Survey of Recent Anti-Counterfeiting Initiatives and Legislation
Peter Maybarduk, Essential Action
September 12, 2008
International
 International Initiatives
o IMPACT (WHO’s International Medical Products Anti-Counterfeiting
Task Force)
o INTERPOL: New counterfeit medicines collaboration
o Pharmaceutical Security Institute (PSI): Collecting, controlling
counterfeiting data
o World Customs Organization: “SECURE”
o U.S.-E.U. Summit: IP enforcement cooperation
o OECD (Organization for Economic Co-operation and Development):
Preparing a report
o Security and Prosperity Partnership (SPP) of North America: Cooperation
for IP enforcement
o Asia-Pacific Economic Cooperation forum (APEC): Anti-Counterfeiting
and Piracy Initiative
o Universal Postal Union: Proposals discussed to protect IP
o U.S. enforcement action against China at WTO
 Accords and Associations
o
o
o
o
o
ACTA leaked proposal
G8 Declaration
Global Congress Combating Counterfeiting and Piracy
Visiongain Conference (IFPMA)
The Internet Treaties: WIPO Copyright Treaty and WIPO Performance
and Phonograms Treaty
o Declaration of Rome
United States
 U.S. Initiatives
o U.S. Chamber of Commerce / Coalition Against Counterfeiting and Piracy
(CACP) “Campaign to Protect America”
o National Intellectual Property Rights Coordination Center
o Food and Drug Administration & Department of Justice: Enforcement
cooperation
o STOP! Initiative
o U.S. Coordinator for International Intellectual Property Enforcement
o Global Intellectual Property Academy
1
o Global Intellectual Property Center (U.S. Chamber)
 U.S. Laws
o Prescription Drug Marketing Act (PDMA) of 1987
o Recent laws supported by Bush Administration
 “Stop Counterfeiting in Manufactured Goods Act (SCMGA), H.R.
32 (March 2006)
 Family Entertainment and Copyright Act, S. 167 (April 2005)
 Anti-Counterfeiting Amendments of 2004, H.R. 3632 (December
2005)
 Intellectual Property Protection Act of 2005
 Proposed (Introduced) Legislation
o H.R. 4076 – Tim Fagan’s Law / Counterfeit Drug Enforcement Act of
2007
o S. 3325 – Enforcement of Intellectual Property Rights Act of 2008
o H.R. 4279 – Prioritizing Resources and Organization for Intellectual
Property Act (PRO-IP) 2008
o H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008
o Intellectual Property Rights Enforcement Act (Introduced in Senate as
S.522.IS, in House as H.R.3578.IH)
o H.R. 780 - Counterfeit Drug Prevention Act of 2007 (Introduced in
House)
o H.R.1218.IH – Medicare Prescription Drug Improvement Act
[Counterfeit-resistant packaging requirements]
Europe







Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on
criminal measures aimed at ensuring the enforcement of intellectual property
rights
Council Resolution of 13 March 2006 on a customs response to latest trends in
counterfeiting and piracy21
Directive 2004/48/EC of the European Parliament and of the Council of 29 April
2004 on the enforcement of intellectual property rights
The European Parliament legislative resolution of 25 April 2007 on the draft of
the Directive on criminal measures amended and clarified various provisions of
the Directive
The EU Strategy for the Enforcement of Intellectual Property Rights in Third
Countries, prepared by Directorate General Trade of the European Commission
European Alliance for Access to Safe Medicines
European Council Regulation (EC) No. 1383/2003
Other


Kenya: Anti-Counterfeit Bill 2007
Canadian Intellectual Property and Trade Advisory Group
2
International
International Initiatives
IMPACT (WHO’s International Medical Products Anti-Counterfeiting Task Force)
In 2006 the World Health Organization convened an International Conference on
Combating Counterfeit Medicines, yielding the Declaration of Rome and IMPACT, the
International Medical Products Anti-Counterfeiting Task Force.
WHO IMPACT emphasizes the need for a coordinated global response to international
counterfeit trafficking. We can expect international anticounterfeiting measures to
strengthen in coming years.
IMPACT also cites trouble with Free Trade Zones. “Drugs are also traded through freetrade zones/free ports where control is lax or absent. In such places drug products are
sometimes relabeled in order to hide their true source and identity.”
INTERPOL: New counterfeit medicines collaboration
“The international police agency Interpol later this year plans to join the fight to stop the
growing trade of counterfeit antiretroviral, tuberculosis and malaria drugs in Africa, John
Newton, manager of Interpol's intellectual property rights project, said Tuesday at the
agency's 76th General Assembly in Marrakech, Morocco, AFP/Yahoo! Health reports.1
“Representatives from Congo, Nigeria, Senegal and Sudan asked the 186-member police
body at the assembly for assistance in preventing smuggling networks from making
counterfeit drugs available in their markets and pharmacies, Newton said. Interpol plans
to train police in African countries on how to eliminate counterfeit drug smuggling
networks, coordinate police operations and track the trade of fake medicines from other
parts of the world to the continent. Interpol also will collaborate with the World Health
Organization and pharmaceutical companies to address the problem, Newton said.”
Pharmaceutical Security Institute (PSI): Collecting, controlling counterfeiting data
1
http://www.medicalnewstoday.com/articles/88254.php
3
14 major pharmaceutical companies formed the Pharmaceutical Security Institute (PSI) in
2002 to “collate their fake drug information to cooperate in fighting the racket.”2 The
Director General of the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) serves as PSI’s President.3 PSI has since grown to 21 member
companies, with offices in Washington, D.C. and London. PSI also runs a coalition
website for reporting counterfeits, safemedicine.org, through which subscribers can even
receive counterfeit warnings in the form of email updates “for your family.”
