SUPPLEMENTARY PROTECTION CERTIFICATES: THE CJEU ISSUES ITS DECISION IN TWO SEMINAL CASES
24 November 2011
SPCs and their availability
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.
Under Regulation (EC) No 469/2009, any "product" that is protected by a basic patent in force and that is validly authorised to be placed on the market as a medicinal product, is eligible for SPC protection, provided that it is new to the market and has not previously been protected by an SPC. The term "product" is defined as: "the active ingredient or combination of active ingredients of a medicinal product".
Cases concerning authorised medicinal products that contain a combination of active ingredients (e.g. A+B) have now brought two issues into sharp relief:
- What are the criteria for determining whether a Product is ‘protected' by a basic patent in force?
- What is a ‘valid authorisation' to place the Product on the market as a medicinal product?
Medeva and Georgetown University et al references
These issues have now been considered by the CJEU upon referral from the UK Courts in appeals lodged by Medeva and Georgetown University et al (cases C-322/10 and C-422/10, respectively).
Both Medeva's and Georgetown University et al's SPC applications relate to vaccines containing multiple antigens authorised in combination. The allowability of the Georgetown University et al and one of the Medeva applications hinges on whether a marketing authorisation for a combination vaccine is a ‘valid authorisation' for Products defined as just one of the antigens, or a sub-combination of antigens, present in the vaccine. The allowability of Medeva's other applications depends upon whether a patent that discloses some, but not all, of the antigens in an approved vaccine nevertheless ‘protects' the entire combination of antigens for the purpose of securing an SPC.
The CJEU has decided the following.
- For an SPC to be granted, the active ingredients representing the Product must be specified in the wording of the claims of the basic patent.
- The Product can be defined as a single active ingredient (or as a sub-combination of active ingredients) even when the medicinal product includes further active ingredients.
- An SPC provides the same protection as the basic patent against an unauthorised use of the Product in the form of any medicinal product that contains that Product (meaning that an SPC to Product A would be infringed, for example, by sale of a medicinal product containing active ingredients A + B).
- Where a basic patent protects a Product, only one certificate may be granted for that basic patent.
The rulings provide clarity on many points, but arguably leave open room for interpretation on others.
What is now absolutely clear are points (b) and (c) above. Further, point (a) above also clarifies that, for SPCs, it is not appropriate to assess the "protection" afforded by a basic patent by using the kind of infringement test that would usually be employed in patent enforcement / validity proceedings.
In connection with point (a), however, there remains some uncertainty. That is, although some degree of ‘specification' of each active ingredient is clearly required, it is not yet known how general the definition of each active ingredient may be whilst still satisfying the requirement of being "specified in the wording of the claims". The test may be broad, requiring merely a positive recitation of claim features that read on each active ingredient. On the other hand, it may be a narrow test, requiring unambiguous individualisation of each active ingredient, or it may instead be something in between.
Finally, there is room for argument that point (d) above means that, for any given basic patent, only one SPC may be available per Product. However, it remains to be seen whether the national courts in Europe will accept this interpretation, or will instead insist on a much more restrictive one SPC per patent rule (regardless of how many different active agents are "protected" by a basic patent). The practice of national patent offices to date has been to accept the former, more generous interpretation, in spite of an earlier case (Biogen, C-181/95) that contained a statement much along the lines of point (d) above.
Aside from the areas of uncertainty that remain, the rulings offer a clear package of rights in the circumstances where a basic patent protects one or more active ingredients which are authorised for the first time in the EU together with one or more other active ingredients. This holistic approach was the one proposed by us on behalf of Georgetown University et al, and provides opportunity for obtaining useful and very broad SPC protection.
Moreover, the rulings will have immediate and far-reaching consequences not only in relation to the broad SPC protection that might now be granted by patent offices in Europe, but also in connection with the scope and validity of SPCs already granted.
Please therefore contact us if you have any queries regarding the scope and/or validity of SPC protection that you may wish to seek, or that is associated with the granted SPCs of others.
If you require any further information, please contact John Miles, Mike Snodin or Michael Pears of our SPC & Regulatory group. John and Michael acted for Georgetown University et al in this matter.