July 8, 2008
First of all we would like to commend the US government for initiating a dialogue aimed at trying to enhance the global fight against piracy. This is a fight that is critical to maintaining US competitiveness, and one that we risk losing unless we can work creatively with our trading partners to ensure that norms and enforcement practices are relevant and appropriate with respect to the challenges confronting modern society.
The record industry, together with all of the copyright industries, faces a piracy challenge of tremendous dimension and diversity. “Piracy” no longer has a single face. If we are to be successful in maintaining the integrity of copyright in the digital age, we must be prepared to successfully attack both physical and online infringement. We have provided a number of proposals for consideration in adapting best practices in the fight against piracy. These are not developed in a vacuum, but rather reflect our experiences in working with law enforcement authorities around the world in attempting to address piracy. We believe that it is essential to begin this process by carefully defining the nature of the challenges that are faced. We offer the following observations.
To begin with, enforcement authorities must recognize that the emergence of commercial scale CD-R piracy has localized pirate production, thus forcing a change in anti-piracy strategies away from uniquely trying to control production and towards simultaneously addressing of consumption as well (i.e. the offer for sale of pirate products in the marketplace). This should take place alongside the adoption of optical disc regulations (requiring the use of SID codes) in territories producing large quantities of pirate discs, or where the production capacity vastly exceeds legitimate needs. Policy makers and law enforcement authorities must also recognize that internet-based infringement, even when done without a profit motive, takes place on a commercial scale and has the same impact on copyright owners as for-profit piracy. It is essential— and required by TRIPS, to criminalize such conduct, even though the individual actor may not be acting with any profit incentive, or possess what one would ordinarily think of as “criminal intent.”
We offer a number of fundamental observations. States should:
1- ensure that criminal penalties are adequate in law and implemented in practice to serve as a deterrent in light of the fact that any fine, no matter what size, can be absorbed as a cost of doing business;
2- amend criminal laws to make copyright offenses cognizable under organized crime and criminal conspiracy provisions, thus giving governments better investigative tools and resources in order to fight organized piracy;
3- criminalize the provision of raw materials in furtherance of piracy;
4- ensure that law enforcement officials have ex officio authority to seize any infringing materials, and that they are directed to seize, without complaint from the copyright owner, any materials that are offered for sale. (this is necessary in light of the practical inability to control piracy by focusing exclusively on the suppression of illegal production–efforts need to be diversified and include market control).
5- secure ratification and implementation of the WIPO Treaties to ensure that adequate rights are established;
6- ensure that ISP’s are required by law to engage in reasonable business practices with respect to the detection and removal of infringing files, preventing access to their networks on the part of known infringers; terminating the accounts of repeat or serious infringers; and employing available technological tools that would prevent infringement provided that use of such tools would not pose an unreasonable financial burden and would not impair the operation of the network;
7- ensure that persons or companies whose actions effectively “induce” the infringement of others are liable for copyright infringement, in line with the US Supreme Court decision in Grokster
8- amend criminal laws so that they relate to the present internet “piracy” problem by applying criminal penalties to acts undertaken WITHOUT any commercial purpose when they are done on a commercial scale, like making materials available through the internet as was done in the US via the Net Act; and
9-increase the ability of law enforcement agencies from different countries to cooperate with each other in multi-territorial cases, including by securing broad adherence to the Cybercrime Convention.
Enforcement Best Practices
A. Legal Obligations
1. Make deterrence against piracy and counterfeiting a priority legal matter.
2. Provide criminal sanctions for any act of copyright infringement that takes place on a commercial scale, including in the online environment, regardless of whether such acts are undertaken with a financial incentive.
3. Make it a criminal offense to import or export, manufacture, sell or otherwise distribute a device or system, or a component of a device or a system, knowing or having reason to know that the device or system is primarily used or designed to circumvent technological protection measures used in conjunction with materials protected by intellectual property rights.
4. Provide monetary fines and sentences of imprisonment for the importation, exportation, distribution, sale or other manner of making available of counterfeit or pirated goods sufficient to deter future infringements, consistent with a policy of removing the infringer’s monetary incentive .
5. provide for the availability of civil and injunctive relief against landlords that fail to reasonably exercise their ability to control the infringing conduct of their tenants.
6. In territories with high rates of production of pirated optical discs, provide for a system of licensing prior to the manufacture or export of optical discs, as well as the import or export of manufacturing equipment, and manufacturing materials, including optical grade polycarbonate, “stampers” and “masters.”
B. Investigatory Provisions Parties shall:
1. provide law enforcement authorities ex officio powers to investigate criminal infringements of intellectual property rights and initiate criminal actions on their own initiative.
