Historically, it was widely thought that it was possible to obtain a separate supplementary protection certificates (SPC) for each product covered by a patent. However, in its judgment in Medeva in 2011, the Court of Justice of the European Union (CJEU) held that where a patent protects a product, only one SPC may be granted per patent. This judgement caused uncertainty and controversy particularly as to whether multiple SPCs could be granted on a patent which covers multiple products.
The CJEU have recently issued a judgement in Georgetown University v Dutch Patent Office which attempts to clarify these issues.
Georgetown University is the proprietor of European Patent 0 647 140, which is directed to 'Papillomavirus vaccines'. The patent included separate claims to various types of recombinant L1 protein of human papillomavirus (HPV). Having already obtained two SPCs based on this patent, Georgetown filed a further application for an SPC directed to recombinant L1 protein HPV type 16.
The application for the SPC was refused by the Dutch Patent Office on several grounds including that the SPC regulation prohibited the grant of more than one SPC per patent regardless of the number of products claimed in the patent. This case was appealed to the District Court of The Hague which referred five questions to the CJEU seeking guidance on whether multiple SPCs can be granted on a basic patent which covers multiple products.
In answer to the first question, which related to whether the SPC regulation precludes the proprietor of the basic patent being issued a certificate for each of the products protected, the CJEU confirmed the Medeva decision that only one SPC may be granted per patent.
The second and third questions asked whether an Applicant having several SPC applications pending at the same time on the same patent can choose which one takes priority, or whether the national authorities take that decision. Clearly it would be desirable for the patentee to be able to make this choice and the CJEU held that it should be the applicant who decides which of his SPC applications proceeds. However, in the absence of the patentee making a choice, it was noted that it is up to the national authorities to resolve the matter under national law.
The remaining questions related to whether the holder of a granted SPC may surrender it with retroactive effect so that he may pursue an alternative SPC on the same patent. While the SPC regulation does include a provision for surrender of SPC rights, the CJEU found that such surrender is unlikely to have a retroactive effect and thus the earlier right would still have existed at the time the subsequent application was filed. The CJEU reasoned that if the SPC holder could retroactively cancel the SPC to substitute it with an SPC of different subject-matter or duration, the legal certainty of the SPC Regulation would be compromised.
It is therefore imperative that patentees give careful thought as to which product they would like to be the subject of an SPC before any application is filed.