Although pharmaceutical companies depend on law enforcement and public resources to
locate counterfeits and maintain consumer confidence in their brands, companies do not
always disclose what they know about counterfeits in the market.4 PSI recorded 76 cases
of counterfeiting in 2004, the FDA only knew of 58.5 Though considered the world’s
best, PSI’s database “is not accessible to the WHO, health authorities or the public.”6
Industry seems to favor general public awareness of the counterfeiting problem, which
may lead to enforcement assistance, but sometimes disfavors public knowledge of
specific counterfeited drugs, which could undermine confidence in industry products.
World Customs Organization: “SECURE”
The proposed Standards to be Employed by Customs for Uniform Rights Enforcement
(SECURE) would coordinate a “global effort to suppress all kind of intellectual property
rights infringements.”7 They have been called “TRIPS-plus-plus” and, among other
things, would extend customs authority to levy penalties for any class of IP infringement,
not only trademark and copyright. Several countries filed a protest to the exclusive
manner in which the standards were drafted at the WCO meeting in June. The standards
are voluntary, but wealthy countries are using WCO as a platform for their wider
acceptance, and Susan Sell expects to see SECURE provisions in forthcoming trade and
investment agreements.8
“The global threat of counterfeit drugs: why industry and governments must communicate the dangers.”
Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White, PLoS
Medicine, April 2005, Volume 2, Issue 4.
2
3
The International Federation of Pharmaceutical Manufacturers and Associations comprises organizations
and research-based companies in 60 countries.
4
Despite warning and reporting resources like safemedicines.org.
5
BUKO at 5.
6
PLoS.
7
http://www.ip-watch.org/weblog/index.php?p=1117
8
www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf
4
U.S.-E.U. Summit
IP-Watch has cited the U.S.-E.U. Summit as a precursor to ACTA.9 At the 2005 United
States–European Union Summit in Washington, D.C., the U.S. and E.U. “committed to
working effectively to combat piracy and counterfeiting at home and abroad.”10 It
appears counterfeiting has remained an agenda item at Summits since.
According to STOP: “In January 2006, the Administration first met with European Union
officials at the White House for a series of meetings to address global piracy. Subsequent
rounds of the U.S.-EU Intellectual Property Working Group meetings have followed, the
next of which is in September 2007. We are breaking new ground and have begun to
expand our cooperation with the EU—focused initially on border enforcement; strategy
development to address problems in third countries; international cooperation; and
increased collaboration with the private sector.”
Specifically, the 2005 Summit charged the parties to:
1. Promote Strong and Effective Enforcement Internally and at our Borders.
o Promote and uphold laws, regulations and/or procedures which provide, where
appropriate, for:
+ Customs authority to retain or suspend the release of suspected goods without
the need for a formal complaint from a private party or right holder;
+ Strong deterrence against piracy and counterfeiting;
+ Judicial authority to seize suspected infringing goods;
+ Disposal and destruction, where appropriate, of pirated and counterfeit goods
and equipment and materials used to produce such goods; and
+ Predictable and clear judicial proceedings and transparent policies and
guidelines related to intellectual property enforcement; and
o Publish information related to our respective intellectual property enforcement
actions, including relevant statistical information.
2. Strengthen Cooperation to Reduce Global Piracy and Counterfeiting.
o Include effective intellectual property rights protection and enforcement rules in
our regional and bilateral agreements;
o Send a clear and consistent message to priority countries on the importance of
effectively enforcing global intellectual property rules, and work together with those
countries to secure commitments and implement actions to reduce piracy and
counterfeiting levels, including through bilateral consultations;
o Make intellectual property rights enforcement a key focus of our trade capacity
building technical assistance to third countries, and improve coordination of our
9
http://www.ip-watch.org/weblog/index.php?p=799
10
http://www.whitehouse.gov/news/releases/2005/06/20050620-6.html
5
respective efforts in this area with a view to avoiding duplication, and to exchanging best
practices and lessons learned; and
o Establish informal mechanisms for IPR, customs, and law enforcement experts to
exchange views on best practices in addressing piracy and counterfeit problems in third
countries.
3. Foster Public-Private Partnerships to Protect Intellectual Property.
o Work with our respective private sectors to exchange information on the risks of
global piracy and counterfeiting and best practices to secure and enforce their rights at
home and abroad;
o Encourage our private sectors to take an active part in the fight against global
piracy and counterfeiting and assist competent enforcement authorities as well as the
WTO and WIPO in promoting the observation of international commitments in the field
of intellectual property; and
o Promote the establishment and support the efforts of networks, associations and
organizations of intellectual property rights holders in third countries.
A recent example of joint enforcement operations is Operation Infrastructure (2007) in
which authorities seized 360,000 counterfeit integrated circuits.
OECD (Organization for Economic Co-operation and Development): Preparing a
report
“Responding to concerns in governments and the business community, the OECD
launched a project in 2005 to assess the magnitude and impact of counterfeiting and
piracy. The objective of the project is to improve factual understanding and awareness of
how large the problem is and the effects that infringements of intellectual property rights
have on governments, business and consumers in member countries and non-member
economies.”11
[My understanding is the concerns came mostly from the U.S. executive.]
Security and Prosperity Partnership (SPP) of North America: Cooperation for IP
enforcement
“The Security and Prosperity Partnership of North America (SPP) was launched in March
of 2005 as a trilateral effort to increase security and enhance prosperity among the United
States, Canada and Mexico through greater cooperation and information sharing… The
SPP builds upon, but is separate from, our long-standing trade and economic
11
http://www.oecd.org/document/50/0,3343,en_2649_34173_39542514_1_1_1_1,00.html
6
relationships. It energizes other aspects of our cooperative relations, such as the
protection of our environment, our food supply, and our public health.”12
According to the SPP Intellectual Property Action Strategy:13
The overall goal of the Security and Prosperity Partnership’s Intellectual Property (IP)
dialogue is for Canada, Mexico and the United States to agree on a work plan that will
constitute a strategy for combating piracy and counterfeiting, in order to contribute to the
overall objective of Promoting Growth, Competitiveness, and Quality of Life. As part of
the “Fake Free North America” initiative, our governments have identified three key
areas of cooperative effort to improve IP protection and enforcement: Detect and Deter
Trade in Pirated and Counterfeit Goods; Public Awareness and Outreach to Our Business
Communities; and Measuring Piracy and Counterfeiting. Industry representatives from
the three countries have committed to concrete actions to support the implementation of
this Strategy. Each element includes goals and specific recommendations for trilateral
public-private cooperation selected to achieve the stated goal.
