The European Court of Justice has delivered two important judgments on applications for Supplementary Protection Certificates (SPCs) for combination medicinal products.
The decisions were delivered in cases involving Medeva BV and Georgetown University and both related to the refusal of the UK Patent Office to grant SPCs for vaccine products containing a combination of ingredients. Medeva BV filed five SPC applications with the Patent Office, four of which were refused on the ground that the applications related to a greater number of active components than were identified in the wording of the claims of the basic patent. The fifth application was refused on the ground that the marketing authorisation submitted in support of the application related to medicinal products containing more active ingredients than those for which SPC protection was sought. Six SPC applications filed by Georgetown University were also refused on this basis. Both parties appealed the decision of the Patent Office to the UK High Court which then referred certain questions of law to the European Court.
The Court held that the relevant EU Regulation relating to SPCs for medicinal products had to be interpreted as precluding the granting of an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application. In other words, the Court held that an SPC may only be granted in respect of the active ingredients that are specified in the wording of the claims of the patent.
The Court further held that only one SPC may be granted in respect of each basic patent. However, an SPC may be granted for a combination of two active ingredients, corresponding to that specified in the wording of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the application contains not only that combination of the two active ingredients, but also other active ingredients.
In relation to the issue of infringement, the Court concluded that an SPC confers on the patent holder the same rights as the basic patent in relation to the product, within the limits of the protection conferred by the basic patent. Therefore, if during the lifetime of the patent, the patent holder could oppose all or certain uses of the product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product.
Pharma companies may now need to reconsider their patent strategies in light of the European Court’s decisions, particularly as the Court has made clear that only one SPC may be granted in respect of each individual patent. Those applying for an SPC for a combination medicinal product should ensure that the application corresponds with the claims set out in the basic patent. There is no requirement, however, to match the combination outlined in the marketing authorisation for the medicinal product.
Contributed by Mary Drennan and Carol Plunkett.
