ACTA v.

Access to Medicines
Sean M. Flynn
Program on Information Justice and Intellectual Property
American University Washington College of Law
 Urgent Communiqué www.pijip.org
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 court-
ordered 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
 TRIPS
• 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 • Will it apply to in-
for import [and in-transit] shipments . . . transit?
[for] [goods suspected of infringing an • Will it apply to all IP?
intellectual property right]
Not patents? All TM
See also FN 20. shall . . . be applied to infringements
shipments of goods consigned to {a local (including confusingly
party/a party in the territory} but similar?
destined for outside the territory • Applying law of the in
FN 22 “under the law of the country in transit country
which the procedures set out in this violates Art. 52 of
Section are invoked.” TRIPS.
P. 11, para 2: “under the laws of the
Party providing the procedures,”
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
• Note: only applies
Article 2.6.1 and 2.7.1 relating to export
or in-transit shipments, each Party shall to “destination
provide that where shipments are Party”
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.]
 Intermediary Liability
ACTA Civil Enforcement, Article 2.X.2: • No knowledge
“The Parties [may] shall ensure that requirement.
right holders are in a position to
• APIs
apply for an injunction against
[infringing] intermediaries whose • Other sections
services are used by a third party to provide for
infringe an intellectual property damages, seizures,
right.” destruction of
Fn 8: “conditions and procedures means
relating to such injunction will be
left to each Party’s legal system.”
 Flexibilities on Injunctions
In civil judicial proceedings TRIPS Art. 44(2)
concerning the enforcement of “[W]here these remedies are
[intellectual property rights], inconsistent with a
each Party shall provide that its Member’s law, declaratory
judicial authorities shall have judgments and adequate
the authority [subject to any compensation shall be
statutory limitations under its available.”
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,
 Expansions to Patents
ACTA Text on Patents TRIPS council notes:
• Injunctions
• Damages – lost profits “One said generic
calculations medicines would not be
• Destruction of goods affected since ACTA
• Information on does not deal with
distribution chain patents.”
• Intermediary liability
• Border measures [?]