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cause for concern. For instance, proposals in the EU-CAN FTA under negotiation remarkably
expand the scope of information that can be requested in IP infringement proceedings.100
91. The most important provisions of the EU-CAN (Andean Community of Nations) proposal
remain those establishing criminal sanctions for IP infringement. Whereas TRIPS mandates
“criminal procedures and penalties to be applied at least in cases of wilful trademark
counterfeiting or copyright piracy on a commercial scale”, the proposal encompasses intentional
infringement on all IP rights, including patents with sanctions ranging from imprisonment,
monetary fines, confiscation of equipment and products, destruction of goods to permanent
closure of involved establishments. Criminalizing patent infringement is particularly worrisome
given that patents challenged in court by alleged infringers are often found to be invalid.101 Such
overreaching provisions, with a low evidentiary standard, may have a chilling impact on
producers of generic medicines who could be threatened with sanctions before the validity of the
patent is even determined.
92. Furthermore, TRIPS-plus IP enforcement can adversely impact access to medicines. In this
regard, the Special Rapporteur is concerned with reports of IP enforcement measures that have
resulted in multiple seizures at some ports of shipments of generic medicines heading to
developing countries and LDCs.102 Customs regulations of some countries allow the seizures of
goods suspected of IP infringement even if they are only in transit.103 Such regulations impose a
far higher standard of IPR enforcement than that required by TRIPS, which requires that IP
enforcement measures should not create barriers to legitimate trade.104 In effect, such actions
can bring to naught TRIPS flexibilities exercised by developing countries and LDCs, and
de facto impose IP protection on LDCs that are not yet required to comply with TRIPS as
generic medicines they need do not reach them. In particular the use of compulsory licensing or
the 30 August decision to export and import medicines is effectively negated.
100
In addition to the requirement mandated by the TRIPS Agreement that the infringing party
provide the information, the EU proposal would also require any other person who was found in
possession of, using, or providing the infringing goods or services on a commercial scale to
provide the information.
101
See “Generic drug entry prior to patent expiration: an FTC study”, Federal Trade
Commission, July 2002, and K.A. Moore, “Judges, juries and patent cases - an empirical peek
inside the black box”, Michigan Law Review, vol. 99, No. 2 (November 2000) p. 365.
102
See Statement by Brazil at TRIPS Council: Public Health dimension of TRIPS Agreement,
3 March 2009 and UNITAID, statement on Dutch confiscation of medicines shipment,
4 March 2009.
103
EU Council Regulation (EC) No. 1383/2003.
104
Article 41, TRIPS Agreement.
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