1. IPR enforcement in the EU Evidence of impact of on the access to generics Johanna von Braun University of Cape Town, South Africa Kiev, 21/22 nd June 2010

2. Outline Framework of EU IP Enforcement Policy EU Directives – IP enforcement – Border measures  Examples of TRIPS plus provisions Impact of provisions

3. Framework for EU enforcement policy Lisbon Strategy (2000) become most competitive knowledge economy by 2010 – Provide an incentive to invest – Protect the IPRs of European businesses Reflected by EU enforcement directives: – Dir. 2004/48 on enforcement of IPRs – Council Reg 1383/2003 customs action against goods infringing IPRs Strategy for IP Enforcement in Third Countries (2004): Identifying various channels of increasing enforcements, including, FTAs, WIPO, ACTA etc.

4. Directive 2004/48: IP enforcement Objective: -Harmonise IP enforcement standards among EU members -Ensuring a high level of protection in the internal market -Provide a deterrent for future infringement  Many aspects in provision go well beyond the minimum standard of enforcement of TRIPS

5. Scope of Directive Requires members to apply effective, dissuasive and proportionate remedies against infringement of all IPRs Harmonises these remedies without substantive changes to national IP laws Does not affect Members States national provisions relating to criminal procedures BUT attempts have been made to extend criminal procedures to all IPRs – rejected by EU Parliament  Features in many EPA proposals  Raises concerns of skills of judges/courts; possibility of abuse, cost and withdrawal from other enforcement agencies

6. Entitled Applicants TRIPS: right holders can apply to civil judicial procedures EU directive: entitled applicants include: -licensees -professional defense bodies -IP collective rights management bodies

7. Provisional & Precautionary Measures TRIPS: The judicial authorities shall have the authority to order prompt and effective provisional measures to prevent an infringement of any IPR from occurring, and to prevent the entry into the channels of commerce EU Directive:  Parties shall provide for interlocutory injunctions, seizure, payment of damages against any party intended to prevent any imminent infringement of an IPR  In some cases without accused parties being heard  Forbid the continuation of an alleged infringement of that right and prevent the product to move within or enter channels of commerce

8. Payment of Damages TRIPS Agreement calls for adequate damages to compensate right holder for wilfull infringement (Nature of payment and covering of legal expenses left to be decided by courts) EU Directive: compensation must cover all aspects including negative economic consequences, damages, lost profits, moral prejudice OR lump sum Where infringer had reasonable grounds to know Legal costs borne by unsuccessful party

9. Border Measures

10. European Council Regulation 1383/2003: Border Measures TRIPS: procedures shall be made available to ‘enable a right holders who has valid grounds for suspecting (…) the importation of counterfeit trademarks or pirated copyright goods (…) to lodge an application with custom officials to for the suspension by customs authority of the release into free circulation of such good…’ ‘It is understood there shall be no obligation to apply such procedures to imports of goods put on the market in another country by or with the consent of the right holder, or to goods in transit.’ Specific distinction between copyright/trademark infringement and other IPRs No mentioning of ex officio actions.

11. EU Directive 1383/2003: -Custom authorities may suspend release of goods suspected of infringing any IP (including patents, plant varieties, GIs etc) -Goods may be detained, held for a certain period, and even destroyed -Does not only affect goods for import into EC internal market but also export, re-export and in transit - even if in custom free zones -Either because of applicants request or on independent suspicion of custom officials

12. Impact

13. Seizure of Drugs 19+ seizures of generic drugs from India in by custom officials in NL, DE, FR – Losartan (blood pressure) – en route from India to Brazil in Dec 2008 – Patented by Merck in EU, off patent in India and Brazil – Seizure by Dutch custom officials of shipment of medicines to treat 300.000 people one month – Returned to India after release Applicants mostly pharmaceutical companies Some cases ex-officio actions included shipment of UN procurement agencies

14. Systemic Public Health Impact Possible impact on use of TRIPS flexibilities – Questions use of CL / parallel import in transit through Europe – Possible impediment of export licenses under Paragraph 6 Blurring of lines between ‘counterfeit medicines’ and generic drugs – Generic drugs different to intentionally faked / substandard medicines – Buts wrong agency in charge of what should be drug quality assessments

15. Trade Distorting Effect While TRIPS is a minimum standard system – there are ceilings Art. 41.1 – TRIPS procedures shall be applied in a manner to avoid the creation of barriers to legitimate trade – Seizure of legitimate goods in transit – Impeding of legitimate competition – Shifting of escalating enforcement cost of private commercial rights to government and taxpayers – Chilling effect on legitimate trade

16. Conclusion Enforcement provisions are new wave of TRIPS plus provisions which undermine access to medicines Export of legislation raises concerns – ACTA and other multilateral fora – Through FTAs / WTO accession – National developments Brazil/India launch trade dispute (May ‘10) on long list of conflicts with TRIPS/GATT with EU/NL – 60 days to resolve

17. Thank you johanna.vonbraun@uct.ac.za