"8+2+1" rule

The « 8+2+1 » rule summarises the term of the regulatory protection attached to the dossier of a reference medicinal product in the European Union. It combines eight years of data protection, two years of market protection and a possible additional year for a new indication. It derives from Article 10 of Directive 2001/83/EC and, for medicinal products authorised through the centralised procedure, from Regulation (EC) No 726/2004. It gives concrete shape to the regime of data exclusivity.

How the three periods work

• For eight years from the first authorisation of the reference in the Union, no application for authorisation of a generic or biosimilar may rely on its dossier.
• From the eighth to the tenth year, the application may be filed and examined and the authorisation granted, but the product may not be marketed.
• Market protection is extended to eleven years where the holder obtains, during the first eight years, a new therapeutic indication bringing a significant clinical benefit.

Rules of computation

The period runs from the first authorisation in the Union, regardless of the State in which authorisation is subsequently sought. Later variations and extensions, such as new strengths, forms or routes of administration, are attached to the global marketing authorisation and do not start a new period. Only a new active substance starts a new clock. The additional year can be obtained only once. This regime applies to reference products for which the application was filed after the 2004 reform became applicable, in autumn 2005, older products remaining subject to the previous terms of six or ten years depending on the State.

Interplay with the patent and the certificate

Regulatory protection is independent of the patent. It becomes decisive where development has been lengthy, since the basic patent, even when extended by a supplementary protection certificate, may then expire before the tenth or eleventh year following authorisation. It also operates on its own where the molecule is no longer patentable or the patent has been held invalid. A reform of EU pharmaceutical legislation, launched by the Commission in 2023, provides for changes to these terms, and its progress should be checked before any analysis.

Key points

The « 8+2+1 » rule sets the baseline protection for every reference medicinal product, whatever the position of its patents. The date of first authorisation in the Union and the scope of the global marketing authorisation should be established precisely, then compared with the dates of the patent, the certificate and any orphan or paediatric exclusivities. The latest date governs the timetable for generic entry, and therefore for legal action.

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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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