Detect and Deter Trade in Pirated and Counterfeit Goods. This element focuses on
developing best practices for overall enforcement, creating enforcement networks to
enhance information sharing and enforcement operations, and improving border
enforcement. Through enhanced cooperation in these areas, our goals are to reduce the
movement of pirated and counterfeit goods into and between Canada, Mexico and the
United States and develop a network of enforcement professionals to collaborate on
transnational IP crime.
Public Awareness and Outreach to Our Business Communities. In this element, our goal
is to encourage the private sector to take a greater role in preventing IP infringement and
assisting enforcement actions by building private sector awareness of the enforcement
systems in Canada, Mexico and the United States. We are also committed to working
with the private sector to develop an initiative to reduce demand for pirated and
counterfeit goods through IP public awareness campaigns for the public and other
relevant constituencies.
Measuring Piracy and Counterfeiting. In this element, the governments agree to facilitate
the ongoing OECD Counterfeiting Study, develop measurements to assess progress, and
refine and apply the results in developing domestic and regional enforcement strategies in
North America, including targeting specific high-risk product sectors.
Asia-Pacific Economic Cooperation forum (APEC): Anti-Counterfeiting and Piracy
Initiative
In 2005, APEC endorsed an Anti-Counterfeiting and Piracy Initiative14 with stated goals
to reduce trade in counterfeit goods and online piracy, and to increase cooperation
12
http://www.spp.gov/
13
www.spp.gov/pdf/spp_ip_strat_final.pdf
7
between governments and with the private sector. Endorsed programs include public
awareness campaigns and training seminars on “the importance of IPR protection and
enforcement,” developing model regional guidelines to control trade in counterfeits,
developing model WIPO/Berne-compliant guidelines against unauthorized copying and
pulling together a regional contact list of anti-counterfeiting law enforcement officials,
among others.
Universal Postal Union: Proposals discussed to protect IP
Development: UN postal agency being roped in to enforce IPR agenda
Published in SUNS #6534 dated 8 August 2008
The 24th Universal Postal Congress (UPC) is meeting in Geneva from 23 July
to 12 August 2008. The UPC is the supreme authority of the Universal Postal
Union.
A Committee of the UPC, on 1 August, discussed the issue of counterfeit and
pirated items sent through the post. Three proposals on this topic were
made, and two of them were adopted by vote.
The proposals discussed were: (1) a Resolution 40 on "Counterfeit and pirated items sent
through the post"; (2) an amendment to the UPU Convention on the list of articles
prohibited through the post; and (3) an amendment to the Convention on sender's
liability.
The discussions on the proposals showed that many countries, including some
developed countries, were concerned that the postal services at national
level were being roped in to fight against counterfeit products when they
did not have the legal and other expertise or the scope to deal with this,
including on determining whether a product is counterfeit or violates
intellectual property laws.
Despite concerns raised by many countries, two of the proposals were
adopted, because the UPU Committee makes decisions based on a vote (after
discussions that are brief and limited, compared to the length of
discussions allowed in other UN organizations), rather than by consensus (as
is the case in most other UN organizations).
U.S. enforcement action against China at WTO
14
Proposal available at: www.mofa.go.jp/policy/economy/apec/2005/initiative-1.pdf. Proposal
subsequently endorsed, see:
http://www.apec.org/apec/ministerial_statements/sectoral_ministerial/trade/2005_trade.html
8
In September 2007 the WTO agreed to “formally examine a US complaint about
shortcomings in China's intellectual property protection…the World Trade Organisation's
dispute settlement body set up a panel to rule on the dispute…”15
International Accords & Associations
ACTA leaked proposal
Wikileaks: “A “Discussion Paper on a Possible Anti-Counterfeiting Trade Agreement”
was reportedly provided to select lobbyists in the intellectual property industry, but not to
public interest organizations concerned with the subject matter of the proposed treaty.”16
According to the leaked document, the objective of ACTA is to “Establish, among
nations committed to strong IPR protection, a common standard for IPR enforcement to
combat global infringements of IPR particularly in the context of counterfeiting and
piracy.” Provisions are organized into three categories: International Cooperation,
Enforcement Practices, and Legal Framework. The leaked document seems to support
the interpretation that ACTA is simply, and nearly exclusively, an IP enforcement treaty.
G8 Declaration
At its June 2007 summit in Germany, the G8 published a final declaration on “Growth
and Responsibility in the World Economy.”17 The 38-page document elevates innovation
through intellectual property rights to one of four principle pillars of global economic
growth, in the exclusive company of competition, open markets and freedom of
investment. Paramount, in the G8’s judgment, to protecting this system of innovation is
combating piracy and counterfeiting. The document broadly supports the International
Medicinal Products Anti-Counterfeit Taskforce (IMPACT) and a Declaration of the
business communities of all G8 countries on “Strategies of G8 Industry and Business to
Promote Intellectual Property Protection and to Prevent Counterfeiting and Piracy.”
More specifically, the G8 calls for technical assistance pilot programs to developing
countries and for a new dialogue on intellectual property protection through the
Organisation of Economic Cooperation and Development (OECD).
Global Congress Combating Counterfeiting and Piracy
15
http://afp.google.com/article/ALeqM5hASBbePC8gtbmtfzExtmfkdNDvKQ
16
http://wikileaks.org/wiki/G-8_plurilateral_intellectual_property_trade_agreement_discussion_paper
17
Available at http://online.wsj.com/public/resources/documents/climate-g8.pdf.
