Recent developments in interim injunctions

1. Recent developments in interim injunctions Biotech & Pharmaceutical Patenting Conference Munich, February 17-18, 2010 Otto Swens - Vondst Advocaten

2. Interim Injunctions 3 scenarios Netherlands UK France Germany

3. SCENARIO 1 • The basic patent for a medicinal product is about to expire (or has just been revoked), but several follow up patents are still in force. • The patentee has learned that a generic company will enter the market any moment with a generic product that it believes infringes one of the follow up patents. Will the patentee be able to obtain an interim injunction?

4. SCENARIO 1: The Netherlands • 1 judge, judgment in 3-4 months • (imminent) infringement  urgency given • No balance of convenience, decision on the merits • Is the patent infringed? • Is there a serious, non negligible chance that the patent will be revoked? • Provisionally enforceable • Cross-border injunction still possible (in spite of ECJ in GAT/LuK)! • No cross-undertaking for damage required / bond is rare

5. SCENARIO 1: The Netherlands What constitutes a threat of infringement? • Has the generic company refused to sign undertaking not to infringe • Has an MA or - in the case of a medical device - CE Mark been granted? • Has the generic company filed a price in the relevant standard (G-Standard of Z Index B.V.) • Has a reimbursement price been determined? • Are there other circumstances that indicate an imminent market entry?

6. SCENARIO 1: The Netherlands Please note: The fact that an MA has been granted and/or the generic company refuses to sign an undertaking not to infringe does not constitute a ‘threat of infringement’ and thus, in that situation, an injunction will not be granted. Sunset clause does not make this different. District Court The Hague, 7 April 2008, Eli Lilly v Ratiopharm

7. Possible factors of influence • Other generics on the market: NL  NO • Revocation proceedings against the follow up patent are pending: NL  NO • If the basic patent was invalidated in a first instance decision: will the filing of an appeal against this decision be of influence: NL  NO • Invalidation of follow up patent by Opposition Division with an appeal pending:NL  YES, DC The Hague gives its own decision, but takes OD / BoA decision seriously. If follow up patent was amended by OD, that version is the one to be decided upon (unless evident error).

8. SCENARIO 1: UK / GERMANY UK: • Balance of convenience decision  Market situation important • Cross-undertaking for damages • Servier / Apotex (“duopoly”? / 67% vs 33%) • KCI / Smith & Nephew (novelty in cross-undertaking: customers can claim damages?) Germany: bifurcated system, otherwise situation more or less similar to the Netherlands

9. SCENARIO 1: FRANCE • Interim injunctions very difficult to obtain • Decision on the merits / weighing of interests of both parties • Only when infringement has occurred (evidence of infringement necessary) • BUT: “also when infringement is imminent” • Mundipharma and Grunenthal vs Mylan – Court of Appeal Lyon, 20 October 2009 • Remains to be seen whether Paris courts will follow this decision

10. SCENARIO 2 • As in Scenario 1, but the patentee wishes to obtain an ex parte interim injunction?(an injunction without hearing the allegedly infringing generic company) Is this possible?

11. SCENARIO 2: The Netherlands • 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.

12. SCENARIO 2: The Netherlands 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)

13. SCENARIO 2: UK / Germany / France UK and France: possible, but very rare, only in exceptional circumstances Germany: possible • einstweilige verfügung • Rare in pharmaceutical and biotech patent cases, since they are generally considered too complicated to deal with ex parte

14. SCENARIO 3 • A patent is declared invalid in first instance and an infringement injunction on the basis of the patent is denied. • The patentee believes the judgment is clearly flawed. • The patentee lodges an appeal, but also still wants to try to obtain interim injunctive relief. Does the patentee have any chance of succeeding?

15. SCENARIO 3: The Netherlands Unlikely • Preliminary Relief Judge The Hague 8 July 2009, Novartis v Actavis. • The preliminary relief judge proceedings must follow the judgment on the merits, except when (cumulative): • Evident error, and • So urgent that the judgment in appeal can not be awaited. • Not applying ‘problem solution’ approach is not an ‘evident error’

16. SCENARIO 3: UK / France / Germany • UK and France: highly unlikely, no known examples • Germany: possible, but rare • Bifurcated system • Oberlandesgericht Dusseldorf, Eli Lilly / Stada (olanzapine), 29 May 2008

17. Any questions? Mr. Otto Swens, Vondst Advocaten Van Leijenberghlaan 199 1082 GG Amsterdam The Netherlands t: + 31 20 504 20 00 f: + 31 20 504 20 10 e: otto.swens@vondst-law.com