CJEU rules on status of emergency MAs in SPC applications

Case C‑210/12, Sumitomo Chemical Co. Ltd v Deutsches Patent- und Markenamt, is a decision of the Court of Justice of the European Union on a reference for a preliminary ruling from the German Bundespatentgericht. What was this case about?

Sumitomo was the proprietor of European patent EP 0 376 279, DE 689 06 668, which covered Germany among other countries. The patent was for the active substance clothianidin, used for insecticide products. Back in February 2003 the United Kingdom authorities issued a marketing authorisation (‘MA’) to a company in the Bayer group, in accordance with Article 8(1) of Directive 91/414, for a product containing clothianidin. That ‘provisional’ MA was the first issued in the European Union for a product containing that active substance. In December of the same year the German authorities, on the basis of the national provisions transposing Article 8(4) of Directive 91/414, issued an emergency MA to a company in the Bayer group for a plant protection product containing the active substance clothianidin. That emergency MA was valid for 120 days, from 15 January to 13 May 2004.

On 14 May 2004, Sumitomo applied to the German patent office for a supplementary protection certificate for plant protection products. In its application Sumitomo referred to (i) the provisional MA granted in the UK in February 2003, this being the first MA granted in the European Union, and (ii) to the emergency MA issued in Germany in December 2003. In September 2004 the German authorities granted, on the basis of the national provisions transposing Article 8(1) of Directive 91/414, a provisional MA to a company in the Bayer group for a product based on clothianidin. The period of validity of that provisional MA was from 8 September 2004 until 7 September 2007. In November 2004 Sumitomo informed the German patent office of the existence of the provisional MA of 8 September 2004.

The German patent office eventually, in January 2006, dismissed Sumitomo's SPC application. Although the application had been lodged within the period set out in Article 7(1) of Regulation 1610/96, the German patent office considered that no SPC could be granted since the MA -- being an emergency MA which had expired -- was no longer valid within the meaning of Article 3(1)(b) of Regulation 1610/96. Sumitomo appealed to the Bundespatentgericht, which decided to refer to the CJEU the following questions for a preliminary ruling:

‘1. Is Article 3(1)(b) of [Regulation No 1610/96] 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]?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of [Regulation 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 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?’

Earlier this month the CJEU ruled as follows:

1. Article 3(1)(b) of Regulation ... 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products must be interpreted as precluding the issue of a supplementary protection certificate for a plant protection product in respect of which an emergency marketing authorisation has been issued under Article 8(4) of Directive 91/414 ... concerning the placing of plant protection products on the market, as amended....

2. Articles 3(1)(b) and 7(1) of Regulation No 1610/96 must be interpreted as precluding an application for a supplementary protection certificate being lodged before the date on which the plant protection product has obtained the marketing authorisation referred to in Article 3(1)(b) of that regulation.

Thanks go to Tony Breen (Syngenta) for drawing our attention to this decision.