When an Excipient is Not an Active Ingredient: the Halozyme Opinion and the Future of SPC Strategy in Europe
by Mario Pozzi, Partner and Paolo Di Giovine, Partner of SIB Società Italiana Brevetti
The pending Halozyme case before the Court of Justice of the European Union (“CJEU”) may soon provide another important clarification about the interpretation of the Regulation (EC), on the Supplementary Protection Certificates (“SPCs”) for medicinal products in Europe.
In particular, the case concerns the interpretation of Article 1(b) of Regulation (EC) No. 469/2009, which defines a “product” as “the active ingredient or combination of active ingredients of a medicinal product”.
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