2. permit law enforcement authorities, both at the border and internally, to seize clearly infringing copyright and trademark materials and to seize and/or place under seal equipment or materials suspected of being used to produce such infringing copies without the need for a complaint from the right holder, and without regard to whether protected materials have been recorded or otherwise registered with border authorities.
3. allow law enforcement officials to communicate and share information with right holders with respect to material evidence
of infringement of intellectual property that officials have in their possession.
4. ensure that courts have the authority to issue ex parte search orders.
5. provide that orders by judicial authorities need not individually identify the items subject to seizure, so long as they fall within general categories specified in the order.
C. Border Control Parties shall:
1. Provide that goods that have been determined to be pirated or counterfeit by competent authorities at the border shall be destroyed, except in exceptional cases.
2. In no event authorize their border authorities, except in exceptional circumstances (such as to facilitate a controlled delivery or other law enforcement operation), to permit the exportation or transshipment of counterfeit or pirated goods.
3. Provide that competent authorities have the authority to initiate border measures ex officio, with respect to imported, exported, or in-transit merchandise suspected of being counterfeit or confusingly similar trademark goods, or pirated copyright goods, without the need for a formal complaint from a private party or right holder, and regardless of whether the relevant right that is being infringed is recorded with Customs otherwise registered.
4. In civil judicial proceedings concerning the enforcement of intellectual property rights, provide that judicial authorities have the authority to order a party to desist from an infringement, in order, inter alia, to prevent, immediately after they clear customs, the entry into the channels of commerce in the jurisdiction of those authorities of imported goods that involve the infringement of an intellectual property right, or to prevent their exportation.
D. Seizure of Materials Parties shall:
1. Provide that judicial authorities have the authority to order the seizure of suspected counterfeit, pirated or other infringing goods, any related materials and implements including that used in the commission of the offense, any assets traceable to the infringing activity, and any documentary evidence relevant to the offense.
2. Provide that orders by judicial authorities need not individually identify the items subject to seizure, especially when the seizure involves a large amount of infringing items, so long as they fall within general categories specified in the order.
3. Allow for ex parte freeze orders to give the territory’s authorities and rights holder an opportunity to ensure that infringer’s profits are confiscated and that monetary damages are recoverable.
E. Destruction of Materials Determined to be Pirated or Counterfeit
1. Provide that goods that have been determined to be pirated by competent authorities shall be destroyed, except in exceptional circumstances.
2. Provide that courts shall confiscate and destroy the equipment used for the manufacture of pirated goods in order to ensure that infringing parties do not repeat their illegal activities,
3. Provide that goods determined to be infringing are subject to forfeiture and destruction regardless of whether any action for infringement is initiated, whether civil, administrative or criminal and without any compensation of any kind to the defendant, and
regardless of whether there has been any finding of liability on the part of any person.
F. Evidentiary Standards Parties shall:
1. Provide that the person whose name is on the protected material is presumed to be the relevant right holder.
2. Provide that proof of ownership may be obtained by means of an affidavit, unless this issue is placed into question by material evidence to the contrary.
3. Provide that the presumption of ownership may be rebutted only if the defendant is able to provide concrete evidence to the contrary.1
4. As a deterrent to groundless defenses, award plaintiffs full costs and fees for overcoming frivolous challenges to titles.
G. Transparent Judicial Proceedings, Policies and Guidelines
1 Absent proof to the contrary, the physical person or legal entity whose name is indicated as author, producer, performer or publisher of the work, performance or phonogram shall be presumed to be the lawful right holder.
1. Provide clear, transparent, and predictable judicial proceedings, policies, and guidelines related to intellectual property enforcement.
2. Provide that final judicial decisions and administrative rulings of general application pertaining to the enforcement of intellectual property rights be in writing and state any relevant findings of fact and reasoning or the legal basis on which the decision or rulings are based
3. Publicize information on their efforts and actions to provide effective enforcement of intellectual property rights in their civil, administrative, and criminal systems, including any statistical information that may be collected for such purpose.
4. Publish information related to respective intellectual property enforcement actions, including relevant statistical information.
H. Penalties Parties shall:
1. Establish policies or guidelines that encourage judicial authorities to impose remedies at levels sufficient to deter future infringements and to adequately compensate right holders, particularly bearing in mind that many large scale infringements
are properly understood as criminal conspiracies and/or organized crime.
2. Establish statutory minimum and maximum penalties that are adequate to deter persons that engage or contemplate engaging in acts of piracy.
3. Provide, whenever law enforcement authorities’ investigatory powers are dependent on the level of minimum/maximum penalties available for criminal infringements, that criminal penalties are set at a level that ensures that law enforcement authorities have adequate powers to investigate copyright infringements. For example, penalties should be set at a level that ensures that law enforcement officials have the authority to initiate investigations, search premises, seize goods, and arrest suspects of criminal activity.
