and provide state and local law enforcement and industry liaisons with information as to how to most effectively partner with the Federal government on intellectual property rights investigations.
Office of Justice Programs
DOJ affirmatively supports the intellectual property enforcement efforts of its state and local law enforcement partners through grants awarded by its Office of Justice Programs, BJA In 2009, BJA cre- ated the Intellectual Property Enforcement, Training, and Technical Assistance Program consisting of eight field-initiated grants and two training and technical assistance grants The program is designed to provide national support and improve the capacity of state and local criminal justice systems to address criminal intellectual property enforcement, including prosecution, prevention, training and technical assistance BJA also formed a partnership with the NW3C and NAAG to improve the quantity and qual- ity of enforcement and prosecution of intellectual property crimes by providing training and technical assistance to state and local officials.
Department of Justice Task Force on Intellectual Property
Overseeing and coordinating all of DOJ’s intellectual property enforcement efforts is the newly revital- ized DOJ Task Force on Intellectual Property This Task Force, which is chaired by the Deputy Attorney General, is composed of senior officials from the offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, the Criminal Division, the Civil Division, the Antitrust Division, the Office of Legal Policy, the Office of Justice Programs, the Attorney General’s Advisory Committee, the Executive Office for U S Attorneys and the FBI The Task Force monitors and coordinates overall intellectual property enforcement efforts at DOJ, provides a vehicle for increased cooperation with Federal, state and local law enforcement and serves as an engine of policy development to com- prehensively address the evolving technological and legal landscape of intellectual property crimes.
Department of State
Protecting American intellectual property abroad is a DOS priority and DOS works closely with other U S government agencies, the private sector and foreign governments to combat piracy and coun- terfeiting U S embassies, consulates and missions are on the front line of protecting U S intellectual property rights: responding to complaints raised by U S companies and vigorously pressing foreign governments to fulfill their bilateral and international obligations In addition to diplomatic resources, DOS uses training and public diplomacy strategies to support these goals.
Robert D Hormats, DOS Undersecretary for Economic, Energy, and Agricultural Affairs, is the senior eco- nomic official at the DOS He advises the Secretary of State on international economic policy, including intellectual property issues, and serves as the U S government’s Sous-Sherpa for the G8/G20 process DOS’ Office of International Intellectual Property Enforcement (IPE), in the Bureau of Economic, Energy, and Business Affairs (EEB), was founded by Congress in 2005, and is dedicated specifically to promoting intellectual property enforcement and innovation The IPE team works with officers at DOS’ overseas posts and regional bureaus to ensure that the interests of American rightholders are represented over- seas, and to highlight the integral role of intellectual property rights protection in the development of the global economy IPE works with other U S Government agencies in international organizations and bilateral negotiations dedicated to intellectual property enforcement, including the WIPO and the WTO/ Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council.
EEB and State’s Bureau of International Narcotics and Law Enforcement together implement a Congressionally-earmarked $4 million/year intellectual property enforcement training and technical assistance for developing countries that funds an average of ten projects per year DOS’ public diplo- macy programs include a group international visitor program sponsored by the Bureau of Educational and Cultural Affairs that invites up to 30 foreign intellectual property stakeholders for three weeks of capacity-building meetings and observations in the US.
Executive Office of the President | United States Trade Representative
USTR is supporting and implementing President Obama’s commitment to aggressively protect American intellectual property internationally As the President said just a few months ago, “Our single greatest asset is the innovation and the ingenuity and creativity of the American people. It is essential to our prosperity and it will only become more so in this century.” The President spoke of the importance of making sure that American businesses are paid appropriately and intellectual property is not stolen He related this to our work at USTR:
“That’s why USTR is using the full arsenal of tools available to crack down on practices that blatantly harm our businesses, and that includes negotiating proper protections and enforcing our existing agreements, and moving forward on new agreements, including the proposed Anti-Counterfeiting Trade Agreement.”
