Summary of product characteristics (SmPC)

The summary of product characteristics is the document, annexed to the marketing authorisation and approved by the authority, that sets out the conditions of use of the medicinal product for healthcare professionals. Its content is laid down by Directive 2001/83/EC. It is authoritative on indications, posology, contraindications and adverse reactions, and it is the reference with which the package leaflet, the labelling and advertising must comply.

Content of the summary

The summary includes the name of the medicinal product, its qualitative and quantitative composition in active substances and in those excipients knowledge of which is essential for proper administration, its pharmaceutical form and the clinical particulars, namely therapeutic indications, posology and method of administration, contraindications, warnings, interactions, use during pregnancy and lactation, adverse reactions and overdose. It then sets out the pharmacological properties and pharmaceutical particulars, such as shelf life and storage precautions. Finally, it states the holder and the number and date of the authorisation. Any change to this information requires a variation of the authorisation.

The generic’s summary and the skinny label

The summary of product characteristics of a generic medicinal product in principle reproduces that of the reference medicinal product. The Directive nevertheless allows the generic to omit those parts relating to indications or dosage forms still covered by patent law at the time it is marketed. This practice, known as the skinny label, makes it possible to obtain and exploit an authorisation limited to unprotected indications while a second medical use patent still covers another indication.

The summary in patent litigation

The summary is a central exhibit in pharmaceutical litigation. It establishes the composition, strength and posology of the allegedly infringing product, and makes it possible to compare those elements with the claims. For use claims, carving out an indication is not always enough to eliminate the risk. The patent holder may argue that the generic will in fact be prescribed and dispensed for the protected indication, which raises the question of indirect infringement or of manufacturing the product with knowledge of its protected use. European courts do not approach this question uniformly, and the Unified Patent Court will have to clarify its position.

Key points

The summary of product characteristics is the regulatory identity card of the medicinal product, approved by the authority, with which all communication about the product must comply. A generic may remove from it the indications still protected by a patent, without that carve-out guaranteeing the absence of infringement. In any pharmaceutical dispute, the competing product’s summary should be filed in evidence, its indications compared with the claims, and any evidence outside the summary revealing use in the protected indication examined.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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