WRITTEN QUESTION E-2360/01

by Cristiana Muscardini (UEN) to the Commission

(6 August 2001)

Subject: Continuing anomaly regarding supplementary patent protection certificates for Italian medicinal products

Under Article 1 of the Italian Law No 349 of 19 October 1991, holders of a patent for an industrial invention applying in Italy to a medicinal product or a process for the manufacture of such a product may obtain a supplementary protection certificate valid for not more than 18 years from the date on which the patent reaches the end of its legal life. Regulation (EEC) No 1768/92(1) has laid down standard rules governing the issue of such certificates by all Member States with effect from 2 January 1993. Article 20, however, stipulates that the Regulation does not apply to rights acquired before the date of its publication in the Official Journal. Given that the force of the certificates issued under the pre-existing Italian legislation will not expire until 2011, it is clear that products protected by

the Italian legislation are being treated differently from products protected by the other Member States, resulting in a distortion of competition, especially in relation to products protected by certificates issued under the above-mentioned Community Regulation. Among other things, this infringement of competition is severely impeding the movement of what are termed generic drugs.

In the light of the foregoing:

1. Does not the Commission believe that the issue of supplementary protection certificates valid for the extremely long period provided for in the Italian legislation is contrary to the Treaty rules on free competition?

2. Does it not consider the anomaly in the Italian situation to pose an obstacle to the development of generic drugs?

3. What steps will it take to make Italy remedy the harm that is plainly being done to free competition?

4. To remove the difficulties referred to above, does it not believe that it should propose amendments to Regulation (EEC) No 1768/92?

(1) OJ L 182, 2.7.1992, p. 1.

Answer given by Mr Bolkestein on behalf of the Commission

(17 October 2001)

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (the SPC Regulation) entered into force on 18 December 1992. The SPC Regulation provides an extended period of patent protection for medicinal products which have been subject to mandatory marketing approval at Member State or Community level prior to being commercialised. The SPC Regulation stipulates the conditions which have to be fulfilled for granting a supplementary protection certificate (SPC), as well as the effects and term of such certificates.

SPCs have to be applied for separately in each Member State in which protection is required and their effects are limited to the territories of the Member States in which they are granted.

The Italian law on SPCs pre-dates the SPC Regulation by a little over a year and provides for terms of protection between five and thirteen years longer than an SPC issued according to the Regulation under analogous conditions. However, according to Article 20 of the SPC Regulation, the Regulation does not apply to SPCs granted under national legislation before the Regulation came into effect. This provision is therefore relevant and has the effect of permitting pre-existing Italian SPCs to continue to exist until they expire with the passing of time. The Commission understands that SPCs are no longer issued under the national law and nor have they been since the SPC Regulation came into effect.

While the Commission acknowledges that the difference between the terms of protection granted under the Italian legislation and the SPC Regulation is significant, this difference was known at the time of adoption of the Regulation by the Parliament and the Council and was nevertheless permitted to remain intact for those certificates issued before the Regulation came into effect. This reflects a general reluctance to disturb previously existing rights when harmonising intellectual property within the Community, and implies an acceptance that some degree of disharmony will persist for a transitional period pending expiry of all protection under the previous legislation.

Nevertheless, the Commission is sensitive to the issues raised, and has in this connection received representations from industry on the matter. Further detailed information has been sought in connection with the products covered and the terms of protection granted, and when this is forthcoming the Commission will be in a position to consider whether the effects of the differences in term of protection under the respective instruments during the transitional period are sufficiently serious to warrant action.