9
This year marked the 4th Global Congress Combating Counterfeiting and Piracy.
It was “convened by the International Criminal Police Organization (INTERPOL)
and the World Intellectual Property Organization (WIPO) with the cooperation of
the world’s business community, represented by the International Chamber of
Commerce (ICC) through its Business Action to Stop Counterfeiting and Piracy
(BASCAP) initiative, the International Trademark Association (INTA) and the
International Security Management Association (ISMA).” 18
Visiongain Conference (IFPMA)
“Visiongain is an independent business information provider for the Telecoms,
Pharmaceutical and Defence industries. We organise conferences, publish reports and
newsletters, and provide consultancy services.”19
“Visiongain's third annual conference on Pharmaceutical Anti-counterfeiting Strategies
kicks off [in July], covering many aspects of the problem from technological deterrents,
regulatory developments in the EU and US and the implications for parallel trade.”
Chaired by Eric Noehrenberg of IFPMA.
The Internet Treaties: WIPO Copyright Treaty and WIPO Performance and
Phonograms Treaty
According to Susan Sell, it remains a goal of “IP maximalists” to get all countries to sign
on to both.
Declaration of Rome20
Participants of the WHO International Conference on Combating
Counterfeit Drugs: Building Effective International Collaboration,
gathered in Rome on 18 February 2006, DECLARE
18
http://www.ccapcongress.net/
19
http://www.visiongain.com/content.aspx?p=3
20
Available at:
http://www.who.int/entity/medicines/areas/quality_safety/regulation_legislation/ic
dra/counterfeitmeds.pdf
10
[Among other things, Calls counterfeiting medicines a “vile and serious criminal
offence” and says WHO should lead establishment of International Medical
Products Anti-Counterfeiting Taskforce (IMPACT)]
United States
U.S. Initiatives
U.S. Chamber of Commerce / Coalition Against Counterfeiting and Piracy (CACP)
“Campaign to Protect America”
On June 14th 2007, the Coalition Against Counterfeiting and Piracy (CACP), made up of
the National Association of Manufacturers, the Recording Industry of America, the
Motion Picture Association and PHrMA, announced an “aggressive campaign” to
persuade the U.S. government to crack down on counterfeiters. Supported by the U.S.
Chamber of Commerce, CACP seeks:21
 Designation of an IP enforcement czar at the White House (a proposal which has
passed the House in H.R. 4279, see below),
 To give Customs and Border Protection agents more legal authority “to audit and
assess fines for importers, exporters, or other parties that materially facilitate the
unlawful entry of counterfeit and pirated goods in to the U.S.”
 Increased funding for law enforcement and enhanced penalties for counterfeiters
who cause bodily injury or death
 Funding for technical assistance to train governments in IP enforcement and
establishing IP attaches at American Embassies,
 To establish a pilot program for judges to handle counterfeiting and piracy cases
 To fund a public awareness campaign, including media ads, and also to direct
funding agencies to favor those campuses that have the most stringent anti-piracy
practices
National Intellectual Property Rights Coordination Center
July 2008 – “WASHINGTON, DC - The US Department of Homeland Security
announced in a press release the opening of a new high-tech National Intellectual
Property Rights Coordination Center (IPR Center) in Northern Virginia that will help
“The Global IP Upward Ratchet, Anti-Counterfeiting and Piracy Enforcement Efforts: The State of
Play,” Susan K. Sell, George Washington University, available at: www.iqsensato.org/wpcontent/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf
21
11
maximize member agencies' authorities and resources to counter the global threat of IPR
violations.”22
“The Department of Homeland Security’s Immigration and Customs Enforcement (ICE) and the
Department of Justice’s Federal Bureau of Investigation (FBI)—two of the lead investigative
agencies in the fight against both domestic and international IPR crime—jointly run the National
IPR Coordination Center. The Center identifies and addresses developing IPR issues and trends
and advances that information through outreach and training with foreign governments.
Additionally, ICE agents from the IPR Coordination Center have shared best practices and
provided IPR training to foreign government and law enforcement officials at the International
Law Enforcement Academies (ILEA) in Bangkok, Lima, El Salvador, and Botswana, for
example.”
Food and Drug Administration & Department of Justice: Enforcement cooperation
The Food and Drug Administration authored “Combating Counterfeit Drugs,”23 which
recommends adopting product tracking technologies, stronger laws and penalties, and
better reporting practices (but does not advocate mandatory disclosure for PHrMA).
The Department of Justice and FDA now collaborate in counterfeit enforcement. In
2006, Congress adjusted the trademark laws to make prosecuting drug counterfeiters
easier. The new laws mandate prison sentences up to ten years for counterfeiting,
whereas the Cosmetic Act previously mandated only three. The FDA also plans to create
(or has created) a Counterfeit Alert Network, “that links together and enhances existing
counterfeit notification systems[.]”24
STOP! Initiative
25
STOP! [the Strategy for Targeting Organized Piracy] is led by the White House and brings
together the Department of Commerce, the Department of Justice, the Department of Homeland
Security, the Food and Drug Administration, the State Department, and the Office of the U.S.
Trade Representative.
The express purpose of STOP! is to protect intellectual property rights. Programs include
increasing the number of American Embassies with IP attaches. Some significant programs by
22
http://www.ag-ip-news.com/getArticle.asp?Art_ID=6099&lang=en
“Combating Counterfeit Drugs: A Report of the Food and Drug Administration,” February 2004,
available at www.fda.gov/oc/initiatives/counterfeit/report02_04.html.
23
“Combating Counterfeit Drugs: A Report of the Food and Drug Administration,” February 2004,
available at www.fda.gov/oc/initiatives/counterfeit/report02_04.html.