4. Continuously monitor the level of fines imposed and where necessary issue sentencing guidelines to ensure that fines imposed by the judicial authorities remove all gains from the infringer and deter future infringements.
5. Provide that right holders are entitled to recover their costs of investigation and litigation against infringers of intellectual property rights.
6. Provide that courts have the authority to close commercial outlets and manufacturing plants that have been used to manufacture or distribute pirate or counterfeit products.
7. In criminal matters, provide that competent authorities keep an inventory of goods and other materials proposed to be destroyed, and have the authority temporarily to exempt such materials from the destruction order to facilitate the preservation of evidence upon notice by the right holder that it wishes to bring a civil or administrative case for damages.
I. Monitoring Activities Parties shall:
1. With respect to A.1 above, provide adequate safeguards against the unauthorized manufacture of infringing optical discs, and provide that facilities producing such products comply with the standards established by the association of replicators (IRMA) in their Anti-Piracy Compliance Program.
2. Compel manufacturers of optical discs in their territory to maintain complete and accurate records to enable right holders and public authorities to trace the person or entity that ordered the infringing discs.
3. Require that OD replicators apply unique source identification codes to all optical discs, including master discs and stampers. Secure and unique identifiers enable the tracing of the source of a product and provide a deterrent against piracy.
Online Infringing Activities
Provide exclusive rights under copyright to unambiguously cover internet use.
Establish appropriate rules regarding liability of service/content providers:
(a) establishing primary liability where a party is involved in direct infringement; and ensure the application of principles of secondary liability, including contributory liability and vicarious civil liability, as well as criminal liability for aiding and abetting if appropriate.
(b) establishing liability for actions which, taken as a whole, encourage infringement by third parties, in particular with respect to products, components and/or services whose predominant application is the facilitation of infringement.
3. Provide remedies and injunctive relief against any entity that:
(a) creates or otherwise maintains directories of infringing materials;
(b) provides “deeplinks” to infringing files;
(c) commits any act, practice or service that has little or no purpose or effect other than to facilitate infringement, or that intentionally induces others to infringe (specifically allowing proof of “intent” by reference to objective standards–i.e. a reasonable person would surmise such an intent);
4. Require internet service providers and other intermediaries to employ readily available measures to inhibit infringement in instances where both legitimate and illegitimate uses were facilitated by their services, including filtering out infringing materials, provided that such measures are not unduly burdensome and do not materially affect the cost or efficiency of delivering legitimate services;
5. Require internet service providers or other intermediaries to restrict or terminate access to their systems with respect to repeat infringers.
6. Establish liability against internet service providers who, upon receiving notices of infringement from content provides via e- mail, or by telephone in cases of pre-release materials or in other exigent circumstances, fail to remove the infringing content, or access to such content, in an expeditious manner, and in no case more than 24 hours;
Provide that, in the absence of proof to the contrary, an internet service provider shall be considered as knowing that the content it stores is infringing or illegal, and thus subject to liability for copyright infringement, after receiving notification from the right holder or its representative, normally in writing, including by
email or by telephone in the case of pre-release materials or in other exigent circumstances.
Establish, adequately fund and provide training for a computer crimes investigatory unit.
Provide injunctive relief against intermediaries whose services are used for infringing activities regardless of whether damages are available.
Establish policies against the use of government networks and computers, as well as those networks and computers of companies that have government contracts, to prevent the use of such computers and networks for the transmission of infringing materials, including a ban on the installation of p2p applications except, and to the extent to which, some particular government use requires such installation.
Consideration to be given to the following: possible rules on data retention, the right to information giving right holders access to data held by ISPs in the preparation and course of proceedings including in civil proceedings, and availability of complete and accurate WHOIS data.
Organizational Issues Parties shall:
1. establish anti-piracy units, including at a minimum Police and Customs officers. Such units will gather intelligence on IP crime in order to facilitate policy formulation and generate criminal investigations. Units would be expected to prepare annual reports on the criminal environment in the key IP sectors. This would document key facts on manufacturing sources and distribution networks, including any international links/exports. Reference would be made, inter alia, to key personalities, organized crime groups, and links to terror networks.
2. establish single point of contact for law enforcement officials from other countries, as well as for affected right holders.
PRINCIPLES FOR THE ANTI-COUNTERFEITING TRADE AGREEMENT
In response to the February 15, 2008 request for comments published in the Federal Register, the undersigned entities submit the following principles that should guide the U.S. delegation in negotiating the Anti-Counterfeiting Trade Agreement (ACTA).
