31 October 2013Biotechnology

No plant SPCs after emergency orders – CJEU

Europe’s highest court has said supplementary protection certificates (SPCs) for plant protection products cannot be granted after the same product has been authorised on emergency grounds.

The Court of Justice of the EU (CJEU) was ruling on a dispute between Sumitomo and the German Patent and Trademark Office (DPM), which rejected the company’s SPC application in 2006.

Sumitomo owns a European patent (covering Germany) directed to the active substance clothianidin, used for insecticide products.

The German authorities, in December 2003, issued an emergency marketing authorisation (MA) to a company in the Bayer group for a plant product containing the active substance clothianidin.

A day after that MA expired, in May 2004, Sumitomo applied to the DPM for an SPC for plant protection products.

Later in 2004, the German authorities granted a provisional MA, valid until September 2007, to a company in the Bayer group for a product based on clothianidin.

In January 2006, the office dismissed Sumitomo’s application because, the CJEU said, “the MA was no longer valid within the meaning of Article 3(1)(b) of Regulation No 1610/96 since the emergency MA had already expired”.

In a ruling on October 17, the CJEU was asked to clarify the interpretation of articles 3(1)(b) and 7(1) of the regulation 1610/96 regarding the creation of an SPC for plant protection products.

First, the CJEU considered whether article 3(1)(b) should be interpreted to preclude an SPC for a plant protection product when an emergency MA has been issued. Next, the court asked, was whether articles 3(1)(b) and 7(1) should be interpreted to preclude an SPC application being lodged before the date on which the plant protection product has obtained the MA referred to in article 3(1)(b).

The CJEU answered both questions in the affirmative.

While the ruling was expected, said Alexa von Uexkuell, partner at law firm Vossius & Partner in Munich, the ruling’s clarity is welcome.

“The ruling makes sense because ... you know what approvals you can rely on. Previously, you did not know if you could rely on emergency approvals.”

SPCs can already be granted when standard (10-year) MAs or provisional (three-year) MAs have been issued, but until now it was unclear what the rules were on emergency orders.

“It had been seen as a little bit unfair as the rules were so chaotic and the German Patent and Trademark Office handled this in a chaotic manner.

“It was not the applicant’s fault,” said von Uexkuell.

She added: “The European SPC regulation is very heavily criticised and the CJEU is too, as they don’t have a great deal of experience dealing with patents. The decisions have been erratic.”

The case will now go back to Germany’s patent court, the Bundespatentgericht, which will reject Sumitomo’s SPC, von Uexkuell said.

“In theory an appeal is possible, but because the CJEU ruling is binding the German Supreme Court would not accept the case.”

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