Transcript Presentation - American University Washington College of Law

ACTA: Risks of Third-Party
Enforcement to Access to
Medicines
Oct. 28, 2010, Public Consultation: UN Special Rapporteur on Health
Professor Brook K. Baker
Northeastern U. School of Law, Affiliate: Program on Human Rights and the Global
Economy;
Honorary Research Fellow, University of KwaZulu Natal, S. Africa;
Health GAP (Global Access Project)
Intermediary Liability – April Text
Art. 2.X.2
“The Parties [may] shall ensure that right
holders are in a position to apply for an
injunction against intermediaries whose services
are used by a third party to infringe an
intellectual property right.”
Art. 2.5X also allowed interlocutory injunctions
to prevent imminent infringement of any IP
right on the same grounds.
Third-Party Enforcement – Oct. Text
Dispute whether Section 2: Civil Enforcement will apply to any
and all intellectual property rights or whether patents will be
excluded as proposed by the US (fn. 2).
Art. 2.X.1: “[J]udicial authorities shall have the authority to issue
an order … to a third party over whom the relevant judicial
authority exercises jurisdiction, to prevent infringing goods from
entering into the channels of commerce.
Art. 2.5.2(a): “[J]udicial authorities shall have the authority to
order provision measures … against a third party over whom the
relevant judicial authority exercises jurisdiction, to prevent an
infringement of any intellectual property rights from occurring, and
in particular to prevent infringing goods from entering into the
channels of commerce."
Preventing IP Violations & Products
Entering into Channels of Commerce
Prevent any IPR violation (provisional measures)
Prevent entering: how long, deep, and wide are
the channels of commerce?
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•
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Upstream liability: API and other component suppliers
Midstream liability: exporters, distributors, shippers,
importers
Deep-stream liability:
• Funders and buyers: PEPFAR, Global Fund, UNITAID, IDA,
MSF, UNICEF, national procurement agents
• Enablers: lawyers, factory workers
• Regulators: drug regulatory authorities
Additional Threats: Trademark
Confusion, Information, Criminal Liability
Although coverage of patents represents biggest threat,
potential coverage of trademark confusion in transit
countries could also adversely impact trade in legitimate
generic medicines.
Art. 2.4 requires production of information "regarding any
person or persons involved in any aspect of the
infringement and regarding the means of production or
distribution channel of such goods and services.”
Art. 2.14.4 (applying to trademark & copyright only)
provides that "Each party shall ensure that criminal
liability for aiding and abetting is available under its law."
Future Threats
PhRMA wants more – clear application to
bulk chemicals and downstream
distribution
ACTA plus trade pressures – FTAs/EPAs,
Special 301, technical assistance
Adverse impacts on generic incentives
and int’l trade of legitimate generics.