The ACTA, mentioned by President Obama, is an initiative to negotiate a new intellectual property enforcement agreement with a number of key trading partners who share our ambition and commit- ment to stepping up the fight against global counterfeiting and piracy
Other key tools that USTR uses to advance the cause of intellectual property rights enforcement include:
• Trade Agreements: USTR works with countries to strengthen their intellectual property enforcement regimes through trade agreements The ACTA negotiations are one example Another is the negotiation, implementation, monitoring and enforcement of U S FTAs that include world- class provisions on intellectual property rights enforcement
• World Trade Organization: This multilateral organization provides opportunities for USTR to lead engagement with trading partners on intellectual property enforcement issues in several contexts, including accession processes for prospective members like Russia, the Council for TRIPS and dispute settlement
• Special 301 and preference program reviews: USTR uses the “Special 301” process to encour- age specific trading partners to address significant deficiencies in intellectual property protec- tion, including weak intellectual property enforcement Each April, USTR issues a Special 301
Report setting out specific intellectual property rights concerns in countries worldwide USTR works with other countries in other contexts, such as reviews under the Generalized System of Preferences (GSP) and other trade preference programs to ensure that the country is making progress on providing adequate and effective protection and enforcement of intellectual property rights.
• Bilateral and Regional Dialogues and Cooperation: USTR leads or is a significant participant in intellectual property enforcement discussion in a wide range of other trade and economic policy dialogues with trading partners A few of the many examples include the APEC Forum; the U S -China Strategic and Economic Dialogue; the U S -China Joint Commission on Commerce and Trade; the U S -EU Summit; and the U S -Russia Intellectual Property Rights Working Group Intellectual property rights issues also feature prominently in many of our Trade and Investment Framework Agreement discussions
• Coordination of U.S. Intellectual Property Rights Enforcement Trade Policy: USTR leads the interagency trade policy coordination process, including on intellectual property rights, pursuant to statute and Executive Orders USTR consults regularly with stakeholders, including through numerous advisory committees USTR provides trade policy leadership and expertise across the full range of interagency initiatives on intellectual property rights and innovation policy, including intellectual property enforcement matters.
The Library of Congress | The Copyright Office
The Copyright Office advises Congress on national and international issues relating to copyright and provides information and assistance to Federal departments and agencies and the Judiciary on national and international issues relating to copyright See 17 U S C §701.
The Copyright Office does not have enforcement duties, but supports the copyright enforcement activi- ties of the US Government in a number of ways.
Regarding international matters, the Office plays a substantive role on the U S delegations to interna- tional organizations such as WIPO, working with USPTO and other interested agencies to establish and implement U S copyright initiatives Copyright issues also frequently arise in the context of trade, in which the Copyright Office works very closely with the USTR and other agencies to address copyright enforcement deficiencies in legal systems of our trading partners.
The Copyright Office always contributes to the Special 301 process and 2010 was no exception This year, the Office’s contribution included detailing an attorney from the Office of Policy and International Affairs to USTR to be the Special 301 Coordinator In addition, the Copyright Office has lent its technical expertise to USTR’s premier enforcement-related initiative, ACTA.
The Copyright Office also engages in training, education and outreach programs For example, in coop- eration with WIPO, the Copyright Office hosted a week-long training program entitled, “International Training for Developing Countries and Countries in Transition on Emerging Issues in Copyright and Related Rights and Issues Pertaining to Blind and Visually Impaired Persons ” The program ran from March 8 to March 12 and featured several panels and speakers devoted to subjects related to copyright enforcement Participation in the enforcement section of the program involved speakers from across the U S Government, including Ms Victoria Espinel, the IPEC, and Ms Kira Alvarez, USTR’s Chief Negotiator for Intellectual Property Enforcement, as well as the Copyright Office and speakers representing a wide array of stakeholders.
On April 21, 2010, the Copyright Office co-sponsored the “Internet Intermediary/Joint Liability Roundtable” in Beijing, China along with USPTO, the National Copyright Administration of China, and China’s Ministry of Commerce This event brought together Chinese copyright and trade officials, judges and academics with U S copyright and trade officials and stakeholders for a frank and candid exchange of copyright enforcement on the Internet.
Agencies’ 2010 Major Intellectual Property Enforcement Activities to date
Department of Agriculture
USDA’s intellectual property enforcement-related activities include:
• Trade Agreements: USDA’s FAS supports USTR in negotiating, implementation, and monitoring and enforcement of FTAs, and interfaces with U S agricultural industry groups on intellectual property trade agreement issues
• World Trade Organization: USDA’s FAS supports dispute settlement, accession processes and negotiations in the WTO related to agriculture
• Bilateral and Regional Dialogues and Cooperation: USDA’s FAS participates in intellectual property enforcement discussion in a wide range of trade and economic policy dialogues with trading partners, and in trade and investment framework agreement discussions FAS Attachés overseas and staff in Washington participate in interagency working groups addressing intellectual property issues
• Coordination of U.S. Intellectual Property Enforcement Trade Policy: USDA’s FAS participates in the Special 301 process, an interagency venue for resolving intellectual property policy issues
Department of Commerce
International Trade Administration
• Trade Agreements Compliance and Market Access: OIPR monitors foreign governments’imple- mentation of and compliance with international trade agreements As part of that work, OIPR assists U S rightholders overcome specific barriers in foreign markets that impede commercial transactions involving U S intellectual property Since January 1, 2010, OIPR has initiated 21 market access and compliance cases in 13 different foreign markets on behalf of U S righthold- ers Of those 21 cases, 18 were on behalf of U S SMEs.
