A/HRC/11/12 page 27 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.

Select target paragraph3

Connect to a paragraph
Connect to an entity
Disable highlights
Add to table of contents