Supplementary Protection Certificates to combination products: a French perspective

By Gaelle Bourout, Yves Bizollon


Under Article 3(a) of EC Regulation 469/2009 governing Supplementary Protection Certificates (SPCs) for medicinal products (which codified EC Regulation 1768/92), one of the conditions for the grant of an SPC is that the product is "protected by a basic patent in force". Article 1(b) expressly states that a "product" may be a "combination of active ingredients". However, the interpretation of Article 3(a) is open to some interpretation, in particular in relation to the required scope of the claims of the basic patent.

In a recent French decision, Daichii Sankyo Company Limited ("Daiichi")[1] was the holder of a marketing authorisation for a combination of Olmesartan Medoxomil and Hydrochlorothiazide. Daiichi was also the owner of European Patent EP 0 503 785 and applied to the French Patent Office (Institut National de la Propriété Industrielle, INPI) for an SPC, citing EP 0 503 785 as the basic patent. EP 503 785 claimed a "pharmaceutical composition", but did not expressly provide for a combination of active ingredients, instead merely referring to an active ingredient in a mixture with a pharmaceutical carrier.

The SPC application was refused by the INPI and the Paris Court of Appeals has upheld the INPI's decision.

In the Appeal Judgment of 6 November 2009, the Court noted that a combination of active ingredients may indeed constitute a ‘product’ for which an SPC may be sought. The Court however held that this combination of active ingredients must be expressly claimed in the basic patent at stake, and found that in Daiichi's application "the combination is not protected by the basic patent since it is not claimed therein" and that "the issue is whether the composition is protected by the patent, and not whether it infringes" it.

It should be noted that the Court expressly rejected the argument forwarded by the Appellant that the equivalent SPC had been granted in other EU jurisdictions.

This decision from the Paris Court of Appeal appears to confirm the general practice of the French Patent Office for the grant of SPCs to combinations of active principles. Indeed, the INPI generally requires that the basic patent comprise a claim expressly directed to such combination preferably identifying each of the individual compounds of the combination (i.e. a combination of A and B), or at least one individual active ingredient with the other active ingredient of the combination being defined as a member of a family of compounds (i.e. combination of A and B, wherein B is selected from a defined compound family). According to the French practice therefore, a basic patent with only a claim to a pharmaceutical composition comprising an active ingredient and a diluent/excipient may not serve as a basis for an SPC to a combination product.

[1]  Daiichi Sankyo Company Limited / Director of the INPI, Cour d'Appel de Paris (Paris Court of Appeals), Docket number 09/06530, November 06, 2009