Patent decision

BL number

O/044/03

Concerning rights in

SPC/GB/99/012 & SPC/GB/00/013

Hearing Officer

Mr R Walker

Decision date

12 February 2003

Person(s) or Company(s) involved

Novartis AG and Universtiy College London; Novartis AG and Institute of Microbiology and Epidemiology

Provisions discussed

Council Regulation (EEC) No. 1768/92, Art. 13(1)

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

The co-applicants provided authorisations granted in Switzerland in support of their applications but reasoned that these authorisations extended to Liechtenstein and not the rest of the community such that the period of the certificates determined by Article 13(1) should not be calculated on the basis of these authorisations.

This was contrary to the examiner’s preliminary view. References to the first authorisation for placing the product on the market in the "Community" as found in Article 8(1)(c) and 13(1) of the Regulation were considered to have been adapted by point 8 of Protocol 1 to the European Economic Area ("EEA") agreement. Adapted references to "Community" being understood as references to territories of the contracting parties to the EEA agreement. Since Liechtenstein's accession to the EEA a marketing authorisation granted by the Swiss authorities but immediately effective in Liechtenstein under its Heilmittelgezetz ("HMG") law was considered an authorisation in the Community and thus capable of determining the duration of the certificates.

The hearing officer concluded:

Point 8 of Protocol 1 on horizontal adaptations to the Agreement applies to Article 13(1) of the EEA version of the Regulation in such a way that the reference in that Article to the territory of the "Community" should be understood as a reference to the territories of the Contracting Parties to the Agreement. Thus, an authorization to place a medicinal product on the market, granted in accordance with the national legislation of an EEA/EFTA State, is relevant for the purposes of Article 13(1) of the Regulation if it is the first in the EEA;

a marketing authorization, granted by the Swiss authorities but effective in Liechtenstein under its HMG law, can be relevant for the purpose of Article 13(1) of the Regulation even though Annex 10 to Decision No. 1/95 of the EEA Council requires that Liechtenstein shall not deliver certificates for medicinal products as laid down in the Regulation; and the adaptation to Annex II to the Agreement made by EEA Council Decision No. 1/95, which requires that the provisions on the free movement of goods contained in the Agreement or in acts referred to shall be applicable to exports from Liechtenstein to the other Contracting Parties only to products in conformity with the acts referred to in Annex II, has no bearing on the question whether a marketing authorization in accordance with Liechtenstein’s HMG law should be relevant for the purpose of determining the duration of a certificate in another EEA Member State in accordance with Article 13(1) of the Regulation.

Accordingly the Hearing Officer found the Swiss authorisations admitted by the co-applicants should determine the duration of the certificates by virtue of their effect in Liechtenstein.