SPCs for Multi-ingredient Medicines to be considered by European Court

Medeva B.V. has been seeking to extend the patent protection available for its Pertussis family of vaccines using the Supplementary Protection Certificate (SPC) system.

The SPC applications - five in total - were rejected by both the UK Intellectual Property Office and the High Court, on the grounds that the products for which protection was sought were either not protected by a basic patent, or not covered by a valid marketing authorisation [see our earlier article - Click Here] The High Court decision is now under appeal.

As described in our earlier article, Medeva B.V. had defined the "product" for the purposes of the first SPC application as the combination of Peractin and filamentous haemagglutinin only; the remaining four applications carried a product definition which required the presence of Peractin and filamentous haemagglutinin and further active ingredients.

In order to determine whether the patent protects the product as defined in each SPC application, and whether a valid marketing authorisation is in place to cover the product defined in each SPC application, the Court of Appeal has referred a series of questions to the Court of Justice of the European Union (formerly the ECJ).  In summary, these are:

1. The grant of an SPC by each of the Member States of the Community to holders of national or European patents should be under the same conditions. In the absence of Community harmonisation of patent law, what is meant in the Regulation by "the product is protected by a basic patent in force" and what are the criteria for deciding this?

2. In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not "the product is protected by a basic patent" and, if so, what are those further or different criteria?

3. In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not "the product is protected by a basic patent" and, if so, what are those further or different criteria?

4. Is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if one antigen of the vaccine is "protected by the basic patent in force"?

5. Is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if all antigens directed against one disease are "protected by the basic patent in force"?

6. Does the SPC Regulation permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:

 (a) a basic patent in force protects the single active ingredient or combination of  active ingredients within the meaning of the SPC Regulation; and

 (b) a medicinal product containing the single active ingredient or combination of  active ingredients together with one or more other active ingredients is the subject of a  valid authorisation which is the first marketing authorization that places the single  active ingredient or combination of active ingredients on the market?

The answers to these questions will hopefully provide much needed clarity as to what can be protected by an SPC in the field of multi-component medications and vaccines.  The opinion of the CJEU can be expected in around a year or so.

Joanna Westwood
Life Sciences & Chemistry Group