Ensuring an SPC Filing is Granted


This article was first published in the Global Legal Group: Pharmaceutical Advertising Guide 2009.

The increasing gap between the commencement of a pharmaceutical patent term and the regulatory approval of a pharmaceutical product protected by the patent, and consequent erosion of the effective term of patent protection, led in the 1980s to lobbying for some form of patent term extension for pharmaceutical patents. In the European Union this led to the creation of the Supplementary Protection Certificate (SPC) under Regulation (EC) No 1768/92 (the Regulation)1. This introductory section outlines the main provisions of the Regulation that govern the allowability of an application for a SPC and the key European Court of Justice (ECJ) judgments that interpret these provisions. The subsequent sections address application procedures and judgments in the key EEA States.

As is well known, a SPC extends to the owner the same rights as were conferred by his patent with the important difference that it only protects the "'product" for which a marketing authorisation for a "medicinal product" has been granted. Many of the difficulties in the interpretation of the Regulation arise from the fact that it addresses an interface between the law relating to patents and the law relating to the regulation of medicinal products. In outline the Regulation is simple enough to understand: the patent owner chooses in each Member State a suitable local patent ("the basic patent") protecting the medicinal product which will be authorised pursuant to Directive 2001/83 (or centrally under Regulation 726/2004); the "product" cannot already have been the subject of a SPC in that Member State and an entity may not have more than one SPC covering the drug active in each Member State; the application for the SPC must be made within six months of the first marketing authorisation for the medicinal product in the Member State or of the grant of the basic patent in that State, whichever is the later, and is filed with the national Patent Office for that State; the SPC comes into force when the basic patent expires and it expires 15 years from the first marketing authorisation in the EEA, subject to a maximum term of five years; and the SPC can be invalidated inter alia on the same grounds that the basic patent could have been. Additionally, as now to be discussed, a SPC can be invalidated for the reason that it should not have been granted in the first place for formalistic reasons and/or that the basic patent does not cover the subject matter of the SPC.

To read the full article please click here.