Supplementary protection for combination products heading for setback at the Court of Justice of the EU
On 13 July 2011, the opinion of the Advocate General (AG) was released in the consolidated cases C-322/10 and C-422/10, “Medeva” and “Georgetown” respectively, concerning supplementary protection certificates (SPCs) for combination vaccines. In her opinion, the AG recommends the adoption of the “disclosure test”, rather than the “infringement test”, to resolve the question whether a product is protected by a basic patent in the sense of Article 3a of the SPC regulation.
The cases concern the interpretation of the EU regulation on supplementary protection certificates (SPCs) for medicinal products, Regulation 469/2009. An SPC may be granted to a patent holder when a product covered by the patent (the “basic patent”) must be subjected to clinical trials in order to be sold. An SPC provides a maximum of five years’ extra protection as a compensation for the delay in getting to the market.
The question in these cases is whether a product is eligible for SPC protection when it comprises a combination of active ingredients and only a subset of these ingredients is the subject of the patent. In particular, the issue has come up in connection with the development of multi-component vaccines, where one vaccine composition may contain many different disease antigens.
In the EU member states, there are currently different approaches. In a few national authorities, notably Germany and Denmark, the tendency is that a product is considered eligible for SPC protection if a combination product would infringe the basic patent (the so called “infringement test”). In most other national patent offices, the requirement is instead the so-called “disclosure test”, which mandates that the product must not only be covered by the patent in the infringement sense, but must also be explicitly described. Exactly how specific this description must be varies between member states. In other words, there is clearly a situation where guidance from the CJEU is needed, and several related referrals for preliminary rulings on this issue are pending. See also Sidsel Hauge’s article in AWA ip Review #2 2010.
The AG opinion released yesterday is a recommendation for the court’s final ruling, and, while followed in the majority of cases, it is not binding on the final judgment. The opinion contains a very detailed analysis of the EU law on the subject, and is interesting reading. To summarize the AG’s position in relation to the ultimate question, however, does not take more than a few words: the AG is of the opinion that the infringement test is definitely not the correct test, but that national law still has to be applied in order to determine whether a combination product forms the subject-matter of the basic patent.
In her opinion, however, the AG also recommends that an SPC should be available for a subset of active ingredients in a combination product when the subset is disclosed in the basic patent, even if the marketing approval concerns a combination of additional active ingredients.
It remains to be seen if the Court comes to the same conclusion in its final opinion.
Niklas Mattsson, European Patent Attorney, Awapatent