Additional year of protection for a new indication

The additional year of protection for a new indication extends the market protection of a reference medicinal product by one year, from ten to eleven years. It is provided for by Article 10(1) of Directive 2001/83/EC and by Regulation (EC) No 726/2004 for medicinal products authorised through the centralised procedure. It rewards the development, in the early years of the product’s life, of an indication that brings genuine clinical progress.

Conditions for grant

The new therapeutic indication must be authorised within the first eight years following the first authorisation of the reference in the Union. In addition, during the scientific evaluation prior to its authorisation, it must be held to bring a significant clinical benefit in comparison with existing therapies, having regard in particular to improved efficacy, better safety or a major contribution to patient care. This benefit is assessed under the Commission’s guidelines and, for centrally authorised products, on the basis of the opinion of the Committee for Medicinal Products for Human Use (CHMP). The year is granted only once, regardless of the number of new indications.

Distinction from other forms of protection

The additional year forms part of the « 8+2+1 » rule and benefits the medicinal product as a whole, not only the new indication. It must not be confused with the non-cumulative year of data protection that Article 10(5) of the Directive grants to a new indication for a substance in well-established use where significant pre-clinical or clinical studies have been carried out. It also differs from paediatric rewards, which require completion of a paediatric investigation plan.

Link with patents and litigation

The new indication may be protected by a second medical use patent. It does not, however, give entitlement to a new supplementary protection certificate, since the Court of Justice of the European Union holds that an authorisation covering a new use of an active ingredient already authorised is not the first authorisation within the meaning of Regulation (EC) No 469/2009. The additional year is thus often the only regulatory protection attached to the indication. Its grant postpones the marketing of all generics by one year, and generic manufacturers check for it in the European public assessment report (EPAR).

Key points

The additional year requires an indication authorised within the first eight years and recognised as bringing a significant clinical benefit. For the holder, the development strategy should build in this timetable and document the benefit from the variation application onwards. For the generic manufacturer, the authorisation decisions and assessment reports should be checked to see whether the year has been granted before setting the launch date.

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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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