News from Abroad: Is an Emergency Marketing Authorisation Valid Basis for an SPC Application for a Plant Protection Product?

The Court of Justice of the European Union (CJEU) has recently ruled that an emergency Marketing Authorisation (MA) for a plant protection product does not provide a valid basis for an SPC for that plant protection product.

Background

Sumitomo ChemicalsClothiamidine is the active ingredient of the insecticide product, Poncho®.  Clothiamidine was protected by European patent EP0376279, filed 27 December 1989, which covered Germany amongst other countries.  In December 2003, Sumitomo Chemical Co. Ltd. was granted an emergency MA for Clothiamidine by the German authorities due to an imminent threat to various crops.  The emergency MA was valid for 120 days.

In May 2004 Sumitomo filed an SPC at the German Patent and Trade Mark Office for Clothiamidine on the basis of the emergency MA and EP0376279.  The SPC application was refused.

Sumitomo appealed the decision to refuse the SPC to the German Federal Patents Court.  The Court, in turn, sought guidance from the CJEU as to whether an emergency MA provides proper basis for the grant of an SPC.

CJEU’s Decision

The CJEU noted that the SPC Regulation specifies a 6 month period from the grant of a marketing authorisation in which to validly file an SPC application for a plant protection product.  While the 6 month period in respect of the emergency MA had not passed when the SPC application as filed, because the emergency MA was only in force for 120 days, it was not valid when the SPC application was filed.  In effect, the emergency MA expired the day before the SPC filing date.

Notwithstanding the issue concerning the expiry of the emergency MA, the CJEU decided that the SPC Regulation ought to be interpreted as precluding the grant of an SPC for a plant protection product on the basis of an emergency MA for the product.  The CJEU noted that an emergency MA, by its very definition, is granted in special circumstances in which an emergency MA is needed in order to counteract an unforeseeable danger to a crop which cannot be contained by means other than the use of the active ingredient in question.  Plant protection products for which an emergency MA is granted do not undergo the same scientific testing and risk evaluation as plant protection products which are granted a provisional MA and which may serve as proper basis for an SPC application.

As an additional point, around 4 months after filing the SPC application, the German authorities granted a provisional MA for Clothiamidine.  Sumitomo attempted to amend its SPC application to refer to the provisional MA.  However, the CJEU confirmed that the SPC Regulation precluded the grant of an SPC for a plant protection product on the basis on an MA which was granted after the SPC application was filed.

This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.