Syngenta is the holder of a European Patent titled “fungicides”, which relates to compounds that contain the active ingredient “azoxystrobin” (the "Basic Patent").
Syngenta obtained a first Supplementary Protection Certificate (“SPC”) on the product “azoxystrobin” and, on the basis of the same Basic Patent, applied for a second SPC for a product consisting of the combination of “azoxystrobin + folpel” ( the "Combination SPC”).
The Director of the French Patent and Trademark Office (“PTO”) refused the Combination SPC on 2 September 2009, because the combination of “Azoxystrobine + folpel” was not covered by the basic patent.
In an attempt to circumvent this unfavorable decision, SYNGENTA requested a (retroactive) limitation of its Basic Patent to obtain claims explicitly covering the combination of “azoxystrobin + folpel”. This request gave rise to parallel proceedings, and the limitation was finally accepted by the Paris Court of Appeal on 25 October 2013.
However, this limitation proved to be useless in relation to SYNGENTA's Combination SPC application. In its decision of 30 May 2014, the Paris Court of Appeal, applied the solution adopted by the French Supreme Court in its “telmisartan + hydrochlorothiazide” ruling of 26 November 2013 (Cass. com., 26 nov. 2013, n° 12-23.775, P+B, Sté Boehringer Ingelheim Pharma Gmbh and Co KG c/ Dir. gén. INPI). The Court held that on the day the Combination SPC was refused by the PTO, the second active ingredient “folpel” was not yet covered by the claims of the Basic Patent. Thus the PTO could not have ruled in any other way than to refuse to grant the Combination SPC.
This case law makes it impossible to overcome a decision refusing a combination SPC by relying on the retroactive effect of a patent limitation. Patentees seeking a combination SPC must therefore ensure that, on the day the PTO hands down its decision on the grant of an SPC, the claims of the basic patent already expressly cover the same combination of active ingredients as in the SPC application. After that date, there seems to be no way back…
This article is part of the International Life Sciences Update for October 2014