- ACTA should focus on the facilitation of legal action against those entities and individuals that intentionally engage in counterfeiting and intellectual property infringement on a commercial scale for commercial purposes. ACTA should not target innocent intermediaries such as shippers, payments systems, search engines, online marketplaces, and Internet access providers that are used by those counterfeiters and infringers. Nor should ACTA target activities that fall within exceptions to exclusive intellectual property rights.
- While the elimination of counterfeiting and commercial infringement certainly is a very important objective, ACTA must ensure that the pursuit of counterfeit and infringing products does not unduly burden legitimate commerce, impede innovation, undermine consumer privacy, or restrict the free flow of information.
- ACTA should concentrate on measures relating to enforcement of intellectual property rights, not on substantive issues of intellectual property such as the scope of protection, limitations and exceptions, and secondary liability.
- ACTA should not serve as a vehicle for changing U.S. domestic law relating to intellectual property enforcement.
- ACTA should be technologically neutral and not create disparate burdens or obligations depending on whether a counterfeit product is sold online or offline. Similarly, ACTA should not encourage the imposition of technology mandates, such as the mandatory filtering of Internet traffic.The Fact Sheet on ACTA distributed by the Office of the U.S. Trade Representative references provisions that may appear in ACTA. The following comments address some of those proposed provisions.
- Public/private advisory groups. Any advisory groups formed pursuant to ACTA must represent the broad spectrum of interests, including rightsholders, intermediaries, and consumers.
- Consumer Public Awareness. Public education campaigns must present a balanced and accurate view of intellectual property. Consumers should learn not only about exclusive rights, but also exceptions and limitations to those rights. If consumers are presented with simplistic and draconian perspectives, they will reject them. ACTA should not mandate a specific role for governments in consumer awareness campaigns, but allow each government flexibility.
• Internet distribution and information technology. As noted above, ACTA should be technologically neutral. While the Internet does pose some unique challenges in terms of identifying, locating, and apprehending perpetrators, it is also far more transparent than other means of distribution and preserves far more evidence that can be used in enforcement proceedings. Furthermore, the harm caused by the distribution of counterfeit and infringing products through the Internet is qualitatively the same as the harm caused by other forms of distribution. Accordingly, special penalties that target the Internet are inappropriate.
Center for Democracy & Technology
Computer & Communications Industry Association Consumer Electronics Association
Library Copyright Alliance
Office of the United States Trade Representative ACTA@ustr.eop.gov
Attn Rachel Bae
Subject: (ACTA): Request for Comments: Federal Register: February 15, 2008 (Volume 73, Number 32)
British American Tobacco Group Comments
The British American Tobacco Group is grateful for the opportunity to submit some perspectives on the international ACTA negotiations to the U.S. Government.
The illicit trade in cigarettes – counterfeiting and smuggling – is a serious problem. By our reckoning, it accounts for 6% of the world’s global tobacco market, deprives governments of up to $20 billion in tax revenue annually, and costs our business upwards of $700 million per year. Illicit trade is a global problem that undermines increases in excise taxes and government regulation of our products.
British American Tobacco is absolutely committed to stamping out illicit trade. Internally, we have linked up our trademark protection, brand enforcement, supply chain protection and legal and regulatory efforts. Externally, we are working with customs and border officials in many of our key markets to help build capacity and better understand ways to address the problem. We have worked assiduously to ensure that our own house is in order by only supplying volumes of product that reflect the market profile and implementing systems that can assure us, and our government stakeholders, that we know where our product is going, how it is getting there, who is selling it and all the points in between. We share intelligence and information with governments around the world on a daily basis and we collaborate with authorities to seize illegitimate product while destroying all our used equipment to make it harder for illegal operators to set up shop.
We applaud the efforts of the U.S. Government in negotiating the ACTA. We believe that ACTA will be a valuable tool to address the growing world market in counterfeit cigarettes. We would strongly advocate tobacco and tobacco products being prioritized in the course of the negotiations when specific areas of concern are being addressed. In terms of the elements of the potential agreement of particular interest to British American Tobacco, we would note that:
- A comprehensive agreement covering all products most susceptible to counterfeiting will make the agreement most credible and useful.
- The issue of enforcement is key and should be reiterated throughout the negotiations. Many countries have rules and laws that are simply not properly enforced. Many countries have no ordered or systemic mechanisms in place to add teeth to anti-counterfeiting commitments. Both of these factors have to be addressed if the agreement is to genuinely improve the situation.
