The European Court of Justice (ECJ) has recently handed down two judgments on the question of when combination products qualify for a supplementary protection certificate (SPC) under the SPC Regulation (469/2009/EC) (Medeva BV v Comptroller General of Patents, Designs and Trade Marks, Case C-322/10; Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller General of Patents, Designs and Trade Marks, Case C-422/10).The decisions will be helpful for pharmaceutical companies involved in products that contain multiple active ingredients, such as vaccines.The SPC system

The patent system aims to encourage innovation by giving the owner of a new invention the right to prevent others from using the invention for a period of 20 years. However, in the pharmaceutical sector, medicines cannot be marketed until regulatory approval has been given (marketing authorisation). While this ensures the safety of medicines, it also significantly delays exploitation of the invention and effectively erodes the 20-year term of patent protection.The European SPC system was introduced to compensate for this "lost" patent term. SPCs are fundamental to ensuring the financial viability of pharmaceutical research and development. The system provides an additional period of protection (up to five years) in the form of an SPC where it has taken over five years following patent application to obtain marketing authorisation.The patent applications

UK case law had provided that for an SPC to be granted, it must cover the same "product" as the basic patent and the marketing authorisation; no more and, in the case of the marketing authorisation, no less. Medeva and Georgetown provided the opportunity for higher courts to consider this position.Medeva. Medeva made five applications for SPC protection, relying on a basic patent that claimed a combination of two active ingredients: filamentous haemagglutinin (FHA) and pertactin, used to make a vaccine against whooping cough.
For public health reasons, Medeva was required to market the vaccine as part of a larger multi-disease vaccine, which contained a number of additional active ingredients. Each of the five SPCs was sought for a different combination of active ingredients (that is, a different "product"). Each combination contained at least the patented combination: FHA and pertactin. The applications also relied on a number of different marketing authorisations (reflecting the fact that they were concerned with different "products").
The High Court held that the four SPC applications for combinations of FHA and pertactin, together with other active ingredients, should be refused. The additional active ingredients meant that the products for which the respective SPCs were sought differed from the product covered by the patent (namely, the combination of FHA and pertactin alone).
The patent made no reference to any combination with additional active ingredients, and so did not "protect" such a combination. Therefore, the products were not protected under Article 3(a) of the SPC Regulation by the basic patent that Medeva had relied on (see box "The SPC Regulation").The fifth application sought an SPC for the combination of FHA and pertactin alone, so this did cover the same combination of active ingredients, and therefore the same "product", as the basic patent. However, the marketing authorisation in support of the application comprised a combination of 11 active ingredients. The court decided that it was not a valid marketing authorisation to place the same "product" on the market under Article 3(b) of the SPC Regulation.This result seemed particularly harsh. Medeva's patent application pre-dated entry into force of the SPC Regulation, so Medeva had no opportunity to craft its patent claims to cover FHA and pertactin together with the additional active ingredients. Further, Medeva had no realistic opportunity of seeking marketing authorisation for FHA and pertactin alone, because the British regulatory authorities required that Medeva's vaccine be combined and administered in a multi-disease vaccine.Georgetown. Georgetown University, Loyola University of Chicago, and University of Rochester each sought SPCs relating to recombinantly produced L1 proteins, which are active ingredients in vaccines against infection by the human papillomavirus (HPV). Each disputed SPC application was for a single HPV protein, constituting a single active ingredient. However, the marketing authorisations relied on for the SPC applications were for the vaccines Gardasil and Ceravix, which each related to a number of HPV strains (combinations of active ingredients).The UK Patent Office refused the SPCs because the marketing authorisations mentioned additional active ingredients not specified in the SPC applications. Therefore, the applicants had not met the Article 3(b) requirement.The ECJ decision
The ECJ considered the various questions that were referred to it in relation to the two cases, and found as follows:An SPC can only be granted under Article 3(a) for a product where all active ingredients are "specified in the wording of the claims" of the basic patent.
Contrary to the English courts' view, an SPC can be granted under Article 3(b) for an active ingredient or combination of active ingredients even if the authorised product includes additional active ingredients not covered by the SPC. So there does not need to be an exact match between the authorised product and the SPC application: the authorised product can be wider. This interpretation was influenced by the ECJ's desire to ensure that the SPC Regulation achieves its objective of encouraging and rewarding innovation.
The cases will now be referred back to the English courts to apply the ECJ's decision to the specific facts of the SPC applications.Issues arising
A number of issues arise from the ECJ's decision in Medeva and Georgetown:Specified in the wording of the claims. What does the ECJ mean by the requirement that active ingredients be "specified in the wording of the claims" in relation to Article 3(a)? It is not uncommon to have patents that claim chemical entities by reference to a class of molecules. How specific do the claims need to be: does a class suffice?First marketing authorisation. A further requirement for obtaining an SPC is that the marketing authorisation relied on is the first in the EU for that "product" (Article 3(c), SPC Regulation).Before the ECJ's decision, it had been understood that the first marketing authorisation for a combination product of, say, FHA and pertactin would be the first marketing authorisation for exactly the combination product FHA and pertactin. However, the ECJ has decided that the first marketing authorisation would be any marketing authorisation that includes FHA and pertactin, even if the medicine was authorised with additional active ingredients.One SPC per patent. Although the ECJ's opinion that no more than one SPC may be obtained per patent is based on the earlier ECJ decision in Biogen Inc. v Smithkline Beecham Biologicals SA (in which the limitation arose in the context of a specific product), there appears to be no basis for this particular point in the SPC Regulation (Case C-181/95).In light of Biogen, there does not appear to be any finding that there cannot be more than one SPC granted where a patent claims more than one product (active ingredient or combination of active ingredients), provided that each SPC relates to a different product.Scope of protection. Does an SPC prevent third parties only from using the authorised medicine alone, or can the SPC be used to prevent any use of the medicine, even when combined with other active ingredients to form a different "product"? The answer to this affects how valuable an SPC really is, and whether it can achieve its aim of encouraging innovation in the pharmaceutical sector.Although this issue was not raised in Medeva and Georgetown, the ECJ appears to have provided an answer (perhaps mindful of the other references in the pipeline). It stated that the SPC confers on the holder the same rights as the patent to prevent uses of the product whether in the form of a medicinal product consisting of the product (the same active ingredients), or in the form of a medicinal product containing the product (that is, combined with additional active ingredients).Outstanding references
Further to its decisions in Medeva and Georgetown, on 25 November 2011, the ECJ handed down orders in three other pending SPC cases: Yeda (C-518/10), Queensland (C-630/10) and Daiichi Sankyo (C-6/11).Katie McConnell is a senior associate at Hogan Lovells International LLP. The SPC Regulation
The SPC Regulation (469/2009/EC) requires, among other things, that for a supplementary protection certificate (SPC) to be granted:The product must be protected by a basic patent in force (Article 3(a)).
There must be a valid marketing authorisation to place the product on the market as a medicinal product (Article 3(b)).
"Product" is the active ingredient or combination of active ingredients of a medicinal product."Basic patent" is a patent which protects a product, and which is designated by its holder for the purpose of the procedure for grant of an SPC."Medicinal product" is any substance or combination of substances presented for treating or preventing disease in human beings or animals.
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