Supplementary Protection Certificates (SPCs) are a useful tool in intellectual property (IP) law that allows pharmaceutical companies extra market exclusivity even when their patent has expired. This is permitted in the EU to recognise the long lag time between inventing a new molecule and having it approved and marketed around the Union. Patents on medicines apply for 20 years, but sometimes several of those years are taken up with regulatory and market access procedures. A loss of market exclusivity makes a market less attractive to a manufacturer, so providing SPCs gives a greater incentive to work in a territory.
A judgment by the Court of Justice of the European Union (CJEU) has clarified ambiguity about classification of medicines and devices, summarised below.
Medical devices may include as a component an active substance, which may or may not be separately classed and approved as a drug. Even if the active substance has been granted marketing authorisation (MA) by the European Medicines Agency, the medical device still needs to be separately approved and granted a CE mark. This has given CE marking a status equivalent to MA under the Medicinal Products Directive (MPD) in some patent offices. Others, however, have interpreted the SPC Regulation as only applicable when MA is granted under the MPD, therefore giving inconsistent rulings.
The CJEU has explained that the classification of medical device or medicinal product is mutually exclusive: since a product with a CE mark is not assessed under MPD but all medicines must be, a medical device is not a medicinal product. The CJEU has clarified that Article 2 of the SPC Regulation cannot be interpreted to include CE-marked devices, and therefore SPCs only apply to medicinal products.
MAP will monitor the effects of this decision, and will keep our users informed on the forthcoming reformed SPC Regulation which may alter its wording.