SPCs for combination products: Clarification from the ECJ today?
In the October issue of our life sciences and healthcare eBulletin, InFocus, we set out the background and discussed Advocate General Trstenjak’s opinion in the joined cases of Medeva (C-322/10) and Georgetown University (C-422/10). The ECJ decisions in both these cases were handed down today.
Why is the decision important?
The decision addresses the meaning of article 3(a) and 3(b) of the Supplementary Protection Certificates (SPC) Regulation and whether and, if so, how and under what conditions, SPCs may be applied for and granted for medicinal products with multiple active ingredients where the combination of active ingredients in these medicinal products is only partially the subject-matter of a patent.
What does the ECJ conclude?
Interpretation of Article 3(a) - Recognising the lack of harmonisation of patent law across the EU Member States, the ECJ in its decision today, has sought to provide a consistent test, that is independent of the national laws of the Member States and can be applied across the EU, to determine whether a product is "protected by a basic patent in force" diverging from the AG's opinion: A SPC can only be granted for a medicinal product comprising an active ingredient or combination of active ingredients where all the active ingredients are "specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate".
Interpretation of Article 3(b) - Although not obliged to, the ECJ has followed the Advocate General’s findings: A SPC can be granted for a medicinal product where the active ingredient is specified in the claims of a basic patent relied on, provided that the marketing authorisation (MA) used in support of the SPC application covers that active ingredient (or that active ingredient in combination with other actives) that is the subject of the SPC and it is the first MA to place that product on the market. It does not matter that additional active ingredients are also included in the supporting marketing authorisation.
Commercial impact of the decision
It is clear following these decisions today that provided all the other conditions for the grant of an SPC, set out in Article 3 of the SPC Regulation, are met, it does not matter that the supporting MA refers to additional active ingredients not the subject of the SPC application.
However, the test for determining if a combination of active ingredients is "protected by a basic patent in force" is now whether that combination of active ingredients is “specified in the wording of the claims of the basic patent". What is meant by “specified" is unclear. Will it be enough to simply refer to one active in combination with a family of other actives or will a particularised list be required? For example will a claim to A plus an antibiotic be sufficient or will a defined list of the antibiotics to be used in combination be required. There are other cases pending, Yeda (C-518/10) and Daiichi (Case C-6/11), that may provide further clarification.
Lawyers Helen Cline, Anna Coleman, Matthew Royle
