EU & UK: Recent English case law on Supplementary Protection Certificates and an overview of the pending references before the CJEU

28 July 2010

Trevor Cook

Recent case law

In our Life Sciences Update for April 2010 we discussed, from a French perspective, the vexed question of protection for combination products under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (the “SPC Regulation”).  This is an area that has also occupied a number of other courts in EU Member States in recent years, including the English Patents Court.  This has had to grapple on several occasions with the question of whether or not a patent is suitable under Article 3(a) of the SPC Regulation to act as a “basic patent” for an SPC on a medicinal product that consists of a fixed dose combination when the patent is directed towards only one element of that combination.  Such a patent is likely to be infringed by such a medicinal product, but is that, in and of itself, sufficient to qualify it as a “basic patent” for such medicinal product?  In a series of cases (Takeda No 3 [2004] RPC 3, Gilead Sciences [2008] EWHC 1902, Astellas [2009] EWHC 1916 and Medeva [2010] EWHC 68) the Patents Court has held, not without misgivings on the part of some judges, that infringement alone does not suffice, and that something more is required, such that there must be at least one claim to a mixture of the active component to which the patent is directed, with another active component, even if that other active is not specifically identified. 

On 23 June 2010, on an appeal to it in the last of these cases, Medeva’s SPC Applications [2010] EWCA 700, the English Court of Appeal referred a number of questions to the Court of Justice of the EU (CJEU), in the light of decisions in Norway and Germany that were apparently inconsistent with the approach taken by the Patents Court.  The Medeva case concerned five applications for SPCs, relating to four different combination vaccines with more active components than those used in the method of the subject matter of the proposed basic patent.  One application related to only two of the active components, and so whilst the basic patent “protected” it in the sense understood by the English courts, these were held not to be the subject of the marketing authorisation and so the application failed under Article 3(b) of the SPC Regulation.  Two of the questions referred, as to Article 3(a) of the SPC Regulation, asked in differing ways what criteria were to be applied in determining whether or not a product was protected by a basic patent, another asked whether a special approach to the Article 3(a) question might apply to vaccines, and the last one raised the Article 3(b) issue. 

The above cases all concerned fixed dose combinations, administered together in the one medicinal product, but some medicinal products, whilst containing only a single active, receive only a marketing authorisation for their use when co-administered with another medicinal product.  In such a case can a patent that specifically claims the combination be treated as a basic patent?  This was the issue before the English Patents Court in Yeda's SPC Application [2010] EWHC 1733.  On 12 July 2010 the Court held that such a patent could not be the basic patent for an SPC to the authorised product alone, and neither could the applicant secure an SPC for the combination, as that was not the subject of the marketing authorisation. 

Pending CJEU references

With the reference to the CJEU in Medeva’s SPC Applications discussed above there are now several pending references to the Court of Justice of the EU (CJEU) under the SPC Regulation:


CaseParties or National Case ReferenceActiveIssue
C-66/09Kirin Amgen Inc v Lithuanian State Patent BureauDarbepoetin alfaTransitional provisions for Lithuania (Advocate General Opinion 25/2/10)
C-195/09Synthon v Merz MemantineWhat constitutes a first Marketing Authorisation in the EU
C-427/09Generics (UK) v SynaptechGalanthamineWhat constitutes a first Marketing Authorisation in the EU
Referred by BGH on 28/1/10Case 15 W 36/08SitagliptinCan an SPC have negative or zero term so as to allow a paediatric extension to be sought? 
Referred by EWCA on 23/6/10Medeva‘s SPC ApplicationVarious combinations of antigensWhat can constitute a basic patent where the marketing authorisation has been granted in respect of a fixed dose combination?

In addition to this, in only the second case to go to the CJEU concerning the parallel supplementary protection certificate system for plant protection products, Case C-229/09 Lovells v Bayer CropScience AG, the Advocate General, in her Opinion of 17 June 2010 recommended that henceforth provisional authorisations for plant protection products not be treated as qualifying authorisations for the purposes of Regulation 1610/96/EC concerning the creation of a supplementary protection certificate for plant protection products.