No SPC possible for active ingredient whose effect does not fall within therapeutic indications

PATENT LAW – SPC
 

SPC in principle possible where the active ingredient is covalently bound to other active ingredients which are part of a medicinal product

"28. that Articles 1(b) and 3(a) of Regulation No 469/2009 must be interpreted as not precluding, in principle, 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."

No SPC possible for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation

"39. that Article 3(b) of Regulation No 469/2009 must be interpreted as precluding the grant of an SPC for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation."

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 marketing authorisation

"54. that Article 1(b) of Regulation No 469/2009 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’ within the meaning of that provision 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 marketing authorisation, a matter which it is for the referring court to determine, in the light of all the facts of the dispute in the main proceedings."

IPPT20150115, CJEU, Forsgren v Patentamt

C613/13 - ECLI:EU:C:2015:13