SPC

A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.

Biologics, Scope of protection, SPC, Validity

(Hoffmann Eitle)/

The German Federal Patent Court (FPC) has recently published its first decision (3 Ni 28/11 of 2 May 2012 “Ranibizumab”, GRUR 2013, 58) dealing with the interpretation of related CJEU Judgments “Medeva” (C-322/10) of 24 November 2011 and “University of Queensland” (C-630/10) of 25 November 2011. In the view of the FPC, the infringement test, which had been utilized by the German Federal Court of Justice in examining the condition of Art. 3(a) of the Regulation, can thus no longer be relied upon. Further, the FPC ruled that the requirement that an SPC can only be granted for active ingredients which are specified or identified in the wording of the claims of the basic patent, applies likewise to products of single active ingredients and combinations of active ingredients.

NPE, SPC, United Kingdom

(Bristows)/ /1 Comment

When the legislation creating supplementary protection certificates (now consolidated in Regulation 469/2009/EC (the “SPC Regulation”)) was first introduced in 1993 no-one could have foreseen the deluge of CJEU references on the interpretation of this “uniform solution” that was to follow. As recently as autumn 2011, one might have expected (or at least hoped) that the…

Enforcement, France, Germany, Injunction, Netherlands, SPC, United Kingdom, Validity

(Rospatt Osten Pross)/

Almost one year ago the European Court of Justice (CJEU) “clarified” the law on supplementary protection certificates. On November 24, 2011 it rendered its verdict in the “Medeva” case (C-322-10). One should not forget that “Georgetown” (C -422/10) was rendered on the same day and only one day later, the Yeda (C-518/10), Queensland (C-630/10) and…

Belgium, Case Law, Injunction, SPC

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The Brussels Court of Appeal issued a preliminary injunction against Eurogenerics on the basis of Lundbeck’s Belgian SPC for escitalopram, despite the fact that the SPC had been invalidated in earlier proceedings, the court found that, given the suspensive effect of the appeal against the decision invalidating the SPC, a preliminary injunction could be granted…

Spain, SPC

(Clifford Chance)/

Until recently, cases involving “Supplementary Protection Certificates” (so-called “SPCs”) were relatively rare in Spain. This is due to the fact that, as a consequence of the transitional provisions of article 21 of Regulation 1768/1992 (the “SPC Regulation), SPCs became available in Spain later than in other European Union member states. However, over the last few…

European Union, France, Injunction, Procedure, SPC

(Véron & Associés)/

On 8 June 2012, the Tribunal de Grande Instance of Paris rendered an interesting decision concerning Losartan. It particularly deals with two questions: the conditions of the SPC’s paediatric extension (Regulation (EC) No. 1901/2006) and the preliminary injunction as organized by Article L. 615-3 (implementing Article 9 of Directive (EC) No. 2004/48) of the French Intellectual Property Code. The US company E.I….

Injunction, Procedure, SPC, United Kingdom

(Bristows)/

Merck Sharp Dohme Corp. and Bristol-Myers Squibb Pharmaceuticals Limited v. Teva Pharma B.V. and Teva UK limited On 15 March 2012, the High Court in England and Wales delivered some useful guidance on when a patentee can obtain an interim injunction in a pharmaceutical patent infringement action. The case was Merck Sharp Dohme Corp. and…