Case C-210/12, Sumitomo Chemical – insecticide and an SPC application
Posted on 21 June 2012
Can a supplementary protection certificate for a plant protection product be issued to a company when the application is made after an earlier marketing authorisation has expired?
In this case involving Sumitomo Chemical, the claimant holds patents for an insecticide with Clothianidine as an active substance (European Patent EP 0 376 279 covering Guanidine derivatives, their production and insecticides; and German patent DE 689 06 668). The claimant had applied for its European Patent on 27 December 1989 so the claimant was now seeking to gain a supplementary protection certificate for the plant protection products known as ‘Poncho Pro’, which contains Clothianidine.
The dispute relates to the fact that on 14 May 2004 the claimant’s legal predecessor sought a plant protection product certificate from the German Patent and Trade Mark Office. The application was supported by reference to a decision of Germany’s Federal Office of Consumer Protection and Food Safety. The authority had issued an authorisation in December 2003 to Bayer CropScience for the latter’s product ‘Poncho Pro’, that contains Clothianidine as an active substance.
Whilst the German Patent and Trade Mark Office was reaching its decision in respect of the claimant’s application, other events were taking place. On 8 September 2004, Germany’s Federal Office of Consumer Protection and Food Safety granted Bayer a provisional authorisation valid for the active substance of Clothianidine – its decision being based on Article 8(1) of Directive 91/414. This provisional authorisation was valid for 3 years until 7 September 2007, an authorisation which later became definitive by dint of a decision taken in June 2007.
Learning of the initial provisional authorisation granted in 2004, the claimant’s legal predecessor informed the German Patent and Trade Mark Office of this development. Time passed. In January 2006, a year and a half after the claimant’s legal predecessor had applied for a plant protection product certificate, the German Patent and Trade Mark Office decided to turn down the application. The reason given for the refusal was that the authorisation which enabled Poncho Pro to be put on the German market had been rather a special one. It had been an emergency authorisation granted in accordance with Article 8(4) of Directive 91/414. The Directive’s provision allows for a limited use of a plant protection substance where this appears necessary because of an unforeseeable danger that cannot be contained by other means. As such, the authorisation had run for only 120 days covering the period from 15 January 2004 until 13 May 2004. Since the claimant’s application had been made on the 14 May 2004, the day after the expiry, a plant protection product certificate could not be granted because the phytosanitary certificate could not be considered to be ‘in force’ for the purposes of Article 3(1)(b) of EC Regulation 1610/96.
The claimant’s legal predecessor launched an appeal against the decision of the German Patent and Trade Mark Office. And it sought to revoke the Office’s decision to grant an emergency certificate to Bayer. In turn, Bayer launched two appeals against the German Patent and Trade Mark Office’s decisions which refused to grant subsequent certificates – even though the company had been granted both provisional and definitive authorisations from Germany’s Federal Office of Consumer Protection and Food Safety.
According to the UK IPO website, the German Federal Patent Court asked:
1. Is Article 3(1)(b) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC?
2. If Question 1 is answered in the affirmative: is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate?
3. If the answer to Question 1 is in the negative: is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?