More Drama For Combination SPCs

The stage is set for another referral to the Court of Justice of the EU (CJEU) on the eligibility criteria for Supplementary Protection Certificates (SPCs) for "combination products" - those comprising two or more active ingredients.

It is common for innovators to develop a medicinal product with a single active ingredient and subsequently obtain authorisation for combination products comprising the single active ingredient and one or more additional active ingredients. These are sometimes described together in the same granted patent and innovators have tried to obtain separate SPCs for the respective single and combination products.

THE PROLOGUE

Under Article 1(b) SPC Regulation, a "product" is defined as the active ingredient or combination of active ingredients of a medicinal product. The literal wording of Article 3(c) SPC Regulation requires that "product" to not have already been the subject of an SPC.