• Translation of SME Training Module to French and Spanish: In April 2010, OIPR launched the French and Spanish versions of its online SME training module, which help firms recognize, register and enforce their intellectual property rights This step increases access to this important resource.
• OIPR Participates in the Mexico and New Zealand Rounds of the ACTA Negotiation: In January and April 2010, OIPR staff represented the ITA on the U S negotiating team during the Mexico and New Zealand rounds for the ACTA negotiations.
• ITA Hosts a Meeting of the Trans-Atlantic Consumer Dialogue on ACTA: In April 2010, OIPR staff hosted and participated in a day-long meeting of the Trans-Atlantic Consumer Dialogue in which both U S and European consumer groups discussed the ACTA negotiation.
• Croatia Intellectual Property Right Tool Kit: The U S Commercial Service in Zagreb, Croatia, in close cooperation with OIPR and USPTO, developed the Croatia Intellectual Property Rights Toolkit to aid U S rightholders in Croatia This toolkit has been posted on the website of the U S Embassy in Zagreb, Croatia, and can also be accessed through a link from www StopFakes gov/
• 2010 Special 301 Report: ITA played a significant role during the interagency review led by USTR in the lead up to the 2010 Special 301 Report’s publication on April 30, 2010 ITA coordinated six industry meetings for DOC staff, and actively participated in all interagency discussions.
• U.S.-EU Intellectual Property Rights Working Group: On June 7, 2010, ITA co-chaired a meet- ing of the U S -EU Intellectual Property Rights Working Group in Brussels, Belgium At the meeting, ITA and other U S Government agencies held detailed discussions with the European Commission on U S -EU cooperative efforts to strengthen intellectual property rights enforce- ment and protection in key third-country ITA also held talks with DG Enterprise on ways in which the U S and EU can leverage resources to help SMEs.
Patent and Trademark Office
• USPTO has participated in the ACTA negotiations, including the recent rounds in Mexico
(January 2010), New Zealand (April 2010), and Switzerland (June 2010)
• In March 2010, USPTO organized an intellectual property border enforcement workshop in Cairo, Egypt, to support efforts by the government of Egypt in revamping its customs laws
• In March 2010, USPTO conducted a regional workshop in Estonia, for investigators and prosecu- tors on investigation and prosecution of digital piracy for officials from Estonia, Latvia, Lithuania and Russia, with officials from Sweden and Finland also participating
• In March 2010, USPTO organized a regional seminar on combating counterfeit products for the East African Community in Dar Es Salaam, Tanzania, with the seminar timed to capitalize on progress the East African Community has made in developing an anti-counterfeiting policy statement and an anti-counterfeiting law
• In March 2010, USPTO participated in the APEC-IPEG 30th meeting in Hiroshima, Japan, at which, USPTO led the U S delegation at the meeting and continued to push initiatives on anti- camcording and signal piracy, as well as trade in counterfeit goods
• As part of a partnership with INTERPOL and the WCO, USPTO co-funded Operation Jupiter trainings in Paraguay (April 2010), Peru (May 2010), and Western Africa (May 2010), with these regional activities focused on transnational criminal organizations involved in intellectual property crime
• USPTO, as part of its on-going partnership with the Association of Southeast Asian Nations (ASEAN), organized and funded intellectual property rights enforcement capacity-building programs for regional customs officials in Brunei, Darussalam (March 2010), and public prosecu- tors and law enforcement officials/police in Cambodia (May 2010)
• In May 2010, USPTO organized a two-week study tour program for Mexican judges in the U S , and will provide a detail to the Embassy in Mexico City to work on intellectual property enforce- ment and protection-related programs from June to September 2010
• USPTO has provided expert technical advice to USTR in the TPP Agreement negotiations on enforcement-related provisions
Commercial Law Development Program
• In March 2010, CLDP held a U S Consultations on Intellectual Property and Technology Transfer for a group of Algerian representatives from the GAO and the private sector
