CJEU Judgment as to what constitutes a marketing authorisation under the Plant Protection Products Supplementary Protection Certificate Regulation

31 January 2011

Trevor Cook

In only its second judgment as to the interpretation of the plant protection products supplementary protection certificate (SPC) regime, as established by Regulation 1610/96, the Court of Justice of the EU (CJEU) has held that a provisional marketing authorisation for a plant protection product qualifies as a marketing authorisation under the Regulation.

Its judgment, given on 11 November 2010 in Case C-229/09, concerned a challenge, referred to the CJEU by the German Federal Patent Court, to the validity of an SPC for a plant protection product granted to Bayer Cropscience AG in relation to the herbicidal active ingredient iodosulfuron.  The basis for the challenge lay in the fact that the SPC had been granted on the basis of a provisional marketing authorisation under Article 8(1) of Directive 91/414 concerning the placing of plant protection products on the market, rather than on the basis of a full marketing authorisation under Article 4 of Directive 91/414, and that Article 3(1)(b) of Regulation 1610/96, setting out the conditions for obtaining an SPC, required that “a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Article 91/414/EEC or an equivalent provision of national law”.  In his Opinion of 17 June 2010 the Advocate General recommended that the CJEU find that a provisional marketing authorisation under Article 8(1) of Directive 91/414 did not count for this purpose but the CJEU disagreed and found that it did.  In so deciding it looked not only at the literal wording of Article 3(1)(b) of Regulation 1610/96 but also at the “overall scheme and objectives of the system of which it is part”.  Having found there to be a functional equivalence between the criteria set out in Articles 4 and 8(1) of Directive 91/414 it found no need to interpret Article 3(1)(b) of Regulation 1610/96 in such a way as to exclude products which had been granted a provisional marketing authorisation under Article 8(1) of Directive 91/414.  It drew support for its interpretation from other provisions of Regulation 1610/96, including Article 13(3), by which “for the purposes of calculating the duration of the certificate, account shall be taken of a provisional first marketing authorisation only if it is directly flowed by a definitive authorisation concerning the same product.”

The wider relevance of this decision for the medicinal products SPC Regulation 469/2009 is limited because of the considerable differences that exist as between the regulatory systems for medicinal products and plant protection products.  Thus there is no equivalent in the medicinal products regulatory system to a provisional marketing authorisation for plant protection products.  Thus “conditional marketing authorisations” under Regulation 507/2006 on the conditional marketing authorisation for medicinal products for human use are merely a particular type of marketing authorisation granted under Article 14 of Regulation 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and so on their face are marketing authorisations that qualify under Article 3(b) of the medicinal products SPC Regulation 469/2009 (referring to marketing authorisations under Directive 2001/83), having regard to Article 13 (1) of Regulation 726/2004, by which a marketing authorisation granted under Article 14 confers the same rights and obligations for each Member State as one granted by that Member State in accordance with Article 6 of Directive 2001/83 on the Community Code relating to medicinal products for human use.