- Key vulnerabilities in the global trading system should be addressed to avoid creating safe havens for counterfeiters. We believe particular attention should be paid to Free Trade Zones. In 2002 there were approximately 3,000 Free Trade Zones spanning 116 countries. The growth since has been quite alarming both in numbers and in size. We view many of these zones as ‘hotspots’ that operate as gateways to counterfeit product and reduce the capacity for supply-chain control. An agreement that does not seek to address enforcement measures in Free Trade Zones will be weaker as a consequence.
- Capacity building of enforcement officials will need to be addressed in the negotiations. This is an area where companies who are already invested in capacity building in key markets may be of assistance. British American Tobacco is committed to capacity building in many of our markets and has good partnership agreements that may add value to the ACTA agenda.
- It is important that ACTA seek to create new IP protection and enforcement provisions that exceed already existing agreements. In addition, it will be important for negotiators to recognize and create synergies with other parallel processes that are seeking to improve the enforcement climate, such as the negotiation of the Framework Convention on Tobacco Control Protocol on Illicit Trade in Tobacco Products.
- It is important to ensure that all ACTA parties keep in mind commercial realities and real-world considerations in the course of the negotiations. For this reason, we see great value in maintaining ongoing private sector consultation. It is also why British American Tobacco very much appreciates the opportunity to provide comments for these negotiations.In addition to the above remarks, British American Tobacco would like to endorse the comments submitted by the Business Action to Stop Counterfeiting and Piracy (BASCAP) and International Trademark Association (INTA), two organizations in which we actively participate.Again, I’d like to reiterate our gratitude in being able to provide our views on this process and please let me take the opportunity to emphasize once more that British American Tobacco remains committed, internally and externally, to doing everything possible to reduce and eliminate illicit trade.
With kind regards,
Global Head of Anti-Illicit Trade British American Tobacco
Submission of the Cable and Satellite Broadcasting Association of Asia (CASBAA) to the Office of the U.S. Trade Representative
March 20, 2008
Negotiation of an Anti-Counterfeiting Trade Agreement
The Cable and Satellite Broadcasting Association of Asia (CASBAA) is a trade association with activities in 15 Asian countries and regions, dedicated to the promotion of multi-channel pay-television via cable, satellite, broadband and wireless video networks. Founded in 1991, CASBAA represents some 125 member companies, which serve more than 3 billion people. US-owned member organizations include AETN International, Bloomberg Television, Boeing Space Systems, Comcast International Media, CNBC Asia, Discovery Networks Asia, ESPN Star Sports, HBO Asia, Intelsat, Microsoft, Morgan Stanley, the Motion Picture Association, Motorola, MTV Networks Asia Pacific, National Geographic Channel, NBC Universal, Playboy Entertainment, Paul, Weiss, Rifkind, PricewaterhouseCoopers, Qualcomm, Cisco, Sony Pictures Television International, STAR Group (NewsCorp), Time Warner, Turner International Asia Pacific, Voom HD Networks, and Walt Disney Television International.
CASBAA appreciates USTR’s request for input on the matters to be covered by an Anti- Counterfeiting Trade Agreement (ACTA). The Request for Public Comment notes that an ACTA should address “today’s challenges” in the field of intellectual property protection; we would urge that as far as possible, the new agreement should be forward- looking, addressing not only the patterns of infringement that are epidemic today, but also those emerging threats that – with the propagation of new technologies and increases in broadband network capacity – are likely to create common forms of international infringement tomorrow.
This is particularly true insofar as our industry is concerned: the rapid spread of broadband internet capacity in many countries has produced a situation where widespread piracy of video content – previously deterred or delayed by a lack of bandwidth – is becoming more easy and therefore more common. Many of these patterns of infringement are becoming increasingly international, with computer servers, index sites, and upload locations present in one country being used to feed piracy in many other countries. Forms of content, such as broadcasts of sporting events which – because of their immediacy and high time-value – have in the past not been widely pirated (on optical media, for example), are now increasingly susceptible to real-time piracy.
Given the many and growing international linkages in these patterns of piracy, we believe it is essential that effective action to address the problem be taken on an international scale. National legislation and national efforts must be supplemented by international cooperation. In this respect, we warmly welcome the initiative to negotiate an ACTA, as we believe such an agreement will set a benchmark for international cooperation that will become a reference, not only for the states and trading entities which are parties to the agreement, but also for the entire international community.
We believe, therefore, that an ACTA can and should be an extremely high-quality agreement. The negotiating parties should not accept a “lowest common denominator” approach that restricts the ACTA to provisions already in place in other broad international trade agreements. Rather, they should seek to include new provisions to cover areas of emerging importance in international infringement. A search for expeditious results is laudable; but we urge the negotiating parties not to allow the quest for speed to mitigate in favor of a weaker agreement. The overriding goal should be achievement of an agreement that sets the highest possible international standards for cooperation in this area.
