by Howard E. Rosenberg, Ph.D.
This year, 2011, may provide some useful guidance (or even a decision or two) in a couple of key Court of Justice of the European Union ("CJEU") cases regarding European Supplementary Protection Certificates (SPCs)--Europe's version of patent term restoration in the U.S. One case concerns the type of marketing authorization that enable a product to qualify for an SPC and the other case is about the meaning of the term "product" being protected by a basic patent in force.
The first case is actually the combination of two cases (galantamine in Generics [UK] Ltd. v. Synaptech and memantine in Synthon v. Merz), where each drug was marketed for many years in one or more member states prior to the later filing of dossiers which included the full regulatory details and studies that are required by the European Economic Community Directive 65/65/EEC. These subsequent EU-wide authorizations were compliant with 65/65/EEC, and SPCs were obtained based on the new 65/65/EEC authorizations. The combined case before the CJEU raises questions to clarify what constitutes an acceptable marketing authorization (i.e., approval under a national law or only under 65/65) and/or whether products marketed for the first time in the EEC without going through the administrative procedure Directive 65/65 actually fall within the scope of SPC law at all.
The second case concerns the availability of SPCs for Medeva's multi-disease vaccines. The UK has generally rejected applications for SPCs where the applications have been based upon a marketing authorization for a product containing a combination of active ingredients, but where the basic patent has explicitly claimed only one of the components. Recently, the UK court has acknowledged that there may be some doubt as to whether the words "protected by a basic patent in force" in Article 3(a) of the SPC Regulation (EC 469/2009) requires a "direct protection" test (the active ingredients of the authorized product must be both disclosed and claimed in the basic patent) or just an "infringement" type test (does the patent claim at least one of the authorized products and thus a third party would infringe that claim).
The Medeva case, referred to the CJEU, specifically asks what is meant in Article 3(a) of the SPC Regulation by "the product is protected by a basic patent in force" and what criteria should be used in deciding it. It also includes an Article 3(b) question as to whether an SPC is available for an approved medicinal product containing a single active ingredient or combination of active ingredients together with one or more other active ingredients which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market.
If you are interested in SPCs or patent term extension in the U.S., FDA Lawyers Blog's own Brian J. Malkin will be speaking at an inaugural American Conference Institute event focusing on patent term adjustments, patent term extension, and SPCs later this month. For more information and an FDA Lawyers Blog reader discount, see here and here.