Access to Medicines
Sean M. Flynn Program on Information Justice and Intellectual Property American University Washington College of Law

Urgent Communiqué
We find that the terms of the publicly released draft of ACTA threaten numerous public interests, including every concern specifically disclaimed by negotiators.
‡ Negotiators claim ACTA will not interfere with citizens' fundamental rights and liberties; it will. ‡ They claim ACTA is consistent with the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS); it is not. ‡ They claim ACTA will not increase border searches or interfere with cross-border transit of legitimate generic medicines; it will. ‡ And they claim that ACTA does not require "graduated response" disconnections of people from the internet; however, the agreement strongly encourages such policies.

. . . [A] fair reading of the April 2010 draft leads to our conclusion that ACTA is hostile to the public interest in at least seven critical areas of global public policy: fundamental rights and freedoms; internet governance; access to medicines; scope and nature of intellectual property law; international trade; international law and institutions; and democratic process.

ACTA would threaten global access to affordable medicines, including by: ‡ Authorizing customs authorities to seize goods in transit countries, even when they do not infringe any laws of the producing or importing countries; ‡ Implicating non-infringing active pharmaceutical ingredient suppliers whose materials may be used downstream in infringing products without their knowledge; ‡ Limiting key flexibilities on injunctions, including in patent cases, that are necessary for government use, for courtordered royalties, and for innovation prizes and other policies that de-link cost of research and development from the price of products. ‡ Expanding its scope to patents in many areas of the agreement, which is an inappropriate subject of a counterfeiting policy;

In transit seizures
‡ 1986 EU reg 1383, TM counterfeiting only ‡ 1994 copyright + ex officio ‡ 1999 patents
± reflects frequent requests from the trade association concerned EC Green Paper

‡ 2008: Sisvel v. Sosecal (Holland): manufacturing fiction ‡ 2009: 20 medicine shipments detained, 50% destroyed

Previous Int l Law
Paris Convention Art. 9(4): The authorities shall not be bound to effect seizure of goods in transit. GATT Art. V(3): Any contracting party may require that traffic in transit through its territory be entered at the proper custom house, but, except in cases of failure to comply with applicable customs laws and regulations, such traffic coming from or going to the territory of other contracting parties shall not be subject to any unnecessary delays or restrictions . . . TRIPS Art. 51, FN no obligation to apply in transit

‡ Art. 44-50: judicial border measures. ‡ Art. 51-52: Border measures authorized by non-judicial competent authority ‡ Art. 52. Any right holder initiating the procedures under Article 51 shall be required to provide . . . . that, under the laws of the country of importation, there is prima facie an infringement

Article 51 Suspension of Release by Customs Authorities Members shall, in conformity with the provisions set out below, adopt procedures to enable a right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. Members may enable such an application to be made in respect of goods which involve other infringements of intellectual property rights, provided that the requirements of this Section are met. Members may also provide for corresponding procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories.

ACTA, Art. 2.6
[1. Each Party shall provide procedures for import [and in-transit] shipments . . . [for] [goods suspected of infringing an intellectual property right] See also FN 20. shall . . . be applied to shipments of goods consigned to {a local party/a party in the territory} but destined for outside the territory FN 22 under the law of the country in which the procedures set out in this Section are invoked. P. 11, para 2: under the laws of the Party providing the procedures, ‡ Will it apply to intransit? ‡ Will it apply to all IP? Not patents? All TM infringements (including confusingly similar? ‡ Applying law of the in transit country violates Art. 52 of TRIPS.

Confusingly Similar?
‡ Ex officio ‡ In transit ‡ Detain based on suspicion ‡ 2009 Frankfurt seizure, 3,047,000 pills of generic amoxicillin because similar to MERK TM Amoxil

Alternative, ACTA p. 12
[As an alternative to procedures in Article 2.6.1 and 2.7.1 relating to export or intransit shipments, each Party shall provide that where shipments are exported from that Party, or shipments are in-transit through that Party, it shall cooperate to provide all available information to the destination Party, upon request of the destination Party, to enable effective enforcement against shipments of infringing goods.] ‡ Note: only applies to destination Party

Intermediary Liability
ACTA Civil Enforcement, Article 2.X.2: The Parties [may] shall ensure that right holders are in a position to apply for an injunction against [infringing] intermediaries whose services are used by a third party to infringe an intellectual property right. Fn 8: conditions and procedures relating to such injunction will be left to each Party s legal system.

‡ No knowledge requirement. ‡ APIs ‡ Other sections provide for damages, seizures, destruction of means

Flexibilities on Injunctions
In civil judicial proceedings concerning the enforcement of [intellectual property rights], each Party shall provide that its judicial authorities shall have the authority [subject to any statutory limitations under its domestic law] to issue [against the infringer an injunction aimed at prohibiting the continuation of the] [an order to a party to desist from an] infringement, TRIPS Art. 44(2) [W]here these remedies are inconsistent with a Member s law, declaratory judgments and adequate compensation shall be available.

Expansions to Patents
ACTA Text on Patents ‡ Injunctions ‡ Damages lost profits calculations ‡ Destruction of goods ‡ Information on distribution chain ‡ Intermediary liability ‡ Border measures [?] TRIPS council notes: One said generic medicines would not be affected since ACTA does not deal with patents.

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