24
http://www.stopfakes.gov/. See “Bush Administration Strategy for Targeting Organized Piracy
Accomplishments and Initiatives
25
12
department include:
Department of Justice: as part of the STOP! Initiative, the Attorney General formed an
Intellectual Property Task Force to examine how it could maximize its efforts to protect
intellectual property rights through two primary programs, the Computer Crimes and Intellectual
Property Section (CCIPS) and Computer Hacking and IP (CHIP) Units, in addition to the work of
the FBI…. In January 2006, the Justice Department deployed an IP Law Enforcement
Coordinator (IPLEC) for Asia, stationed in Bangkok, Thailand….
DOJ has convened three Victim Industry Conferences. Most recently, on May 22, 2007, DOJ cosponsored a victim industry conference in Silicon Valley with the Business Software Alliance and
the regional computer crime task force (REACT). The one-day conference included more than
80 representatives of industries directly affected by intellectual property crime, particularly
software and film companies harmed by copyright piracy.
Customs and Border Protection: CBP added a new enforcement tool to complement traditional
physical examination of goods at the border with post-entry verifications (IPR audits). CBP now
issues penalties on imports of fakes uncovered during IPR audits…
U.S. Coordinator for International Intellectual Property Enforcement
June 5, 2008: “The President intends to appoint Wayne B. Paugh, of Virginia, to be
Coordinator for International Intellectual Property Enforcement at the Department of
Commerce.”26
“As Coordinator, Paugh will work with agencies across the
Administration to coordinate policies and programs to enforce intellectual property rights
overseas through both the Administration’s STOP! Initiative, the Strategy Targeting
Organized Piracy, and the National Intellectual Property Law Enforcement Coordination
Council.”27
Global Intellectual Property Academy
A name given to the United States’ international training programs for judges,
administrators, and enforcement officials in intellectual property protection, which the
U.S. intends to expand.
Global Intellectual Property Center (U.S. Chamber)
U.S. Chamber Launches Global Intellectual Property Center
Counterfeiting and Piracy Seen as Increasing Threat
26
http://www.whitehouse.gov/news/releases/2008/06/20080605-11.html
27
http://www.stopfakes.gov/
13
WASHINGTON, D.C.--U.S. Chamber President and CEO Tom Donohue
Today announced the formation of the Global Intellectual Property (IP) Center at the
Chamber's 4th Annual Anti-Counterfeiting and Piracy Summit. The center will build
upon existing efforts and is dedicated to protecting and defending intellectual property
and innovation around the globe.
"The intellectual property of our key industries is under assault around the globe and we
believe that IP protection is among a handful of issues that will determine America's
competitiveness in the 21st century," said Tom Donohue. "If we lose our ability to create,
innovate, and generate the best artistic, technological, and knowledge-based IP, then our
economic formula for success in the global economy will fail."
Among the center's top priorities will be to (1) demonstrate to global policymakers that
the failure to protect IP undermines innovation and investment, erodes living standards,
and endangers public health; (2) conduct a sustained, comprehensive communications
campaign to convince lawmakers to strengthen IP protection; and (3) build a coalition of
IP advocates around the world.
U.S. Laws (in effect)
Prescription Drug Marketing Act (PDMA) of 1987
The FDA may soon begin (if it has not already) to enforce the Prescription Drug
Marketing Act (PDMA) of 1987, after many years developing implementation rules. The
resultant pedigree requirement may blend paper records and track and trace technologies
to verify the history of drug shipments. In 2000, Public Citizen commented that the
PDMA only required unauthorized distributors to provide a paper trail, whereas all
distributors should have been required to do so. I am not sure where this matter stands
now, but it seems the practice of repackaging parallel drug imports – which industry
groups argue creates opportunity to introduce counterfeits in international trade – would
support a broad pedigree requirement.
Recent laws supported by Bush Administration
“The Bush Administration has worked with Congress to strengthen laws and penalties
related to intellectual property rights enforcement, including the:28
“Stop Counterfeiting in Manufactured Goods Act (SCMGA), H.R. 32 (March 2006)
28
Stopfakes.gov. See “Strategy for Targeting Organized Piracy: Accomplishments and Initiatives.”
14

Prohibits the trafficking of counterfeit labels, emblems, containers or similar
labeling components that may be used to facilitate counterfeiting; provides for
forfeiture of articles bearing or consisting of a counterfeit mark and proceeds of
any property derived from proceeds of, or used in the commission of, a violation;
expands the definition of "trafficking" for certain counterfeiting crimes and
clarifying that trafficking in counterfeit goods or labels includes possession with
intent to traffic in such items.
• Family Entertainment and Copyright Act, S. 167 (April 2005)
 Outlaws cam cording in movie theaters and provides a new 3-year felony for the
distribution of a pre-release work by making it available on a publicly-accessible
computer network. Recognizes the premium value of copyrighted works before
they are released to the public.
• Anti-Counterfeiting Amendments of 2004, H.R. 3632 (December 2005)
 Allows law enforcement officials to seize material and equipment used to make
counterfeit products and labels.
 [This became the Intellectual Property Protection and Courts Amendments Act of
2004, and is now Public Law No. 108-482.]
• Intellectual Property Protection Act of 2005
 The Department of Justice transmitted to Congress the Administration’s proposed
legislation entitled the “Intellectual Property Protection Act of 2005,” a
comprehensive reform package that would toughen penalties for intellectual
property crimes, expand criminal intellectual property protections, and add
investigative tools for criminal and civil intellectual property rights enforcement.
Portions of this bill were incorporated into the SCMGA.”
Proposed (introduced) legislation (Summaries and status from THOMAS)
H.R. 4076 – Tim Fagan’s Law / Counterfeit Drug Enforcement Act of 2007
Congressman Steve Israel of New York’s second district has introduced legislation,
called Tim Fagan’s law, to enact stricter penalties against counterfeiters and require
pharmaceutical companies to disclose knowledge of counterfeits of their products in the
market.
Introduced in 110th Congress, 1st session, Nov. 5th 2007 by Steve Israel.
