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19 December, 2013

On 12 December 2013 the Court of Justice of the European Union (CJEU) handed down three rulings in relation to Supplementary Protection Certificates (SPCs) which seek to clarify the level of specificity required for a medicinal product to be considered “protected by” a basic patent, and confirm whether multiple SPCs can be obtained from a single basic patent. Here the CJEU has confirmed that a second SPC can, in principle, be granted for a single active ingredient or a combination product provided this is protected as such by the basic patent. However, the issue of how much specificity is required for an active ingredient, or combination thereof, to be considered protected as by a basic patent has been left open, and further referrals on this point therefore appear likely.

An SPC provides an additional period of up to five years protection for a patented medicinal product and is intended to compensate the Patentee for lengthy delays associated with obtaining marketing approval in Europe. In recent years there has been much controversy surrounding the interpretation of the SPC regulation (469/2009/EC), and this looks set to continue as the present rulings fail to conclusively resolve the outstanding issues.

Georgetown University (C-484/12)
Georgetown University sought to obtain seven SPCs for different combinations of Human Papilloma Virus (HPV) antigens and the individual antigens, based upon its basic patent EP0647140. Two of these SPCs (for HPV-6/HPV-11/HPV-16/HPV-18 and HPV-16/HPV-18) have been granted and four remain pending, but the present decision relates to the rejection of Georgetown’s application for an SPC for HPV-16 alone on the basis that Article 3(c) of the SPC regulation permits only a single SPC to be based upon a basic patent.

The CJEU has now decided that Article 3(c) does not preclude an SPC being granted for a single active ingredient where, based on the same basic patent, an SPC has already been granted for that active ingredient as part of a combination product, provided the individual ingredient is protected as such by the basic patent. This is contradictory to the Advocate General’s Preliminary Opinion which we reported recently (click here)

Although the CJEU decision does neatly address the specific situation encountered by Georgetown, it does not comment on whether multiple SPCs could be based on a single basic patent under different circumstances, and somewhat frustratingly refrains from clarifying the requirements for an active ingredient to be protected as such by the basic patent. Georgetown University Decision (C-484/12)

Actavis v Sanofi (C-443/12)
Sanofi’s EP0454511 patent relates primarily to the antihypertensive agent ibersartan, and includes a dependent claim directed to a pharmaceutical composition comprising ibersartan and one of a selection of generically defined additional therapeutic agents, including diuretics. Having obtained marketing approval for ibersartan, Sanofi obtained an SPC for this medicinal product and following the separate approval of CoAprovel (a composition comprising ibersartan and the diuretic hydrochlorothiazide) a second SPC was granted.

Actavis challenged the validity of the second SPC on the basis that the combination of ibersartan and hydrochlorothiazide was not specifically recited in the patent and that a second SPC should not be granted from a single basic patent, and two questions were subsequently referred to the CJEU.

The CJEU has now decided that Sanofi’s second SPC (issued for the combination product CoAprovel) is invalid because, having obtained a first SPC directed to a single patented active ingredient, a Proprietor may not validly obtain a second SPC for a combination product containing the active ingredient in combination with another active ingredient which is not protected as such by the basic patent. In agreement with the Georgetown University decision discussed above, the CJEU here left open the possibility for a second SPC to be granted from a single basic patent if the combination with another active ingredient is protected as such by the basic patent. Nevertheless, considering that the rules for filing divisional applications will be relaxed in April 2014 (hyperlink to bulletin on this), Proprietors would be well advised to file separate divisional application for each commercially relevant combination in order to ensure their right to file an SPC.

Having decided that Sanofi was not entitled to a second SPC, the CJEU again declined to discuss the criteria for deciding whether a product is protected by a basic patent in force under Article 3(a) of the SPC regulation. Actavis v Sanofi Decision (C-443/12)

Eli Lilly v HGS (C493-12)
HGS obtained an SPC for its anti-Neutrokine-a antibody belimumab, based upon a claim directed to an isolated antibody or portion thereof that binds specifically to Neutrokine-a. Eli Lilly objected to the SPC on the basis that the antibody which formed the active ingredient was not protected by the basic patent in force (EP0939804), as required by Article 3(a) of the SPC regulation, because the structural features of the antibody which formed the active ingredient were not specified in the wording of the claims.

The CJEU has now ruled that it is not necessary for the active ingredient to be identified by a structural formula in order to satisfy the requirement of Article 3(a) that the active ingredient is ‘protected by a basic patent in force’; a functional definition of the active ingredient is, in principle, enough to obtain an SPC, provided it can be concluded that the claims of the patent, interpreted in light of the description, relate to that active ingredient necessarily and specifically.

In making this ruling, the CJEU referred extensively to Article 69 EPC, which specifies that the extent of protection conferred by a European patent shall be determined based upon the claims interpreted on the basis of the description and the drawings. Since the provisions of the EPC are outside the jurisdiction of the CJEU, the CJEU declined to provide any further guidance to national courts as to the manner in which they should determine the extent of protection conferred by the claims of a patent granted under the EPC. It will therefore fall to the national courts to decide whether the claims of a particular patent, interpreted in accordance with Article 69, relate to the active ingredient in a suitably specific manner to meet the requirement of Article 3(a). Unfortunately, the CJEU’s ruling provides no further guidance as to the circumstances in which patent claims based on a purely functional definition of the active ingredient would be considered specific enough to satisfy Article 3(a). Eli Lilly v HGS Decision (C-493/12)

Whilst these three decisions have clarified that it is, in principle, possible to obtain multiple SPCs from a single basic patent, they have done nothing to clarify the level of specificity required for an active ingredient to be considered to be protected by the basis patent other to indicate that the active ingredient should be protected “as such” by the basic patent. It seems likely that the current spate of referrals to the CJEU will persist as Proprietors and courts alike continue to struggle to interpret the SPC regulation.

For further information on this case, please contact Jennifer O’Farrell or your usual Boult Wade Tennant adviser.

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