Keywords
Summary

Keywords

Approximation of laws – Uniform legislation – Industrial and commercial property – Patent right – Supplementary protection certificate for medicinal products – Duration of the certificate

(European Parliament and Council Regulation No 1901/2006, Art. 36; Council Regulation No 1768/92, Art. 13)

Summary

On a proper construction of Article 13 of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation No 1901/2006 on medicinal products for paediatric use, read in conjunction with Article 36 of Regulation No 1901/2006, medicinal products may be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the date of the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.

If the supplementary protection certificate application had to be refused because the calculation provided for in Article 13(1) of Regulation No 1768/92 results in a negative or zero duration, the holder of the basic patent could not obtain an extension of protection conferred by such a patent, even if it has conducted all the studies according to the approved paediatric investigation plan, under Article 36 of Regulation No 1901/2006. Such a refusal would be capable of compromising the useful effect of Regulation No 1901/2006 and could jeopardise the objectives of that regulation, namely, the compensation of effort made to evaluate the paediatric effects of the medicinal product at issue.

Consequently, it follows from Regulation No 1768/92 read in conjunction with Regulation No 1901/2006 that the supplementary protection certificate and the paediatric extension together confer on the holder of the basic patent an exclusive right of a maximum duration of 15 years and 6 months from the date of the grant of the first marketing authorisation for the medicinal product in question in the Union.

It follows from that maximum duration that a paediatric extension is of use if the negative duration of a supplementary protection certificate is not more than six months. In other words, the objective of Regulation No 1901/2006 is achieved where the holder of the basic patent obtained its first marketing authorisation for the medicinal product in question in the European Union during a period between four and a half and five years after the basic patent application. Therefore, a supplementary protection certificate may be granted when a period of less than five years has elapsed between the date of the application for a basic patent and the date of the first marketing authorisation.

It follows that the grant of a supplementary protection certificate cannot be refused by reason only of the fact that the duration determined in accordance with the calculation rules laid down in Article 13(1) of Regulation No 1768/92 is not positive.

As to the question concerning the time at which the paediatric extension of six months must begin to run, it must be held that, in the case in which the period that has elapsed between the date on which the application for a basic patent was lodged and the date of the first marketing authorisation in the European Union is less than five years, the starting point for that extension cannot be established as the expiry date of the basic patent, so that the duration of that certificate be considered to be equal to zero. Such an approach would be contrary to the calculation rules laid down in Article 13(1) of Regulation No 1768/92, in so far as that provision provides that the duration of a supplementary protection certificate corresponds to the period which elapsed between the date on which the application for the basic patent was lodged and the date of the first marketing authorisation in the Community, reduced by a period of five years. Therefore, where the duration of a supplementary protection certificate is negative, it cannot be rounded to zero. The period of the paediatric extension provided for by Regulation No 1901/2006 starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between lodging the patent application and obtaining the first marketing authorisation.

(see paras 37-42, 45 and operative part)