• CLDP held a follow up workshop in March 2010 for representatives of Kosovo’s information technology industry on intellectual property and software licensing
• In April 2010, in collaboration with DHS and DOJ, CLDP held a two-day training consultation on intellectual property enforcement at the borders for 150 participants from the Malian Customs Service as well as regional delegations from Cameroon, Cote d’Ivoire, Togo, Benin, Burkina Faso and Senegal, in Bamako
• In April 2010, as a part of ongoing judicial capacity building programs in Libya, CLDP arranged consultations and training with DOJ enforcement attorneys, and USPTO enforcement attorneys for four high-level Justice Officials from Libya
• In May 2010, CLDP held a three-day workshop in Accra for 50 participants that facilitated the development of an Interagency Intellectual Property Task Force, by bringing together a wide range of Ghanaian agencies and stakeholders involved in the fight against counterfeiting and piracy
• In May 2010, as part of the AGCI program, CLDP held a regional workshop on the adjudication of intellectual property cases in collaboration with USPTO and DOJ and the Southern African Development Community (SADC) for a group of judges from across the SADC region to Botswana
• In May and June 2010, CLDP implemented a two-part program in Pakistan focusing on intel- lectual property Part one helped create a core group of specialists able to advise tenants of university technology incubators and to manage university technology transfer offices Part two built the information technology community’s capacity to manage intellectual capital, and support its efforts to modify the legislative and institutional environment (focus on copyright registration)
• In June 2010, CLDP held a program in Ukraine for 65 customs officials and other government authorities of Ukraine, Poland, Slovakia, Hungary, Romania, Moldova and Russia on ways to better interdict the entry of infringing goods
Department of Health and Human Services | Food and Drug Administration
• In January 2010, HHS/FDA issued a public warning about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, which included an incorrect active ingredient that should not be used without a prescription and could be harmful to certain patients
• In March 2010, the FDA issued a standard for unique identification for packages of prescription drugs, which is an important first step towards establishing track and trace and supply chain security in the U S
• In March 2010, the FDA warned health care providers and consumers about counterfeit surgical mesh being distributed in the U S under the C R Bard/Davol brand name Surgical mesh products are used to reinforce soft tissue where weakness exists
• In May 2010, the FDA was actively engaged in discussions at the World Health Assembly, seek- ing international consensus on public health strategies to address the problem of counterfeit medical products
• Throughout 2010, the FDA and CBP are conducting drug inspection “blitzes” to identify coun- terfeit and substandard drugs sent to U S consumers usually as a result of purchases over the Internet
Department of Homeland Security
DHS has conducted a number of intellectual property rights enforcement activities in 2010
• QHSR: In February 2010, DHS presented the QHSR to Congress, which identified the safeguarding of lawful trade and travel as one if its key goals
• Anti-Counterfeiting Trade Agreement: DHS, including CBP and the Office of Policy, served as subject matter experts advising the USTR at the Mexico negotiating round in January, and CBP, ICE, and the Office of Policy attended the New Zealand negotiating rounds in April
• 2010 Special 301 Report: DHS provided significant input and subject matter expertise to the interagency review led by USTR to publish the 2010 Special 301 Report on April 30, 2010
Customs and Border Protection
• 5-Year Strategy for Intellectual Property Rights Enforcement: In early July, CBP will unveil an ambitious and comprehensive 5-year strategy for intellectual property enforcement aimed at improving enforcement throughout the entire international trade process This multi-layered strategy manages intellectual property rights risk by expanding the border to fight counterfeit- ing, not only as cargo arrives at our ports of entry, but also internationally before cargo is laden on vessels destined for our shores, and after illicit goods arrive in our country.
