The request was
put to the Court of Justice within the following factual framework:
- A dispute arose
between the Austrian Patent Office and the owner of a European patent relating
to Protein D.
- Protein D is
present in a pneumococcal
vaccine for paediatric use called Synflorix, for which the necessary marketing
authorization (MA) had been obtained.
- Protein D is
not contained as such in
Synflorix, but is covalently bonded to other active ingredients.
- Aside from being part
of that covalent bond, Protein D has
a therapeutic effect of its own as a vaccine against the Haemophilus influenzae
bacterium. However, the Synflorix MA describes Protein D only as a carrier and
makes no specific reference to that therapeutic effect.
In response to the questions raised by
the Austrian referring court, the Court of Justice states:
- First, the
Community Regulation does not preclude the
possibility that an active ingredient can give rise to the grant of an SPC
where the active ingredient is covalently bound to other active ingredients
which are part of a medicinal product.
- Second, the Regulation
does, on the other hand, preclude the grant of an SPC for an active ingredient
whose effect does not fall within the therapeutic indications covered by the
wording of the MA. The CJEU reasons that, since no trial or data concerning the
therapeutic effects of Protein D against Haemophilus
influenzae was integrated
into the marketing authorisation procedure, that procedure could not have
delayed the commercial use of the basic patent. In such circumstances, the
grant of an SPC would have been contrary to the aim pursued by the Regulation,
which is to offset, at least in part, the delay to the commercial use of a
patented invention on account of the time needed for the first MA in the
European Union to be granted.
- Third, the Regulation must be interpreted as meaning that a
carrier protein conjugated with a polysaccharide antigen by means of a covalent
binding may be categorised as an active ingredient only if it is established
that it produces a pharmacological, immunological or metabolic action of its
own which is covered by the therapeutic indications of the MA. That is a matter
for the referring court to determine in the light of all the circumstances of
the case.
In the second and
third replies the CJEU rejects the contentions of the applicant for the SPC
with respect to Protein D and upholds the views taken by the European
Commission.
Author: Enrique Armijo Chávarri
