ECJ GIVES PHARMACIA RULING

The European Court of Justice handed down its decision yesterday in Case C-31/03 Pharmacia Italia SpA, a reference from the German Bundesgerichtshof on the transitional arrangements relating to the grant of supplementary protection certificates (SPCs) that extend the duration of protection for pharmaceutical patents. The problem was that SPCs can only be granted in respect of expired patents for products that first received market authorisations in Germany after 1 January 1988. Pharmacia's product, Cabergoline, received market authorisation in Germany for use as a medicine (DOSTINEX) in 1994, having been authorised within the Community (and therefore in Germany) as early as 1992. However, Cabergoline had already been authorised as a veterinary medicinal product (GALASTOP) in the Community back in 1987, as a drug for curing phantom pregnancies in dogs. Did the earlier veterinary authorisation preclude the grant of an SPC for the use of Cabergoline as a regular human medicine?

The ECJ ruled that Pharmacia was not entitled to the grant of an SPC. Said the Court:

"Whilst Pharmacia admits that the wording of Article 19(1) of the regulation refers in general terms to the first marketing authorisation in the Community without distinguishing between marketing authorisations for medicinal products for human use and veterinary medicinal products, it nevertheless submits that it follows from an examination of the regulation as a whole, its broad logic and purpose, that the regulation draws a distinction in principle between medicinal products for human use and veterinary medicinal products so that in the present case, the first marketing authorisation to be taken into consideration is that granted for the medicinal product for human use in the Netherlands" (para.17);

"Whilst noting that the term ‘first marketing authorisation in the Community’ must be interpreted in the same way in each of the provisions of the regulation in which it is used, it should be pointed out that, according to the sixth recital in its preamble, that regulation seeks to provide a uniform solution at Community level to the problem of inadequate patent protection, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community. However, an interpretation such as that proposed by Pharmacia would prevent the realisation of that objective. Under Pharmacia’s interpretation, the duration of the protection conferred by the certificate, calculated in accordance with Article 13 of the regulation, might be different for the same product" (para.21).

The IPKat thinks this is right. SPCs are an exception to the basic principle that patent rights expire at a date no later than 20 years after the date of application for patent protection. Where further protection is granted, it should be granted on the basis of the firm but fair criteria laid down by the law.

More on phantom pregnancies here, here and here