The impact of the EU Enforcement Directive on Dutch IP litigation London, October 5, 2009 Otto Swens Vondst Advocaten Van Leijenberghlaan GG Amsterdam The Netherlands t: f: e:

Topics 1.Enforcement Directive 2004/48/EG 2.Dutch implementation 3.Securing of evidence 4.(Ex Parte) injunctions 5.Costs recovery

1. Enforcement Directive 2004/48/EG Adopted in 2004 Implementation by 29 April 2006 Introduction of new, far reaching enforcement possibilities in intellectual property

1. Enforcement Directive 2004/48/EG (2) Directive based on Part III TRIPS Article 43 : Evidence Article 6 and 8 Directive Article 50 sub 1(a) and (b): preventive injunction or protection of evidence Article 9(1) a – b Directive Article 50 sub 2: ex parte without the other party having been heard,in particular when irreparable harm or demonstrable risk of destruction of evidence Article 7(1) and 9(4) Directive

1. Enforcement Directive 2004/48/EG (3) Purpose of the Directive is to provide for: if necessary, ex parte effective (complexity / costs / time), proportional, and dissuasive measures to prevent and sanction IP infringement and to safeguard evidence and prevent destruction; Fair, reasonable, and in line with EHCR (respect defendants rights) Safeguards against abuse (confidential information).

2. Implementation in Netherlands New section in Dutch Code of Civil Procedure: Of legal procedure in relation to rights concerning intellectual property Articles 1019(a) – 1019(i) Late implementation (1 May 2007 instead of 29 April 2006)

3. Securing of evidence Articles 1019 (b), (c) and (d) Dutch Code of Civil Proceedings. Step 1: Seizure Step 2: Access No saisie contrefacon, no juge rapporteur, no UK style discovery

3. Securing of evidence (2) Procedure Written request filed with the Preliminary Relief Judge Procedural laws apply, but generally ex parte; surprise element is the key factor Rejection: merely a short motivation No appeal possible but, Glaxo Group / Pharmachemie (July 2009): Administrative Appeal rejection is an Administrative Decision (withdrawn, no outcome, uncertain)

3. Securing of evidence (3) Procedure very informal If judge finds request not convincing or too broad, he will contact lawyer by phone, discuss his objections and the lawyer will be given opportunity to amend If Judge finds there is a risk of disclosing confidential information, he will contact lawyer by phone: withdraw request or defendant is heard… DC The Hague: we are always suspicious (pro infringer?) / are there alternatives? But: presumption of validity in patent cases. Practices differ per court…

3. Securing of evidence (4) What should the IP right owner prove? Sufficiently convincing argument of infringement (threat) DC The Hague, Abbott / Teva (July 2007):Threshold is lower than in preliminary relief proceedings. DC The Hague, Synthon / Astellas (July 2007):(threat of) infringement may also exist outside NL

3. Securing of evidence (5) Preventing abuse and fishing expeditions Pre-emptive: make application black or grey (no formal rules / differs per court always try!) During seizure: Bailiff preliminary relief proceedings – 438(4) DCCP (DC Maastricht, Medtronic / Abbott (July 2008) After seizure: immediate lift proceedings (leave may contain date and time for possible hearing to lift the seizure (generally within 1-2 weeks, ultimately; 20 working days / 31 days) Also: liability for damages

3. Securing of evidence (6) Examples of safeguarding confidentiality DC The Hague, Wuesthoff / Grünewald (April 2008) confidentiality declarations required no copies of administration allowed Not all days and times DC The Hague, PCV2 (December 2008): packed and sealed description selection and description samples by independent patent attorney

3. Securing of evidence (7) How is the seizure executed? Judge determines how in the leave (detailed!) Bailiff executes the seizure Independent technical expert can accompany bailiff, if necessary (patent cases) Representatives of parties allowed, unless objection by seizee or confidentiality issues No obligation to use leave immediately ( problems…)