Latest Congressional action: Referred to the Committee on Energy and Commerce, Nov.
5 2007.
“H.R. 4076. To amend the Federal Food, Drug, and Cosmetic Act to increase criminal
penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or
misbranded, to modify requirements for maintaining records of the chain-of-custody of
prescription drugs, to establish recall authority regarding drugs, and for other purposes.”
15
S. 3325 – Enforcement of Intellectual Property Rights Act of 2008
Title: A bill to enhance remedies for violations of intellectual property laws, and for other
purposes.
Sponsor: Sen Leahy, Patrick J. [VT] (introduced 7/24/2008) Cosponsors (7)
Latest major action: 7/24/2008 Referred to Senate committee. Status: Read twice and
referred to the Committee on the Judiciary. (text of measure as introduced: CR S72817286)
[Abridged contents:]
TITLE I--AUTHORIZATION OF CIVIL COPYRIGHT ENFORCEMENT BY
ATTORNEY GENERAL
TITLE II--ENHANCEMENTS TO CIVIL INTELLECTUAL PROPERTY LAWS
TITLE III--ENHANCEMENTS TO CRIMINAL INTELLECTUAL PROPERTY LAWS
TITLE IV--COORDINATION AND STRATEGIC PLANNING OF FEDERAL
EFFORT AGAINST COUNTERFEITING AND PIRACY
SEC. 401. INTELLECTUAL PROPERTY ENFORCEMENT COORDINATOR.
TITLE V--DEPARTMENT OF JUSTICE PROGRAMS
SEC. 501. LOCAL LAW ENFORCEMENT GRANTS.
SEC. 502. IMPROVED INVESTIGATIVE AND FORENSIC RESOURCES FOR
ENFORCEMENT OF LAWS RELATED TO INTELLECTUAL PROPERTY CRIMES.
H.R. 4279 – Prioritizing Resources and Organization for Intellectual Property Act
(PRO-IP) 2008
Title: To enhance remedies for violations of intellectual property laws, and for other
purposes.
Sponsor: Rep Conyers, John, Jr.
Major Congressional actions:
12/5/2007
Introduced in House
5/5/2008
Reported (Amended) by the Committee on Judiciary. H. Rept. 110-617.
5/8/2008
Passed/agreed to in House: On motion to suspend the rules and pass the
bill, as amended Agreed to by recorded vote (2/3 required): 410 - 11 (Roll no. 300).
5/12/2008
Referred to Senate committee: Received in the Senate and Read twice and
referred to the Committee on the Judiciary.
[Abridged contents:]
16
TITLE I--ENHANCEMENTS TO CIVIL INTELLECTUAL PROPERTY LAWS
SEC. 104. TREBLE DAMAGES IN COUNTERFEITING CASES.
TITLE III--COORDINATION AND STRATEGIC PLANNING OF FEDERAL
EFFORT AGAINST COUNTERFEITING AND PIRACY
Subtitle A--Office of the United States Intellectual Property Enforcement Representative
SEC. 301. OFFICE OF THE UNITED STATES INTELLECTUAL PROPERTY
ENFORCEMENT REPRESENTATIVE.
[From Rohit at Oxfam:]
During a trip to DC this week I held a meeting with a House Judiciary Staffer (Christal
Sheppard) - who has been shepherding through a new bill that would introduce a cabinet
level position to improve enforcement of IP. The bill is primarily concerned with
counterfeiting, copyright and trademark infringement, but the structure the bill creates
a separate cabinet position for IP, IP coordinators, IP attaches in embassies, consultation
with the private sector, technical assistance etc - it is a gift to the pharmaceutical
industry/seed industry etc to use this new 'creation' to push for stricter IP in upcoming
years.
Intellectual Property Watch
10 December 2007
US Lawmakers Seek IP Enforcement Agency; Satellite Radio Royalties Set29
By Dugie Standeford for Intellectual Property Watch
A bipartisan group of US legislators is calling for tougher civil and criminal penalties for
copyright and trademark infringement through new legislation introduced last week.
Meanwhile, the US Library of Congress Copyright Royalty Board (CRB) has set
royalties for satellite radio services, as webcast radio companies lobbied for rate parity.
The "Prioritising Resources and Organisation for Intellectual Property Act of 2007 (PRO
IP)," introduced 5 December, would create an IP enforcement czar, establish a new IP
division in the Department of Justice, and authorise the appointment of IP officers to help
foreign countries combat piracy and counterfeiting.
H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008
Title: To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of
drugs.
Sponsor: Rep Buyer, Steve [IN-4] (introduced 4/17/2008) Cosponsors (11)
Congressional action:
29
http://www.ip-watch.org/weblog/index.php?p=863
17
4/17/2008:
Referred to the House Committee on Energy and Commerce.
4/17/2008:
Referred to the Subcommittee on Health.
[Abridged contents:]
Sec. 2. Table of contents.
Sec. 3. Destruction of counterfeit drugs offered for import.
Sec. 4. Interim provisions to assure the safety of the wholesale distribution of
prescription drugs.
Sec. 5. Unique standardized numerical identifiers for each prescription drug.
Sec. 6. Prescription drug identification and tracking system.
Sec. 7. Facilitating prescription drug identification and tracking system for small
pharmacies.
Sec. 8. Uniform national standards.
Sec. 9. Report to Congress.
Sec. 10. Requirements for licensure of wholesale distributors.
Sec. 11. Injunctions; civil penalties.
Sec. 12. State enforcement of Federal requirements.
Sec. 13. Study on threats to domestic prescription drug supply chain.
Intellectual Property Rights Enforcement Act (Introduced in Senate as S.522.IS, in
House as H.R.3578.IH)
Title: To safeguard the economic health of the United States and the health and safety of
United States citizens by improving the management, coordination, and effectiveness of
domestic and international intellectual property rights enforcement, and for other
purposes.