CASBAA suggests three areas of particular relevance to the international pay-TV industry, for attention in the ACTA:
1) Signal Piracy: The ACTA should recognize that infringement of copyrights through interception and unauthorized commercial use of international satellite transmissions is a serious and growing problem in many parts of the world. As a technical matter, it is not possible to narrowly restrict satellite transmissions to the territory of individual countries. However, misuse of the signals can and should be addressed. Parties to the treaty should agree upon effective action to prevent all commercial misuse of such signals.
Common commercial infringements in today’s world include:
— Unauthorized interception, decryption and retransmission of encrypted broadcast signals to multiple customers of commercial cable networks or other broadcasters.
— Unauthorized interception, decryption and retransmission of encrypted broadcast signals to multiple dwelling units by apartment building managers, as part of their building management business.
— Unauthorized interception, decryption and public exhibition of encrypted broadcast signals, in public commercial venues such as restaurants, bars, hotels, and members’ clubs.
— Unauthorized distribution and use of broadcast signals (whether encrypted or unencrypted) to increase traffic to and through online websites.
— Other unauthorized distribution and use of broadcast signals (whether encrypted or unencrypted), such as via pirated DVDs.
(It should be stressed that even where broadcast streams are delivered on an unencrypted basis, this does not imply authorization for retransmission of this content, or otherwise detract from the intellectual property and other legitimate rights of the content owner and/or licensee. Any use of unencrypted content also requires the consent of the content owner and/or licensee, and unauthorized use can significantly damage the brands and business models of broadcasting organizations.)
In all of these areas, the ACTA should embody international agreement that the damage to the interests of rights holders and broadcasters should be the principal criterion for setting penalties.
In addition to these commercially-based infringements, we believe that the ACTA should also address the problem of individual use of circumvention devices to view unauthorized broadcast programming. End-user piracy of this type should be made a criminal offense, so that governments cut off the financial flows that support the circumvention industry, and to send an unambiguous message to individuals about what is right and what is wrong.
We would suggest the following additional specific means of attacking these problems, for inclusion in the ACTA:
— Agreement that, where publicly-licensed infringing organizations are misusing broadcast signals, governments will act suo moto to suspend those licenses. (These might include cable operating licenses, telecom licenses, public spectrum licenses, or business operating licenses.) Final judicial determination of copyright violations should not be required to invoke license suspension; regulatory authorities should be empowered to act under their own administrative procedures. Licenses of repeat offenders should be totally revoked without hope of renewal.
— Application of strong criminal penalties to commercially-motivated retransmission of unauthorized broadcast signals to more than a minimum number of premises (say, 5 homes).
— In civil law, enactment of statutory damages of sufficient size to have a meaningful deterrent effect which will also take into account the difficulty in assessing the damage to copyright holders and broadcasting organizations from public exhibition or retransmission of a single broadcast signal.
2) Unauthorized online distribution of video programming: Increasingly, online piracy includes not only individual works of video programming but entire streams of broadcast programming. We would urge the negotiating parties to ensure that ACTA’s treatment of online piracy take account of the fact that, apart from the ownership of the individual works in question, ongoing piracy of broadcast streams does incalculable damage to the
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brands and business models of broadcasting organizations. ACTA’s provisions should include measures to suppress piracy both by host servers and by P-2-P networks.
ACTA parties should also agree to apply adequate and effective penalties against those who profit from unauthorized downloading, as well as those who induce the online infringement of others. This category includes websites offering directory and search services for online content, as well as websites in one country which market infringing content which is actually hosted on servers in another jurisdiction.
3) International traffic in circumvention devices and services: A key support for international signal piracy, on both a commercial and individual level, is widespread trafficking in circumvention devices and services. ACTA parties should agree to apply adequate and effective border measures to interdict the supply of circumvention devices. Specifically, where an equipment supplier in one country has a record of trading in devices which function to circumvent pay-TV access controls or encryption, then future shipments of goods from that supplier should be subject to intensive inspection to ensure that those goods are not susceptible to use as circumvention devices.
ACTA parties should also agree to enact legislation to suppress the international supply of circumvention services, e.g. by the internet. (One real-world example concerns so- called “card sharing” of smart card encryption information: circumvention syndicates set up computer servers in one country which supply decryption data on a real-time basis which, when connected via the Internet to pre-equipped set top boxes, permit the mass unauthorized and unremunerated reception of pay-TV content. In some countries it is currently impossible to take legal action against such servers.)
A) We support creation of an effective peer review mechanism to allow ACTA parties to assess each others’ policies and practices. Functioning international examples of such peer review mechanisms exist for several matters under the purview of the OECD and CSCE. An ACTA peer review mechanism should incorporate provisions for input from rights holders and other stake holders, so that the peers can examine the real-world impact of IP policies.