• Intellectual Property Rights Seizures Increase: At mid-year FY 2010, intellectual property rights seizures are at almost 9,700, an increase of approximately 50% over mid-year FY 2009
• Supply Chain Management Program: CBP hosted a kick-off meeting with private sector stakeholders on the development of a trade partnership to expedite entry of shipments into the U S that are at low risk for intellectual property rights infringement and to better focus CBP’s inspection resources on shipments of high or unknown risk
• Intellectual Property Rights Targeting Models: CBP coupled the expertise of its Intellectual Property Rights National Targeting and Analysis Group with new technology and targeting methods to build a new intellectual property rights risk model In just completed testing, the model increased effectiveness in identifying shipments of counterfeit goods by a factor of four
• Applications for Intellectual Property Rights Enforcement: CBP approved 862 applications, known as recordations, from trademark and copyright owners for CBP to protect their rights against counterfeit and pirated goods
• Technical Analyses: Scientists in CBP’s Office of Laboratories and Scientific Services have ana- lyzed approximately 3,000 samples of suspected intellectual property rights-infringing products so far this year These laboratory tests have resulted in seizures of products such as circuit boards, computer chips, video game systems, cigarettes, watches, perfumes and pharmaceuticals
• Foreign Training and Capacity-Building: This year, CBP has traveled to Brunei, Cairo, Egypt, Bangkok, Thailand, Lima, Peru and Bamako, Mali to provide intellectual property enforce- ment expertise for regional training and capacity-building programs sponsored by the U S Government
• Enforcement Operations: As a result of its targeting and interdiction successes, including targeting and interdiction for the IPR Center Operation Guardian and Operation Apothecary (see previous section), CBP continues to be the leading source of referrals to ICE for possible criminal investigations
Immigration and Customs Enforcement
• Operation Holiday Hoax: Operation Holiday Hoax was a joint operation with CBP, the FDA and the USPIS that seized counterfeit goods in transit, at transportation hubs and at local retail sales points throughout the U S and Mexico In the U S , ICE and its partners seized more than 700,000 counterfeit items, with a total value of more than $26 million Fifteen individuals were arrested in New York and Texas Mexico’s efforts resulted in the execution of 100 search warrants and the seizure of 274 tons of counterfeit goods.
• Operation Spring Cleaning: Initiated in April 2010, Spring Cleaning was an interagency intel- lectual property theft enforcement surge operation that targeted the manufacture, distribution and retail sale of counterfeit goods Coupled with a simultaneous multi-national investigation in Baltimore, the two actions resulted in a combined total of 45 arrests and the seizure of 1 7 million items of counterfeit merchandise valued at $263 million.
• Operation Global Hoax: Initiated in May 2010, Operation Global Hoax is a multinational effort to identify, investigate and interdict the distribution of pirated movie and music products Between
May and July 2010, 35 countries around the globe will work with the WCO in this operation and exchange gathered intelligence in furtherance of this effort
• Operation Mercury II: Operation Mercury II is a five-day surge operation planned for June 2010 to combat the importation and distribution of substandard and counterfeit pharmaceuticals This operation will be a joint effort with the WCO
• Between January and March 2010, ICE and CBP teamed with the NFL, NBA, NCAA, industry and local law enforcement to conduct operations targeting counterfeit sports merchandise sold during the Super Bowl, NBA All-Star Game, and the NCAA Final Four and Frozen Four tourna- ments These operations resulted in seizures of over 14,000 items valued at more than $760,000
• In April 2010, ICE announced partnerships with state and local law enforcement, resulting in the formation of 22 IPTETs, in which 70 federal, state and local law enforcement agencies have joined the 10 federal partners of the IPR Center in collaborating on activities to more effectively combat intellectual property theft nationwide
• In early June 2010, ICE and the IPR Center, along with INTERPOL, co-hosted the 2010 Certification Industry Against Counterfeiting (CIAC) North America conference
• In early June 2010, the IPR Center hosted a Symposium on International Organized Crime, Terrorism and Intellectual Property Theft, bringing together academia, industry, law enforce- ment and government
• From January 1, 2010 through May 19, 2010, ICE’s intellectual property theft enforcement activ- ity resulted in 166 criminal arrests, 56 indictments, 34 convictions, and 1,078 seizures valued at more than $358 million.
Department of Justice
Over the past several months, DOJ spearheaded several key intellectual property initiatives:
• In February 2010, DOJ created a revitalized DOJ Task Force on Intellectual Property The Task Force monitors and coordinates DOJ’s overall intellectual property enforcement efforts
• In March 2010, BJA posted its FY 2010 Intellectual Property Enforcement Program solicitation, making $4 million in funding available to state and local enforcement entities, including pros- ecutors, for intellectual property enforcement task forces and local intellectual property training and technical assistance BJA anticipates, based on the $200,000 maximum award amount, awarding 20 field-initiated grants The grants awarded in 2010 will build upon the previous intellectual property grant awards of nearly $2 million in August 2009 to eight state and local law enforcement agencies and two non-profit enforcement member organizations.
