EU Patent Term Extensions: Zeroing in on Zero-Term SPCs

Author:Mr Martin Weber, Christian B. Fulda and Jens P. Grabenstein
Profession:Jones Day
 
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Patent holders beware: The European Court of Justice has been requested to decide on zero-term Supplementary Protection Certificates ("SPC") for patents covering pharmaceutical products for human use. The current patchwork of national practice will therefore be soon harmonized—one way or the other. This Commentary provides a background to the request submitted by the German Federal Patent Court, summarizes the request, and alerts patent holders to the potential impact of the upcoming decision. Background SPCs are granted under the European legislation (originally by Regulation no. 1768/92/EEC, codified by Regulation no. 469/2009/EC, the "SPC Regulation") to extend protection for, among others, pharmaceutical products. At first glance, it therefore seems counterintuitive that a zero-term or even negative-term SPC should be sought by patent holders, let alone granted by some European patent offices. However, an SPC may be extended in turn under Regulation (EC) 1901/2006 (the "Pediatric Regulation"). Given the economic benefits of extending exclusivity by a few months (especially for a blockbuster drug), manufactures have demonstrated a keen interest in obtaining zero- or negative-term SPCs. The Pediatric Regulation aims at facilitating the development and accessibility of medicinal products for use in the pediatric population. To improve the information available on the use of medicinal products in the pediatric populations, the regulation establishes a system of both obligations and incentives to ensure that performing clinical trials in the pediatric population becomes an integral part of the development of medicinal products for the general population. Provided that (a) all the measures included in a pediatric investigation plan ("PID") approved by the European Medicines Authority EMA are complied with, (b) a medicinal product is authorized in all Member States, and (c) relevant information on the results of studies in pediatric populations is included in the product information, a reward is granted in the form of a six-month extension of the SPC. An application for an extension of the duration of the SPC pursuant to the Pediatric Regulation is only admissible where a certificate is granted pursuant to the SPC Regulation. An SPC supplements the protection of a basic patent covering the active ingredient of a medicinal product for which marketing authorization has been granted by providing additional exclusivity for up to a maximum of five years. The...

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