The end of 2013 saw a flurry of legal activity on Supplementary Protection Certificates (SPCs) with the issuance of three further decisions from the Court of Justice of the European Union (CJEU), the highest appeal court in the EU. As ever, the decisions raise some issues that are likely to result in further references to the CJEU, but they do settle some significant points.
Some recent CJEU cases had cast doubt on the general question of whether one basic patent could form the basis for more than one SPC. In case C-484/12 Georgetown University v Octrooicentrum Nederland (the Dutch Patent Office), the CJEU ruled that it is possible for more than one SPC to be based on a single patent. There remains the requirement that each of the SPCs must protect a different product and that each SPC must be directed to a product protected by the basic patent and contained in a medicinal product that is the subject of a marketing authorisation (MA). Georgetown University has already been granted two Dutch SPCs, directed to combinations of several HPV antigens including HPV-16. The decision paves the way for them to additionally try to obtain an SPC to HPV-16 antigen alone. Proceedings on that will now resume before the Dutch Patent Office.
The extent to which several SPCs can be allowable based on the same patent is tempered by the ruling in the second CJEU decision C443/12, Actavis v Sanofi. In the Georgetown case, the same MA was the basis for the single compound SPC application and the combination product SPC application, and all SPCs would therefore have the same expiry date. In Actavis v Sanofi, Sanofi had first been granted an SPC for its Irbesartan product on the basis of an MA in 1997 for Irbesartan on its own. Later, in 1998, Sanofi obtained an MA for a combination product of Irbesartan with the diuretic hydrochlorothiazide, and then successfully obtained an SPC for the combination product. Because the second MA had a later date than the first, the second SPC had a later expiry date than the first SPC. Actavis challenged the validity of the combination SPC. The CJEU has now ruled that the SPC regulation precludes the grant of a second SPC for a combination product when, on the basis of the same patent, the holder has already been granted an SPC for the single ingredient. The CJEU found that the additional term provided by a second SPC was not justified by the purpose of the SPC regulation.
The third decision, C-493/12 Eli Lilly v HGS, deals with the question of how precisely a compound must be defined in a patent in order for the compound to be considered "protected by the basic patent". HGS's patent covers the signalling compound neutrokine-α and it includes a claim to an antibody against it. The antibody is defined in functional terms, not structurally. The CJEU decided that a functional definition of a compound (here the antibody against the neutrokine-α) can be sufficient for the compound to be considered protected. The ruling says that what is necessary is for the claims, when interpreted in light of the description of the invention, to "relate, implicitly but necessarily and unambiguously, to the active ingredient in question". Questions of claim interpretation will be a matter for national patent offices and courts to resolve, potentially leading to different interpretations in different countries.
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