B) We also support creation of public-private cooperation in various forms to address the piracy problems. The pervasiveness and technical complexity of the intellectual property problems afflicting our industry mean that neither public administrations nor private operators have sufficient resources to address them individually; apart from specific infringement cases, public-private cooperation is essential to keeping an adequate level of enforcement awareness in an environment of constant technical change and development.
TO: The Office of the United States Trade Representative (USTR) via ACTA@ustr.eop.gov
Colorcon, Inc. Response to Anti-Counterfeiting Trade Agreement (ACTA) Request for Public Comments Regarding International Cooperation, Enforcement Practices and Legal Framework Provisions
March 14, 2008
Frederick R. Kettinger General Manager
Brand Enhancement Services
Colorcon, Inc. 415 Moyer Boulevard
P.O. Box 24 West Point, Pennsylvania 19486 P 215-699-7733 F 215-661-2605 www.colorcon.com
This response regarding the request for public comments for ACTA (Anti-Counterfeiting Trade Agreement) international cooperation, enforcement and legal framework practices to contribute to the effective enforcement of Intellectual Property Rights (IPRs) and strengthening the relevant IPR enforcement measures is provided by Colorcon, Inc. with specific interest in protecting the public safety against counterfeit pharmaceuticals.
Specific comments requested and addressed below include:
- ACTA International Cooperation
- ACTA Enforcement Practices
- ACTA Legal FrameworkOur comments are as follows:ACTA International Cooperation
Pharmaceutical counterfeiting is a global problem affecting the health and lives of people around the world. Counterfeit drugs present a global financial burden as well as a health and safety burden, currently projected to approach $75 billion (U.S. Dollars) in lost pharmaceutical sales revenues by 2010. All peoples of the world and all pharmaceutical companies are affected by the threatening acceleration of counterfeit drugs both as a health and safety issue as well as an economic impact on the cost of drugs. Currently it is estimated that on the global level, 10% of all drugs are counterfeits.
This global problem can only be resolved through international cooperation. Intellectual Property Rights with specific focus on Trademark Protection needs to be embraced by all countries worldwide as trading partners. Trademark law is well established throughout the world through the Paris Convention, the Madrid Agreement and Madrid Protocol for International trademarks, various regional trademark systems such as the European Community Trademark system, etc. The International Trademark Association (INTA) has served to harmonize international trademark law throughout the world, thereby establishing a legal platform upon which countries can cooperate in managing and controlling the legal flow of product brands and the prevention of counterfeit trade. In the United States, this same platform enables pharmaceutical companies to leverage the power of IPR protection through Trademark Registration in conjunction with Customs Border Protection Recordation of the Registered Trademark. It is this platform that would serve to harmonize ACTA International Cooperation to resist the growing counterfeit pharmaceutical exportation and importation threat to public safety.
ACTA Enforcement Practices
Effective anti-counterfeit drug enforcement practices require cooperation between the pharmaceutical industry and IPR Enforcement by the governments of the world.
Branded and generic pharmaceutical products flow across country borders. Pharmaceutical supply chain security is a global issue. Counterfeit breach of global supply chains through repackaging and counterfeit introduction requires strengthening of IPR Enforcement worldwide to protect the public at the package level as well as the dosage level.
Pharmaceutical companies, both brand innovators as well as generic manufacturers, apply their Trade name, trademark or brand to the drug package and often the product dosage. Additionally, pharmaceutical product innovators are trending to design unique dosages to enable trademarking of the actual dosage design including the color, shape, size and imprint logo of the dosage (much like the trademark for the unique shape of the Coca Cola® bottle). For example, the Viagra® (sildenafil citrate) tablet manufactured by Pfizer, Inc. is a globally registered trademark for the blue color and diamond shape of the tablet for erectile dysfunction. The tablets contain the name Pfizer to identify the manufacturer. Pfizer has utilized the registered trademark of the Viagra tablet to enable legal protection against counterfeit importation into the United States. In this regard, Enforcement Practices utilize the registered trade name of the manufacturer and/or the registered trademark design of the dosage plus recordation of the registered trademark with Customs Border Protection (as in the United States and other countries), to enable Customs Border Protection (CBP) through existing IP law and enforcement systems, to identify and authenticate imported pharmaceuticals. Customs and Border Protection in the United States can serve as a model for international harmonization as it serves to protect against the importation of goods which infringe / violate Intellectual Property Rights (IPR) by devoting substantial resources toward identifying and seizing shipments of infringing articles. Global governmental conventions and alliances to coordinate the same approach to IPR protection are essential to preventing counterfeit pharmaceutical importation at the border.