3. Securing of evidence (8) What can be seized?

3. Securing of evidence (9) Detailed description of the infringing products or machines, materials and documents by the bailiff (proces verbaal) Samples of infringing products (or machines), and all materials and products that were used in the process of manufacturing them (no more than 3) Copies of all documents relating to the infringement can be seized (PCs, USB sticks, files, papers etc.) Visual or sounds recordings and photographs

3. Securing of evidence (10) Complex technology independent patent attorney can accompany bailiff and give instructions to bailiff Description can be made by bailiff of confidential - description in general terms, content of document cannot be part of the description. Samples / other seized materials are moved away and held in custody by a custodian (appeal possible!) Custodian appointed by the Preliminary Relief Judge.

3. Securing of evidence (11) When will the court lift an evidence seizure? DC The Hague Trendhopper (December 2008): urgent interest required. DC The Hague, Tieleman / Meyn (May 2008): Ex parte injunction lifted because provisional view is that the patent is invalid evidence seizure not lifted! DC Arnhem, Synthon/Astellas (July 2007): threat of infringement is not in the Netherlands is no reason to lift

3. Securing of evidence (12) Access to seized evidence? Proces-verbaal: yes, but restricted (PVC2 vaccin case) Other seized evidence (videos, photographs, administration etc.): no, and also use in subsequent infringement proceedings not allowed! Purpose is not to collect evidence, but to preserve evidence (DC The Hague / DC Maastricht / DC Den Bosch in Abbott / Medtronic (2008), DC The Hague, John Deere (April 2008) Exception: DC The Hague, Meissen / Deko (April 2008): Tremendous Piracy

3. Securing of evidence (13) Access must be obtained in separate, follow-up proceedings (843a DCCP) Access allowed Yes, if it concerns evidence is needed to establish if there is an infringement No, if it concerns evidence to establish extent, territory or duration of infringement Appeal Court Den Bosch, Abbott / Medtronic (March 2008), DC The Hague, Abbott / Medtronic (March 2008)

3. Securing of evidence (14) Often applied trick to obtain evidence and immediate access: Send warning letter not only to manufacturer, but also to user of infringing machine (buyer etc.), and withdraw claim against the user in return for access to machine (photographs, video etc.)

4. Ex Parte injunctions Enforcement Directive: ex parte injunction awarded where necessary, in particular in situations where a delay may cause irreparable harm to the IP right owner Implemented in in the Netherlands in article 1019 (e) Dutch Code of Civil Proceedings.

4. Ex Parte Injunctions (2) High threshold for assumption of infringement! No reasonable doubt, DC The Hague, Schoone lei (August 2008) Urgent interest: DC Haarlem: higher urgency required than in preliminary relief proceedings. DC The Hague does not agree. Stronger precautions concerning abuse Due process (date for hearing immediately scheduled)

4. Ex Parte injunctions (3) Ex parte injunctions in patent cases? DC The Hague has exclusive jurisdiction Request must include information on invalidity proceedings or opposition proceedings Exceptional, but possible when, e.g. : Repeated infringement; Against a distributor when infringement against manufacturer has already been decided (DC The Hague, Novartis / Friederichs (March 2009)

5. Recovery of costs Article 14 ED: compensation for reasonable and proportionate legal costs and other expenses. Before implementation very small awards, even in complicated patent cases. Immediate after implementation awards for full costs of the proceedings. 1019h DCCP

5. Recovery of costs (2) Nowadays more balanced with national (courts) Guideline (only applies to cases in first instance) Trade mark, design and copyright cases: fixed amounts (unless…). Patent cases: full costs, incl. legal assistance and patent attorney assistance.

5. Recovery of costs (3) Downside: detailed specification for costs must be provided to the court. The parties can also agree on an amount and inform the court of their agreement on costs. Manage risk of costs Avoids sending invoices to the Court Pizzagate Dutch courts accept this practice

Any questions…? Otto Swens Vondst Advocaten Van Leijenberghlaan GG Amsterdam The Netherlands t: f: e: