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

Clothiamidine 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.