Recent Advances in Interim Injunctions: Biotech and Pharmaceutical Patenting in Europe
The conference addresses the complexities of interim injunctions in biotech and pharmaceutical patenting across various jurisdictions, including the Netherlands, UK, France, and Germany. Three scenarios present different challenges faced by patentees seeking injunctions: 1) Threat of imminent generic competition, 2) Ex parte injunctions for urgent relief, and 3) Appeals following invalidated patents. Key insights into judicial processes, urgency assessments, and the balance of convenience are discussed, highlighting the nuanced differences across European jurisdictions.
Recent Advances in Interim Injunctions: Biotech and Pharmaceutical Patenting in Europe
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Presentation Transcript
Recent developments in interim injunctions Biotech & Pharmaceutical Patenting Conference Munich, February 17-18, 2010 Otto Swens - Vondst Advocaten
Interim Injunctions 3 scenarios Netherlands UK France Germany
SCENARIO 1 • The basic patent for a medicinal product is about to expire (or has just been revoked), but several follow up patents are still in force.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?
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
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?
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
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).
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
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
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?
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.
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)
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
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?
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’
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
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
