- Court of Justice holds SPCs cannot be granted for new formulations of known active ingredients (Abraxis Bioscience v Comptroller General of Patents)
- What are the practical implications of this case?
- What was the background?
- What did the court decide?
- Case details
Life sciences analysis: this Court of Justice judgment concerns a referral by the Patents Court of England & Wales on the interpretation of Article 3(d) of Regulation (EC) 469/2009, the supplementary protection certificate (SPC) Regulation. Article 3(d) precludes the grant of SPCs where the marketing authorisation (MA) relied upon in support of the SPC application is not the first MA for the active ingredient or combination of active ingredients. The Court of Justice held that an MA to cover a new and inventive formulation of a previously authorised active ingredient cannot be regarded as being the first MA for the purposes of the Article 3(d) of the SPC Regulation. Consequently, an SPC cannot be granted on the basis of an MA for a new formulation of an old active ingredient, and this remains the case even if the new formulation increases the efficacy of the active ingredient.
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