Sumitomo Chemical reference: When are marketing authorisations valid?

By Dr Beatriz San Martín & Phil Bilney

In the recent Sumitomo Chemical preliminary ruling which is of relevance not only to the chemical and agriculture industry but also to the pharmaceutical industry, the CJEU has held that a supplementary protection certificate (“SPC”) for a plant protection product (“PPP”) cannot be sought on the basis of an emergency marketing authorisation (“MA”) or of an MA that has yet to be granted. Background PPPs are any active substances that protect plants against harmful organisms, regulate plant growth, preserve plants and destroy undesirable plants or parts of plants (such as pesticides and herbicides).  Before any such products can be placed in the market in the EU, innovators must obtain an MA leading to delay and erosion of the patent term.  To compensate innovators for this delay and promote research in the industry, it is possible under certain conditions to obtain SPCs to extend the protection of the PPP for up to five years after patent expiry. Article 3 of Regulation (EC) No 1610/96 concerning the creation of SPCs for PPPs (the “Regulation”) sets out the conditions for obtaining an SPC.  Article 3(1)(b) requires a valid MA to place the product on the market to have been granted in accordance with Article 4 of Directive 91/414.  This Directive concerns the placing of PPPs on the market and the provisions of Article 4 includes the submission of a technical dossier with the information necessary for evaluating efficacy and foreseeable risks. Obtaining an MA under Article 4 of Directive 91/414 can be very time consuming.  To speed the process up, Article 8 contains a number of derogations from Article 4 with less stringent requirements.  Article 8(1) allows the grant of a provisional MA for a maximum period of 3 years and Article 8(4) provides an emergency MA for a maximum of 120 days for limited and controlled use if such a measure appears necessary because of unforeseeable danger which cannot be contained by other means. The facts Sumitomo owned a European Patent for the insecticide clothianidin (granted in 1993 and which expired in 2009) which was issued in Germany, amongst other Member States.  In February 2003, the UK authorities granted the first provisional MA for a product containing clothianidin to a Bayer group company.  Then, in December 2003, the German authorities issued an emergency MA ending on 13 May 2004 for a product containing clothianidin to a Bayer group company.  The day after expiry of this emergency MA, Sumitomo applied to the German Patent Office for an SPC for clothianidin based on Bayer’s emergency MA.  Shortly thereafter, on 8 September 2004, the German authorities granted a provisional MA to a Bayer group company for a product based on clothianidin.  Sumitomo, in support of their earlier application, wrote to the German Patent Office informing them of this later MA. The German Patent Office dismissed the application taking the view that the certificate could not be granted as the emergency MA was no longer valid within the meaning of Art 3(1)(b) since it had expired.  Sumitomo appealed to the German Federal Patent Court who decided to stay proceedings and refer three questions to the CJEU. The CJEU decision In a previous decision[1] the CJEU held that the criteria for granting a temporary MA under Article 8(1) of Directive 91/414 were functionally equivalent to those for MAs granted under Article 4.  Thus, an SPC application could be based on such temporary MAs.  In contrast, the CJEU has now held that, as an emergency MA does not require prior safety and efficacy tests, the criteria for its grant are therefore not functionally equivalent to MAs granted under Article 4.  Consequently, emergency MAs are not ‘valid’ MAs for the purposes of seeking SPC protection.  The CJEU has also held that an SPC application cannot be lodged before the date of grant of a valid MA. Comment This is a welcome decision from the CJEU, particularly for its clarity.  A main justification for the need for SPCs is to compensate innovators for regulatory delay in obtaining MAs by providing them with a sufficient period of exclusivity.  Emergency MAs do not suffer from such delays and, consequently, such justification does not apply. The decision that SPC applications cannot rely on pending MA applications is also to be welcomed.  Had the CJEU decided otherwise, it would have created uncertainty in the market as to whether granted SPCs would continue to be valid until the authorities’ decision of whether to grant such MAs.  It could also have provided effective extensions to patent protection; third parties would have been compelled to delay applying for marketing authorisations if there was any risk that a patent holder might use that pending application in its application for an SPC. Interestingly, use of clothianidin is highly controversial and has been linked with toxicity in the bee population.  By the end of this year, use of clothianidin for personal purposes will be banned as well as on crops considered to be attractive to bees.

[1] Hogan Lovells International [2010] ECR I-11335 Case