Anti-counterfeiting enforcement technologies, to identify and authenticate pharmaceutical dosages versus counterfeit dosages, are being applied by pharmaceutical manufacturers to their products while meeting FDA and global regulatory and safety requirements for the ingestion of the product(s) by patients. Some of these systems are forensic requiring laboratory analysis, but the latest technology now provides for quick identification and authentication of pharmaceutical solid dosages in the field. The quick identification and authentication systems are covertly applied to the dosage form, and can provide Customs Border Protection with quick, economical and confident field determinations of a product’s authenticity or counterfeit status. It is also anticipated that these systems will be interoperable with electronic Track and Trace anti- counterfeiting and e-Pedigree systems currently being developed in the United States and Europe. These systems can be applied to branded products as well as generic products with inspection guidance available to Customs Border Protection agents. Generic products present a special concern for import authentication, because generic products may be plain, white, round tablets that are easy for counterfeit replication. Generic products can easily be identified and authenticated by these on-dosage enforcement systems. These systems in conjunction with ACTA Border IP Enforcement can provide a critical security check point for import protection for the public from counterfeit drugs. The on-dosage anti-counterfeiting systems are critical to ensuring that the actual drug dosage is not counterfeit while in an authenticated package. It is the drug that is ingested by the patient, and it is therefore the drug, not the package, that absolutely must be authenticated.
ACTA Legal Framework
A model of the legal framework for global IP Protection and counterfeiting import prevention exists in the United States as a coordinated multi-agency enforcement team under the Immigration and Customs Enforcement (ICE) organization. The ICE organization can protect IP
from counterfeit importation through the protection of Trademarks that are registered in the United States Patent and Trademark Office and are Recorded with the Customs Border Protection (CBP). Registered Trademarks can be recorded with the CBP at: http://cbp.gov/xp/cgov/import/commercial_enforcement/ipr/ipr_enforcement/ipr_protect_infring e.xml
The recordation of the Registered Trademark allows for the CBP to prevent import Trademark infringement by “Counterfeits” and “Confusingly Similar” articles. The definitions for these terms are as follows:
“Counterfeit” – A spurious (false, non-genuine) trademark which is identical to, or substantially indistinguishable from, a federally registered U.S. trademark.
“Confusingly Similar” – A mark which is similar to the genuine trademark such that it is likely to cause confusion as to source or sponsorship.
The legal framework and Enforcement Systems described above, for registered and CBP- Recorded Trademarks, can provide the following protection:
- Aid in CBP detection of counterfeit pharmaceutical solid dosages
- Reduce potential for “confusingly similar” products
- Enable border control of violative imports (Exclude from entry, detain, and / or seizearticles)
- Facilitate government criminal prosecution of violators (e.g. through inter-agencycoordination with the FBI, Postal Inspection, Coast Guard, TSA, DOC, Federal State and Local Law Enforcement. Also, through International Customs Coordination as currently through Europe).
- Broadens penalties: Financial and incarcerationIntellectual Property Trademark Law with Customs Border Protection Laws and Enforcement, as coordinated in the U.S. by Immigration and Customs Enforcement to protect against counterfeit importation, can serve as a legal framework model for international coordination and application throughout the world.
COUNTERFEIT DRUGS: THE GOOD, THE BAD AND THE UGLY
Kevin Outterson? & Ryan Smith?? TABLE OF CONTENTS
- INTRODUCTION ………………………………………………………….. 526
- THE DATABASE ON COUNTERFEIT MEDICINES ISUNRELIABLE ………………………………………………………………526
- A NEW PHARMACEUTICAL LEXICON IS NEEDED ……………..530
- The Good …………………………………………………………….. 531
- The Bad ………………………………………………………………. 534
- The Ugly …………………………………………………………….. 535
- INTELLECTUAL PROPERTY LAWS ARE AN UNDERLYING
CAUSE OF COUNTERFEIT DRUGS …………………………………..537
- Counterfeiting is a Major Threat toPharmaceutical Innovation …………………………………..541
- Government Reimbursement Systems in High–Income Countries are a Less Significant Threat……..542
- Alternatives to Patent–Based R&D Cost RecoveryMay Eliminate the Incentive to Counterfeit……………542
- CONCLUSION ……………………………………………………………… 543
? Associate Professor of Law, West Virginia University College of Law. I am grateful to Albany Law School for the invitation to present at this symposium, and to the symposium participants for their excellent comments and questions. I also thank my research assistant, David Davis, for his work.
?? J.D. candidate, West Virginia University College of Law. 525
526 ALB. L.J. SCI. & TECH.