• On March 12, 2010, DOJ conducted an Antitrust Workshop: Agricultural and Antitrust Enforcement in our 21st Century—Issues for Farmers The workshop included a panel that discussed how the patenting of genetically modified seeds has affected the competitive dynamics of the seed industry, and issues facing the industry as patents covering certain traits are nearing expiration.
• In April, 2010, DOJ announced the appointment of 20 additional FBI Special Agents dedicated to investigating intellectual property rights cases These agents joined the 31 agents already deployed to field offices around the country devoted to investigating intellectual property crimes As a result of these new appointments, the FBI created four enhanced intellectual property enforcement squads and increased personnel resources to six additional field offices.
• In April 2010, DOJ also announced the appointment of 15 new Assistant U S Attorneys positions devoted to prosecution of high tech crime, including computer crime and intellectual property offenses The new positions will be located in California, the District of Columbia, Maryland, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Virginia and Washington.
• On May 26, DOJ participated in a first of its kind tri-agency workshop with the Federal Trade Commission (FTC) and USPTO (including high-level officials from each agency) on significant patent and antitrust issues that can have critical implications on innovation and competition The workshop, labeled “The Intersection of Patent Policy and Competition Policy,” discussed standard-setting, the patent backlog and the use of injunctions in district courts and at the ITC.
• During July, in coordination with USTR and FTC, DOJ will be holding an intellectual property/ antitrust workshop for the Chinese antimonopoly agencies in China as part of our ongoing technical assistance.
• Over the past year, the Attorney General has also personally emphasized DOJ’s renewed focus and efforts to combat intellectual property crime through cooperation with international law enforcement partners On February 24, 2010, the Attorney General met with officials from the Rio De Janeiro Prosecutor’s General’s Office to emphasize the need for strong enforcement of criminal intellectual property laws and to develop stronger partnerships with Brazil as both countries seek to enhance their intellectual property enforcement efforts.
In addition to program-wide initiatives, DOJ has successfully participated in several high-profile intel- lectual property cases:
• In January 2010, a defendant was sentenced to 30 months in prison and ordered to pay $790,683 in restitution to Cisco Systems, Inc , as a result of his conviction for trafficking in counterfeit Cisco computer products The defendant, a citizen of China, carried out the scheme while doing busi- ness as Gaoyi Tech, a company located in Shenzhen, China The defendant procured counterfeit Cisco products in China in response to orders and then shipped the products to the U S [FBI].
• In 2009, an investigation uncovered a scheme to sell free-to-air satellite TV receiver boxes which would illegally decrypt Dish Network/Nagrastar signals and provide them free to the free-to-air receiver box purchasers The main defendant hired computer hackers to break the encryption algorithm that Dish Network/Nagrastar used (know as Nagra 3) for placement into his free-to-air boxes His co-conspirators received over $650,000 in payments from the main subject for their part in recruiting and trying to crack the encryption Dish Network estimated its losses would have been more than $100 million if the subjects had succeeded in breaking the encryption The three defendants pled guilty to conspiracy to violate the Digital Millennium Copyright Act In January 2010, the main subject was sentenced to 18 months in custody followed by three years supervised release The two co-defendants were sentenced to one month in custody and five months of house arrest [FBI].
• In February 2010, DOJ filed a second brief in connection with the proposed class action settle- ment in the Google Books matter (The Authors Guild Inc. et al. v. Google (S D N Y ) DOJ submitted its views on the proposed settlement, indicating that the settlement raised class certification, copyright and antitrust concerns.
• In May 2010, two defendants were sentenced, respectively, to 10 years and one month in prison and seven years and 10 months in prison for roles in operating a major Internet-based DVD importation and distribution business as well as fraudulent receipt of government benefits The defendants imported counterfeit DVDs in bulk from suppliers in the Philippines by means of false Customs declarations and sold them through websites [FBI, USPIS and CBP].
• In May 2010, a man pleaded guilty to selling counterfeit cancer drugs using the Internet The defendant admitted selling what he falsely claimed was the experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the U S , Canada, the United Kingdom, Belgium and the Netherlands The defendant admitted that, in actuality, he sent vic- tims a white powdery substance that was later determined through laboratory tests to contain starch, dextrin, dextrose or lactose, and contained no DCA According to court documents, along with the counterfeit DCA, the packages also contained a fraudulent certificate of analysis from a fictitious laboratory and instructions on how to dilute and ingest the bogus DCA DCA is an experimental cancer drug that has not yet been approved by the FDA for use in the U S [FBI].