House:
Sponsor: Rep Sherman, Brad [CA-27] (introduced 9/18/2007) Cosponsors (9)
Latest Major Action: 10/12/2007 Referred to House subcommittee.
Status: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Senate: Sponsor: Sen Bayh, Evan [IN] (introduced 2/7/2007) Cosponsors (13)
Related Bills: H.R.3578
Latest Major Action: 11/7/2007 Senate committee/subcommittee actions. Status:
Committee on the Judiciary. Hearings held.
[Abridged contents:]
SEC. 3. NATIONAL INTELLECTUAL PROPERTY LAW ENFORCEMENT
COORDINATION COUNCIL REPEAL.
Section 653 of the Treasury and General Government Appropriations Act, 2000 (15
U.S.C. 1128) is repealed.
18
SEC. 4. THE INTELLECTUAL PROPERTY ENFORCEMENT NETWORK.
(a) Establishment(1) IN GENERAL- There is established the Intellectual Property Enforcement
Network (in this section referred to as the `IPEN').
(2) MEMBERSHIP- The IPEN shall consist of the following officials or their
designees:
(A) The Deputy Director for Management of the Office of Management and
Budget, who shall serve as the chairperson of the IPEN.
(B) The Coordinator for Intellectual Property Enforcement, described in
subsection (b)(2)(A), who shall serve as vice chairperson of the IPEN.
(C) The Deputy Attorney General.
(D) The Deputy Secretary for Homeland Security.
(E) The Deputy Secretary of the Treasury.
(F) The Deputy Secretary of Commerce.
(G) The Deputy Secretary of State.
(H) A Deputy United States Trade Representative, as determined by the
United States Trade Representative.
(c) Duties- The IPEN, established under subsection (a), shall be responsible for the
following:
(2) Establishing policies, objectives, and priorities concerning international
intellectual property protection and intellectual property law enforcement. The policies,
objectives, and priorities shall include—
(E) strengthening the capacity of other countries to protect and enforce
intellectual property rights and reducing the number of countries that fail to
enforce laws that prevent the financing, production, trafficking, and sale of
counterfeit and pirated goods; and
H.R. 780 - Counterfeit Drug Prevention Act of 2007 (Introduced in House)
Title: To amend the Federal Food, Drug, and Cosmetic Act with respect to counterfeit
drugs, and for other purposes.
Sponsor: Rep Rogers, Mike J. [MI-8] (introduced 1/31/2007)
Cosponsors (9)
Latest Major Action: 3/1/2007 Referred to House subcommittee. Status: Referred to the
Subcommittee on Crime, Terrorism, and Homeland Security.
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to counterfeit drugs,
and for other purposes.
SEC. 2. PENALTIES REGARDING COUNTERFEIT DRUGS.
19
Section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) is
amended by adding at the end the following paragraph:
`(3) Notwithstanding paragraph (1) or (2), any person who engages in any conduct
described in section 301(i)(2) knowing that the conduct concerns the rendering of a drug
as a counterfeit drug, or who engages in conduct described in section 301(i)(3) knowing
that the conduct will cause a drug to be a counterfeit drug or knowing that a drug held,
sold, or dispensed is a counterfeit drug, shall be fined in accordance with title 18, United
States Code, or imprisoned not more than 20 years, or both, except that if the use of the
counterfeit drug by a consumer is the proximate cause of the death of the consumer, the
term of imprisonment shall be any term of years or for life.'.
SEC. 3. OTHER CRIMINAL PENALTIES; CLARIFICATION REGARDING FINES.
H.R.1218.IH – Medicare Prescription Drug Improvement Act [Counterfeit-resistant
packaging requirements]
Title: To amend part D of title XVIII of the Social Security Act to authorize the Secretary
of Health and Human Services to negotiate for lower prices for Medicare prescription
drugs and to eliminate the gap in coverage of Medicare prescription drug benefits, to
authorize the Secretary of Health and Human Services to promulgate regulations for the
reimportation of prescription drugs, and for other purposes.
Sponsor: Rep Wu, David [OR-1] (introduced 2/27/2007)
Cosponsors (None)
Latest Major Action: 3/7/2007 Referred to House subcommittee. Status: Referred to the
Subcommittee on Health.
[Abridged contents:]
SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES.
`(a) Incorporation of Counterfeit-Resistant Technologies Into Prescription Drug
Packaging- The Secretary shall require that the packaging of any drug subject to section
503(b) incorporate-`(1) overt optically variable counterfeit-resistant technologies that are described in
subsection (b) and comply with the standards of subsection (c); or
20
Europe
Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on
criminal measures aimed at ensuring the enforcement of intellectual property
rights30
… it should be emphasised that the direct objective of this initiative is to implement
Article 17(2) of the Charter of Fundamental Rights which states that “Intellectual
property shall be protected
Article 3… Article 3
This Article obliges Member States to consider all intentional infringements of an
intellectual property right on a commercial scale as a criminal offence. It also covers
attempting, aiding or abetting and inciting such offences. The “commercial scale”
criterion is borrowed from Article 61 of the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS Agreement), concluded on 15 April 1994 and signed
by all the members of the World Trade Organisation. Article 61 obliges Members to
“provide for criminal procedures and penalties to be applied at least in cases of wilful
trademark counterfeiting or copyright piracy on a commercial scale. Remedies available
shall include imprisonment and/or monetary fines sufficient to provide a deterrent,
consistently with the level of penalties applied for crimes of a corresponding gravity. In
appropriate cases, remedies available shall also include the seizure, forfeiture and
destruction of the infringing goods and of any materials and implements the predominant
use of which has been in the commission of the offence.
Council Resolution of 13 March 2006 on a customs response to
latest trends in counterfeiting and piracy2131
. INVITES the Commission to
— present appropriate proposals to support the implementation of the approach set out in
the Communication, paying special attention to enhancing the information exchange both
between customs and between customs and operators involved in combating
counterfeiting and piracy;
— to report on the implementation of the Communication and the actions set out therein
as part of the annual report foreseen in Article 23 of Council Regulation (EC) No
1383/2003 (1);
8. INVITES the Commission and the Member States, within their respective
competencies, to implement the comprehensive approach set out in the Communication
thereby further improving customs controls and co-operation in order to combat the
growing menace of counterfeiting and piracy.
