The CJEU delivers a mixed Christmas package for SPC owners
On the 12 December the CJEU delivered three important rulings on supplementary protection certificates under Regulation 469/2009/EC ("SPC Regulation"). All the rulings follow in the aftermath of the CJEU's seminal Medeva (C-322/10) decision of 2011. However, only two (Georgetown University and Actavis Group v Sanofi) can be said to clarify matters. Indeed, Georgetown will provide considerable relief for SPC owners. However, the third, Eli Lilly, sends an important issue back to the national courts, where different interpretations now seem inevitable:
Georgetown University (C-484/12)
In Georgetown University (C-484/12) the CJEU has held that the SPC Regulation does not preclude the grant of more than one SPC per patent when the basic patent in force actually protects several products.
In 2007 Georgetown University filed seven SPC applications referring to its basic patent entitled "Vaccine against HPV" covering the combination of the four active ingredients as well as one active ingredient individually. Two SPCs were issued, a further application was rejected and four others remained pending. Georgetown University challenged this rejection; the competent court referred 5 questions to the CJEU concentrating on whether only one SPC per patent may be granted.
While the opinion of the Advocate General (see our previous e-alert on this matter) proceeded from the assumption of a preclusion of more than one SPC, the court took another view on the issue.
According to the court's ruling, it is possible, in principle, on the basis of a patent which protects several different products, to obtain several SPCs in relation to each of those different products. Each of those products should, however, be protected as such by that basic patent and be contained in a medicinal product and subject to a marketing authorisation. By establishing the need for protection under the basic patent the court draws a line with the Actavis Group v Sanofi case (see below) which concerns a combination of an active ingredient protected by the basic patent with an active ingredient which was not protected as such by that patent.
Actavis Group v Sanofi (C 443/12)
The dispute in Actavis Group v Sanofi relates to irbesartan, an antihypertensive drug. Irbesartan was first authorised as a single product and later authorised in a fixed-dose combination with hydrochlorothiazide (HCTZ), a diuretic. Sanofi owned a patent covering irbesartan, including a claim to the combination of irbesartan and a diuretic, and obtained two SPCs on this patent on the basis of its two MAs: an SPC for irbesartan alone and a later-expiring SPC for irbesartan in combination with HCTZ.
Actavis challenged the validity of the combination SPC on the basis that:
- the combination of irbesartan and HCTZ was not "protected by" the patent because HCTZ was not specified (or identified) in the wording of the claim, as required by Article 3(a) of the SPC Regulation; and
- irbesartan had already been the subject of an SPC and a marketing authorisation, for irbesartan alone, contrary to Article 3(c) of the SPC Regulation.
Mr Justice Arnold made a reference to the CJEU on the correct interpretation of Articles 3(a) and (c) in relation to both points raised by Actavis.
The CJEU ruled on the interpretation of Article 3(c) only. The CJEU held that, where the patentee has already obtained an SPC on the basis of an MA for a single product, the patent holder is precluded from obtaining a second SPC on the basis of the same patent for a combination product which includes another active ingredient which is not protected as such by the patent. The case is therefore distinct from Georgetown (above) and, in view of the answer rendering Sanofi's combination SPC invalid, the CJEU held that there was no need to rule on the interpretation of Article 3(a).
Eli Lilly v HGS (C 493/12)
The third dispute ruled on by the CJEU on 12 December, Eli Lilly v HGS, relates to therapeutic antibodies to neutrokine-α. HGS owns a patent covering such antibodies and has approval for Benlysta (belimumab) to treat SLE which it developed with its partner GSK.
Eli Lilly has also developed an antibody (tabalumab) which is in clinical trials but has not yet been approved. When it is approved, HGS will have the opportunity to apply for a SPC for tabalumab which it could enforce against Eli Lilly. In an attempt to avoid this, Eli Lilly sought a declaration that any such SPC would be invalid at least because Eli Lilly's antibody was not specified in the claim - the claim being worded generally to cover any antibody to neutrokine-α.
Mr Justice Warren referred questions to the CJEU about the correct interpretation of article 3(a) of the SPC Regulation and, in particular, the meaning of protected by a basic patent in force.
The judgment from the CJEU, handed down today, explains that it is not necessary for the product to be identified by a structural formula (in this context an antibody sequence) but that a functional definition may be acceptable if "…the claims relate, implicitly but necessarily and specifically, to the active ingredient in question". The claims should be construed in accordance with Article 69 EPC and as the CJEU does not have jurisdiction to interpret these provisions, it is for the referring court to do so. Putting the onus on the national courts like this is unlikely to lead to consistent decisions on SPCs across the EU.
In addition, the test is notably different to the test set out in Medeva. This appears to be on the basis that Medeva related to a combination SPC whereas this would be a single agent.