Supplementary Protection Certificates: Two Important Decisions from the CJEU

The Court of Justice of the European Union (CJEU) has recently delivered its judgement in two key cases, Medeva (Case C-322/10) and Georgetown University (C-422/10), relating to Supplementary Protection Certificates (SPCs). The full decisions can be accessed via the links below.

Medeva

http://curia.europa.eu/juris/celex.jsf?celex=62010CJ0322&lang1=en&type=NOT&ancre=

Georgetown University

http://curia.europa.eu/juris/celex.jsf?celex=62010CJ0422&lang1=en&type=NOT&ancre=

Background to SPCs

SPCs provide protection, beyond the expiration of a patent, for medicinal (and plant) products which require a marketing authorisation.

Often a substantial period of time elapses between the filing of a patent application for a new medicinal product and grant of the authorisation to place the product on the market. This period of time (where several years of patent term will pass before the patented product can actually be marketed) potentially makes the period of effective protection under the patent insufficient to cover the investment put into discovering and obtaining marketing approval for the drug. Thus, the purpose of an SPC is to provide adequate effective protection to this type of product.

Questions Referred to the CJEU

Both cases relate to SPC applications covering vaccines which contain multiple combinations of active ingredients. In both Medeva and Georgetown University, the question of whether an SPC could be based on a marketing authorisation (MA) which contains additional active ingredients besides those covered in the SPC application was referred to the CJEU.

In addition to this, the UK Court of Appeal in Medeva referred the question of whether an SPC could be granted for a product which contains additional active ingredients to those that were specified in the claims of the basic patent.

Review of the CJEU’s Decisions

It was decided that an SPC for a single active ingredient or combination of active ingredients could be based on a MA for those active ingredients in combination with others. This has the effect that the first MA to include the active ingredient or combination of active ingredients is the relevant MA on which the SPC application should be based, even when the MA contains additional active ingredients.

In other words, an SPC for active ingredient A or active ingredients A+B can be based on an MA for a combination product containing active ingredients A+B+C+D.

The CJEU also decided that an SPC could only be granted in relation to active ingredients specified in the wording of the claims of the basic patent. 

Thus, it appears that where a patent covers a single active ingredient, an SPC for a combination product comprising that active ingredient plus one or more additional actives could not be based upon that patent. 

Notably, clear guidance as to what is meant by ‘specified in the wording of the claims’ was not provided and there is some uncertainty as to how specific the reference to the active ingredients must be.  For example, would a patent claiming ‘A in combination with another active ingredient’ be suitable basis for an SPC covering A+B?

In paragraph 41 of the Medeva judgment, the CJEU stated that:

“… where a patent protects a product, … , only one certificate may be granted for that basic patent.”

At first glance, it appears that this statement constitutes a bar to basing more than one SPC on a particular patent.  However, an alternative construction which appears to correspond more closely with prior case law of the CJEU would be that only one patent per product can be obtained per patent.

In unrelated proceedings before the CJEU (C-442/11), questions are being considered regarding the applicability of SPCs covering monotherapy products to combination products comprising the protected active ingredient and one or more other actives.

Although such questions were not referred to the CJEU in the Medeva or Georgetown cases, from comments made by the CJEU in paragraph 39 of the Medeva decision, the Court appears to imply that SPCs covering monotherapy products are infringed by combination products including the protected active.  However, until the judgment in case number C-442/11 is delivered, uncertainty on this point will remain.