30
31
europa.eu.int/eur-lex/lex/LexUriServ/site/en/com/2005/com2005_0276en01.pdf
www.iqsensato.org/wp-content/uploads/Sell_IP_Enforcement_State_of_Play-OPs_1_June_2008.pdf
21
Directive 2004/48/EC of the European Parliament and of the Council of 29 April
2004 on the enforcement of intellectual property rights32
This Directive concerns the measures, procedures and remedies necessary to ensure the
enforcement of intellectual property rights. For the purposes of this Directive, the term
"intellectual property rights" includes industrial property rights.
Article 9(1.) Member States shall ensure that the judicial authorities may, at the request
of the applicant:
(a) issue against the alleged infringer an interlocutory injunction intended to prevent any
imminent infringement of an intellectual property right,33
… the judicial authorities may order the precautionary seizure of the movable and
immovable property of the alleged infringer, including the blocking of his bank accounts
and other assets
The European Parliament legislative resolution of 25 April 2007 on
the draft of the Directive on criminal measures amended and
clarified various provisions of the Directive
European Parliament (2007) P6_TA(2007)0145, legislative resolution of 25 April 2007
on the amended proposal for a Directive of the European Parliament and of the Council
on criminal measures aimed at ensuring the enforcement of intellectual property rights,
first reading,which clarifies that the Directive does not apply to any infringement of an
intellectual property right related to patents, utility models and supplementary protection
certificates or to parallel imports of original goods which have been marketed with the
agreement of a right holder in the third country.
The EU Strategy for the Enforcement of Intellectual Property Rights
in Third Countries, prepared by Directorate General Trade of the
European Commission34
Proposed actions to address the problem
1) Identifying the priority countries
2) Multilateral / bilateral agreements
3) Political dialogue
4) Incentives / Technical cooperation
5) Dispute settlement / Sanctions
6) Creation of public-private partnerships
32
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:157:0045:0086:EN:PDF
33
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:157:0045:0086:EN:PDF
34
http://trade.ec.europa.eu/doclib/html/122636.htm
22
7) Awareness raising / Drawing on our own experience
8) Institutional cooperation
European Alliance for Access to Safe Medicines
“The EAEPC has also hit out at the most recent example of what it sees as such
abuse –the publication last week of a report from the European Alliance for
Access to Safe Medicines (EAASM), which claims that parallel pharmaceutical
trade (PPT) represents “a clear and present danger to the safety of every European
patient.”
In the report, which has been presented to the European Parliament, author
Jonathan Harper alleges that parallel traders practice of repacking and relabelling
medicines undermines supply chain security, and says there is evidence of PPT
being an entry point of counterfeit medicines in to the legitimate supply chain.”
European Council Regulation (EC) No. 1383/200335
“Concerning customs action against goods suspected of infringing certain intellectual
property rights and the measures to be taken against goods found to have infringed such
rights has been in force since 1 July 2004. Specifically, the Regulation: extends the scope
of the former Regulation to cover more intellectual property rights such as plant variety
rights, geographical indications, and designations of origin.”36
Other
Kenya: Anti-Counterfeit Bill 2007
Under the bill, “counterfeiting” means:
without the authority of the owner of any intellectual property right subsisting in Kenya
or elsewhere in respect of protected goods—
(a) the manufacture, production, packaging, re-packaging, labelling or making, whether
in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such
manner and to such a degree that those other goods are identical or substantially similar
35
Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003R1383:en:NOT
“The fight against counterfeiting and piracy in the bilateral trade agreements of the EU.”
www.europarl.europa.eu/activities/committees/studies/download.do?file=21459
36
23
copies of the protected goods;
(b) the manufacture, production or making, whether in Kenya or elsewhere, the subject
matter of that intellectual property, or a colourable imitation thereof so that the other
goods are calculated to be confused with or to be taken as being the protected goods of
the said owner or any goods manufactured, produced or made under his licence;
(c) the manufacturing, producing or making of copies, in Kenya or elsewhere, in
violation of an author’s rights or related rights;
Canadian Intellectual Property and Trade Advisory Group
Michael Geist reports37:
According to documents obtained under the Access to Information Act, the
government has been crafting an Intellectual Property and Trade Advisory
Group. The initial plans for membership in the group were limited exclusively to
12 government departments and 14 industry lobby groups. These include the
Canadian Recording Industry Association, the Canadian Motion Picture and
Distributors Association, and the Entertainment Software Association of Canada
[full list includes Canadian Anti-Counterfeiting Network, Canadian Chamber of
Commerce Entertainment Software Association of Canada Canada's ResearchBased Pharmaceutical Companies, Intellectual Property Institute of Canada,
Retail Council of Canada, Canadian Recording Industry Association, Canadian
Motion Picture and Distributors Association, Canadian Council of Chief
Executives, Canadian Manufacturers and Exporters, Canadian Association of
Importers and Exporters, Canadian Generic Pharmaceutical Association
Underwriters Laboratories, and Canadian Standards Association].
The early membership lists omit several key industry representatives likely to be
affected by ACTA, including telecommunications, technology, and Internet
companies. Moreover, there is absolutely no representation of the public interest
- no privacy representation despite the obvious privacy implications of the treaty
(the Office of the Privacy Commissioner of Canada was not included on the
government invitee list), no consumer representation despite the effects on
consumer interests, and no civil liberties representation on a treaty that could
fundamentally alter Canadian civil rights.
The government documents indicate that members would engage in "in-depth
exchanges on technical negotiating issues" and therefore be required to sign
confidentiality agreements in order to participate.
37
http://www.michaelgeist.ca/content/view/3229/159/
24